Postmortem diagnosis and toxicological validation of illicit substance use

PubMed Central

Lehrmann, E; Afanador, ZR; Deep-Soboslay, A; Gallegos, G; Darwin, WD; Lowe, RH; Barnes, AJ; Huestis, MA; Cadet, JL; Herman, MM; Hyde, TM; Kleinman, JE; Freed, WJ

2008-01-01

The present study examines the diagnostic challenges of identifying ante-mortem illicit substance use in human postmortem cases. Substance use, assessed by clinical case history reviews, structured next-of-kin interviews, by general toxicology of blood, urine, and/or brain, and by scalp hair testing, identified 33 cocaine, 29 cannabis, 10 phencyclidine and 9 opioid cases. Case history identified 42% cocaine, 76% cannabis, 10% phencyclidine, and 33% opioid cases. Next-of-kin interviews identified almost twice as many cocaine and cannabis cases as Medical Examiner (ME) case histories, and were crucial in establishing a detailed lifetime substance use history. Toxicology identified 91% cocaine, 68% cannabis, 80% phencyclidine, and 100% opioid cases, with hair testing increasing detection for all drug classes. A cocaine or cannabis use history was corroborated by general toxicology with 50% and 32% sensitivity, respectively, and with 82% and 64% sensitivity by hair testing. Hair testing corroborated a positive general toxicology for cocaine and cannabis with 91% and 100% sensitivity, respectively. Case history corroborated hair toxicology with 38% sensitivity for cocaine and 79% sensitivity for cannabis, suggesting that both case history and general toxicology underestimated cocaine use. Identifying ante-mortem substance use in human postmortem cases are key considerations in case diagnosis and for characterization of disorder-specific changes in neurobiology. The sensitivity and specificity of substance use assessments increased when ME case history was supplemented with structured next-of-kin interviews to establish a detailed lifetime substance use history, while comprehensive toxicology, and hair testing in particular, increased detection of recent illicit substance use. PMID:18201295

Hantavirus pulmonary syndrome clinical findings: evaluating a surveillance case definition.

PubMed

Knust, Barbara; Macneil, Adam; Rollin, Pierre E

2012-05-01

Clinical cases of hantavirus pulmonary syndrome (HPS) can be challenging to differentiate from other acute respiratory diseases, which can lead to delays in diagnosis, treatment, and disease reporting. Rapid onset of severe disease occurs, at times before diagnostic test results are available. This study's objective was to examine the clinical characteristics of patients that would indicate HPS to aid in detection and reporting. Test results of blood samples from U.S. patients suspected of having HPS submitted to the Centers for Disease Control and Prevention from 1998-2010 were reviewed. Patient information collected by case report forms was compared between HPS-confirmed and test-negative patients. Diagnostic sensitivity, specificity, predictive values, and likelihood ratios were calculated for individual clinical findings and combinations of variables. Of 567 patients included, 36% were HPS-confirmed. Thrombocytopenia, chest x-rays with suggestive signs, and receiving supplemental oxygenation were highly sensitive (>95%), while elevated hematocrit was highly specific (83%) in detecting HPS. Combinations that maximized sensitivity required the presence of thrombocytopenia. Using a national sample of suspect patients, we found that thrombocytopenia was a highly sensitive indicator of HPS and should be included in surveillance definitions for suspected HPS. Using a sensitive suspect case definition to identify potential HPS patients that are confirmed by highly specific diagnostic testing will ensure accurate reporting of this disease.

Rapid detection of pandemic influenza in the presence of seasonal influenza

PubMed Central

2010-01-01

Background Key to the control of pandemic influenza are surveillance systems that raise alarms rapidly and sensitively. In addition, they must minimise false alarms during a normal influenza season. We develop a method that uses historical syndromic influenza data from the existing surveillance system 'SERVIS' (Scottish Enhanced Respiratory Virus Infection Surveillance) for influenza-like illness (ILI) in Scotland. Methods We develop an algorithm based on the weekly case ratio (WCR) of reported ILI cases to generate an alarm for pandemic influenza. From the seasonal influenza data from 13 Scottish health boards, we estimate the joint probability distribution of the country-level WCR and the number of health boards showing synchronous increases in reported influenza cases over the previous week. Pandemic cases are sampled with various case reporting rates from simulated pandemic influenza infections and overlaid with seasonal SERVIS data from 2001 to 2007. Using this combined time series we test our method for speed of detection, sensitivity and specificity. Also, the 2008-09 SERVIS ILI cases are used for testing detection performances of the three methods with a real pandemic data. Results We compare our method, based on our simulation study, to the moving-average Cumulative Sums (Mov-Avg Cusum) and ILI rate threshold methods and find it to be more sensitive and rapid. For 1% case reporting and detection specificity of 95%, our method is 100% sensitive and has median detection time (MDT) of 4 weeks while the Mov-Avg Cusum and ILI rate threshold methods are, respectively, 97% and 100% sensitive with MDT of 5 weeks. At 99% specificity, our method remains 100% sensitive with MDT of 5 weeks. Although the threshold method maintains its sensitivity of 100% with MDT of 5 weeks, sensitivity of Mov-Avg Cusum declines to 92% with increased MDT of 6 weeks. For a two-fold decrease in the case reporting rate (0.5%) and 99% specificity, the WCR and threshold methods, respectively, have MDT of 5 and 6 weeks with both having sensitivity close to 100% while the Mov-Avg Cusum method can only manage sensitivity of 77% with MDT of 6 weeks. However, the WCR and Mov-Avg Cusum methods outperform the ILI threshold method by 1 week in retrospective detection of the 2009 pandemic in Scotland. Conclusions While computationally and statistically simple to implement, the WCR algorithm is capable of raising alarms, rapidly and sensitively, for influenza pandemics against a background of seasonal influenza. Although the algorithm was developed using the SERVIS data, it has the capacity to be used at other geographic scales and for different disease systems where buying some early extra time is critical. PMID:21106071

Challenges in congenital syphilis surveillance: how are congenital syphilis investigations classified?

PubMed

Introcaso, Camille E; Gruber, DeAnn; Bradley, Heather; Peterman, Thomas A; Ewell, Joy; Wendell, Debbie; Foxhood, Joseph; Su, John R; Weinstock, Hillard S; Markowitz, Lauri E

2013-09-01

Congenital syphilis is a serious, preventable, and nationally notifiable disease. Despite the existence of a surveillance case definition, congenital syphilis is sometimes classified differently using an algorithm on the Centers for Disease Control and Prevention's case reporting form. We reviewed Louisiana's congenital syphilis electronic reporting system for investigations of infants born from January 2010 to October 2011, abstracted data required for classification, and applied the surveillance definition and the algorithm. We calculated the sensitivities and specificities of the algorithm and Louisiana's classification using the surveillance definition as the surveillance gold standard. Among 349 congenital syphilis investigations, the surveillance definition identified 62 cases. The algorithm had a sensitivity of 91.9% and a specificity of 64.1%. Louisiana's classification had a sensitivity of 50% and a specificity of 91.3% compared with the surveillance definition. The differences between the algorithm and the surveillance definition led to misclassification of congenital syphilis cases. The algorithm should match the surveillance definition. Other state and local health departments should assure that their reported cases meet the surveillance definition.

Comparative study of dot enzyme immunoassay (Typhidot-M) and Widal test in the diagnosis of typhoid fever.

PubMed

Narayanappa, D; Sripathi, Rachana; Jagdishkumar, K; Rajani, H S

2010-04-01

We compared the sensitivity and specificity of Typhidot-M and Widal test with blood culture (gold standard) for diagnosing typhoid fever in 105 children aged 1-15 years admitted with clinical suspicion of typhoid fever. Of the 105 cases, blood culture was positive for S.typhi in 41 (39%) children, Widal test was positive in 48 (45.7%) and Typhidot-M was positive in 78 (74.3%) cases. Sensitivity and specificity of Typhidot-M was 92.6% and 37.5% while sensitivity and specificity of Widal test was 34.1% and 42.8%, respectively. In children with fever of less than 7 days duration, Typhidot-M was positive in 97%, compared to 24.2% by Widal test. Typhidot-M is a simple and sensitive test for early diagnosis of typhoid fever in children.

Clinical case definition for the diagnosis of acute intussusception.

PubMed

Bines, Julie E; Ivanoff, Bernard; Justice, Frances; Mulholland, Kim

2004-11-01

Because of the reported association between intussusception and a rotavirus vaccine, future clinical trials of rotavirus vaccines will need to include intussusception surveillance in the evaluation of vaccine safety. The aim of this study is to develop and validate a clinical case definition for the diagnosis of acute intussusception. A clinical case definition for the diagnosis of acute intussusception was developed by analysis of an extensive literature review that defined the clinical presentation of intussusception in 70 developed and developing countries. The clinical case definition was then assessed for sensitivity and specificity using a retrospective chart review of hospital admissions. Sensitivity of the clinical case definition was assessed in children diagnosed with intussusception over a 6.5-year period. Specificity was assessed in patients aged <2 years admitted with bowel obstruction and in patients aged <19 years presenting with symptoms that may occur in intussusception. The clinical case definition accurately identified 185 of 191 assessable cases as "probable" intussusception and six cases as "possible" intussusception (sensitivity, 97%). No case of radiologic or surgically proven intussusception failed to be identified by the clinical case definition. The specificity of the definition in correctly identifying patients who did not have intussusception ranged from 87% to 91%. The clinical case definition for intussusception may assist in the prompt identification of patients with intussusception and may provide an important tool for the future trials of enteric vaccines.

Evaluation of the WHO clinical case definition for pediatric HIV infection in Bloemfontein, South Africa.

PubMed

van Gend, Christine L; Haadsma, Maaike L; Sauer, Pieter J J; Schoeman, Cornelius J

2003-06-01

The WHO clinical case definition for pediatric HIV infection has been designed to be used in countries where diagnostic laboratory resources are limited. We evaluated the WHO case definition to determine whether it is a useful instrument to discriminate between HIV-positive and HIV-negative children. In addition, clinical features not included in this case definition were recorded. We recorded clinical data from 300 consecutively admitted children in a state hospital in Bloemfontein, South Africa, and tested these children for HIV infection. A total of 222 children were included in the study; 69 children (31.1 per cent) were HIV positive. The sensitivity of the WHO case definition in this study was 14.5 per cent, the specificity was 98.6 per cent. Apart from weight loss and generalized dermatitis, the signs of the WHO case definition were significantly more often seen in HIV-positive than in HIV-negative children. Of the clinical signs not included in the WHO case definition, marasmus and hepatosplenomegaly especially occurred more frequently in HIV-positive children. Based on these findings we composed a new case definition consisting of four signs: marasmus, hepatosplenomegaly, oropharyngeal candidiasis, and generalized lymphadenopathy. HIV infection is suspected in a child presenting with at least two of these four signs. The sensitivity of this case definition was 63.2 per cent, the specificity was 96.0 per cent. We conclude that in this study the WHO case definition was not a useful instrument to discriminate between HIV-positive and HIV-negative children, mainly because its sensitivity was strikingly low. The simplified case definition we propose, proved to be more sensitive than the WHO case definition (63.2 vs. 14.5 per cent), whilst its specificity remained high.

Comparison of next-generation sequencing mutation profiling with BRAF and IDH1 mutation-specific immunohistochemistry.

PubMed

Jabbar, Kausar J; Luthra, Rajalakshmi; Patel, Keyur P; Singh, Rajesh R; Goswami, Rashmi; Aldape, Ken D; Medeiros, L Jeffrey; Routbort, Mark J

2015-04-01

Mutation-specific antibodies for BRAF V600E and IDH1 R132H offer convenient immunohistochemical (IHC) assays to detect these mutations in tumors. Previous studies using these antibodies have shown high sensitivity and specificity, but use in routine diagnosis with qualitative assessment has not been well studied. In this retrospective study, we reviewed BRAF and IDH1 mutation-specific IHC results compared with separately obtained clinical next-generation sequencing results. For 67 tumors with combined IDH1 IHC and mutation data, IHC was unequivocally reported as positive or negative in all cases. Sensitivity of IHC for IDH1 R132H was 98% and specificity was 100% compared with mutation status. Four IHC-negative samples showed non-R132H IDH1 mutations including R132C, R132G, and P127T. For 128 tumors with combined BRAF IHC and mutation data, IHC was positive in 33, negative in 82, and equivocal in 13 tumors. The sensitivity of IHC was 97% and specificity was 99% when including only unequivocally positive or negative results. If equivocal IHC cases were included in the analysis as negative, sensitivity fell to 81%. If equivocal cases were classified as positive, specificity dropped to 91%. Eight IHC-negative samples showed non-V600E BRAF mutations including V600K, N581I, V600M, and K601E. We conclude that IHC for BRAF V600E and IDH1 R132H is relatively sensitive and specific, but there is a discordance rate that is not trivial. In addition, a significant proportion of patients harbor BRAF non-V600E or IDH1 non-R132H mutations not detectable by IHC, potentially limiting utility of IHC screening for BRAF and IDH1 mutations.

Evaluation of Visual Field Progression in Glaucoma: Quasar Regression Program and Event Analysis.

PubMed

Díaz-Alemán, Valentín T; González-Hernández, Marta; Perera-Sanz, Daniel; Armas-Domínguez, Karintia

2016-01-01

To determine the sensitivity, specificity and agreement between the Quasar program, glaucoma progression analysis (GPA II) event analysis and expert opinion in the detection of glaucomatous progression. The Quasar program is based on linear regression analysis of both mean defect (MD) and pattern standard deviation (PSD). Each series of visual fields was evaluated by three methods; Quasar, GPA II and four experts. The sensitivity, specificity and agreement (kappa) for each method was calculated, using expert opinion as the reference standard. The study included 439 SITA Standard visual fields of 56 eyes of 42 patients, with a mean of 7.8 ± 0.8 visual fields per eye. When suspected cases of progression were considered stable, sensitivity and specificity of Quasar, GPA II and the experts were 86.6% and 70.7%, 26.6% and 95.1%, and 86.6% and 92.6% respectively. When suspected cases of progression were considered as progressing, sensitivity and specificity of Quasar, GPA II and the experts were 79.1% and 81.2%, 45.8% and 90.6%, and 85.4% and 90.6% respectively. The agreement between Quasar and GPA II when suspected cases were considered stable or progressing was 0.03 and 0.28 respectively. The degree of agreement between Quasar and the experts when suspected cases were considered stable or progressing was 0.472 and 0.507. The degree of agreement between GPA II and the experts when suspected cases were considered stable or progressing was 0.262 and 0.342. The combination of MD and PSD regression analysis in the Quasar program showed better agreement with the experts and higher sensitivity than GPA II.

Diagnostic performance of contrast-enhanced spectral mammography: Systematic review and meta-analysis.

PubMed

Tagliafico, Alberto Stefano; Bignotti, Bianca; Rossi, Federica; Signori, Alessio; Sormani, Maria Pia; Valdora, Francesca; Calabrese, Massimo; Houssami, Nehmat

2016-08-01

To estimate sensitivity and specificity of CESM for breast cancer diagnosis. Systematic review and meta-analysis of the accuracy of CESM in finding breast cancer in highly selected women. We estimated summary receiver operating characteristic curves, sensitivity and specificity according to quality criteria with QUADAS-2. Six hundred four studies were retrieved, 8 of these reporting on 920 patients with 994 lesions, were eligible for inclusion. Estimated sensitivity from all studies was: 0.98 (95% CI: 0.96-1.00). Specificity was estimated from six studies reporting raw data: 0.58 (95% CI: 0.38-0.77). The majority of studies were scored as at high risk of bias due to the very selected populations. CESM has a high sensitivity but very low specificity. The source studies were based on highly selected case series and prone to selection bias. High-quality studies are required to assess the accuracy of CESM in unselected cases. Copyright © 2016 Elsevier Ltd. All rights reserved.

The ClASsification for Psoriatic ARthritis (CASPAR) criteria--a retrospective feasibility, sensitivity, and specificity study.

PubMed

Tillett, William; Costa, Luisa; Jadon, Deepak; Wallis, Dinny; Cavill, Charlotte; McHugh, Jessica; Korendowych, Eleanor; McHugh, Neil

2012-01-01

To evaluate the sensitivity, specificity, and feasibility of the ClASsification criteria for Psoriatic ARthritis (CASPAR) to retrospectively classify an existing research cohort. In total, 480 patient records were reviewed from the Royal National Hospital for Rheumatic Diseases Psoriatic Arthritis (PsA) cohort and for 100 consecutive controls with inflammatory arthritis from a general rheumatology clinic. The CASPAR score was modified for retrospective use; both "inflammation" and "current psoriasis" were recorded as present if they had ever been confirmed in the rheumatology clinic. Sensitivity and specificity of the CASPAR criteria were compared with expert clinical diagnosis. A total of 480 database records were identified. Nine sets of records had been lost or destroyed. The diagnoses had changed in 15 cases, which were transferred to the control arm, leaving 456 patients with an expert diagnosis of PsA. Of 115 controls, 96 had rheumatoid arthritis, 5 osteoarthritis, 3 reactive arthritis, 3 seronegative arthritis, 3 undifferentiated arthralgia, 2 ankylosing spondylitis, 1 spondyloarthritis, and 2 systemic sclerosis. Sensitivity (99.7%) and specificity (99.1%) were both high and equivalent to previous reports. Sensitivity remained high even after inclusion of 7 PsA patients with insufficient data to complete the CASPAR assessment (sensitivity 98.2%, specificity 99.1%). The criteria were found to be easy and practical to apply to case records. Our study demonstrates that the feasibility, specificity, and sensitivity of the CASPAR are maintained when adapted for retrospective use to classify an established research cohort.

Effects of imperfect test sensitivity and specificity on observational studies of influenza vaccine effectiveness.

PubMed

Jackson, Michael L; Rothman, Kenneth J

2015-03-10

The recently developed test-negative design is now standard for observational studies of influenza vaccine effectiveness (VE). It is unclear how influenza test misclassification biases test-negative VE estimates relative to VE estimates from traditional cohort or case-control studies. We simulated populations whose members may develop acute respiratory illness (ARI) due to influenza and to non-influenza pathogens. In these simulations, vaccination reduces the risk of influenza but not of non-influenza ARI. Influenza test sensitivity and specificity, risks of influenza and non-influenza ARI, and VE were varied across the simulations. In each simulation, we estimated influenza VE using a cohort design, a case-control design, and a test-negative design. In the absence of influenza test misclassification, all three designs accurately estimated influenza VE. In the presence of misclassification, all three designs underestimated VE. Bias in VE estimates was slightly greater in the test-negative design than in cohort or case-control designs. Assuming the use of highly sensitive and specific reverse-transcriptase polymerase chain reaction tests for influenza, bias in the test-negative studies was trivial across a wide range of realistic values for VE. Although influenza test misclassification causes more bias in test-negative studies than in traditional cohort or case-control studies, the difference is trivial for realistic combinations of attack rates, test sensitivity/specificity, and VE. Copyright © 2015 Elsevier Ltd. All rights reserved.

Allergy to cow's milk proteins: what contribution does hypersensitivity in skin tests have to this diagnosis?

PubMed

Costa, Aldo José Fernandes; Sarinho, Emanuel Sávio Cavalcanti; Motta, Maria Eugênia Farias Almeida; Gomes, Priscila Nogueira; de Oliveira de Melo, Sabrina Maria; da Silva, Giselia Alves Pontes

2011-02-01

Food allergy is an immunologically mediated adverse reaction to food protein. Cow's milk protein allergy (CMPA) is the most frequent type and is the one that is most difficult to diagnose. This study had the objective of analyzing the accuracy of hypersensitivity and specific IgE skin tests among children with CMPA and predominantly gastrointestinal clinical manifestations. The participants in this study were 192 children aged one and five (median of 2 yr). Among these, 122 underwent open oral challenge to the suspected food. After evaluating the sensitivity, specificity and positive and negative predictive values (respectively, PPV and NPV) of skin and specific IgE tests in relation to the gold standard (open oral challenge); all the children underwent the skin prick test (SPT), specific IgE test and atopy patch test (APT) for cow's milk, eggs, wheat and peanuts and the open oral challenge for the food to which the child was sensitive or had suspected sensitivity. Presence of food allergy was confirmed for 50 children (40.9%). Among these cases, 44/50 (88%) were of allergy to cow's milk protein. Children who presented a positive response to an oral challenge to cow's milk protein were considered to be cases, while the controls were children with negative response. Twenty-two of the 44 cases (50.0%) presented symptoms within the first 4 h after the challenge. The SPT presented 31.8% sensitivity, 90.3% specificity, 66.7% PPV and 68.4% NPV. The APT presented 25.0% sensitivity, 81.9% specificity, 45.8% PPV and 64.1% NPV. The specific IgE test presented, respectively, 20.5%, 88.9%, 52.9% and 64.6%. Despite the operational difficulty and the possible exposure risk, oral challenge is the best method for diagnosing CMPA, because of the low sensitivity and PPV of skin and specific IgE tests. © 2011 John Wiley & Sons A/S.

English-Medium Instruction and Intercultural Sensitivity: A Korean Case Study

ERIC Educational Resources Information Center

Kim, Jeongyeon; Choi, Jinsook; Tatar, Bradley

2017-01-01

This case study examined the reactions of local students to the diversity in student population. Specifically, it investigated how the local students' intercultural sensitivity to the international students is interrelated with their perception of the English-medium instruction (EMI) policy. The quantitative and qualitative analyses of the…

Analysis of 30 breast implant rupture cases.

PubMed

Tark, Kwan Chul; Jeong, Hii Sun; Roh, Tae Suk; Choi, Jong Woo

2005-01-01

Breast implants used for augmentation mammoplasty or breast reconstruction could rupture from various causes such as trauma or spontaneous failure. The objectives of this study were to investigate the relationships between the causes of implant rupture and the degree of capsular contracture, and then to evaluate the relative efficacies of specific signs on magnetic resonance imaging (MRI) known to be beneficial for diagnosing the rupture. A retrospective review identified patients with prosthetic implant rupture or impending rupture treated by the senior author. The 30 cases of implant rupture available for review were classified into two groups: intracapsular and extracapsular ruptures. The 30 cases of breast implant ruptures were analyzed with respect to the clinical symptoms and signs, the causes of rupture, the degree of capsular contracture, and therapeutic plans. Among the 30 cases, 14 patients who had undergone MRI during the diagnostic period were analyzed with respect to the relationships between MRI readings and operative findings. Spontaneous rupture of membranes was most common (80%), followed by failure because of trauma (7%) and valve or implant base (4%). The symptoms during implant rupture were contour deformity, palpated mass-like lesions, pain, and focal inflammation. According to the analysis of specific MRI signs, the sensitivity and specificity of the linguine sign were 87% and 100%, respectively, for intracapsular rupture. For extracapsular rupture, the sensitivity and specificity of the linguine sign were, respectively, 67% and 75%. The sensitivity and specificity of the rat-tail sign and tear drop sign were 14% and 50%, respectively. Breast implant rupture was correlated with the degree of capsular contracture in our study. Among the various specific MRI signs used in diagnosing the rupture, the linguine sign was reliable and had a high sensitivity and specificity, especially in cases of intracapsular rupture. On the other hand, the rat-tail and tear drop signs were nonspecific signs for diagnosing the rupture of breast implant.

Sensitivity and Specificity of Interictal EEG-fMRI for Detecting the Ictal Onset Zone at Different Statistical Thresholds

PubMed Central

Tousseyn, Simon; Dupont, Patrick; Goffin, Karolien; Sunaert, Stefan; Van Paesschen, Wim

2014-01-01

There is currently a lack of knowledge about electroencephalography (EEG)-functional magnetic resonance imaging (fMRI) specificity. Our aim was to define sensitivity and specificity of blood oxygen level dependent (BOLD) responses to interictal epileptic spikes during EEG-fMRI for detecting the ictal onset zone (IOZ). We studied 21 refractory focal epilepsy patients who had a well-defined IOZ after a full presurgical evaluation and interictal spikes during EEG-fMRI. Areas of spike-related BOLD changes overlapping the IOZ in patients were considered as true positives; if no overlap was found, they were treated as false-negatives. Matched healthy case-controls had undergone similar EEG-fMRI in order to determine true-negative and false-positive fractions. The spike-related regressor of the patient was used in the design matrix of the healthy case-control. Suprathreshold BOLD changes in the brain of controls were considered as false positives, absence of these changes as true negatives. Sensitivity and specificity were calculated for different statistical thresholds at the voxel level combined with different cluster size thresholds and represented in receiver operating characteristic (ROC)-curves. Additionally, we calculated the ROC-curves based on the cluster containing the maximal significant activation. We achieved a combination of 100% specificity and 62% sensitivity, using a Z-threshold in the interval 3.4–3.5 and cluster size threshold of 350 voxels. We could obtain higher sensitivity at the expense of specificity. Similar performance was found when using the cluster containing the maximal significant activation. Our data provide a guideline for different EEG-fMRI settings with their respective sensitivity and specificity for detecting the IOZ. The unique cluster containing the maximal significant BOLD activation was a sensitive and specific marker of the IOZ. PMID:25101049

Uniform research case definition criteria differentiate tuberculous and bacterial meningitis in children.

PubMed

Solomons, Regan S; Wessels, Marie; Visser, Douwe H; Donald, Peter R; Marais, Ben J; Schoeman, Johan F; van Furth, Anne M

2014-12-01

Tuberculous meningitis (TBM) research is hampered by low numbers of microbiologically confirmed TBM cases and the fact that they may represent a select part of the disease spectrum. A uniform TBM research case definition was developed to address these limitations, but its ability to differentiate TBM from bacterial meningitis has not been evaluated. We assessed all children treated for TBM from 1985 to 2005 at Tygerberg Children's Hospital, Cape Town, South Africa. For comparative purposes, a group of children with culture-confirmed bacterial meningitis, diagnosed between 2003 and 2009, was identified from the National Health Laboratory Service database. The performance of the proposed case definition was evaluated in culture-confirmed TBM and bacterial meningitis cases. Of 554 children treated for TBM, 66 (11.9%) were classified as "definite TBM," 408 (73.6%) as "probable TBM," and 72 (13.0%) as "possible TBM." "Probable TBM" criteria identified culture-confirmed TBM with a sensitivity of 86% and specificity of 100%; sensitivity was increased but specificity reduced when using "possible TBM" criteria (sensitivity 100%, specificity 56%). "Probable TBM" criteria accurately differentiated TBM from bacterial meningitis and could be considered for use in clinical trials; reduced sensitivity in children with early TBM (stage 1 disease) remains a concern. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A guide to unclassified sensitive information protection

DOE Office of Scientific and Technical Information (OSTI.GOV)

Donahue, S.C.

1996-11-14

This document is a reference guide for CIC-Division employees who lead or participate in projects that use and/or produce unclassified sensitive information. It is intended for use on a case by case basis to develop project specific sensitive information handling procedures and standards. It contains criteria for identifying sensitive information and determining levels of sensitivity, and describes cost effective measures for protecting various levels of sensitive information. The goal of this document is to help establish good business practices that benefit both the Laboratory and its customers. Division personnel are encouraged to apply these guidelines.

Skin Sensitizing Potency of Halogenated Platinum Salts.

EPA Science Inventory

The relationship between occupational exposure to halogenated platinum (Pt) salts and Pt-specific allergic sensitization is well-established. Although human case reports and clinical studies demonstrate that Pt salts are potent skin sensitizers, no studies have been published tha...

Identification of women at risk of depression in pregnancy: using women's accounts to understand the poor specificity of the Whooley and Arroll case finding questions in clinical practice.

PubMed

Darwin, Zoe; McGowan, Linda; Edozien, Leroy C

2016-02-01

Antenatal mental health assessment is increasingly common in high-income countries. Despite lacking evidence on validation or acceptability, the Whooley questions (modified PHQ-2) and Arroll 'help' question are used in the UK at booking (the first formal antenatal appointment) to identify possible cases of depression. This study investigated validation of the questions and women's views on assessment. Women (n = 191) booking at an inner-city hospital completed the Whooley and Arroll questions as part of their routine clinical care then completed a research questionnaire containing the Edinburgh postnatal depression scale (EPDS). A purposive subsample (n = 22) were subsequently interviewed. The Whooley questions 'missed' half the possible cases identified using the EPDS (EPDS threshold ≥ 10: sensitivity 45.7 %, specificity 92.1 %; ≥ 13: sensitivity 47.8 %, specificity 86.1 %), worsening to nine in ten when adopting the Arroll item (EPDS ≥ 10: sensitivity 9.1 %, specificity 98.2 %; ≥ 13: sensitivity 9.5 %, specificity 97.1 %). Women's accounts indicated that under-disclosure relates to the context of assessment and perceived relevance of depression to maternity services. Depression symptoms are under-identified in current local practice. While validated tools are needed that can be readily applied in routine maternity care, psychometric properties will be influenced by the context of disclosure when implemented in practice.

Glaucoma progression detection: agreement, sensitivity, and specificity of expert visual field evaluation, event analysis, and trend analysis.

PubMed

Antón, Alfonso; Pazos, Marta; Martín, Belén; Navero, José Manuel; Ayala, Miriam Eleonora; Castany, Marta; Martínez, Patricia; Bardavío, Javier

2013-01-01

To assess sensitivity, specificity, and agreement among automated event analysis, automated trend analysis, and expert evaluation to detect glaucoma progression. This was a prospective study that included 37 eyes with a follow-up of 36 months. All had glaucomatous disks and fields and performed reliable visual fields every 6 months. Each series of fields was assessed with 3 different methods: subjective assessment by 2 independent teams of glaucoma experts, glaucoma/guided progression analysis (GPA) event analysis, and GPA (visual field index-based) trend analysis. Kappa agreement coefficient between methods and sensitivity and specificity for each method using expert opinion as gold standard were calculated. The incidence of glaucoma progression was 16% to 18% in 3 years but only 3 cases showed progression with all 3 methods. Kappa agreement coefficient was high (k=0.82) between subjective expert assessment and GPA event analysis, and only moderate between these two and GPA trend analysis (k=0.57). Sensitivity and specificity for GPA event and GPA trend analysis were 71% and 96%, and 57% and 93%, respectively. The 3 methods detected similar numbers of progressing cases. The GPA event analysis and expert subjective assessment showed high agreement between them and moderate agreement with GPA trend analysis. In a period of 3 years, both methods of GPA analysis offered high specificity, event analysis showed 83% sensitivity, and trend analysis had a 66% sensitivity.

Multimodal intraoperative neuromonitoring in corrective surgery for adolescent idiopathic scoliosis: Evaluation of 354 consecutive cases

PubMed Central

Kundnani, Vishal K; Zhu, Lisa; Tak, HH; Wong, HK

2010-01-01

Background: Multimodal intraoperative neuromonitoring is recommended during corrective spinal surgery, and has been widely used in surgery for spinal deformity with successful outcomes. Despite successful outcomes of corrective surgery due to increased safety of the patients with the usage of spinal cord monitoring in many large spine centers, this modality has not yet achieved widespread popularity. We report the analysis of prospectively collected intraoperative neurophysiological monitoring data of 354 consecutive patients undergoing corrective surgery for adolescent idiopathic scoliosis (AIS) to establish the efficacy of multimodal neuromonitoring and to evaluate comparative sensitivity and specificity. Materials and Methods: The study group consisted of 354 (female = 309; male = 45) patients undergoing spinal deformity corrective surgery between 2004 and 2008. Patients were monitored using electrophysiological methods including somatosensory-evoked potentials and motor-evoked potentials simultaneously. Results: Mean age of patients was 13.6 years (±2.3 years). The operative procedures involved were instrumented fusion of the thoracic/lumbar/both curves, Baseline somatosensory-evoked potentials (SSEP) and neurogenic motor-evoked potentials (NMEP) were recorded successfully in all cases. Thirteen cases expressed significant alert to prompt reversal of intervention. All these 13 cases with significant alert had detectable NMEP alerts, whereas significant SSEP alert was detected in 8 cases. Two patients awoke with new neurological deficit (0.56%) and had significant intraoperative SSEP + NMEP alerts. There were no false positives with SSEP (high specificity) but 5 patients with false negatives with SSEP (38%) reduced its sensitivity. There was no false negative with NMEP but 2 of 13 cases were false positive with NMEP (15%). The specificity of SSEP (100%) is higher than NMEP (96%); however, the sensitivity of NMEP (100%) is far better than SSEP (51%). Due to these results, the overall sensitivity, specificity and positive predictive value of combined multimodality neuromonitoring in this adult deformity series was 100, 98.5 and 85%, respectively. Conclusion: Neurogenic motor-evoked potential (NMEP) monitoring appears to be superior to conventional SSEP monitoring for identifying evolving spinal cord injury. Used in conjunction, the sensitivity and specificity of combined neuromonitoring may reach up to 100%. Multimodality monitoring with SSEP + NMEP should be the standard of care. PMID:20165679

Chronic pesticide poisoning from persistent low-dose exposures in Ecuadorean floriculture workers: toward validating a low-cost test battery.

PubMed

Breilh, Jaime; Pagliccia, Nino; Yassi, Annalee

2012-01-01

Chronic pesticide poisoning is difficult to detect. We sought to develop a low-cost test battery for settings such as Ecuador's floriculture industry. First we had to develop a case definition; as with all occupational diseases a case had to have both sufficient effective dose and associated health effects. For the former, using canonical discriminant analysis, we found that adding measures of protection and overall environmental stressors to occupational category and duration of exposure was useful. For the latter, factor analysis suggested three distinct manifestations of pesticide poisoning. We then determined sensitivity and specificity of various combinations of symptoms and simple neurotoxicity tests from the Pentox questionnaire, and found that doing so increased sensitivity and specificity compared to use of acethylcholinesterase alone--the current screening standard. While sensitivity and specificity varied with different case definitions, our results support the development of a low-cost test battery for screening in such settings.

Detection of Albumin Expression by RNA In Situ Hybridization Is a Sensitive and Specific Method for Identification of Hepatocellular Carcinomas and Intrahepatic Cholangiocarcinomas.

PubMed

Lin, Fan; Shi, Jianhui; Wang, Hanlin L; Ma, Xiao-Jun; Monroe, Robert; Luo, Yuling; Chen, Zongming; Liu, Haiyan

2018-05-09

Inconsistent data on detection of albumin expression by ribonucleic acid (RNA) in situ hybridization have been reported. We investigated the utility of RNAscope (Advanced Cell Diagnostics, Hayward, CA) in detection of albumin in hepatocellular carcinomas (HCCs), intrahepatic cholangiocarcinomas (ICCs), and carcinomas from various organs using manual and automated staining. RNAscope for albumin detection was performed on 482 cases on tissue microarray sections and on 22 cases of ICC, including 14 surgical resection and eight core biopsy specimens. Thirty-six of 37 (97%) HCCs had detectable mRNA, whereas all non-HCC and non-ICC cases, except one lung adenocarcinoma, were negative for albumin. Fourteen of 22 ICCs (64%) were positive for albumin. RNAscope for albumin is highly sensitive and specific for identifying HCCs and is highly specific and moderately sensitive for detection of ICCs; however, rare carcinomas (non-HCC, non-ICC, and those with no hepatoid histomorphology) can also have aberrant expression of albumin.

Detection of Bacteriuria by Canine Olfaction

PubMed Central

Maurer, Maureen; McCulloch, Michael; Willey, Angel M.; Hirsch, Wendi; Dewey, Danielle

2016-01-01

Background. Urinary tract infections (UTIs) are a significant medical problem , particularly for patients with neurological conditions and the elderly. Detection is often difficult in these patients, resulting in delayed diagnoses and more serious infections such as pyelonephritis and life-threatening sepsis. Many patients have a higher risk of UTIs because of impaired bladder function, catheterization, and lack of symptoms. Urinary tract infections are the most common nosocomial infection; however, better strategies are needed to improve early detection of the disease. Methods. In this double-blinded, case-control, validation study, we obtained fresh urine samples daily in a consecutive case series over a period of 16 weeks. Dogs were trained to distinguish urine samples that were culture-positive for bacteriuria from those of culture-negative controls, using reward-based clicker and treat methods. Results. Samples were obtained from 687 individuals (from 3 months to 92 years of age; 86% female and 14% male; 34% culture-positive and 66% culture-negative controls). Dogs detected urine samples positive for 100 000 colony-forming units/mL Escherichia coli (N = 250 trials; sensitivity 99.6%, specificity 91.5%). Dilution of E coli urine with distilled water did not affect accuracy at 1% (sensitivity 100%, specificity 91.1%) or 0.1% (sensitivity 100%, specificity 93.6%) concentration. Diagnostic accuracy was similar to Enterococcus (n = 50; sensitivity 100%, specificity 93.9%), Klebsiella (n = 50; sensitivity 100%, specificity 95.1%), and Staphylococcus aureus (n = 50; sensitivity 100%, specificity 96.3%). All dogs performed with similarly high accuracy: overall sensitivity was at or near 100%, and specificity was above 90%. Conclusions. Canine scent detection is an accurate and feasible method for detection of bacteriuria. PMID:27186578

Poliomyelitis case confirmation: characteristics for use by national eradication programmes.

PubMed Central

Biellik, R. J.; Bueno, H.; Olive, J. M.; de Quadros, C.

1992-01-01

Highly sensitive case definitions were first introduced by national poliomyelitis eradication programmes to avoid missing true cases of the disease, though false-positive diagnostic errors could still occur owing to low specificity. Extensive data from all 1620 cases of acute, flaccid paralysis reported in Brazil during 1987-88 provided an opportunity to study the characteristics of confirmed poliomyelitis cases and epidemiologically to evaluate potential case definitions that maximized both sensitivity and specificity. Cases that had been confirmed by wild poliomyelitis virus isolation were compared with those that had been rejected (non-polio cases). To guarantee the consistency of clinical, epidemiological and laboratory investigations, only cases less than 10 years of age that had been investigated within 15 days of the onset and with complete laboratory specimens were included. No single practical case definition combining both high sensitivity and high specificity emerged from the study. However, the results showed that poliomyelitis endemic countries with limited resources should give priority to the investigation of cases in less than 5-year-olds, cases with prodromal fever, cases without involvement in all four limbs, cases without progression greater than 3 days after the onset, and cases occurring in areas where poliomyelitis had recently been confirmed. In countries without laboratory resources, cases of acute, flaccid paralysis with initial involvement in one or both lower limbs and residual neurological sequelae at 60 days should be confirmed. Countries that are close to eradication may selectively reject any cases lacking laboratory confirmation, despite adequate specimen collection, if they do not have initial involvement in one or both lower limbs and residual neurological sequelae at 60 days. PMID:1314710

Multi-Country Evaluation of the Sensitivity and Specificity of Two Commercially-Available NS1 ELISA Assays for Dengue Diagnosis

PubMed Central

Guzman, Maria G.; Jaenisch, Thomas; Gaczkowski, Roger; Ty Hang, Vo Thi; Sekaran, Shamala Devi; Kroeger, Axel; Vazquez, Susana; Ruiz, Didye; Martinez, Eric; Mercado, Juan C.; Balmaseda, Angel; Harris, Eva; Dimano, Efren; Leano, Prisca Susan A.; Yoksan, Sutee; Villegas, Elci; Benduzu, Herminia; Villalobos, Iris; Farrar, Jeremy; Simmons, Cameron P.

2010-01-01

Background Early diagnosis of dengue can assist patient triage and management and prevent unnecessary treatments and interventions. Commercially available assays that detect the dengue virus protein NS1 in the plasma/serum of patients offers the possibility of early and rapid diagnosis. Methodology/Principal Findings The sensitivity and specificity of the Pan-E Dengue Early ELISA and the Platelia™ Dengue NS1 Ag assays were compared against a reference diagnosis in 1385 patients in 6 countries in Asia and the Americas. Platelia was more sensitive (66%) than Pan-E (52%) in confirmed dengue cases. Sensitivity varied by geographic region, with both assays generally being more sensitive in patients from SE Asia than the Americas. Both kits were more sensitive for specimens collected within the first few days of illness onset relative to later time points. Pan-E and Platelia were both 100% specific in febrile patients without evidence of acute dengue. In patients with other confirmed diagnoses and healthy blood donors, Platelia was more specific (100%) than Pan-E (90%). For Platelia, when either the NS1 test or the IgM test on the acute sample was positive, the sensitivity versus the reference result was 82% in samples collected in the first four days of fever. NS1 sensitivity was not associated to disease severity (DF or DHF) in the Platelia test, whereas a trend for higher sensitivity in DHF cases was seen in the Pan-E test (however combined with lower overall sensitivity). Conclusions/Significance Collectively, this multi-country study suggests that the best performing NS1 assay (Platelia) had moderate sensitivity (median 64%, range 34–76%) and high specificity (100%) for the diagnosis of dengue. The poor sensitivity of the evaluated assays in some geographical regions suggests further assessments are needed. The combination of NS1 and IgM detection in samples collected in the first few days of fever increased the overall dengue diagnostic sensitivity. PMID:20824173

SVM-based automatic diagnosis method for keratoconus

NASA Astrophysics Data System (ADS)

Gao, Yuhong; Wu, Qiang; Li, Jing; Sun, Jiande; Wan, Wenbo

2017-06-01

Keratoconus is a progressive cornea disease that can lead to serious myopia and astigmatism, or even to corneal transplantation, if it becomes worse. The early detection of keratoconus is extremely important to know and control its condition. In this paper, we propose an automatic diagnosis algorithm for keratoconus to discriminate the normal eyes and keratoconus ones. We select the parameters obtained by Oculyzer as the feature of cornea, which characterize the cornea both directly and indirectly. In our experiment, 289 normal cases and 128 keratoconus cases are divided into training and test sets respectively. Far better than other kernels, the linear kernel of SVM has sensitivity of 94.94% and specificity of 97.87% with all the parameters training in the model. In single parameter experiment of linear kernel, elevation with 92.03% sensitivity and 98.61% specificity and thickness with 97.28% sensitivity and 97.82% specificity showed their good classification abilities. Combining elevation and thickness of the cornea, the proposed method can reach 97.43% sensitivity and 99.19% specificity. The experiments demonstrate that the proposed automatic diagnosis method is feasible and reliable.

Accuracy, Sensitivity and Specificity of Fine Needle Aspiration Biopsy for Salivary Gland Tumors: A Retrospective Study from 2006 to 2011

PubMed

Silva, William P P; Stramandinoli-Zanicotti, Roberta T; Schussel, Juliana L; Ramos, Gyl H A; Ioshi, Sergio O; Sassi, Laurindo M

2016-11-01

Objective: This article concerns evaluation of the sensitivity, specificity and accuracy of FNAB for pre-surgical diagnosis of benign and malignant lesions of major and minor salivary glands of patients treated in the Department of Head and Neck Surgery of Erasto Gartner Hospital. Methods: This retrospective study analyzed medical records from January 2006 to December 2011 from patients with salivary gland lesions who underwent preoperative FNAB and, after surgical excision of the lesion, histopathological examination. Results: The study had a cohort of 130 cases, but 34 cases (26.2%) were considered unsatisfactory regarding cytology analyses. Based on the data, sensitivity was 66.7% (6/9), specificity was 81.6% (71/87), accuracy was 80.2% (77/96), the positive predictive value was 66,7% (6/9) and the negative predictive value was 81.6% (71/87). Conclusion: Despite the high rate of inadequate samples obtained in the FNAB in this study the technique offers high specificity, accuracy and acceptable sensitivity. Creative Commons Attribution License

Adjusting for outcome misclassification: the importance of accounting for case-control sampling and other forms of outcome-related selection.

PubMed

Jurek, Anne M; Maldonado, George; Greenland, Sander

2013-03-01

Special care must be taken when adjusting for outcome misclassification in case-control data. Basic adjustment formulas using either sensitivity and specificity or predictive values (as with external validation data) do not account for the fact that controls are sampled from a much larger pool of potential controls. A parallel problem arises in surveys and cohort studies in which participation or loss is outcome related. We review this problem and provide simple methods to adjust for outcome misclassification in case-control studies, and illustrate the methods in a case-control birth certificate study of cleft lip/palate and maternal cigarette smoking during pregnancy. Adjustment formulas for outcome misclassification that ignore case-control sampling can yield severely biased results. In the data we examined, the magnitude of error caused by not accounting for sampling is small when population sensitivity and specificity are high, but increases as (1) population sensitivity decreases, (2) population specificity decreases, and (3) the magnitude of the differentiality increases. Failing to account for case-control sampling can result in an odds ratio adjusted for outcome misclassification that is either too high or too low. One needs to account for outcome-related selection (such as case-control sampling) when adjusting for outcome misclassification using external information. Copyright © 2013 Elsevier Inc. All rights reserved.

Nested PCR Assay for Eight Pathogens: A Rapid Tool for Diagnosis of Bacterial Meningitis.

PubMed

Bhagchandani, Sharda P; Kubade, Sushant; Nikhare, Priyanka P; Manke, Sonali; Chandak, Nitin H; Kabra, Dinesh; Baheti, Neeraj N; Agrawal, Vijay S; Sarda, Pankaj; Mahajan, Parikshit; Ganjre, Ashish; Purohit, Hemant J; Singh, Lokendra; Taori, Girdhar M; Daginawala, Hatim F; Kashyap, Rajpal S

2016-02-01

Bacterial meningitis is a dreadful infectious disease with a high mortality and morbidity if remained undiagnosed. Traditional diagnostic methods for bacterial meningitis pose a challenge in accurate identification of pathogen, making prognosis difficult. The present study is therefore aimed to design and evaluate a specific and sensitive nested 16S rDNA genus-based polymerase chain reaction (PCR) assay using clinical cerebrospinal fluid (CSF) for rapid diagnosis of eight pathogens causing the disease. The present work was dedicated to development of an in-house genus specific 16S rDNA nested PCR covering pathogens of eight genera responsible for causing bacterial meningitis using newly designed as well as literature based primers for respective genus. A total 150 suspected meningitis CSF obtained from the patients admitted to Central India Institute of Medical Sciences (CIIMS), India during the period from August 2011 to May 2014, were used to evaluate clinical sensitivity and clinical specificity of optimized PCR assays. The analytical sensitivity and specificity of our newly designed genus-specific 16S rDNA PCR were found to be ≥92%. With such a high sensitivity and specificity, our in-house nested PCR was able to give 100% sensitivity in clinically confirmed positive cases and 100% specificity in clinically confirmed negative cases indicating its applicability in clinical diagnosis. Our in-house nested PCR system therefore can diagnose the accurate pathogen causing bacterial meningitis and therefore be useful in selecting a specific treatment line to minimize morbidity. Results are obtained within 24 h and high sensitivity makes this nested PCR assay a rapid and accurate diagnostic tool compared to traditional culture-based methods.

Functional measures developed for clinical populations identified impairment among active workers with upper extremity disorders

PubMed Central

Gardner, Bethany T.; Dale, Ann Marie; Buckner-Petty, Skye; Rachford, Robert; Strickland, Jaime; Kaskutas, Vicki; Evanoff, Bradley

2017-01-01

Purpose Few studies have explored measures of function across a range of health outcomes in a general working population. Using four upper extremity (UE) case definitions from the scientific literature, we described the performance of functional measures of work, activities of daily living, and overall health. Methods A sample of 573 workers completed several functional measures: modified recall versions of the QuickDASH, Levine Functional Status Scale (FSS), DASH Work module (DASH-W), and standard SF-8 physical component score. We determined case status based on four UE case definitions: 1) UE symptoms, 2) UE musculoskeletal disorders (MSD), 3) carpal tunnel syndrome (CTS), and 4) work limitations due to UE symptoms. We calculated effect sizes for each case definition to show the magnitude of the differences that were detected between cases and non-cases for each case definition on each functional measure. Sensitivity and specificity analyses showed how well each measure identified functional impairments across the UE case definitions. Results All measures discriminated between cases and non-cases for each case definition with the largest effect sizes for CTS and work limitations, particularly for the modified FSS and DASH-W measures. Specificity was high and sensitivity was low for outcomes of UE symptoms and UE MSD in all measures. Sensitivity was high for CTS and work limitations. Conclusions Functional measures developed specifically for use in clinical, treatment-seeking populations may identify mild levels of impairment in relatively healthy, active working populations, but measures performed better among workers with CTS or those reporting limitations at work. PMID:26091980

Evaluation of 3D-CPA, HR-HPV, and TCT joint detection on cervical disease screening.

PubMed

Liang, Hui; Fu, Min; Zhou, Jian; Song, Lei

2016-08-01

The application value of three-dimensional color power angiography (3D-CPA), high-risk human papillomavirus (HR-HPV), ThinPrep cytology test (TCT) joint detection on cervical disease screening was investigated. In total, 1,900 patients that were examined in Gynecological and Cervix Clinic of Maternal and Child Care Service Center of Xuzhou from June 2012 to March 2015 were enrolled in the present study. After admission, the patients underwent TCT, HR-HPV and 3D-CPA examinations, and vascular morphology and typing, vascularization index (VI) were recorded. Colposcopic biopsy was performed in patients with a positive outcome of any of the three indices. Pathological diagnosis was taken as the golden standard to assess the sensitivity, specificity, diagnostic rate, and Youden index of the three methods being used independently or jointly. Of the 1,900 patients, 276 cases (14.53%) were HR-HPV-positive, 214 cases (11.26%) were VI-positive and 164 cases (8.63%) were TCT-positive. A total of 418 cases were confirmed with a positive outcome of any of the three indices and a cervical biopsy was obtained. Of the 418 cases, 162 cases (38.75%) were diagnosed with chronic cervicitis, 146 cases with low-level cervical intraepithelial neoplasia (CIN) (34.93%), 104 cases (24.88%) with high level CIN, 6 cases (1.44%) with cervical cancer. Histology more than low level CIN was defined as positive: i) screening results when the three methods were used independently: HPV was confirmed with the highest sensitivity (90.63%), VI with the highest specificity (83.95%), and HPV with the highest diagnostic accuracy (83.73%); ii) screening results under HPV+TCT and HPV+TCT+VI: HPV+TCT+VI was confirmed with the highest sensitivity and specificity: sensitivity (94.53%), specificity (81.48%), diagnosis coincidence rate (89.47%) and the highest Youden index of 0.760; and iii) vascular morphology and grading were significantly different in the early stage cervical carcinoma, high level CIM, and cervicitis groups. In conclusion, the joint detection of 3D-CPA, HR-HPV, and TCT improved the sensitivity and accuracy of cervical disease screening. 3D-CPA technology may therefore be used as an auxiliary screening method for cervical cancer.

Association of C-Reactive Protein With Bacterial and Respiratory Syncytial Virus–Associated Pneumonia Among Children Aged <5 Years in the PERCH Study

PubMed Central

Le, Tham; O’Brien, Katherine L.; Murdoch, David R.; Prosperi, Christine; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Kotloff, Karen L.; Levine, Orin S.; Scott, J. Anthony G.; Thea, Donald M.; Awori, Juliet O.; Baillie, Vicky L.; Cascio, Stephanie; Chuananon, Somchai; DeLuca, Andrea N.; Driscoll, Amanda J.; Ebruke, Bernard E.; Endtz, Hubert P.; Kaewpan, Anek; Kahn, Geoff; Karani, Angela; Karron, Ruth A.; Moore, David P.; Park, Daniel E.; Rahman, Mohammed Ziaur; Salaudeen, Rasheed; Seidenberg, Phil; Somwe, Somwe Wa; Sylla, Mamadou; Tapia, Milagritos D.; Zeger, Scott L.; Deloria Knoll, Maria; Madhi, Shabir A.; O’Brien, Katherine L.; Levine, Orin S.; Knoll, Maria Deloria; Feikin, Daniel R.; DeLuca, Andrea N.; Driscoll, Amanda J.; Fancourt, Nicholas; Fu, Wei; Hammitt, Laura L.; Higdon, Melissa M.; Kagucia, E. Wangeci; Karron, Ruth A.; Li, Mengying; Park, Daniel E.; Prosperi, Christine; Wu, Zhenke; Zeger, Scott L.; Watson, Nora L.; Crawley, Jane; Murdoch, David R.; Brooks, W. Abdullah; Endtz, Hubert P.; Zaman, Khalequ; Goswami, Doli; Hossain, Lokman; Jahan, Yasmin; Ashraf, Hasan; Howie, Stephen R. C.; Ebruke, Bernard E.; Antonio, Martin; McLellan, Jessica; Machuka, Eunice; Shamsul, Arifin; Zaman, Syed M.A.; Mackenzie, Grant; Scott, J. Anthony G.; Awori, Juliet O.; Morpeth, Susan C.; Kamau, Alice; Kazungu, Sidi; Ominde, Micah Silaba; Kotloff, Karen L.; Tapia, Milagritos D.; Sow, Samba O.; Sylla, Mamadou; Tamboura, Boubou; Onwuchekwa, Uma; Kourouma, Nana; Toure, Aliou; Madhi, Shabir A.; Moore, David P.; Adrian, Peter V.; Baillie, Vicky L.; Kuwanda, Locadiah; Mudau, Azwifarwi; Groome, Michelle J.; Mahomed, Nasreen; Baggett, Henry C.; Thamthitiwat, Somsak; Maloney, Susan A.; Bunthi, Charatdao; Rhodes, Julia; Sawatwong, Pongpun; Akarasewi, Pasakorn; Thea, Donald M.; Mwananyanda, Lawrence; Chipeta, James; Seidenberg, Phil; Mwansa, James; Wa Somwe, Somwe; Kwenda, Geoffrey; Anderson, Trevor P.; Mitchell, Joanne

2017-01-01

Abstract Background. Lack of a gold standard for identifying bacterial and viral etiologies of pneumonia has limited evaluation of C-reactive protein (CRP) for identifying bacterial pneumonia. We evaluated the sensitivity and specificity of CRP for identifying bacterial vs respiratory syncytial virus (RSV) pneumonia in the Pneumonia Etiology Research for Child Health (PERCH) multicenter case-control study. Methods. We measured serum CRP levels in cases with World Health Organization–defined severe or very severe pneumonia and a subset of community controls. We evaluated the sensitivity and specificity of elevated CRP for “confirmed” bacterial pneumonia (positive blood culture or positive lung aspirate or pleural fluid culture or polymerase chain reaction [PCR]) compared to “RSV pneumonia” (nasopharyngeal/oropharyngeal or induced sputum PCR-positive without confirmed/suspected bacterial pneumonia). Receiver operating characteristic (ROC) curves were constructed to assess the performance of elevated CRP in distinguishing these cases. Results. Among 601 human immunodeficiency virus (HIV)–negative tested controls, 3% had CRP ≥40 mg/L. Among 119 HIV-negative cases with confirmed bacterial pneumonia, 77% had CRP ≥40 mg/L compared with 17% of 556 RSV pneumonia cases. The ROC analysis produced an area under the curve of 0.87, indicating very good discrimination; a cut-point of 37.1 mg/L best discriminated confirmed bacterial pneumonia (sensitivity 77%) from RSV pneumonia (specificity 82%). CRP ≥100 mg/L substantially improved specificity over CRP ≥40 mg/L, though at a loss to sensitivity. Conclusions. Elevated CRP was positively associated with confirmed bacterial pneumonia and negatively associated with RSV pneumonia in PERCH. CRP may be useful for distinguishing bacterial from RSV-associated pneumonia, although its role in discriminating against other respiratory viral-associated pneumonia needs further study. PMID:28575375

Reliability of Diagnostic Criteria for Neurocysticercosis for Patients with Ventricular Cystic Lesions or Granulomas: A systematic review.

PubMed

Bustos, Javier A; García, Hector H; Del Brutto, Oscar H

2017-09-01

Intraventricular neurocysticercosis (NCC) is a severe form of NCC requiring prompt diagnosis and treatment. We aimed to assess the reliability of the most recent version of diagnostic criteria for this form of NCC. Two systematic literature reviews were performed; one included case reports of patients with intraventricular cysticercosis and the other included case reports of patients with intraventricular cystic lesions or granulomas caused by infections other than NCC. All assessed cases were categorized according to the last revision of the long-standing Del Brutto's set of diagnostic criteria to determine its sensitivity, specificity, and predictive value for this form of NCC. The search disclosed 128 patients with intraventricular NCC and 41 with other infections. The set of diagnostic criteria classified as definitive NCC 93 cases with intraventricular NCC (sensitivity 72.7%, 95% CI, 63.9-79.9%), as well as four cases with other infections (specificity 90.2%, 95% CI, 75.9-96.8%). The positive and negative predictive values of the criteria were 0.96 (95% CI, 0.89-0.99) and 0.51 (95% CI, 0.39-0.63), respectively. The revised Del Brutto's set of diagnostic criteria for NCC is acceptably sensitive and highly specific for diagnosing patients with the ventricular form of the disease.

Two Cases of Occupational Contact Urticaria Caused by Percutaneous Sensitization to Parvalbumin

PubMed Central

Sano, Akiyo; Yagami, Akiko; Suzuki, Kayoko; Iwata, Yohei; Kobayashi, Tsukane; Arima, Masaru; Kondo, Yasuto; Yoshikawa, Tetsushi; Matsunaga, Kayoko

2015-01-01

Background In recent years, it has been proposed that the primary mechanism for the development of food allergies is percutaneous sensitization. Since 2010, in Japan, the number of immediate-type wheat allergy due to hydrolyzed wheat protein has dramatically increased among those who have been using soap containing hydrolyzed wheat. This incidence supports the hypothesis that food allergens arise through percutaneous sensitization. Clinical Summary A 25-year-old man (case 1) and an 18-year-old girl (case 2) with atopic dermatitis visited our Department because of food allergy and hand eczema. After starting their work with fish, severe itchy eczema appeared on their hands. They subsequently started to experience oral allergic symptoms, intraoral itchiness and dyspnea after eating fish. Specific IgE antibodies were detected for many fishes, and skin prick tests showed positive reactions for a variety of fishes in both cases. Furthermore, the fluorescence intensities of specific IgE antibodies against parvalbumin from various types of fish in microarray immunoassay analysis showed positive reactions. We diagnosed them as contact urticaria caused by percutaneous sensitization to parvalbumin through job-related physical contact with fish. Conclusion The patients' histories and findings indicate the possibility of percutaneous sensitization through occupational exposure to parvalbumin, leading to food allergy. PMID:26464568

A hybrid model for combining case-control and cohort studies in systematic reviews of diagnostic tests

PubMed Central

Chen, Yong; Liu, Yulun; Ning, Jing; Cormier, Janice; Chu, Haitao

2014-01-01

Systematic reviews of diagnostic tests often involve a mixture of case-control and cohort studies. The standard methods for evaluating diagnostic accuracy only focus on sensitivity and specificity and ignore the information on disease prevalence contained in cohort studies. Consequently, such methods cannot provide estimates of measures related to disease prevalence, such as population averaged or overall positive and negative predictive values, which reflect the clinical utility of a diagnostic test. In this paper, we propose a hybrid approach that jointly models the disease prevalence along with the diagnostic test sensitivity and specificity in cohort studies, and the sensitivity and specificity in case-control studies. In order to overcome the potential computational difficulties in the standard full likelihood inference of the proposed hybrid model, we propose an alternative inference procedure based on the composite likelihood. Such composite likelihood based inference does not suffer computational problems and maintains high relative efficiency. In addition, it is more robust to model mis-specifications compared to the standard full likelihood inference. We apply our approach to a review of the performance of contemporary diagnostic imaging modalities for detecting metastases in patients with melanoma. PMID:25897179

Use of digital abdominal radiography for the diagnosis of enterolithiasis in equids: 238 cases (2008-2011).

PubMed

Kelleher, Maureen E; Puchalski, Sarah M; Drake, Christiana; le Jeune, Sarah S

2014-07-01

To evaluate the sensitivity and specificity of direct digital abdominal radiography for the diagnosis of enterolithiasis in equids and to assess the effect of the number and anatomic location of enteroliths and gas distention of the gastrointestinal tract on diagnostic sensitivity of the technique. Retrospective case series. 238 horses and ponies ≥ 1 year old that underwent digital abdominal radiography with subsequent exploratory celiotomy or postmortem examination. For each case, 3 reviewers independently evaluated radiographic views. Radiographic images were evaluated for presence or absence and location of enteroliths and the degree of gas distention. Signalment, definitive diagnosis based on exploratory celiotomy or postmortem examination findings, and number and anatomic location of enteroliths were obtained from the medical records. 70 of the 238 (29.4%) equids had confirmed enterolithiasis. With regard to diagnosis of enterolithiasis via digital radiography, overall sensitivity and specificity for the 3 reviewers were 84% and 96%, respectively. Sensitivity was lower for small colon enteroliths (61.5%) than for large colon enteroliths (88.9%) and was negatively affected by gas distention of the gastrointestinal tract. Sensitivity was not affected by the number of enteroliths. Sensitivity and specificity of digital radiography for the diagnosis of large colon enterolithiasis in equids was high. Sensitivity of digital radiography for detection of small colon enteroliths was lower than that for large colon enteroliths, but was higher than that typically associated with computed radiography. In geographic regions in which enterolithiasis in equids is endemic, digital abdominal radiography could be used as a diagnostic test for equids with colic.

Survey Definitions of Gout for Epidemiologic Studies: Comparison With Crystal Identification as the Gold Standard.

PubMed

Dalbeth, Nicola; Schumacher, H Ralph; Fransen, Jaap; Neogi, Tuhina; Jansen, Tim L; Brown, Melanie; Louthrenoo, Worawit; Vazquez-Mellado, Janitzia; Eliseev, Maxim; McCarthy, Geraldine; Stamp, Lisa K; Perez-Ruiz, Fernando; Sivera, Francisca; Ea, Hang-Korng; Gerritsen, Martijn; Scire, Carlo A; Cavagna, Lorenzo; Lin, Chingtsai; Chou, Yin-Yi; Tausche, Anne-Kathrin; da Rocha Castelar-Pinheiro, Geraldo; Janssen, Matthijs; Chen, Jiunn-Horng; Cimmino, Marco A; Uhlig, Till; Taylor, William J

2016-12-01

To identify the best-performing survey definition of gout from items commonly available in epidemiologic studies. Survey definitions of gout were identified from 34 epidemiologic studies contributing to the Global Urate Genetics Consortium (GUGC) genome-wide association study. Data from the Study for Updated Gout Classification Criteria (SUGAR) were randomly divided into development and test data sets. A data-driven case definition was formed using logistic regression in the development data set. This definition, along with definitions used in GUGC studies and the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria were applied to the test data set, using monosodium urate crystal identification as the gold standard. For all tested GUGC definitions, the simple definition of "self-report of gout or urate-lowering therapy use" had the best test performance characteristics (sensitivity 82%, specificity 72%). The simple definition had similar performance to a SUGAR data-driven case definition with 5 weighted items: self-report, self-report of doctor diagnosis, colchicine use, urate-lowering therapy use, and hyperuricemia (sensitivity 87%, specificity 70%). Both of these definitions performed better than the 1977 American Rheumatism Association survey criteria (sensitivity 82%, specificity 67%). Of all tested definitions, the 2015 ACR/EULAR criteria had the best performance (sensitivity 92%, specificity 89%). A simple definition of "self-report of gout or urate-lowering therapy use" has the best test performance characteristics of existing definitions that use routinely available data. A more complex combination of features is more sensitive, but still lacks good specificity. If a more accurate case definition is required for a particular study, the 2015 ACR/EULAR gout classification criteria should be considered. © 2016, American College of Rheumatology.

Validation of Case Finding Algorithms for Hepatocellular Cancer from Administrative Data and Electronic Health Records using Natural Language Processing

PubMed Central

Sada, Yvonne; Hou, Jason; Richardson, Peter; El-Serag, Hashem; Davila, Jessica

2013-01-01

Background Accurate identification of hepatocellular cancer (HCC) cases from automated data is needed for efficient and valid quality improvement initiatives and research. We validated HCC ICD-9 codes, and evaluated whether natural language processing (NLP) by the Automated Retrieval Console (ARC) for document classification improves HCC identification. Methods We identified a cohort of patients with ICD-9 codes for HCC during 2005–2010 from Veterans Affairs administrative data. Pathology and radiology reports were reviewed to confirm HCC. The positive predictive value (PPV), sensitivity, and specificity of ICD-9 codes were calculated. A split validation study of pathology and radiology reports was performed to develop and validate ARC algorithms. Reports were manually classified as diagnostic of HCC or not. ARC generated document classification algorithms using the Clinical Text Analysis and Knowledge Extraction System. ARC performance was compared to manual classification. PPV, sensitivity, and specificity of ARC were calculated. Results 1138 patients with HCC were identified by ICD-9 codes. Based on manual review, 773 had HCC. The HCC ICD-9 code algorithm had a PPV of 0.67, sensitivity of 0.95, and specificity of 0.93. For a random subset of 619 patients, we identified 471 pathology reports for 323 patients and 943 radiology reports for 557 patients. The pathology ARC algorithm had PPV of 0.96, sensitivity of 0.96, and specificity of 0.97. The radiology ARC algorithm had PPV of 0.75, sensitivity of 0.94, and specificity of 0.68. Conclusion A combined approach of ICD-9 codes and NLP of pathology and radiology reports improves HCC case identification in automated data. PMID:23929403

Validation of Case Finding Algorithms for Hepatocellular Cancer From Administrative Data and Electronic Health Records Using Natural Language Processing.

PubMed

Sada, Yvonne; Hou, Jason; Richardson, Peter; El-Serag, Hashem; Davila, Jessica

2016-02-01

Accurate identification of hepatocellular cancer (HCC) cases from automated data is needed for efficient and valid quality improvement initiatives and research. We validated HCC International Classification of Diseases, 9th Revision (ICD-9) codes, and evaluated whether natural language processing by the Automated Retrieval Console (ARC) for document classification improves HCC identification. We identified a cohort of patients with ICD-9 codes for HCC during 2005-2010 from Veterans Affairs administrative data. Pathology and radiology reports were reviewed to confirm HCC. The positive predictive value (PPV), sensitivity, and specificity of ICD-9 codes were calculated. A split validation study of pathology and radiology reports was performed to develop and validate ARC algorithms. Reports were manually classified as diagnostic of HCC or not. ARC generated document classification algorithms using the Clinical Text Analysis and Knowledge Extraction System. ARC performance was compared with manual classification. PPV, sensitivity, and specificity of ARC were calculated. A total of 1138 patients with HCC were identified by ICD-9 codes. On the basis of manual review, 773 had HCC. The HCC ICD-9 code algorithm had a PPV of 0.67, sensitivity of 0.95, and specificity of 0.93. For a random subset of 619 patients, we identified 471 pathology reports for 323 patients and 943 radiology reports for 557 patients. The pathology ARC algorithm had PPV of 0.96, sensitivity of 0.96, and specificity of 0.97. The radiology ARC algorithm had PPV of 0.75, sensitivity of 0.94, and specificity of 0.68. A combined approach of ICD-9 codes and natural language processing of pathology and radiology reports improves HCC case identification in automated data.

Promoter methylation of MCAM, ERα and ERβ in serum of early stage prostate cancer patients.

PubMed

Brait, Mariana; Banerjee, Mithu; Maldonado, Leonel; Ooki, Akira; Loyo, Myriam; Guida, Elisa; Izumchenko, Evgeny; Mangold, Leslie; Humphreys, Elizabeth; Rosenbaum, Eli; Partin, Alan; Sidransky, David; Hoque, Mohammad Obaidul

2017-02-28

Prostate cancer (PC) is the second most common cancer among men worldwide. Currently, the most common non-invasive approach for screening and risk assessment of PC is measuring the level of serum prostate-specific antigen (PSA). However, the sensitivity of PSA is 42.8 % and specificity is 41.1%. As a result, the serum PSA test leads to numerous unneeded biopsies. Therefore, a rigorous search for biomarkers for early detection of PC is ongoing. In this study, we aim to assess a panel of epigenetic markers in an intend to develop an early detection test for PC. The sensitivity and specificity of hypermethylation of MCAM was 66% and 73% respectively which is an improvement from the sensitivity and specificity of PSA. Considering a combination marker panel of MCAM, ERα and ERβ increased the sensitivity to 75% and the specificity became 70% for the minimally invasive early detection test of PC. Sixteen primary matched tumor and serum were analyzed by quantitative methylation specific PCR (QMSP) to determine analytical and clinical sensitivity of the genes tested (SSBP2, MCAM, ERα, ERβ, APC, CCND2, MGMT, GSTP1, p16 and RARβ2). Additionally, serum samples from eighty four cases of PC, thirty controls and seven cases diagnosed as high grade Prostatic Intraepithelial Neoplasia (HGPIN) were analyzed. Promoter methylation of MCAM, ERα and ERβ have a potential to be utilized as biomarker for the early detection of prostate PC as their sensitivity and specificity seem to be better than serum PSA in our cohort of samples. After robust validation in a larger prospective cohort, our findings may reduce the numbers of unwarranted prostate biopsies.

Characterization of IDH1 p.R132H Mutant Clones Using Mutation-specific Antibody in Myeloid Neoplasms.

PubMed

Kurt, Habibe; Bueso-Ramos, Carlos E; Khoury, Joseph D; Routbort, Mark J; Kanagal-Shamanna, Rashmi; Patel, Umang V; Jorgensen, Jeffrey L; Wang, Sa A; Ravandi, Farhad; DiNardo, Courtney; Luthra, Rajyalakshmi; Medeiros, L Jeffrey; Patel, Keyur P

2018-05-01

Isocitrate dehydrogenase 1 (IDH1) and IDH2 mutations occur in a variety of myeloid neoplasms. Immunohistochemistry (IHC)-based direct visualization of mutant clones of hematopoietic cells can be useful for rapid diagnostic screening and for monitoring treatment response. In this study, we first evaluated the sensitivity and specificity of the IDH1 p.R132H mutation-specific antibody by IHC. All IDH1 wild type cases (n=11) and IDH1 mutant cases with a non-p.R132H mutation (n=30) were negative by IHC, demonstrating 100% antibody specificity. All the initial diagnostic specimens with IDH1 p.R132H mutation including acute myeloid leukemia (n=30), myelodysplastic syndromes (MDS) (n=10), MDS/myeloproliferative neoplasms (MPN) (n=4), and MPN (n=5) were positive by IHC, demonstrating 100% antibody sensitivity. Both immature and mature myeloid cells showed immunoreactivity. Erythroid precursors, lymphoid cells, endothelial cells, and osteoblasts were consistently negative by IHC. We then evaluated the follow-up specimens with a known IDH1 mutation status including acute myeloid leukemia (n=23), MDS (n=2), MDS/MPN (n=2), and MPN (n=2). Thirty-three IDH1 p.R132H mutant cases were positive by IHC and 12 IDH1 mutation negative cases were negative by IHC. However, IHC reactivity in up to 25% of bone marrow cells was noted in 8 of 20 polymerase chain reaction-negative cases, all from patients with a known history of IDH1 p.R132H mutation indicating sampling error or a sensitivity issue with molecular tests. These data indicate that IHC is a highly specific and sensitive tool to detect IDH1 p.R132H mutation in bone marrow involved by myeloid neoplasms. In addition, IDH1 p.R132H IHC also allows localization and assessment of the maturation stage of the clones carrying the mutation.

Efficiency measures and output specification : the case of European railways

DOT National Transportation Integrated Search

2000-12-01

This study analyzes the sensitivity of the efficiency indicators of a sample of European railway companies to different alternatives in output specification. The results vary according to the specification selected. Investigating the causes of these ...

Evaluating the Diagnostic Accuracy of Xpert MTB/RIF Assay in Pulmonary Tuberculosis

PubMed Central

Sharma, Surendra K; Kohli, Mikashmi; Yadav, Raj Narayan; Chaubey, Jigyasa; Bhasin, Dinkar; Sreenivas, Vishnubhatla; Sharma, Rohini; Singh, Binit K

2015-01-01

Pulmonary tuberculosis still remains a major communicable disease worldwide. In 2013, 9 million people developed TB and 1.5 million people died from the disease. India constitutes 24% of the total TB burden. Early detection of TB cases is the key to successful treatment and reduction of disease transmission. Xpert MTB/RIF, an automated cartridge-based molecular technique detects Mycobacterium tuberculosis and rifampicin resistance within two hours has been endorsed by WHO for rapid diagnosis of TB. Our study is the first study from India with a large sample size to evaluate the performance of Xpert MTB/RIF assay in PTB samples. The test showed an overall sensitivity and specificity of 95.7% (430/449) and 99.3% (984/990) respectively. In smear negative-culture positive cases, the test had a sensitivity of 77.7%. The sensitivity and specificity for detecting rifampicin resistance was 94.5% and 97.7% respectively with respect to culture as reference standard. However, after resolving the discrepant samples with gene sequencing, the sensitivity and specificity rose to 99.0% and 99.3% respectively. Hence, while solid culture still forms the foundation of TB diagnosis, Xpert MTB/RIF proposes to be a strong first line diagnostic tool for pulmonary TB cases. PMID:26496123

A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China.

PubMed

Ou, Xichao; Xia, Hui; Li, Qiang; Pang, Yu; Wang, Shengfen; Zhao, Bing; Song, Yuanyuan; Zhou, Yang; Zheng, Yang; Zhang, Zhijian; Zhang, Zhiying; Li, Junchen; Dong, Haiyan; Chi, Junying; Zhang, Jack; Kam, Kai Man; Huan, Shitong; Jun, Yue; Chin, Daniel P; Zhao, Yanlin

2015-02-01

To evaluate the performance of Xpert MTB/RIF (MTB/RIF) in the county-level tuberculosis (TB) laboratory in China. From April 2011 to January 2012, patients with suspected multidrug-resistant tuberculosis (MDR-TB) and non-MDR-TB were enrolled consecutively from four county-level TB laboratories. The detection of Mycobacterium tuberculosis (MTB) by MTB/RIF was compared to detection by Löwenstein-Jensen culture. The detection of rifampin resistance was compared to detection by conventional drug-susceptibility testing. The impact of multiple specimens on the performance of MTB/RIF was also evaluated. A total of 2142 suspected non-MDR-TB cases and 312 suspected MDR-TB cases were enrolled. For MTB detection in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 94.4% and 90.2%, respectively. The sensitivity in smear-negative patients was 88.8%. For the detection of rifampin resistance in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 97.9%, respectively. For the detection of rifampin resistance in suspected MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 91.0%, respectively. Using multiple sputum specimens had no significant influence on the performance of MTB/RIF for MTB detection. The introduction of MTB/RIF could increase the accuracy of detection of MTB and rifampin resistance in peripheral-level TB laboratories in China. One single specimen is adequate for TB diagnosis by MTB/RIF. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

MRI of placenta percreta: differentiation from other entities of placental adhesive disorder.

PubMed

Thiravit, Shanigarn; Lapatikarn, Sukanya; Muangsomboon, Kobkun; Suvannarerg, Voraparee; Thiravit, Phakphoom; Korpraphong, Pornpim

2017-01-01

To retrospectively review the MRI findings of placenta percreta and identify those helpful for differentiation from non-placenta percreta. The MRI images of 21 patients with a preliminary diagnosis of placental adhesive disorder scanned between 2005 and 2014 were evaluated. Radiologists blinded to the final diagnosis evaluated six previously described MRI findings of placenta adhesive disorder. The sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV) of MRI for the diagnosis of placenta percreta were also calculated. The study included 12 cases of placenta percreta and 9 cases of non-placenta percreta. Invasion of placental tissue outside the uterus was found only in placenta percreta (p = 0.045; sensitivity 41.7 %; specificity 100 %). All placenta percreta cases also had a moderate to marked degree of heterogeneous placental signal intensity (p = 0.063; sensitivity 100 %; specificity 33.3 %). The size of the dark bands on T2-weighted imaging, and the presence of disorganized intra-placental vessels, showed no statistically significant difference between placenta percreta and non-placenta percreta. The sensitivity, specificity, NPV, PPV, and accuracy of MRI for detection of placenta percreta were 91.7, 44, 80, 68, and 71.4 %, respectively. MRI is recommended for the evaluation of placenta percreta, with the most specific signs including the invasion of placental tissue outside the uterus on B-FFE sequences, and consideration of the degree of placental signal heterogeneity. The size of the T2 dark band alone, or bizarre disorganized intra-placental vessels, did not correlate with the severity of invasion.

Lipopolysaccharide Specific Immunochromatography Based Lateral Flow Assay for Serogroup Specific Diagnosis of Leptospirosis in India

PubMed Central

Vanithamani, Shanmugam; Shanmughapriya, Santhanam; Narayanan, Ramasamy; Raja, Veerapandian; Kanagavel, Murugesan; Sivasankari, Karikalacholan; Natarajaseenivasan, Kalimuthusamy

2015-01-01

Background Leptospirosis is a re-emerging infectious disease that is under-recognized due to low-sensitivity and cumbersome serological tests. MAT is the gold standard test and it is the only serogroup specific test used till date. Rapid reliable alternative serogroup specific tests are needed for surveillance studies to identify locally circulating serogroups in the study area. Methods/Principal Findings In the present investigation the serological specificity of leptospiral lipopolysaccharides (LPS) was evaluated by enzyme linked immunosorbent assay (ELISA), dot blot assay and rapid immunochromatography based lateral flow assay (ICG-LFA). Sera samples from 120 MAT positive cases, 174 cases with febrile illness other than leptospirosis, and 121 seronegative healthy controls were evaluated for the diagnostic sensitivity and specificity of the developed assays. LPS was extracted from five locally predominant circulating serogroups including: Australis (27.5%), Autumnalis (11.7%), Ballum (25.8%), Grippotyphosa (12.5%), Pomona (10%) and were used as antigens in the diagnostics to detect IgM antibodies in patients’ sera. The sensitivity observed by IgM ELISA and dot blot assay using various leptospiral LPS was >90% for homologous sera. Except for Ballum LPS, no other LPS showed cross-reactivity to heterologous sera. An attempt was made to develop LPS based ICG-LFA for rapid and sensitive serogroup specific diagnostics of leptospirosis. The developed ICG-LFA showed sensitivity in the range between 93 and 100% for homologous sera. The Wilcoxon analysis showed LPS based ICG-LFA did not differ significantly from the gold standard MAT (P>0.05). Conclusion The application of single array of LPS for serogroup specific diagnosis is first of its kind. The developed assay could potentially be evaluated and employed for as MAT alternative. PMID:26340095

The sensitivity and specificity of Lassa virus IgM by ELISA as screening tool at early phase of Lassa fever infection.

PubMed

Ibekwe, Titus S; Nwegbu, Maxwell M; Asogun, Daniel; Adomeh, Donatus I; Okokhere, Peter O

2012-10-01

Early diagnosis, prompt treatment, and disease containment are vital measures in the management of Lassa fever (LF), a lethal and contagious arenaviral hemorrhagic disease prevalent in West Africa. Lassa Virus (LAV)-specific Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test, the gold standard for diagnosis, is unavailable in most centers. Serologic detection of LAV IgM is a more accessible tool and this work was to investigate its adequacy as an early marker for LF. A prospective case-control study conducted July 2007-March 2011 in a tertiary referral health center in Nigeria. Blood samples for test and control were evaluated for Lassa specific antigens and IgM using RT-PCR (primers S36+ and LVS 339) and indirect ELISA (Lassa Nucleo-protein (NP)-Antigen) respectively. RT-PCR outcome was used as standard to test for the sensitivity and specificity of IgM. Of the 37 confirmed cases of LF infection by RT-PCR, 21 (57%) were IgM positive. Amongst the 35 confirmed negative cases (control group), eight were IgM positive. The diagnostic sensitivity and specificity of the IgM assay were 57% and 77% respectively. The negative and positive predictive values of the IgM serological assay were 63% and 72%, respectively, while the efficiency of the test was 67%. The specificity and sensitivity of IgM as a screening tool for early detection of LF appear weak and, hence, the need for a reliable LF "rapid screening kit" since RT-PCR is unavailable in most centers. In the interim, "high clinical index of suspicion," irrespective of IgM status, requires urgent referral to confirmatory centers.

Comparison of the diagnostic accuracy, sensitivity and specificity of four odontological methods for age evaluation in Italian children at the age threshold of 14 years using ROC curves.

PubMed

Pinchi, Vilma; Pradella, Francesco; Vitale, Giulia; Rugo, Dario; Nieri, Michele; Norelli, Gian-Aristide

2016-01-01

The age threshold of 14 years is relevant in Italy as the minimum age for criminal responsibility. It is of utmost importance to evaluate the diagnostic accuracy of every odontological method for age evaluation considering the sensitivity, or the ability to estimate the true positive cases, and the specificity, or the ability to estimate the true negative cases. The research aims to compare the specificity and sensitivity of four commonly adopted methods of dental age estimation - Demirjian, Haavikko, Willems and Cameriere - in a sample of Italian children aged between 11 and 16 years, with an age threshold of 14 years, using receiver operating characteristic curves and the area under the curve (AUC). In addition, new decision criteria are developed to increase the accuracy of the methods. Among the four odontological methods for age estimation adopted in the research, the Cameriere method showed the highest AUC in both female and male cohorts. The Cameriere method shows a high degree of accuracy at the age threshold of 14 years. To adopt the Cameriere method to estimate the 14-year age threshold more accurately, however, it is suggested - according to the Youden index - that the decision criterion be set at the lower value of 12.928 for females and 13.258 years for males, obtaining a sensitivity of 85% and specificity of 88% in females, and a sensitivity of 77% and specificity of 92% in males. If a specificity level >90% is needed, the cut-off point should be set at 12.959 years (82% sensitivity) for females. © The Author(s) 2015.

Moderate sensitivity and high specificity of emergency department administrative data for transient ischemic attacks.

PubMed

Yu, Amy Y X; Quan, Hude; McRae, Andrew; Wagner, Gabrielle O; Hill, Michael D; Coutts, Shelagh B

2017-09-18

Validation of administrative data case definitions is key for accurate passive surveillance of disease. Transient ischemic attack (TIA) is a condition primarily managed in the emergency department. However, prior validation studies have focused on data after inpatient hospitalization. We aimed to determine the validity of the Canadian 10th International Classification of Diseases (ICD-10-CA) codes for TIA in the national ambulatory administrative database. We performed a diagnostic accuracy study of four ICD-10-CA case definition algorithms for TIA in the emergency department setting. The study population was obtained from two ongoing studies on the diagnosis of TIA and minor stroke versus stroke mimic using serum biomarkers and neuroimaging. Two reference standards were used 1) the emergency department clinical diagnosis determined by chart abstractors and 2) the 90-day final diagnosis, both obtained by stroke neurologists, to calculate the sensitivity, specificity, positive and negative predictive values (PPV and NPV) of the ICD-10-CA algorithms for TIA. Among 417 patients, emergency department adjudication showed 163 (39.1%) TIA, 155 (37.2%) ischemic strokes, and 99 (23.7%) stroke mimics. The most restrictive algorithm, defined as a TIA code in the main position had the lowest sensitivity (36.8%), but highest specificity (92.5%) and PPV (76.0%). The most inclusive algorithm, defined as a TIA code in any position with and without query prefix had the highest sensitivity (63.8%), but lowest specificity (81.5%) and PPV (68.9%). Sensitivity, specificity, PPV, and NPV were overall lower when using the 90-day diagnosis as reference standard. Emergency department administrative data reflect diagnosis of suspected TIA with high specificity, but underestimate the burden of disease. Future studies are necessary to understand the reasons for the low to moderate sensitivity.

MPT64 antigen detection test improves routine diagnosis of extrapulmonary tuberculosis in a low-resource setting: A study from the tertiary care hospital in Zanzibar.

PubMed

Jørstad, Melissa Davidsen; Marijani, Msafiri; Dyrhol-Riise, Anne Ma; Sviland, Lisbet; Mustafa, Tehmina

2018-01-01

Extrapulmonary tuberculosis (EPTB) is a diagnostic challenge. An immunochemistry-based MPT64 antigen detection test (MPT64 test) has reported higher sensitivity in the diagnosis of EPTB compared with conventional methods. The objective of this study was to implement and evaluate the MPT64 test in routine diagnostics in a low-resource setting. Patients with presumptive EPTB were prospectively enrolled at Mnazi Mmoja Hospital, Zanzibar, and followed to the end of treatment. Specimens collected were subjected to routine diagnostics, GeneXpert® MTB/RIF assay and the MPT64 test. The performance of the MPT64 test was assessed using a composite reference standard, defining the patients as tuberculosis (TB) cases or non-TB cases. Patients (n = 132) were classified as confirmed TB (n = 12), probable TB (n = 34), possible TB (n = 18), non-TB (n = 62) and uncategorized (n = 6) cases. Overall, in comparison to the composite reference standard for diagnosis, the sensitivity, specificity, positive predictive value, negative predictive value and accuracy of the MPT64 test was 69%, 95%, 94%, 75% and 82%, respectively. The MPT64 test performance was best in TB lymphadenitis cases (n = 67, sensitivity 79%, specificity 97%) and in paediatric TB (n = 41, sensitivity 100%, specificity 96%). We show that the MPT64 test can be implemented in routine diagnostics in a low-resource setting and improves the diagnosis of EPTB, especially in TB lymphadenitis and in children.

Fever detection from free-text clinical records for biosurveillance.

PubMed

Chapman, Wendy W; Dowling, John N; Wagner, Michael M

2004-04-01

Automatic detection of cases of febrile illness may have potential for early detection of outbreaks of infectious disease either by identification of anomalous numbers of febrile illness or in concert with other information in diagnosing specific syndromes, such as febrile respiratory syndrome. At most institutions, febrile information is contained only in free-text clinical records. We compared the sensitivity and specificity of three fever detection algorithms for detecting fever from free-text. Keyword CC and CoCo classified patients based on triage chief complaints; Keyword HP classified patients based on dictated emergency department reports. Keyword HP was the most sensitive (sensitivity 0.98, specificity 0.89), and Keyword CC was the most specific (sensitivity 0.61, specificity 1.0). Because chief complaints are available sooner than emergency department reports, we suggest a combined application that classifies patients based on their chief complaint followed by classification based on their emergency department report, once the report becomes available.

Validation of ICD-9 Codes for Stable Miscarriage in the Emergency Department.

PubMed

Quinley, Kelly E; Falck, Ailsa; Kallan, Michael J; Datner, Elizabeth M; Carr, Brendan G; Schreiber, Courtney A

2015-07-01

International Classification of Disease, Ninth Revision (ICD-9) diagnosis codes have not been validated for identifying cases of missed abortion where a pregnancy is no longer viable but the cervical os remains closed. Our goal was to assess whether ICD-9 code "632" for missed abortion has high sensitivity and positive predictive value (PPV) in identifying patients in the emergency department (ED) with cases of stable early pregnancy failure (EPF). We studied females ages 13-50 years presenting to the ED of an urban academic medical center. We approached our analysis from two perspectives, evaluating both the sensitivity and PPV of ICD-9 code "632" in identifying patients with stable EPF. All patients with chief complaints "pregnant and bleeding" or "pregnant and cramping" over a 12-month period were identified. We randomly reviewed two months of patient visits and calculated the sensitivity of ICD-9 code "632" for true cases of stable miscarriage. To establish the PPV of ICD-9 code "632" for capturing missed abortions, we identified patients whose visits from the same time period were assigned ICD-9 code "632," and identified those with actual cases of stable EPF. We reviewed 310 patient records (17.6% of 1,762 sampled). Thirteen of 31 patient records assigned ICD-9 code for missed abortion correctly identified cases of stable EPF (sensitivity=41.9%), and 140 of the 142 patients without EPF were not assigned the ICD-9 code "632"(specificity=98.6%). Of the 52 eligible patients identified by ICD-9 code "632," 39 cases met the criteria for stable EPF (PPV=75.0%). ICD-9 code "632" has low sensitivity for identifying stable EPF, but its high specificity and moderately high PPV are valuable for studying cases of stable EPF in epidemiologic studies using administrative data.

Comparison of Six Automated Treponema-Specific Antibody Assays.

PubMed

Park, Borae G; Yoon, Jihoon G; Rim, John Hoon; Lee, Anna; Kim, Hyon-Suk

2016-01-01

Six different Treponema (TP)-specific immunoassays were compared to the fluorescent treponemal antibody absorption (FTA-ABS) test. A total of 615 samples were tested. The overall percent agreement, analytical sensitivity, and analytical specificity of each assay compared to the FTA-ABS test were as follows: Architect Syphilis TP, 99.2%, 96.8%, and 100%; Cobas Syphilis, 99.8%, 99.4%, and 100%; ADVIA Centaur Syphilis, 99.8%, 99.4%, and 100%; HISCL Anti-TP assay kit, 99.7%, 98.7%, and 100%; Immunoticles Auto3 TP, 99.0%, 97.5%, and 99.6%; Mediace TPLA, 98.0%, 98.1%, and 98.0%. All results that were discrepant between the TP-specific assays were associated with samples from noninfectious cases (11 immunoassay false positives and 7 from previous syphilis cases). Our study demonstrated that TP-specific immunoassays generally showed high sensitivities, specificities, and percentages of agreement compared to FTA-ABS, with rare cases of false-positive or false-negative results. Therefore, most TP-specific immunoassays are acceptable for use in screening for syphilis. However, it is important to perform a thorough review of a patient's clinical and treatment history for interpreting the results of syphilis serology. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

The Usefulness of Clinical-Practice-Based Laboratory Data in Facilitating the Diagnosis of Dengue Illness

PubMed Central

Liu, Jien-Wei; Lee, Ing-Kit; Wang, Lin; Chen, Rong-Fu; Yang, Kuender D.

2013-01-01

Alertness to dengue and making a timely diagnosis is extremely important in the treatment of dengue and containment of dengue epidemics. We evaluated the complementary role of clinical-practice-based laboratory data in facilitating suspicion/diagnosis of dengue. One hundred overall dengue (57 dengue fever [DF] and 43 dengue hemorrhagic fever [DHF]) cases and another 100 nondengue cases (78 viral infections other than dengue, 6 bacterial sepsis, and 16 miscellaneous diseases) were analyzed. We separately compared individual laboratory variables (platelet count [PC] , prothrombin time [PT], activated partial thromboplastin time [APTT], alanine aminotransferase [ALT], and aspartate aminotransferase [AST]) and varied combined variables of DF and/or DHF cases with the corresponding ones of nondengue cases. The sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) in the diagnosis of DF and/or DHF were measured based on these laboratory variables. While trade-off between sensitivity and specificity, and/or suboptimal PPV/NPV was found at measurements using these variables, prolonged APTT + normal PT + PC < 100 × 109 cells/L had a favorable sensitivity, specificity, PPV, and NPV in diagnosis of DF and/or DHF. In conclusion, these data suggested that prolonged APTT + normal PT + PC < 100 × 109 cells/L is useful in evaluating the likelihood of DF and/or DHF. PMID:24455678

Diagnostic accuracy of administrative data algorithms in the diagnosis of osteoarthritis: a systematic review.

PubMed

Shrestha, Swastina; Dave, Amish J; Losina, Elena; Katz, Jeffrey N

2016-07-07

Administrative health care data are frequently used to study disease burden and treatment outcomes in many conditions including osteoarthritis (OA). OA is a chronic condition with significant disease burden affecting over 27 million adults in the US. There are few studies examining the performance of administrative data algorithms to diagnose OA. The purpose of this study is to perform a systematic review of administrative data algorithms for OA diagnosis; and, to evaluate the diagnostic characteristics of algorithms based on restrictiveness and reference standards. Two reviewers independently screened English-language articles published in Medline, Embase, PubMed, and Cochrane databases that used administrative data to identify OA cases. Each algorithm was classified as restrictive or less restrictive based on number and type of administrative codes required to satisfy the case definition. We recorded sensitivity and specificity of algorithms and calculated positive likelihood ratio (LR+) and positive predictive value (PPV) based on assumed OA prevalence of 0.1, 0.25, and 0.50. The search identified 7 studies that used 13 algorithms. Of these 13 algorithms, 5 were classified as restrictive and 8 as less restrictive. Restrictive algorithms had lower median sensitivity and higher median specificity compared to less restrictive algorithms when reference standards were self-report and American college of Rheumatology (ACR) criteria. The algorithms compared to reference standard of physician diagnosis had higher sensitivity and specificity than those compared to self-reported diagnosis or ACR criteria. Restrictive algorithms are more specific for OA diagnosis and can be used to identify cases when false positives have higher costs e.g. interventional studies. Less restrictive algorithms are more sensitive and suited for studies that attempt to identify all cases e.g. screening programs.

Utility of ultrasound and magnetic resonance imaging in prenatal diagnosis of placenta accreta: A prospective study.

PubMed

Satija, Bhawna; Kumar, Sanyal; Wadhwa, Leena; Gupta, Taru; Kohli, Supreethi; Chandoke, Rajkumar; Gupta, Pratibha

2015-01-01

Placenta accreta is the abnormal adherence of the placenta to the uterine wall and the most common cause for emergency postpartum hysterectomy. Accurate prenatal diagnosis of affected pregnancies allows optimal obstetric management. To summarize our experience in the antenatal diagnosis of placenta accreta on imaging in a tertiary care setup. To compare the accuracy of ultrasound (USG) with color Doppler (CDUS) and magnetic resonance imaging (MRI) in prenatal diagnosis of placenta accreta. Prospective study in a tertiary care setup. A prospective study was conducted on pregnant females with high clinical risk of placenta accreta. Antenatal diagnosis was established based on CDUS and MRI. The imaging findings were compared with final diagnosis at the time of delivery and/or pathologic examination. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for both CDUS and MRI. The sensitivity and specificity values of USG and MRI were compared by the McNemar test. Thirty patients at risk of placenta accreta underwent both CDUS and MRI. Eight cases of placenta accreta were identified (3 vera, 4 increta, and 1 percreta). All patients had history of previous cesarean section. Placenta previa was present in seven out of eight patients. USG correctly identified the presence of placenta accreta in seven out of eight patients (87.5% sensitivity) and the absence of placenta accreta in 19 out of 22 patients (86.4% specificity). MRI correctly identified the presence of placenta accreta in 6 out of 8 patients (75.0% sensitivity) and absence of placenta accreta in 17 out of 22 patients (77.3% specificity). There were no statistical differences in sensitivity (P = 1.00) and specificity (P = 0.687) between USG and MRI. Both USG and MRI have fairly good sensitivity for prenatal diagnosis of placenta accreta; however, specificity does not appear to be as good as reported in other studies. Both modalities have complimentary role and in cases of inconclusive findings with one imaging modality, the other modality may be useful for obtaining the diagnosis. CDUS remains the first primary modality for antenatal diagnosis of placenta accreta, with MRI reserved for cases where USG is inconclusive.

Modeling screening, prevention, and delaying of Alzheimer's disease: an early-stage decision analytic model

PubMed Central

2010-01-01

Background Alzheimer's Disease (AD) affects a growing proportion of the population each year. Novel therapies on the horizon may slow the progress of AD symptoms and avoid cases altogether. Initiating treatment for the underlying pathology of AD would ideally be based on biomarker screening tools identifying pre-symptomatic individuals. Early-stage modeling provides estimates of potential outcomes and informs policy development. Methods A time-to-event (TTE) simulation provided estimates of screening asymptomatic patients in the general population age ≥55 and treatment impact on the number of patients reaching AD. Patients were followed from AD screen until all-cause death. Baseline sensitivity and specificity were 0.87 and 0.78, with treatment on positive screen. Treatment slowed progression by 50%. Events were scheduled using literature-based age-dependent incidences of AD and death. Results The base case results indicated increased AD free years (AD-FYs) through delays in onset and a reduction of 20 AD cases per 1000 screened individuals. Patients completely avoiding AD accounted for 61% of the incremental AD-FYs gained. Total years of treatment per 1000 screened patients was 2,611. The number-needed-to-screen was 51 and the number-needed-to-treat was 12 to avoid one case of AD. One-way sensitivity analysis indicated that duration of screening sensitivity and rescreen interval impact AD-FYs the most. A two-way sensitivity analysis found that for a test with an extended duration of sensitivity (15 years) the number of AD cases avoided was 6,000-7,000 cases for a test with higher sensitivity and specificity (0.90,0.90). Conclusions This study yielded valuable parameter range estimates at an early stage in the study of screening for AD. Analysis identified duration of screening sensitivity as a key variable that may be unavailable from clinical trials. PMID:20433705

Modeling screening, prevention, and delaying of Alzheimer's disease: an early-stage decision analytic model.

PubMed

Furiak, Nicolas M; Klein, Robert W; Kahle-Wrobleski, Kristin; Siemers, Eric R; Sarpong, Eric; Klein, Timothy M

2010-04-30

Alzheimer's Disease (AD) affects a growing proportion of the population each year. Novel therapies on the horizon may slow the progress of AD symptoms and avoid cases altogether. Initiating treatment for the underlying pathology of AD would ideally be based on biomarker screening tools identifying pre-symptomatic individuals. Early-stage modeling provides estimates of potential outcomes and informs policy development. A time-to-event (TTE) simulation provided estimates of screening asymptomatic patients in the general population age > or =55 and treatment impact on the number of patients reaching AD. Patients were followed from AD screen until all-cause death. Baseline sensitivity and specificity were 0.87 and 0.78, with treatment on positive screen. Treatment slowed progression by 50%. Events were scheduled using literature-based age-dependent incidences of AD and death. The base case results indicated increased AD free years (AD-FYs) through delays in onset and a reduction of 20 AD cases per 1000 screened individuals. Patients completely avoiding AD accounted for 61% of the incremental AD-FYs gained. Total years of treatment per 1000 screened patients was 2,611. The number-needed-to-screen was 51 and the number-needed-to-treat was 12 to avoid one case of AD. One-way sensitivity analysis indicated that duration of screening sensitivity and rescreen interval impact AD-FYs the most. A two-way sensitivity analysis found that for a test with an extended duration of sensitivity (15 years) the number of AD cases avoided was 6,000-7,000 cases for a test with higher sensitivity and specificity (0.90,0.90). This study yielded valuable parameter range estimates at an early stage in the study of screening for AD. Analysis identified duration of screening sensitivity as a key variable that may be unavailable from clinical trials.

Ultrasonographic Differentiation Between Nodular Hyperplasia and Neoplastic Follicular-Patterned Lesions of the Thyroid Gland.

PubMed

Song, Yong Sub; Kim, Ji-Hoon; Na, Dong Gyu; Min, Hye Sook; Won, Jae-Kyung; Yun, Tae Jin; Choi, Seung Hong; Sohn, Chul-Ho

2016-08-01

We evaluate the gray-scale ultrasonographic characteristics that differentiate between nodular hyperplasia (NH) and neoplastic follicular-patterned lesions (NFPLs) of the thyroid gland. Ultrasonographic features of 750 patients with 832 thyroid nodules (NH, n = 361; or NFPLs, follicular adenoma, n = 123; follicular carcinoma, n = 159; and follicular variant papillary carcinoma, n = 189) were analyzed. Except for echogenicity, over two-thirds of the cases of NH and NFPLs share the ultrasonographic characteristics of solid internal content, a well-defined smooth margin and round-to-ovoid shape. Independent predictors for NH were non-solid internal content (sensitivity 27.1%, specificity 90.2%), isoechogenicity (sensitivity 69.5%, specificity 63.5%) and an ill-defined margin (sensitivity 18.8%, specificity 94.5%). Independent predictors for NFPLs were hypoechogenicity (sensitivity 60.5%, specificity 70.4%), marked hypoechogenicity (sensitivity 2.8%, specificity 99.4%) and taller-than-wide shape (sensitivity 6.6%, specificity 98.1%). Although NH and NFPLs commonly share ultrasonographic characteristics, non-solid internal content and ill-defined margin are specific to NH and marked hypoechogenicity and taller-than-wide shape are specific to NFPLs. Copyright © 2016 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

Diagnosis of knee injuries: comparison of the physical examination and magnetic resonance imaging with the findings from arthroscopy☆

PubMed Central

Orlando Júnior, Nilton; de Souza Leão, Marcos George; de Oliveira, Nelson Henrique Carvalho

2015-01-01

Objectives To ascertain the sensitivity, specificity, accuracy and concordance of the physical examination (PE) and magnetic resonance imaging (MRI) in comparison with arthroscopy, in diagnosing knee injuries. Methods Prospective study on 72 patients, with evaluation and comparison of PE, MRI and arthroscopic findings, to determine the concordance, accuracy, sensitivity and specificity. Results PE showed sensitivity of 75.00%, specificity of 62.50% and accuracy of 69.44% for medial meniscal (MM) lesions, while it showed sensitivity of 47.82%, specificity of 93.87% and accuracy of 79.16% for lateral meniscal (LM) lesions. For anterior cruciate ligament (ACL) injuries, PE showed sensitivity of 88.67%, specificity of 94.73% and accuracy of 90.27%. For MM lesions, MRI showed sensitivity of 92.50%, specificity of 62.50% and accuracy of 69.44%, while for LM injuries, it showed sensitivity of 65.00%, specificity of 88.46% and accuracy of 81.94%. For ACL injuries, MRI showed sensitivity of 86.79%, specificity of 73.68% and accuracy of 83.33%. For ACL injuries, the best concordance was with PE, while for MM and LM lesions, it was with MRI (p < 0.001). Conclusions Meniscal and ligament injuries can be diagnosed through careful physical examination, while requests for MRI are reserved for complex or doubtful cases. PE and MRI used together have high sensitivity for ACL and MM lesions, while for LM lesions the specificity is higher. Level of evidence II – Development of diagnostic criteria on consecutive patients (with universally applied reference “gold” standard). PMID:27218085

Evaluation of magnetic resonance imaging for the differentiation of inflammatory, neoplastic, and vascular intradural spinal cord diseases in the dog.

PubMed

Masciarelli, Amanda E; Griffin, John F; Fosgate, Geoffrey T; Hecht, Silke; Mankin, Joseph M; Holmes, Shannon P; Platt, Simon R; Kent, Marc; Pancotto, Theresa E; Chen, Annie V; Levine, Jonathan M

2017-07-01

Magnetic resonance imaging (MRI) is a common test for dogs with suspected intradural spinal cord lesions, however studies on diagnostic performance for this test are lacking. Objectives of this multi-institutional, retrospective, case-control study were to estimate sensitivity and specificity of MRI for (1) distinguishing between histopathologically confirmed intradural spinal cord disease versus degenerative myelopathy in dogs, (2) categorizing intradural spinal cord diseases as neoplastic, inflammatory, or vascular; and (3) determining tumor type within the etiologic category of neoplasia. Additional aims were to (1) determine whether knowledge of clinical data affects sensitivity and specificity of MRI diagnoses; and (2) report interrater agreement for MRI classification of intradural spinal lesions. Cases were recruited from participating hospital databases over a 7-year period. Three reviewers independently evaluated each MRI study prior to and after provision of clinical information. A total of 87 cases were sampled (17 degenerative myelopathy, 53 neoplasia, nine inflammatory, and eight vascular). Magnetic resonance imaging had excellent (>97.6%) sensitivity for diagnosis of intradural spinal cord lesions but specificity varied before and after provision of clinical data (68.6% vs. 82.4%, P = 0.023). Magnetic resonance imaging had good sensitivity (86.8%) and moderate specificity (64.7-72.5%) for diagnosing neoplasia. Sensitivity was lower for classifying inflammatory lesions but improved with provision of clinical data (48.1% vs. 81.5%, P = 0.015). Magnetic resonance imaging was insensitive for diagnosing vascular lesions (25.0%). Interrater agreement was very good for correctly diagnosing dogs with intradural lesions (ĸ = 0.882-0.833), and good (ĸ = 0.726-0.671) for diagnosing dogs with neoplasia. © 2017 American College of Veterinary Radiology.

Evaluation of brush cytology and DNA image cytometry for the detection of cancer of the oral cavity.

PubMed

Kaur, Manveen; Handa, Uma; Mohan, Harsh; Dass, Arjun

2016-03-01

Cancer of the oral cavity is the sixth most common malignancy reported worldwide. This study was undertaken to evaluate the efficacy of brush cytology and the adjunctive role of DNA image cytometry (ICM) in the diagnosis of oral cancer. Oral brush smears and biopsy were obtained from 100 consecutive patients presenting with suspicious oral lesions. DNA-ICM was performed on 96 cytology smears which had adequate cellularity. On cytology, 54 cases were benign, 36 were malignant, 6 were suspicious for malignancy, and 4 were inadequate due to scanty cellularity. On histopathologic examination, 49 cases were diagnosed as squamous cell carcinoma and 51 cases as benign. The sensitivity of brush cytology for the detection of cancer was 83.3% and the specificity was 95.8%. The positive and negative predictive values were 95.2% and 85.2%, respectively, with a diagnostic accuracy of 86%. Out of 96 cases analyzed by image analysis to assess DNA ploidy, 33 cases were aneuploid and 63 were diploid. The sensitivity, specificity, positive predictive value, and negative predictive value of DNA-ICM were 68.7%, 100%, 100%, and 76.1%, respectively, giving a diagnostic accuracy of 81%. The combination of cytology and DNA cytometry increased the sensitivity to 92% and specificity to 100%. The study demonstrates the usefulness of DNA-ICM as an adjunct to brush cytology to diagnose oral cancer. It reduces the false negative cases on cytology and also adds to objectivity in cytologically doubtful cases. © 2016 Wiley Periodicals, Inc.

Assessment of medial coronoid disease in 180 canine lame elbow joints: a sensitivity and specificity comparison of radiographic, computed tomographic and arthroscopic findings.

PubMed

Villamonte-Chevalier, A; van Bree, H; Broeckx, Bjg; Dingemanse, W; Soler, M; Van Ryssen, B; Gielen, I

2015-09-25

Diagnostic imaging is essential to assess the lame patient; lesions of the elbow joint have traditionally been evaluated radiographically, however computed tomography (CT) has been suggested as a useful technique to diagnose various elbow pathologies. The primary objective of this study was to determine the sensitivity and specificity of CT to assess medial coronoid disease (MCD), using arthroscopy as gold standard. The secondary objective was to ascertain the radiographic sensitivity and specificity for MCD compared with CT. For this study 180 elbow joints were assessed, of which 141 had been examined with radiography, CT and arthroscopy; and 39 joints, had radiographic and CT assessment. Sensitivity and specificity were calculated for CT and radiographic findings using available statistical software. Sensitivity and specificity of CT using arthroscopy as gold standard resulted in high values for sensitivity (100 %) and specificity (93 %) for the assessment of MCD. For the radiographic evaluation, a sensitivity of 98 % and specificity of 64 - 69 % using CT as the technique of reference, were found. These results suggest that in case of doubt during radiographic assessment, CT could be used as a non-invasive technique to assess the presence of MCD. Based on the high sensitivity and specificity obtained in this study it has been considered that CT, rather than arthroscopy, is the preferred noninvasive technique to assess MCD lesions of the canine elbow joint.

Performance characteristics of a reverse transcriptase-polymerase chain reaction assay for the detection of tumor-specific fusion transcripts from archival tissue.

PubMed

Fritsch, Michael K; Bridge, Julia A; Schuster, Amy E; Perlman, Elizabeth J; Argani, Pedram

2003-01-01

Pediatric small round cell tumors still pose tremendous diagnostic problems. In difficult cases, the ability to detect tumor-specific gene fusion transcripts for several of these neoplasms, including Ewing sarcoma/peripheral primitive neuroectodermal tumor (ES/PNET), synovial sarcoma (SS), alveolar rhabdomyosarcoma (ARMS), and desmoplastic small round cell tumor (DSRCT) using reverse transcriptase-polymerase chain reaction (RT-PCR), can be extremely helpful. Few studies to date, however, have systematically examined several different tumor types for the presence of multiple different fusion transcripts in order to determine the specificity and sensitivity of the RT-PCR method, and no study has addressed this issue for formalin-fixed material. The objectives of this study were to address the specificity, sensitivity, and practicality of such an assay applied strictly to formalin-fixed tissue blocks. Our results demonstrate that, for these tumors, the overall sensitivity for detecting each fusion transcript is similar to that reported in the literature for RT-PCR on fresh or formalin-fixed tissues. The specificity of the assay is very high, being essentially 100% for each primer pair when interpreting the results from visual inspection of agarose gels. However, when these same agarose gels were examined using Southern blotting, a small number of tumors also yielded reproducibly detectable weak signals for unexpected fusion products, in addition to a strong signal for the expected fusion product. Fluorescence in situ hybridization (FISH) studies in one such case indicated that a rearrangement that would account for the unexpected fusion was not present, while another case was equivocal. The overall specificity for each primer pair used in this assay ranged from 94 to 100%. Therefore, RT-PCR using formalin-fixed paraffin-embedded tissue sections can be used to detect chimeric transcripts as a reliable, highly sensitive, and highly specific diagnostic assay. However, we strongly suggest that the final interpretation of the results from this assay be viewed in light of the other features of the case, including clinical history, histology, and immunohistochemistry, by the diagnostic pathologist. Additional studies such as FISH may be useful in clarifying the nature of equivocal or unexpected results.

Association of C-Reactive Protein With Bacterial and Respiratory Syncytial Virus-Associated Pneumonia Among Children Aged <5 Years in the PERCH Study.

PubMed

Higdon, Melissa M; Le, Tham; O'Brien, Katherine L; Murdoch, David R; Prosperi, Christine; Baggett, Henry C; Brooks, W Abdullah; Feikin, Daniel R; Hammitt, Laura L; Howie, Stephen R C; Kotloff, Karen L; Levine, Orin S; Scott, J Anthony G; Thea, Donald M; Awori, Juliet O; Baillie, Vicky L; Cascio, Stephanie; Chuananon, Somchai; DeLuca, Andrea N; Driscoll, Amanda J; Ebruke, Bernard E; Endtz, Hubert P; Kaewpan, Anek; Kahn, Geoff; Karani, Angela; Karron, Ruth A; Moore, David P; Park, Daniel E; Rahman, Mohammed Ziaur; Salaudeen, Rasheed; Seidenberg, Phil; Somwe, Somwe Wa; Sylla, Mamadou; Tapia, Milagritos D; Zeger, Scott L; Deloria Knoll, Maria; Madhi, Shabir A

2017-06-15

Lack of a gold standard for identifying bacterial and viral etiologies of pneumonia has limited evaluation of C-reactive protein (CRP) for identifying bacterial pneumonia. We evaluated the sensitivity and specificity of CRP for identifying bacterial vs respiratory syncytial virus (RSV) pneumonia in the Pneumonia Etiology Research for Child Health (PERCH) multicenter case-control study. We measured serum CRP levels in cases with World Health Organization-defined severe or very severe pneumonia and a subset of community controls. We evaluated the sensitivity and specificity of elevated CRP for "confirmed" bacterial pneumonia (positive blood culture or positive lung aspirate or pleural fluid culture or polymerase chain reaction [PCR]) compared to "RSV pneumonia" (nasopharyngeal/oropharyngeal or induced sputum PCR-positive without confirmed/suspected bacterial pneumonia). Receiver operating characteristic (ROC) curves were constructed to assess the performance of elevated CRP in distinguishing these cases. Among 601 human immunodeficiency virus (HIV)-negative tested controls, 3% had CRP ≥40 mg/L. Among 119 HIV-negative cases with confirmed bacterial pneumonia, 77% had CRP ≥40 mg/L compared with 17% of 556 RSV pneumonia cases. The ROC analysis produced an area under the curve of 0.87, indicating very good discrimination; a cut-point of 37.1 mg/L best discriminated confirmed bacterial pneumonia (sensitivity 77%) from RSV pneumonia (specificity 82%). CRP ≥100 mg/L substantially improved specificity over CRP ≥40 mg/L, though at a loss to sensitivity. Elevated CRP was positively associated with confirmed bacterial pneumonia and negatively associated with RSV pneumonia in PERCH. CRP may be useful for distinguishing bacterial from RSV-associated pneumonia, although its role in discriminating against other respiratory viral-associated pneumonia needs further study. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

The sensitivity and specificity of a urine based Rapid Diagnostic Test for the diagnosis of plasmodium falciparum in a malaria endemic area in Odisha, India.

PubMed

Samal, Ajit Gopal; Behera, Prativa Kumari; Mohanty, Akshay Kumar; Satpathi, Sanghamitra; Kumar, Abhishek; Panda, Rabi Ratna; Minz, Aruna Mukti; Mohanty, Sanjib; Samal, Abhijit; Van Der Pluijm, Rob W

2017-10-01

Rapid and accurate diagnosis is crucial in the treatment of malaria. Rapid Diagnostic Tests (RDTs) using blood have been recommended by the WHO as an acceptable method for the diagnosis of malaria. RDTs provide results quickly, is simple to use and easy to interpret. However, its use requires collection of blood by skin puncture. Hence the aim of the pilot study is to explore the sensitivity and specificity of RDTs using urine (collected non-invasively) for diagnosis of Plasmodium falciparum malaria and to assess the relation between parasite density in blood with HRP-2 Ag detection in urine. All fever cases admitted to Ispat General Hospital (IGH) Rourkela, India, during June 2012-March 2013 with a clinical diagnosis of malaria were examined for the presence of asexual forms of P. falciparum in peripheral blood smears. All smear positive febrile patients who met the eligibility criteria were enrolled. Smear negative fever cases were enrolled as control cases. RDTs were performed using both urine and blood samples by using commercially available blood specific kits. Sixty blood smear positive cases and 51 febrile blood smear negative cases were enrolled. Sensitivity and specificity of RDT urine were 86.67% (95%CI:75.83-93.09) and 94.12% (95%CI:84.08-97.98) respectively whereas those of RDT blood were 91.67% (95% CI: 81.93-96.39) and 98.04% (95% CI 89.7-99.65). The sensitivity of both RDT urine as well as RDT blood were found to be dependent on the level of parasitemia. Results of this study are promising. Larger studies are needed to assess whether RDTs using urine could serve as a practical, reliable method for the detection of P. falciparum in a non-invasive manner where invasive blood taking is less feasible.

The lymphocyte transformation test for the diagnosis of drug allergy: sensitivity and specificity.

PubMed

Nyfeler, B; Pichler, W J

1997-02-01

The diagnosis of a drug allergy is mainly based upon a very detailed history and the clinical findings. In addition, several in vitro or in vivo tests can be performed to demonstrate a sensitization to a certain drug. One of the in vitro tests is the lymphocyte transformation test (LTT), which can reveal a sensitization of T-cells by an enhanced proliferative response of peripheral blood mononuclear cells to a certain drug. To evaluate the sensitivity and specificity of the LTT, 923 case histories of patients with suspected drug allergy in whom a LTT was performed were retrospectively analysed. Based on the history and provocation tests, the probability (P) of a drug allergy was estimated to be > 0.9, 0.5-0.9, 0.1-0.5 or < 0.1, and was put in relation to a positive or negative LTT. Seventy-eight of 100 patients with a very likely drug allergy (P > 0.9) had a positive LTT, which indicates a sensitivity of 78%. If allergies to betalactam-antibiotics were analysed separately, the sensitivity was 74.4%. Fifteen of 102 patients where a classical drug allergy could be excluded (P < 0.1), had nevertheless a positive LTT (specificity thus 85%). The majority of these cases were classified as so-called pseudo-allergic reaction to NSAIDs. Patients with a clear history and clinical findings for a cotrimoxazole-related allergy, all had a positive LTT (6/6), and in patients who reacted to drugs containing proteins, sensitization could be demonstrated as well (i.e. hen's egg lysozyme, 7/7). In 632 of the 923 cases, skin tests were also performed (scratch and/or epicutaneous), for which we found a lower sensitivity than for the LTT (64%), while the specificity was the same (85%). Although our data are somewhat biased by the high number of penicillin allergies and cannot be generalized to drug allergies caused by other compounds, we conclude that the LTT is a useful diagnostic test in drug allergies, able to support the diagnosis of a drug allergy and to pinpoint the relevant drug.

Evaluation of usefulness of fine-needle aspiration cytology in the diagnosis of tumours of the accessory parotid gland: a preliminary analysis of a case series in Japan.

PubMed

Iguchi, Hiroyoshi; Wada, Tadashi; Matsushita, Naoki; Oishi, Masahiro; Teranishi, Yuichi; Yamane, Hideo

2014-07-01

The accuracy and sensitivity of fine-needle aspiration cytology (FNAC) in this analysis were not satisfactory, and the false-negative rate seemed to be higher than for parotid tumours. The possibility of low-grade malignancy should be considered in the surgical treatment of accessory parotid gland (APG) tumours, even if the preoperative results of FNAC suggest that the tumour is benign. Little is known about the usefulness of FNAC in the preoperative evaluation of APG tumours, probably due to the paucity of APG tumour cases. We examined the usefulness of FNAC in the detection of malignant APG tumours. We conducted a retrospective analysis of 3 cases from our hospital, along with 18 previously reported Japanese cases. We compared the preoperative FNAC results with postoperative histopathological diagnoses of APG tumours and evaluated the accuracy, sensitivity, specificity and false-negative rates of FNAC in detecting malignant APG tumours. There were four false-negative cases (19.0%), three of mucoepidermoid carcinomas and one of malignant lymphoma. One false-positive result was noted in the case of a myoepithelioma, which was cytologically diagnosed as suspected adenoid cystic carcinoma. The accuracy, sensitivity and specificity of FNAC in detecting malignant tumours were 76.2%, 60.0% and 90.9%, respectively.

Case definition for clinical and subclinical bacterial kidney disease (BKD) in Atlantic Salmon (Salmo salar L.) in New Brunswick, Canada.

PubMed

Boerlage, A S; Stryhn, H; Sanchez, J; Hammell, K L

2017-03-01

Bacterial kidney disease (BKD) is considered an important cause of loss in salmon aquaculture in Atlantic Canada. Causative agent of BKD is the Gram-positive bacteria Renibacterium salmoninarum. Infected salmon are often asymptomatic (subclinical infection), and the disease is considered chronic. One of the challenges in quantifying information from farm production and health records is the application of a standardized case definition. Case definitions for farm-level and cage-level clinical and subclinical BKD were developed using retrospective longitudinal data from aquaculture practices in New Brunswick, Canada, combining (i) industry records of weekly production data including mortalities, (ii) field observations for BKD using reports of veterinarians and/or fish health technicians, (iii) diagnostic submissions and test results and (iv) treatments used to control BKD. Case definitions were evaluated using veterinarians' expert judgements as reference standard. Eighty-nine and 66% of sites and fish groups, respectively, were associated with BKD at least once. For BKD present (subclinical or clinical), sensitivity and specificity of the case definition were 75-100% varying between event, fish group, site cycle and level (site pen). For clinical BKD, sensitivities were 29-64% and specificities 91-100%. Industry data can be used to develop sensitive case definitions. © 2016 John Wiley & Sons Ltd.

Evaluation of the WHO clinical case definition of AIDS among children in India.

PubMed

Gurprit, Grover; Tripti, Pensi; Gadpayle, A K; Tanushree, Banerjee

2008-03-01

The need of a clinical case definition (CCD) for Acquired Immunodeficiency Syndrome (AIDS) was felt by public health agencies to monitor diseases resulting from human immunodeficiency virus (HIV) infection. To test the statistical significance of the existing World Health Organization (WHO) CCD for the diagnosis of AIDS in areas where diagnostic resources are limited in India, a prospective study was conducted in the Paediatrics department at Dr. Ram Manohar Lohia Hospital, New Delhi. 360 cases between 18 months-12 years of age satisfying WHO case definitions of AIDS were included in the study group. Informed consent was taken from the parents. The serum of patients was subjected to ELISA to conform the diagnosis of HIV infection. Our study detected 16.66% (60) of HIV prevalence in children visiting paediatrics outpatient clinic. 20% cases manifested 3 major and 2 minor signs. This definition had a sensitivity of 73.33%, specificity of 90.66%, positive predictive value (PPV) of 61.11% and negative predictive value (NPV) of 94.44%. On using stepwise logistic regression analysis weight loss, chronic fever > 1 month and total lymphocyte count of less than 1500 cells/mm3 emerged as important predictors. Cases showing 2 major and 2 minor signs were 86 (23.89%) with a sensitivity and specificity of 86.66% and 88.66% respectively. Based on these findings, we propose a clinical case definition based on 13 clinical signs and symptoms for paediatric AIDS in India with better sensitivity and PPV than the WHO case definition but with almost similar specificity. Thus multicentric studies are further required to modify these criteria in Indian set up.

Comparison of skin prick tests with specific serum immunoglobulin E in the diagnosis of fungal sensitization in patients with severe asthma.

PubMed

O'Driscoll, B R; Powell, G; Chew, F; Niven, R M; Miles, J F; Vyas, A; Denning, D W

2009-11-01

It has been shown that patients with allergic bronchopulmonary aspergillosis (ABPA) and patients with severe asthma with fungal sensitization (SAFS) can benefit from antifungal therapy. It is not known whether allergy skin prick tests (SPT) or specific IgE tests are more sensitive in the identification of patients who are sensitized to fungi and who are therefore candidates for antifungal therapy. To compare SPT and specific serum IgE tests for fungal sensitization in patients with severe asthma. We have undertaken SPT and specific serum IgE tests to six fungi (Aspergillus fumigatus, Candida albicans, Penicillium notatum, Cladosporium herbarum, Alternaria alternata and Botrytis cineria) and specific serum IgE test for Trichophyton in 121 patients with severe asthma (British Thoracic Society/SIGN steps 4 and 5). Sixty-six percent of patients were sensitized to one or more fungi based on SPT and/or specific serum IgE results. Positivity to SPT and/or specific serum IgE was as follows: A. fumigatus 45%, C. albicans 36%, P. notatum 29%, C. herbarum 24%, A. alternata 22%, B. cineria 18%, Trichophyton 17% (specific serum IgE only). Concordance between the tests was 77% overall but only 14-56% for individual fungi. Twenty-nine (24%) patients were sensitized to a single fungus and seven (6%) were sensitized to all seven fungal species. Fifty percent of patients were sensitized to fungal and non-fungal extracts, 21% were sensitized only to non-fungal extracts, 16% were sensitized only to fungal extracts and 13% had no positive tests. This study is consistent with previous reports that fungal sensitization is common in patients with severe asthma. At present, it remains necessary to undertake both SPT and specific serum IgE testing to identify all cases of fungal sensitization. This may be important in the identification of patients with ABPA and SAFS who may benefit from antifungal therapy.

Use of basal serum or plasma cortisol concentrations to rule out a diagnosis of hypoadrenocorticism in dogs: 123 cases (2000-2005).

PubMed

Lennon, Elizabeth M; Boyle, Tonya E; Hutchins, Rae Grace; Friedenthal, Arit; Correa, Maria T; Bissett, Sally A; Moses, Lorra S; Papich, Mark G; Birkenheuer, Adam J

2007-08-01

To determine whether basal serum or plasma cortisol concentration can be used as a screening test to rule out hypoadrenocorticism in dogs. Retrospective case-control study. 110 dogs with nonadrenal gland illnesses and 13 dogs with hypoadrenocorticism. Sensitivity and specificity of basal serum or plasma cortisol concentrations of either 2 microg/dL that are not receiving corticosteroids, mitotane, or ketoconazole are highly unlikely to have hypoadrenocorticism. However, if the basal cortisol concentration is

Does more favourable handling of the cerebrospinal fluid increase the diagnostic sensitivity of Borrelia burgdorferi sensu lato-specific PCR in Lyme neuroborreliosis?

PubMed

Forselv, Kristine J N; Lorentzen, Åslaug R; Ljøstad, Unn; Mygland, Åse; Eikeland, Randi; Kjelland, Vivian; Noraas, Sølvi; Quarsten, Hanne

2018-04-01

Tests for direct detection of Borrelia burgdorferi sensu lato (Bb) in Lyme neuroborreliosis (LNB) are needed. Detection of Bb DNA using PCR is promising, but clinical utility is hampered by low diagnostic sensitivity. We aimed to examine whether diagnostic sensitivity can be improved by the use of larger cerebrospinal fluid (CSF) volumes and faster handling of samples. Patients who underwent CSF examination for LNB were included. We collected two millilitres of CSF for PCR analysis, extracted DNA from the pellets within 24 h and analysed the eluate by two real-time PCR protocols (16S rRNA and OspA). Patients who fulfilled diagnostic criteria for LNB were classified as LNB cases and the rest as controls. Bb DNA in CSF was detected by PCR in seven of 28 adults with LNB. Two were Bb antibody negative. No Bb DNA was detected in CSF from 137 controls. Diagnostic sensitivity was 25% and specificity 100%. There was a non-significant trend towards larger CSF sample volume, faster handling of the sample, shorter duration of symptoms, and higher CSF cell count in the PCR-positive cases. We did not find that optimized handling of CSF increased diagnostic sensitivity of PCR in adults with LNB. However, our case series is small and we hypothesize that the importance of these factors will be clarified in further studies with larger case series and altered study design. PCR for diagnosis of LNB may be useful in cases without Bb antibodies due to short duration of symptoms.

SFEMG in ocular myasthenia gravis diagnosis.

PubMed

Padua, L; Stalberg, E; LoMonaco, M; Evoli, A; Batocchi, A; Tonali, P

2000-07-01

In typical cases, the patient's history and clinical examination make it possible to diagnose ocular myasthenia gravis (OMG). But, in many cases a clear clinical picture is not present and OMG diagnosis is very difficult because gold diagnostic standard tests are not available. The diagnostic tests for OMG are usually unable to display a good sensitivity and specificity simultaneously. In this paper, we studied 86 cases submitted for suspected OMG. The patients were studied clinically and with various other tests used in OMG diagnosis (SFEMG, repetitive nerve stimulation, Ab anti AChR titration, tensilon test). SFEMG showed the highest sensitivity (100%) while Ab anti AChR showed the highest specificity (100%). To our knowledge this is the largest population of suspected OMG studied using most of the diagnostic parameters, reported in the literature.

Reducing false positives of microcalcification detection systems by removal of breast arterial calcifications.

PubMed

Mordang, Jan-Jurre; Gubern-Mérida, Albert; den Heeten, Gerard; Karssemeijer, Nico

2016-04-01

In the past decades, computer-aided detection (CADe) systems have been developed to aid screening radiologists in the detection of malignant microcalcifications. These systems are useful to avoid perceptual oversights and can increase the radiologists' detection rate. However, due to the high number of false positives marked by these CADe systems, they are not yet suitable as an independent reader. Breast arterial calcifications (BACs) are one of the most frequent false positives marked by CADe systems. In this study, a method is proposed for the elimination of BACs as positive findings. Removal of these false positives will increase the performance of the CADe system in finding malignant microcalcifications. A multistage method is proposed for the removal of BAC findings. The first stage consists of a microcalcification candidate selection, segmentation and grouping of the microcalcifications, and classification to remove obvious false positives. In the second stage, a case-based selection is applied where cases are selected which contain BACs. In the final stage, BACs are removed from the selected cases. The BACs removal stage consists of a GentleBoost classifier trained on microcalcification features describing their shape, topology, and texture. Additionally, novel features are introduced to discriminate BACs from other positive findings. The CADe system was evaluated with and without BACs removal. Here, both systems were applied on a validation set containing 1088 cases of which 95 cases contained malignant microcalcifications. After bootstrapping, free-response receiver operating characteristics and receiver operating characteristics analyses were carried out. Performance between the two systems was compared at 0.98 and 0.95 specificity. At a specificity of 0.98, the sensitivity increased from 37% to 52% and the sensitivity increased from 62% up to 76% at a specificity of 0.95. Partial areas under the curve in the specificity range of 0.8-1.0 were significantly different between the system without BACs removal and the system with BACs removal, 0.129 ± 0.009 versus 0.144 ± 0.008 (p<0.05), respectively. Additionally, the sensitivity at one false positive per 50 cases and one false positive per 25 cases increased as well, 37% versus 51% (p<0.05) and 58% versus 67% (p<0.05) sensitivity, respectively. Additionally, the CADe system with BACs removal reduces the number of false positives per case by 29% on average. The same sensitivity at one false positive per 50 cases in the CADe system without BACs removal can be achieved at one false positive per 80 cases in the CADe system with BACs removal. By using dedicated algorithms to detect and remove breast arterial calcifications, the performance of CADe systems can be improved, in particular, at false positive rates representative for operating points used in screening.

Diagnostic accuracy of contrast-enhanced spectral mammography in comparison to conventional full-field digital mammography in a population of women with dense breasts.

PubMed

Mori, Miki; Akashi-Tanaka, Sadako; Suzuki, Satoko; Daniels, Murasaki Ikeda; Watanabe, Chie; Hirose, Masanori; Nakamura, Seigo

2017-01-01

Contrast-enhanced spectral mammography to compare clinical efficacy of contrast-enhanced spectral mammography (CESM) and conventional digital mammography (MMG) with histopathology as gold standard in dense breasts. A total of 143 breasts of 72 women who underwent CESM and MMG between 2011 and 2014 at Showa University Hospital were analyzed. 129 (90.2 %) of 143 breasts revealed dense breasts on MMG. 58 (40.6 %) of 143 breasts were diagnosed with breast cancer at histopathology. The remaining 85 breasts were diagnosed with benign findings after image assessments and/or core needle biopsy. CESM revealed 8 false-negative cases among 58 breast cancer cases (sensitivity 86.2 %) and 5 false-positive cases (specificity 94.1 %). Accuracy was 90.9 %. Conventional MMG was assessed true positive in 31 of 58 breast cancer cases (sensitivity 53.4 %) and false positive in 12 cases (specificity 85.9 %). Accuracy was 72.7 %. Sensitivity (p < 0.001), specificity (p = 0.016) and accuracy (p < 0.001) were significantly higher on CESM compared to MMG. MMG missed malignancy in 27 breasts. Of these, 25 were dense breasts. Of these 25, 20 (80.0 %) breasts were positive on CESM. These findings suggest that CESM offers superior clinical performance compared to MMG. Use of CESM may decrease false negatives especially for women with dense breasts.

Prenatal Diagnosis of Placenta Accreta: Sonography or Magnetic Resonance Imaging?

PubMed Central

Dwyer, Bonnie K.; Belogolovkin, Victoria; Tran, Lan; Rao, Anjali; Carroll, Ian; Barth, Richard; Chitkara, Usha

2009-01-01

Objective The purpose of this study was to compare the accuracy of transabdominal sonography and magnetic resonance imaging (MRI) for prenatal diagnosis of placenta accreta. Methods A historical cohort study was undertaken at 3 institutions identifying women at risk for placenta accreta who had undergone both sonography and MRI prenatally. Sonographic and MRI findings were compared with the final diagnosis as determined at delivery and by pathologic examination. Results Thirty-two patients who had both sonography and MRI prenatally to evaluate for placenta accreta were identified. Of these, 15 had confirmation of placenta accreta at delivery. Sonography correctly identified the presence of placenta accreta in 14 of 15 patients (93% sensitivity; 95% confidence interval [CI], 80%–100%) and the absence of placenta accreta in 12 of 17 patients (71% specificity; 95% CI, 49%–93%). Magnetic resonance imaging correctly identified the presence of placenta accreta in 12 of 15 patients (80% sensitivity; 95% CI, 60%–100%) and the absence of placenta accreta in 11 of 17 patients (65% specificity; 95% CI, 42%–88%). In 7 of 32 cases, sonography and MRI had discordant diagnoses: sonography was correct in 5 cases, and MRI was correct in 2. There was no statistical difference in sensitivity (P = .25) or specificity (P = .5) between sonography and MRI. Conclusions Both sonography and MRI have fairly good sensitivity for prenatal diagnosis of placenta accreta; however, specificity does not appear to be as good as reported in other studies. In the case of inconclusive findings with one imaging modality, the other modality may be useful for clarifying the diagnosis. PMID:18716136

Validation of administrative case ascertainment algorithms for chronic childhood arthritis in Manitoba, Canada.

PubMed

Shiff, Natalie Jane; Oen, Kiem; Rabbani, Rasheda; Lix, Lisa M

2017-09-01

We validated case ascertainment algorithms for juvenile idiopathic arthritis (JIA) in the provincial health administrative databases of Manitoba, Canada. A population-based pediatric rheumatology clinical database from April 1st 1980 to March 31st 2012 was used to test case definitions in individuals diagnosed at ≤15 years of age. The case definitions varied the number of diagnosis codes (1, 2, or 3), time frame (1, 2 or 3 years), time between diagnoses (ever, >1 day, or ≥8 weeks), and physician specialty. Positive predictive value (PPV), sensitivity, and specificity with 95% confidence intervals (CIs) are reported. A case definition of 1 hospitalization or ≥2 diagnoses in 2 years by any provider ≥8 weeks apart using diagnosis codes for rheumatoid arthritis and ankylosing spondylitis produced a sensitivity of 89.2% (95% CI 86.8, 91.6), specificity of 86.3% (95% CI 83.0, 89.6), and PPV of 90.6% (95% CI 88.3, 92.9) when seronegative enthesopathy and arthropathy (SEA) was excluded as JIA; and sensitivity of 88.2% (95% CI 85.7, 90.7), specificity of 90.4% (95% CI 87.5, 93.3), and PPV of 93.9% (95% CI 92.0, 95.8) when SEA was included as JIA. This study validates case ascertainment algorithms for JIA in Canadian administrative health data using diagnosis codes for both rheumatoid arthritis (RA) and ankylosing spondylitis, to better reflect current JIA classification than codes for RA alone. Researchers will be able to use these results to define cohorts for population-based studies.

Diagnostic usefulness of MUC1 and MUC4 for distinguishing between metastatic adenocarcinoma cells and reactive mesothelial cells in effusion cell blocks.

PubMed

Cho, Jin Seong; Kim, Ga-Eon; Lee, Ji Shin; Lee, Jae Hyuk; Nam, Jong Hee; Choi, Chan

2013-01-01

The aim of our study was to determine the diagnostic value of MUC1 and MUC4 for distinguishing between metastatic adenocarcinoma cells (MAC) and reactive mesothelial cells (RMC) in effusion fluids. A total of 237 cell block specimens from pleural and peritoneal effusions, including 196 malignant effusions with MAC and 41 benign effusions with RMC, were stained with antibodies against MUC1 and MUC4. Membranous staining with or without cytoplasmic staining was considered to be positive. MUC1 immunoreactivity was observed in 194 (99.0%) of 196 cases of MAC and in 20 (48.8%) of 41 cases of RMC. MUC4 immunoreactivity was observed in 174 (88.8%) of 196 cases of MAC and in 4 (9.8%) of 41 cases of RMC. For distinguishing MAC from RMC, the MUC1 reactivity was found to be 99.0% sensitive and 51.2% specific with a positive predictive value of 90.7% and a negative predictive value of 91.3%. The sensitivity of MUC4 for MAC was 88.8%, the specificity was 90.2%, the negative predictive value was 62.7%, and the positive predictive value was 97.8%. Our data suggest that MUC4 appears to be a sensitive and specific marker for differentiating between MAC and RMC. Copyright © 2013 S. Karger AG, Basel.

Screening for Binge Eating Disorders Using the Patient Health Questionnaire in a Community Sample

PubMed Central

Striegel-Moore, Ruth H.; Perrin, Nancy; DeBar, Lynn; Wilson, G. Terence; Rosselli, Francine; Kraemer, Helena C.

2009-01-01

Objective To examine the operating characteristics of the Patient Health Questionnaire eating disorder module (PHQ-ED) for identifying bulimia nervosa/binge eating disorder (BN/BED) or recurrent binge eating (RBE) in a community sample, and to compare true positive (TP) versus false positive (FP) cases on clinical validators. Method 259 screen positive individuals and a random sample of 89 screen negative cases completed a diagnostic interview. Sensitivity, specificity, and Positive Predictive Value (PPV) were calculated. TP and FP cases were compared using t-tests and Chi-Square tests. Results The PHQ-ED had high sensitivity (100%) and specificity (92%) for detecting BN/BED or RBE, but PPV was low (15% or 19%). TP and FP cases did not differ significantly on frequency of subjective bulimic episodes, objective overeating, restraint, on BMI, and on self-rated health. Conclusions The PHQ-ED is recommended for use in large populations only in conjunction with follow-up questions to rule out cases without objective bulimic episodes. PMID:19424976

Allergen Sensitization Pattern by Sex: A Cluster Analysis in Korea.

PubMed

Ohn, Jungyoon; Paik, Seung Hwan; Doh, Eun Jin; Park, Hyun-Sun; Yoon, Hyun-Sun; Cho, Soyun

2017-12-01

Allergens tend to sensitize simultaneously. Etiology of this phenomenon has been suggested to be allergen cross-reactivity or concurrent exposure. However, little is known about specific allergen sensitization patterns. To investigate the allergen sensitization characteristics according to gender. Multiple allergen simultaneous test (MAST) is widely used as a screening tool for detecting allergen sensitization in dermatologic clinics. We retrospectively reviewed the medical records of patients with MAST results between 2008 and 2014 in our Department of Dermatology. A cluster analysis was performed to elucidate the allergen-specific immunoglobulin (Ig)E cluster pattern. The results of MAST (39 allergen-specific IgEs) from 4,360 cases were analyzed. By cluster analysis, 39items were grouped into 8 clusters. Each cluster had characteristic features. When compared with female, the male group tended to be sensitized more frequently to all tested allergens, except for fungus allergens cluster. The cluster and comparative analysis results demonstrate that the allergen sensitization is clustered, manifesting allergen similarity or co-exposure. Only the fungus cluster allergens tend to sensitize female group more frequently than male group.

A hybrid Bayesian hierarchical model combining cohort and case-control studies for meta-analysis of diagnostic tests: Accounting for partial verification bias.

PubMed

Ma, Xiaoye; Chen, Yong; Cole, Stephen R; Chu, Haitao

2016-12-01

To account for between-study heterogeneity in meta-analysis of diagnostic accuracy studies, bivariate random effects models have been recommended to jointly model the sensitivities and specificities. As study design and population vary, the definition of disease status or severity could differ across studies. Consequently, sensitivity and specificity may be correlated with disease prevalence. To account for this dependence, a trivariate random effects model had been proposed. However, the proposed approach can only include cohort studies with information estimating study-specific disease prevalence. In addition, some diagnostic accuracy studies only select a subset of samples to be verified by the reference test. It is known that ignoring unverified subjects may lead to partial verification bias in the estimation of prevalence, sensitivities, and specificities in a single study. However, the impact of this bias on a meta-analysis has not been investigated. In this paper, we propose a novel hybrid Bayesian hierarchical model combining cohort and case-control studies and correcting partial verification bias at the same time. We investigate the performance of the proposed methods through a set of simulation studies. Two case studies on assessing the diagnostic accuracy of gadolinium-enhanced magnetic resonance imaging in detecting lymph node metastases and of adrenal fluorine-18 fluorodeoxyglucose positron emission tomography in characterizing adrenal masses are presented. © The Author(s) 2014.

A Hybrid Bayesian Hierarchical Model Combining Cohort and Case-control Studies for Meta-analysis of Diagnostic Tests: Accounting for Partial Verification Bias

PubMed Central

Ma, Xiaoye; Chen, Yong; Cole, Stephen R.; Chu, Haitao

2014-01-01

To account for between-study heterogeneity in meta-analysis of diagnostic accuracy studies, bivariate random effects models have been recommended to jointly model the sensitivities and specificities. As study design and population vary, the definition of disease status or severity could differ across studies. Consequently, sensitivity and specificity may be correlated with disease prevalence. To account for this dependence, a trivariate random effects model had been proposed. However, the proposed approach can only include cohort studies with information estimating study-specific disease prevalence. In addition, some diagnostic accuracy studies only select a subset of samples to be verified by the reference test. It is known that ignoring unverified subjects may lead to partial verification bias in the estimation of prevalence, sensitivities and specificities in a single study. However, the impact of this bias on a meta-analysis has not been investigated. In this paper, we propose a novel hybrid Bayesian hierarchical model combining cohort and case-control studies and correcting partial verification bias at the same time. We investigate the performance of the proposed methods through a set of simulation studies. Two case studies on assessing the diagnostic accuracy of gadolinium-enhanced magnetic resonance imaging in detecting lymph node metastases and of adrenal fluorine-18 fluorodeoxyglucose positron emission tomography in characterizing adrenal masses are presented. PMID:24862512

The effect of prevalence of disease on performance of residents and fellows during training for interpreting DBT in a test-train-test observer study

NASA Astrophysics Data System (ADS)

Hakim, Christiane M.; Chang Sen, Lauren; Degnan, Andrew; Delic, Joseph; Pai, Sarah; Sagreiya, Hersh; Sparrow, Mark; Thomas, Ernestine; Yannes, Michael; Gur, David

2017-03-01

There are no data on the effect of disease prevalence during training for interpreting digital breast tomosynthesis (DBT) based screening examinations on the performance of residents and fellows. We assessed the performance of six residents (four after one breast imaging rotation and two after two rotations) and two fellows in breast imaging when interpreting DBT screening examinations in a multi-case, mode balanced, test- train-test retrospective reader study (127 training and 160 testing cases). Half were trained with feedback of verified truth after reviewing each case with low prevalence of disease (13/127) and half with high prevalence (52/128). The pre- and post- training dataset was the same. Performance measures were compared (sensitivity, specificity and AUC). Readers trained with the low prevalence set decreased the overall recall rate of non-cancer cases (FPF from 0.21 to 0.13, <0.001), and of cases with known malignancies (TPF from 0.70 to 0.61, p=0.004, due primarily to one clearly outlier reader). Readers trained with the high prevalence increased the overall recall rate (albeit, not statistically significant) of non-cancer cases (FPF from 0.16 to 0.18, p=0.07), and a borderline significant increase of cancer cases (TPF from 0.61 to 0.66, p=0.04). Fellows post six months of specialty training in each group had no significant changes in sensitivity, specificity, or AUC after training (smallest p>0.07). Both residents with two rotations experience had significant changes in sensitivity and specificity (highest p<0.028), but not in AUC. Early training with low disease prevalence of "what not to recall" should be included during training.

Model-based methods for case definitions from administrative health data: application to rheumatoid arthritis

PubMed Central

Kroeker, Kristine; Widdifield, Jessica; Muthukumarana, Saman; Jiang, Depeng; Lix, Lisa M

2017-01-01

Objective This research proposes a model-based method to facilitate the selection of disease case definitions from validation studies for administrative health data. The method is demonstrated for a rheumatoid arthritis (RA) validation study. Study design and setting Data were from 148 definitions to ascertain cases of RA in hospital, physician and prescription medication administrative data. We considered: (A) separate univariate models for sensitivity and specificity, (B) univariate model for Youden’s summary index and (C) bivariate (ie, joint) mixed-effects model for sensitivity and specificity. Model covariates included the number of diagnoses in physician, hospital and emergency department records, physician diagnosis observation time, duration of time between physician diagnoses and number of RA-related prescription medication records. Results The most common case definition attributes were: 1+ hospital diagnosis (65%), 2+ physician diagnoses (43%), 1+ specialist physician diagnosis (51%) and 2+ years of physician diagnosis observation time (27%). Statistically significant improvements in sensitivity and/or specificity for separate univariate models were associated with (all p values <0.01): 2+ and 3+ physician diagnoses, unlimited physician diagnosis observation time, 1+ specialist physician diagnosis and 1+ RA-related prescription medication records (65+ years only). The bivariate model produced similar results. Youden’s index was associated with these same case definition criteria, except for the length of the physician diagnosis observation time. Conclusion A model-based method provides valuable empirical evidence to aid in selecting a definition(s) for ascertaining diagnosed disease cases from administrative health data. The choice between univariate and bivariate models depends on the goals of the validation study and number of case definitions. PMID:28645978

Evaluation of surveillance case definition in the diagnosis of leptospirosis, using the Microscopic Agglutination Test: a validation study.

PubMed

Dassanayake, Dinesh L B; Wimalaratna, Harith; Agampodi, Suneth B; Liyanapathirana, Veranja C; Piyarathna, Thibbotumunuwe A C L; Goonapienuwala, Bimba L

2009-04-22

Leptospirosis is endemic in both urban and rural areas of Sri Lanka and there had been many out breaks in the recent past. This study was aimed at validating the leptospirosis surveillance case definition, using the Microscopic Agglutination Test (MAT). The study population consisted of patients with undiagnosed acute febrile illness who were admitted to the medical wards of the Teaching Hospital Kandy, from 1st July 2007 to 31st July 2008. The subjects were screened to diagnose leptospirosis according to the leptospirosis case definition. MAT was performed on blood samples taken from each patient on the 7th day of fever. Leptospirosis case definition was evaluated in regard to sensitivity, specificity and predictive values, using a MAT titre >or= 1:800 for confirming leptospirosis. A total of 123 patients were initially recruited of which 73 had clinical features compatible with the surveillance case definition. Out of the 73 only 57 had a positive MAT result (true positives) leaving 16 as false positives. Out of the 50 who didn't have clinical features compatible with the case definition 45 had a negative MAT as well (true negatives), therefore 5 were false negatives. Total number of MAT positives was 62 out of 123. According to these results the test sensitivity was 91.94%, specificity 73.77%, positive predictive value and negative predictive values were 78.08% and 90% respectively. Diagnostic accuracy of the test was 82.93%. This study confirms that the surveillance case definition has a very high sensitivity and negative predictive value with an average specificity in diagnosing leptospirosis, based on a MAT titre of >or= 1: 800.

How does the Distress Thermometer compare to the Hospital Anxiety and Depression Scale for detecting possible cases of psychological morbidity among cancer survivors?

PubMed

Boyes, Allison; D'Este, Catherine; Carey, Mariko; Lecathelinais, Christophe; Girgis, Afaf

2013-01-01

Use of the Distress Thermometer (DT) as a screening tool is increasing across the cancer trajectory. This study examined the accuracy and optimal cut-off score of the DT compared to the Hospital Anxiety and Depression Scale (HADS) for detecting possible cases of psychological morbidity among adults in early survivorship. This study is a cross-sectional survey of 1,323 adult cancer survivors recruited from two state-based cancer registries in Australia. Participants completed the DT and the HADS at 6 months post-diagnosis. Compared to the HADS subscale threshold ≥8, the DT performed well in discriminating between cases and non-cases of anxiety, depression and comorbid anxiety-depression with an area under the curve of 0.85, 0.84 and 0.87, respectively. A DT cut-off score of ≥2 was best for clinical use (sensitivity, 87-95 %; specificity, 60-68 %), ≥4 was best for research use (sensitivity, 67-82 %; specificity, 81-88 %) and ≥3 was the best balance between sensitivity (77-88 %) and specificity (72-79 %) for detecting cases of anxiety, depression and comorbid anxiety-depression. The DT demonstrated a high level of precision in identifying non-cases of psychological morbidity at all possible thresholds (negative predictive value, 77-99 %). The recommended DT cut-off score of ≥4 was not supported for universal use among recent cancer survivors. The optimal DT threshold depends upon whether the tool is being used in the clinical or research setting. The DT may best serve to initially identify non-cases as part of a two-stage screening process. The performance of the DT against 'gold standard' clinical interview should be evaluated with cancer survivors.

Development and validation of an administrative case definition for inflammatory bowel diseases

PubMed Central

Rezaie, Ali; Quan, Hude; Fedorak, Richard N; Panaccione, Remo; Hilsden, Robert J

2012-01-01

BACKGROUND: A population-based database of inflammatory bowel disease (IBD) patients is invaluable to explore and monitor the epidemiology and outcome of the disease. In this context, an accurate and validated population-based case definition for IBD becomes critical for researchers and health care providers. METHODS: IBD and non-IBD individuals were identified through an endoscopy database in a western Canadian health region (Calgary Health Region, Calgary, Alberta). Subsequently, using a novel algorithm, a series of case definitions were developed to capture IBD cases in the administrative databases. In the second stage of the study, the criteria were validated in the Capital Health Region (Edmonton, Alberta). RESULTS: A total of 150 IBD case definitions were developed using 1399 IBD patients and 15,439 controls in the development phase. In the validation phase, 318,382 endoscopic procedures were searched and 5201 IBD patients were identified. After consideration of sensitivity, specificity and temporal stability of each validated case definition, a diagnosis of IBD was assigned to individuals who experienced at least two hospitalizations or had four physician claims, or two medical contacts in the Ambulatory Care Classification System database with an IBD diagnostic code within a two-year period (specificity 99.8%; sensitivity 83.4%; positive predictive value 97.4%; negative predictive value 98.5%). An alternative case definition was developed for regions without access to the Ambulatory Care Classification System database. A novel scoring system was developed that detected Crohn disease and ulcerative colitis patients with a specificity of >99% and a sensitivity of 99.1% and 86.3%, respectively. CONCLUSION: Through a robust methodology, a reproducible set of criteria to capture IBD patients through administrative databases was developed. The methodology may be used to develop similar administrative definitions for chronic diseases. PMID:23061064

Lung Ultrasonography to Diagnose Transient Tachypnea of the Newborn.

PubMed

Liu, Jing; Chen, Xin-Xin; Li, Xiang-Wen; Chen, Shui-Wen; Wang, Yan; Fu, Wei

2016-05-01

This study explored the sensitivity and specificity of ultrasound for diagnosing transient tachypnea of the newborn (TTN). Ultrasound was performed by one export. Patients were placed in a supine, lateral recumbent, or prone position. The probe was placed perpendicular or parallel to the ribs, and each region of the lung was scanned. The scan results were compared with conventional chest radiographic results. A total of 1,358 infants were included in this study. We identified 412 cases without pulmonary diseases, 228 TTN cases, 358 respiratory distress syndrome (RDS) cases, 85 meconium aspiration syndrome (MAS) cases, 215 infectious pneumonia cases, and 60 other cases. The primary ultrasonic characteristic of TTN was pulmonary edema. "White lung" or a "compact B-line" were only observed in severe cases, whereas TTN primarily presented as pulmonary interstitial syndrome or "double lung point." Furthermore, double lung point could appear during the recovery period of severe TTN or RDS, MAS, and pneumonia. Lung consolidation with air bronchograms was not observed in TTN patients. The results showed that white lung or a compact B-line exhibited a sensitivity of 33.8% and a specificity of 91.3% in diagnosing TTN, whereas double lung point exhibited a sensitivity of 45.6% and a specificity of 94.8% in diagnosing severe TTN. Pulmonary edema, alveolar-interstitial syndrome, double lung point, white lung, and compact B-line are the primary ultrasound characteristics of TTN. Ultrasonic diagnosis of TTN based on these findings is accurate and reliable. TTN can be ruled out in the presence of lung consolidation with air bronchograms. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Performance characteristics of broth-only cultures after revision total joint arthroplasty.

PubMed

Smith, Eric B; Cai, Jenny; Wynne, Rachael; Maltenfort, Mitchell; Good, Robert P

2014-11-01

Surgeons frequently obtain intraoperative cultures at the time of revision total joint arthroplasty. The use of broth or liquid medium before applying the sample to the agar medium may be associated with contamination and false-positive cultures; however, the degree to which this is the case is not known. We (1) calculated the performance characteristics of broth-only cultures (sensitivity, specificity, positive predictive value, and negative predictive value) and (2) characterized the organisms identified in broth to determine whether a specific organism showed increased proclivity for true-positive periprosthetic joint infection (PJI). A single-institution retrospective chart review was performed on 257 revision total joint arthroplasties from 2009 through 2010. One hundred ninety (74%) had cultures for review. All culture results, as well as treatment, if any, were documented and patients were followed for a minimum of 1 year for evidence of PJI. Cultures were measured as either positive from the broth only or broth negative. The true diagnosis of infection was determined by the Musculoskeletal Infection Society criteria during the preoperative workup or postoperatively at 1 year for purposes of calculating the performance characteristics of the broth-only culture. The sensitivity, specificity, positive predictive value, and negative predictive value were 19%, 88%, 13%, and 92%, respectively. The most common organism identified was coagulase-negative Staphylococcus (16 of 24 cases, 67%). Coagulase-negative Staphylococcus was present in all three true-positive cases; however, it was also found in 13 of the false-positive cases. The broth-only positive cultures showed poor sensitivity and positive predictive value but good specificity and negative predictive value. The good specificity indicates that it can help to rule in the presence of PJI; however, the poor sensitivity makes broth-only culture an unreliable screening test. We recommend that broth-only culture results be carefully scrutinized and decisions on the diagnosis and treatment of infection should be based specifically on the Musculoskeletal Infection Society criteria. Level IV, diagnostic study. See Instructions for Authors for a complete description of levels of evidence.

Triple Test in Carcinoma Breast

PubMed Central

Sameer; Mukherjee, Arindam

2014-01-01

Introduction: The commonest clinical presentation in majority of breast pathology is a lump. A definite diagnosis of breast lump is very important for the surgeon to decide on the final course of treatment and also saves the patient from unnecessary physical, emotional and psychological trauma if there is a definite preoperative diagnosis of benign lesion. The present study was done to evaluate the effectiveness and relevance of “TRIPLE TEST”in diagnosis of carcinoma breast in rural labour class population. Materials and Methods: The present study was a prospective study conducted on patients over 35 years of age having palpable breast lumps presenting in the out patient department of general surgery, ESI Hospital Basaidarapur New Delhi, India. The duration of study was from May 2007 to June 2009 and a total of 100 cases were studied. Each patient was subjected to a detailed history, clinical breast examination ,diagnostic mammography and FNAC. In this study, the results of each modality was divided in three groups: benign, suspicious and malignant. The sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of each test was calculated individually and as combined. Result: Out of 100 patients enrolled in this study, 60 cases were benign and 40 cases were of malignant breast disease. The age of patients with carcinoma breast in the series varied from 35 years to 70 years. The highest incidence of malignancy noted was 30% in 41-50 years age group (4th decade) followed by 27.5% in 51-60 years age group (5th decade). The sensitivity of clinical examination was found to be 75%, specificity was 83.3%, positive predictive value (PPV) of 75% and diagnostic accuracy of 80%. The sensitivity, specificity, positive predictive value and diagnostic accuracy of mammography was calculated and was found to be 94.9% , 90% , 86% and 92% respectively. The sensitivity, specificity, positive predictive value and diagnostic accuracy of FNAC was 94.7%, 98.3%, 97.3% and 96.6% respectively. Out of 100 cases triple test was concordant (all three test either benign or malignant) in 80 cases, all the benign cases detected by triple test were benign on final biopsy i.e. 100% specificity and 100% negative predictive value. Conclusion: TTS is an accurate and least invasive diagnostic test based on which definitive treatment can be initiated. PMID:25478391

Detection of Entamoeba histolytica by Recombinase Polymerase Amplification

PubMed Central

Nair, Gayatri; Rebolledo, Mauricio; White, A. Clinton; Crannell, Zachary; Richards-Kortum, R. Rebecca; Pinilla, A. Elizabeth; Ramírez, Juan David; López, M. Consuelo; Castellanos-Gonzalez, Alejandro

2015-01-01

Amebiasis is an important cause of diarrheal disease worldwide and has been associated with childhood malnutrition. Traditional microscopy approaches are neither sensitive nor specific for Entamoeba histolytica. Antigen assays are more specific, but many cases are missed unless tested by molecular methods. Although polymerase chain reaction (PCR) is effective, the need for sophisticated, expensive equipment, infrastructure, and trained personnel limits its usefulness, especially in the resource-limited, endemic areas. Here, we report development of a recombinase polymerase amplification (RPA) method to detect E. histolytica specifically. Using visual detection by lateral flow (LF), the test was highly sensitive and specific and could be performed without additional equipment. The availability of this inexpensive, sensitive, and field-applicable diagnostic test could facilitate rapid diagnosis and treatment of amebiasis in endemic regions. PMID:26123960

Beer, Cider, and Wine Allergy

PubMed Central

Tadros, Susan

2017-01-01

Background. Allergy to beer is often due to specific proteins in barley and sometimes to lipid transfer protein. Allergy to wine is frequently due to a sensitivity to grape proteins. We present a rare case of allergy to beer, wine, and cider resulting from IgE reactivity to yeasts and moulds which also explained the patient's additional sensitivity to yeast extracts and blue cheese. Case Presentation. The patient's symptoms included throat and facial itching accompanied by mild wheeze and severe urticaria. Diagnosis of allergy to yeast was confirmed by specific IgE testing as well as that to relevant foods and beverages. The patient's ongoing management included advice to avoid beer, wine, and other food groups containing specific yeasts, in addition to carrying a short acting nonsedating antihistamine as well as an adrenaline autoinjector. Conclusions. Cases of yeast allergy are extremely rare in medical literature but may be underrecognised and should be considered in patients presenting with reactions to alcoholic beverages and other yeast-containing products. PMID:28396809

Beer, Cider, and Wine Allergy.

PubMed

Bansal, Rhea A; Tadros, Susan; Bansal, Amolak S

2017-01-01

Background . Allergy to beer is often due to specific proteins in barley and sometimes to lipid transfer protein. Allergy to wine is frequently due to a sensitivity to grape proteins. We present a rare case of allergy to beer, wine, and cider resulting from IgE reactivity to yeasts and moulds which also explained the patient's additional sensitivity to yeast extracts and blue cheese. Case Presentation . The patient's symptoms included throat and facial itching accompanied by mild wheeze and severe urticaria. Diagnosis of allergy to yeast was confirmed by specific IgE testing as well as that to relevant foods and beverages. The patient's ongoing management included advice to avoid beer, wine, and other food groups containing specific yeasts, in addition to carrying a short acting nonsedating antihistamine as well as an adrenaline autoinjector. Conclusions . Cases of yeast allergy are extremely rare in medical literature but may be underrecognised and should be considered in patients presenting with reactions to alcoholic beverages and other yeast-containing products.

[Accuracy of placenta accreta prenatal diagnosis by ultrasound and MRI in a high-risk population].

PubMed

Daney de Marcillac, F; Molière, S; Pinton, A; Weingertner, A-S; Fritz, G; Viville, B; Roedlich, M-N; Gaudineau, A; Sananes, N; Favre, R; Nisand, I; Langer, B

2016-02-01

Main objective was to compare accuracy of ultrasonography and MRI for antenatal diagnosis of placenta accreta. Secondary objectives were to specify the most common sonographic and RMI signs associated with diagnosis of placenta accreta. This retrospective study used data collected from all potential cases of placenta accreta (patients with an anterior placenta praevia with history of scarred uterus) admitted from 01/2010 to 12/2014 in a level III maternity unit in Strasbourg, France. High-risk patients beneficiated antenatally from ultrasonography and MRI. Sonographic signs registered were: abnormal placental lacunae, increased vascularity on color Doppler, absence of the retroplacental clear space, interrupted bladder line. MRI signs registered were: abnormal uterine bulging, intraplacental bands of low signal intensity on T2-weighted images, increased vascularity, heterogeneous signal of the placenta on T2-weighed, interrupted bladder line, protrusion of the placenta into the cervix. Diagnosis of placenta accreta was confirmed histologically after hysterectomy or clinically in case of successful conservative treatment. Twenty-two potential cases of placenta accreta were referred to our center and underwent both ultrasonography and MRI. All cases of placenta accreta had a placenta praevia associated with history of scarred uterus. Sensibility and specificity for ultrasonography were, respectively, 0.92 and 0.67, for MRI 0.84 and 0.78 without significant difference (p>0.05). The most relevant signs associated with diagnosis of placenta accreta in ultrasonography were increased vascularity on color Doppler (sensibility 0.85/specificity 0.78), abnormal placental lacunae (sensibility 0.92/specificity 0.55) and loss of retroplacental clear space (sensibility 0.76/specificity 1.0). The most relevant signs in MRI were: abnormal uterine bulging (sensitivity 0.92/specificity 0.89), dark intraplacental bands on T2-weighted images (sensitivity 0.83/specificity 0.80) or placental heterogeneity (sensitivity 0.92/specificity 0.89). Association of two sonographic or MRI signs had the best sensitivity/specificity ratio. Ultrasonography and RMI represent two interesting and complementary diagnostic tools for antenatal diagnosis of placenta accreta. Because of its cost and accessibility, ultrasonography remains the first in line to be used for diagnosis. Use of an analytical grid for diagnosis of placenta accreta could be helpful. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Difficulties in clinical diagnosis of measles: proposal for modified clinical case definition.

PubMed

Ferson, M J; Young, L C; Robertson, P W; Whybin, L R

1995-10-02

To examine the accuracy of clinical diagnosis of measles and to develop an improved measles clinical case definition. Case survey. Eastern Sydney, December 1990 to August 1993. All cases of measles notified to the Eastern Sydney Public Health Unit without or before serological confirmation. Demographic and clinical details, measles- and rubella-specific IgM and measles complement fixation titres in acute and convalescent (when available) sera and epidemiological links with confirmed measles cases. Of 49 subjects reported and with complete follow-up, 24 were confirmed with measles, four with rubella and 21 had no definite diagnosis. Clinical diagnosis of measles had a false positive rate of 51%. Subjects with confirmed measles were significantly more likely to have a cough (23/24) than those with no definite diagnosis (15/21; P = 0.03) and to be febrile on the day of rash onset (23/24 versus 10/21; P = 0.001). The Centers for Disease Control definition had a sensitivity of 92% but specificity of only 24%. A modified case definition of rash, cough and fever present at onset of rash had equal sensitivity but greater specificity (57%). As measles is no longer common in Australia, clinical diagnosis is unreliable. When a public health response is needed, cases should be confirmed by serological tests or, if not available, we propose use of our modified clinical case definition.

Duodenal endoscopic findings and histopathologic confirmation of intestinal lymphangiectasia in dogs.

PubMed

Larson, R N; Ginn, J A; Bell, C M; Davis, M J; Foy, D S

2012-01-01

The diagnosis of intestinal lymphangiectasia (IL) has been associated with characteristic duodenal mucosal changes. However, the sensitivity and specificity of the endoscopic duodenal mucosal appearance for the diagnosis of IL are not reported. To evaluate the utility of endoscopic images of the duodenum for diagnosis of IL. Endoscopic appearance of the duodenal mucosal might predict histopathologic diagnosis of IL with a high degree of sensitivity and specificity. 51 dogs that underwent upper gastrointestinal (GI) endoscopy and endoscopic biopsies. Retrospective review of images acquired during endoscopy. Dogs were included if adequate biopsies were obtained during upper GI endoscopy and digital images were saved during the procedure. Images were assessed for the presence and severity of IL. Using histopathology as the gold standard, the sensitivity and specificity of endoscopy for diagnosing IL were calculated. Intestinal lymphangiectasia (IL) was diagnosed in 25/51 dogs. Gross endoscopic appearance of the duodenal mucosa had a sensitivity and specificity (95% confidence interval) of 68% (46%, 84%) and 42% (24%, 63%), respectively for diagnosis of IL. Endoscopic images in cases with lymphopenia, hypocholesterolemia, and hypoalbuminemia had a sensitivity of 80%. Endoscopic duodenal mucosa appearance alone lacks specificity and has only a moderate sensitivity for diagnosis of IL. Evaluation of biomarkers associated with PLE improved the sensitivity; however, poor specificity for diagnosis of IL supports the need for histopathologic confirmation. Copyright © 2012 by the American College of Veterinary Internal Medicine.

Sensitivity and specificity: twin goals of proteomics assays. Can they be combined?

PubMed

Wilson, Robert

2013-04-01

A major ambition of proteomics is the provision of assays that can diagnose disease and monitor therapies. These assays are required to be sensitive and specific for individual proteins, and in most cases to quantify more than one protein in the same sample. The two main technologies currently used for proteomics assays are based on mass spectrometry and panels of affinity molecules such as antibodies. In the first part of this review the most sensitive existing assays based on these technologies are described and compared with the gold standard of ELISA. Analytical sensitivity is defined and related to the limit of detection, and analytical specificity is defined and shown to depend on molecular proofreading steps, similar to those applied in living systems whenever there is a need for high fidelity. It is shown that at present neither mass spectrometry nor panels of affinity molecules offer the necessary combination of sensitivity and specificity required for multiplexed assays. In the second part of this review the growing numbers of assays that use additional proofreading steps to combine sensitivity with specificity are described. These include assays based on proximity ligation and slow off-rate modified aptamers. Finally the review considers what improvements might be possible in the near future, and concludes that further development of proteomics assays incorporating advanced proofreading steps are most likely to provide the necessary combination of sensitivity and specificity, without incurring high development costs.

The prevalence and overlap of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome in men: results of the RAND Interstitial Cystitis Epidemiology male study.

PubMed

Suskind, Anne M; Berry, Sandra H; Ewing, Brett A; Elliott, Marc N; Suttorp, Marika J; Clemens, J Quentin

2013-01-01

As part of the RICE (RAND Interstitial Cystitis Epidemiology) study, we developed validated case definitions to identify interstitial cystitis/bladder pain syndrome in women and chronic prostatitis/chronic pelvic pain syndrome in men. Using population based screening methods, we applied these case definitions to determine the prevalence of these conditions in men. A total of 6,072 households were contacted by telephone to screen for men who had symptoms of interstitial cystitis/bladder pain syndrome or chronic prostatitis/chronic pelvic pain syndrome. An initial 296 men screened positive, of whom 149 met the inclusionary criteria and completed the telephone interview. For interstitial cystitis/bladder pain syndrome 2 case definitions were applied (1 with high sensitivity and 1 with high specificity), while for chronic prostatitis/chronic pelvic pain syndrome a single case definition (with high sensitivity and specificity) was used. These case definitions were used to classify subjects into groups based on diagnosis. The interstitial cystitis/bladder pain syndrome weighted prevalence estimates for the high sensitivity and high specificity definitions were 4.2% (3.1-5.3) and 1.9% (1.1-2.7), respectively. The chronic prostatitis/chronic pelvic pain syndrome weighted prevalence estimate was 1.8% (0.9-2.7). These values equate to 1,986,972 (95% CI 966,042-2,996,924) men with chronic prostatitis/chronic pelvic pain syndrome and 2,107,727 (95% CI 1,240,485-2,974,969) men with the high specificity definition of interstitial cystitis/bladder pain syndrome in the United States. The overlap between men who met the high specificity interstitial cystitis/bladder pain syndrome case definition or the chronic prostatitis/chronic pelvic pain syndrome case definition was 17%. Symptoms of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome are widespread among men in the United States. The prevalence of interstitial cystitis/bladder pain syndrome symptoms in men approaches that in women, suggesting that this condition may be underdiagnosed in the male population. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Early Diagnosis of Scrub Typhus with a Rapid Flow Assay Using Recombinant Major Outer Membrane Protein Antigen (r56) of Orientia tsutsugamushi

PubMed Central

Ching, W.-M.; Rowland, D.; Zhang, Z.; Bourgeois, A. L.; Kelly, D.; Dasch, G. A.; Devine, P. L.

2001-01-01

The variable 56-kDa major outer membrane protein of Orientia tsutsugamushi is the immunodominant antigen in human scrub typhus infections. We developed a rapid immunochromatographic flow assay (RFA) for the detection of immunoglobulin M (IgM) and IgG antibodies to O. tsutsugamushi. The RFA employs a truncated recombinant 56-kDa protein from the Karp strain as the antigen. The performance of the RFA was evaluated with a panel of 321 sera (serial bleedings of 85 individuals suspected of scrub typhus) which were collected in the Pescadore Islands, Taiwan, from 1976 to 1977. Among these 85 individuals, IgM tests were negative for 7 cases by both RFA and indirect fluorescence assay (IFA) using Karp whole-cell antigen. In 29 cases specific responses were detected by the RFA earlier than by IFA, 44 cases had the same detection time, and 5 cases were detected earlier by IFA than by RFA. For IgG responses, 4 individuals were negative with both methods, 37 cases exhibited earlier detection by RFA than IFA, 42 cases were detected at the same time, and 2 cases were detected earlier by IFA than by RFA. The sensitivities of RFA detection of antibody in sera from confirmed cases were 74 and 86% for IgM and IgG, respectively. When IgM and IgG results were combined, the sensitivity was 89%. A panel of 78 individual sera collected from patients with no evidence of scrub typhus was used to evaluate the specificity of the RFA. The specificities of the RFA were 99% for IgM and 97% for IgG. The sensitivities of IFA were 53 and 73% for IgM and IgG, respectively, and were 78% when the results of IgM and IgG were combined. The RFA test was significantly better than the IFA test for the early detection of antibody to scrub typhus in primary infections, while both tests were equally sensitive with reinfected individuals. PMID:11238230

Utility of ultrasound and magnetic resonance imaging in prenatal diagnosis of placenta accreta: A prospective study

PubMed Central

Satija, Bhawna; Kumar, Sanyal; Wadhwa, Leena; Gupta, Taru; Kohli, Supreethi; Chandoke, Rajkumar; Gupta, Pratibha

2015-01-01

Context: Placenta accreta is the abnormal adherence of the placenta to the uterine wall and the most common cause for emergency postpartum hysterectomy. Accurate prenatal diagnosis of affected pregnancies allows optimal obstetric management. Aims: To summarize our experience in the antenatal diagnosis of placenta accreta on imaging in a tertiary care setup. To compare the accuracy of ultrasound (USG) with color Doppler (CDUS) and magnetic resonance imaging (MRI) in prenatal diagnosis of placenta accreta. Settings and Design: Prospective study in a tertiary care setup. Materials and Methods: A prospective study was conducted on pregnant females with high clinical risk of placenta accreta. Antenatal diagnosis was established based on CDUS and MRI. The imaging findings were compared with final diagnosis at the time of delivery and/or pathologic examination. Statistical Analysis Used: The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for both CDUS and MRI. The sensitivity and specificity values of USG and MRI were compared by the McNemar test. Results: Thirty patients at risk of placenta accreta underwent both CDUS and MRI. Eight cases of placenta accreta were identified (3 vera, 4 increta, and 1 percreta). All patients had history of previous cesarean section. Placenta previa was present in seven out of eight patients. USG correctly identified the presence of placenta accreta in seven out of eight patients (87.5% sensitivity) and the absence of placenta accreta in 19 out of 22 patients (86.4% specificity). MRI correctly identified the presence of placenta accreta in 6 out of 8 patients (75.0% sensitivity) and absence of placenta accreta in 17 out of 22 patients (77.3% specificity). There were no statistical differences in sensitivity (P = 1.00) and specificity (P = 0.687) between USG and MRI. Conclusions: Both USG and MRI have fairly good sensitivity for prenatal diagnosis of placenta accreta; however, specificity does not appear to be as good as reported in other studies. Both modalities have complimentary role and in cases of inconclusive findings with one imaging modality, the other modality may be useful for obtaining the diagnosis. CDUS remains the first primary modality for antenatal diagnosis of placenta accreta, with MRI reserved for cases where USG is inconclusive. PMID:26752827

Screening for emotional disorders in patients with cancer using the Brief Symptom Inventory (BSI) and the BSI-18 versus a standardized psychiatric interview (the World Health Organization Composite International Diagnostic Interview).

PubMed

Grassi, Luigi; Caruso, Rosangela; Mitchell, Alex J; Sabato, Silvana; Nanni, Maria Giulia

2018-06-01

Given the adverse consequences of psychiatric and psychosocial morbidity on the quality of life for patients with cancer, prompt detection of psychological symptoms is mandatory. The authors examined the properties and accuracy of the Brief Symptom Inventory (the 53-item version [BSI] and the 18-item version [BSI-18]) for the detection of psychiatric morbidity compared with the World Health Organization Composite International Diagnostic Interview (CIDI) for International Classification of Diseases-10th Revision psychiatric diagnoses. A convenience sample of 498 patients with newly diagnosed cancer who were recruited in cancer outpatient services participated in the CIDI interview and in BSI and BSI-18 assessments. The prevalence of psychiatric morbidity was 39.75%. When participants were classified as cases using the BSI standard case rule, agreement with the CIDI was potentially acceptable (sensitivity, 72.7%; specificity, 88.7%). In contrast, the accuracy of the BSI-18 in identifying cases was poor according to the standard case rule, with very low sensitivity (29.3%) (misclassification rate, 28.7%). By using a first alternative case-rule system (a BSI-18 global severity index [GSI] T-score ≥57), sensitivity marginally improved (45%), whereas a second alternative case-rule system (a GSI T-score ≥50) significantly increased sensitivity (77.3%). In receiver operating characteristic curve analysis, a further cutoff GSI T-score ≥48 exhibited good discrimination levels (sensitivity, 82.3%; specificity, 72.4%). There were some differences in GSI cutoff T-scores according to the International Classification of Diseases-10th Revision diagnosis and sex. The BSI appeared to have acceptable diagnostic accuracy compared with a standardized psychiatric interview. For the BSI-18, it is mandatory to use alternative case-rule systems, to identify patients with psychiatric morbidity. Cancer 2018;124:2415-26. © 2018 American Cancer Society. © 2018 American Cancer Society.

Clinical evaluation and validation of laboratory methods for the diagnosis of Bordetella pertussis infection: Culture, polymerase chain reaction (PCR) and anti-pertussis toxin IgG serology (IgG-PT).

PubMed

Lee, Adria D; Cassiday, Pamela K; Pawloski, Lucia C; Tatti, Kathleen M; Martin, Monte D; Briere, Elizabeth C; Tondella, M Lucia; Martin, Stacey W

2018-01-01

The appropriate use of clinically accurate diagnostic tests is essential for the detection of pertussis, a poorly controlled vaccine-preventable disease. The purpose of this study was to estimate the sensitivity and specificity of different diagnostic criteria including culture, multi-target polymerase chain reaction (PCR), anti-pertussis toxin IgG (IgG-PT) serology, and the use of a clinical case definition. An additional objective was to describe the optimal timing of specimen collection for the various tests. Clinical specimens were collected from patients with cough illness at seven locations across the United States between 2007 and 2011. Nasopharyngeal and blood specimens were collected from each patient during the enrollment visit. Patients who had been coughing for ≤ 2 weeks were asked to return in 2-4 weeks for collection of a second, convalescent blood specimen. Sensitivity and specificity of each diagnostic test were estimated using three methods-pertussis culture as the "gold standard," composite reference standard analysis (CRS), and latent class analysis (LCA). Overall, 868 patients were enrolled and 13.6% were B. pertussis positive by at least one diagnostic test. In a sample of 545 participants with non-missing data on all four diagnostic criteria, culture was 64.0% sensitive, PCR was 90.6% sensitive, and both were 100% specific by LCA. CRS and LCA methods increased the sensitivity estimates for convalescent serology and the clinical case definition over the culture-based estimates. Culture and PCR were most sensitive when performed during the first two weeks of cough; serology was optimally sensitive after the second week of cough. Timing of specimen collection in relation to onset of illness should be considered when ordering diagnostic tests for pertussis. Consideration should be given to including IgG-PT serology as a confirmatory test in the Council of State and Territorial Epidemiologists (CSTE) case definition for pertussis.

Nested PCR for specific diagnosis of Taenia solium taeniasis.

PubMed

Mayta, Holger; Gilman, Robert H; Prendergast, Emily; Castillo, Janeth P; Tinoco, Yeny O; Garcia, Hector H; Gonzalez, Armando E; Sterling, Charles R

2008-01-01

Taeniasis due to Taenia solium is a disease with important public health consequences, since the larval stage is not exclusive to the animal intermediate, the pig, but also infects humans, causing neurocysticercosis. Early diagnosis and treatment of T. solium tapeworm carriers is important to prevent human cysticercosis. Current diagnosis based on microscopic observation of eggs lacks both sensitivity and specificity. In the present study, a nested-PCR assay targeting the Tso31 gene was developed for the specific diagnosis of taeniasis due to T. solium. Initial specificity and sensitivity testing was performed using stored known T. solium-positive and -negative samples. The assay was further analyzed under field conditions by conducting a case-control study of pretreatment stool samples collected from a population in an area of endemicity. Using the archived samples, the assay showed 97% (31/32) sensitivity and 100% (123/123) specificity. Under field conditions, the assay had 100% sensitivity and specificity using microscopy/enzyme-linked immunosorbent assay coproantigen testing as the gold standards. The Tso31 nested PCR described here might be a useful tool for the early diagnosis and prevention of taeniasis/cysticercosis.

Evaluation of a new point-of-care test for influenza A and B virus in travellers with influenza-like symptoms.

PubMed

Weitzel, T; Schnabel, E; Dieckmann, S; Börner, U; Schweiger, B

2007-07-01

Point-of-care (POC) tests for influenza facilitate clinical case management, and might also be helpful in the care of travellers who are at special risk for influenza infection. To evaluate influenza POC testing in travellers, a new assay, the ImmunoCard STAT! Flu A and B, was used to investigate travellers presenting with influenza-like symptoms. Influenza virus infection was diagnosed in 27 (13%) of 203 patients by influenza virus-specific PCR and viral culture. The POC test had sensitivity and specificity values of 64% and 99% for influenza A, and 67% and 100% for influenza B, respectively. Combined sensitivity and specificity were 67% and 99%, respectively, yielding positive and negative predictive values of 95%, and positive and negative likelihood ratios of 117 and 0.34, respectively. The convenient application, excellent specificity and high positive likelihood ratio of the POC test allowed rapid identification of influenza cases. However, negative test results might require confirmation by other methods because of limitations in sensitivity. Overall, influenza POC testing appeared to be a useful tool for the management of travellers with influenza-like symptoms.

Low sensitivity of implant sonication when screening for infection in revision surgery

PubMed Central

Van Diek, Floor M; Albers, Christiaan G M; Van Hooff, Miranda L; Meis, Jacques F; Goosen, Jon H M

2017-01-01

Background and purpose Prosthetic-joint infection (PJI) is the most serious complication of arthroplasty, and accurate identification of a potentially responsible microorganism is essential for successful antibiotic treatment. We therefore determined the diagnostic accuracy of sonication and compared it with tissue culture as a screening tool in detecting prosthetic joint infection in revision arthroplasty. Patients and methods 252 consecutive revision arthroplasty cases were enrolled. These cases were determined as being suspected or unsuspected of having infection according to standard criteria. Perioperatively, 6 periprosthetic interface tissue biopsies were obtained from each patient and the implants removed were sonicated. The sensitivity and specificity of periprosthetic tissue culture and sonication fluid cultures were determined. Results Preoperatively, 75 revision cases were classified as having PJI (33 early and 42 late) and 177 were unsuspected of having infection. Compared with tissue culture, the sensitivity of the sonication fluid analysis was low: 0.47 (95% CI: 0.35–0.59) for sonication as compared to 0.68 (95% CI: 0.56–0.78) for tissue culture. The specificity of the sonication fluid analysis was higher than that for tissue culture: 0.99 (95% CI: 0.96–1.0) as compared to 0.80 (95% CI: 0.74–0.86). Interpretation Sonication is a highly specific test for diagnosis of PJI. However, due to the low sensitivity, a negative sonication result does not rule out the presence of PJI. Thus, sonication is not of value for screening of microorganisms during revision surgery. PMID:28287012

A new multiplex real-time polymerase chain reaction assay for the diagnosis of periprosthetic joint infection.

PubMed

Kawamura, Masaki; Kobayashi, Naomi; Inaba, Yutaka; Choe, Hyonmin; Tezuka, Taro; Kubota, So; Saito, Tomoyuki

2017-11-01

A new multiplex real-time polymerase chain reaction (PCR) assay was developed to detect methicillin-resistant Staphylococcus (MRS) and to distinguish between gram-positive and gram-negative bacteria. In this study, we validated the sensitivity and specificity of this assay with periprosthetic joint infections (PJIs) and evaluated the utility of PCR for culture-negative PJI. Forty-five samples from 23 infectious PJI cases and 106 samples from 64 non-infectious control cases were analyzed by real-time PCR using a LightCycler Nano ® system. Twenty-eight clinical samples, comprising bacteria of known species isolated consecutively in the microbiological laboratory of our hospital, were used to determine the spectrum of bacterial species that could be detected using the new multiplex primers and probes. The sensitivity and specificity of the MRS- and universal-PCR assays were 92% and 99%, and 91% and 88%, respectively. Twenty-eight species of clinically isolated bacteria were detected using this method and the concordance rate for the identification of gram-positive or gram-negative organisms was 96%. Eight samples were identified as PCR-positive despite a culture-negative result. This novel multiplex real-time PCR system has acceptable sensitivity and specificity and several advantages; therefore, it has potential use for the diagnosis of PJIs, particularly in culture-negative cases.

Application of a protocol for magnetic resonance spectroscopy of adrenal glands: an experiment with over 100 cases.

PubMed

Melo, Homero José de Farias E; Goldman, Suzan M; Szejnfeld, Jacob; Faria, Juliano F; Huayllas, Martha K P; Andreoni, Cássio; Kater, Cláudio E

2014-01-01

To evaluate a protocol for two-dimensional (2D) hydrogen proton (1H) magnetic resonance spectroscopy (MRS) (Siemens Medical Systems; Erlangen, Germany) in the detection of adrenal nodules and differentiation between benign and malignant masses (adenomas, pheochromocytomas, carcinomas and metastases). A total of 118 patients (36 men; 82 women) (mean age: 57.3 ± 13.3 years) presenting with 138 adrenal nodules/masses were prospectively assessed. A multivoxel system was utilized with a 2D point-resolved spectroscopy/chemical shift imaging sequence. The following ratios were calculated: choline (Cho)/creatine (Cr), 4.0-4.3/Cr, lipid (Lip)/Cr, Cho/Lip and lactate (Lac)/Cr. 2D-1H-MRS was successful in 123 (89.13%) lesions. Sensitivity and specificity values observed for the ratios and cutoff points were the following: Cho/Cr ≥ 1.2, 100% sensitivity, 98.2% specificity (differences between adenomas/pheochromocytomas and carcinomas/ metastases); 4.0-4.3 ppm/Cr ≥ 1.5, 92.3% sensitivity, 96.9% specificity (differences between carcinomas/pheochromocytomas and adenomas/metastases); Lac/Cr ≤ -7.449, 90.9% sensitivity and 77.8% specificity (differences between pheochromocytomas and carcinomas/adenomas). Information provided by 2D-1H-MRS were effective and allowed for the differentiation between adrenal masses and nodules in most cases of lesions with > 1.0 cm in diameter.

Safety and clinical performance of acoustic reflex tests.

PubMed

Hunter, L L; Ries, D T; Schlauch, R S; Levine, S C; Ward, W D

1999-12-01

Safety and effectiveness of acoustic reflex tests are important issues because these tests are widely applied to screen for retrocochlear pathology. Previous studies have reported moderately high sensitivity and specificity for detection of acoustic neuroma. However, there have been reports of possible iatrogenic hearing loss resulting from acoustic reflex threshold (ART) and decay (ARD) tests. This study assessed safety and clinical performance of ART tests for detection of acoustic neuroma. We report a case in which ARD testing resulted in a significant bilateral permanent threshold shift. This case was the impetus for us to investigate the clinical utility of ART and ARD tests. We analyzed sensitivity and specificity of ART, as well as asymmetry in pure-tone thresholds (PTT) for detection of acoustic neuroma in 56 tumor and 108 non-tumor ears. Sensitivity and specificity were higher for PTT asymmetry than for ART. Ipsilateral ART at 1000 Hz had poor sensitivity and specificity for detection of acoustic neuroma, and involves some potential risk to residual hearing for presentation levels higher than 115 dB SPL. Approximately half of the acoustic neuroma group had ipsilateral ARTs that would require administration of ARD tests at levels exceeding 115 dB SPL. Therefore, we conclude that PTT asymmetry is a more effective test for detection of acoustic neuroma, and involves no risk to residual hearing. Future studies of contralateral reflex threshold and ARD in combination with PTT asymmetry are recommended.

Comparing the usefulness of the 1997 and 2009 WHO dengue case classification: a systematic literature review.

PubMed

Horstick, Olaf; Jaenisch, Thomas; Martinez, Eric; Kroeger, Axel; See, Lucy Lum Chai; Farrar, Jeremy; Ranzinger, Silvia Runge

2014-09-01

The 1997 and 2009 WHO dengue case classifications were compared in a systematic review with 12 eligible studies (4 prospective). Ten expert opinion articles were used for discussion. For the 2009 WHO classification studies show: when determining severe dengue sensitivity ranges between 59-98% (88%/98%: prospective studies), specificity between 41-99% (99%: prospective study) - comparing the 1997 WHO classification: sensitivity 24.8-89.9% (24.8%/74%: prospective studies), specificity: 25%/100% (100%: prospective study). The application of the 2009 WHO classification is easy, however for (non-severe) dengue there may be a risk of monitoring increased case numbers. Warning signs validation studies are needed. For epidemiological/pathogenesis research use of the 2009 WHO classification, opinion papers show that ease of application, increased sensitivity (severe dengue) and international comparability are advantageous; 3 severe dengue criteria (severe plasma leakage, severe bleeding, severe organ manifestation) are useful research endpoints. The 2009 WHO classification has clear advantages for clinical use, use in epidemiology is promising and research use may at least not be a disadvantage. © The American Society of Tropical Medicine and Hygiene.

Anti-nucleosome antibodies in patients with systemic lupus erythematosus: potential utility as a diagnostic tool and disease activity marker and its comparison with anti-dsDNA antibody.

PubMed

Saigal, Renu; Goyal, Laxmi Kant; Agrawal, Abhishek; Mehta, Archna; Mittal, Pradeep; Yadav, R N; Meena, P D; Wadhvani, Dilip

2013-06-01

To compare the utility of anti-nucleosome antibodies and anti-dsDNA antibodies in diagnosis of Systemic Lupus Erythematosus (SLE) and as a marker of disease activity. This is a hospital based observational study among 40 (37 females and 3 males) selected cases of SLE (> or = 4 ACR criteria) and 80 control. 40 cases of other systemic autoimmune disease (SAD) [e g. 29 cases of Rheumatoid arthritis, 4 cases of Systemic sclerosis/scleroderma, 4 cases of Sjögren syndrome, 3 cases of MCTD and 40 Healthy blood were taken as control. From each patient venous blood samples were collected and submitted for anti-nucleosome and anti-dsDNA antibodies assay by enzyme linked immunosorbent assay (ELISA). Anti-nucleosome antibodies were positive in 19 (47.5%) SLE, 02 (05%) other SAD and none of the healthy persons. Anti dsDNA antibodies were positive in 15 (37.5%) SLE patients, 07 (17.5%) other SAD and 01(2.5%) healthy persons. For diagnosis of SLE, sensitivity of anti-ds DNA and anti-nucleosome antibody was found to be 37.5% and 47.50% respectively. The specificity of anti-nucleosome was 100% and that of anti-dsDNA was 97.50%. So, anti-nucleosome antibody test is more specific and more sensitive for diagnosis of SLE than anti-dsDNA. When SLE cases were compared with SAD, sensitivity of anti-dsDNA and anti-nucleosome antibody, for diagnosis of SLE, found to be 37.50% and 47.50% respectively but the specificity of anti-nucleosome was 95% and that of anti-dsDNA was 82.50%. Both antibodies show positive correlation with SLEDAI score .The correlation coefficient was stronger for anti-dsDNA antibodies (r = +0.550, P = < .001) than anti-nucleosome antibodies (r = +0.332, P = < .05) CONCLUSIONS: Anti-nucleosome antibodies show higher positivity than anti-dsDNA antibodies among SLE than other SAD and healthy population. Anti-nucleosome antibodies are more sensitive and specific for the diagnosis of SLE than anti-dsDNA antibodies. Anti-nucleosome and anti-dsDNA both show positive correlation with SLEDAI. But anti-dsDNA antibodies show stronger correlation with SLEDAI than anti-nucleosome. So, anti-nucleosome antibodies can be used as an additional marker for diagnosis of SLE and SLE disease activity.

The Clinical Impact of Bet v 6 in Birch Pollen-Sensitized Patients.

PubMed

Gellrich, Donata; Eder, Katharina; San Nicoló, Marion; Berghaus, Alexander; Gröger, Moritz

2017-01-01

Bet v 6, a minor birch pollen allergen, is commercially available for allergen-specific IgE antibody testing. However, there is hardly any literature on the clinical impact of Bet v 6. The aim of the present study was to analyze if testing specific IgE against Bet v 6 can add valuable benefit to the standard diagnostics of birch pollen-sensitized patients, especially in patients with unknown sensitization-eliciting allergens. Birch pollen-sensitized patients with missing IgE reactivity against Bet v 1, 2, and 4 were tested for specific IgE antibodies against Bet v 6. For comparison, an equal number of randomly selected patients with birch pollen sensitization, regardless of their individual sensitization patterns, were tested for specific anti-Bet v 6. Of 57 cases with missing reactivity against the standard birch pollen allergens, 2 patients were positive for Bet v 6. In the representative sample, 3 patients showed specific IgE against Bet v 6 - resulting in a total prevalence of 5%. None of the Bet v 6-positive patients showed allergic symptoms after exposure to birch pollen or an oral allergy syndrome. An increased prevalence of asthma and a higher degree of sensitization were the only distinctive clinical features in Bet v 6-positive patients. Among birch pollen-sensitized patients, the prevalence of specific IgE against Bet v 6 is low. Further, sensitization to Bet v 6, which shows characteristics of a panallergen, remains clinically silent. Therefore, determination of anti-Bet v 6 is not considered useful in the clinical routine. © 2017 S. Karger AG, Basel.

Evaluation of NGS and RT-PCR Methods for ALK Rearrangement in European NSCLC Patients: Results from the European Thoracic Oncology Platform Lungscape Project.

PubMed

Letovanec, Igor; Finn, Stephen; Zygoura, Panagiota; Smyth, Paul; Soltermann, Alex; Bubendorf, Lukas; Speel, Ernst-Jan; Marchetti, Antonio; Nonaka, Daisuke; Monkhorst, Kim; Hager, Henrik; Martorell, Miguel; Sejda, Aleksandra; Cheney, Richard; Hernandez-Losa, Javier; Verbeken, Eric; Weder, Walter; Savic, Spasenija; Di Lorito, Alessia; Navarro, Atilio; Felip, Enriqueta; Warth, Arne; Baas, Paul; Meldgaard, Peter; Blackhall, Fiona; Dingemans, Anne-Marie; Dienemann, Hendrik; Dziadziuszko, Rafal; Vansteenkiste, Johan; O'Brien, Cathal; Geiger, Thomas; Sherlock, Jon; Schageman, Jeoffrey; Dafni, Urania; Kammler, Roswitha; Kerr, Keith; Thunnissen, Erik; Stahel, Rolf; Peters, Solange

2018-03-01

The reported prevalence of ALK receptor tyrosine kinase gene (ALK) rearrangement in NSCLC ranges from 2% to 7%. The primary standard diagnostic method is fluorescence in situ hybridization (FISH). Recently, immunohistochemistry (IHC) has also proved to be a reproducible and sensitive technique. Reverse-transcriptase polymerase chain reaction (RT-PCR) has also been advocated, and most recently, the advent of targeted next-generation sequencing (NGS) for ALK and other fusions has become possible. This study compares anaplastic lymphoma kinase (ALK) evaluation with all four techniques in resected NSCLC from the large European Thoracic Oncology Platform Lungscape cohort. A total of 96 cases from the European Thoracic Oncology Platform Lungscape iBiobank, with any ALK immunoreactivity were examined by FISH, central RT-PCR, and NGS. An H-score higher than 120 defines IHC positivity. RNA was extracted from the same formalin-fixed, paraffin-embedded tissues. For RT-PCR, primers covered the most frequent ALK translocations. For NGS, the Oncomine Solid Tumour Fusion Transcript Kit (Thermo Fisher Scientific, Waltham, MA) was used. The concordance was assessed using the Cohen κ coefficient (two-sided α ≤ 5%). NGS provided results for 77 of the 95 cases tested (81.1%), whereas RT-PCR provided results for 77 of 96 (80.2%). Concordance occurred in 55 cases of the 60 cases tested with all four methods (43 ALK negative and 12 ALK positive). Using ALK copositivity for IHC and FISH as the criterion standard, we derived a sensitivity for RT-PCR/NGS of 70.0%/85.0%, with a specificity of 87.1%/79.0%. When either RT-PCR or NGS was combined with IHC, the sensitivity remained the same, whereas the specificity increased to 88.7% and 83.9% respectively. NGS evaluation with the Oncomine Solid Tumour Fusion transcript kit and RT-PCR proved to have high sensitivity and specificity, advocating their use in routine practice. For maximal sensitivity and specificity, ALK status should be assessed by using two techniques and a third one in discordant cases. We therefore propose a customizable testing algorithm. These findings significantly influence existing testing paradigms and have clear clinical and economic impact. Copyright © 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

[Diagnostic values of plasma CD64 and sTREM-1 for pediatric pneumonia].

PubMed

Zhong, Mei-Feng; Zhao, Jian-Mei

2016-07-01

To determine the diagnostic values of plasma CD64 and soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) in children with pneumonia. Sixty children with pneumonia between August 2014 and October 2015 were classified into bacterial pneumonia group (25 cases), viral pneumonia group (17 cases), and Mycoplasma pneumonia group (18 cases) according to their clinical manifestations, pathogen cultures, and X-ray findings. Another 30 healthy children who underwent physical examination during the same period were selected as the control group. The concentrations of CD64 and sTREM-1 in blood samples were determined using ELISA. The receiver operating characteristic (ROC) curve was used to evaluate the diagnostic sensitivity and specificity of plasma CD64 and/or sTREM-1 for bacterial pneumonia. The expression of CD64 and sTREM-1 in the bacterial pneumonia group was significantly higher than that in the viral pneumonia, Mycoplasma pneumonia, and control groups (P<0.05). The areas under the ROC curves of CD64, sTREM-1, and a combination of the two markers for diagnosing bacterial pneumonia were 0.878, 0.805, and 0.956, respectively. The sensitivity and specificity of CD64 for diagnosing bacterial pneumonia were 81.30% and 92.32%, respectively, when the cut-off value was 641 pg/mL. The sensitivity and specificity of sTREM-1 for diagnosing bacterial pneumonia were 78.65% and 84.67%, respectively, when the cut-off value was 1 479 pg/mL. The sensitivity and specificity of a combination of the two markers for diagnosing bacterial pneumonia were 93.15% and 91.54%, respectively. Plasma CD64 and sTREM-1 can be used as markers for diagnosing pediatric bacterial pneumonia, and a combination of the two markers results in better diagnosis.

Comparison of Abbott RealTime High-Risk HPV and Hybrid Capture 2 Assays for Detection of HPV Infection.

PubMed

Ko, Kiwoong; Yu, Shinae; Lee, Eun Hee; Park, Hyosoon; Woo, Hee-Yeon; Kwon, Min-Jung

2016-09-01

Various assays for detecting high-risk human papillomavirus (HR HPV) have been introduced recently, including the Abbott RealTime High-Risk HPV assay. We sought to compare the performance of Abbott PCR to Hybrid Capture 2 for the detection of HR HPV. A total of 941 cervical swab specimens were obtained. We submitted all specimens for HR HPV detection with HC2 and Abbott PCR, and then additionally analyzed discordant and concordant positive results using restriction fragment mass polymorphism (RFMP) genotyping analysis. HC2 detected one of 13 HR HPV types in 12.3% (116/941) of cases, while Abbott PCR detected one of 14 detectable HR HPV types in 12.9% (121/941) of cases. The overall agreement rate was 97.3% with a kappa coefficient of 0.879. Discordant results between these two assays were observed in 25 cases. HC2 showed a sensitivity of 90.0% and specificity of 95.9%, while Abbott PCR showed a sensitivity of 98.0% and specificity of 96.8% when using RFMP results as the gold standard. For HPV 16/18 detection, Abbott PCR showed 95.8%/88.9% sensitivity and 99.2%/99.8% specificity, respectively. The overall coinfection rate between HPV 16, 18 and non-16/18 was 9.9% (12/121) in Abbott PCR analysis. Considering its high agreement rate with HC2, higher sensitivity/specificity compared to HC2, and ability to differentiate HPV 16/18 from other HPV types, Abbott PCR could be a reliable laboratory testing method for the screening of HPV infections. © 2016 by the Association of Clinical Scientists, Inc.

Evaluation of the SD Bioline Cholera Rapid Diagnostic Test During the 2016 Cholera Outbreak in Lusaka, Zambia.

PubMed

Mwaba, John; Ferreras, Eva; Chizema-Kawesa, Elizabeth; Mwimbe, Daniel; Tafirenyika, Francis; Rauzier, Jean; Blake, Alexandre; Rakesh, Ankur; Poncin, Marc; Stoitsova, Savina; Kwenda, Geoffrey; Azman, Andrew S; Chewe, Orbrie; Serafini, Micaela; Lukwesa-Musyani, Chileshe; Cohuet, Sandra; Quilici, Marie-Laure; Luquero, Francisco J; Page, Anne-Laure

2018-05-31

To assess the performance of the SD Bioline Cholera Ag O1/O139 rapid diagnostic test (RDT) compared to a reference standard combining culture and PCR for the diagnosis of cholera cases during an outbreak. RDT and bacterial culture were performed on site using fresh stools collected from cholera suspected cases, and from stools enriched in alkaline peptone water. Dried stool samples on filter paper were tested for V. cholerae by PCR in Lusaka (as part of a laboratory technology transfer project) and at a reference laboratory in Paris, France. A sample was considered positive for cholera by the reference standard if any of the culture or PCR tests was positive for V. cholerae O1 or O139. Among the 170 samples tested with SD Bioline and compared to the reference standard, the RDT showed a sensitivity of 90.9% (95% CI: 81.3-96.6) and specificity of 95.0% (95% CI: 89.1-98.4). After enrichment, the sensitivity was 95.5% (95% CI: 87.3-99.1) and specificity 100% (5% CI: 96.5-100). The observed sensitivity and specificity were within recommendations set by the Global Task Force for Cholera Control on the use of cholera RDT (sensitivity=90% : specificity=85%). Although the sample size was small, our findings suggest that the SD Bioline RDT could be used in the field to rapidly alert public health officials to the likely presence of cholera cases when an outbreak is suspected. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Assessment of algorithms to identify patients with thrombophilia following venous thromboembolism.

PubMed

Delate, Thomas; Hsiao, Wendy; Kim, Benjamin; Witt, Daniel M; Meyer, Melissa R; Go, Alan S; Fang, Margaret C

2016-01-01

Routine testing for thrombophilia following venous thromboembolism (VTE) is controversial. The use of large datasets to study the clinical impact of thrombophilia testing on patterns of care and patient outcomes may enable more efficient analysis of this practice in a wide range of settings. We set out to examine how accurately algorithms using International Classification of Diseases 9th Revision (ICD-9) codes and/or pharmacy data reflect laboratory-confirmed thrombophilia diagnoses. A random sample of adult Kaiser Permanente Colorado patients diagnosed with unprovoked VTE between 1/2004 and 12/2010 underwent medical record abstraction of thrombophilia test results. Algorithms using "ICD-9" (positive if a thrombophilia ICD-9 code was present), "Extended anticoagulation (AC)" (positive if AC therapy duration was >6 months), and "ICD-9 & Extended AC" (positive for both) criteria to identify possible thrombophilia cases were tested. Using positive thrombophilia laboratory results as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value of each algorithm were calculated, along with 95% confidence intervals (CIs). In our cohort of 636 patients, sensitivities were low (<50%) for each algorithm. "ICD-9" yielded the highest PPV (41.5%, 95% CI 26.3-57.9%) and a high specificity (95.9%, 95% CI 94.0-97.4%). "Extended AC" had the highest sensitivity but lowest specificity, and "ICD-9 & Extended AC" had the highest specificity but lowest sensitivity. ICD-9 codes for thrombophilia are highly specific for laboratory-confirmed cases, but all algorithms had low sensitivities. Further development of methods to identify thrombophilia patients in large datasets is warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Automatic Detection of Diabetic Retinopathy and Age-Related Macular Degeneration in Digital Fundus Images

PubMed Central

Barriga, E. Simon; Murray, Victor; Nemeth, Sheila; Crammer, Robert; Bauman, Wendall; Zamora, Gilberto; Pattichis, Marios S.; Soliz, Peter

2011-01-01

Purpose. To describe and evaluate the performance of an algorithm that automatically classifies images with pathologic features commonly found in diabetic retinopathy (DR) and age-related macular degeneration (AMD). Methods. Retinal digital photographs (N = 2247) of three fields of view (FOV) were obtained of the eyes of 822 patients at two centers: The Retina Institute of South Texas (RIST, San Antonio, TX) and The University of Texas Health Science Center San Antonio (UTHSCSA). Ground truth was provided for the presence of pathologic conditions, including microaneurysms, hemorrhages, exudates, neovascularization in the optic disc and elsewhere, drusen, abnormal pigmentation, and geographic atrophy. The algorithm was used to report on the presence or absence of disease. A detection threshold was applied to obtain different values of sensitivity and specificity with respect to ground truth and to construct a receiver operating characteristic (ROC) curve. Results. The system achieved an average area under the ROC curve (AUC) of 0.89 for detection of DR and of 0.92 for detection of sight-threatening DR (STDR). With a fixed specificity of 0.50, the system's sensitivity ranged from 0.92 for all DR cases to 1.00 for clinically significant macular edema (CSME). Conclusions. A computer-aided algorithm was trained to detect different types of pathologic retinal conditions. The cases of hard exudates within 1 disc diameter (DD) of the fovea (surrogate for CSME) were detected with very high accuracy (sensitivity = 1, specificity = 0.50), whereas mild nonproliferative DR was the most challenging condition (sensitivity= 0.92, specificity = 0.50). The algorithm was also tested on images with signs of AMD, achieving a performance of AUC of 0.84 (sensitivity = 0.94, specificity = 0.50). PMID:21666234

Automatic detection of diabetic retinopathy and age-related macular degeneration in digital fundus images.

PubMed

Agurto, Carla; Barriga, E Simon; Murray, Victor; Nemeth, Sheila; Crammer, Robert; Bauman, Wendall; Zamora, Gilberto; Pattichis, Marios S; Soliz, Peter

2011-07-29

To describe and evaluate the performance of an algorithm that automatically classifies images with pathologic features commonly found in diabetic retinopathy (DR) and age-related macular degeneration (AMD). Retinal digital photographs (N = 2247) of three fields of view (FOV) were obtained of the eyes of 822 patients at two centers: The Retina Institute of South Texas (RIST, San Antonio, TX) and The University of Texas Health Science Center San Antonio (UTHSCSA). Ground truth was provided for the presence of pathologic conditions, including microaneurysms, hemorrhages, exudates, neovascularization in the optic disc and elsewhere, drusen, abnormal pigmentation, and geographic atrophy. The algorithm was used to report on the presence or absence of disease. A detection threshold was applied to obtain different values of sensitivity and specificity with respect to ground truth and to construct a receiver operating characteristic (ROC) curve. The system achieved an average area under the ROC curve (AUC) of 0.89 for detection of DR and of 0.92 for detection of sight-threatening DR (STDR). With a fixed specificity of 0.50, the system's sensitivity ranged from 0.92 for all DR cases to 1.00 for clinically significant macular edema (CSME). A computer-aided algorithm was trained to detect different types of pathologic retinal conditions. The cases of hard exudates within 1 disc diameter (DD) of the fovea (surrogate for CSME) were detected with very high accuracy (sensitivity = 1, specificity = 0.50), whereas mild nonproliferative DR was the most challenging condition (sensitivity = 0.92, specificity = 0.50). The algorithm was also tested on images with signs of AMD, achieving a performance of AUC of 0.84 (sensitivity = 0.94, specificity = 0.50).

Sensitivity and specificity of General Movements Assessment for diagnostic accuracy of detecting cerebral palsy early in an Australian context.

PubMed

Morgan, Catherine; Crowle, Cathryn; Goyen, Traci-Anne; Hardman, Caroline; Jackman, Michelle; Novak, Iona; Badawi, Nadia

2016-01-01

The aim of this study was to calculate the sensitivity and specificity of the General Movements Assessment (GMA) for estimating diagnostic accuracy in detecting cerebral palsy (CP) in an Australian context by a newly established NSW rater network. A prospective longitudinal cross-sectional study was conducted. The GMA was blind-rated from conventional video by two independent certified raters, blinded to medical history. A third rater resolved disagreements. High-risk population screening for CP using the GMA during the fidgety period (12-20 weeks) was carried out in four neonatal intensive care units and one CP service over a 30-month period (2012-2013). Participants were 259 high-risk infants. Sensitivity and specificity values were calculated with true positives defined as a confirmed diagnosis of CP from a medical doctor. Of the 259 infants assessed, 1-year follow-up data were available for 187. Of these, n = 48 had absent fidgety (high risk for CP), n = 138 had normal fidgety (low risk for CP), and n = 1 had abnormal fidgety (high risk for a neurological disorder). Of the 48 with absent fidgety movements, 39 had received a diagnosis of CP by 18 months and another 6 had an abnormal outcome. Of the n = 138 normal fidgety cases, n = 99 cases had a normal outcome, n = 38 had an abnormal outcome but not CP, and n = 1 had CP. For detecting CP, we had a sensitivity of 98% and specificity of 94%. GMA was feasible in an Australian context and accurately identified CP with a sensitivity and specificity comparable with European standards and published neuroimaging data. © 2015 The Authors. Journal of Paediatrics and Child Health © 2015 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Professionals' Attitude Toward Reporting Child Sexual Abuse in Saudi Arabia.

PubMed

Al-Saif, Dalia M; Al-Eissa, Majid; Saleheen, Hassan; Al-Mutlaq, Huda; Everson, Mark D; Almuneef, Maha A

2018-01-01

Child sexual abuse (CSA) requires specialized knowledge and training that includes forensic interview skills. The aim of this study was to determine variations in professionals' attitudes toward CSA by measuring three aspects of forensic attitudes (sensitivity, specificity, and skepticism) and evaluating disagreements concerning the assessment of CSA cases in Saudi Arabia. A cross-sectional, web-based study, in which the Child Forensic Attitude Scale was used to measure professionals' attitudes, was conducted. Professionals who dealt with suspected cases of CSA as part of their jobs or were in professions that necessitated involvement with such cases, were selected as participants. Of 327 participants, 53% were aged ≤40 years, and 54% were men. In addition, 24% were doctors/nurses, 20% were therapists/psychiatrists, 24% were social workers, 17% were educators, 9% were law enforcement professionals, and 5% were medical examiners. Attitude subscale scores differed significantly according to participants' sex, specialty, and training. Women, healthcare professionals, and those who had participated in more than five training courses were more concerned about the underreporting of abuse (high sensitivity) relative to other professionals. In comparison, men, medical examiners, law enforcement officers, and undertrained professionals tended to underreport suspected sexual abuse cases (high specificity). High specificity in attitudes toward suspected cases of CSA could affect professionals' judgment and contribute to low reporting rates. Certain strategies, including increasing self-awareness of personal bias, specific CSA recognition courses, and team approaches to case assessment and management, should be implemented to control the influence of subjective factors.

Local connected fractal dimension analysis in gill of fish experimentally exposed to toxicants.

PubMed

Manera, Maurizio; Giari, Luisa; De Pasquale, Joseph A; Sayyaf Dezfuli, Bahram

2016-06-01

An operator-neutral method was implemented to objectively assess European seabass, Dicentrarchus labrax (Linnaeus, 1758) gill pathology after experimental exposure to cadmium (Cd) and terbuthylazine (TBA) for 24 and 48h. An algorithm-derived local connected fractal dimension (LCFD) frequency measure was used in this comparative analysis. Canonical variates (CVA) and linear discriminant analysis (LDA) were used to evaluate the discrimination power of the method among exposure classes (unexposed, Cd exposed, TBA exposed). Misclassification, sensitivity and specificity, both with original and cross-validated cases, were determined. LCFDs frequencies enhanced the differences among classes which were visually selected after their means, respective variances and the differences between Cd and TBA exposed means, with respect to unexposed mean, were analyzed by scatter plots. Selected frequencies were then scanned by means of LDA, stepwise analysis, and Mahalanobis distance to detect the most discriminative frequencies out of ten originally selected. Discrimination resulted in 91.7% of cross-validated cases correctly classified (22 out of 24 total cases), with sensitivity and specificity, respectively, of 95.5% (1 false negative with respect to 21 really positive cases) and 75% (1 false positive with respect to 3 really negative cases). CVA with convex hull polygons ensured prompt, visually intuitive discrimination among exposure classes and graphically supported the false positive case. The combined use of semithin sections, which enhanced the visual evaluation of the overall lamellar structure; of LCFD analysis, which objectively detected local variation in complexity, without the possible bias connected to human personnel; and of CVA/LDA, could be an objective, sensitive and specific approach to study fish gill lamellar pathology. Furthermore this approach enabled discrimination with sufficient confidence between exposure classes or pathological states and avoided misdiagnosis. Copyright © 2016 Elsevier B.V. All rights reserved.

Proteomic Profiling of Serial Prediagnostic Serum Samples for Early Detection of Colon Cancer in the U.S. Military.

PubMed

Shao, Stephanie; Neely, Benjamin A; Kao, Tzu-Cheg; Eckhaus, Janet; Bourgeois, Jolie; Brooks, Jasmin; Jones, Elizabeth E; Drake, Richard R; Zhu, Kangmin

2017-05-01

Background: Serum proteomic biomarkers offer a promising approach for early detection of cancer. In this study, we aimed to identify proteomic profiles that could distinguish colon cancer cases from controls using serial prediagnostic serum samples. Methods: This was a nested case-control study of active duty military members. Cases consisted of 264 patients diagnosed with colon cancer between 2001 and 2009. Controls were matched to cases on age, gender, race, serum sample count, and collection date. We identified peaks that discriminated cases from controls using random forest data analysis with a 2/3 training and 1/3 validation dataset. We then included epidemiologic data to see whether further improvement of model performance was obtainable. Proteins that corresponded to discriminatory peaks were identified. Results: Peaks with m/z values of 3,119.32, 2,886.67, 2,939.23, and 5,078.81 were found to discriminate cases from controls with a sensitivity of 69% and a specificity of 67% in the year before diagnosis. When smoking status was included, sensitivity increased to 76% while histories of other cancer and tonsillectomy raised specificity to 76%. Peaks at 2,886.67 and 3,119.32 m/z were identified as histone acetyltransferases while 2,939.24 m/z was a transporting ATPase subunit. Conclusions: Proteomic profiles in the year before cancer diagnosis have the potential to discriminate colon cancer patients from controls, and the addition of epidemiologic information may increase the sensitivity and specificity of discrimination. Impact: Our findings indicate the potential value of using serum prediagnostic proteomic biomarkers in combination with epidemiologic data for early detection of colon cancer. Cancer Epidemiol Biomarkers Prev; 26(5); 711-8. ©2016 AACR . ©2016 American Association for Cancer Research.

Sensitivity and specificity of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC) for detecting post-cardiac surgery delirium: A single-center study in Japan.

PubMed

Nishimura, Katsuji; Yokoyama, Kanako; Yamauchi, Noriko; Koizumi, Masako; Harasawa, Nozomi; Yasuda, Taeko; Mimura, Chizuru; Igita, Hazuki; Suzuki, Eriko; Uchiide, Yoko; Seino, Yusuke; Nomura, Minoru; Yamazaki, Kenji; Ishigooka, Jun

2016-01-01

To compare the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC) for detecting post-cardiac surgery delirium. These tools have not been tested in a specialized cardio-surgical ICU. Sensitivities and specificities of each tool were assessed in a cardio-surgical ICU in Japan by two trained nurses independently. Results were compared with delirium diagnosed by psychiatrists using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision. There were 110 daily, paired assessments in 31 patients. The CAM-ICU showed 38% sensitivity and 100% specificity for both nurses. All 20 false-negative cases resulted from high scores in the auditory attention screening in CAM-ICU. The ICDSC showed 97% and 94% sensitivity, and 97% and 91% specificity for the two nurses (cutoff ≥4). In a Japanese cardio-surgical ICU, the ICDSC had a higher sensitivity than the CAM-ICU. Copyright © 2016 Elsevier Inc. All rights reserved.

Detection of Entamoeba histolytica by Recombinase Polymerase Amplification.

PubMed

Nair, Gayatri; Rebolledo, Mauricio; White, A Clinton; Crannell, Zachary; Richards-Kortum, R Rebecca; Pinilla, A Elizabeth; Ramírez, Juan David; López, M Consuelo; Castellanos-Gonzalez, Alejandro

2015-09-01

Amebiasis is an important cause of diarrheal disease worldwide and has been associated with childhood malnutrition. Traditional microscopy approaches are neither sensitive nor specific for Entamoeba histolytica. Antigen assays are more specific, but many cases are missed unless tested by molecular methods. Although polymerase chain reaction (PCR) is effective, the need for sophisticated, expensive equipment, infrastructure, and trained personnel limits its usefulness, especially in the resource-limited, endemic areas. Here, we report development of a recombinase polymerase amplification (RPA) method to detect E. histolytica specifically. Using visual detection by lateral flow (LF), the test was highly sensitive and specific and could be performed without additional equipment. The availability of this inexpensive, sensitive, and field-applicable diagnostic test could facilitate rapid diagnosis and treatment of amebiasis in endemic regions. © The American Society of Tropical Medicine and Hygiene.

454 next generation-sequencing outperforms allele-specific PCR, Sanger sequencing, and pyrosequencing for routine KRAS mutation analysis of formalin-fixed, paraffin-embedded samples

PubMed Central

Altimari, Annalisa; de Biase, Dario; De Maglio, Giovanna; Gruppioni, Elisa; Capizzi, Elisa; Degiovanni, Alessio; D’Errico, Antonia; Pession, Annalisa; Pizzolitto, Stefano; Fiorentino, Michelangelo; Tallini, Giovanni

2013-01-01

Detection of KRAS mutations in archival pathology samples is critical for therapeutic appropriateness of anti-EGFR monoclonal antibodies in colorectal cancer. We compared the sensitivity, specificity, and accuracy of Sanger sequencing, ARMS-Scorpion (TheraScreen®) real-time polymerase chain reaction (PCR), pyrosequencing, chip array hybridization, and 454 next-generation sequencing to assess KRAS codon 12 and 13 mutations in 60 nonconsecutive selected cases of colorectal cancer. Twenty of the 60 cases were detected as wild-type KRAS by all methods with 100% specificity. Among the 40 mutated cases, 13 were discrepant with at least one method. The sensitivity was 85%, 90%, 93%, and 92%, and the accuracy was 90%, 93%, 95%, and 95% for Sanger sequencing, TheraScreen real-time PCR, pyrosequencing, and chip array hybridization, respectively. The main limitation of Sanger sequencing was its low analytical sensitivity, whereas TheraScreen real-time PCR, pyrosequencing, and chip array hybridization showed higher sensitivity but suffered from the limitations of predesigned assays. Concordance between the methods was k = 0.79 for Sanger sequencing and k > 0.85 for the other techniques. Tumor cell enrichment correlated significantly with the abundance of KRAS-mutated deoxyribonucleic acid (DNA), evaluated as ΔCt for TheraScreen real-time PCR (P = 0.03), percentage of mutation for pyrosequencing (P = 0.001), ratio for chip array hybridization (P = 0.003), and percentage of mutation for 454 next-generation sequencing (P = 0.004). Also, 454 next-generation sequencing showed the best cross correlation for quantification of mutation abundance compared with all the other methods (P < 0.001). Our comparison showed the superiority of next-generation sequencing over the other techniques in terms of sensitivity and specificity. Next-generation sequencing will replace Sanger sequencing as the reference technique for diagnostic detection of KRAS mutation in archival tumor tissues. PMID:23950653

Reducing false positives of microcalcification detection systems by removal of breast arterial calcifications

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mordang, Jan-Jurre, E-mail: Jan-Jurre.Mordang@radboudumc.nl; Gubern-Mérida, Albert; Karssemeijer, Nico

Purpose: In the past decades, computer-aided detection (CADe) systems have been developed to aid screening radiologists in the detection of malignant microcalcifications. These systems are useful to avoid perceptual oversights and can increase the radiologists’ detection rate. However, due to the high number of false positives marked by these CADe systems, they are not yet suitable as an independent reader. Breast arterial calcifications (BACs) are one of the most frequent false positives marked by CADe systems. In this study, a method is proposed for the elimination of BACs as positive findings. Removal of these false positives will increase the performancemore » of the CADe system in finding malignant microcalcifications. Methods: A multistage method is proposed for the removal of BAC findings. The first stage consists of a microcalcification candidate selection, segmentation and grouping of the microcalcifications, and classification to remove obvious false positives. In the second stage, a case-based selection is applied where cases are selected which contain BACs. In the final stage, BACs are removed from the selected cases. The BACs removal stage consists of a GentleBoost classifier trained on microcalcification features describing their shape, topology, and texture. Additionally, novel features are introduced to discriminate BACs from other positive findings. Results: The CADe system was evaluated with and without BACs removal. Here, both systems were applied on a validation set containing 1088 cases of which 95 cases contained malignant microcalcifications. After bootstrapping, free-response receiver operating characteristics and receiver operating characteristics analyses were carried out. Performance between the two systems was compared at 0.98 and 0.95 specificity. At a specificity of 0.98, the sensitivity increased from 37% to 52% and the sensitivity increased from 62% up to 76% at a specificity of 0.95. Partial areas under the curve in the specificity range of 0.8–1.0 were significantly different between the system without BACs removal and the system with BACs removal, 0.129 ± 0.009 versus 0.144 ± 0.008 (p<0.05), respectively. Additionally, the sensitivity at one false positive per 50 cases and one false positive per 25 cases increased as well, 37% versus 51% (p<0.05) and 58% versus 67% (p<0.05) sensitivity, respectively. Additionally, the CADe system with BACs removal reduces the number of false positives per case by 29% on average. The same sensitivity at one false positive per 50 cases in the CADe system without BACs removal can be achieved at one false positive per 80 cases in the CADe system with BACs removal. Conclusions: By using dedicated algorithms to detect and remove breast arterial calcifications, the performance of CADe systems can be improved, in particular, at false positive rates representative for operating points used in screening.« less

Differential sensitivity between a virtual reality (VR) balance module and clinically used concussion balance modalities

PubMed Central

Teel, Elizabeth F; Gay, Michael R; Arnett, Peter A; Slobounov, Semyon M

2015-01-01

Objective Balance assessments are part of the recommended clinical concussion evaluation, along with computerized neuropsychological testing and self-reported symptoms checklists. New technology has allowed for the creation of virtual reality (VR) balance assessments to be used in concussion care, but there is little information on the sensitivity and specificity of these evaluations. The purpose of this study is to establish the sensitivity and specificity of a VR balance module for detecting lingering balance deficits clinical concussion care. Design Retrospective, case-control study Setting Institutional research laboratory Participants Normal controls (n=94) and concussed participants (n=27) Interventions All participants completed a VR balance assessment paradigm. Concussed participants were diagnosed by a Certified Athletic Trainer or physician (with 48 hours post-injury) and tested in the lab between 7-10 days post-injury. ROC curves were performed in order to establish the VR module’s sensitivity and specificity for detecting lingering balance deficits. Main Outcome Measures Final balance score Results For the VR balance module, a cutoff score of 8.25 was established to maximize sensitivity at 85.7% and specificity at 87.8%. Conclusions The VR balance module has high sensitivity and specificity for detecting sub-acute balance deficits after concussive injury. PMID:26505696

Nuclear morphology for the detection of alterations in bronchial cells from lung cancer: an attempt to improve sensitivity and specificity.

PubMed

Fafin-Lefevre, Mélanie; Morlais, Fabrice; Guittet, Lydia; Clin, Bénédicte; Launoy, Guy; Galateau-Sallé, Françoise; Plancoulaine, Benoît; Herlin, Paulette; Letourneux, Marc

2011-08-01

To identify which morphologic or densitometric parameters are modified in cell nuclei from bronchopulmonary cancer based on 18 parameters involving shape, intensity, chromatin, texture, and DNA content and develop a bronchopulmonary cancer screening method relying on analysis of sputum sample cell nuclei. A total of 25 sputum samples from controls and 22 bronchial aspiration samples from patients presenting with bronchopulmonary cancer who were professionally exposed to cancer were used. After Feulgen staining, 18 morphologic and DNA content parameters were measured on cell nuclei, via image cytom- etry. A method was developed for analyzing distribution quantiles, compared with simply interpreting mean values, to characterize morphologic modifications in cell nuclei. Distribution analysis of parameters enabled us to distinguish 13 of 18 parameters that demonstrated significant differences between controls and cancer cases. These parameters, used alone, enabled us to distinguish two population types, with both sensitivity and specificity > 70%. Three parameters offered 100% sensitivity and specificity. When mean values offered high sensitivity and specificity, comparable or higher sensitivity and specificity values were observed for at least one of the corresponding quantiles. Analysis of modification in morphologic parameters via distribution analysis proved promising for screening bronchopulmonary cancer from sputum.

Sensitivity and specificity of optical coherence tomography angiography (OCT-A) for detection of choroidal neovascularization in real-life practice and varying retinal expertise level.

PubMed

Souedan, Vaël; Souied, Eric H; Caillaux, Violaine; Miere, Alexandra; Ameen, Ala El; Blanco-Garavito, Rocio

2017-05-25

To evaluate the diagnostic accuracy of OCT angiography (OCT-A) detecting or predicting choroidal neovascularization (CNV), by ophthalmologists of disparate degrees of skills in retinal diseases, using spectral domain optical coherence tomography (SD-OCT) and fluorescein angiography (FA) as a standard reference. Retrospective observational case series. Patient presenting maculopathy and complete imaging were included. FA, SD-OCT, OCT-A and FA coupled to SD-OCT images were graded independently for presence or absence of CNV by ophthalmologists with varying expertise levels. Overall sensitivity of OCT-A was 85.62% (95% CI 79.04-90.76%) and specificity was 81.51% (95% CI 73.36-88.03). Sensitivity of FA was 74.51% (95% CI 66.84-81.20), and specificity was 82.35% (95% CI 74.30-88.73). Sensitivity of FA + SD-OCT was 92.72% (95% CI 87.34-96.30), and specificity was 90.91% (95% CI 84.31-95.37). OCT-A has good sensitivity and specificity for the detection of CNV in all expertise level groups. OCT-A may soon become a routine tool for CNV diagnosis and follow-up.

Differentiation of Mycobacterium tuberculosis complex from non-tubercular mycobacteria by nested multiplex PCR targeting IS6110, MTP40 and 32kD alpha antigen encoding gene fragments.

PubMed

Sinha, Pallavi; Gupta, Anamika; Prakash, Pradyot; Anupurba, Shampa; Tripathi, Rajneesh; Srivastava, G N

2016-03-12

Control of the global burden of tuberculosis is obstructed due to lack of simple, rapid and cost effective diagnostic techniques that can be used in resource poor-settings. To facilitate the early diagnosis of TB directly from clinical specimens, we have standardized and validated the use of nested multiplex PCR, targeting gene fragments IS6110, MTP40 and 32kD α-antigen encoding genes specific for Mycobacterium tuberculosis complex and non-tubercular mycobacteria (NTM), in comparison to smear microscopy, solid culture and single step multiplex PCR. The results were evaluated in comparison to a composite reference standard (CRS) comprising of microbiological results (smear and culture), clinical, radiological and cytopathological findings, clinical treatment and response to anti-tubercular therapy. The nested multiplex PCR (nMPCR) assay was evaluated to test its utility in 600 (535 pulmonary and 65 extra-pulmonary specimens) clinically suspected TB cases. All specimens were processed for smear, culture, single step multiplex PCR and nested multiplex PCR testing. Out of 535 screened pulmonary and 65 extra-pulmonary specimens, 329 (61.5%) and 19 (29.2%) cases were culture positive for M. tuberculosis. Based on CRS, 450 patients had "clinical TB" (definitive-TB, probable-TB and possible-TB). Remaining 150 were confirmed "non-TB" cases. For culture, the sensitivity was low, 79.3% for pulmonary and 54.3% for extra-pulmonary cases. The sensitivity and specificity results for nMPCR test were evaluated taken composite reference standard as a gold standard. The sensitivity of the nMPCR assay was 97.1% for pulmonary and 91.4% for extra-pulmonary TB cases with specificity of 100% and 93.3% respectively. Nested multiplex PCR using three gene primers is a rapid, reliable and highly sensitive and specific diagnostic technique for the detection and differentiation of M. tuberculosis complex from NTM genome and will be useful in diagnosing paucibacillary samples. Nested multiplex PCR assay was found to be better than single step multiplex PCR for assessing the diagnosis of TB.

GeneXpert MTB/RIF Assay for the Diagnosis of Tuberculous Lymphadenitis on Concentrated Fine Needle Aspirates in High Tuberculosis Burden Settings.

PubMed

Tadesse, Mulualem; Abebe, Gemeda; Abdissa, Ketema; Aragaw, Dossegnaw; Abdella, Kedir; Bekele, Alemayehu; Bezabih, Mesele; Apers, Ludwig; de Jong, Bouke C; Rigouts, Leen

2015-01-01

The diagnosis of tuberculous lymphadenitis (TBL) remains challenging. The routinely used methods (cytology and smear microscopy) have sub-optimal sensitivity. Recently, WHO recommends GeneXpert to be used as the initial diagnostic test in patients suspected of having extra-pulmonary tuberculosis (EPTB). However, this was a conditional recommendation due to very low-quality evidence available and more studies are needed. In this study we evaluated the performance of Xpert for the diagnosis of TBL on concentrated fine needle aspirates (FNA) in Southwest Ethiopia. FNA was collected from presumptive TBL cases. Two smears were prepared from each aspirate and processed for cytology and conventional microscopy. The remaining aspirate was treated with N-acetyl-L-cysteine-NaOH and centrifuged for 15minutes at 3000g. The concentrated sediment was used for culture and Xpert test. Capilia TB-Neo test was used to differentiate M. tuberculosis complex (MTBC) from non-tuberculous mycobacteria (NTM). Composite bacteriological methods (culture and/or smear microscopy) were considered as a reference standard. Out of 143 enrolled suspects, 64.3% (92/143) were confirmed TBL cases by the composite reference standard (CRS). Xpert detected M. tuberculosis complex (MTBC) in 60.1% (86/143) of the presumptive TBL cases. The sensitivity of Xpert compared to CRS was 87.8% [95% CI: 81.0-94.5] and specificity 91.1% [95% CI: 82.8-99.4]. The sensitivity was 27.8% for smear microscopy and 80% for cytology compared to CRS. Cytology showed the lowest specificity (57.8%). Xpert was positive in 4 out of 45 culture- and smear-negative cases. Among 47 cytomorphologically non-TBL cases, 15 were positive on Xpert. More than half of Xpert-positive cases were in the range of very low cut-off threshold values (28

Evaluation of diagnostic cytology via endoscopic naso-pancreatic drainage for pancreatic tumor

PubMed Central

Iwata, Tomoyuki; Kitamura, Katsuya; Yamamiya, Akira; Ishii, Yu; Sato, Yoshiki; Nomoto, Tomohiro; Ikegami, Akitoshi; Yoshida, Hitoshi

2014-01-01

AIM: To evaluate the usefulness of cytology of the pancreatic juice obtained via the endoscopic naso-pancreatic drainage tube (ENPD-C). METHODS: ENPD was performed in cases where a diagnosis could not be made other than by using endoscopic retrograde cholangiopancreatography and in cases of pancreatic neoplasms or cystic tumors, including intraductal papillary mucinous neoplasm (IPMN) suspected to have malignant potential. 35 patients (21 males and 14 females) underwent ENPD between January 2007 and June 2013. The pancreatic duct was imaged and the procedure continued in one of ENPD-C or ENPD-C plus brush cytology (ENPD-BC). We checked the cytology result and the final diagnosis. RESULTS: The mean patient age was 69 years (range, 48-86 years). ENPD-C was performed in 24 cases and ENPD-C plus brush cytology (ENPD-BC) in 11 cases. The ENPD tube was inserted for an average of 3.5 d. The final diagnosis was confirmed on the basis of the resected specimen in 18 cases and of follow-up findings at least 6 mo after ENPD in the 18 inoperable cases. Malignancy was diagnosed in 21 cases and 14 patients were diagnosed as having a benign condition. The ratios of class V/IV:III:II/I findings were 7:7:7 in malignant cases and 0:3:11 in benign cases. The sensitivity and specificity for all patients were 33.3% and 100%, respectively. The cytology-positive rate was 37.5% (6/16) for pancreatic cancer. For IPMN cases, the sensitivity and specificity were 33% and 100%, respectively. CONCLUSION: Sensitivity may be further increased by adding brush cytology. Although we can diagnosis cancer in cases of a positive result, the accuracy of ENPD-C remains unsatisfactory. PMID:25132920

Comparison of digital mammography and digital breast tomosynthesis in the detection of architectural distortion.

PubMed

Dibble, Elizabeth H; Lourenco, Ana P; Baird, Grayson L; Ward, Robert C; Maynard, A Stanley; Mainiero, Martha B

2018-01-01

To compare interobserver variability (IOV), reader confidence, and sensitivity/specificity in detecting architectural distortion (AD) on digital mammography (DM) versus digital breast tomosynthesis (DBT). This IRB-approved, HIPAA-compliant reader study used a counterbalanced experimental design. We searched radiology reports for AD on screening mammograms from 5 March 2012-27 November 2013. Cases were consensus-reviewed. Controls were selected from demographically matched non-AD examinations. Two radiologists and two fellows blinded to outcomes independently reviewed images from two patient groups in two sessions. Readers recorded presence/absence of AD and confidence level. Agreement and differences in confidence and sensitivity/specificity between DBT versus DM and attendings versus fellows were examined using weighted Kappa and generalised mixed modeling, respectively. There were 59 AD patients and 59 controls for 1,888 observations (59 × 2 (cases and controls) × 2 breasts × 2 imaging techniques × 4 readers). For all readers, agreement improved with DBT versus DM (0.61 vs. 0.37). Confidence was higher with DBT, p = .001. DBT achieved higher sensitivity (.59 vs. .32), p < .001; specificity remained high (>.90). DBT achieved higher positive likelihood ratio values, smaller negative likelihood ratio values, and larger ROC values. DBT decreases IOV, increases confidence, and improves sensitivity while maintaining high specificity in detecting AD. • Digital breast tomosynthesis decreases interobserver variability in the detection of architectural distortion. • Digital breast tomosynthesis increases reader confidence in the detection of architectural distortion. • Digital breast tomosynthesis improves sensitivity in the detection of architectural distortion.

Assessing the accuracy of the International Classification of Diseases codes to identify abusive head trauma: a feasibility study.

PubMed

Berger, Rachel P; Parks, Sharyn; Fromkin, Janet; Rubin, Pamela; Pecora, Peter J

2015-04-01

To assess the accuracy of an International Classification of Diseases (ICD) code-based operational case definition for abusive head trauma (AHT). Subjects were children <5 years of age evaluated for AHT by a hospital-based Child Protection Team (CPT) at a tertiary care paediatric hospital with a completely electronic medical record (EMR) system. Subjects were designated as non-AHT traumatic brain injury (TBI) or AHT based on whether the CPT determined that the injuries were due to AHT. The sensitivity and specificity of the ICD-based definition were calculated. There were 223 children evaluated for AHT: 117 AHT and 106 non-AHT TBI. The sensitivity and specificity of the ICD-based operational case definition were 92% (95% CI 85.8 to 96.2) and 96% (95% CI 92.3 to 99.7), respectively. All errors in sensitivity and three of the four specificity errors were due to coder error; one specificity error was a physician error. In a paediatric tertiary care hospital with an EMR system, the accuracy of an ICD-based case definition for AHT was high. Additional studies are needed to assess the accuracy of this definition in all types of hospitals in which children with AHT are cared for. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Whipple Resection: Concordance Between Frozen Section And Permanent Section Diagnosis Of Surgical Margins.

PubMed

Bilal, Muhammad; Tariq, Hina; Mamoon, Nadira

2018-01-01

Margin assessment is done in Whipple procedures which are usually performed to resect tumours of head of pancreas and ampullary/periampullary region. Aims and objective of the study are to determine the concordance between frozen sections (FS) and permanent sections (PS) of surgical margins in Whipple resections. It is a retrospective study, from January 2008 to January 2015 (07 years). It includes the specimen with malignancy in final report and for which FS of pancreatic and/or CBD margin(s) were requested. Data was retrieved from Laboratory information system (LIS) database. Of the 41 bile duct margins in cases of ampullary tumours, 03 were positive on FS as well as PS, 35 were negative on FS as well as on PS. Results showed 100% sensitivity, 92.1% specificity, 50% PPV and 100% NPV. Results of 36 pancreatic margins in cases of ampullary showed 100% sensitivity, 97.1% specificity, 50% PPV and 100% NPV. In pancreatic carcinoma cases, none of CBD margins were reported as positive on FS, 02 margins reported as negative were found positive on PS, while 17 were negative on FS as well as PS. Results showed 100% specificity and 89.5% NPV. Of the 27 pancreatic margins tested in pancreatic tumours 100% sensitivity, 94.1% specificity, 88.9% PPV and 100% NPV was found. Factors such as absent prior tissue diagnosis and/or inflammatory processes make margin diagnosis difficult. However, a high concordance was observed between our FS and PS diagnosis.

Proposed epidemiological case definition for serious skin infection in children.

PubMed

O'Sullivan, Cathryn E; Baker, Michael G

2010-04-01

Researching the rising incidence of serious skin infections in children is limited by the lack of a consistent and valid case definition. We aimed to develop and evaluate a good quality case definition, for use in future research and surveillance of these infections. We tested the validity of the existing case definition, and then of 11 proposed alternative definitions, by assessing their screening performance when applied to a population of paediatric skin infection cases identified by a chart review of 4 years of admissions to a New Zealand hospital. Previous studies have largely used definitions based on the International Classification of Diseases skin infection subchapter. This definition is highly specific (100%) but poorly sensitive (61%); it fails to capture skin infections of atypical anatomical sites, those secondary to primary skin disease and trauma, and those recorded as additional diagnoses. Including these groups produced a new case definition with 98.9% sensitivity and 98.8% specificity. Previous analyses of serious skin infection in children have underestimated the true burden of disease. Using this proposed broader case definition should allow future researchers to produce more valid and comparable estimates of the true burden of these important and increasing infections.

Contribution of Neonatal Amniotic Fluid Testing to Diagnosis of Congenital Toxoplasmosis

PubMed Central

Filisetti, Denis; Villard, Odile; Escande, Benoît; Wafo, Estelle; Houfflin-Debarge, Véronique; Delhaes, Laurence; Bastien, Patrick

2015-01-01

We evaluated the molecular diagnosis of congenital toxoplasmosis (CT) on neonatal amniotic fluid samples from 488 mother-child pairs. Maternal infection during pregnancy was diagnosed and dated or could not be ruled out. Forty-six cases of CT were defined according to the European Research Network on CT classification system and case definitions. Neonatal amniotic fluid testing had an overall sensitivity of 54% (95% confidence interval [95% CI], 39 to 69%) and a specificity of 100% (95% CI, 99 to 100%). Its sensitivity was 33% (95% CI, 13 to 59%) when antenatal diagnosis was positive and 68% (95% CI, 48 to 84%) when antenatal diagnosis was negative or lacking. This difference in sensitivity may have been due to treatment of antenatally diagnosed cases. Relative to postnatal serology, neonatal amniotic fluid testing allowed an earlier diagnosis to be made in 26% of the cases (95% CI, 9 to 51%). PMID:25694528

Differential Sensitivity Between a Virtual Reality Balance Module and Clinically Used Concussion Balance Modalities.

PubMed

Teel, Elizabeth F; Gay, Michael R; Arnett, Peter A; Slobounov, Semyon M

2016-03-01

Balance assessments are part of the recommended clinical concussion evaluation, along with computerized neuropsychological testing and self-reported symptoms checklists. New technology has allowed for the creation of virtual reality (VR) balance assessments to be used in concussion care, but there is little information on the sensitivity and specificity of these evaluations. The purpose of this study is to establish the sensitivity and specificity of a VR balance module for detecting lingering balance deficits clinical concussion care. Retrospective case-control study. Institutional research laboratory. Normal controls (n = 94) and concussed participants (n = 27). All participants completed a VR balance assessment paradigm. Concussed participants were diagnosed by a Certified Athletic Trainer or physician (with 48 hours postinjury) and tested in the laboratory between 7 and 10 days postinjury. Receiver operating characteristic curves were performed to establish the VR module's sensitivity and specificity for detecting lingering balance deficits. Final balance score. For the VR balance module, a cutoff score of 8.25 was established to maximize sensitivity at 85.7% and specificity at 87.8%. The VR balance module has high sensitivity and specificity for detecting subacute balance deficits after concussive injury. The VR balance has a high subacute sensitivity and specificity as a stand-alone balance assessment tool and may detect ongoing balance deficits not readily detectable by the Balance Error Scoring System or Sensory Organization Test. Virtual reality balance modules may be a beneficial addition to the current clinical concussion diagnostic battery.

[Diagnosis of septic loosening of hip prosthesis with LeukoScan. SPECT scan with 99mTc-labeled monoclonal antibodies].

PubMed

Kaisidis, A; Megas, P; Apostolopoulos, D; Spiridonidis, T; Koumoundourou, D; Zouboulis, P; Lambiris, E; Vassilakos, P

2005-05-01

Diagnosis of septic loosening of hip endoprosthesis with antigranulocyte scintigraphy (AGS) was analysed. Twenty-one hip prostheses were studied using laboratory tests and, in cases of elevated values, three-phase bone scan (BS) and AGS. Elective SPECT/CT scans were performed. Histologic and microbiologic exams verified the diagnosis. The AGS analysis revealed sensitivity, specificity and accuracy of value 1, while positive and negative predictive values were also 1. BS showed sensitivity of 1 and specificity of 0.33. In three cases, SPECT/CT scans corroborated the AGS interpretation. This diagnostic algorithm proved effective in the detection of septic loosening of hip prostheses. AGS can be avoided without risk of infection being overlooked.

Computer-aided detection in musculoskeletal projection radiography: A systematic review.

PubMed

Gundry, M; Knapp, K; Meertens, R; Meakin, J R

2018-05-01

To investigated the accuracy of computer-aided detection (CAD) software in musculoskeletal projection radiography via a systematic review. Following selection screening, eligible studies were assessed for bias, and had their study characteristics extracted resulting in 22 studies being included. Of these 22 three studies had tested their CAD software in a clinical setting; the first study investigated vertebral fractures, reporting a sensitivity score of 69.3% with CAD, compared to 59.8% sensitivity without CAD. The second study tested dental caries diagnosis producing a sensitivity score of 68.8% and specificity of 94.1% with CAD, compared to sensitivity of 39.3% and specificity of 96.7% without CAD. The third indicated osteoporotic cases based on CAD, resulting in 100% sensitivity and 81.3% specificity. The current evidence reported shows a lack of development into the clinical testing phase; however the research does show future promise in the variation of different CAD systems. Copyright © 2017 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.

The Effect of Nature Documentaries on Students' Environmental Sensitivity: A Case Study

ERIC Educational Resources Information Center

Barbas, Tasos A.; Paraskevopoulos, Stefanos; Stamou, Anastasia G.

2009-01-01

Despite the potential educational value of nature documentaries, the contribution of such films to environmental education is largely unknown. In the present study, we attempt to delineate the role of nature documentaries to the environmental sensitivity of students when the films are simply introduced to the class. More specifically, the present…

Screening for cognitive dysfunction in ALS: validation of the Edinburgh Cognitive and Behavioural ALS Screen (ECAS) using age and education adjusted normative data.

PubMed

Pinto-Grau, Marta; Burke, Tom; Lonergan, Katie; McHugh, Caroline; Mays, Iain; Madden, Caoifa; Vajda, Alice; Heverin, Mark; Elamin, Marwa; Hardiman, Orla; Pender, Niall

2017-02-01

Cognitive and behavioural changes are an important aspect in Amyotrophic Lateral Sclerosis (ALS). The Edinburgh Cognitive and Behavioural ALS Screen (ECAS) briefly assesses these changes in ALS. To validate the ECAS against a standardised neuropsychological battery and assess its sensitivity and specificity using age and education adjusted cut-off scores. 30 incident ALS cases were assessed on both, ECAS and neuropsychological battery. Age and education adjusted cut-off scores were created from a sample of 82 healthy controls. ECAS composite scores (Total, ALS Specific and Non-Specific) were highly correlated with battery composite scores. High correlations were also observed between ECAS and full battery cognitive domains and subtests. The ECAS Total, ALS Specific and Non-Specific scores were highly sensitive to cognitive impairment. ECAS ALS-Specific cognitive domains also evidenced high sensitivity. Individual subtest sensitivity was medium to low, suggesting that caution should be used when interpreting these scores. Low positive predictive values indicated the presence of false positives. Psychometric properties of the ECAS using age and education adjusted norms indicate that the ECAS, when used as an overall measure of cognitive decline, is highly sensitive. Further comprehensive assessment is required for patients that present as impaired on the ECAS.

Clinical and epidemiological features of typhoid fever in Pemba, Zanzibar: assessment of the performance of the WHO case definitions.

PubMed

Thriemer, Kamala; Ley, Benedikt; Ley, Benedikt B; Ame, Shaali S; Deen, Jaqueline L; Pak, Gi Deok; Chang, Na Yoon; Hashim, Ramadhan; Schmied, Wolfgang Hellmut; Busch, Clara Jana-Lui; Nixon, Shanette; Morrissey, Anne; Puri, Mahesh K; Ochiai, R Leon; Wierzba, Thomas; Clemens, John D; Ali, Mohammad; Jiddawi, Mohammad S; von Seidlein, Lorenz; Ali, Said M

2012-01-01

The gold standard for diagnosis of typhoid fever is blood culture (BC). Because blood culture is often not available in impoverished settings it would be helpful to have alternative diagnostic approaches. We therefore investigated the usefulness of clinical signs, WHO case definition and Widal test for the diagnosis of typhoid fever. Participants with a body temperature ≥37.5°C or a history of fever were enrolled over 17 to 22 months in three hospitals on Pemba Island, Tanzania. Clinical signs and symptoms of participants upon presentation as well as blood and serum for BC and Widal testing were collected. Clinical signs and symptoms of typhoid fever cases were compared to other cases of invasive bacterial diseases and BC negative participants. The relationship of typhoid fever cases with rainfall, temperature, and religious festivals was explored. The performance of the WHO case definitions for suspected and probable typhoid fever and a local cut off titre for the Widal test was assessed. 79 of 2209 participants had invasive bacterial disease. 46 isolates were identified as typhoid fever. Apart from a longer duration of fever prior to admission clinical signs and symptoms were not significantly different among patients with typhoid fever than from other febrile patients. We did not detect any significant seasonal patterns nor correlation with rainfall or festivals. The sensitivity and specificity of the WHO case definition for suspected and probable typhoid fever were 82.6% and 41.3% and 36.3 and 99.7% respectively. Sensitivity and specificity of the Widal test was 47.8% and 99.4 both forfor O-agglutinin and H- agglutinin at a cut-off titre of 1:80. Typhoid fever prevalence rates on Pemba are high and its clinical signs and symptoms are non-specific. The sensitivity of the Widal test is low and the WHO case definition performed better than the Widal test.

Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection

PubMed Central

Qasmieh, Saba; Mounts, Anthony Wayne; Alexander, Burmaa; Besselaar, Terry; Briand, Sylvie; Brown, Caroline; Clark, Seth; Dueger, Erica; Gross, Diane; Hauge, Siri; Hirve, Siddhivinayak; Jorgensen, Pernille; Katz, Mark A; Mafi, Ali; Malik, Mamunur; McCarron, Margaret; Meerhoff, Tamara; Mori, Yuichiro; Mott, Joshua; Olivera, Maria Teresa da Costa; Ortiz, Justin R; Palekar, Rakhee; Rebelo-de-Andrade, Helena; Soetens, Loes; Yahaya, Ali Ahmed; Zhang, Wenqing; Vandemaele, Katelijn

2018-01-01

Abstract The formulation of accurate clinical case definitions is an integral part of an effective process of public health surveillance. Although such definitions should, ideally, be based on a standardized and fixed collection of defining criteria, they often require revision to reflect new knowledge of the condition involved and improvements in diagnostic testing. Optimal case definitions also need to have a balance of sensitivity and specificity that reflects their intended use. After the 2009–2010 H1N1 influenza pandemic, the World Health Organization (WHO) initiated a technical consultation on global influenza surveillance. This prompted improvements in the sensitivity and specificity of the case definition for influenza – i.e. a respiratory disease that lacks uniquely defining symptomology. The revision process not only modified the definition of influenza-like illness, to include a simplified list of the criteria shown to be most predictive of influenza infection, but also clarified the language used for the definition, to enhance interpretability. To capture severe cases of influenza that required hospitalization, a new case definition was also developed for severe acute respiratory infection in all age groups. The new definitions have been found to capture more cases without compromising specificity. Despite the challenge still posed in the clinical separation of influenza from other respiratory infections, the global use of the new WHO case definitions should help determine global trends in the characteristics and transmission of influenza viruses and the associated disease burden. PMID:29403115

Validity of Heart Failure Diagnoses in Administrative Databases: A Systematic Review and Meta-Analysis

PubMed Central

McCormick, Natalie; Lacaille, Diane; Bhole, Vidula; Avina-Zubieta, J. Antonio

2014-01-01

Objective Heart failure (HF) is an important covariate and outcome in studies of elderly populations and cardiovascular disease cohorts, among others. Administrative data is increasingly being used for long-term clinical research in these populations. We aimed to conduct the first systematic review and meta-analysis of studies reporting on the validity of diagnostic codes for identifying HF in administrative data. Methods MEDLINE and EMBASE were searched (inception to November 2010) for studies: (a) Using administrative data to identify HF; or (b) Evaluating the validity of HF codes in administrative data; and (c) Reporting validation statistics (sensitivity, specificity, positive predictive value [PPV], negative predictive value, or Kappa scores) for HF, or data sufficient for their calculation. Additional articles were located by hand search (up to February 2011) of original papers. Data were extracted by two independent reviewers; article quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool. Using a random-effects model, pooled sensitivity and specificity values were produced, along with estimates of the positive (LR+) and negative (LR−) likelihood ratios, and diagnostic odds ratios (DOR = LR+/LR−) of HF codes. Results Nineteen studies published from1999–2009 were included in the qualitative review. Specificity was ≥95% in all studies and PPV was ≥87% in the majority, but sensitivity was lower (≥69% in ≥50% of studies). In a meta-analysis of the 11 studies reporting sensitivity and specificity values, the pooled sensitivity was 75.3% (95% CI: 74.7–75.9) and specificity was 96.8% (95% CI: 96.8–96.9). The pooled LR+ was 51.9 (20.5–131.6), the LR− was 0.27 (0.20–0.37), and the DOR was 186.5 (96.8–359.2). Conclusions While most HF diagnoses in administrative databases do correspond to true HF cases, about one-quarter of HF cases are not captured. The use of broader search parameters, along with laboratory and prescription medication data, may help identify more cases. PMID:25126761

Clinical profiling and use of loop-mediated isothermal amplification assay for rapid detection of Mycobacterium tuberculosis from sputum.

PubMed

Poudel, A; Pandey, B D; Lekhak, B; Rijal, B; Sapkota, B R; Suzuki, Y

2009-01-01

Tuberculosis is a global health problem and the situation is worsening with newer incidences of drug resistance and HIV association. Diagnosis of tuberculosis can be done by many methods and test, culture of sputum being the ideal one. Nucleic acid amplification (NAA) assay are more time efficient one, that amplify and detect specific nucleic acid sequences allows rapid, sensitive and specific detection of M. tuberculosis in sputum samples. The present study intends to compile the clinical presentations of the pulmonary tuberculosis (PTB) patients and to evaluate the efficacy of in-house loop-mediated isothermal amplification (LAMP) in detecting Mycobacterium tuberculosis in sputum samples by comparing with microscopy and culture. Two hundred two sputum samples were collected from 202 patients at National Tuberculosis Center, Bhaktapur, Nepal. Complete clinical profiling, epidemiological data and record on BCG vaccination were noted and the samples were subjected for microscopy, culture and in-house LAMP with six primers specific for 16S RNA gene of Mycobacterium tuberculosis. Of the 176 cases of clinical profiling, productive cough was most common symptom in 147 (83.52%), followed by chest pain 136 (77.27%), fever 133 (75.56%) and haemoptysis 61 (34.66%). There was a statistically significant association between BCG vaccination and development of TB (chi(2)=5.33, P=0.02). Of 202 cases, 115 (56.93%) were chest X-ray positive, 101(50%) were direct smear-positive and 100 (49.51%) were culture positive. LAMP had a sensitivity of 97% and specificity of 94.12% while comparing with culture. In addition, its sensitivity and specificity were 91.09% and 89.11% respectively with reference to microscopy. As in our previous study, overall, the result of present study further confirms that the in-house LAMP is a simple, rapid, sensitive and specific DNA amplification technique for PTB diagnosis. Because of rapidity of microscopy and specificity of culture, in-house LAMP assay can be used as a very powerful and useful supplementary tool with complete clinical profiling of the patients for rapid diagnosis of TB in both AFB-positive and negative cases who are suspected as PTB in disease endemic country like Nepal.

Immunocytochemical detection of Mycobacterium Tuberculosis complex specific antigen, MPT64, improves diagnosis of tuberculous lymphadenitis and tuberculous pleuritis.

PubMed

Tadele, Agerie; Beyene, Demissew; Hussein, Jemal; Gemechu, Tuffa; Birhanu, Asaye; Mustafa, Tehmina; Tsegaye, Aster; Aseffa, Abraham; Sviland, Lisbet

2014-11-25

A rapid, sensitive and accurate laboratory diagnosis is of prime importance in suspected extrapulmonary tuberculosis (EPTB) cases. However, traditional techniques for the detection of acid-fast bacilli have limitations. The aim of the study was to evaluate the diagnostic value of immunocytochemical staining for detection of Mycobacterium tuberculosis complex specific antigen, MPT64, in aspirates from pleural effusions and lymph nodes, the most common presentations of EPTB. A cross-sectional study was conducted by including patients at Tikur Anbessa Specialized Hospital and the United Vision Medical Services from December 2011 to June 2012. Lymph node aspirates and pleural fluid samples were collected and analyzed from a total of 51 cases (26 tuberculous (TB) pleuritis and 25 TB lymphadenitis) and 67 non-TB controls. Each specimen was subjected to Ziehl-Neelsen (ZN) staining, culture on Lowenstein- Jensen (LJ) medium, cytological examination, Polymerase Chain Reaction (PCR) using IS1081gene sequence as a primer and immunocytochemistry (ICC) with polyclonal anti-MPT64 antibody. All patients were screened for HIV. ICC was positive in 38 of 51 cases and in the 7 of 67 controls giving an overall sensitivity and specificity of 74.5% and 89.5%, respectively. Using IS1081-PCR as a reference method, the sensitivity and specificity, positive and negative predictive value of ICC was 88.1%, 89.5%, 82.2% and 93.2%, respectively. The case detection rate increased from 13.7% by ZN stain to 19.6% by LJ culture, to 66.7% by cytology and 74.5% by ICC. Immunocytochemistry with anti-MPT64 antigen improved detection of TB in pleural effusion and lymph node aspirates. Further studies using monoclonal antibodies on samples from other sites of EPTB is recommended to validate this relatively simple diagnostic method for EPTB.

[Comparison of efficacy between the serum cortisol and 24 hour urine free cortisol in combined dexamethasone suppression test in the diagnosis of Cushing syndrome].

PubMed

Lu, L; Chen, J H; Zhu, H J; Song, A L; Li, M; Chen, S; Pan, H; Gong, F Y; Wang, R Z; Xing, B; Yao, Y; Feng, M; Lu, Z L

2016-07-19

To compare the sensitivity and specificity between the 24 hour urine free cortisol (24 h UFC) and serum cortisol in dexamethasone suppression test (DST) in the diagnosis of Cushing syndrome (CS). Combined low dose DST (LDDST) and high dose DST (HDDST) were carried out in 67 cases of CS with surgically confirmed cases in recent 3 years(from January 2011 to November 2015). The serum cortisol and 24 h UFC were collected simultaneously for each subject and the sensitivity and specificity of serum cortisol and 24 h UFC were compared. There were Cushing disease (CD) group (n=53), ectopic adrenocorticotropic hormone (ACTH) syndrome group (n=7) and ACTH-independent Cushing syndrome group (n=7) according to the etiology of hypercorticordism.There were no significant differences among 3 groups in gender and age.The sensitivity of serum cortisol of different cut off points(50, 110, 140 nmol/L and 50% of control)after LDDST was 97.01%, 86.57%, 83.58% and 70.15% respectively.Meanwhile, the sensitivity of cutoff point of 24 h UFC <32 nmol in combined LDDST was 92.54% in the diagnosis of Cushing syndrome.There was no significant differences in two groups between serum cortisol <110 nmol/L and 24 h UFC <32 nmol.However, the sensitivity of serum cortisol <50 nmol/L was significantly higher than 24 h UFC<32 nmol (P<0.05). Furthermore, in combined HDDST, if the suppression rate was ≥50%, the sensitivity of serum cortisol and 24 h UFC in differentiating the etiology of Cushing disease was 60.38% and 90.57%, and the specificity was 91.43% and 96.00% respectively.There were significant differences between serum cortisol and 24 h UFC in both of sensitivity and specificity (both P<0.05). In addition, if the suppression rate of 24 h UFC in HDDST was adjusted to 60.85% according to receiver operating characteristic (ROC) curve, it could have the best levels of sensitivity (92.6%) with the specificity of 85.7%. If the suppression rate of serum cortisol was adjusted to 61.53% in HDDST according to ROC curve, it could have the best sensitivity (64.8%) with the specificity of 78.6% accordingly. In combined LDDST, the serum cortisol <50 nmol/L had a higher sensitivity than the 24 h UFC<32 nmol when they were used as the criteria in determining the diagnosis of CS.In HDDST, the sensitivity and specificity of suppression rate of 24 h UFC ≥50% were better than serum cortisol to differentiate the etiology of CS.

Sensitivity and Specificity of CT and Its signs for Diagnosis of Strangulation in Patients with Acute Small Bowel Obstruction.

PubMed

Jha, Ashwini Kumar; Tang, Wen Hao; Bai, Zhi Bin; Xiao, Jia Quan

2014-01-01

To perform a meta-analysis to review the sensitivity and specificity of computed tomography and different known computed yomography signs for the diagnosis of strangulation in patients with acute small bowel obstruction. A comprehensive Pubmed search was performed for all reports that evaluated the use of CT and discussed different CT criteria for the diagnosis of acute SBO. Articles published in English language from January 1978 to June 2008 were included. Review articles, case reports, pictorial essays and articles without original data were excluded. The bivariate random effect model was used to obtain pooled sensitivity and pooled specificity. Summary receiver operating curve was calculated using Meta-Disc. Software Openbugs 3.0.3 was used to summarize the data. A total of 12 studies fulfilled the inclusion criteria. The pooled sensitivity and specificity of CT in the diagnosis of strangulation was 0.720 (95% CI 0.674 to 0.763) and 0.866 (95% CI 0.837 to 0.892) respectively. Among different CT signs, mesenteric edema had highest Pooled sensitivity of 0. 741 and lack of bowel wall enhancement had highest pooled specificity of 0.991. This review demonstrates that CT is highly sensitive as well as specific in the preoperative diagnosis of strangulation SBO which are in accordance with the published studies. Our analysis also shows that "presence of mesenteric fluid" is most sensitive, and "lack of bowel wall enhancement" is most specific CT sign of strangulation, and also justifies need of large scale prospective studies to validate the results obtained as well as to determine a clinical protocol.

ALLERGENIC RELATIONSHIP OF THE POLLENS OF DWARF AND GIANT RAGWEED TO SEVERAL OF THEIR BOTANIC RELATIVES.

PubMed

Simon, F A

1943-02-01

Thirty-eight of forty patients, allergic to the pollen of dwarf and giant ragweed, were found to be allergic also to the pollen of botanically related species. There was definite variation in the degree of reactivity to the various pollens in different patients. One additional patient reacted to dwarf ragweed but not to giant ragweed or to four other composites. Antibody neutralization studies in six cases indicated that (a) in four cases dwarf ragweed could have been the only sensitizing allergen. (b) In one case either dwarf or giant ragweed could have been the only sensitizing allergen. (c) In one case cosmos plus either of the ragweeds or some undetermined pollen could have been the sensitizing allergen, (d) In none of the six cases studied could cosmos, sunflower, goldenrod, or dandelion have been the only sensitizing allergens. The evidence presented supports the following concepts: (1) Hypersensitiveness of this type develops as the result of allergenic stimulation. (2) The pollens of the ragweeds and their botanic relatives contain, in addition to species-specific allergens, multiple common allergenic determinants which vary in their distribution among related species. (3) A person exposed simultaneously to a group of allergens may become sensitized to certain members of the group and not to others, while another person, exposed to the same group of allergens, may become sensitized to different members of the group.

Biceps-Related Physical Findings Are Useful to Prevent Misdiagnosis of Cervical Spondylotic Amyotrophy as a Rotator Cuff Tear.

PubMed

Iwata, Eiichiro; Shigematsu, Hideki; Inoue, Kazuya; Egawa, Takuya; Tanaka, Masato; Okuda, Akinori; Morimoto, Yasuhiko; Masuda, Keisuke; Yamamoto, Yusuke; Sakamoto, Yoshihiro; Koizumi, Munehisa; Tanaka, Yasuhito

2018-02-01

Case-control study. The aim of the present study was to identify physical findings useful for differentiating between cervical spondylotic amyotrophy (CSA) and rotator cuff tears to prevent the misdiagnosis of CSA as a rotator cuff tear. CSA and rotator cuff tears are often confused among patients presenting with difficulty in shoulder elevation. Twenty-five patients with CSA and 27 with rotator cuff tears were enrolled. We included five physical findings specific to CSA that were observed in both CSA and rotator cuff tear patients. The findings were as follows: (1) weakness of the deltoid muscle, (2) weakness of the biceps muscle, (3) atrophy of the deltoid muscle, (4) atrophy of the biceps muscle, and (5) swallow-tail sign (assessment of the posterior fibers of the deltoid). Among 25 CSA patients, 10 (40.0%) were misdiagnosed with a rotator cuff tear on initial diagnosis. The sensitivity and specificity of each physical finding were as follows: (1) deltoid weakness (sensitivity, 92.0%; specificity, 55.6%), (2) biceps weakness (sensitivity, 80.0%; specificity, 100%), (3) deltoid atrophy (sensitivity, 96.0%; specificity, 77.8%), (4) biceps atrophy (sensitivity, 88.8%; specificity, 92.6%), and (5) swallow-tail sign (sensitivity, 56.0%; specificity, 74.1%). There were statistically significant differences in each physical finding. CSA is likely to be misdiagnosed as a rotator cuff tear; however, weakness and atrophy of the biceps are useful findings for differentiating between CSA and rotator cuff tears to prevent misdiagnosis.

Accuracy of malaria rapid diagnostic tests in community studies and their impact on treatment of malaria in an area with declining malaria burden in north-eastern Tanzania.

PubMed

Ishengoma, Deus S; Francis, Filbert; Mmbando, Bruno P; Lusingu, John P A; Magistrado, Pamela; Alifrangis, Michael; Theander, Thor G; Bygbjerg, Ib C; Lemnge, Martha M

2011-06-26

Despite some problems related to accuracy and applicability of malaria rapid diagnostic tests (RDTs), they are currently the best option in areas with limited laboratory services for improving case management through parasitological diagnosis and reducing over-treatment. This study was conducted in areas with declining malaria burden to assess; 1) the accuracy of RDTs when used at different community settings, 2) the impact of using RDTs on anti-malarial dispensing by community-owned resource persons (CORPs) and 3) adherence of CORPs to treatment guidelines by providing treatment based on RDT results. Data were obtained from: 1) a longitudinal study of passive case detection of fevers using CORPs in six villages in Korogwe; and 2) cross-sectional surveys (CSS) in six villages of Korogwe and Muheza districts, north-eastern, Tanzania. Performance of RDTs was compared with microscopy as a gold standard, and factors affecting their accuracy were explored using a multivariate logistic regression model. Overall sensitivity and specificity of RDTs in the longitudinal study (of 23,793 febrile cases; 18,154 with microscopy and RDTs results) were 88.6% and 88.2%, respectively. In the CSS, the sensitivity was significantly lower (63.4%; χ2=367.7, p<0.001), while the specificity was significantly higher (94.3%; χ2=143.1, p<0.001) when compared to the longitudinal study. As determinants of sensitivity of RDTs in both studies, parasite density of<200 asexual parasites/μl was significantly associated with high risk of false negative RDTs (OR≥16.60, p<0.001), while the risk of false negative test was significantly lower among cases with fever (axillary temperature ≥37.5 °C) (OR≤0.63, p≤0.027). The risk of false positive RDT (as a determinant of specificity) was significantly higher in cases with fever compared to afebrile cases (OR≥2.40, p<0.001). Using RDTs reduced anti-malarials dispensing from 98.9% to 32.1% in cases aged ≥5 years. Although RDTs had low sensitivity and specificity, which varied widely depending on fever and parasite density, using RDTs reduced over-treatment with anti-malarials significantly. Thus, with declining malaria prevalence, RDTs will potentially identify majority of febrile cases with parasites and lead to improved management of malaria and non-malaria fevers. © 2011 Ishengoma et al; licensee BioMed Central Ltd.

Accuracy of malaria rapid diagnostic tests in community studies and their impact on treatment of malaria in an area with declining malaria burden in north-eastern Tanzania

PubMed Central

2011-01-01

Background Despite some problems related to accuracy and applicability of malaria rapid diagnostic tests (RDTs), they are currently the best option in areas with limited laboratory services for improving case management through parasitological diagnosis and reducing over-treatment. This study was conducted in areas with declining malaria burden to assess; 1) the accuracy of RDTs when used at different community settings, 2) the impact of using RDTs on anti-malarial dispensing by community-owned resource persons (CORPs) and 3) adherence of CORPs to treatment guidelines by providing treatment based on RDT results. Methods Data were obtained from: 1) a longitudinal study of passive case detection of fevers using CORPs in six villages in Korogwe; and 2) cross-sectional surveys (CSS) in six villages of Korogwe and Muheza districts, north-eastern, Tanzania. Performance of RDTs was compared with microscopy as a gold standard, and factors affecting their accuracy were explored using a multivariate logistic regression model. Results Overall sensitivity and specificity of RDTs in the longitudinal study (of 23,793 febrile cases; 18,154 with microscopy and RDTs results) were 88.6% and 88.2%, respectively. In the CSS, the sensitivity was significantly lower (63.4%; χ2 = 367.7, p < 0.001), while the specificity was significantly higher (94.3%; χ2 = 143.1, p < 0.001) when compared to the longitudinal study. As determinants of sensitivity of RDTs in both studies, parasite density of < 200 asexual parasites/μl was significantly associated with high risk of false negative RDTs (OR≥16.60, p < 0.001), while the risk of false negative test was significantly lower among cases with fever (axillary temperature ≥37.5°C) (OR ≤ 0.63, p ≤ 0.027). The risk of false positive RDT (as a determinant of specificity) was significantly higher in cases with fever compared to afebrile cases (OR≥2.40, p < 0.001). Using RDTs reduced anti-malarials dispensing from 98.9% to 32.1% in cases aged ≥5 years. Conclusion Although RDTs had low sensitivity and specificity, which varied widely depending on fever and parasite density, using RDTs reduced over-treatment with anti-malarials significantly. Thus, with declining malaria prevalence, RDTs will potentially identify majority of febrile cases with parasites and lead to improved management of malaria and non-malaria fevers. PMID:21703016

Applying the Paris System for Reporting Urine Cytology Increases the Rate of Atypical Urothelial Cells in Benign Cases: A Need for Patient Management Recommendations.

PubMed

Granados, Rosario; Duarte, Joanny A; Corrales, Teresa; Camarmo, Encarnación; Bajo, Paloma

2017-01-01

The Paris System (TPS) for reporting urinary cytology attempts to unify the terminology in this field. To analyze the impact of adopting TPS by measuring nomenclature agreement and cytohistological correlation. Voided urine liquid-based cytology samples corresponding to 149 biopsy-proven cases (76 high-grade carcinomas, 40 low-grade carcinomas, and 33 benign lesions), were reclassified by the same pathologist using TPS. Diagnostic agreement and sensitivity for both nomenclature systems was measured. When using TPS, the rate of atypical samples increased 8 times (from 3 to 24.2%) in benign cases, 10 times (from 2.5 to 25%) in low-grade carcinomas, and 2.4 times (from 6.6 to 15.8%) in high-grade carcinomas. The false-positive rate (abnormal cytology in negative or low-grade carcinoma cases) increased from 11 to 34.2%. Sensitivity was higher (63 vs. 49%) with TPS at the expense of a lower specificity (73 vs. 91%). The agreement between both nomenclatures was moderate for negative and high-grade carcinoma cases (k = 0.42 and 0.56, respectively) and weak for low-grade tumors (k = 0.35). Adopting TPS for reporting urine cytology results in a considerable increase in atypical diagnoses, improving sensitivity but lowering specificity. Appropriate management recommendations for patients with an atypical cytological diagnosis are required. © 2016 S. Karger AG, Basel.

Diagnostic sensitivity and specificity of a participatory disease surveillance method for highly pathogenic avian influenza in household chicken flocks in Indonesia.

PubMed

Robyn, M; Priyono, W B; Kim, L M; Brum, E

2012-06-01

A study was conducted to assess the diagnostic sensitivity and specificity of a disease surveillance method for diagnosis of highly pathogenic avian influenza (HPAI) outbreaks in household chicken flocks used by participatory disease surveillance (PDS) teams in Yogyakarta Province, Indonesia. The Government of Indonesia, in partnership with the Food and Agriculture Organization of the United Nations, has implemented a PDS method for the detection of HPAI outbreaks in poultry since 2006. The PDS method in Indonesia utilizes both a clinical case definition (CD) and the result of a commercial rapid antigen test kit Yogyakarta 55611, to diagnose HPAI outbreaks, primarily in backyard chicken flocks. The following diagnostic sensitivities and specificities were obtained relative to real-time reverse transcription-PCR as the gold standard diagnostic test: 1) 89% sensitivity (CI95: 75%-97%) and 96% specificity (CI95: 89%-99%) for the PDS CD alone; 2) 86% sensitivity (CI95: 71%-95%) and 99% specificity (CI95: 94%-100%) for the rapid antigen test alone; and 3) 84% sensitivity (CI95: 68%-94%) and 100% specificity (CI95: 96%-100%) for the PDS CD result combined with the rapid antigen test result. Based on these results, HPAI outbreaks in extensively raised household chickens can be diagnosed with sufficient sensitivity and specificity using the PDS method as implemented in Indonesia. Subject to further field evaluation, data from this study suggest that the diagnostic sensitivity of the PDS method may be improved by expanding the PDS CD to include more possible clinical presentations of HPAI and by increasing the number of rapid antigen tests to three different birds with HPAI-compatible signs of same flock.

Argon laser photocoagulation versus intrastromal voriconazole injection in treatment of mycotic keratitis

PubMed Central

Khater, Mohammad M.; El-Shorbagy, Mohammad S.; Selima, Adel A.

2016-01-01

AIM To compare argon laser photocoagulation and intrastromal injection of voriconazole as adjunctive treatment modalities in cases of resistant mycotic corneal ulcers. METHODS Two groups each of them included 20 cases of resistant mycotic corneal ulcers. Both groups treated with local and systemic specific antimicrobial drugs guided with culture and sensitivity results. In one group argon laser photocoagulation was used as an adjunctive therapy to the specific antifungal drugs and in the other group, intrastromal injection of voriconazole was done besides the specific antifungal drugs. The 40 cases included in the study were proven according to culture and sensitivity to be 28 cases with pure fungal results and 12 cases with mixed (fungal and bacterial). In argon laser group, argon laser irradiation of the corneal ulcer was performed using argon laser 532 nm wavelength (Carl Zeiss LSL 532s AG; Meditec, Inc.) after fluorescein staining. In the other group, voriconazole solution (500 µg/mL) was prepared and injected in the corneal stroma. All cases were followed up for 3mo after healing was achieved. RESULTS Complete healing of the epithelial defect and resolution of stromal infiltration with no adverse effects were achieved in argon laser group in duration ranged from 2-4wk in 90% of cases. In voriconazole group 4 cases needed amniotic membrane graft due to thinning and 16 cases healed in duration ranged from 2-6wk (80% of cases). CONCLUSION Argon laser photocoagulation is superior to intrastromal voriconazole injection in treatment of resistant fungal corneal ulcers. PMID:26949639

Prevalence of food sensitization and probable food allergy among adults in India: the EuroPrevall INCO study.

PubMed

Mahesh, P A; Wong, Gary W K; Ogorodova, L; Potts, J; Leung, T F; Fedorova, O; Holla, Amrutha D; Fernandez-Rivas, M; Clare Mills, E N; Kummeling, I; Versteeg, S A; van Ree, R; Yazdanbakhsh, M; Burney, P

2016-07-01

Data are lacking regarding the prevalence of food sensitization and probable food allergy among general population in India. We report the prevalence of sensitization and probable food allergy to 24 common foods among adults from general population in Karnataka, South India. The study was conducted in two stages: a screening study and a case-control study. A total of 11 791 adults in age group 20-54 were randomly sampled from general population in South India and answered a screening questionnaire. A total of 588 subjects (236 cases and 352 controls) participated in the case-control study involving a detailed questionnaire and specific IgE estimation for 24 common foods. A high level of sensitization (26.5%) was observed for most of the foods in the general population, higher than that observed among adults in Europe, except for those foods that cross-react with birch pollen. Most of the sensitization was observed in subjects who had total IgE above the median IgE level. A high level of cross-reactivity was observed among different pollens and foods and among foods. The prevalence of probable food allergy (self-reports of adverse symptoms after the consumption of food and specific IgE to the same food) was 1.2%, which was mainly accounted for cow's milk (0.5%) and apple (0.5%). Very high levels of sensitization were observed for most foods, including those not commonly consumed in the general population. For the levels of sensitization, the prevalence of probable food allergy was low. This disassociation needs to be further explored in future studies. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Profile of children with urinary tract infection and the utility of urine dipstick as a diagnostic tool.

PubMed

Ojha, A R; Aryal, U R

2014-01-01

Urinary tract infection is a common problem in children and its early diagnosis and treatment is important to prevent long-term complications. Urine dipstick can be an important tool in this respect. The aim of this study is to look at the utility of urine dipstick as a diagnostic tool for UTI and will also see the clinical profile of children with UTI and sensitivity pattern of antibiotics among the isolates of urine culture. Urine samples of all children below 14 years of age who were suspected of urinary tract infection were sent for routine microscopic examination and dipstick testing. Urine culture and sensitivity were sent for those samples that were tested positive for nitrite, leucocyte esterase activity or both. For every fifth sample, which is dipstick negative, a culture and sensitivity testing was done. Among 110 children enrolled, 32(29%) cases had significant bacteriuria. Out of 32 culture positive cases 18(56%) were female. Fever was the main complaint (62.5%)). Escherichia Coli was isolated in 81.25% of cases. Amikacin was sensitive in 93% and amoxicillinwas resistant in 82%. The sensitivity, specificity, positive predictive value, negative predictive value of nitrite test was 65%, 80%, 58%, 85% respectively; those of leucocyte esterase are 84%, 55%, 43%, 89% respectively; those for significant microscopic pyuria >10/hpf were 65%, 74%, 51%, 84% respectively. E. Coli is the commonest uropathogen in children with UTI. Amikacin is the most sensitive antibiotic against all the isolates. A positive dipstick both for nitrite and leucocyte esterase is associated with high sensitivity and specificity for urinary tract infection as compared to either of them positive alone. In addition, urine WBC ≥10/hpf is associated with high probability of UTI.

Case-Deletion Diagnostics for Maximum Likelihood Multipoint Quantitative Trait Locus Linkage Analysis

PubMed Central

Mendoza, Maria C.B.; Burns, Trudy L.; Jones, Michael P.

2009-01-01

Objectives Case-deletion diagnostic methods are tools that allow identification of influential observations that may affect parameter estimates and model fitting conclusions. The goal of this paper was to develop two case-deletion diagnostics, the exact case deletion (ECD) and the empirical influence function (EIF), for detecting outliers that can affect results of sib-pair maximum likelihood quantitative trait locus (QTL) linkage analysis. Methods Subroutines to compute the ECD and EIF were incorporated into the maximum likelihood QTL variance estimation components of the linkage analysis program MAPMAKER/SIBS. Performance of the diagnostics was compared in simulation studies that evaluated the proportion of outliers correctly identified (sensitivity), and the proportion of non-outliers correctly identified (specificity). Results Simulations involving nuclear family data sets with one outlier showed EIF sensitivities approximated ECD sensitivities well for outlier-affected parameters. Sensitivities were high, indicating the outlier was identified a high proportion of the time. Simulations also showed the enormous computational time advantage of the EIF. Diagnostics applied to body mass index in nuclear families detected observations influential on the lod score and model parameter estimates. Conclusions The EIF is a practical diagnostic tool that has the advantages of high sensitivity and quick computation. PMID:19172086

The sensitivity and specificity of Lassa virus IgM by ELISA as screening tool at early phase of Lassa fever infection

PubMed Central

Ibekwe, Titus S.; Nwegbu, Maxwell M.; Asogun, Daniel; Adomeh, Donatus I.; Okokhere, Peter O.

2012-01-01

Background: Early diagnosis, prompt treatment, and disease containment are vital measures in the management of Lassa fever (LF), a lethal and contagious arenaviral hemorrhagic disease prevalent in West Africa. Lassa Virus (LAV)-specific Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test, the gold standard for diagnosis, is unavailable in most centers. Serologic detection of LAV IgM is a more accessible tool and this work was to investigate its adequacy as an early marker for LF. Patients and Methods: A prospective case–control study conducted July 2007-March 2011 in a tertiary referral health center in Nigeria. Blood samples for test and control were evaluated for Lassa specific antigens and IgM using RT-PCR (primers S36+ and LVS 339) and indirect ELISA (Lassa Nucleo-protein (NP)-Antigen) respectively. RT-PCR outcome was used as standard to test for the sensitivity and specificity of IgM. Results: Of the 37 confirmed cases of LF infection by RT-PCR, 21 (57%) were IgM positive. Amongst the 35 confirmed negative cases (control group), eight were IgM positive. The diagnostic sensitivity and specificity of the IgM assay were 57% and 77% respectively. The negative and positive predictive values of the IgM serological assay were 63% and 72%, respectively, while the efficiency of the test was 67%. Conclusion: The specificity and sensitivity of IgM as a screening tool for early detection of LF appear weak and, hence, the need for a reliable LF “rapid screening kit” since RT-PCR is unavailable in most centers. In the interim, “high clinical index of suspicion,” irrespective of IgM status, requires urgent referral to confirmatory centers. PMID:23661877

[Cost-benefit analysis of the active screening of pulmonary tuberculosis in a recluse population entering prison].

PubMed

Martín, V; Domínguez, A; Alcaide, J

1997-01-01

In spanish prisons, tuberculosis is a serious problem of public health and health authorities don't take it seriously. To prove the efficiency of pulmonary tuberculosis case-finding on arrival at prison in order to get location resources in this activity. Cost-benefit analysis of a case-finding program compared with to wait for diagnostic to illness. The sensitivity of test was fixed in 80% and the specificity in 99.99%. The cost was based on market prices. Sensitivity analysis was done in every variables as well as tridimensional analysis in those one of more influence. The case-finding was efficient on prevalences of tuberculosis over 5 per mil. Its efficiency was hardly affected by discount social rates or the sensitivity of diagnostic tests. The prevalence of illness, the cost of diagnostic activities as well as the success of treatment and the specificity of diagnostic tests used had as influence on the efficiency model. The tridimensional analysis proved that the case-finding of pulmonary tuberculosis has efficiency on low prevalences (1 per thousand), provided the number of people cured is a 5% higher than the alternative one and the costs of case-finding less than 1,000 pesetas per subject. The case-finding pulmonary tuberculosis on arrival at prisons is of high efficiency. In a cost-opportunity situation (location of available resources, penitentiary and extrapenitentiary) the program is very efficacious taking into account the fact of higher prevalence of pulmonary tuberculosis in this people.

Transcutaneous bowel sonography for inflammatory bowel disease is sensitive and specific when performed in a nonexpert low-volume North American center.

PubMed

Sey, Michael Sai Lai; Gregor, Jamie; Chande, Nilesh; Ponich, Terry; Bhaduri, Mousumi; Lum, Andrea; Zaleski, Witek; Yan, Brian

2013-08-01

Transcutaneous bowel sonography is a nonionizing imaging modality used in inflammatory bowel disease. Although available in Europe, its uptake in North America has been limited. Since the accuracy of bowel sonography is highly operator dependent, low-volume centers in North America may not achieve the same diagnostic accuracy reported in the European literature. Our objective was to determine the diagnostic accuracy of bowel sonography in a nonexpert low-volume center. All cases of bowel sonography at a single tertiary care center during an 18-month period were reviewed. Bowel sonography was compared with reference standards, including small-bowel follow-through, computed tomography, magnetic resonance imaging, colonoscopy, and surgical findings. A total of 103 cases were included for analysis during the study period. The final diagnoses included Crohn disease (72), ulcerative colitis (8), hemolytic uremic syndrome (1), and normal (22). The sensitivity and specificity of bowel sonography for intestinal wall inflammation were 87.8% and 92.6%, respectively. In the subset of patients who had complications of Crohn disease, the sensitivity and specificity were 50% and 100% for fistulas and 14% and 100% for strictures. One patient had an abscess, which was detected by bowel sonography. Abnormal bowel sonographic findings contributed to the escalation of treatment in 55% of cases. Bowel sonography for inflammatory bowel disease can be performed in low-volume centers and provides diagnostic accuracy for luminal disease comparable with published data, although it is less sensitive for complications of Crohn disease.

Developing a Screening Algorithm for Type II Diabetes Mellitus in the Resource-Limited Setting of Rural Tanzania.

PubMed

West, Caroline; Ploth, David; Fonner, Virginia; Mbwambo, Jessie; Fredrick, Francis; Sweat, Michael

2016-04-01

Noncommunicable diseases are on pace to outnumber infectious disease as the leading cause of death in sub-Saharan Africa, yet many questions remain unanswered with concern toward effective methods of screening for type II diabetes mellitus (DM) in this resource-limited setting. We aim to design a screening algorithm for type II DM that optimizes sensitivity and specificity of identifying individuals with undiagnosed DM, as well as affordability to health systems and individuals. Baseline demographic and clinical data, including hemoglobin A1c (HbA1c), were collected from 713 participants using probability sampling of the general population. We used these data, along with model parameters obtained from the literature, to mathematically model 8 purposed DM screening algorithms, while optimizing the sensitivity and specificity using Monte Carlo and Latin Hypercube simulation. An algorithm that combines risk assessment and measurement of fasting blood glucose was found to be superior for the most resource-limited settings (sensitivity 68%, sensitivity 99% and cost per patient having DM identified as $2.94). Incorporating HbA1c testing improves the sensitivity to 75.62%, but raises the cost per DM case identified to $6.04. The preferred algorithms are heavily biased to diagnose those with more severe cases of DM. Using basic risk assessment tools and fasting blood sugar testing in lieu of HbA1c testing in resource-limited settings could allow for significantly more feasible DM screening programs with reasonable sensitivity and specificity. Copyright © 2016 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

Molecular allergy diagnostics using IgE singleplex determinations: methodological and practical considerations for use in clinical routine: Part 18 of the Series Molecular Allergology.

PubMed

Kleine-Tebbe, Jörg; Jakob, Thilo

Allergen molecules (synonyms: single allergens, allergen components) open up new horizons for the targeted allergen-specific diagnostics of immunoglobulin E (IgE) in singleplex determination. The following rationales support the targeted use of allergen molecules and, more importantly, improve test properties: (1) increased test sensitivity ("analytical sensitivity"), particularly when important allergens are under-represented or lacking in the extract; (2) improved test selectivity (analytical specificity), particularly when the selected IgE repertoire against an allergen yields additional information on: (a) potential risk, (b) possible cross-reactivity, or (c) primary (species-specific) sensitization. However, the appropriate indication for the use of single allergens can only be established on a case-by-case basis (depending on the clinical context and previous history) and in an allergen-specific manner (depending on the allergen source and the single allergens available), rather than in a standardized way. Numerous investigations on suspected food allergy, insect venom allergy, or sensitization to respiratory allergens have meanwhile demonstrated the successful use of defined molecules for allergen-specific singleplex IgE diagnosis. Specific IgE to single allergens is limited in its suitability to predict the clinical relevance of sensitivity on an individual basis. In food allergies, one can at best identify the relative risk of a clinical reaction on the basis of an IgE profile, but no absolutely reliable prediction on (future) tolerance can be made. Ultimately, the clinical relevance of all IgE findings depends on the presence of corresponding symptoms and can only be assessed on an individual basis (previous history, symptom log, and provocation testing with the relevant allergen source where appropriate). Thus, also in molecular allergology, the treating physician and not the test result should determine the clinical relevance of diagnostic findings. Supplementary material is available for this article at 10.1007/s40629-015-0067-z and is accessible for authorized users.

Diagnostic sensitivity and specificity of in situ hybridization and immunohistochemistry for Eastern equine encephalitis virus and West Nile virus in formalin-fixed, paraffin-embedded brain tissue of horses.

PubMed

Pennick, Kate E; McKnight, Christy A; Patterson, Jon S; Latimer, Kenneth S; Maes, Roger K; Wise, Annabel G; Kiupel, Matti

2012-03-01

Immunohistochemistry (IHC) and in situ hybridization (ISH) can be used either to detect or to differentiate between Eastern equine encephalitis virus (EEEV) and West Nile virus (WNV) within formalin-fixed, paraffin-embedded (FFPE) brain tissue of horses. To compare the diagnostic sensitivity and specificity of ISH and IHC, FFPE brain tissue from 20 EEEV-positive horses and 16 WNV-positive horses were tested with both EEEV and WNV oligoprobes and EEEV- and WNV-specific antibodies. Reverse transcription polymerase chain reaction (RT-PCR) for detection of EEEV and WNV was used as the gold standard to confirm infection. All horses that tested positive for EEEV by RT-PCR also tested positive by IHC and ISH, except for 1 case that was false-negative by ISH. In contrast, all horses that tested positive for WNV by RT-PCR tested negative by IHC and only 2 horses tested positive by ISH. No false-positives were detected with either method for both viruses. Both IHC and ISH are highly specific and sensitive diagnostic methods to detect EEEV in equine FFPE brain tissues, although neither appear effective for the diagnosis of WNV in equine neurologic cases.

Molecular diagnosis and immunotherapy.

PubMed

Sastre, Joaquín; Sastre-Ibañez, Marina

2016-12-01

To describe recent insights into how molecular diagnosis can improve indication and selection of suitable allergens for specific immunotherapy and increase the safety of this therapy. As specific allergen immunotherapy targets specific allergens, identification of the disease-eliciting allergen is a prerequisite for accurate prescription of treatment. In areas of complex sensitization to aeroallergens or in cases of hymenoptera venom allergy, the use of molecular diagnosis has demonstrated that it may lead to a change in indication and selection of allergens for immunotherapy in a large proportion of patients when compared with diagnosis based on skin prick testing and/or specific IgE determination with commercial extracts. These changes in immunotherapy prescription aided by molecular diagnosis have been demonstrated to be cost-effective in some scenarios. Certain patterns of sensitization to grass or olive pollen and bee allergens may identify patients with higher risk of adverse reaction during immunotherapy. Molecular diagnosis, when used with other tools and patients' clinical records, can help clinicians better to select the most appropriate patients and allergens for specific immunotherapy and, in some cases, predict the risk of adverse reactions. The pattern of sensitization to allergens could potentially predict the efficacy of allergen immunotherapy provided that these immunotherapy products contain a sufficient amount of these allergens. Nevertheless, multiplex assay remains a third-level approach, not to be used as screening method in current practice.

Validity and reliability of self-reported arthritis: Georgia senior centers, 2000-2001.

PubMed

Bombard, Jennifer M; Powell, Kenneth E; Martin, Linda M; Helmick, Charles G; Wilson, William H

2005-04-01

Arthritis and other rheumatic conditions are a common cause of disability among adults in the United States. Telephone interviews of the state-based Behavioral Risk Factor Surveillance System (BRFSS) are used by states and territories to estimate the prevalence of arthritis. The purpose of this study was to assess the validity and reliability of the 1996-2001 BRFSS arthritis case definition in a senior center population. A total of 487 respondents at selected senior centers in Georgia were surveyed by telephone, evaluated 3 to 4 weeks later by board-certified rheumatologists, and completed a written survey in 2000 to 2001. Using the rheumatologists' summary assessment "Does this person have arthritis or a related condition" as the standard, the sensitivity and specificity of the BRFSS arthritis case definitions were calculated. Reliability for the BRFSS arthritis case definition was also calculated by comparing responses to the telephone survey with responses to a written survey. Sensitivity was 70.8% (95% confidence interval [CI]=65.9-75.6), and the specificity was 70.3% (95% CI=62.9-77.8). The agreement between the telephone and written responses indicating self-reported arthritis was high (kappa=0.68). Analyses were conducted in 2002 to 2004. Self-reported arthritis in the 1996-2001 BRFSS was highly reliable, and moderately sensitive and specific among these senior center participants.

Gender Sensitive Educational Policy and Practice: The Case of Malawi

ERIC Educational Resources Information Center

Maluwa-Banda, Dixie

2004-01-01

This case study focuses on qualitative indicators, though a number of quantitative indicators will be included to provide context. Qualitative issues to be looked at will include: education policies and, more specifically, curriculum-related policies containing provisions aimed at gender parity and equality in all aspects of education; gender…

Multiantigen Print Immunoassay for Comparison of Diagnostic Antigens for Taenia solium Cysticercosis and Taeniasis▿

PubMed Central

Handali, Sukwan; Klarman, Molly; Gaspard, Amanda N.; Noh, John; Lee, Yeuk-Mui; Rodriguez, Silvia; Gonzalez, Armando E.; Garcia, Hector H.; Gilman, Robert H.; Tsang, Victor C. W.; Wilkins, Patricia P.

2010-01-01

One of the best-characterized tests for the diagnosis of neurocysticercosis is the enzyme-linked immunoelectrotransfer blot assay, developed at the CDC, which uses lentil lectin-purified glycoproteins (LLGPs) extracted from Taenia solium cysticerci. The purification of the LLGP antigens has been difficult to standardize, and the polyacrylamide gel system used for the immunoblot assay is not easily transferable to other laboratories. In this study, we developed a multiantigen printing immunoassay (MAPIA) to compare the performance of multiple recombinant Taenia solium proteins with the potential for the detection of cysticercosis and taeniasis. We prepared MAPIA strips using six cysticercosis and two taeniasis diagnostic proteins and compared the performance of the proteins with sera collected from defined cysticercosis and taeniasis cases. Of the six cysticercosis antigens, rT24H performed well in detecting cases with two or more viable cysts in the brain (sensitivity and specificity, 97% and 99.4%, respectively); the use of a combination of cysticercosis antigens did not improve the sensitivity of the test and decreased the specificity. None of the antigens could differentiate the different clinical presentations of cysticercosis. Both of the taeniasis antigens (rES33 and rES38) had the same sensitivity of 99.4% and specificities of 93.9% and 94.5%, respectively. Some cross-reactivity against rES33 and rES38 was found, especially with sera from cases infected with Schistosoma mansoni. We conclude that MAPIA is a simple and effective tool that may be used to compare antibody responses to different cysticercosis and taeniasis antigens and, in this case, may be useful for the rapid detection of T. solium cases. PMID:19906893

Multiantigen print immunoassay for comparison of diagnostic antigens for Taenia solium cysticercosis and taeniasis.

PubMed

Handali, Sukwan; Klarman, Molly; Gaspard, Amanda N; Noh, John; Lee, Yeuk-Mui; Rodriguez, Silvia; Gonzalez, Armando E; Garcia, Hector H; Gilman, Robert H; Tsang, Victor C W; Wilkins, Patricia P

2010-01-01

One of the best-characterized tests for the diagnosis of neurocysticercosis is the enzyme-linked immunoelectrotransfer blot assay, developed at the CDC, which uses lentil lectin-purified glycoproteins (LLGPs) extracted from Taenia solium cysticerci. The purification of the LLGP antigens has been difficult to standardize, and the polyacrylamide gel system used for the immunoblot assay is not easily transferable to other laboratories. In this study, we developed a multiantigen printing immunoassay (MAPIA) to compare the performance of multiple recombinant Taenia solium proteins with the potential for the detection of cysticercosis and taeniasis. We prepared MAPIA strips using six cysticercosis and two taeniasis diagnostic proteins and compared the performance of the proteins with sera collected from defined cysticercosis and taeniasis cases. Of the six cysticercosis antigens, rT24H performed well in detecting cases with two or more viable cysts in the brain (sensitivity and specificity, 97% and 99.4%, respectively); the use of a combination of cysticercosis antigens did not improve the sensitivity of the test and decreased the specificity. None of the antigens could differentiate the different clinical presentations of cysticercosis. Both of the taeniasis antigens (rES33 and rES38) had the same sensitivity of 99.4% and specificities of 93.9% and 94.5%, respectively. Some cross-reactivity against rES33 and rES38 was found, especially with sera from cases infected with Schistosoma mansoni. We conclude that MAPIA is a simple and effective tool that may be used to compare antibody responses to different cysticercosis and taeniasis antigens and, in this case, may be useful for the rapid detection of T. solium cases.

Field performance of clinical case definitions for influenza screening during the 2009 pandemic.

PubMed

Chen, Shey-Ying; Chen, Yee-Chun; Chiang, Wen-Chu; Kung, Hsiang-Chi; King, Chwan-Chuen; Lai, Mei-Shu; Chie, Wei-Chu; Chen, Shyr-Chyr; Chen, Wen-Jone; Chang, Shan-Chwen

2012-11-01

The aim of this study was to assess the performance of 3 different influenza-like illness (ILI) case definitions, adopted by the European (European-CDC), USA (USA-CDC), and Taiwan Centers for Disease Prevention and Control (Taiwan-CDC), as screening tools for influenza during the 2009 H1N1 pandemic. From August 15 to 30, 2009, all emergency department patients with clinical symptoms or at epidemiologic risk for influenza were enrolled in an observational cohort study. Influenza diagnosis was established by positive rapid influenza diagnostic test or virus isolation. Sensitivity, specificity, positive predictive value, and negative predictive value of the European-, USA, and Taiwan-CDC ILI case definitions for screening were determined. A total of 870 patients were screened during the study period. Rapid influenza diagnostic test was positive in 315 patients, 273 (85.6%) of whom had fever duration less than 72 hours. Virus isolation identified 4 more patients with influenza A initially negative by rapid influenza diagnostic test. The mean (SD) age of these 319 patients was 24.3 (18.1) years. Of the 870 screened patients, 670 (77.0%), 476 (54.7%), and 325 (37.4%) met the European-, USA-, and Taiwan-CDC ILI case definition, respectively. Screening sensitivity was 95%, 77.7%, and 57.7% and specificity was 33.4%, 58.6%, and 74.4%, respectively. Differences in sensitivity and specificity between any 2 of the 3 groups were statistically significant (P < .05). First-line physicians should recognize the advantage and limitation of different ILI case definitions in influenza screening, especially confronted by pandemic or highly pathogenic avian influenza in the future. Copyright © 2012 Elsevier Inc. All rights reserved.

Online platform for applying space-time scan statistics for prospectively detecting emerging hot spots of dengue fever.

PubMed

Chen, Chien-Chou; Teng, Yung-Chu; Lin, Bo-Cheng; Fan, I-Chun; Chan, Ta-Chien

2016-11-25

Cases of dengue fever have increased in areas of Southeast Asia in recent years. Taiwan hit a record-high 42,856 cases in 2015, with the majority in southern Tainan and Kaohsiung Cities. Leveraging spatial statistics and geo-visualization techniques, we aim to design an online analytical tool for local public health workers to prospectively identify ongoing hot spots of dengue fever weekly at the village level. A total of 57,516 confirmed cases of dengue fever in 2014 and 2015 were obtained from the Taiwan Centers for Disease Control (TCDC). Incorporating demographic information as covariates with cumulative cases (365 days) in a discrete Poisson model, we iteratively applied space-time scan statistics by SaTScan software to detect the currently active cluster of dengue fever (reported as relative risk) in each village of Tainan and Kaohsiung every week. A village with a relative risk >1 and p value <0.05 was identified as a dengue-epidemic area. Assuming an ongoing transmission might continuously spread for two consecutive weeks, we estimated the sensitivity and specificity for detecting outbreaks by comparing the scan-based classification (dengue-epidemic vs. dengue-free village) with the true cumulative case numbers from the TCDC's surveillance statistics. Among the 1648 villages in Tainan and Kaohsiung, the overall sensitivity for detecting outbreaks increases as case numbers grow in a total of 92 weekly simulations. The specificity for detecting outbreaks behaves inversely, compared to the sensitivity. On average, the mean sensitivity and specificity of 2-week hot spot detection were 0.615 and 0.891 respectively (p value <0.001) for the covariate adjustment model, as the maximum spatial and temporal windows were specified as 50% of the total population at risk and 28 days. Dengue-epidemic villages were visualized and explored in an interactive map. We designed an online analytical tool for front-line public health workers to prospectively detect ongoing dengue fever transmission on a weekly basis at the village level by using the routine surveillance data.

Prospective, multicenter clinical trial to validate new products for skin tests in the diagnosis of allergy to penicillin.

PubMed

Fernández, J; Torres, M J; Campos, J; Arribas-Poves, F; Blanca, M

2013-01-01

Allergy to penicillin is the most commonly reported type of drug hypersensitivity. Diagnosis is currently confirmed using skin tests with benzylpenicillin reagents, ie, penicilloyl-polylysine (PPL) as the major determinant of benzylpenicillin and benzylpenicillin, benzylpenicilloate and benzylpenilloate as a minor determinant mixture (MDM). To synthesize and assess the diagnostic capacity of 2 new benzylpenicillin reagents in patients with immediate hypersensitivity reactions to B-lactams: benzylpenicilloyl octa-L-lysine (BP-OL) as the major determinant and benzylpenilloate (penilloate) as the minor determinant. Prospective multicenter clinical trial performed in 18 Spanish centers. Efficacy was assessed by detection of positive skin test results in an allergic population and negative skin test results in a nonallergic, drug-exposed population. Sensitivity, specificity, and negative and positive predictive values were determined. The study sample comprised 94 allergic patients: 31 (35.23%) presented anaphylaxis, 4 (4.55%) anaphylactic shock, 51 (58.04%) urticaria, and 2 (2.27%) no specific condition. The culprit 8-lactams were amoxicillin in 63 cases (71.60%), benzypencillin in 14 cases (15.89%), cephalosporins in 2 cases (2.27%), other drugs in 3 cases (3.42%), and unidentified agents in 6 cases (6.82%). The results of testing with BP-OL were positive in 46 cases (52.3%); the results of testing with penilloate were positive in 33 cases (37.5%). When both reagents were taken into consideration, sensitivity reached 61.36% and specificity 100%. Skin testing with penilloate was significantly more often negative when the interval between the reaction and the study was longer. The sensitivity of BP-OL and penilloate was 61%. Considering that amoxicillin was the culprit drug in 71% of reactions, these results indicate that most patients were allergic to the whole group of penicillins. These data support the use of benzylpenicillin determinants in the diagnosis of allergy to beta-lactams, even in predominantly amoxicillin-allergic populations.

Application of Normative Occipital Condyle-C1 Interval Measurements to Detect Atlanto-Occipital Injury in Children.

PubMed

Corcoran, B; Linscott, L L; Leach, J L; Vadivelu, S

2016-05-01

Prior studies have found that widening or asymmetry of the occipital condyle-C1 interval on CT is a sensitive and specific marker for atlanto-occipital dislocation. Previously reported abnormal occipital condyle-C1 interval values are not age-specific, possibly leading to false-positive findings in younger children, in whom this joint space is normally larger than that in adults. This study assesses the utility of applying age-specific normative occipital condyle-C1 interval ranges to documented cases of atlanto-occipital injury compared with previously reported abnormal cutoff values. Retrospective review of CT and MR imaging of 14 subjects with atlanto-occipital injury was performed, and occipital condyle-C1 interval measurements were made for each subject. Sensitivities and specificities of proposed occipital condyle-C1 interval cutoffs of 2 and 3 SDs above the mean and previously published occipital condyle-C1 interval cutoffs for atlanto-occipital injury were then calculated on the basis of occipital condyle-C1 interval measurements for each subject. An occipital condyle-C1 interval 2 SDs above the age-specific mean has a sensitivity of 50% and specificity of 89%-100%, depending on the age group. An occipital condyle-C1 interval 3 SDs above the age-specific mean has a sensitivity of 50% and a specificity of 95%-100%. A 4.0-mm occipital condyle-C1 interval has a sensitivity of 36% and a specificity of 100% in all age groups. A 2.5-mm occipital condyle-C1 interval has a sensitivity of 93% and a specificity of 18%-100%. Occipital condyle-C1 interval widening cutoffs used to establish atlanto-occipital injury lack both sensitivity and specificity in children and young teenagers. MR imaging is necessary to establish a diagnosis of atlanto-occipital injury in children and young teenagers when the appropriate mechanism of injury is present. © 2016 by American Journal of Neuroradiology.

An evaluation of the diagnostic accuracy of the 1991 American College of Chest Physicians/Society of Critical Care Medicine and the 2001 Society of Critical Care Medicine/European Society of Intensive Care Medicine/American College of Chest Physicians/American Thoracic Society/Surgical Infection Society sepsis definition.

PubMed

Zhao, Huifang; Heard, Stephen O; Mullen, Marie T; Crawford, Sybil; Goldberg, Robert J; Frendl, Gyorgy; Lilly, Craig M

2012-06-01

Limited research has been conducted to compare the test characteristics of the 1991 and 2001 sepsis consensus definitions. This study assessed the accuracy of the two sepsis consensus definitions among adult critically ill patients compared to sepsis case adjudication by three senior clinicians. Observational study of patients admitted to intensive care units. Seven intensive care units of an academic medical center. A random sample of 960 patients from all adult intensive care unit patients between October 2007 and December 2008. None. Sensitivity, specificity, and the area under the receiver operating characteristic curve for the two consensus definitions were calculated by comparing the number of patients who met or did not meet consensus definitions vs. the number of patients who were or were not diagnosed with sepsis by adjudication. The 1991 sepsis definition had a high sensitivity of 94.6%, but a low specificity of 61.0%. The 2001 sepsis definition had a slightly increased sensitivity but a decreased specificity, which were 96.9% and 58.3%, respectively. The areas under the receiver operating characteristic curve for the two definitions were not statistically different (0.778 and 0.776, respectively). The sensitivities and areas under the receiver operating characteristic curve of both definitions were lower at the 24-hr time window level than those of the intensive care unit stay level, though their specificities increased slightly. Fever, high white blood cell count or immature forms, low Glasgow coma score, edema, positive fluid balance, high cardiac index, low PaO2/FIO2 ratio, and high levels of creatinine and lactate were significantly associated with sepsis by both definitions and adjudication. Both the 1991 and the 2001 sepsis definition have a high sensitivity but low specificity; the 2001 definition has a slightly increased sensitivity but a decreased specificity compared to the 1991 definition. The diagnostic performances of both definitions were suboptimal. A parsimonious set of significant predictors for sepsis diagnosis is likely to improve current sepsis case definitions.

Serological diagnosis of mumps: Value of the titration of specific IgG.

PubMed

Sanz, Juan Carlos; Ramos, Belén; Fernández, Aurora; García-Comas, Luis; Echevarría, Juan Emilio; de Ory, Fernando

2018-03-01

The aim of this study was to evaluate a cut-off point of the titration of IgG by ELISA in the diagnosis of mumps. A study was made of serum samples from 85 mumps cases (confirmed by PCR in saliva) and 2,351 controls of the general population of the Region of Madrid. The IgM detection was positive in 21 cases (sensitivity of 24.7%). The best cut-off point corresponded to IgG titres ≥4,900 (sensitivity of 64.7% and specificity of 86.1%). Among 42 patients immunised with at least one dose of measles mumps, rubella vaccine IgM was detected in 4 cases. However, the detection of IgG ≥4,900 was positive in 29 (sensitivity of 69.0%). An IgG result of ≥4.900 was almost 5 times more probable in a patient with mumps than in a non-infected patient. The detection of high titres of IgG against mumps could improve the IgM results in vaccinated people. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

[Roles of histologic examination and polymerase chain reaction in diagnosis of toxoplasmic lymphadenitis].

PubMed

Dai, Lin; Huang, Juan; Tang, Yuan; Liao, Dian-ying; Dong, Dan-dan; Xu, Gang; Li, Gan-di

2010-06-01

To study the roles of histologic examination and polymerase chain reaction in diagnosis of toxoplasmic lymphadenitis (TL). Forty-six archival cases of histologically diagnosed TL, encountered during the period from April, 1999 to September, 2009 and with the paraffin-embedded lymph node tissue blocks available, were enrolled into the study. The presence of genome fragments of Toxoplasma gondii (T. gondii) was analyzed using semi-nested polymerase chain reaction (PCR). Thirty cases of one or two histopathologic triad of TL as the controls. The positive rate of PCR in TL group was 76.1% (35/46), as compared to 10.0% (3/30) in the control group. The difference was of statistical significance. The sensitivity and specificity of the histologic triad in diagnosing TL was 92.1% (35/38) and 71.1% (27/38), respectively. The predictive value of positive and negative PCR results was 76.1% (35/46) and 90.0% (27/30). respectively. The high specificity but low sensitivity of applying the histologic triad in diagnosing TL cases may be due to the occurrence of atypical histologic pattern. The sensitivity is improved with the use of semi-nested PCR in detecting T. gondii DNA.

New telemedicine techniques in dermatology - evaluation with reflectance confocal microscopy via cloud-based platform.

PubMed

Łudzik, Joanna; Witkowski, Alexander Michael; Roterman-Konieczna, Irena

Dermoscopically equivocal skin lesions may present a diagnostic challenge in daily clinical practice and are regularly sent for second expert opinion. We present a new approach to handling these cases in a consultation referral system that enables communication between the initial doctor at the image upload site and dermatology experts at a distance via cloud-based telemedicine. In our study we retrospectively evaluated 100 equivocal cases with complete digital dermoscopy-reflectance confocal microscopy image sets and compared suggested management of the initial doctor to a second expert confocal reader. We evaluated the effect of reader concordance on final management of these lesions resulting in a single reader overall sensitivity of 89% and specificity of 66% and double reader concordance method sensitivity of 98% and specificity of 54%. In conclusion, we found that application of double reader evaluation of these image sets with automatic referral of lesions for removal in the case of discordant diagnosis between two doctors improved the sensitivity of diagnosis in this subset of lesions and may increase the safety threshold of management choice reducing potential misdiagnosis in telemedicine settings. This paper concerns the application of telemedicine in practical medicine.

rTES-30USM: cloning via assembly PCR, expression, and evaluation of usefulness in the detection of toxocariasis.

PubMed

Norhaida, A; Suharni, M; Liza Sharmini, A T; Tuda, J; Rahmah, N

2008-03-01

Currently, the laboratory diagnosis of toxocariasis, caused by Toxocara canis or T. cati, mainly relies on serological tests. Unfortunately, however, the specificities of most of the commercial tests that are available for the serodiagnosis of this disease are not very high and this may cause problems, especially in tropical countries where co-infections with other helminths are common. In an effort to develop a serological assay with improved specificity for the detection of Toxocara infection, an IgG(4)-ELISA based on a recombinant version (rTES-30USM) of the 30-kDa Toxocara excretory-secretory antigen (TES-30) has recently been developed. To produce the antigen, the TES-30 gene was cloned via assembly PCR, subcloned into a His-tagged prokaryotic expression vector, and purified by affinity chromatography using Ni(2+)-nitrilotriacetic-acid (Ni-NTA) resin. The performance of the ELISA based on the recombinant antigen was then compared with that of commercial kit, based on an IgG-ELISA, for the serodiagnosis of toxocariasis (Toxocara IgG-ELISA; Cypress Diagnostics, Langdorp, Belgium). Both assays were used to test 338 serum samples, including 26 samples from probable cases of toxocariasis. Assuming that all the probable cases were true cases, the assay based on rTES-30USM demonstrated a sensitivity of 92.3% (24/26) and a specificity of 89.6% (103/115) whereas the commercial kit exhibited a sensitivity of 100% (26/26) but a specificity of only 55.7% (64/115). The high sensitivity and specificity exhibited by the new IgG(4)-ELISA should make the assay a good choice for use in tropical countries and any other area where potentially cross-reactive helminthic infections are common.

Sensitivity of resistive and Hall measurements to local inhomogeneities: Finite-field, intensity, and area corrections

NASA Astrophysics Data System (ADS)

Koon, Daniel W.; Wang, Fei; Petersen, Dirch Hjorth; Hansen, Ole

2014-10-01

We derive exact, analytic expressions for the sensitivity of sheet resistance and Hall sheet resistance measurements to local inhomogeneities for the cases of nonzero magnetic fields, strong perturbations, and perturbations over a finite area, extending our earlier results on weak perturbations. We express these sensitivities for conductance tensor components and for other charge transport quantities. Both resistive and Hall sensitivities, for a van der Pauw specimen in a finite magnetic field, are a superposition of the zero-field sensitivities to both sheet resistance and Hall sheet resistance. Strong perturbations produce a nonlinear correction term that depends on the strength of the inhomogeneity. Solution of the specific case of a finite-sized circular inhomogeneity coaxial with a circular specimen suggests a first-order correction for the general case. Our results are confirmed by computer simulations on both a linear four-point probe array on a large circular disc and a van der Pauw square geometry. Furthermore, the results also agree well with Náhlík et al. published experimental results for physical holes in a circular copper foil disc.

Age-adjusted versus clinical probability-adjusted D-dimer to exclude pulmonary embolism.

PubMed

Takach Lapner, Sarah; Stevens, Scott M; Woller, Scott C; Snow, Gregory; Kearon, Clive

2018-05-05

A low D-dimer can exclude suspected pulmonary embolism (PE) in cases with low or intermediate clinical probability of disease. Yet D-dimer is nonspecific, so many cases without PE require imaging. D-dimer's specificity is improved by increasing the threshold for a positive test with age (age × 10 ng/mL; age-adjusted D-dimer; AADD) or clinical probability of PE (1000 ng/mL if low and 500 ng/mL if intermediate clinical probability; clinical probability-adjusted D-dimer; CPADD). It is unclear which approach is preferable. We report the sensitivity, specificity and negative predictive value (NPV) of AADD compared to CPADD in suspected PE. A retrospective cohort of 3500 consecutive cases imaged for suspected PE at two U.S. emergency departments was assembled. We analyzed cases with low or intermediate clinical probability of PE (Revised Geneva Score) who had a D-dimer. The outcome was acute PE on imaging at presentation. Of the 3500 cases, 1745 were eligible. 37% were low, and 63% were intermediate clinical probability of PE. PE was present in 145 (8.3%) cases. Sensitivity of CPADD was 87.5% vs. 96.6% for AADD (difference 9.1%; 95% CI 4.3% to 14.0%). NPV of CPADD was 97.1% vs. 99.0% for AADD (difference 1.9%; 95% CI, 0.7% to 3.1%). Specificity of CPADD was 37.5% vs. 30.2% for AADD (difference -7.3%; 95% CI -9.4% to -5.1%). D-dimer was negative in 35.4% of cases using CPADD vs. 28.0% using AADD. CPADD modestly improved the specificity of D-dimer, but had a lower NPV than AADD. AADD appears preferable in this analysis. Copyright © 2018 Elsevier Ltd. All rights reserved.

Gastric band slippage: a case-controlled study comparing new and old radiographic signs of this important surgical complication.

PubMed

Swenson, David W; Pietryga, Jason A; Grand, David J; Chang, Kevin J; Murphy, Brian L; Egglin, Thomas K

2014-07-01

The purpose of this study was to compare the diagnostic performance of four radiographic signs of gastric band slippage: abnormal phi angle, the "O sign," inferior displacement of the superolateral gastric band margin, and presence of an air-fluid level above the gastric band. A search of the electronic medical record identified 21 patients with a surgically proven slipped gastric band and 63 randomly-selected asymptomatic gastric band patients who had undergone barium swallow studies. These studies were evaluated for the four signs of band slippage by two independent radiologists who were blinded to clinical data. Sensitivity, specificity, and positive and negative predictive values were calculated for each radiographic sign of band slippage. Interobserver agreement between radiologists was assessed using the Fleiss kappa statistic. In evaluating for gastric band slippage, an abnormal phi angle greater than 58° was 91-95% sensitive and 52-62% specific (κ = 0.78), the O sign was 33-48% sensitive but 97% specific (κ = 0.84), inferior displacement of the superolateral band margin by more than 2.4 cm from the diaphragm was 95% sensitive and 97-98% specific (κ = 0.97), and the presence of an air-fluid level was 95% sensitive and 100% specific (κ = 1.00). We report two previously undescribed radiographic signs of gastric band slippage that are both sensitive and specific for this important surgical complication and recommend that these signs should be incorporated into the imaging evaluation of gastric band patients.

Analysis of Factors Influencing Diagnostic Accuracy of T-SPOT.TB for Active Tuberculosis in Clinical Practice.

PubMed

Zhang, Lifan; Shi, Xiaochun; Zhang, Yueqiu; Zhang, Yao; Huo, Feifei; Zhou, Baotong; Deng, Guohua; Liu, Xiaoqing

2017-08-10

T-SPOT.TB didn't perform a perfect diagnosis for active tuberculosis (ATB), and some factors may influence the results. We did this study to evaluate possible factors associated with the sensitivity and specificity of T-SPOT.TB, and the diagnostic parameters under varied conditions. Patients with suspected ATB were enrolled prospectively. Influencing factors of the sensitivity and specificity of T-SPOT.TB were evaluated using logistic regression models. Sensitivity, specificity, predictive values (PV), and likelihood ratios (LR) were calculated with consideration of relevant factors. Of the 865 participants, 205 (23.7%) had ATB, including 58 (28.3%) microbiologically confirmed TB and 147 (71.7%) clinically diagnosed TB. 615 (71.7%) were non-TB. 45 (5.2%) cases were clinically indeterminate and excluded from the final analysis. In multivariate analysis, serous effusion was the only independent risk factor related to lower sensitivity (OR = 0.39, 95% CI: 0.18-0.81) among patients with ATB. Among non-TB patients, age, TB history, immunosuppressive agents/glucocorticoid treatment and lymphocyte count were the independent risk factors related to specificity of T-SPOT.TB. Sensitivity, specificity, PV+, PV-, LR+ and LR- of T-SPOT.TB for diagnosis of ATB were 78.5%, 74.1%, 50.3%, 91.2%, 3.0 and 0.3, respectively. This study suggests that influencing factors of sensitivity and specificity of T-SPOT.TB should be considered for interpretation of T-SPOT.TB results.

[Sensitive character: an almost forgotten personality disorder - illustrated by the case Anton Reiser].

PubMed

Tölle, R

2013-03-01

n his famous 1918 book „The sensitive relative delusion” Ernst Kretschmer not only described this specific delusional disorder but also the underlying sensitive personality disorder. Until now, relatively little attention has been paid to this part of his work. The incomplete reception is outlined, followed by a description of the symptoms, psychodynamics and course of sensitive personality disorder. The interpretation of "Anton Reiser: a psychological novel" - the autobiographical work by Karl Philipp Moritz in 1785 – is used as an example since it describes Anton Reiser as a sensitive personality.

Case finding of lifestyle and mental health disorders in primary care: validation of the ‘CHAT’ tool

PubMed Central

Goodyear-Smith, Felicity; Coupe, Nicole M; Arroll, Bruce; Elley, C Raina; Sullivan, Sean; McGill, Anne-Thea

2008-01-01

Background Primary care is accessible and ideally placed for case finding of patients with lifestyle and mental health risk factors and subsequent intervention. The short self-administered Case-finding and Help Assessment Tool (CHAT) was developed for lifestyle and mental health assessment of adult patients in primary health care. This tool checks for tobacco use, alcohol and other drug misuse, problem gambling, depression, anxiety and stress, abuse, anger problems, inactivity, and eating disorders. It is well accepted by patients, GPs and nurses. Aim To assess criterion-based validity of CHAT against a composite gold standard. Design of study Conducted according to the Standards for Reporting of Diagnostic Accuracy statement for diagnostic tests. Setting Primary care practices in Auckland, New Zealand. Method One thousand consecutive adult patients completed CHAT and a composite gold standard. Sensitivities, specificities, positive and negative predictive values, and likelihood ratios were calculated. Results Response rates for each item ranged from 79.6 to 99.8%. CHAT was sensitive and specific for almost all issues screened, except exercise and eating disorders. Sensitivity ranged from 96% (95% confidence interval [CI] = 87 to 99%) for major depression to 26% (95% CI = 22 to 30%) for exercise. Specificity ranged from 97% (95% CI = 96 to 98%) for problem gambling and problem drug use to 40% (95% CI = 36 to 45%) for exercise. All had high likelihood ratios (3–30), except exercise and eating disorders. Conclusion CHAT is a valid and acceptable case-finding tool for most common lifestyle and mental health conditions. PMID:18186993

Deriving a no expected sensitization induction level for fragrance ingredients without animal testing: An integrated approach applied to specific case studies.

PubMed

Natsch, Andreas; Emter, Roger; Haupt, Tina; Ellis, Graham

2018-06-01

Cosmetic regulations prohibit animal testing for the purpose of safety assessment and recent REACH guidance states that the local lymph node assay (LLNA) in mice shall only be conducted if in vitro data cannot give sufficient information for classification and labelling. However, Quantitative Risk Assessment (QRA) for fragrance ingredients requires a NESIL, a dose not expected to cause induction of skin sensitization in humans. In absence of human data, this is derived from the LLNA and it remains a key challenge for risk assessors to derive this value from non-animal data. Here we present a workflow using structural information, reactivity data and KeratinoSens results to predict a LLNA result as a point of departure. Specific additional tests (metabolic activation, complementary reactivity tests) are applied in selected cases depending on the chemical domain of a molecule. Finally, in vitro and in vivo data on close analogues are used to estimate uncertainty of the prediction in the specific chemical domain. This approach was applied to three molecules which were subsequently tested in the LLNA and 22 molecules with available and sometimes discordant human and LLNA data. Four additional case studies illustrate how this approach is being applied to recently developed molecules in the absence of animal data. Estimation of uncertainty and how this can be applied to determine a final NESIL for risk assessment is discussed. We conclude that, in the data-rich domain of fragrance ingredients, sensitization risk assessment without animal testing is possible in most cases by this integrated approach.

The Minimum Basic Data Set (MBDS) as a tool for cancer epidemiological surveillance.

PubMed

Fernández-Navarro, Pablo; López-Abente, Gonzalo; Salido-Campos, Carmen; Sanz-Anquela, José Miguel

2016-10-01

This work aims to evaluate the Minimum Basic Data Set (MBDS) as a data source in the detection of malignant tumors and explore its usefulness as a tool for epidemiological surveillance of cancer. MBDS hospital data discharge from Prince of Asturias University Hospital (HUPA, Alcalá de Henares, Madrid, Spain) and cancer cases recorded in the Hospital Cancer Registry (HCR) have been collected for the period between January 2012 and June 2014. Both databases have been linked by the number of clinical history. For the process of evaluation of MBDS, the types of cancer with more than 100 cases have been analyzed and sensitivity, specificity, positive and negative predictive values(PPV, NPV) of MBDS were calculated using as reference the diagnoses recorded in the HCR. 3438 cases of cancer were accounted in the MBDS and 2445 in the HCR. The MBDS has a sensitivity to detect cases of cancer above 60%, although it varies depending on the type of tumor, reaching the highest values for bladder cancer. The specificity and the VPN were very high for all types of cancer studied, always on top of 95%. Finally, the VPP is generally moderate, between 50% and 70%. The systematic exploitation of the MBDS can provide a valuable tool in the monitoring of cancer by its acceptable sensitivity and high specificity, allowing obtaining information without the delays involved in the consolidation of the annotations of the HCR. Furthermore, its use could partly mitigate the lack of data in important regions of Spain. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Clinical evaluation and validation of laboratory methods for the diagnosis of Bordetella pertussis infection: Culture, polymerase chain reaction (PCR) and anti-pertussis toxin IgG serology (IgG-PT)

PubMed Central

Cassiday, Pamela K.; Pawloski, Lucia C.; Tatti, Kathleen M.; Martin, Monte D.; Briere, Elizabeth C.; Tondella, M. Lucia; Martin, Stacey W.

2018-01-01

Introduction The appropriate use of clinically accurate diagnostic tests is essential for the detection of pertussis, a poorly controlled vaccine-preventable disease. The purpose of this study was to estimate the sensitivity and specificity of different diagnostic criteria including culture, multi-target polymerase chain reaction (PCR), anti-pertussis toxin IgG (IgG-PT) serology, and the use of a clinical case definition. An additional objective was to describe the optimal timing of specimen collection for the various tests. Methods Clinical specimens were collected from patients with cough illness at seven locations across the United States between 2007 and 2011. Nasopharyngeal and blood specimens were collected from each patient during the enrollment visit. Patients who had been coughing for ≤ 2 weeks were asked to return in 2–4 weeks for collection of a second, convalescent blood specimen. Sensitivity and specificity of each diagnostic test were estimated using three methods—pertussis culture as the “gold standard,” composite reference standard analysis (CRS), and latent class analysis (LCA). Results Overall, 868 patients were enrolled and 13.6% were B. pertussis positive by at least one diagnostic test. In a sample of 545 participants with non-missing data on all four diagnostic criteria, culture was 64.0% sensitive, PCR was 90.6% sensitive, and both were 100% specific by LCA. CRS and LCA methods increased the sensitivity estimates for convalescent serology and the clinical case definition over the culture-based estimates. Culture and PCR were most sensitive when performed during the first two weeks of cough; serology was optimally sensitive after the second week of cough. Conclusions Timing of specimen collection in relation to onset of illness should be considered when ordering diagnostic tests for pertussis. Consideration should be given to including IgG-PT serology as a confirmatory test in the Council of State and Territorial Epidemiologists (CSTE) case definition for pertussis. PMID:29652945

Characterization of the VEGA ASIC coupled to large area position-sensitive Silicon Drift Detectors

NASA Astrophysics Data System (ADS)

Campana, R.; Evangelista, Y.; Fuschino, F.; Ahangarianabhari, M.; Macera, D.; Bertuccio, G.; Grassi, M.; Labanti, C.; Marisaldi, M.; Malcovati, P.; Rachevski, A.; Zampa, G.; Zampa, N.; Andreani, L.; Baldazzi, G.; Del Monte, E.; Favre, Y.; Feroci, M.; Muleri, F.; Rashevskaya, I.; Vacchi, A.; Ficorella, F.; Giacomini, G.; Picciotto, A.; Zuffa, M.

2014-08-01

Low-noise, position-sensitive Silicon Drift Detectors (SDDs) are particularly useful for experiments in which a good energy resolution combined with a large sensitive area is required, as in the case of X-ray astronomy space missions and medical applications. This paper presents the experimental characterization of VEGA, a custom Application Specific Integrated Circuit (ASIC) used as the front-end electronics for XDXL-2, a large-area (30.5 cm2) SDD prototype. The ASICs were integrated on a specifically developed PCB hosting also the detector. Results on the ASIC noise performances, both stand-alone and bonded to the large area SDD, are presented and discussed.

Research Diagnostic Criteria for Temporomandibular Disorders: Validity of Axis I Diagnoses

PubMed Central

Truelove, Edmond; Pan, Wei; Look, John O.; Mancl, Lloyd A.; Ohrbach, Richard K.; Velly, Ana; Huggins, Kimberly; Lenton, Patricia; Schiffman, Eric L.

2011-01-01

AIMS To estimate the criterion validity of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I TMD diagnoses. METHODS A combined total of 614 TMD community and clinic cases and 91 controls were examined at 3 study sites. RDC/TMD Axis I diagnoses were algorithmically derived from an examination performed by calibrated dental hygienists. Reference standards (Gold Standards) were established by means of consensus diagnoses rendered by 2 TMD experts using all available clinical data, including imaging studies. Validity of the RDC/TMD Axis I TMD diagnoses was estimated relative to reference-standard diagnoses (gold standard diagnoses). Target sensitivity and specificity were set a priori at ≥ 0.70 and ≥ 0.95, respectively. RESULTS Target sensitivity and specificity were not observed for any of the 8 RDC/TMD diagnoses. The highest validity was achieved for Group Ia myofascial pain (sensitivity 0.65, specificity 0.92) and Group Ib myofascial pain with limited opening (sensitivity 0.79, specificity 0.92). Target sensitivity and specificity were observed only when both Group I diagnoses were combined (0.87 and 0.98, respectively). For Group II (disc displacements) and Group III (arthralgia, arthritis, arthrosis) diagnoses, all estimates for sensitivity were below target (0.03 to 0.53), and specificity ranged from below to on target (0.86 to 0.99). CONCLUSION The RDC/TMD Axis I TMD diagnoses did not reach the targets set at sensitivity of ≥ 0.70 and specificity of ≥ 0.95. Target validity was obtained only for myofascial pain without differentiation between normal and limited opening. Revision of the current Axis I TMD diagnostic algorithms is warranted to improve their validity. PMID:20213030

Sensitivity and specificity of the lymphocyte transformation test in drug reaction with eosinophilia and systemic symptoms causality assessment.

PubMed

Cabañas, R; Calderón, O; Ramírez, E; Fiandor, A; Caballero, T; Heredia, R; Herranz, P; Madero, R; Quirce, S; Bellón, T

2018-03-01

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a severe delayed hypersensitivity reaction. The determination of drug causality is complex. The lymphocyte transformation test (LTT) has been reported positive in more than 50% of DRESS cases. Nevertheless, the sensitivity and specificity of LTT specifically in DRESS have not yet been established. Rechallenge with the culprit drug is contraindicated and cannot be used as gold standard for sensitivity and specificity determination. To estimate the sensitivity and specificity of LTT in a clinically defined series of patients with DRESS. Some 41 patients diagnosed with DRESS were included in the study. The results of the algorithm of the Spanish Pharmacovigilance System were used as the standard for a correct diagnosis of drug causality. A standard LTT was performed with involved drugs in acute or recovery samples. A stimulation index (SI) ≥2 in at least one concentration except for beta-lactams (SI ≥3) and contrast media (SI ≥4) was considered positive. Contingency tables and ROC curves were used for analysis. Sensitivity and specificity of LTT in the recovery phase of DRESS were 73% and 82%, respectively, whereas in the acute phase, they were only 40% and 30%, respectively. Comparison of skin tests and LTT confirmed a higher sensitivity and specificity of LTT in DRESS. LTT showed high sensitivity (S) and specificity (Sp) for anticonvulsants (S 100%, Sp 100%; P = .008), anti-TB drugs (S 87.5%, Sp 100%; P = .004), and beta-lactams (S 73%, Sp 100%; P = .001). ROC curves revealed that the best criteria for LTT positivity for all drugs are SI ≥2 in at least one concentration, increasing overall sensitivity to 80%, and for beta-lactams from 73% to 92%. LTT is a good diagnostic tool for drug causality in DRESS, mainly when performed in the recovery phase. © 2017 John Wiley & Sons Ltd.

Clostridium perfringens type-D enterotoxaemia in cattle: the diagnostic significance of intestinal epsilon toxin.

PubMed

Jones, A L; Dagleish, M P; Caldow, G L

2015-10-17

The aims of this study were to describe 42 cases of Clostridium perfringens type-D enterotoxaemia in cattle seen between 2003 and 2014 and to determine the diagnostic value of detecting epsilon toxin in bovine intestinal content. All cases in the series had histological brain changes considered pathognomonic for C. perfringens type-D enterotoxaemia in sheep and goats and the epsilon toxin of C. perfringens was concurrently detected in the intestinal contents of 15 (36 per cent) cases. The data from the case series indicate that intestinal epsilon toxin has a sensitivity of 56 per cent compared with histology of the brain for diagnosis of bovine C. perfringens type-D enterotoxaemia. The diagnostic specificity of detecting epsilon toxin in bovine intestinal content was investigated by screening intestinal contents of 60 bovine carcases submitted for postmortem examination. Epsilon toxin was detected in 11 (18 per cent) carcases but no pathognomonic histological brain change was found in any. The specificity of intestinal epsilon toxin was estimated to be 80.4 per cent. These studies demonstrate that for a definitive diagnosis of C. perfringens type-D enterotoxaemia in cattle histological examination of the brain is essential as the presence of epsilon toxin in the intestinal contents alone is neither sensitive nor specific enough. British Veterinary Association.

[Prospective performance evaluation of first trimester screenings in Germany for risk calculation through http://www.firsttrimester.net].

PubMed

Kleinsorge, F; Smetanay, K; Rom, J; Hörmansdörfer, C; Hörmannsdörfer, C; Scharf, A; Schmidt, P

2010-12-01

In 2008, 2 351 first trimester screenings were calculated by a newly developed internet database ( http:// www.firsttrimester.net ) to evaluate the risk for the presence of Down's syndrome. All data were evaluated by the conventional first trimester screening according to Nicolaides (FTS), based on the previous JOY Software, and by the advanced first trimester screening (AFS). After receiving the feedback of the karyotype as well as the rates of the correct positives, correct negatives, false positives, false negatives, the sensitivity and specificity were calculated and compared. Overall 255 cases were investigated which were analysed by both methods. These included 2 cases of Down's syndrome and one case of trisomy 18. The FTS and the AFS had a sensitivity of 100%. The specificity was 88.5% for the FTS and 93.0% for the AFS. As already shown in former studies, the higher specificity of the AFS is a result of a reduction of the false positive rate (28 to 17 cases). As a consequence of the AFS with a detection rate of 100% the rate of further invasive diagnostics in pregnant women is decreased by having 39% fewer positive tested women. © Georg Thieme Verlag KG Stuttgart · New York.

False-negative syphilis treponemal enzyme immunoassay results in an HIV-infected case-patient.

PubMed

Katz, Alan R; Komeya, Alan Y; Tomas, Juval E

2017-06-01

We present a case report of a false-negative syphilis treponemal enzyme immunoassay test result in an HIV-infected male. While treponemal tests are widely considered to be more sensitive and specific than non-treponemal tests, our findings point to potential challenges using the reverse sequence syphilis screening algorithm.

Sensitization of a child to cyanobacteria after recreational swimming in a lake

EPA Science Inventory

We report a case of an 11 year-old white female who developed an allergic reaction after swimming in Lake Ontario, Canada. Specific IgE reactivity to various species of cyanobacteria extracts was found to be increased in the patient’s serum. This case emphasizes the importance of...

Efficient molecular screening of Lynch syndrome by specific 3' promoter methylation of the MLH1 or BRAF mutation in colorectal cancer with high-frequency microsatellite instability.

PubMed

Nakagawa, Hitoshi; Nagasaka, Takeshi; Cullings, Harry M; Notohara, Kenji; Hoshijima, Naoko; Young, Joanne; Lynch, Henry T; Tanaka, Noriaki; Matsubara, Nagahide

2009-06-01

It is sometimes difficult to diagnose Lynch syndrome by the simple but strict clinical criteria, or even by the definitive genetic testing for causative germline mutation of mismatch repair genes. Thus, some practical and efficient screening strategy to select highly possible Lynch syndrome patients is exceedingly desirable. We performed a comprehensive study to evaluate the methylation status of whole MLH1 promoter region by direct bisulfite sequencing of the entire MLH1 promoter regions on Lynch and non-Lynch colorectal cancers (CRCs). Then, we established a convenient assay to detect methylation in key CpG islands responsible for the silencing of MLH1 expression. We studied the methylation status of MLH1 as well as the CpG island methylator phenotype (CIMP) and immunohistochemical analysis of mismatch repair proteins on 16 cases of Lynch CRC and 19 cases of sporadic CRCs with high-frequency microsatellite instability (MSI-H). Sensitivity to detect Lynch syndrome by MLH1 (CCAAT) methylation was 88% and the specificity was 84%. Positive likelihood ratio (PLR) was 5.5 and negative likelihood ratio (NLR) was 0.15. Sensitivity by mutational analysis of BRAF was 100%, specificity was 84%, PLR was 6.3 and NLR was zero. By CIMP analysis; sensitivity was 88%, specificity was 79%, PLR was 4.2, and NLR was 0.16. BRAF mutation or MLH1 methylation analysis combined with MSI testing could be a good alternative to screen Lynch syndrome patients in a cost effective manner. Although the assay for CIMP status also showed acceptable sensitivity and specificity, it may not be practical because of its rather complicated assay.

Application of the 2016 diagnostic approach for autoimmune encephalitis from Lancet Neurology to Chinese patients.

PubMed

Li, Lin; Sun, Lin; Du, Rong; Zheng, Yuanchu; Dai, Feifei; Ma, Qiuying; Wang, Jiawei

2017-11-06

A unified clinical approach to diagnose autoimmune encephalitis was published in Lancet Neurology in 2016. Purpose of our study is to examine the feasibility and reasonability of the 2016 "A clinical approach to diagnosis of autoimmune encephalitis" in China with a retrospective study. We retrospectively collected 95 cases of autoimmune encephalitis and non autoimmune encephalitis cases with detailed clinical data from Beijing Tongren Hospital and the China National Knowledge Infrastructure (CNKI). All cases were analysed stepwise according to the approach in Lancet Neurology to compare the new diagnosis with the final clinical diagnosis. The disease course of these 95 cases ranged from 2 to 540 days. Initial symptoms include fever, headache, seizure, mental and behavioral disorders, memory deterioration and illusion. Based on symptoms and signs when the patient came to the hospital, the sensitivity and specificity of criteria were as follows: possible autoimmune encephalitis (pAE) 84% and 94%, definite autoimmune limbic encephalitis (dALE) 38% and 96%, probable anti-N-methyl-D-aspartate receptor encephalitis (prNMDARE) 49% and 98%. The sensitivities of the above three criteria and the specificity of pAE were low during early disease stage, while the specificities of dALE and prNMDAER remained relatively high in different time periods. This new autoimmune encephalitis diagnostic approach can recognize possible autoimmune encephalitis. The chances of a case being autoimmune-mediated following classification as autoimmune encephalitis with the new criteria are high. The flowchart is recommended to use as a whole. At the early disease stage, criteria with low sensitivity and high specificity, such as dALE and prNMDARE, lead most cases to enter subsequent diagnosis steps, namely autoantibody detection in the flowchart. Final diagnoses can only be made by autoantibody tests. These factors may make it challenging for clinicians to make diagnosis promptly and to begin immune-modulating therapy immediately. Moreover, the criteria for patients with paraneoplastic syndromes (PNSs) should be considered to avoid diagnosis omission. For Chinese patients, a multi-centre, prospective study on the clinical manifestations, laboratory diagnostic technology, therapy, and prognosis is greatly needed.

Contribution of neonatal amniotic fluid testing to diagnosis of congenital toxoplasmosis.

PubMed

Filisetti, Denis; Yera, Hélène; Villard, Odile; Escande, Benoît; Wafo, Estelle; Houfflin-Debarge, Véronique; Delhaes, Laurence; Bastien, Patrick

2015-05-01

We evaluated the molecular diagnosis of congenital toxoplasmosis (CT) on neonatal amniotic fluid samples from 488 mother-child pairs. Maternal infection during pregnancy was diagnosed and dated or could not be ruled out. Forty-six cases of CT were defined according to the European Research Network on CT classification system and case definitions. Neonatal amniotic fluid testing had an overall sensitivity of 54% (95% confidence interval [95% CI], 39 to 69%) and a specificity of 100% (95% CI, 99 to 100%). Its sensitivity was 33% (95% CI, 13 to 59%) when antenatal diagnosis was positive and 68% (95% CI, 48 to 84%) when antenatal diagnosis was negative or lacking. This difference in sensitivity may have been due to treatment of antenatally diagnosed cases. Relative to postnatal serology, neonatal amniotic fluid testing allowed an earlier diagnosis to be made in 26% of the cases (95% CI, 9 to 51%). Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Evaluation of a Turbidimetric β-d-Glucan Test for Detection of Pneumocystis jirovecii Pneumonia.

PubMed

Dichtl, Karl; Seybold, Ulrich; Wagener, Johannes

2018-07-01

Currently, diagnosis of Pneumocystis jirovecii pneumonia (PJP) relies on analysis of lower respiratory specimens, either by microscopy or quantitative real-time PCR (qPCR). Thus, bronchoscopy is required, which is associated with increased risk of respiratory failure. We assessed the value of noninvasive serologic β-d-glucan (BDG) testing for laboratory diagnosis of PJP using a newly available turbidimetric assay. We identified 73 cases of PJP with positive qPCR results from lower respiratory specimens for Pneumocystis and serology samples dating from 1 week before to 4 weeks after qPCR. In addition, 25 sera from controls with suspected PJP but specimens negative for Pneumocystis by qPCR were identified. Sera were tested with a turbidimetric BDG assay (Fujifilm Wako Chemicals Europe GmbH, Neuss, Germany), using an 11-pg/ml cutoff. Sensitivity and specificity were calculated based on qPCR test results as a reference. The turbidimetric BDG assay identified 63/73 patients with positive or slightly positive qPCR tests for an overall sensitivity of 86%; after exclusion of cases with only slightly positive qPCR results, sensitivity was 91%. No correlation between serum BDG levels and respiratory specimen DNA levels was found. Serologic BDG testing was negative in 25/25 controls with negative qPCR for a specificity of 100% using the predefined cutoff. In 22/25 samples (88%), no BDG was detected. Serologic BDG testing using the turbidimetric assay showed high sensitivity and specificity compared to qPCR of lower respiratory specimens for the diagnosis of PJP. Both turnover time and test performance will allow clinicians to delay or in some cases forego bronchoscopy. Copyright © 2018 American Society for Microbiology.

Automated classification of neurological disorders of gait using spatio-temporal gait parameters.

PubMed

Pradhan, Cauchy; Wuehr, Max; Akrami, Farhoud; Neuhaeusser, Maximilian; Huth, Sabrina; Brandt, Thomas; Jahn, Klaus; Schniepp, Roman

2015-04-01

Automated pattern recognition systems have been used for accurate identification of neurological conditions as well as the evaluation of the treatment outcomes. This study aims to determine the accuracy of diagnoses of (oto-)neurological gait disorders using different types of automated pattern recognition techniques. Clinically confirmed cases of phobic postural vertigo (N = 30), cerebellar ataxia (N = 30), progressive supranuclear palsy (N = 30), bilateral vestibulopathy (N = 30), as well as healthy subjects (N = 30) were recruited for the study. 8 measurements with 136 variables using a GAITRite(®) sensor carpet were obtained from each subject. Subjects were randomly divided into two groups (training cases and validation cases). Sensitivity and specificity of k-nearest neighbor (KNN), naive-bayes classifier (NB), artificial neural network (ANN), and support vector machine (SVM) in classifying the validation cases were calculated. ANN and SVM had the highest overall sensitivity with 90.6% and 92.0% respectively, followed by NB (76.0%) and KNN (73.3%). SVM and ANN showed high false negative rates for bilateral vestibulopathy cases (20.0% and 26.0%); while KNN and NB had high false negative rates for progressive supranuclear palsy cases (76.7% and 40.0%). Automated pattern recognition systems are able to identify pathological gait patterns and establish clinical diagnosis with good accuracy. SVM and ANN in particular differentiate gait patterns of several distinct oto-neurological disorders of gait with high sensitivity and specificity compared to KNN and NB. Both SVM and ANN appear to be a reliable diagnostic and management tool for disorders of gait. Copyright © 2015 Elsevier Ltd. All rights reserved.

Diagnostic accuracy of fungal PCR and β-d-glucan for detection of candidaemia: a preliminary evaluation.

PubMed

McKeating, Cara; White, P Lewis; Posso, Raquel; Palmer, Michael; Johnson, Elizabeth; McMullan, Ronan

2018-05-01

Although treatment for candidaemia is time critical, culture-based tests prolong turnaround times and may promote underdiagnosis. Non-culture-based tests have the potential to overcome these difficulties but are in limited clinical use. The aim of this work was to undertake an initial evaluation of two non-culture-based tests for diagnosis of candidaemia. Patients with candidaemia were identified prospectively over a 4-month period. Sera drawn from case (candidaemic) and control (non-candidaemic) patients on the same day as the positive blood culture were tested with both the Renishaw RenDx Fungiplex test and a commercial β-d-glucan (BDG) assay (Fungitell, Associates of Cape Cod). Sensitivity and specificity were calculated independently and in combination, using paired blood culture as the reference standard. There were 10 eligible case patients and 39 negative controls. PCR sensitivity and specificity were found to be 44.4% (95% CI 18.9% to 73.3%) and 87.2% (72.8% to 94.8%), respectively. BDG sensitivity and specificity were 80% (47.9% to 95.4%) and 89.7% (75.9% to 96.5%), respectively. When combining PCR and BDG, sensitivity was 90% (95% CI 57.4% to 100%) and specificity was 79.5% (64.2% to 89.5%). When two sequential specimens were tested, PCR sensitivity increased to 60% (95% CI 31.2% to 83.3%) and BDG sensitivity to 90% (54.7% to 100%). A combination of tests, or a single test at multiple time points, may be preferable to relying on one test at a single time point. This should be accounted for in design of future diagnostic accuracy studies of tests for invasive candidosis. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Interobserver variability and feasibility of polymerase chain reaction-based assay in distinguishing ischemic colitis from Clostridium difficile colitis in endoscopic mucosal biopsies.

PubMed

Wiland, Homer O; Procop, Gary W; Goldblum, John R; Tuohy, Marion; Rybicki, Lisa; Patil, Deepa T

2013-06-01

Polymerase chain reaction (PCR)-based assays using stool samples are currently the most effective method of detecting Clostridium difficile. This study examines the feasibility of this assay using mucosal biopsy samples and evaluates the interobserver reproducibility in diagnosing and distinguishing ischemic colitis from C difficile colitis. Thirty-eight biopsy specimens were reviewed and classified by 3 observers into C difficile and ischemic colitis. The findings were correlated with clinical data. PCR was performed on 34 cases using BD GeneOhm C difficile assay. The histologic interobserver agreement was excellent (κ= 0.86) and the agreement between histologic and clinical diagnosis was good (κ = 0.84). All 19 ischemic colitis cases tested negative (100% specificity) and 3 of 15 cases of C difficile colitis tested positive (20% sensitivity). C difficile colitis can be reliably distinguished from ischemic colitis using histologic criteria. The C difficile PCR test on endoscopic biopsy specimens has excellent specificity but limited sensitivity.

Immunocytochemistry for MUC4 and MUC16 is a useful adjunct in the diagnosis of pancreatic adenocarcinoma on fine-needle aspiration cytology.

PubMed

Horn, Adam; Chakraborty, Subhankar; Dey, Parama; Haridas, Dhanya; Souchek, Joshua; Batra, Surinder K; Lele, Subodh M

2013-04-01

Diagnoses rendered as atypical/suspicious for malignancy on fine-needle aspiration (FNA) of pancreatic mass lesions range from 2% to 29% in various studies. We have identified the expression of 3 genes, MUC4, MUC16, and NGAL that are highly upregulated in pancreatic adenocarcinoma. In this study, we analyzed the expression of these markers in FNA samples to determine whether they could improve sensitivity and specificity. To evaluate the utility of MUC4, MUC16, and NGAL in the evaluation of pancreatic FNA specimens. Records of pancreatic FNAs performed during 10 consecutive years were reviewed. Unstained sections from corresponding cell blocks were immunostained for MUC4, MUC16, and NGAL (polyclonal). Immunostaining was assessed using the H-score (range, 0-3). Any case with an H-score of >0.5 was considered positive. Cases were classified using cytomorphologic criteria as adenocarcinoma (31 of 64; 48.4%), benign (17 of 64; 26.6%), and atypical/suspicious (16 of 64; 25%). On follow-up, all cases (100%; 31 of 31) diagnosed as carcinoma on cytology were confirmed on biopsy/resection samples or by clinical follow-up (such as unresectable disease). Of the cases diagnosed as atypical/suspicious, 69% (11 of 16) were found to be positive for adenocarcinoma and 31% (5 of 16) were benign on subsequent follow-up. Overall sensitivity and specificity, respectively, for the various markers for the detection of pancreatic adenocarcinoma were as follows: MUC4 (74% and 100%), MUC16 (62.9% and 100%), and NGAL (61.3% and 58.8%). In cases that were atypical/suspicious on cytology, expression of MUC4 and MUC16 was 100% specific for carcinoma with sensitivities of 63.6% and 66.7%, respectively. Immunocytochemistry for MUC4 and MUC16 appears to be a useful adjunct in the classification of pancreatic FNA samples, especially in cases that are equivocal (atypical/suspicious) for adenocarcinoma on cytomorphologic assessment.

Utility of hand-held devices in diagnosis and triage of cardiovascular emergencies. Observations during implementation of a PACS-based system in an acute aortic syndrome (AAS) network.

PubMed

Matar, Ralph; Renapurkar, Rahul; Obuchowski, Nancy; Menon, Venu; Piraino, David; Schoenhagen, Paul

2015-01-01

Prompt diagnosis and early referral to specialized centers is critical for patients presenting with cardiovascular emergencies, including acute aortic syndromes (AAS). Prior data has suggested that mobile access to imaging studies with hand-held devices can accelerate diagnosis and management. We conducted a study to determine the diagnostic accuracy of a hand-held device compared to conventional dedicated work-stations for diagnosing a spectrum of cardiovascular emergencies, predominantly acute aortic pathology. This study included 104 cases who underwent computed tomography (CT)-scan during "on-call'' hours between January, 2013 and August, 2014 for suspected AAS. Assessment was performed on a hand-held device independently by two readers using an iPhone5 connected via secure connection to web-based PACS servers. The subsequent interpretation from a dedicated workstation coupled with the diagnosis at the time of discharge was used as the reference standard for determining the presence or absence of an acute abnormality. Sensitivity and Specificity were calculated on a per patient basis. Readers' sensitivity and specificity using the hand-held device to diagnose acute chest pathology were calculated. Hand-held device evaluation was determined to have a sensitivity of 85.2% and a specificity of 98.6% by reader A and a sensitivity of 96.3% and specificity of 100% by reader B. Of 103 cases interpreted by both readers, the readers agreed about the diagnosis in 98 cases (95.1%). This study demonstrates that hand-held devices can be a potential useful tool to assist in diagnosis and triage of patients presenting with cardiovascular emergencies. Further studies are needed to assess the impact of screen size and resolution. Copyright © 2015 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Comparison of MY09/11 consensus PCR and type-specific PCRs in the detection of oncogenic HPV types.

PubMed

Depuydt, C E; Boulet, G A V; Horvath, C A J; Benoy, I H; Vereecken, A J; Bogers, J J

2007-01-01

The causal relationship between persistent infection with high-risk HPV and cervical cancer has resulted in the development of HPV DNA detection systems. The widely used MY09/11 consensus PCR targets a 450bp conserved sequence in the HPV L1 gene, and can therefore amplify a broad spectrum of HPV types. However, limitations of these consensus primers are evident, particularly in regard to the variability in detection sensitivity among different HPV types. This study compared MY09/11 PCR with type-specific PCRs in the detection of oncogenic HPV types. The study population comprised 15, 774 patients. Consensus PCR failed to detect 522 (10.9%) HPV infections indicated by type-specific PCRs. A significant correlation between failure of consensus PCR and HPV type was found. HPV types 51, 68 and 45 were missed most frequently. The clinical relevance of the HPV infections missed by MY09/11 PCR was reflected in the fraction of cases with cytological abnormalities and in follow-up, showing 104 (25.4%) CIN2+ cases. The MY09/11 false negativity could be the result of poor sensitivity, mismatch of MY09/11 primers or disruption of L1 target by HPV integration or DNA degradation. Furthermore, MY09/11 PCR lacked specificity for oncogenic HPVs. Diagnostic accuracy of the PCR systems, in terms of sensitivity (MY09/11 PCR: 87.9%; type-specific PCRs: 98.3%) and specificity (MY09/11 PCR: 38.7%; type-specific PCRs: 76.14%), and predictive values for histologically confirmed CIN2+, suggest that type-specific PCRs could be used in a clinical setting as a reliable screening tool.

Improved artificial neural networks in prediction of malignancy of lesions in contrast-enhanced MR-mammography.

PubMed

Vomweg, T W; Buscema, M; Kauczor, H U; Teifke, A; Intraligi, M; Terzi, S; Heussel, C P; Achenbach, T; Rieker, O; Mayer, D; Thelen, M

2003-09-01

The aim of this study was to evaluate the capability of improved artificial neural networks (ANN) and additional novel training methods in distinguishing between benign and malignant breast lesions in contrast-enhanced magnetic resonance-mammography (MRM). A total of 604 histologically proven cases of contrast-enhanced lesions of the female breast at MRI were analyzed. Morphological, dynamic and clinical parameters were collected and stored in a database. The data set was divided into several groups using random or experimental methods [Training & Testing (T&T) algorithm] to train and test different ANNs. An additional novel computer program for input variable selection was applied. Sensitivity and specificity were calculated and compared with a statistical method and an expert radiologist. After optimization of the distribution of cases among the training and testing sets by the T & T algorithm and the reduction of input variables by the Input Selection procedure a highly sophisticated ANN achieved a sensitivity of 93.6% and a specificity of 91.9% in predicting malignancy of lesions within an independent prediction sample set. The best statistical method reached a sensitivity of 90.5% and a specificity of 68.9%. An expert radiologist performed better than the statistical method but worse than the ANN (sensitivity 92.1%, specificity 85.6%). Features extracted out of dynamic contrast-enhanced MRM and additional clinical data can be successfully analyzed by advanced ANNs. The quality of the resulting network strongly depends on the training methods, which are improved by the use of novel training tools. The best results of an improved ANN outperform expert radiologists.

Novel diagnostic procedure for determining metastasis to sentinel lymph nodes in breast cancer using a semi-dry dot-blot method.

PubMed

Otsubo, Ryota; Oikawa, Masahiro; Hirakawa, Hiroshi; Shibata, Kenichiro; Abe, Kuniko; Hayashi, Tomayoshi; Kinoshita, Naoe; Shigematsu, Kazuto; Hatachi, Toshiko; Yano, Hiroshi; Matsumoto, Megumi; Takagi, Katsunori; Tsuchiya, Tomoshi; Tomoshige, Koichi; Nakashima, Masahiro; Taniguchi, Hideki; Omagari, Takeyuki; Itoyanagi, Noriaki; Nagayasu, Takeshi

2014-02-15

We developed an easy, quick and cost-effective detection method for lymph node metastasis called the semi-dry dot-blot (SDB) method, which visualizes the presence of cancer cells with washing of sectioned lymph nodes by anti-pancytokeratin antibody, modifying dot-blot technology. We evaluated the validity and efficacy of the SDB method for the diagnosis of lymph node metastasis in a clinical setting (Trial 1). To evaluate the validity of the SDB method in clinical specimens, 180 dissected lymph nodes from 29 cases, including breast, gastric and colorectal cancer, were examined. Each lymph node was sliced at the maximum diameter and the sensitivity, specificity and accuracy of the SDB method were determined and compared with the final pathology report. Metastasis was detected in 32 lymph nodes (17.8%), and the sensitivity, specificity and accuracy of the SDB method were 100, 98.0 and 98.3%, respectively (Trial 2). To evaluate the efficacy of the SDB method in sentinel lymph node (SLN) biopsy, 174 SLNs from 100 cases of clinically node-negative breast cancer were analyzed. Each SLN was longitudinally sliced at 2-mm intervals and the sensitivity, specificity, accuracy and time required for the SDB method were determined and compared with the intraoperative pathology report. Metastasis was detected in 15 SLNs (8.6%), and the sensitivity, specificity, accuracy and mean required time of the SDB method were 93.3, 96.9, 96.6 and 43.3 min, respectively. The SDB method is a novel and reliable modality for the intraoperative diagnosis of SLN metastasis. © 2013 UICC.

Evaluation of chondromalacia of the patella with axial inversion recovery-fast spin-echo imaging.

PubMed

Lee, S H; Suh, J S; Cho, J; Kim, S J; Kim, S J

2001-03-01

The purpose of our study was to assess the accuracy of inversion recovery-fast spin-echo (IR-FSE) imaging for the evaluation of chondromalacia of the patella. Eighty-six patients were included, they underwent magnetic resonance (MR) examination and subsequent knee arthroscopy. Medial and lateral facets of the patella were evaluated separately. Axial images were obtained by using IR-FSE (TR/TE/TI = 3000/25/150 msec; echo train length, 8; 4-mm thickness; 12-cm field of view; 512 x 256 matrix; two, number of excitations) with a 1.5-T MR machine. MR interpretation of chondromalacia was made on the basis of the arthroscopic grading system. Of a total of 172 facets graded, arthroscopy revealed chondromalacia in 14 facets with various grades (G0, 158; G1, 1; G2, 3; G3, 6; G4, 4). Sensitivity, specificity, and accuracy in the chondromalacia grades were 57.1%, 93.0%, and 90.1%, respectively. There was one false-negative case (G4) and 11 false-positive cases (G1, eight; G2, two; G3, one). Sensitivity and specificity corrected by one grade difference were improved to 85.7% and 98.1%, respectively. When cartilage changes were grouped into early (corresponding to grade 1 and 2) and advanced (grade 3 and 4) diseases, sensitivity and specificity of the early and advanced diseases were 75% and 94% and 80% and 99%, respectively. IR-FSE imaging of the knee revealed high specificity but low sensitivity for the evaluation of chondromalacia of the patella.

Exploration of Analysis Methods for Diagnostic Imaging Tests: Problems with ROC AUC and Confidence Scores in CT Colonography

PubMed Central

Mallett, Susan; Halligan, Steve; Collins, Gary S.; Altman, Doug G.

2014-01-01

Background Different methods of evaluating diagnostic performance when comparing diagnostic tests may lead to different results. We compared two such approaches, sensitivity and specificity with area under the Receiver Operating Characteristic Curve (ROC AUC) for the evaluation of CT colonography for the detection of polyps, either with or without computer assisted detection. Methods In a multireader multicase study of 10 readers and 107 cases we compared sensitivity and specificity, using radiological reporting of the presence or absence of polyps, to ROC AUC calculated from confidence scores concerning the presence of polyps. Both methods were assessed against a reference standard. Here we focus on five readers, selected to illustrate issues in design and analysis. We compared diagnostic measures within readers, showing that differences in results are due to statistical methods. Results Reader performance varied widely depending on whether sensitivity and specificity or ROC AUC was used. There were problems using confidence scores; in assigning scores to all cases; in use of zero scores when no polyps were identified; the bimodal non-normal distribution of scores; fitting ROC curves due to extrapolation beyond the study data; and the undue influence of a few false positive results. Variation due to use of different ROC methods exceeded differences between test results for ROC AUC. Conclusions The confidence scores recorded in our study violated many assumptions of ROC AUC methods, rendering these methods inappropriate. The problems we identified will apply to other detection studies using confidence scores. We found sensitivity and specificity were a more reliable and clinically appropriate method to compare diagnostic tests. PMID:25353643

Exploration of analysis methods for diagnostic imaging tests: problems with ROC AUC and confidence scores in CT colonography.

PubMed

Mallett, Susan; Halligan, Steve; Collins, Gary S; Altman, Doug G

2014-01-01

Different methods of evaluating diagnostic performance when comparing diagnostic tests may lead to different results. We compared two such approaches, sensitivity and specificity with area under the Receiver Operating Characteristic Curve (ROC AUC) for the evaluation of CT colonography for the detection of polyps, either with or without computer assisted detection. In a multireader multicase study of 10 readers and 107 cases we compared sensitivity and specificity, using radiological reporting of the presence or absence of polyps, to ROC AUC calculated from confidence scores concerning the presence of polyps. Both methods were assessed against a reference standard. Here we focus on five readers, selected to illustrate issues in design and analysis. We compared diagnostic measures within readers, showing that differences in results are due to statistical methods. Reader performance varied widely depending on whether sensitivity and specificity or ROC AUC was used. There were problems using confidence scores; in assigning scores to all cases; in use of zero scores when no polyps were identified; the bimodal non-normal distribution of scores; fitting ROC curves due to extrapolation beyond the study data; and the undue influence of a few false positive results. Variation due to use of different ROC methods exceeded differences between test results for ROC AUC. The confidence scores recorded in our study violated many assumptions of ROC AUC methods, rendering these methods inappropriate. The problems we identified will apply to other detection studies using confidence scores. We found sensitivity and specificity were a more reliable and clinically appropriate method to compare diagnostic tests.

Sensitivity and specificity of ultrasonography in early diagnosis of metatarsal bone stress fractures: a pilot study of 37 patients.

PubMed

Banal, Frédéric; Gandjbakhch, Frédérique; Foltz, Violaine; Goldcher, Alain; Etchepare, Fabien; Rozenberg, Sylvie; Koeger, Anne-Claude; Bourgeois, Pierre; Fautrel, Bruno

2009-08-01

To date, early diagnosis of stress fractures depends on magnetic resonance imaging (MRI) or bone scan scintigraphy, as radiographs are usually normal at onset of symptoms. These examinations are expensive or invasive, time-consuming, and poorly accessible. A recent report has shown the ability of ultrasonography (US) to detect early stress fractures. Our objective was to evaluate sensitivity and specificity of US versus dedicated MRI (0.2 Tesla), taken as the gold standard, in early diagnosis of metatarsal bone stress fractures. A case-control study from November 2006 to December 2007 was performed. All consecutive patients with mechanical pain and swelling of the metatarsal region for less than 3 months and with normal radiographs were included. US and dedicated MRI examinations of the metatarsal bones were performed the same day by experienced rheumatologists with expertise in US and MRI. Reading was undertaken blind to the clinical assessment and MRI/US results. Forty-one feet were analyzed on US and dedicated MRI from 37 patients (28 women, 9 men, mean age 52.7 +/- 14.1 yrs). MRI detected 13 fractures in 12 patients. Sensitivity of US was 83%, specificity 76%, positive predictive value 59%, and negative predictive value 92%. Positive likehood ratio was 3.45, negative likehood ratio 0.22. In cases of normal radiographs, US is indicated in the diagnosis of metatarsal bone stress fractures, as it is a low cost, noninvasive, rapid, and easy technique with good sensitivity and specificity. From these data, we propose a new imaging algorithm including US.

Multislice computed tomography with colon water distension (MSCT-c) in the study of intestinal and ureteral endometriosis.

PubMed

Iosca, Simona; Lumia, Domenico; Bracchi, Elena; Duka, Ejona; De Bon, Monica; Lekaj, Manjola; Uccella, Stefano; Ghezzi, Fabio; Fugazzola, Carlo

2013-01-01

This study evaluates retrospectively the accuracy and reproducibility of multislice computed tomography with colon water distension (MSCT-c) in diagnosing bowel (BE) and ureteral (UE) endometriosis. Sixty-four patients underwent MSCT-c and videolaparoscopic surgery. Two radiologists reviewed MSCT-c examinations: sensitivity and specificity were calculated, considering histological exam as reference standard. In the BE cases, the degree of bowel wall infiltration was also assessed. Sensitivity and specificity for both readers were 100% and 97.6% for BE and 72.2% and 100% for UE; the interobserver agreement was excellent. The degree of bowel wall involvement was correctly defined in 90.9% of cases. MSCT-c is an accurate and reproducible technique but-considering the age of the patients-delivers a nonnegligible radiation dose. © 2013 Elsevier Inc. All rights reserved.

Duplex scanning diagnosis of internal carotid artery dissections. A case control study.

PubMed

Alecu, C; Fortrat, J O; Ducrocq, X; Vespignani, H; de Bray, J M

2007-01-01

The reliability of duplex scanning (DS) for the diagnosis of internal carotid artery dissections (ICAD) is not clear. Nine DS signs known to be suggestive for the diagnosis of ICAD were compared between 70 patients with ICAD and 70 matched patients without dissection. Visible internal tapering occlusion, regular eccentric narrowing channel, ectasia beyond the carotid bulb, resistive index asymmetry, blood flow slowdown, ophthalmic artery blood flow inversion, and biphasic flow are more frequent in cases than in controls (p < 0.001). Atheroma plaques were absent in 80% of ICAD. When DS direct signs and hemodynamic signs were studied, sensitivity was 90% and specificity 60%. Diagnosis of ICAD by DS could be improved if direct signs were combined with hemodynamic signs, giving a high sensitivity and a rather good specificity. Copyright 2007 S. Karger AG, Basel.

Chicken egg yolk antibodies (IgY) for detecting circulating antigens of Schistosoma japonicum.

PubMed

Cai, Yu-Chun; Guo, Jian; Chen, Shao-Hong; Tian, Li-Guang; Steinmann, Peter; Chen, Mu-Xin; Li, Hao; Ai, Lin; Chen, Jia-Xu

2012-09-01

IgY isolated from egg yolk has been widely used in immunodiagnostic tests, including tests to detect circulating antigen (soluble egg antigen or SEA) of Schistosoma japonicum. A sandwich ELISA was established using a combination of anti-S. japonicum SEA-IgY polyclonal antibodies and IgM monoclonal antibodies. To explore sensitivity and specificity of the sandwich ELISA, serum samples from 43 patients infected with S. japonicum were tested. All acute cases and 91.3% of the chronic cases showed a positive reaction. Only 5% of the control sera from healthy persons gave a positive response. Cross-reactions with antibodies to nine other parasites were rare. The developed immunoassay is reasonably sensitive and specific. It could be used for field research and treatment efficacy assessments. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Noninvasive prenatal diagnosis of common aneuploidies by semiconductor sequencing

PubMed Central

Liao, Can; Yin, Ai-hua; Peng, Chun-fang; Fu, Fang; Yang, Jie-xia; Li, Ru; Chen, Yang-yi; Luo, Dong-hong; Zhang, Yong-ling; Ou, Yan-mei; Li, Jian; Wu, Jing; Mai, Ming-qin; Hou, Rui; Wu, Frances; Luo, Hongrong; Li, Dong-zhi; Liu, Hai-liang; Zhang, Xiao-zhuang; Zhang, Kang

2014-01-01

Massively parallel sequencing (MPS) of cell-free fetal DNA from maternal plasma has revolutionized our ability to perform noninvasive prenatal diagnosis. This approach avoids the risk of fetal loss associated with more invasive diagnostic procedures. The present study developed an effective method for noninvasive prenatal diagnosis of common chromosomal aneuploidies using a benchtop semiconductor sequencing platform (SSP), which relies on the MPS platform but offers advantages over existing noninvasive screening techniques. A total of 2,275 pregnant subjects was included in the study; of these, 515 subjects who had full karyotyping results were used in a retrospective analysis, and 1,760 subjects without karyotyping were analyzed in a prospective study. In the retrospective study, all 55 fetal trisomy 21 cases were identified using the SSP with a sensitivity and specificity of 99.94% and 99.46%, respectively. The SSP also detected 16 trisomy 18 cases with 100% sensitivity and 99.24% specificity and 3 trisomy 13 cases with 100% sensitivity and 100% specificity. Furthermore, 15 fetuses with sex chromosome aneuploidies (10 45,X, 2 47,XYY, 2 47,XXX, and 1 47,XXY) were detected. In the prospective study, nine fetuses with trisomy 21, three with trisomy 18, three with trisomy 13, and one with 45,X were detected. To our knowledge, this is the first large-scale clinical study to systematically identify chromosomal aneuploidies based on cell-free fetal DNA using the SSP and provides an effective strategy for large-scale noninvasive screening for chromosomal aneuploidies in a clinical setting. PMID:24799683

Sensitivity and specificity of narrow-band imaging nasoendoscopy compared to histopathology results in patients with suspected nasopharyngeal carcinoma

NASA Astrophysics Data System (ADS)

Adham, M.; Musa, Z.; Lisnawati; Suryati, I.

2017-08-01

Nasopharyngeal carcinoma (NPC) is a disease which is prevalent in developing countries like Indonesia. There were 164 new cases of nasopharyngeal carcinoma in the ear, nose, and throat (ENT) oncology outpatient clinic of the Cipto Mangunkusumo hospital in 2014, and 142 cases in 2015. Unfortunately, almost all of these cases presented at an advanced stage. The success of nasopharyngeal carcinoma treatment is largely determined by the stage when patients are diagnosed; it is critical to diagnose NPC as early as possible. Narrow-band imaging (NBI) is an endoscopic instrument with a light system that can improve the visualization of blood vessels of mucosal epithelial malignant tumors. NBI is expected to help clinicians to assess whether a lesion is malignant or not; to do so, it is important to know the value of sensitivity and specificity. This study is a cross-sectional form of a diagnostic test which was performed in the outpatient clinic of the ENT Head and Neck Surgery Department for the Cipto Mangunkusumo Hospital, from January to June 2016, and involved 56 subjects. Patients with a nasopharyngeal mass discovered by physical examination or imaging, and a suspected nasopharyngeal carcinoma were included as a subject. An NBI examination and biopsy was performed locally. Based on this research, NBI could be used as a screening tool for nasopharyngeal carcinoma with high sensitivity (100%), but with a low specificity result (6.7%).

Contrast-enhanced spectral mammography improves diagnostic accuracy in the symptomatic setting.

PubMed

Tennant, S L; James, J J; Cornford, E J; Chen, Y; Burrell, H C; Hamilton, L J; Girio-Fragkoulakis, C

2016-11-01

To assess the diagnostic accuracy of contrast-enhanced spectral mammography (CESM), and gauge its "added value" in the symptomatic setting. A retrospective multi-reader review of 100 consecutive CESM examinations was performed. Anonymised low-energy (LE) images were reviewed and given a score for malignancy. At least 3 weeks later, the entire examination (LE and recombined images) was reviewed. Histopathology data were obtained for all cases. Differences in performance were assessed using receiver operator characteristic (ROC) analysis. Sensitivity, specificity, and lesion size (versus MRI or histopathology) differences were calculated. Seventy-three percent of cases were malignant at final histology, 27% were benign following standard triple assessment. ROC analysis showed improved overall performance of CESM over LE alone, with area under the curve of 0.93 versus 0.83 (p<0.025). CESM showed increased sensitivity (95% versus 84%, p<0.025) and specificity (81% versus 63%, p<0.025) compared to LE alone, with all five readers showing improved accuracy. Tumour size estimation at CESM was significantly more accurate than LE alone, the latter tending to undersize lesions. In 75% of cases, CESM was deemed a useful or significant aid to diagnosis. CESM provides immediately available, clinically useful information in the symptomatic clinic in patients with suspicious palpable abnormalities. Radiologist sensitivity, specificity, and size accuracy for breast cancer detection and staging are all improved using CESM as the primary mammographic investigation. Copyright © 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Sensitivity and specificity of oral HPV detection for HPV-positive head and neck cancer.

PubMed

Gipson, Brooke J; Robbins, Hilary A; Fakhry, Carole; D'Souza, Gypsyamber

2018-02-01

The incidence of HPV-related head and neck squamous cell carcinoma (HPV-HNSCC) is increasing. Oral samples are easy and non-invasive to collect, but the diagnostic accuracy of oral HPV detection methods for classifying HPV-positive HNSCC tumors has not been well explored. In a systematic review, we identified eight studies of HNSCC patients meeting our eligibility criteria of having: (1) HPV detection in oral rinse or oral swab samples, (2) tumor HPV or p16 testing, (3) a publication date within the last 10 years (January 2007-May 2017, as laboratory methods change), and (4) at least 15 HNSCC cases. Data were abstracted from each study and a meta-analysis performed to calculate sensitivity and specificity. Eight articles meeting inclusion criteria were identified. Among people diagnosed with HNSCC, oral HPV detection has good specificity (92%, 95% CI = 82-97%) and moderate sensitivity (72%, 95% CI = 45-89%) for HPV-positive HNSCC tumor. Results were similar when restricted to studies with only oropharyngeal cancer cases, with oral rinse samples, or testing for HPV16 DNA (instead of any oncogenic HPV) in the oral samples. Among those who already have HNSCC, oral HPV detection has few false-positives but may miss one-half to one-quarter of HPV-related cases (false-negatives). Given these findings in cancer patients, the utility of oral rinses and swabs as screening tests for HPV-HNSCC among healthy populations is probably limited. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluation of IOTA Simple Ultrasound Rules to Distinguish Benign and Malignant Ovarian Tumours.

PubMed

Garg, Sugandha; Kaur, Amarjit; Mohi, Jaswinder Kaur; Sibia, Preet Kanwal; Kaur, Navkiran

2017-08-01

IOTA stands for International Ovarian Tumour Analysis group. Ovarian cancer is one of the common cancers in women and is diagnosed at later stage in majority. The limiting factor for early diagnosis is lack of standardized terms and procedures in gynaecological sonography. Introduction of IOTA rules has provided some consistency in defining morphological features of ovarian masses through a standardized examination technique. To evaluate the efficacy of IOTA simple ultrasound rules in distinguishing benign and malignant ovarian tumours and establishing their use as a tool in early diagnosis of ovarian malignancy. A hospital based case control prospective study was conducted. Patients with suspected ovarian pathology were evaluated using IOTA ultrasound rules and designated as benign or malignant. Findings were correlated with histopathological findings. Collected data was statistically analysed using chi-square test and kappa statistical method. Out of initial 55 patients, 50 patients were included in the final analysis who underwent surgery. IOTA simple rules were applicable in 45 out of these 50 patients (90%). The sensitivity for the detection of malignancy in cases where IOTA simple rules were applicable was 91.66% and the specificity was 84.84%. Accuracy was 86.66%. Classifying inconclusive cases as malignant, the sensitivity and specificity was 93% and 80% respectively. High level of agreement was found between USG and histopathological diagnosis with Kappa value as 0.323. IOTA simple ultrasound rules were highly sensitive and specific in predicting ovarian malignancy preoperatively yet being reproducible, easy to train and use.

Osteocalcin and Osteonectin Expression in Canine Osteosarcoma.

PubMed

Wehrle-Martinez, A S; Dittmer, K E; Aberdein, D; Thompson, K G

2016-07-01

Osteosarcoma (OSA) is a malignant heterogeneous primary bone tumor responsible for up to 90% of all primary bone tumors in dogs. In this study, osteocalcin (OC) and osteonectin (ON) immunoreactivity was evaluated in 23 canine OSAs, 4 chondrosarcomas, 4 fibrosarcomas, 2 hemangiosarcomas, and 4 histiocytic sarcomas. The effects of three different decalcification agents (ethylenediaminetetraetic acid [EDTA], formic acid and hydrochloric acid [HCl]) on the immunoreactivity for OC and ON was also assessed. Immunoreactivity to OC was present in 19/23 (83%) cases of OSA and all cases of chondrosarcoma. In three OSAs the extracellular matrix showed immunoreactivity to OC. None of the fibrosarcomas, histiocytic sarcomas or hemangiosarcomas showed immunoreactivity to OC. The sensitivity and specificity for OC in canine OSA in this study was 83% and 71% respectively. For ON, 100% of both OSAs (23/23) and non-OSAs (14/14) showed cytoplasmic immunoreactivity to this antibody, giving a sensitivity of 100% but a complete lack of specificity. There were no significant differences in immunoreactivity for OC and ON between the different decalcification agents used. In conclusion, OC showed high sensitivity for identifying OSA but it failed to distinguish between OSA and chondrosarcoma, and the osteoid produced by neoplastic cells in most cases did not show immunoreactivity to OC. These factors may limit the practical utility of OC in the diagnosis of OSA in dogs when chondrosarcoma is a differential diagnosis. ON showed no specificity in detecting OSA and has little practical application for the diagnosis of OSA in dogs. © The Author(s) 2016.

The Clinical Interview Schedule-Revised (CIS-R)-Malay Version, Clinical Validation.

PubMed

Subramaniam, Kavitha; Krishnaswamy, Saroja; Jemain, Abdul Aziz; Hamid, Abdul; Patel, Vikram

2006-01-01

Use of instruments or questionnaires in different cultural settings without proper validation can result in inaccurate results. Issues like reliability, validity, feasibility and acceptability should be considered in the use of an instrument. The study aims to determine the usefulness of the CIS-R Malay version in detecting common mental health problems specifically to establish the validity. The CIS-R instrument (PROQSY* format) was translated through the back translation process into Malay. Inter rater reliability was established for raters who were medical students. Cases and controls for the study were psychiatric in patients, out patient and relatives or friends accompanying the patients to the clinic or visiting the inpatients. The Malay version of CIS-R was administered to all cases and controls. All cases and controls involved in the study were rated by psychiatrists for psychiatric morbidity using the SCID as a guideline. Specificity and sensitivity of the CIS-R to the assessment by the psychiatrist were determined. The Malay version of CIS-R showed 100% sensitivity and 96.15% specificity at a cut off score of 9. The CIS-R can be a useful instrument for clinical and research use in the Malaysian population for diagnosing common mental disorders like depression and anxiety.

Challenges in Routine Implementation and Quality Control of Rapid Diagnostic Tests for Malaria–Rufiji District, Tanzania

PubMed Central

McMorrow, Meredith L.; Masanja, M. Irene; Abdulla, Salim M. K.; Kahigwa, Elizeus; Kachur, S. Patrick

2018-01-01

Rapid diagnostic tests (RDTs) represent an alternative to microscopy for malaria diagnosis and have shown high sensitivity and specificity in a variety of study settings. Current World Health Organization (WHO) guidelines for quality control of RDTs provide detailed instructions on pre-field testing, but offer little guidance for quality assurance once RDTs are deployed in health facilities. From September 2006 to April 2007, we introduced a histidine-rich protein II (HRP2)-based RDT (Paracheck) for suspected malaria cases five years of age and older in nine health facilities in Rufiji District, Tanzania, to assess sensitivity and specificity of RDTs in routine use at rural health facilities. Thick blood smears were collected for all patients tested with RDTs and stained and read by laboratory personnel in each facility. Thick smears were subsequently reviewed by a reference microscopist to determine RDT sensitivity and specificity. In all nine health facilities, there were significant problems with the quality of staining and microscopy. Sensitivity and specificity of RDTs were difficult to assess given the poor quality of routine blood smear staining. Mean operational sensitivity of RDTs based on reference microscopy was 64.8%, but varied greatly by health facility, range 18.8–85.9%. Sensitivity of RDTs increased with increasing parasite density. Specificity remained high at 87.8% despite relatively poor slide quality. Institution of quality control of RDTs based on poor quality blood smear staining may impede reliable measurement of sensitivity and specificity and undermine confidence in the new diagnostic. There is an urgent need for the development of alternative quality control procedures for rapid diagnostic tests that can be performed at the facility level. PMID:18784230

Multiplex quantitative PCR for detection of lower respiratory tract infection and meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae and Neisseria meningitidis

PubMed Central

2010-01-01

Background Streptococcus pneumoniae and Haemophilus influenzae cause pneumonia and as Neisseria meningitidis they are important agents of meningitis. Although several PCR methods have been described for these bacteria the specificity is an underestimated problem. Here we present a quantitative multiplex real-time PCR (qmPCR) for detection of S. pneumoniae (9802 gene fragment), H. influenzae (omp P6 gene) and N. meningitidis (ctrA gene). The method was evaluated on bronchoalveolar lavage (BAL) samples from 156 adults with lower respiratory tract infection (LRTI) and 31 controls, and on 87 cerebrospinal fluid (CSF) samples from meningitis patients. Results The analytical sensitivity was not affected by using a combined mixture of reagents and a combined DNA standard (S. pneumoniae/H. influenzae/N. meningitidis) in single tubes. By blood- and BAL-culture and S. pneumoniae urinary antigen test, S. pneumoniae and H. influenzae were aetiological agents in 21 and 31 of the LTRI patients, respectively. These pathogens were identified by qmPCR in 52 and 72 of the cases, respectively, yielding sensitivities and specificities of 95% and 75% for S. pneumoniae, and 90% and 65% for H. influenzae, respectively. When using a cut-off of 105 genome copies/mL for clinical positivity the sensitivities and specificities were 90% and 80% for S. pneumoniae, and 81% and 85% for H. influenzae, respectively. Of 44 culture negative but qmPCR positive for H. influenzae, 41 were confirmed by fucK PCR as H. influenzae. Of the 103 patients who had taken antibiotics prior to sampling, S. pneumoniae and H. influenzae were identified by culture in 6% and 20% of the cases, respectively, and by the qmPCR in 36% and 53% of the cases, respectively. In 87 CSF samples S. pneumoniae and N. meningitidis were identified by culture and/or 16 S rRNA in 14 and 10 samples and by qmPCR in 14 and 10 samples, respectively, giving a sensitivity of 100% and a specificity of 100% for both bacteria. Conclusions The PCR provides increased sensitivity and the multiplex format facilitates diagnosis of S. pneumoniae, H. influenzae and N. meningitidis and the assay enable detection after antibiotic treatment has been installed. Quantification increases the specificity of the etiology for pneumonia. PMID:21129171

Multiplex quantitative PCR for detection of lower respiratory tract infection and meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae and Neisseria meningitidis.

PubMed

Abdeldaim, Guma M K; Strålin, Kristoffer; Korsgaard, Jens; Blomberg, Jonas; Welinder-Olsson, Christina; Herrmann, Björn

2010-12-03

Streptococcus pneumoniae and Haemophilus influenzae cause pneumonia and as Neisseria meningitidis they are important agents of meningitis. Although several PCR methods have been described for these bacteria the specificity is an underestimated problem. Here we present a quantitative multiplex real-time PCR (qmPCR) for detection of S. pneumoniae (9802 gene fragment), H. influenzae (omp P6 gene) and N. meningitidis (ctrA gene). The method was evaluated on bronchoalveolar lavage (BAL) samples from 156 adults with lower respiratory tract infection (LRTI) and 31 controls, and on 87 cerebrospinal fluid (CSF) samples from meningitis patients. The analytical sensitivity was not affected by using a combined mixture of reagents and a combined DNA standard (S. pneumoniae/H. influenzae/N. meningitidis) in single tubes. By blood- and BAL-culture and S. pneumoniae urinary antigen test, S. pneumoniae and H. influenzae were aetiological agents in 21 and 31 of the LTRI patients, respectively. These pathogens were identified by qmPCR in 52 and 72 of the cases, respectively, yielding sensitivities and specificities of 95% and 75% for S. pneumoniae, and 90% and 65% for H. influenzae, respectively. When using a cut-off of 10⁵ genome copies/mL for clinical positivity the sensitivities and specificities were 90% and 80% for S. pneumoniae, and 81% and 85% for H. influenzae, respectively. Of 44 culture negative but qmPCR positive for H. influenzae, 41 were confirmed by fucK PCR as H. influenzae. Of the 103 patients who had taken antibiotics prior to sampling, S. pneumoniae and H. influenzae were identified by culture in 6% and 20% of the cases, respectively, and by the qmPCR in 36% and 53% of the cases, respectively.In 87 CSF samples S. pneumoniae and N. meningitidis were identified by culture and/or 16 S rRNA in 14 and 10 samples and by qmPCR in 14 and 10 samples, respectively, giving a sensitivity of 100% and a specificity of 100% for both bacteria. The PCR provides increased sensitivity and the multiplex format facilitates diagnosis of S. pneumoniae, H. influenzae and N. meningitidis and the assay enable detection after antibiotic treatment has been installed. Quantification increases the specificity of the etiology for pneumonia.

Cervical and Ocular VEMP Testing in Diagnosing Superior Semicircular Canal Dehiscence.

PubMed

Hunter, Jacob B; Patel, Neil S; O'Connell, Brendan P; Carlson, Matthew L; Shepard, Neil T; McCaslin, Devin L; Wanna, George B

2017-05-01

Objective To determine the sensitivity and specificity of ocular and cervical vestibular evoked myogenic potentials (VEMPs) in the diagnosis of superior semicircular canal dehiscence (SCD) and to describe the VEMP response characteristics that are most sensitive to SCD and compare the findings to previous reports. Study Design Case series with chart review. Setting Two tertiary neurotologic referral centers. Subjects and Methods Cervical and ocular VEMP peak-to-peak amplitudes and thresholds from 39 adult patients older than 18 years with surgically confirmed SCD were compared with 84 age-matched controls. Results Using receiver operating characteristic (ROC) curves, cervical VEMP (cVEMP) amplitudes, cVEMP thresholds, and ocular VEMP (oVEMP) amplitudes had areas under the curve of 0.731, 0.912, and 0.856, respectively, all of which were statistically significant ( P < .0001). For cVEMP thresholds, at the clinical equivalent ≤85-dB normalized hearing level (nHL) threshold, the sensitivity and specificity were 97.3% and 31.3%, respectively. At the ≤70-dB nHL threshold, the sensitivity and specificity were 73.0% and 94.0%, respectively. For oVEMP amplitudes >12.0 µV, the sensitivity and specificity were 78.6% and 81.7%, respectively. Conclusion Data from this multicenter study suggest that both cVEMP thresholds and oVEMP amplitudes remain good diagnostic tests for identifying SCD, with each test dependent on a number of factors. The sensitivity and specificity of these individual tests may vary slightly between centers depending on testing parameters used.

Accuracy of dementia diagnosis: a direct comparison between radiologists and a computerized method.

PubMed

Klöppel, Stefan; Stonnington, Cynthia M; Barnes, Josephine; Chen, Frederick; Chu, Carlton; Good, Catriona D; Mader, Irina; Mitchell, L Anne; Patel, Ameet C; Roberts, Catherine C; Fox, Nick C; Jack, Clifford R; Ashburner, John; Frackowiak, Richard S J

2008-11-01

There has been recent interest in the application of machine learning techniques to neuroimaging-based diagnosis. These methods promise fully automated, standard PC-based clinical decisions, unbiased by variable radiological expertise. We recently used support vector machines (SVMs) to separate sporadic Alzheimer's disease from normal ageing and from fronto-temporal lobar degeneration (FTLD). In this study, we compare the results to those obtained by radiologists. A binary diagnostic classification was made by six radiologists with different levels of experience on the same scans and information that had been previously analysed with SVM. SVMs correctly classified 95% (sensitivity/specificity: 95/95) of sporadic Alzheimer's disease and controls into their respective groups. Radiologists correctly classified 65-95% (median 89%; sensitivity/specificity: 88/90) of scans. SVM correctly classified another set of sporadic Alzheimer's disease in 93% (sensitivity/specificity: 100/86) of cases, whereas radiologists ranged between 80% and 90% (median 83%; sensitivity/specificity: 80/85). SVMs were better at separating patients with sporadic Alzheimer's disease from those with FTLD (SVM 89%; sensitivity/specificity: 83/95; compared to radiological range from 63% to 83%; median 71%; sensitivity/specificity: 64/76). Radiologists were always accurate when they reported a high degree of diagnostic confidence. The results show that well-trained neuroradiologists classify typical Alzheimer's disease-associated scans comparable to SVMs. However, SVMs require no expert knowledge and trained SVMs can readily be exchanged between centres for use in diagnostic classification. These results are encouraging and indicate a role for computerized diagnostic methods in clinical practice.

Accuracy of dementia diagnosis—a direct comparison between radiologists and a computerized method

PubMed Central

Stonnington, Cynthia M.; Barnes, Josephine; Chen, Frederick; Chu, Carlton; Good, Catriona D.; Mader, Irina; Mitchell, L. Anne; Patel, Ameet C.; Roberts, Catherine C.; Fox, Nick C.; Jack, Clifford R.; Ashburner, John; Frackowiak, Richard S. J.

2008-01-01

There has been recent interest in the application of machine learning techniques to neuroimaging-based diagnosis. These methods promise fully automated, standard PC-based clinical decisions, unbiased by variable radiological expertise. We recently used support vector machines (SVMs) to separate sporadic Alzheimer's disease from normal ageing and from fronto-temporal lobar degeneration (FTLD). In this study, we compare the results to those obtained by radiologists. A binary diagnostic classification was made by six radiologists with different levels of experience on the same scans and information that had been previously analysed with SVM. SVMs correctly classified 95% (sensitivity/specificity: 95/95) of sporadic Alzheimer's disease and controls into their respective groups. Radiologists correctly classified 65–95% (median 89%; sensitivity/specificity: 88/90) of scans. SVM correctly classified another set of sporadic Alzheimer's disease in 93% (sensitivity/specificity: 100/86) of cases, whereas radiologists ranged between 80% and 90% (median 83%; sensitivity/specificity: 80/85). SVMs were better at separating patients with sporadic Alzheimer's disease from those with FTLD (SVM 89%; sensitivity/specificity: 83/95; compared to radiological range from 63% to 83%; median 71%; sensitivity/specificity: 64/76). Radiologists were always accurate when they reported a high degree of diagnostic confidence. The results show that well-trained neuroradiologists classify typical Alzheimer's disease-associated scans comparable to SVMs. However, SVMs require no expert knowledge and trained SVMs can readily be exchanged between centres for use in diagnostic classification. These results are encouraging and indicate a role for computerized diagnostic methods in clinical practice. PMID:18835868

Comparison of Heidelberg Retina Tomograph-3 glaucoma probability score and Moorfields regression analysis of optic nerve head in glaucoma patients and healthy individuals.

PubMed

Caglar, Çagatay; Gul, Adem; Batur, Muhammed; Yasar, Tekin

2017-01-01

To compare the sensitivity and specificity of Moorfields regression analysis (MRA) and glaucoma probability score (GPS) between healthy and glaucomatous eyes with Heidelberg Retinal Tomograph 3 (HRT-3). The study included 120 eyes of 75 glaucoma patients and 138 eyes of 73 normal subjects, for a total of 258 eyes of 148 individuals. All measurements were performed with the HRT-3. Diagnostic test criteria (sensitivity, specificity, etc.) were used to evaluate how efficiently GPS and MRA algorithms in the HRT-3 discriminated between the glaucoma and control groups. The GPS showed 88 % sensitivity and 66 % specificity, whereas MRA had 71.5 % sensitivity and 82.5 % specificity. There was 71 % agreement between the final results of MRA and GPS in the glaucoma group. Excluding borderline patients from both analyses resulted in 91.6 % agreement. In the control group the level of agreement between MRA and GPS was 64 % including borderline patients and 84.1 % after excluding borderline patients. The accuracy rate is 92 % for MRA and 91 % for GPS in the glaucoma group excluding borderline patients. The difference was nor statistically different. In both cases, agreement was higher between MRA and GPS in the glaucoma group. We found that both sensitivity and specificity increased with disc size for MRA, while the sensitivity increased and specificity decreased with larger disc sizes for GPS. HRT is able to quantify and clearly reveal structural changes in the ONH and RNFL in glaucoma.

Estimation of sensitivity and specificity of brain magnetic resonance imaging and single photon emission computed tomography in the diagnosis of olfactory dysfunction after head traumas.

PubMed

Atighechi, Saeid; Zolfaghari, Aliasghar; Baradaranfar, Mohammadhossein; Dadgarnia, Mohammadhossein

2013-01-01

Olfactory dysfunction has an incidence of 5-10% after head injury. Several objective and subjective tests had been proposed. Recent studies showed that brain single photon emission computed tomography (SPECT) and brain magnetic resonance imaging (MRI) have good diagnostic value in this era in which the most common sites of involvement were olfactory bulb and olfactory nerve in MRI and frontal lobe in SPECT. This study aimed to estimate the sensitivity and specificity of brain MRI and brain SPECT in the diagnosis of traumatic hyposmia and anosmia. From February 2009 to March 2011, 63 patients with head injury and smell complaint were selected for this study. Using an identification test and a threshold smell test, 28 were anosmic and 27 had hyposmia and the remaining 8 were normosmic. All of them underwent brain MRI and SPECT. The sensitivity of SPECT was 81.5 and 85.7% in hyposmia and anosmia, respectively. Its specificity was 87.5% in anosmia and 87.7% in anosmia. MRI sensitivity was 66.7% in hyposmia but 82.1% in anosmia. Its specificity was 85.7% in anosmia and 87.7% in anosmia. If MRI and SPECT were considered together, the sensitivity was 92.3% in hyposmia and 92% in anosmia, but the specificity was 87% in both cases. According to our study, both brain MRI and SPECT have high sensitivity and specificity in the diagnosis of traumatic anosmia, although brain SPECT is slightly superior to MRI. If the two techniques are applied together, the accuracy will be increased.

Sensitivity and Specificity of Cardiac Tissue Discrimination Using Fiber-Optics Confocal Microscopy.

PubMed

Huang, Chao; Sachse, Frank B; Hitchcock, Robert W; Kaza, Aditya K

2016-01-01

Disturbances of the cardiac conduction system constitute a major risk after surgical repair of complex cases of congenital heart disease. Intraoperative identification of the conduction system may reduce the incidence of these disturbances. We previously developed an approach to identify cardiac tissue types using fiber-optics confocal microscopy and extracellular fluorophores. Here, we applied this approach to investigate sensitivity and specificity of human and automated classification in discriminating images of atrial working myocardium and specialized tissue of the conduction system. Two-dimensional image sequences from atrial working myocardium and nodal tissue of isolated perfused rodent hearts were acquired using a fiber-optics confocal microscope (Leica FCM1000). We compared two methods for local application of extracellular fluorophores: topical via pipette and with a dye carrier. Eight blinded examiners evaluated 162 randomly selected images of atrial working myocardium (n = 81) and nodal tissue (n = 81). In addition, we evaluated the images using automated classification. Blinded examiners achieved a sensitivity and specificity of 99.2 ± 0.3% and 98.0 ± 0.7%, respectively, with the dye carrier method of dye application. Sensitivity and specificity was similar for dye application via a pipette (99.2 ± 0.3% and 94.0 ± 2.4%, respectively). Sensitivity and specificity for automated methods of tissue discrimination were similarly high. Human and automated classification achieved high sensitivity and specificity in discriminating atrial working myocardium and nodal tissue. We suggest that our findings facilitate clinical translation of fiber-optics confocal microscopy as an intraoperative imaging modality to reduce the incidence of conduction disturbances during surgical correction of congenital heart disease.

How sensitive and specific is urinalysis 'dipstick' testing for detection of hyperglycaemia and ketosis? An audit of findings from coronial autopsies.

PubMed

Mitchell, Rebecca; Thomas, Sunethra Devika; Langlois, Neil E I

2013-10-01

Biochemical analysis of glucose and ketones in the vitreous humour obtained at post-mortem examination is representative of the levels in the blood prior to death. Elevated levels can be indicative of conditions including diabetic ketoacidosis, which can be a cause for unexpected death. A rapid screening test for such conditions can be performed during the autopsy through urinalysis using test strips (urine 'dipstick' testing). The aim of this study was to assess the utility of urinalysis testing for post-mortem detection of derangements of glucose and ketone levels. The results of vitreous biochemical analysis and urinalysis were collated from 188 forensic autopsy cases. A vitreous glucose result of above 10 mmol/L was regarded as high. When this was compared to urinalysis results it was found that any urinalysis result above negative had a sensitivity of 0.83 and a specificity of 0.93. A vitreous ketone level of above 5 mmol/L was regarded as significantly elevated; a urinalysis result above negative had a sensitivity of 1, but a specificity of 0.12. Urinalysis ('dipstick' testing) for glucose has a good sensitivity and specificity for high vitreous glucose levels, which are regarded as indicative of pathological hyperglycaemia during life. It was found that urine testing for ketones either has an excellent sensitivity with low specificity or a poor sensitivity with a good specificity; however, this finding has to be viewed in the context of uncertainty of the biochemical level of significant ketosis.

Case definition for Ebola and Marburg haemorrhagic fevers: a complex challenge for epidemiologists and clinicians.

PubMed

Pittalis, Silvia; Fusco, Francesco Maria; Lanini, Simone; Nisii, Carla; Puro, Vincenzo; Lauria, Francesco Nicola; Ippolito, Giuseppe

2009-10-01

Viral haemorrhagic fevers (VHFs) represent a challenge for public health because of their epidemic potential, and their possible use as bioterrorism agents poses particular concern. In 1999 the World Health Organization (WHO) proposed a case definition for VHFs, subsequently adopted by other international institutions with the aim of early detection of initial cases/outbreaks in western countries. We applied this case definition to reports of Ebola and Marburg virus infections to estimate its sensitivity to detect cases of the disease. We analyzed clinical descriptions of 795 reported cases of Ebola haemorrhagic fever: only 58.5% of patients met the proposed case definition. A similar figure was obtained reviewing 169 cases of Marburg diseases, of which only 64.5% were in accordance with the case definition. In conclusion, the WHO case definition for hemorrhagic fevers is too specific and has poor sensitivity both for case finding during Ebola or Marburg outbreaks, and for early detection of suspected cases in western countries. It can lead to a hazardous number of false negatives and its use should be discouraged for early detection of cases.

Testing Pneumonia Vaccines in the Elderly: Determining a Case Definition for Pneumococcal Pneumonia in the Absence of a Gold Standard.

PubMed

Jokinen, Jukka; Snellman, Marja; Palmu, Arto A; Saukkoriipi, Annika; Verlant, Vincent; Pascal, Thierry; Devaster, Jeanne-Marie; Hausdorff, William P; Kilpi, Terhi M

2018-06-01

Clinical assessments of vaccines to prevent pneumococcal community-acquired pneumonia (CAP) require sensitive and specific case definitions, but there is no gold standard diagnostic test. To develop a new case definition suitable for vaccine efficacy studies, we applied latent class analysis (LCA) to the results from 7 diagnostic tests for pneumococcal etiology on clinical specimens from 323 elderly persons with radiologically confirmed pneumonia enrolled in the Finnish Community-Acquired Pneumonia Epidemiology study during 2005-2007. Compared with the conventional use of LCA, which is mainly to determine sensitivities and specificities of different tests, we instead used LCA as an appropriate instrument to predict the probability of pneumococcal etiology for each CAP case based on individual test profiles, and we used the predictions to minimize the sample size that would be needed for a vaccine efficacy trial. When compared with the conventional laboratory criteria of encapsulated pneumococci in culture, in blood culture or high-quality sputum culture, or urine antigen positivity, our optimized case definition for pneumococcal CAP resulted in a trial sample size that was almost 20,000 subjects smaller. We believe that the novel application of LCA detailed here to determine a case definition for pneumococcal CAP could also be similarly applied to other diseases without a gold standard.

Siemens Immulite Aspergillus-specific IgG assay for chronic pulmonary aspergillosis diagnosis.

PubMed

Page, Iain D; Richardson, Malcolm D; Denning, David W

2018-05-14

Chronic pulmonary aspergillosis (CPA) complicates underlying lung disease, including treated tuberculosis. Measurement of Aspergillus-specific immunoglobulin G (IgG) is a key diagnostic step. Cutoffs have been proposed based on receiver operating characteristic (ROC) curve analyses comparing CPA cases to healthy controls, but performance in at-risk populations with underlying lung disease is unclear. We evaluated optimal cutoffs for the Siemens Immulite Aspergillus-specific IgG assay for CPA diagnosis in relation to large groups of healthy and diseased controls with treated pulmonary tuberculosis. Sera from 241 patients with CPA attending the UK National Aspergillosis Centre, 299 Ugandan blood donors (healthy controls), and 398 Ugandans with treated pulmonary tuberculosis (diseased controls) were tested. Radiological screening removed potential CPA cases from diseased controls (234 screened diseased controls). ROC curve analyses were performed and optimal cutoffs identified by Youden J statistic. CPA versus control ROC area under curve (AUC) results were: healthy controls 0.984 (95% confidence interval 0.972-0.997), diseased controls 0.972 (0.959-0.985), screened diseased controls 0.979 (0.967-0.992). Optimal cutoffs were: healthy controls 15 mg/l (94.6% sensitivity, 98% specificity), unscreened diseased controls 15 mg/l (94.6% sensitivity, 94.5% specificity), screened diseased controls 25 mg/l (92.9% sensitivity, 98.7% specificity). Results were similar in healthy and diseased controls. We advocate a cutoff of 20 mg/l as this is the midpoint of the range of optimal cutoffs. Cutoffs calculated in relation to healthy controls for other assays are likely to remain valid for use in a treated tuberculosis population.

Analytic Validation of a Clinical-Grade PTEN Immunohistochemistry Assay in Prostate Cancer by Comparison to PTEN FISH

PubMed Central

Lotan, Tamara L.; Wei, Wei; Ludkovski, Olga; Morais, Carlos L.; Guedes, Liana B.; Jamaspishvili, Tamara; Lopez, Karen; Hawley, Sarah T.; Feng, Ziding; Fazli, Ladan; Hurtado-Coll, Antonio; McKenney, Jesse K.; Simko, Jeffrey; Carroll, Peter R.; Gleave, Martin; Lin, Daniel W.; Nelson, Peter S.; Thompson, Ian M.; True, Lawrence D.; Brooks, James D.; Lance, Raymond; Troyer, Dean; Squire, Jeremy A.

2016-01-01

PTEN loss is a promising prognostic and predictive biomarker in prostate cancer. Because it occurs most commonly via PTEN gene deletion, we developed a clinical-grade, automated and inexpensive immunohistochemical assay to detect PTEN loss. We studied the sensitivity and specificity of PTEN immunohistochemistry relative to 4-color fluorescence in situ hybridization (FISH) for detection of PTEN gene deletion in a multi-institutional cohort of 731 primary prostate tumors. Intact PTEN immunostaining was 91% specific for absence of PTEN gene deletion, (549/602 tumors with 2 copies of the PTEN gene by FISH showed intact expression of PTEN by immunohistochemistry) and 97% sensitive for presence of homozygous PTEN gene deletion (absent PTEN protein expression by immunohistochemistry in 65/67 tumors with homozygous deletion). PTEN immunohistochemistry was 65% sensitive for presence of hemizygous PTEN gene deletion, with protein loss in 40/62 hemizygous tumors. We reviewed the 53 cases where immunohistochemistry showed PTEN protein loss and FISH showed 2 intact copies of the PTEN gene. On re-review, there was ambiguous immunohistochemistry loss in 6% (3/53) and failure to analyze the same tumor area by both methods in 34% (18/53). Of the remaining discordant cases, 41% (13/32) revealed hemizygous (n=8) or homozygous (n=5) PTEN gene deletion that was focal in most cases (11/13). The remaining 19 cases had 2 copies of the PTEN gene by FISH, representing truly discordant cases. Our automated PTEN immunohistochemistry assay is a sensitive method for detection of homozygous PTEN gene deletions. Immunohistochemistry screening is particularly useful to identify cases with heterogeneous PTEN gene deletion in a subset of tumor glands. Mutations, small insertions or deletions and/or epigenetic or microRNA-mediated mechanisms may lead to PTEN protein loss in tumors with normal or hemizygous PTEN gene copy number. PMID:27174589

Parasite detection in patients with post kala-azar dermal leishmaniasis in India: a comparison between molecular and immunological methods

PubMed Central

Salotra, P; Sreenivas, G; Beena, K R; Mukherjee, A; Ramesh, V

2003-01-01

Aims: To evaluate the sensitivity and specificity of serological, immunohistochemical, and molecular methods in the diagnosis of post kala-azar dermal leishmaniasis (PKDL). Methods: Twenty five patients with confirmed PKDL and 25 controls were included in the study. G2D10, a monoclonal antibody against Leishmania, was used for the immunohistochemical (IHC) staining of lesion sections to visualise anti-Leishmania donovani antibodies. The diagnostic usefulness of IHC was compared with enzyme linked immunosorbent assay (ELISA) with a recombinant (rk39) antigen, and a species specific polymerase chain reaction (PCR) assay, amplifying a kinetoplast minicircle DNA sequence. Results: IHC detected 22 of 25 PKDL cases, giving a sensitivity of 88%. The diagnostic sensitivity of both the ELISA and PCR tests was higher (96%). All of the 25 controls examined were negative in PCR, indicating 100% specificity of the test, whereas ELISA showed 96% specificity. Conclusions: IHC with G2D10 significantly enhances the sensitivity of detection of PKDL over routine haematoxylin and eosin staining. ELISA with a recombinant antigen is an economical and practical assay. PCR is the most sensitive and specific diagnostic method for PKDL. The tests described would facilitate the recognition of patients with PKDL, enabling timely treatment, which would contribute greatly to the control of kala-azar. PMID:14600129

Optical Coherence Tomography Angiography versus Dye Angiography in Age-Related Macular Degeneration: Sensitivity and Specificity Analysis.

PubMed

Nikolopoulou, Eleni; Lorusso, Massimo; Micelli Ferrari, Luisa; Cicinelli, Maria Vittoria; Bandello, Francesco; Querques, Giuseppe; Micelli Ferrari, Tommaso

2018-01-01

Optical coherence tomography angiography (OCTA) could be a valid tool to detect choroidal neovascularization (CNV) in neovascular age-related macular degeneration (nAMD), allowing the analysis of the type, the morphology, and the extension of CNV in most of the cases. To determine the sensitivity and specificity of OCTA in detecting CNV secondary to nAMD, compared to fluorescein angiography (FA) and indocyanine green angiography (ICGA). Prospective observational study. Patients with suspected nAMD were recruited between May and December 2016. Patients underwent FA, ICGA, spectral domain OCT, and OCTA (AngioVue, Optovue, Inc.). Sensitivity and specificity of FA, with or without ICGA, were assessed and compared with OCTA. Seventy eyes of 70 consecutive patients were included: 32 eyes (45.7%) with type I CNV, 8 eyes (11.4%) with type II CNV, 4 eyes (5.7%) with type III CNV, 6 eyes (8.6%) with mixed type I and type II CNV, and 20 eyes (28.6%) with no CNV. Sensitivity of OCTA was 88% and specificity was 90%. Concordance between FA/ICGA and OCTA was very good (0,91; range 0,81-1,00). OCTA showed high sensitivity and specificity for detection of CNV. Concordance between OCTA and gold-standard dye-based techniques was excellent. OCTA may represent a first-line noninvasive method for the diagnosis of nAMD.

Indication for Computed Tomography Scan in Shoulder Instability: Sensitivity and Specificity of Standard Radiographs to Predict Bone Defects After Traumatic Anterior Glenohumeral Instability.

PubMed

Delage Royle, Audrey; Balg, Frédéric; Bouliane, Martin J; Canet-Silvestri, Fanny; Garant-Saine, Laurianne; Sheps, David M; Lapner, Peter; Rouleau, Dominique M

2017-10-01

Quantifying glenohumeral bone loss is key in preoperative surgical planning for a successful Bankart repair. Simple radiographs can accurately measure bone defects in cases of recurrent shoulder instability. Cohort study (diagnosis); Level of evidence, 2. A true anteroposterior (AP) view, alone and in combination with an axillary view, was used to evaluate the diagnostic properties of radiographs compared with computed tomography (CT) scan, the current gold standard, to predict significant bone defects in 70 patients. Sensitivity, specificity, and positive and negative predictive values were evaluated and compared. Detection of glenoid bone loss on plain film radiographs, with and without axillary view, had a sensitivity of 86% for both views and a specificity of 73% and 64% with and without the axillary view, respectively. For detection of humeral bone loss, the sensitivity was 8% and 17% and the specificity was 98% and 91% with and without the axillary view, respectively. Regular radiographs would have missed 1 instance of significant bone loss on the glenoid side and 20 on the humeral side. Interobserver reliabilities were moderate for glenoid detection (κ = 0.473-0.503) and poor for the humeral side (κ = 0.278-0.336). Regular radiographs showed suboptimal sensitivity, specificity, and reliability. Therefore, CT scan should be considered in the treatment algorithm for accurate quantification of bone loss to prevent high rates of recurrent instability.

Detection of MPL mutations by a novel allele-specific PCR-based strategy.

PubMed

Furtado, Larissa V; Weigelin, Helmut C; Elenitoba-Johnson, Kojo S J; Betz, Bryan L

2013-11-01

MPL mutation testing is recommended in patients with suspected primary myelofibrosis or essential thrombocythemia who lack the JAK2 V617F mutation. MPL mutations can occur at allelic levels below 15%, which may escape detection by commonly used mutation screening methods such as Sanger sequencing. We developed a novel multiplexed allele-specific PCR assay capable of detecting most recurrent MPL exon 10 mutations associated with primary myelofibrosis and essential thrombocythemia (W515L, W515K, W515A, and S505N) down to a sensitivity of 2.5% mutant allele. Test results were reviewed from 15 reference cases and 1380 consecutive specimens referred to our laboratory for testing. Assay performance was compared to Sanger sequencing across a series of 58 specimens with MPL mutations. Positive cases consisted of 45 with W515L, 6 with S505N, 5 with W515K, 1 with W515A, and 1 with both W515L and S505N. Seven cases had mutations below 5% that were undetected by Sanger sequencing. Ten additional cases had mutation levels between 5% and 15% that were not consistently detected by sequencing. All results were easily interpreted in the allele-specific test. This assay offers a sensitive and reliable solution for MPL mutation testing. Sanger sequencing appears insufficiently sensitive for robust MPL mutation detection. Our data also suggest the relative frequency of S505N mutations may be underestimated, highlighting the necessity for inclusion of this mutation in MPL test platforms. Copyright © 2013 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

[Cost effectiveness of mass orthoptic screening in kindergarten for early detection of developmental vision disorders].

PubMed

König, H H; Barry, J C; Leidl, R; Zrenner, E

2000-04-01

Orthoptic screening in the kindergarten is one option to improve early detection of amblyopia in children aged 3 years. The purpose of this study was to analyse the cost-effectiveness of such a screening programme in Germany. Based on data from the literature and own experience gained from orthoptic screening in kindergarten a decision-analytic model was developed. According to the model, all children in kindergarten, aged 3 years, who had not been treated for amblyopia before, were subjected to an orthoptic examination. Non-cooperative children were reexamined in kindergarten after one year. Children with positive test results were examined by an ophthalmologist for diagnosis. Effects were measured by the number of newly diagnosed cases of amblyopia, non-obvious strabismus and amblyogenic refractive errors. Direct costs were estimated from a third-party payer perspective. The influence of uncertain model parameters was tested by sensitivity analysis. In the base analysis the cost per orthoptic screening test was DM 15.39. Examination by an ophthalmologist cost DM 71.20. The total cost of the screening programme in all German kindergartens was DM 6.1 million. With a 1.5% age-specific prevalence of undiagnosed cases, a sensitivity of 95% and a specificity of 98%, a total of 4,261 new cases would be detected. The cost-effectiveness ratio was DM 1,421 per case detected. Sensitivity analysis showed considerable influence of prevalence and specificity on the cost-effectiveness ratio. It was more cost-effective to re-screen non-cooperative children in kindergarten than to have them examined by an ophthalmologist straight-away. The decision-analytic model showed stable results which may serve as a basis for discussion on the implementation of orthoptic screening and for planning a field study.

Diagnostic yield of electromyography in children with myopathic disorders.

PubMed

Ghosh, Partha S; Sorenson, Eric J

2014-08-01

Interpretation of pediatric electromyography interpretation in myopathic disorders is technically challenging. We assessed our electromyographic experience with respect to sensitivity and specificity in pediatric myopathy. We did a retrospective chart review of patients ≤18 years between 2009 and 2013. Two hundred twenty-four electromyographic studies were reviewed with the following referral diagnoses: myopathy, muscle weakness, neuromuscular disorders, myositis, myalgia, myoglobinuria, myasthenia, myotonia, cramps, periodic paralysis, hypotonia, and developmental delay. Only children who had an electromyography and muscle biopsy were included for analysis. Patients with neurogenic electromyography and neuromuscular junction disorders were excluded. Myopathic electromyography was defined as short duration, low amplitude, polyphasic motor unit potentials with rapid recruitment. Seventy-two patients were included (age range, 6 months-18 years). The following observations were made: group A: myopathic electromyography or pathognomonic of muscle disease and biopsy or genetically confirmed myopathy (32 cases); group B: myopathic electromyography but biopsy normal or nondiagnostic (12 cases); group C: normal electromyography but biopsy or genetically confirmed myopathy (three cases, all with metabolic myopathy); and group D: electromyography normal and biopsy normal or nondiagnostic (25 cases). The most common diagnoses were congenital myopathy (seven cases), metabolic myopathy (six cases), muscular dystrophy (six cases), genetically confirmed myopathy (five cases), myopathy, undefined (five cases), and inflammatory myopathy (four cases). Pediatric electromyography was 91% sensitive and 67% specific in myopathic disorders. The metabolic myopathies were commonly missed by electromyography. Copyright © 2014 Elsevier Inc. All rights reserved.

Ultrasound detection of placenta accreta in the first trimester of pregnancy.

PubMed

Rahimi-Sharbaf, Fatemeh; Jamal, Ashraf; Mesdaghinia, Elaheh; Abedzadeh-Kalahroudi, Masoumeh; Niroomanesh, Shirin; Atoof, Fatemeh

2014-06-01

Placenta accreta is considered a life-threatening condition and the main cause of maternal mortality. Prenatal diagnosis of placenta accreta usually is made by clinical presentation, imaging studies like ultrasound and MRI in the second and third trimester. To determine accuracy of ultrasound findings for placenta accreta in the first trimester of pregnancy. In a longitudinal study 323 high risk patients for placenta accreta were assessed. The eligible women were examined by vaginal and abdominal ultrasound for gestational sac and placental localization and they were followed up until the end of pregnancy. The ultrasound findings were compared with histopathological examinations as a gold standard. The sensitivity, specificity, positive and negative predictive value of ultrasound were estimated for the first trimester and compared with other 2 trimesters in the case of repeated ultrasound examination. Ultrasound examinations in the first trimester revealed that 28 cases had the findings in favor of placenta accreta which ultimately was confirmed in 7 cases. The ultrasound sensitivity and specificity for detecting placenta accreta in the first trimester was 41% [95% CI: 16.2-62.7] and 88% [95% CI: 88.2-94.6] respectively. Ultrasound screening for placenta accreta in the first trimester of pregnancy could not achieve the high sensitivity as second and third trimester of pregnancy.

Sensitivity and Specificity of Fenyö-Lindberg and Teicher Scores in the Diagnosis of Acute Appendicitis in Women

PubMed

Madžar, Zrinko; Kopljar, Mario; Madžar, Tomislav; Mesić, Marko; Mužina Mišić, Dubravka; Čiček, Slaven; Zovak, Mario

2016-12-01

The aim of the study was to assess diagnostic accuracy (sensitivity and specificity) of Fenyö-Lindberg and Teicher scores for distinguishing patients that need immediate surgical treatment from the others, in a female population from an urban setting. The study prospectively included 130 female patients admitted to the emergency department with abdominal pain indicating acute appendicitis. The scores and parameters of validity were calculated and compared to definitive diagnosis. For Fenyö-Lindberg score of -17 or less, 84.5% sensitivity, 55.6% specificity, 87.9% positive predictive value (PPV) and 48.4% negative predictive value (NPV) were recorded. For cut-off value greater or equal to -2, there was 59.2% sensitivity, 77.8% specificity, 91% PPV and 33.3% NPV. The Receiver Operating Characteristic (ROC) curve analysis of Fenyö-Lindberg score showed that the best single cut-off value for discriminating acute appendicitis in the study population was -15. For Teicher score, values greater than -3 yielded 89.3% sensitivity and 22.2% specificity, 81.4% PPV and 35.3% NPV. In conclusion, Fenyö-Lindberg score could be used as an additional tool to exclude appendicitis and avoid unnecessary appendectomies. Teicher score may help in recognizing patients with appendicitis. None of the two scores can indicate or decline appendectomy in all cases. Scoring systems may be useful for pointing to important clinical signs and symptoms in specific subpopulations.

Clinical utility of urinary soluble Fas in screening for bladder cancer.

PubMed

Srivastava, Anupam Kumar; Singh, Pankaj Kumar; Singh, Dhramveer; Dalela, Divakar; Rath, Srikanta Kumar; Bhatt, Madan Lal Brahma

2016-06-01

Early diagnosis of carcinoma of urinary bladder remains a challenge. Urine cytology, as an adjunct to cystoscopy, is less sensitive for low-grade tumors. Soluble Fas (sFas), a cell-surface receptor and member of the tumor necrosis factor superfamily, is frequently expressed in urinary bladder carcinoma. The objective of this study was to investigate the urinary sFas for diagnosis of transitional cell carcinoma (TCC) of urinary bladder. We examined urinary sFas concentration in 74 controls and 117 cases of TCC, both primary and recurrent disease, by using enzyme-linked immunosorbent assay and compared it with urinary cytology. Urinary sFas concentration was found to be significantly higher in the patient as compared to control group (P < 0.05). An optimal cutoff value of 174.0 pg/mL was proposed. The urinary sFas level was found to have an approximate sensitivity and specificity of 88.03% and 89.19% (P < 0.001), whereas urine cytology had sensitivity of 66.67% and specificity of 95.95%. sFas had better sensitivity in higher grade and both primary and recurrent cases of urinary bladder cancer in comparison with cytology. Out of 15 node positive bladder cancer cases, 13 had high urinary sFas levels, whereas 12 were urinary cytology positive for malignancy. Urinary sFas can be used as a non-invasive diagnostic biomarker for TCC of urinary bladder, both for primary and recurrent disease. © 2014 Wiley Publishing Asia Pty Ltd.

Intra-Operative Frozen Sections for Ovarian Tumors – A Tertiary Center Experience

PubMed Central

Arshad, Nur Zaiti Md; Ng, Beng Kwang; Paiman, Noor Asmaliza Md; Mahdy, Zaleha Abdullah; Noor, Rushdan Mohd

2018-01-01

Background: Accuracy of diagnosis with intra-operative frozen sections is extremely important in the evaluation of ovarian tumors so that appropriate surgical procedures can be selected. Study design: All patients who with intra-operative frozen sections for ovarian masses in a tertiary center over nine years from June 2008 until April 2017 were reviewed. Frozen section diagnosis and final histopathological reports were compared. Main outcome measures: Sensitivity, specificity, positive and negative predictive values of intra-operative frozen section as compared to final histopathological results for ovarian tumors. Results: A total of 92 cases were recruited for final evaluation. The frozen section diagnoses were comparable with the final histopathological reports in 83.7% of cases. The sensitivity, specificity, positive predictive value and negative predictive value for benign and malignant ovarian tumors were 95.6%, 85.1%, 86.0% and 95.2% and 69.2%, 100%, 100% and 89.2% respectively. For borderline ovarian tumors, the sensitivity and specificity were 76.2% and 88.7%, respectively; the positive predictive value was 66.7% and the negative predictive value was 92.7%. Conclusion: The accuracy of intra-operative frozen section diagnoses for ovarian tumors is high and this approach remains a reliable option in assessing ovarian masses intra-operatively. PMID:29373916

Development and deployment of a rapid recombinase polymerase amplification Ebola virus detection assay in Guinea in 2015.

PubMed

Faye, Oumar; Faye, Ousmane; Soropogui, Barré; Patel, Pranav; El Wahed, Ahmed Abd; Loucoubar, Cheikh; Fall, Gamou; Kiory, Davy; Magassouba, N'Faly; Keita, Sakoba; Kondé, Mandy Kader; Diallo, Alpha Amadou; Koivogui, Lamine; Karlberg, Helen; Mirazimi, Ali; Nentwich, Oliver; Piepenburg, Olaf; Niedrig, Matthias; Weidmann, Manfred; Sall, Amadou Alpha

2015-01-01

In the absence of a vaccine or specific treatments for Ebola virus disease (EVD), early identification of cases is crucial for the control of EVD epidemics. We evaluated a new extraction kit (SpeedXtract (SE), Qiagen) on sera and swabs in combination with an improved diagnostic reverse transcription recombinase polymerase amplification assay for the detection of Ebola virus (EBOV-RT-RPA). The performance of combined extraction and detection was best for swabs. Sensitivity and specificity of the combined SE and EBOV-RT-RPA were tested in a mobile laboratory consisting of a mobile glovebox and a Diagnostics-in-a-Suitcase powered by a battery and solar panel, deployed to Matoto Conakry, Guinea as part of the reinforced surveillance strategy in April 2015 to reach the goal of zero cases. The EBOV-RT-RPA was evaluated in comparison to two real-time PCR assays. Of 928 post-mortem swabs, 120 tested positive, and the combined SE and EBOV-RT-RPA yielded a sensitivity and specificity of 100% in reference to one real-time RT-PCR assay. Another widely used real-time RT-PCR was much less sensitive than expected. Results were provided very fast within 30 to 60 min, and the field deployment of the mobile laboratory helped improve burial management and community engagement.

Can integrated 18F-FDG PET/MR replace sentinel lymph node resection in malignant melanoma?

PubMed

Schaarschmidt, Benedikt Michael; Grueneisen, Johannes; Stebner, Vanessa; Klode, Joachim; Stoffels, Ingo; Umutlu, Lale; Schadendorf, Dirk; Heusch, Philipp; Antoch, Gerald; Pöppel, Thorsten Dirk

2018-06-06

To compare the sensitivity and specificity of 18F-fluordesoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT), 18F-FDG PET/magnetic resonance (18F-FDG PET/MR) and 18F-FDG PET/MR including diffusion weighted imaging (DWI) in the detection of sentinel lymph node metastases in patients suffering from malignant melanoma. Fifty-two patients with malignant melanoma (female: n = 30, male: n = 22, mean age 50.5 ± 16.0 years, mean tumor thickness 2.28 ± 1.97 mm) who underwent 18F-FDG PET/CT and subsequent PET/MR & DWI for distant metastasis staging were included in this retrospective study. After hybrid imaging, lymphoscintigraphy including single photon emission computed tomography/CT (SPECT/CT) was performed to identify the sentinel lymph node prior to sentinel lymph node biopsy (SLNB). In a total of 87 sentinel lymph nodes in 64 lymph node basins visible on SPECT/CT, 17 lymph node metastases were detected by histopathology. In separate sessions PET/CT, PET/MR, and PET/MR & DWI were assessed for sentinel lymph node metastases by two independent readers. Discrepant results were resolved in a consensus reading. Sensitivities, specificities, positive predictive values and negative predictive values were calculated with histopathology following SPECT/CT guided SLNB as a reference standard. Compared with histopathology, lymph nodes were true positive in three cases, true negative in 65 cases, false positive in three cases and false negative in 14 cases in PET/CT. PET/MR was true positive in four cases, true negative in 63 cases, false positive in two cases and false negative in 13 cases. Hence, we observed a sensitivity, specificity, positive predictive value and negative predictive value of 17.7, 95.6, 50.0 and 82.3% for PET/CT and 23.5, 96.9, 66.7 and 82.3% for PET/MR. In DWI, 56 sentinel lymph node basins could be analyzed. Here, the additional analysis of DWI led to two additional false positive findings, while the number of true positive findings could not be increased. In conclusion, integrated 18F-FDG PET/MR does not reliably differentiate N-positive from N-negative melanoma patients. Additional DWI does not increase the sensitivity of 18F-FDG PET/MR. Hence, sentinel lymph node biopsy cannot be replaced by 18F-FDG-PE/MR or 18F-FDG-PET/CT.

IMRT QA: Selecting gamma criteria based on error detection sensitivity.

PubMed

Steers, Jennifer M; Fraass, Benedick A

2016-04-01

The gamma comparison is widely used to evaluate the agreement between measurements and treatment planning system calculations in patient-specific intensity modulated radiation therapy (IMRT) quality assurance (QA). However, recent publications have raised concerns about the lack of sensitivity when employing commonly used gamma criteria. Understanding the actual sensitivity of a wide range of different gamma criteria may allow the definition of more meaningful gamma criteria and tolerance limits in IMRT QA. We present a method that allows the quantitative determination of gamma criteria sensitivity to induced errors which can be applied to any unique combination of device, delivery technique, and software utilized in a specific clinic. A total of 21 DMLC IMRT QA measurements (ArcCHECK®, Sun Nuclear) were compared to QA plan calculations with induced errors. Three scenarios were studied: MU errors, multi-leaf collimator (MLC) errors, and the sensitivity of the gamma comparison to changes in penumbra width. Gamma comparisons were performed between measurements and error-induced calculations using a wide range of gamma criteria, resulting in a total of over 20 000 gamma comparisons. Gamma passing rates for each error class and case were graphed against error magnitude to create error curves in order to represent the range of missed errors in routine IMRT QA using 36 different gamma criteria. This study demonstrates that systematic errors and case-specific errors can be detected by the error curve analysis. Depending on the location of the error curve peak (e.g., not centered about zero), 3%/3 mm threshold = 10% at 90% pixels passing may miss errors as large as 15% MU errors and ±1 cm random MLC errors for some cases. As the dose threshold parameter was increased for a given %Diff/distance-to-agreement (DTA) setting, error sensitivity was increased by up to a factor of two for select cases. This increased sensitivity with increasing dose threshold was consistent across all studied combinations of %Diff/DTA. Criteria such as 2%/3 mm and 3%/2 mm with a 50% threshold at 90% pixels passing are shown to be more appropriately sensitive without being overly strict. However, a broadening of the penumbra by as much as 5 mm in the beam configuration was difficult to detect with commonly used criteria, as well as with the previously mentioned criteria utilizing a threshold of 50%. We have introduced the error curve method, an analysis technique which allows the quantitative determination of gamma criteria sensitivity to induced errors. The application of the error curve method using DMLC IMRT plans measured on the ArcCHECK® device demonstrated that large errors can potentially be missed in IMRT QA with commonly used gamma criteria (e.g., 3%/3 mm, threshold = 10%, 90% pixels passing). Additionally, increasing the dose threshold value can offer dramatic increases in error sensitivity. This approach may allow the selection of more meaningful gamma criteria for IMRT QA and is straightforward to apply to other combinations of devices and treatment techniques.

Multifocal blue-on-yellow visual evoked potentials in early glaucoma.

PubMed

Klistorner, Alexander; Graham, Stuart L; Martins, Alessandra; Grigg, John R; Arvind, Hemamalini; Kumar, Rajesh S; James, Andrew C; Billson, Francis A

2007-09-01

To determine the sensitivity and specificity of blue-on-yellow multifocal visual evoked potentials (mfVEPs) in early glaucoma. Cross-sectional study. Fifty patients with a confirmed diagnosis of early glaucoma and 60 normal participants. Black-and-white mfVEPs and blue-on-yellow mfVEPs were recorded using the Accumap version 2.0 (ObjectiVision Pty. Ltd., Sydney, Australia). All patients also underwent achromatic standard automated perimetry (SAP). Multifocal VEP amplitude and latency values in glaucoma patients were analyzed and compared with those of the normal controls. Based on the definition of visual field defect, in the group of glaucomatous eyes with SAP defects, amplitude of blue-on-yellow mfVEP was abnormal in all 64 cases (100% sensitivity), whereas black-and-white mfVEP missed 5 cases (92.2% sensitivity). Generally, larger scotomata were noted on blue-on-yellow mfVEP compared with black-and-white mfVEP for the same eyes. There was high topographic correspondence between SAP and amplitude of blue-on-yellow mfVEP and significant (P<0.0001) correlation between them (correlation coefficient, 0.73). Abnormal amplitude was detected in 3 of 60 eyes of control subjects (95% specificity). There was, however, no correlation between visual field defect and latency delay in glaucoma patients. Although there was a significant difference between averaged latency of control and glaucoma eyes, values considerably overlapped. The blue-on-yellow mfVEP is a sensitive and specific tool for detecting early glaucoma based on amplitude analysis.

Sensitivity and specificity of HAT Sero-K-SeT, a rapid diagnostic test for serodiagnosis of sleeping sickness caused by Trypanosoma brucei gambiense: a case-control study.

PubMed

Büscher, Philippe; Mertens, Pascal; Leclipteux, Thierry; Gilleman, Quentin; Jacquet, Diane; Mumba-Ngoyi, Dieudonné; Pyana, Patient Pati; Boelaert, Marleen; Lejon, Veerle

2014-06-01

Human African trypanosomiasis (HAT) is a life-threatening infection affecting rural populations in sub-Saharan Africa. Large-scale population screening by antibody detection with the Card Agglutination Test for Trypanosomiasis (CATT)/Trypanosoma brucei (T b) gambiense helped reduce the number of reported cases of gambiense HAT to fewer than 10 000 in 2011. Because low case numbers lead to decreased cost-effectiveness of such active screening, we aimed to assess diagnostic accuracy of a rapid serodiagnostic test (HAT Sero-K-SeT) applicable in primary health-care centres. In our case-control study, we assessed participants older than 11 years who presented for HAT Sero-K-SeT and CATT/T b gambiense at primary care centres or to mobile teams (and existing patients with confirmed disease status at these centres) in Bandundu Province, DR Congo. We defined cases as patients with trypanosomes that had been identified in lymph node aspirate, blood, or cerebrospinal fluid. During screening, we recruited controls without previous history of HAT or detectable trypanosomes in blood or lymph who resided in the same area as the cases. We assessed diagnostic accuracy of three antibody detection tests for gambiense HAT: HAT Sero-K-SeT and CATT/T b gambiense (done with venous blood at the primary care centres) and immune trypanolysis (done with plasma at the Institute of Tropical Medicine, Antwerp, Belgium). Between June 6, 2012, and Feb 25, 2013, we included 134 cases and 356 controls. HAT Sero-K-SeT had a sensitivity of 0·985 (132 true positives, 95% CI 0·947-0·996) and a specificity of 0·986 (351 true negatives, 0·968-0·994), which did not differ significantly from CATT/T b gambiense (sensitivity 95% CI 0·955, 95% CI 0·906-0·979 [128 true positives] and specificity 0·972, 0·949-0·985 [346 true negatives]) or immune trypanolysis (sensitivity 0·985, 0·947-0·996 [132 true positives] and specificity 0·980, 0·960-0·990 [349 true negatives]). The diagnostic accuracy of HAT Sero-K-SeT is adequate for T b gambiense antibody detection in local health centres and could be used for active screening whenever a cold chain and electricity supply are unavailable and CATT/T b gambiense cannot be done. Copyright © 2014 Büscher et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by .. All rights reserved.

[Flicker comparison of optic disc photographs: sensitivity and specificity].

PubMed

Funk, Jens; Lagrèze, Wolf; Zeyen, Thierry

2002-12-01

Examination and documentation of the optic nerve head are essential in monitoring glaucoma patients. Even minor changes in optic nerve head morphology can be visualised using the so-called flicker test: Two optic nerve head photographs, taken at consecutive examinations, are superimposed by projection. When occluding the pictures in a rapid alternating fashion, changes in optic nerve head morphology appear as motion. In this study, we evaluated sensitivity and specificity of the flicker test. A set of 33 pairs of serial optic disc slides was used as gold standard. These 33 pairs had been classified earlier by 3 independent groups of experts. 23 had been classified as "no change over time", 10 had been classified as "change". All 33 pairs were now evaluated by flicker comparison in a masked fashion. Flicker comparison usually took 1 minute per pair of slides. Sensitivity was 90 %, specificity was 65 %. The sensitivity was reasonably high. The moderate specificity was due to some cases showing "change" with the flicker comparison which might have been overlooked by the expert groups. Flicker comparison is an easy, fast and reliable technique to evaluate pairs of consecutive optic disc photographs.

Central sensitization in chronic low back pain: A narrative review.

PubMed

Sanzarello, Ilaria; Merlini, Luciano; Rosa, Michele Attilio; Perrone, Mariada; Frugiuele, Jacopo; Borghi, Raffaele; Faldini, Cesare

2016-11-21

Low back pain is one of the four most common disorders in all regions, and the greatest contributor to disability worldwide, adding 10.7% of total years lost due to this health state. The etiology of chronic low back pain is, in most of the cases (up to 85%), unknown or nonspecific, while the specific causes (specific spinal pathology and neuropathic/radicular disorders) are uncommon. Central sensitization has been recently recognized as a potential pathophysiological mechanism underlying a group of chronic pain conditions, and may be a contributory factor for a sub-group of patients with chronic low back pain. The purposes of this narrative review are twofold. First, to describe central sensitization and its symptoms and signs in patients with chronic pain disorders in order to allow its recognition in patients with nonspecific low back pain. Second, to provide general treatment principles of chronic low back pain with particular emphasis on pharmacotherapy targeting central sensitization.

Assessment of activity in Sarcoidosis. Sensitivity and specificity of 67Gallium scintigraphy, serum ACE levels, chest roentgenography, and blood lymphocyte subpopulations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Klech, H.; Kohn, H.; Kummer, F.

1982-12-01

The value of different factors are examined to assess activity in 60 patients with biopsy-proven sarcoidosis. In patients with active sarcoidosis (n . 35), /sup 67/Ga scans proved to be the most sensitive method (94 percent sensitivity), followed by serum angiotensin I converting enzyme (S-ACE) levels, chest x-ray films, and lymphocyte assays. In patients with peripheral pulmonary lesions, chest x-ray films failed in 32 percent of cases to document activity (68 percent sensitivity) whereas /sup 67/Ga scans and S-ACE levels remained to give reliable results. Despite poor specificity, negative /sup 67/Ga scans together with normal ACE levels have a highmore » predictive value for exclusion of active sarcoidosis. In patients with peripheral pulmonary lesions, chest roentgenography is of doubtful value for staging lung involvement and assessment of activity including monitoring and control of therapy.« less

Sensitivity and Specificity of the World Health Organization Dengue Classification Schemes for Severe Dengue Assessment in Children in Rio de Janeiro

PubMed Central

Macedo, Gleicy A.; Gonin, Michelle Luiza C.; Pone, Sheila M.; Cruz, Oswaldo G.; Nobre, Flávio F.; Brasil, Patrícia

2014-01-01

Background The clinical definition of severe dengue fever remains a challenge for researchers in hyperendemic areas like Brazil. The ability of the traditional (1997) as well as the revised (2009) World Health Organization (WHO) dengue case classification schemes to detect severe dengue cases was evaluated in 267 children admitted to hospital with laboratory-confirmed dengue. Principal Findings Using the traditional scheme, 28.5% of patients could not be assigned to any category, while the revised scheme categorized all patients. Intensive therapeutic interventions were used as the reference standard to evaluate the ability of both the traditional and revised schemes to detect severe dengue cases. Analyses of the classified cases (n = 183) demonstrated that the revised scheme had better sensitivity (86.8%, P<0.001), while the traditional scheme had better specificity (93.4%, P<0.001) for the detection of severe forms of dengue. Conclusions/Significance This improved sensitivity of the revised scheme allows for better case capture and increased ICU admission, which may aid pediatricians in avoiding deaths due to severe dengue among children, but, in turn, it may also result in the misclassification of the patients' condition as severe, reflected in the observed lower positive predictive value (61.6%, P<0.001) when compared with the traditional scheme (82.6%, P<0.001). The inclusion of unusual dengue manifestations in the revised scheme has not shifted the emphasis from the most important aspects of dengue disease and the major factors contributing to fatality in this study: shock with consequent organ dysfunction. PMID:24777054

Sensitivity and specificity of the World Health Organization dengue classification schemes for severe dengue assessment in children in Rio de Janeiro.

PubMed

Macedo, Gleicy A; Gonin, Michelle Luiza C; Pone, Sheila M; Cruz, Oswaldo G; Nobre, Flávio F; Brasil, Patrícia

2014-01-01

The clinical definition of severe dengue fever remains a challenge for researchers in hyperendemic areas like Brazil. The ability of the traditional (1997) as well as the revised (2009) World Health Organization (WHO) dengue case classification schemes to detect severe dengue cases was evaluated in 267 children admitted to hospital with laboratory-confirmed dengue. Using the traditional scheme, 28.5% of patients could not be assigned to any category, while the revised scheme categorized all patients. Intensive therapeutic interventions were used as the reference standard to evaluate the ability of both the traditional and revised schemes to detect severe dengue cases. Analyses of the classified cases (n = 183) demonstrated that the revised scheme had better sensitivity (86.8%, P<0.001), while the traditional scheme had better specificity (93.4%, P<0.001) for the detection of severe forms of dengue. This improved sensitivity of the revised scheme allows for better case capture and increased ICU admission, which may aid pediatricians in avoiding deaths due to severe dengue among children, but, in turn, it may also result in the misclassification of the patients' condition as severe, reflected in the observed lower positive predictive value (61.6%, P<0.001) when compared with the traditional scheme (82.6%, P<0.001). The inclusion of unusual dengue manifestations in the revised scheme has not shifted the emphasis from the most important aspects of dengue disease and the major factors contributing to fatality in this study: shock with consequent organ dysfunction.

Comparison of the Wake-up Test and Combined TES-MEP and CSEP Monitoring in Spinal Surgery.

PubMed

Chen, Bailing; Chen, Yuguang; Yang, Junlin; Xie, Denghui; Su, Haihua; Li, Fobao; Wan, Yong; Peng, Xinsheng; Zheng, Zhaomin

2015-11-01

A retrospective clinical analysis. The aim of this study was to compare the effectiveness of the wake-up test with that of combined monitoring of transcranial electrical stimulation motor evoked potentials (TES-MEP) and cortical somatosensory evoked potentials (CSEP) in spinal surgery. TES-MEP/CSEP combined monitoring is being increasingly recognized as the ideal approach to detect spinal neurophysiological compromise during spinal surgery; however, as a result the merit of the wake-up test is now in doubt. TES-MEP/CSEP combined monitoring was performed simultaneously in 426 patients who underwent spinal surgery at our department, and wake-up tests were conducted on 23 patients because of positive neurophysiological monitoring results with uncertain causes or persistent positive monitoring findings after all potential causes had been resolved. Preoperative and postoperative neurological examinations were performed as the gold standard to detect irreversible spinal function compromise. All data were collected to compare the efficiency of TES-MEP/CSEP combined monitoring with that of the wake-up test. Positive results of TES-MEP/CSEP combined monitoring were recorded in 64 cases. Among them, the positive monitoring findings agreed with the results of the neurological examination in 51 cases, and the monitoring results did not match that of neurological examination in 13 cases. No false-negative result was observed. The sensitivity of TES-MEP/CSEP monitoring was 100%, the specificity was 96.5%, and the Youden index was 0.965. Wake-up tests were conducted in 23 cases. In 8 patients the positive monitoring findings completely matched the postoperative neurological examination results. In contrast, in the other 15 cases with negative neurophysiological monitoring results, only 9 patients retained intact neurological function and 6 patients suffered compromised neurological function. The sensitivity of the wake-up test was 57.1%, the specificity was 100%, and the Youden index was 0.571. Combined TES-MEP and CSEP monitoring, with its high sensitivity and specificity, is an effective method for monitoring spinal function during surgery and should be the preferred choice. The wake-up test is a useful complementary method for monitoring because of its high specificity.

Validation of a case definition for leptospirosis diagnosis in patients with acute severe febrile disease admitted in reference hospitals at the State of Pernambuco, Brazil.

PubMed

Albuquerque Filho, Alfredo Pereira Leite de; Araújo, Jéssica Guido de; Souza, Inacelli Queiroz de; Martins, Luciana Cardoso; Oliveira, Marta Iglis de; Silva, Maria Jesuíta Bezerra da; Montarroyos, Ulisses Ramos; Miranda Filho, Demócrito de Barros

2011-01-01

Leptospirosis is often mistaken for other acute febrile illnesses because of its nonspecific presentation. Bacteriologic, serologic, and molecular methods have several limitations for early diagnosis: technical complexity, low availability, low sensitivity in early disease, or high cost. This study aimed to validate a case definition, based on simple clinical and laboratory tests, that is intended for bedside diagnosis of leptospirosis among hospitalized patients. Adult patients, admitted to two reference hospitals in Recife, Brazil, with a febrile illness of less than 21 days and with a clinical suspicion of leptospirosis, were included to test a case definition comprising ten clinical and laboratory criteria. Leptospirosis was confirmed or excluded by a composite reference standard (microscopic agglutination test, ELISA, and blood culture). Test properties were determined for each cutoff number of the criteria from the case definition. Ninety seven patients were included; 75 had confirmed leptospirosis and 22 did not. Mean number of criteria from the case definition that were fulfilled was 7.8±1.2 for confirmed leptospirosis and 5.9±1.5 for non-leptospirosis patients (p<0.0001). Best sensitivity (85.3%) and specificity (68.2%) combination was found with a cutoff of 7 or more criteria, reaching positive and negative predictive values of 90.1% and 57.7%, respectively; accuracy was 81.4%. The case definition, for a cutoff of at least 7 criteria, reached average sensitivity and specificity, but with a high positive predictive value. Its simplicity and low cost make it useful for rapid bedside leptospirosis diagnosis in Brazilian hospitalized patients with acute severe febrile disease.

Evaluation of the Loop Mediated Isothermal DNA Amplification (LAMP) Kit for Malaria Diagnosis in P. vivax Endemic Settings of Colombia

PubMed Central

Vallejo, Andrés F.; Martínez, Nora L.; González, Iveth J.; Arévalo-Herrera, Myriam; Herrera, Sócrates

2015-01-01

Background Most commonly used malaria diagnostic tests, including microscopy and antigen-detecting rapid tests, cannot reliably detect low-density infections which are frequent in low transmission settings. Molecular methods such as polymerase chain reaction (PCR) are highly sensitive but remain too laborious for field deployment. In this study, the applicability of a malaria diagnosis kit based on loop-mediated isothermal amplification (mLAMP) was assessed in malaria endemic areas of Colombia with Plasmodium vivax predominance. Methodology/Principal Findings First, a passive case detection (PCD) study on 278 febrile patients recruited in Tierralta (department of Cordoba) was conducted to assess the diagnostic performance of the mLAMP method. Second, an active case detection (ACD) study on 980 volunteers was conducted in 10 sentinel sites with different epidemiological profiles. Whole blood samples were processed for microscopic and mLAMP diagnosis. Additionally RT-PCR and nested RT-PCR were used as reference tests. In the PCD study, P. falciparum accounted for 23.9% and P. vivax for 76.1% of the infections and no cases of mixed-infections were identified. Microscopy sensitivity for P. falciparum and P. vivax were 100% and 86.1%, respectively. mLAMP sensitivity for P. falciparum and P. vivax was 100% and 91.4%, respectively. In the ACD study, mLAMP detected 65 times more cases than microscopy. A high proportion (98.0%) of the infections detected by mLAMP was from volunteers without symptoms. Conclusions/Significance mLAMP sensitivity and specificity were comparable to RT-PCR. LAMP was significantly superior to microscopy and in P. vivax low-endemicity settings and under minimum infrastructure conditions, it displayed sensitivity and specificity similar to that of single-well RT-PCR for detection of both P. falciparum and P. vivax infections. Here, the dramatically increased detection of asymptomatic malaria infections by mLAMP demonstrates the usefulness of this new tool for diagnosis, surveillance, and screening in elimination strategies. PMID:25569550

Rapid Molecular Microbiologic Diagnosis of Prosthetic Joint Infection

PubMed Central

Cazanave, Charles; Greenwood-Quaintance, Kerryl E.; Hanssen, Arlen D.; Karau, Melissa J.; Schmidt, Suzannah M.; Gomez Urena, Eric O.; Mandrekar, Jayawant N.; Osmon, Douglas R.; Lough, Lindsay E.; Pritt, Bobbi S.; Steckelberg, James M.

2013-01-01

We previously showed that culture of samples obtained by prosthesis vortexing and sonication was more sensitive than tissue culture for prosthetic joint infection (PJI) diagnosis. Despite improved sensitivity, culture-negative cases remained; furthermore, culture has a long turnaround time. We designed a genus-/group-specific rapid PCR assay panel targeting PJI bacteria and applied it to samples obtained by vortexing and sonicating explanted hip and knee prostheses, and we compared the results to those with sonicate fluid and periprosthetic tissue culture obtained at revision or resection arthroplasty. We studied 434 subjects with knee (n = 272) or hip (n = 162) prostheses; using a standardized definition, 144 had PJI. Sensitivities of tissue culture, of sonicate fluid culture, and of PCR were 70.1, 72.9, and 77.1%, respectively. Specificities were 97.9, 98.3, and 97.9%, respectively. Sonicate fluid PCR was more sensitive than tissue culture (P = 0.04). PCR of prosthesis sonication samples is more sensitive than tissue culture for the microbiologic diagnosis of prosthetic hip and knee infection and provides same-day PJI diagnosis with definition of microbiology. The high assay specificity suggests that typical PJI bacteria may not cause aseptic implant failure. PMID:23658273

Sensitization of Children to Storage Mites in Kutahya, Turkey

PubMed Central

Soyucen, Erdogan

2009-01-01

Specific IgE against Acarus siro, Glycphagus domesticus, Tyrophagus putrescentiae, and Lepidoglyphus destructor have been investigated by ELISA in sera of 92 children. Of them, 41 were found to be specific IgE positive (≥ 0.35 IU/ml) against at least one of house dust mite species, Dermatophagoides pteronyssinus and Dermatophagoides farinae, by an immunoblot. In 65.9% of the dust mite-sensitized children, specific IgE against at least one of these mite species was found. Sensitization levels, including co-sensitization cases were found to be 35.7% against A. siro, 24.4% against T. putrescentiae, 31.7% against L. destructor, and 26.8% against G. domesticus. In non-sensitized children, dust mite sensitization level was found to be 25.5%. Breakdown of sensitization by individual species in this group was; against A. siro and T. putrescentiae at 7.8%, against L. destructor at 13.7%, and against G. domesticus at 9.8%. When all children were reckoned, 43.5% was found to be sensitized against at least one storage mite species, with sensitizations against A. siro at 18.5%, T. putrescentiae at 26.1%, L. destructor at 21.7%, and G. domesticus at 17.4%. In dust samples collected from the dwellings of children, distribution of species was found to be A. siro (17%), G. domesticus (23%), T. putrescentiae (29%), L. destructor (25%), and unidentified (6%). In Fisher's chi-square test on SPSS program, there was a relationship between dust mite sensitization and storage mite sensitization (P < 0.05), but no meaningful relationship was found on the basis of individual mite species. PMID:19967087

Comparative Evaluation of Serological and Molecular Methods for the Diagnosis of Scrub Typhus in Indian Settings.

PubMed

Gupta, Nitin; Chaudhry, Rama; Kabra, Sushil K; Lodha, Rakesh; Mirdha, Bijay Ranjan; Das, Bimal Kumar; Dey, Aparajit Ballay; Sreenivas, Vishnubhatla

2017-03-24

The major brunt of scrub typhus is borne by developing countries like India but the disease remains neglected. The rapid progression of this infection to serious complications and associated mortality calls for improved diagnostics. The immunoglobulin (Ig)M immunofluorescence assay (IFA), with all of its limitations remains the gold standard. Of 218 suspected cases from patients enrolled in a 2-year study, 30 cases of scrub typhus were detected by IgM IFA, using a 1:64 dilution. The sensitivities of the IgM enzyme-linked immunosorbent assay, IgM rapid flow assay (RFA), and IgG RFA were found to be 97%, 87%, and 77%, respectively. Their respective specificities were 100%, 100%, and 92%, respectively. The sensitivity and specificity of a nested PCR assay targeting a gene encoding a 56-kDa protein were found to be 50% and 100%, respectively.

Cost effectiveness of OptiMal® rapid diagnostic test for malaria in remote areas of the Amazon Region, Brazil

PubMed Central

2010-01-01

Background In areas with limited structure in place for microscopy diagnosis, rapid diagnostic tests (RDT) have been demonstrated to be effective. Method The cost-effectiveness of the Optimal® and thick smear microscopy was estimated and compared. Data were collected on remote areas of 12 municipalities in the Brazilian Amazon. Data sources included the National Malaria Control Programme of the Ministry of Health, the National Healthcare System reimbursement table, hospitalization records, primary data collected from the municipalities, and scientific literature. The perspective was that of the Brazilian public health system, the analytical horizon was from the start of fever until the diagnostic results provided to patient and the temporal reference was that of year 2006. The results were expressed in costs per adequately diagnosed cases in 2006 U.S. dollars. Sensitivity analysis was performed considering key model parameters. Results In the case base scenario, considering 92% and 95% sensitivity for thick smear microscopy to Plasmodium falciparum and Plasmodium vivax, respectively, and 100% specificity for both species, thick smear microscopy is more costly and more effective, with an incremental cost estimated at US$549.9 per adequately diagnosed case. In sensitivity analysis, when sensitivity and specificity of microscopy for P. vivax were 0.90 and 0.98, respectively, and when its sensitivity for P. falciparum was 0.83, the RDT was more cost-effective than microscopy. Conclusion Microscopy is more cost-effective than OptiMal® in these remote areas if high accuracy of microscopy is maintained in the field. Decision regarding use of rapid tests for diagnosis of malaria in these areas depends on current microscopy accuracy in the field. PMID:20937094

Office-Based Point of Care Testing (IgA/IgG-Deamidated Gliadin Peptide) for Celiac Disease.

PubMed

Lau, Michelle S; Mooney, Peter D; White, William L; Rees, Michael A; Wong, Simon H; Hadjivassiliou, Marios; Green, Peter H R; Lebwohl, Benjamin; Sanders, David S

2018-06-19

Celiac disease (CD) is common yet under-detected. A point of care test (POCT) may improve CD detection. We aimed to assess the diagnostic performance of an IgA/IgG-deamidated gliadin peptide (DGP)-based POCT for CD detection, patient acceptability, and inter-observer variability of the POCT results. From 2013-2017, we prospectively recruited patients referred to secondary care with gastrointestinal symptoms, anemia and/or weight loss (group 1); and patients with self-reported gluten sensitivity with unknown CD status (group 2). All patients had concurrent POCT, IgA-tissue transglutaminase (IgA-TTG), IgA-endomysial antibodies (IgA-EMA), total IgA levels, and duodenal biopsies. Five hundred patients completed acceptability questionnaires, and inter-observer variability of the POCT results was compared among five clinical staff for 400 cases. Group 1: 1000 patients, 58.5% female, age 16-91, median age 57. Forty-one patients (4.1%) were diagnosed with CD. The sensitivities of the POCT, IgA-TTG, and IgA-EMA were 82.9, 78.1, and 70.7%; the specificities were 85.4, 96.3, and 99.8%. Group 2: 61 patients, 83% female; age 17-73, median age 35. The POCT had 100% sensitivity and negative predictive value in detecting CD in group 2. Most patients preferred the POCT to venepuncture (90.4% vs. 2.8%). There was good inter-observer agreement on the POCT results with a Fleiss Kappa coefficient of 0.895. The POCT had comparable sensitivities to serology, and correctly identified all CD cases in a gluten sensitive cohort. However, its low specificity may increase unnecessary investigations. Despite its advantage of convenience and rapid results, it may not add significant value to case finding in an office-based setting.

Ultra-deep sequencing confirms immunohistochemistry as a highly sensitive and specific method for detecting BRAF V600E mutations in colorectal carcinoma.

PubMed

Rössle, Matthias; Sigg, Michèle; Rüschoff, Jan H; Wild, Peter J; Moch, Holger; Weber, Achim; Rechsteiner, Markus P

2013-11-01

The activating BRAF (V600) mutation is a well-established negative prognostic biomarker in metastatic colorectal carcinoma (CRC). A recently developed monoclonal mouse antibody (clone VE1) has been shown to detect reliably BRAF (V600E) mutated protein by immunohistochemistry (IHC). In this study, we aimed to compare the detection of BRAF (V600E) mutations by IHC, Sanger sequencing (SaS), and ultra-deep sequencing (UDS) in CRC. VE1-IHC was established in a cohort of 68 KRAS wild-type CRCs. The VE1-IHC was only positive in the three patients with a known BRAF (V600E) mutation as assessed by SaS and UDS. The test cohort consisted of 265 non-selected, consecutive CRC samples. Thirty-nine out of 265 cases (14.7%) were positive by VE1-IHC. SaS of 20 randomly selected IHC negative tumors showed BRAF wild-type (20/20). Twenty-four IHC-positive cases were confirmed by SaS (24/39; 61.5%) and 15 IHC-positive cases (15/39; 38.5%) showed a BRAF wild-type by SaS. UDS detected a BRAF (V600E) mutation in 13 of these 15 discordant cases. In one tumor, the mutation frequency was below our threshold for UDS positivity, while in another case, UDS could not be performed due to low DNA amount. Statistical analysis showed sensitivities of 100% and 63% and specificities of 95 and 100% for VE1-IHC and SaS, respectively, compared to combined results of SaS and UDS. Our data suggests that there is high concordance between UDS and IHC using the anti-BRAF(V600E) (VE1) antibody. Thus, VE1 immunohistochemistry is a highly sensitive and specific method in detecting BRAF (V600E) mutations in colorectal carcinoma.

Sensitivity and Specificity of OCT Angiography to Detect Choroidal Neovascularization.

PubMed

Faridi, Ambar; Jia, Yali; Gao, Simon S; Huang, David; Bhavsar, Kavita V; Wilson, David J; Sill, Andrew; Flaxel, Christina J; Hwang, Thomas S; Lauer, Andreas K; Bailey, Steven T

2017-01-01

To determine the sensitivity and specificity of optical coherence tomography angiography (OCTA) in the detection of choroidal neovascularization (CNV) in age-related macular degeneration (AMD). Prospective case series. Prospective series of seventy-two eyes were studied, which included eyes with treatment-naive CNV due to AMD, non-neovascular AMD, and normal controls. All eyes underwent OCTA with a spectral domain (SD) OCT (Optovue, Inc.). The 3D angiogram was segmented into separate en face views including the inner retinal angiogram, outer retinal angiogram, and choriocapillaris angiogram. Detection of abnormal flow in the outer retina served as candidate CNV with OCTA. Masked graders reviewed structural OCT alone, en face OCTA alone, and en face OCTA combined with cross-sectional OCTA for the presence of CNV. The sensitivity and specificity of CNV detection compared to the gold standard of fluorescein angiography (FA) and OCT was determined for structural SD-OCT alone, en face OCTA alone, and with en face OCTA combined with cross-sectional OCTA. Of 32 eyes with CNV, both graders identified 26 true positives with en face OCTA alone, resulting in a sensitivity of 81.3%. Four of the 6 false negatives had large subretinal hemorrhage (SRH) and sensitivity improved to 94% for both graders if eyes with SRH were excluded. The addition of cross-sectional OCTA along with en face OCTA improved the sensitivity to 100% for both graders. Structural OCT alone also had a sensitivity of 100%. The specificity of en face OCTA alone was 92.5% for grader A and 97.5% for grader B. The specificity of structural OCT alone was 97.5% for grader A and 85% for grader B. Cross-sectional OCTA combined with en face OCTA had a specificity of 97.5% for grader A and 100% for grader B. Sensitivity and specificity for CNV detection with en face OCTA combined with cross-sectional OCTA approaches that of the gold standard of FA with OCT, and it is better than en face OCTA alone. Structural OCT alone has excellent sensitivity for CNV detection. False positives from structural OCT can be mitigated with the addition of flow information with OCTA.

Sensitivity and specificity of the Distress Thermometer in screening for distress in long-term nasopharyngeal cancer survivors.

PubMed

Hong, J S; Tian, J

2013-12-01

The Distress Thermometer (dt) is a screening tool recommended to quickly identify cancer patients with distress. Our study aimed to examine the sensitivity and specificity of the dt in detecting psychological distress in long-term Chinese nasopharyngeal cancer (npc) survivors. Data for the 442 participating npc survivors were collected through a self-administered questionnaire based on the dt and the Hospital Anxiety and Depression Scale (hads). The hads was used to define cases of psychological distress. Positive and negative groups were defined based on 4 hads criteria (Anxiety, Depression, Anxiety or Depression, and overall score). Receiver operating characteristic (roc) curves were used to examine the ability of all possible cut-off values of the dt to detect positive and negative cases. For each roc curve, the area under the curve (auc) was used as an indicator of the overall accuracy of the dt to identify positive cases of distress. The positive auc values [with 95% confidence intervals (ci)] for the 4 hads criteria were 0.715 (95% ci: 0.667 to 0.764), 0.714 (95% ci: 0.661 to 0.768), 0.724 (95% ci: 0.677 to 0.771), and 0.724 (95% ci: 0.664 to 0.775) respectively. At a cut-off score of 4, the sensitivity of the dt to the four hads criteria was, respectively, 0.366 (95% ci: 0.296 to 0.436), 0.448 (95% ci: 0.364 to 0.532), 0.362 (95% ci: 0.299 to 0.425), and 0.421 (95% ci: 0.339 to 0.502), and the specificity of the dt to the 4 hads criteria was, respectively, 0.860 (95% ci: 0.818 to 0.902), 0.860 (95% ci: 0.821 to 0.899), 0.854 (95% ci: 0.814 to 0.894), and 0.854 (95% ci: 0.814 to 0.894). At a cut-off score of 5, the corresponding sensitivities were lower than those at the cut-off score of 4. All potential cut-off scores showed poor sensitivity (<0.90). The roc analysis showed poor discrimination. No potential dt cut-off score had an acceptable sensitivity. The dt showed poor sensitivity in npc survivors. Thus, the dt might not be a valid scale for psychological distress screening in long-term Chinese npc survivors.

Sensitivity and specificity of the Distress Thermometer in screening for distress in long-term nasopharyngeal cancer survivors

PubMed Central

Hong, J.S.; Tian, J.

2013-01-01

Background The Distress Thermometer (dt) is a screening tool recommended to quickly identify cancer patients with distress. Our study aimed to examine the sensitivity and specificity of the dt in detecting psychological distress in long-term Chinese nasopharyngeal cancer (npc) survivors. Methods Data for the 442 participating npc survivors were collected through a self-administered questionnaire based on the dt and the Hospital Anxiety and Depression Scale (hads). The hads was used to define cases of psychological distress. Positive and negative groups were defined based on 4 hads criteria (Anxiety, Depression, Anxiety or Depression, and overall score). Receiver operating characteristic (roc) curves were used to examine the ability of all possible cut-off values of the dt to detect positive and negative cases. For each roc curve, the area under the curve (auc) was used as an indicator of the overall accuracy of the dt to identify positive cases of distress. Results The positive auc values [with 95% confidence intervals (ci)] for the 4 hads criteria were 0.715 (95% ci: 0.667 to 0.764), 0.714 (95% ci: 0.661 to 0.768), 0.724 (95% ci: 0.677 to 0.771), and 0.724 (95% ci: 0.664 to 0.775) respectively. At a cut-off score of 4, the sensitivity of the dt to the four hads criteria was, respectively, 0.366 (95% ci: 0.296 to 0.436), 0.448 (95% ci: 0.364 to 0.532), 0.362 (95% ci: 0.299 to 0.425), and 0.421 (95% ci: 0.339 to 0.502), and the specificity of the dt to the 4 hads criteria was, respectively, 0.860 (95% ci: 0.818 to 0.902), 0.860 (95% ci: 0.821 to 0.899), 0.854 (95% ci: 0.814 to 0.894), and 0.854 (95% ci: 0.814 to 0.894). At a cut-off score of 5, the corresponding sensitivities were lower than those at the cut-off score of 4. All potential cut-off scores showed poor sensitivity (<0.90). Conclusions The roc analysis showed poor discrimination. No potential dt cut-off score had an acceptable sensitivity. The dt showed poor sensitivity in npc survivors. Thus, the dt might not be a valid scale for psychological distress screening in long-term Chinese npc survivors. PMID:24311958

Age specific fast breathing in under-five diarrheal children in an urban hospital: Acidosis or pneumonia?

PubMed

Nuzhat, Sharika; Ahmed, Tahmeed; Kawser, Chowdhury Ali; Khan, Azharul Islam; Islam, S M Rafiqul; Shahrin, Lubaba; Shahunja, K M; Shahid, Abu S M S B; Al Imran, Abdullah; Chisti, Mohammod Jobayer

2017-01-01

Children with diarrhea often present with fast breathing due to metabolic acidosis from dehydration. On the other hand, age specific fast breathing is the cornerstone for the diagnosis of pneumonia following classification of pneumonia recommended by the World Health Organization (WHO). Correction of metabolic acidosis by rehydrating the diarrheal children requires time, which delays early initiation of appropriate antimicrobials for pneumonia and thereby increases the risk of deaths. We need to further investigate the simple clinical features other than fast breathing which might help us in earliest diagnosis of pneumonia in children with diarrhea Thus, the objective of our study was to identify other contributing clinical features that may independently help for early diagnosis of pneumonia in diarrheal children who present with age specific fast breathing. This was an unmatched case-control study. Diarrheal children aged 0-59 months, admitted to Dhaka Hospital of the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b) during January 2014 to December 2014 having age specific fast breathing (<2 month ≥60 breath/min, 2-11 months ≥50 breaths/min, >11-59 months ≥40 breaths/min) were studied. The study children with clinical and radiological pneumonia constituted the cases (n = 276) and those without pneumonia constituted the controls (n = 446). Comparison of clinical features and outcomes between the cases and the controls was made. The distribution of acidosis among the cases and the controls was comparable (35% vs. 41%, p = 0.12). The cases had proportionately higher deaths compared to the controls, however, the difference was not statistically significant (3% vs. 1%; p = 0.23). In logistic regression analysis after adjusting for potential confounders, the cases were independently associated with cough (OR = 62.19, 95% CI = 27.79-139.19; p<0.01) and chest wall indrawing (OR = 31.05, 95%CI = 13.43-71.82; p<0.01) and less often had severe acute malnutrition (OR = 0.33, 95%CI = 0.13-0.79; p<0.01). The sensitivity and specificity of cough were 83% (78-87%) and 93% (91-96%). The sensitivity and specificity for lower chest wall indrawing were 65% (59-71%) and 95% (93-97%). However, the sensitivity and specificity of cough and lower chest wall indrawing combined were 94% (89-97%) and 99% (97-100%). Thus, diarrheal children having fast breathing who present with cough and/or lower chest wall indrawing, irrespective of presence or absence of metabolic acidosis, are more likely to have radiological pneumonia. The results underscore the importance of early identification of these simple clinical features that may help to minimize potential delay due to rehydration in initiating prompt treatment of pneumonia in order to reduce fatal consequences in such children.

Improving digital breast tomosynthesis reading time: A pilot multi-reader, multi-case study using concurrent Computer-Aided Detection (CAD).

PubMed

Balleyguier, Corinne; Arfi-Rouche, Julia; Levy, Laurent; Toubiana, Patrick R; Cohen-Scali, Franck; Toledano, Alicia Y; Boyer, Bruno

2017-12-01

Evaluate concurrent Computer-Aided Detection (CAD) with Digital Breast Tomosynthesis (DBT) to determine impact on radiologist performance and reading time. The CAD system detects and extracts suspicious masses, architectural distortions and asymmetries from DBT planes that are blended into corresponding synthetic images to form CAD-enhanced synthetic images. Review of CAD-enhanced images and navigation to corresponding planes to confirm or dismiss potential lesions allows radiologists to more quickly review DBT planes. A retrospective, crossover study with and without CAD was conducted with six radiologists who read an enriched sample of 80 DBT cases including 23 malignant lesions in 21 women. Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) compared the readings with and without CAD to determine the effect of CAD on overall interpretation performance. Sensitivity, specificity, recall rate and reading time were also assessed. Multi-reader, multi-case (MRMC) methods accounting for correlation and requiring correct lesion localization were used to analyze all endpoints. AUCs were based on a 0-100% probability of malignancy (POM) score. Sensitivity and specificity were based on BI-RADS scores, where 3 or higher was positive. Average AUC across readers without CAD was 0.854 (range: 0.785-0.891, 95% confidence interval (CI): 0.769,0.939) and 0.850 (range: 0.746-0.905, 95% CI: 0.751,0.949) with CAD (95% CI for difference: -0.046,0.039), demonstrating non-inferiority of AUC. Average reduction in reading time with CAD was 23.5% (95% CI: 7.0-37.0% improvement), from an average 48.2 (95% CI: 39.1,59.6) seconds without CAD to 39.1 (95% CI: 26.2,54.5) seconds with CAD. Per-patient sensitivity was the same with and without CAD (0.865; 95% CI for difference: -0.070,0.070), and there was a small 0.022 improvement (95% CI for difference: -0.046,0.089) in per-lesion sensitivity from 0.790 without CAD to 0.812 with CAD. A slight reduction in specificity with a -0.014 difference (95% CI for difference: -0.079,0.050) and a small 0.025 increase (95% CI for difference: -0.036,0.087) in recall rate in non-cancer cases were observed with CAD. Concurrent CAD resulted in faster reading time with non-inferiority of radiologist interpretation performance. Radiologist sensitivity, specificity and recall rate were similar with and without CAD. Copyright © 2017 Elsevier B.V. All rights reserved.

[Diagnostic performance of T-SPOT.TB on peripheral blood in combination with adenosine deaminase on pleural fluid for the diagnosis of tuberculous pleurisy within different age group].

PubMed

Xu, H Y; Zhang, D Q; Ye, J R; Su, S S; Xie, Y P; Chen, C S; Li, Y P

2017-06-27

Objective: To evaluate the performance of T cell enzyme-linked immuno-spot assay (T-SPOT) on peripheral blood in combination with adenosine deaminase (ADA) on pleural fluid for diagnosis of tuberculous (TB) pleurisy within different age groups. Methods: The data of patients with pleural effusion from the Department of Pulmonary and Critical Care Medicine of the First Affiliated Hospital of Wenzhou Medical University from April 2012 to November 2016 were retrospectively analyzed, and the diagnoses of these patients were histopathologically confirmed through medical thoracoscopy. The cases who had confirmed diagnosis, in the same time, received peripheral blood T-SPOT.TB were enrolled. The performance of peripheral blood T-SPOT.TB in combination with pleural fluid ADA on diagnosing TB pleurisy in the younger patients (16-59 years old) and elderly patients (≥60 years old) were analyzed respectively. The sensitivity, specificity and the receiver operating characteristic (ROC) curve were adopted for statistical analysis. Results: A total of 448 cases were finally enrolled, 341(76.1%) confirmed with TB pleurisy, 224 males, 117 females, (47±19) years old; and 107 (23.9%) classified as non-TB pleurisy, 65 males, 42 females, (61±14) years old. There were 285 cases who were classified as younger group, and the other 163 cases were classified as elderly group. The sensitivity and specificity of peripheral blood T-SPOT.TB were 85.4% (204/239) and 71.7% (33/46) in the younger patients, 76.5% (78/102) and 59.0% (36/61) respectively in the elderly patients. The sensitivity of peripheral blood T-SPOT.TB in the younger patients was significantly higher than that in the elderly patients ( P =0.047). The sensitivity and specificity were 99.2% and 95.7% in combination with peripheral blood T-SPOT.TB and pleural fluid ADA respectively in the younger patients. The area under ROC curve (AUC) of T-SPOT.TB in the younger patients was 0.833, AUC of T-SPOT.TB combined with ADA was 0.911. The combination test of 2 tests had the sensitivity of 96.1% and the specificity of 90.2% respectively in the elderly patients. The AUC of T-SPOT.TB in the elderly patients was 0.747, AUC of T-SPOT.TB combined with ADA was 0.911. Conclusion: Peripheral blood T-SPOT.TB combined with pleural fluid ADA can improve the diagnostic performance for TB pleurisy with different ages, especially for elderly patients who can't tolerate pleural biopsy.

Performance of Ultrasound in the Diagnosis of Gout in a Multicenter Study: Comparison With Monosodium Urate Monohydrate Crystal Analysis as the Gold Standard.

PubMed

Ogdie, Alexis; Taylor, William J; Neogi, Tuhina; Fransen, Jaap; Jansen, Tim L; Schumacher, H Ralph; Louthrenoo, Worawit; Vazquez-Mellado, Janitzia; Eliseev, Maxim; McCarthy, Geraldine; Stamp, Lisa K; Perez-Ruiz, Fernando; Sivera, Francisca; Ea, Hang-Korng; Gerritsen, Martijn; Cagnotto, Giovanni; Cavagna, Lorenzo; Lin, Chingtsai; Chou, Yin-Yi; Tausche, Anne-Kathrin; Lima Gomes Ochtrop, Manuella; Janssen, Matthijs; Chen, Jiunn-Horng; Slot, Ole; Lazovskis, Juris; White, Douglas; Cimmino, Marco A; Uhlig, Till; Dalbeth, Nicola

2017-02-01

To examine the performance of ultrasound (US) for the diagnosis of gout using the presence of monosodium urate monohydrate (MSU) crystals as the gold standard. We analyzed data from the Study for Updated Gout Classification Criteria (SUGAR), a large, multicenter observational cross-sectional study of consecutive subjects with at least 1 swollen joint who conceivably may have gout. All subjects underwent arthrocentesis; cases were subjects with confirmed MSU crystals. Rheumatologists or radiologists who were blinded with regard to the results of the MSU crystal analysis performed US on 1 or more clinically affected joints. US findings of interest were double contour sign, tophus, and snowstorm appearance. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Multivariable logistic regression models were used to examine factors associated with positive US results among subjects with gout. US was performed in 824 subjects (416 cases and 408 controls). The sensitivity, specificity, PPV, and NPV for the presence of any 1 of the features were 76.9%, 84.3%, 83.3%, and 78.2%, respectively. Sensitivity was higher among subjects with a disease duration of ≥2 years and among subjects with subcutaneous nodules on examination (suspected tophus). Associations with a positive US finding included suspected clinical tophus (odds ratio [OR] 4.77 [95% confidence interval (95% CI) 2.23-10.21]), any abnormality on plain radiography (OR 4.68 [95% CI 2.68-8.17]), and serum urate level (OR 1.31 [95% CI 1.06-1.62]). US features of MSU crystal deposition had high specificity and high PPV but more limited sensitivity for early gout. The specificity remained high in subjects with early disease and without clinical signs of tophi. © 2016, American College of Rheumatology.

Performance of Ultrasound in the Diagnosis of Gout in a Multi-Center Study: Comparison with Monosodium Urate Crystal Analysis as the Gold Standard

PubMed Central

Ogdie, Alexis; Taylor, William J; Neogi, Tuhina; Fransen, Jaap; Jansen, Tim L; Schumacher, H. Ralph; Louthrenoo, Worawit; Vazquez-Mellado, Janitzia; Eliseev, Maxim; McCarthy, Geraldine; Stamp, Lisa K.; Perez-Ruiz, Fernando; Sivera, Francisca; Ea, Hang-Korng; Gerritsen, Martijn; Cagnotto, Giovanni; Cavagna, Lorenzo; Lin, Chingtsai; Chou, Yin-Yi; Tausche, Anne-Kathrin; Ochtrop, Manuella Lima Gomes; Janssen, Matthijs; Chen, Jiunn-Horng; Slot, Ole; Lazovskis, Juris; White, Douglas; Cimmino, Marco A.; Uhlig, Till; Dalbeth, Nicola

2017-01-01

Objectives To examine the performance of ultrasound for the diagnosis of gout using presence of monosodium urate (MSU) crystals as the gold standard. Methods We analyzed data from the Study for Updated Gout Classification Criteria (SUGAR), a large, multi-center observational cross-sectional study of consecutive subjects with at least one swollen joint who conceivably may have gout. All subjects underwent arthrocentesis; cases were subjects with MSU crystal confirmation. Rheumatologists or radiologists, blinded to the results of the MSU crystal analysis, performed ultrasound on one or more clinically affected joints. Ultrasound findings of interest were: double contour sign (DCS), tophus, and ‘snowstorm’ appearance. Sensitivity, specificity, positive and negative predictive values (PPV and NPV) were calculated. Multivariable logistic regression models were used to examine factors associated with positive ultrasound results among subjects with gout. Results Ultrasound was performed in 824 subjects (416 cases and 408 controls). The sensitivity, specificity, PPV and NPV for the presence of any one of the features were 76.9%, 84.3%, 83.3% and 78.1% respectively. Sensitivity was higher among subjects with disease ≥2 years duration and among subjects with subcutaneous nodules on exam (suspected tophus). Associations with a positive ultrasound finding included suspected clinical tophus (odds ratio 4.77; 95% CI 2.23–10.21), any abnormal plain film radiograph (4.68; 2.68–8.17) and serum urate (1.31; 1.06–1.62). Conclusions Ultrasound features of MSU crystal deposition had high specificity and high positive predictive value but more limited sensitivity for early gout. The specificity remained high in subjects with early disease and without clinical signs of tophi. PMID:27748084

Comparative Evaluation of Preliminary Screening Methods for Colorectal Cancer in a Mass Program.

PubMed

Ye, Ding; Huang, Qiuchi; Li, Qilong; Jiang, Xiyi; Mamat, Mayila; Tang, Mengling; Wang, Jianbing; Chen, Kun

2017-09-01

The fecal immunochemical test (FIT) has been widely used in preliminary screening for colorectal cancer (CRC). The high-risk factor questionnaire (HRFQ) and quantitative risk-assessment method (QRAM) are recommended for estimating the risk of CRC qualitatively and quantitatively in China. We aimed to prospectively compare the diagnostic values of CRC preliminary screening methods to identify which method is preferable as a screening strategy. Individuals aged 40-74 years old were enrolled in a mass CRC screening program from January 1, 2007 to December 31, 2014, in Jiashan County, Zhejiang Province, China. FIT of two stool specimens at 1-week intervals was performed by laboratory personnel and face-to-face interviews were conducted by trained investigators. Screening data in the program were linked to a CRC surveillance and registry system, and CRC cases reported in the system were regarded as true patients. A total of 96,043 subjects were included. The sensitivity and specificity of FIT for detecting CRC cases were 75.49% (95% CI 69.84-80.39) and 90.36% (95% CI 90.17-90.54), respectively. QRAM was more sensitive (p < 0.001) and less specific (p < 0.001) than HRFQ. The sensitivity and specificity of FIT along with HRFQ were 86.56% (95% CI 81.81-90.22) and 81.37% (95% CI 81.12-81.62), and those of FIT along with QRAM were 88.93% (95% CI 84.47-92.23) and 73.95% (95% CI 73.67-74.23). Our findings suggest that CRC preliminary screening with FIT and QRAM in parallel has high sensitivity and satisfactory specificity, and is a useful strategy in mass screening programs.

Accuracy of a Mouse Bioassay for the Diagnosis of Botulism in Horses.

PubMed

Johnson, A L; McAdams-Gallagher, S C; Aceto, H

2016-07-01

The laboratory diagnosis of botulism in horses traditionally has relied upon the mouse bioassay (MBA). The accuracy of this test for the diagnosis of botulism in horses is unknown. Our goal was to determine the sensitivity, specificity, positive predictive value, and negative predictive value of the MBA on laboratory-processed fecal and gastrointestinal samples for foals and adult horses. Cases included all horses with a final clinical diagnosis of botulism that were admitted between 1986 and 2011 and had MBA testing performed. Controls included horses without botulism that were admitted during the same time period and had MBA testing performed. Retrospective study. Horses suspected of having botulism had fecal or (less commonly) gastrointestinal content samples tested using MBA. For every hospitalized botulism suspect, control samples were obtained from ≥1 additional hospitalized horses not suspected to have botulism. One hundred and twenty-nine adult horses and 253 adult controls were identified. Overall sensitivity of the MBA was only 32% but specificity was 97%. Forty-three foal cases and 21 foal controls were evaluated; sensitivity of the MBA was 53% and specificity was 100%. Positive predictive value was substantially higher (100% for foals and 89% for adults) than negative predictive value (51% for foals and 67% for adults). Mouse bioassay has low sensitivity but high specificity for the diagnosis of botulism in horses. Positive results are highly suggestive of botulism but negative results do not exclude the diagnosis. Unaffected horses and foals rarely shed C. botulinum in their feces. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Testing the woman abuse screening tool to identify intimate partner violence in Indonesia.

PubMed

Iskandar, Livia; Braun, Kathryn L; Katz, Alan R

2015-04-01

Intimate Partner Violence (IPV) is a global public health problem. IPV prevalence in Indonesia has been estimated to be less than 1%, based on reported cases. It is likely that IPV prevalence is underreported in Indonesia, as it is in many other countries. Screening for IPV has been found to increase IPV identification, but no screening tools are in use in Indonesia. The aim of this study was to test the translated Woman Abuse Screening Tool (WAST) for detecting IPV in Indonesia. The WAST was tested against a diagnostic interview by a trained psychologist on 240 women attending two Primary Health Centers in Jakarta. IPV prevalence and the reliability, sensitivity, and specificity of the WAST were estimated. Prevalence of IPV by diagnostic interview was 36.3%, much higher than published estimates. The most common forms of IPV identified were psychological (85%) and physical abuse (24%). Internal reliability of the WAST was high (α = .801). A WAST score of 13 (out of 24) is the recommended cutoff for identifying IPV, but only 17% of the Indonesian sample scored 13 or higher. Test sensitivity of the WAST with a cutoff score of 13 was only 41.9%, with a specificity of 96.8%. With a cutoff score of 10, the sensitivity improved to 84.9%, while the specificity decreased to 61.0%. Use of the WAST with a cutoff score of 10 provides good sensitivity and reasonable specificity and would provide a much-needed screening tool for use in Indonesia. Although a lower cutoff would yield a greater proportion of false positives, most of the true cases would be identified, increasing the possibility that women experiencing abuse would receive needed assistance. © The Author(s) 2014.

Diagnostic algorithm for detection of targetable driver mutations in lung adenocarcinomas: Comprehensive analyses of 205 cases with immunohistochemistry, real-time PCR and fluorescence in situ hybridization methods.

PubMed

Kao, Hua-Lin; Yeh, Yi-Chen; Lin, Chin-Hsuan; Hsu, Wei-Fang; Hsieh, Wen-Yu; Ho, Hsiang-Ling; Chou, Teh-Ying

2016-11-01

Analysis of the targetable driver mutations is now recommended in all patients with advanced lung adenocarcinoma. Molecular-based methods are usually adopted, however, along with the implementation of highly sensitive and/or mutation-specific antibodies, immunohistochemistry (IHC) has been considered an alternative method for identifying driver mutations in lung adenocarcinomas. A total of 205 lung adenocarcinomas were examined for EGFR mutations and ALK and ROS1 rearrangements using real-time PCR, fluorescence in situ hybridization (FISH) and IHC in parallel. The performance of different commercially available IHC antibody clones toward targetable driver mutations was evaluated. The association between these driver mutations and clinicopathological characteristics was also analyzed. In 205 cases we studied, 58.5% were found to harbor EGFR mutations, 6.3% ALK rearrangements and 1.0% ROS1 rearrangements. Compared to molecular-based methods, IHC of EGFR mutations showed an excellent specificity but the sensitivity is suboptimal, while IHC of ALK and ROS1 rearrangements demonstrated high sensitivity and specificity. No significant difference regarding the performance of different antibody clones toward these driver mutations was observed, except that clone SP125 showed a higher sensitivity than 43B2 in the detection of p.L858R of EGFR. In circumstances such as poor quality of nucleic acids or low content of tumor cells, IHC of EGFR mutation-specific antibodies could be used as an alternative method. Patients negative for EGFR mutations are subjected to further analysis on ALK and ROS1 rearrangements using IHC methods. Herein, we proposed a lung adenocarcinoma testing algorithm for the application of IHC in therapeutic diagnosis. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Sensitivity and Specificity of the Coma Recovery Scale--Revised Total Score in Detection of Conscious Awareness.

PubMed

Bodien, Yelena G; Carlowicz, Cecilia A; Chatelle, Camille; Giacino, Joseph T

2016-03-01

To describe the sensitivity and specificity of Coma Recovery Scale-Revised (CRS-R) total scores in detecting conscious awareness. Data were retrospectively extracted from the medical records of patients enrolled in a specialized disorders of consciousness (DOC) program. Sensitivity and specificity analyses were completed using CRS-R-derived diagnoses of minimally conscious state (MCS) or emerged from minimally conscious state (EMCS) as the reference standard for conscious awareness and the total CRS-R score as the test criterion. A receiver operating characteristic curve was constructed to demonstrate the optimal CRS-R total cutoff score for maximizing sensitivity and specificity. Specialized DOC program. Patients enrolled in the DOC program (N=252, 157 men; mean age, 49y; mean time from injury, 48d; traumatic etiology, n=127; nontraumatic etiology, n=125; diagnosis of coma or vegetative state, n=70; diagnosis of MCS or EMCS, n=182). Not applicable. Sensitivity and specificity of CRS-R total scores in detecting conscious awareness. A CRS-R total score of 10 or higher yielded a sensitivity of .78 for correct identification of patients in MCS or EMCS, and a specificity of 1.00 for correct identification of patients who did not meet criteria for either of these diagnoses (ie, were diagnosed with vegetative state or coma). The area under the curve in the receiver operating characteristic curve analysis is .98. A total CRS-R score of 10 or higher provides strong evidence of conscious awareness but resulted in a false-negative diagnostic error in 22% of patients who demonstrated conscious awareness based on CRS-R diagnostic criteria. A cutoff score of 8 provides the best balance between sensitivity and specificity, accurately classifying 93% of cases. The optimal total score cutoff will vary depending on the user's objective. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Prenatal diagnosis using polymerase chain reaction on amniotic fluid for congenital toxoplasmosis.

PubMed

Romand, S; Wallon, M; Franck, J; Thulliez, P; Peyron, F; Dumon, H

2001-02-01

To evaluate sensitivity, specificity, and predictive values of a prenatal amniotic fluid (AF) polymerase chain reaction (PCR) test for diagnosis of congenital toxoplasmosis. A multicenter prospective study was done on 271 women with proved primary Toxoplasma infection during pregnancy and who had amniocentesis for prenatal diagnosis by PCR. Live-born infants were eligible for analysis only if a serologic follow-up could assess a definitive infection status. Of the 270 evaluable cases, 75 were congenitally infected, 48 of whom had a positive PCR at prenatal diagnosis. Overall sensitivity of PCR on AF was estimated at 64% (95% confidence interval [CI] 53.1%, 74.9%), negative predictive value of 87.8% (95% CI 83.5%, 92.1%), whereas specificity and positive predictive value were 100% (95% CIs 98%, 100% and 92.3%, 100%, respectively). Among cases with congenital toxoplasmosis, there were no significant differences between those with positive or negative PCR with regard to median gestational age at maternal infection, interval between maternal infection and amniocentesis, or duration of treatment before amniocentesis. However, sensitivity of PCR was found to be significantly higher for maternal infections that occurred between 17 and 21 weeks' gestation (P <.02). A negative PCR of AF cannot rule out congenital infection. In this case, continuation of treatment with spiramycin combined with ultrasonographic follow-up and postnatal follow-up are warranted. Our results also suggest presumptive treatment combining pyrimethamine and sulfonamides in case of maternal infection occurring late in pregnancy.

Diagnostic Accuracy of Ascites Fluid Gross Appearance in Detection of Spontaneous Bacterial Peritonitis.

PubMed

Aminiahidashti, Hamed; Hosseininejad, Seyed Mohammad; Montazer, Hosein; Bozorgi, Farzad; Goli Khatir, Iraj; Jahanian, Fateme; Raee, Behnaz

2014-01-01

Spontaneous bacterial peritonitis (SBP) as a monomicrobial infection of ascites fluid is one of the most important causes of morbidity and mortality in cirrhotic patients. This study was aimed to determine the diagnostic accuracy of ascites fluid color in detection of SBP in cirrhotic cases referred to the emergency department. Cirrhotic patients referred to the ED for the paracentesis of ascites fluid were enrolled. For all studied patients, the results of laboratory analysis and gross appearance of ascites fluid registered and reviewed by two emergency medicine specialists. The sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ration of the ascites fluid gross appearance in detection of SBP were measured with 95% confidence interval. The present project was performed in 80 cirrhotic patients with ascites (52.5 female). The mean of the subjects' age was 56.25±12.21 years (35-81). Laboratory findings revealed SBP in 23 (29%) cases. Fifty nine (73%) cases had transparent ascites fluid appearance of whom 17 (29%) ones suffered from SBP. From 21 (26%) cases with opaque ascites appearance, 15 (71%) had SBP. The sensitivity and specificity of the ascites fluid appearance in detection of SBP were 46.88% (Cl: 30.87-63.55) and 87.50% (95% Cl: 75.3-94.14), respectively. It seems that the gross appearance of ascites fluid had poor diagnostic accuracy in detection of SBP and considering its low sensitivity, it could not be used as a good screening tool for this propose.

Evaluation of diagnostic value of CT scan, physical examination and ultrasound based on pathological findings in patients with pelvic masses.

PubMed

Firoozabadi, Razieh Dehghani; Karimi Zarchi, Mojgan; Mansurian, Hamid Reza; Moghadam, Bita Rafiei; Teimoori, Soraya; Naseri, Ali

2011-01-01

Because benign and malignant cervical and ovarian masses occur with different percentages in different age groups, the importance of primary diagnosis and selection of a suitable surgical procedure is underlined. Diagnosis of pelvic masses is carried out using ultrasound, physical examination, CT scan and MRI. The objective of this study is to evaluate the diagnostic value of CT scan in pelvic masses in comparison with physical examination-ultrasound based on pathology of the lesion in patients undergoing laparotomic surgery. This analytic-descriptive study focused on age, sonographic findings, physical examinations, CT scan and pathological findings in 139 patients with pelvic mass, gathered with questionnaires and statistically analayzed using the SPSS software programme. Of 139 patients with pelvic mass (patients aged from 17 to 75 years old), 62 (44%) cases were diagnosed as benign and 77 (55.4%) as malignant; among them malignant tratoma serocyst adenocarsinoma with 33 (23.7%) cases and benign myoma with 21 (15.2%) cases comprised the most frequent cases. The sensitivity and specificity of sonography-physical examination were 51.9% and 87.9% respectively and the sensitivity and specificity of CT scan images were 79.2% and 91.6% respectively. It was shown that CT scan images were more consistant with pathological findings in predicting appropriate surgical procedures than do sonography-physical examinations. The sensitivity of CT scan is far higher than that of sonography-physical examination in the diagnosis of pelvic mass malignancy.

Resisting majesty: Apis cerana, has lower antennal sensitivity and decreased attraction to queen mandibular pheromone than Apis mellifera

NASA Astrophysics Data System (ADS)

Dong, Shihao; Wen, Ping; Zhang, Qi; Li, Xinyu; Tan, Ken; Nieh, James

2017-03-01

In highly social bees, queen mandibular pheromone (QMP) is vital for colony life. Both Apis cerana (Ac) and Apis mellifera (Am) share an evolutionarily conserved set of QMP compounds: (E)-9-oxodec-2-enoic acid (9-ODA), (E)-9-hydroxydec-2-enoic acid (9-HDA), (E)-10-hydroxy-dec-2-enoic acid (10-HDA), 10-hydroxy-decanoic acid (10-HDAA), and methyl p-hydroxybenzoate (HOB) found at similar levels. However, evidence suggests there may be species-specific sensitivity differences to QMP compounds because Ac workers have higher levels of ovarian activation than Am workers. Using electroantennograms, we found species-specific sensitivity differences for a blend of the major QMP compounds and three individual compounds (9-HDA, 10-HDAA, and 10-HDA). As predicted, Am was more sensitive than Ac in all cases (1.3- to 2.7- fold higher responses). There were also species differences in worker retinue attraction to three compounds (9-HDA, HOB, and 10-HDA). In all significantly different cases, Am workers were 4.5- to 6.2-fold more strongly attracted than Ac workers were. Thus, Ac workers responded less strongly to QMP than Ac workers, and 9-HDA and 10-HDA consistently elicited stronger antennal and retinue formation responses.

Resisting majesty: Apis cerana, has lower antennal sensitivity and decreased attraction to queen mandibular pheromone than Apis mellifera.

PubMed

Dong, Shihao; Wen, Ping; Zhang, Qi; Li, Xinyu; Tan, Ken; Nieh, James

2017-03-15

In highly social bees, queen mandibular pheromone (QMP) is vital for colony life. Both Apis cerana (Ac) and Apis mellifera (Am) share an evolutionarily conserved set of QMP compounds: (E)-9-oxodec-2-enoic acid (9-ODA), (E)-9-hydroxydec-2-enoic acid (9-HDA), (E)-10-hydroxy-dec-2-enoic acid (10-HDA), 10-hydroxy-decanoic acid (10-HDAA), and methyl p-hydroxybenzoate (HOB) found at similar levels. However, evidence suggests there may be species-specific sensitivity differences to QMP compounds because Ac workers have higher levels of ovarian activation than Am workers. Using electroantennograms, we found species-specific sensitivity differences for a blend of the major QMP compounds and three individual compounds (9-HDA, 10-HDAA, and 10-HDA). As predicted, Am was more sensitive than Ac in all cases (1.3- to 2.7- fold higher responses). There were also species differences in worker retinue attraction to three compounds (9-HDA, HOB, and 10-HDA). In all significantly different cases, Am workers were 4.5- to 6.2-fold more strongly attracted than Ac workers were. Thus, Ac workers responded less strongly to QMP than Am workers, and 9-HDA and 10-HDA consistently elicited stronger antennal and retinue formation responses [corrected].

Increased sensitivity of prolonged P-wave during exercise stress test in detection of angiographically documented coronary artery disease.

PubMed

Wsol, Agnieszka; Wydra, Wioletta; Chmielewski, Marek; Swiatowiec, Andrzej; Kuch, Marek

2017-01-01

A retrospective study was designed to investigate P-wave duration changes in exercise stress test (EST) for the prediction of angiographically documented substantial coronary artery disease (CAD). We analyzed 265 cases of patients, who underwent EST and subsequently coronary angiography. Analysis of P-wave duration was performed in leads II, V5 at rest, and in the recovery period. The sensitivity and specificity for the isolated ST-segment depression were only 31% and 76%, respectively. The combination of ST-depression with other exercise-induced clinical and electrocardio-graphic abnormalities (chest pain, ventricular arrhythmia, hypotension, left bundle branch block) was characterized by 41% sensitivity and 69% specificity. The combination of abnormal recovery P-wave duration (≥ 120 ms) with ST-depression and other exercise-induced abnormalities had 83% sensitivity but only 20% specificity. Combined analysis of increased delta P-wave duration, ST-depression and other exercise-induced abnormalities had 69% sensitivity and 42% specificity. Sensitivity and specificity of the increase in delta P-wave duration for left CAD was 69% and 47%, respectively, and for 3-vessel CAD 70% and 50%, respectively. The presence of arterial hypertension negatively influenced the prog-nostic value of P-wave changes in the stress test. The results of the study show that an addition of P-wave duration changes assessment to ST-depression analysis and other exercise-induced abnormalities increase sensitivity of EST, especially for left CAD and 3-vessel coronary disease. We have also provided evidence for the negative influence of the presence of arterial hypertension on the predictive value of P-wave changes in the stress test. (Cardiol J 2017; 24, 2: 159-166).

[Optimized application of nested PCR method for detection of malaria].

PubMed

Yao-Guang, Z; Li, J; Zhen-Yu, W; Li, C

2017-04-28

Objective To optimize the application of the nested PCR method for the detection of malaria according to the working practice, so as to improve the efficiency of malaria detection. Methods Premixing solution of PCR, internal primers for further amplification and new designed primers that aimed at two Plasmodium ovale subspecies were employed to optimize the reaction system, reaction condition and specific primers of P . ovale on basis of routine nested PCR. Then the specificity and the sensitivity of the optimized method were analyzed. The positive blood samples and examination samples of malaria were detected by the routine nested PCR and the optimized method simultaneously, and the detection results were compared and analyzed. Results The optimized method showed good specificity, and its sensitivity could reach the pg to fg level. The two methods were used to detect the same positive malarial blood samples simultaneously, the results indicated that the PCR products of the two methods had no significant difference, but the non-specific amplification reduced obviously and the detection rates of P . ovale subspecies improved, as well as the total specificity also increased through the use of the optimized method. The actual detection results of 111 cases of malarial blood samples showed that the sensitivity and specificity of the routine nested PCR were 94.57% and 86.96%, respectively, and those of the optimized method were both 93.48%, and there was no statistically significant difference between the two methods in the sensitivity ( P > 0.05), but there was a statistically significant difference between the two methods in the specificity ( P < 0.05). Conclusion The optimized PCR can improve the specificity without reducing the sensitivity on the basis of the routine nested PCR, it also can save the cost and increase the efficiency of malaria detection as less experiment links.

Detection of LipL32-specific IgM by ELISA in sera of patients with a clinical diagnosis of leptospirosis

PubMed Central

Vedhagiri, Kumaresan; Velineni, Sridhar; Timoney, John F; Shanmughapriya, Santhanam; Vijayachari, Paluru; Narayanan, Ramasamy; Natarajaseenivasan, Kalimuthusamy

2013-01-01

Successful treatment of leptospirosis is heavily dependent on early diagnosis and prompt initiation of antibiotic therapy. An ELISA test to detect specific IgM antibodies against LipL32 for early diagnosis of leptospirosis is described and evaluated here. One thousand one hundred and eighty sera from clinically suspected leptospirosis cases were enrolled together with 109 healthy volunteers selected from an endemic area between October 2007 and January 2010. Patients were categorized based on their clinical signs and symptoms. Sera were screened for leptospiral antibodies by the microscopic agglutination test (MAT) using a panel of locally circulating serovars followed by enzyme-linked immunosorbent assay (ELISA) based on recombinant LipL32 from Leptospira interrogans serovar Autumnalis strain N2. The sensitivity and specificity of the ELISA test were determined to establish its diagnostic efficiency. The cut-off value was determined to be 0.205. Overall sensitivity and specificity compared to the MAT were found to be 96.4 and 90.4%, respectively. The LipL32-specific IgM ELISA had good sensitivity and acceptable specificity and may be a candidate for the early serodiagnosis of human leptospirosis. PMID:23683367

Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome.

PubMed

Sjoding, Michael W; Schoenfeld, David A; Brown, Samuel M; Hough, Catherine L; Yealy, Donald M; Moss, Marc; Angus, Derek C; Iwashyna, Theodore J

2017-01-01

After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT's power to measure significant differences in these outcomes is poorly understood. Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes. We derived a general formula and Stata code for calculating an RCT's power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress-like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT ( www.clinicaltrials.gov identifier NCT02509078). On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity. Examining instruments' power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities.

Evaluation of a New Immunochromatography Technology Test (LDBio Diagnostics) To Detect Toxoplasma IgG and IgM: Comparison with the Routine Architect Technique

PubMed Central

Flori, Pierre; Delaunay, Edouard; Guillerme, Cécile; Charaoui, Sana; Raberin, Hélène; Hafid, Jamal; L'Ollivier, Coralie

2017-01-01

ABSTRACT A study comparing the ICT (immunochromatography technology) Toxoplasma IgG and IgM rapid diagnostic test (LDBio Diagnostics, France) with a fully automated system, Architect, was performed on samples from university hospitals of Marseille and Saint-Etienne. A total of 767 prospective sera and 235 selected sera were collected. The panels were selected to test various IgG and IgM parameters. The reference technique, Toxoplasma IgGII Western blot analysis (LDBio Diagnostics), was used to confirm the IgG results, and commercial kits Platelia Toxo IgM (Bio-Rad) and Toxo-ISAgA (bioMérieux) were used in Saint-Etienne and Marseille, respectively, as the IgM reference techniques. Sensitivity and specificity of the ICT and the Architect IgG assays were compared using a prospective panel. Sensitivity was 100% for the ICT test and 92.1% for Architect (cutoff at 1.6 IU/ml). The low-IgG-titer serum results confirmed that ICT sensitivity was superior to that of Architect. Specificity was 98.7% (ICT) and 99.8% (Architect IgG). The ICT test is also useful for detecting IgM without IgG and is both sensitive (100%) and specific (100%), as it can distinguish nonspecific IgM from specific Toxoplasma IgM. In comparison, IgM sensitivity and specificity on Architect are 96.1% and 99.6%, respectively (cutoff at 0.5 arbitrary units [AU]/ml). To conclude, this new test overcomes the limitations of automated screening techniques, which are not sensitive enough for IgG and lack specificity for IgM (rare IgM false-positive cases). PMID:28954897

Verification bias: an under-recognized source of error in assessing the efficacy of MRI of the meniscii.

PubMed

Richardson, Michael L; Petscavage, Jonelle M

2011-11-01

The sensitivity and specificity of magnetic resonance imaging (MRI) for diagnosis of meniscal tears has been studied extensively, with tears usually verified by surgery. However, surgically unverified cases are often not considered in these studies, leading to verification bias, which can falsely increase the sensitivity and decrease the specificity estimates. Our study suggests that such bias may be very common in the meniscal MRI literature, and illustrates techniques to detect and correct for such bias. PubMed was searched for articles estimating sensitivity and specificity of MRI for meniscal tears. These were assessed for verification bias, deemed potentially present if a study included any patients whose MRI findings were not surgically verified. Retrospective global sensitivity analysis (GSA) was performed when possible. Thirty-nine of the 314 studies retrieved from PubMed specifically dealt with meniscal tears. All 39 included unverified patients, and hence, potential verification bias. Only seven articles included sufficient information to perform GSA. Of these, one showed definite verification bias, two showed no bias, and four others showed bias within certain ranges of disease prevalence. Only 9 of 39 acknowledged the possibility of verification bias. Verification bias is underrecognized and potentially common in published estimates of the sensitivity and specificity of MRI for the diagnosis of meniscal tears. When possible, it should be avoided by proper study design. If unavoidable, it should be acknowledged. Investigators should tabulate unverified as well as verified data. Finally, verification bias should be estimated; if present, corrected estimates of sensitivity and specificity should be used. Our online web-based calculator makes this process relatively easy. Copyright © 2011 AUR. Published by Elsevier Inc. All rights reserved.

Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome

PubMed Central

Schoenfeld, David A.; Brown, Samuel M.; Hough, Catherine L.; Yealy, Donald M.; Moss, Marc; Angus, Derek C.; Iwashyna, Theodore J.

2017-01-01

Rationale: After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT’s power to measure significant differences in these outcomes is poorly understood. Objectives: Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes. Methods: We derived a general formula and Stata code for calculating an RCT’s power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress–like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT (www.clinicaltrials.gov identifier NCT02509078). Measurements and Main Results: On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity. Conclusions: Examining instruments’ power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities. PMID:27788018

Multi-test cervical cancer diagnosis with missing data estimation

NASA Astrophysics Data System (ADS)

Xu, Tao; Huang, Xiaolei; Kim, Edward; Long, L. Rodney; Antani, Sameer

2015-03-01

Cervical cancer is a leading most common type of cancer for women worldwide. Existing screening programs for cervical cancer suffer from low sensitivity. Using images of the cervix (cervigrams) as an aid in detecting pre-cancerous changes to the cervix has good potential to improve sensitivity and help reduce the number of cervical cancer cases. In this paper, we present a method that utilizes multi-modality information extracted from multiple tests of a patient's visit to classify the patient visit to be either low-risk or high-risk. Our algorithm integrates image features and text features to make a diagnosis. We also present two strategies to estimate the missing values in text features: Image Classifier Supervised Mean Imputation (ICSMI) and Image Classifier Supervised Linear Interpolation (ICSLI). We evaluate our method on a large medical dataset and compare it with several alternative approaches. The results show that the proposed method with ICSLI strategy achieves the best result of 83.03% specificity and 76.36% sensitivity. When higher specificity is desired, our method can achieve 90% specificity with 62.12% sensitivity.

Laboratory evaluation of 3M Petrifilms and University of Minnesota Bi-plates as potential on-farm tests for clinical mastitis.

PubMed

McCarron, J L; Keefe, G P; McKenna, S L B; Dohoo, I R; Poole, D E

2009-05-01

The objective was to determine test characteristics and compare 2 potential on-farm culture systems for clinical mastitis, the Minnesota Easy Culture System II Bi-plate and Petrifilm. The tests were evaluated using clinically positive mastitic milk samples (n = 282) to determine their ability to differentiate appropriate treatment groups; all cases that had gram-positive growth were considered treatment candidates (n = 161), whereas cases that grew gram-negative organisms only or yielded no bacterial growth were classified as no treatment (n = 121). For Petrifilm, both undiluted and 1:10 diluted milk samples were used. To create treatment categories, 2 types of Petrifilms were used, Aerobic Count (AC) and Coliform Count (CC). Both Bi-plates and Petrifilms were read after 24 h of incubation. Analysis was conducted at various colony count thresholds for the Petrifilm test system. The combination of Petrifilms that had the highest sensitivity classified a case as gram-negative if there were > or =20 colonies present on the CC. If there were <20 colonies present on the CC and >5 colonies present on the AC, a case would be classified as gram-positive. The Bi-plate had a sensitivity of 97.9% and a specificity of 68.6%. The Petrifilm test system had a sensitivity of 93.8% and a specificity of 70.1%. There was no significant difference in the sensitivities between the tests. All Bi-plates and Petrifilms were read by a laboratory technician and a group of masked readers with limited microbiology training. Kappa values for the masked readers were 0.75 for Bi-plates and 0.84 and 0.86 for AC and CC Petrifilms, respectively. The Bi-plate and Petrifilm were able to successfully categorize clinical cases of mastitis into 2 treatments based on their ability to detect the presence of a gram-positive organism. Neither method had the ability to determine if a sample was contaminated. The results of this study indicate that both tests were able to appropriately categorize cases, which could potentially result in a reduction in the quantity of antibiotics used to treat clinical cases of mastitis.

FLOCK cluster analysis of mast cell event clustering by high-sensitivity flow cytometry predicts systemic mastocytosis.

PubMed

Dorfman, David M; LaPlante, Charlotte D; Pozdnyakova, Olga; Li, Betty

2015-11-01

In our high-sensitivity flow cytometric approach for systemic mastocytosis (SM), we identified mast cell event clustering as a new diagnostic criterion for the disease. To objectively characterize mast cell gated event distributions, we performed cluster analysis using FLOCK, a computational approach to identify cell subsets in multidimensional flow cytometry data in an unbiased, automated fashion. FLOCK identified discrete mast cell populations in most cases of SM (56/75 [75%]) but only a minority of non-SM cases (17/124 [14%]). FLOCK-identified mast cell populations accounted for 2.46% of total cells on average in SM cases and 0.09% of total cells on average in non-SM cases (P < .0001) and were predictive of SM, with a sensitivity of 75%, a specificity of 86%, a positive predictive value of 76%, and a negative predictive value of 85%. FLOCK analysis provides useful diagnostic information for evaluating patients with suspected SM, and may be useful for the analysis of other hematopoietic neoplasms. Copyright© by the American Society for Clinical Pathology.

Clinical and laboratory features of urinary tract infections in young infants.

PubMed

Lo, Denise Swei; Rodrigues, Larissa; Koch, Vera Hermina Kalika; Gilio, Alfredo Elias

2018-04-26

Urinary tract infection (UTI) is the most common serious bacterial infection in young infants. Signs and symptoms are often nonspecific. To describe clinical, demographic and laboratory features of UTI in infants ≤ 3 months old. Cross-sectional study of infants ≤ 3 months old with UTI diagnosed in a pediatric emergency department, for the period 2010-2012. UTI was defined as ≥ 50,000 colony-forming units per milliliter of a single uropathogen isolated from bladder catheterization. Paired urinalysis and urine culture from group culture-positive and group culture-negative were used to determine the sensitivity and specificity of pyuria and nitrite tests in detecting UTI. Of 519 urine cultures collected, UTI was diagnosed in 65 cases (prevalence: 12.5%); with male predominance (77%). The most common etiologies were Escherichia coli (56.9%), Klebsiella pneumoniae (18.5%) and Enterococcus faecalis (7.7%). Frequent clinical manifestations were fever (77.8%), irritability (41.4%) and vomiting (25.4%). The median temperature was 38.7°C. The sensitivity of the nitrite test was 30.8% (95%CI:19.9-43.4%), specificity of 100% (95%CI:99.2-100%). Pyuria ≥ 10,000/mL had a sensitivity of 87.7% (95%CI:77.2-94.5%), specificity of 74.9% (95%CI:70.6 -78.8%). The median peripheral white blood cell count was 13,150/mm3; C-reactive protein levels were normal in 30.5% of cases. The male: female ratio for urinary tract infection was 3.3:1. Non-Escherichia coli etiologies should be considered in empirical treatment. Fever was the main symptom. Positive nitrite is highly suggestive of UTI but has low sensitivity; whereas pyuria ≥ 10,000/mL revealed good sensitivity, but low specificity. Peripheral white blood cell count and C-reactive protein concentration have limited usefulness to suggest UTI.

Clinical and laboratory features of urinary tract infections in young infants.

PubMed

Lo, Denise Swei; Rodrigues, Larissa; Koch, Vera Hermina Kalika; Gilio, Alfredo Elias

2018-01-01

Urinary tract infection (UTI) is the most common serious bacterial infection in young infants. Signs and symptoms are often nonspecific. To describe clinical, demographic and laboratory features of UTI in infants ≤ 3 months old. Cross-sectional study of infants ≤ 3 months old with UTI diagnosed in a pediatric emergency department, for the period 2010-2012. UTI was defined as ≥ 50,000 colony-forming units per milliliter of a single uropathogen isolated from bladder catheterization. Paired urinalysis and urine culture from group culture-positive and group culture-negative were used to determine the sensitivity and specificity of pyuria and nitrite tests in detecting UTI. Of 519 urine cultures collected, UTI was diagnosed in 65 cases (prevalence: 12.5%); with male predominance (77%). The most common etiologies were Escherichia coli (56.9%), Klebsiella pneumoniae (18.5%) and Enterococcus faecalis (7.7%). Frequent clinical manifestations were fever (77.8%), irritability (41.4%) and vomiting (25.4%). The median temperature was 38.7°C. The sensitivity of the nitrite test was 30.8% (95%CI:19.9-43.4%), specificity of 100% (95%CI:99.2-100%). Pyuria ≥ 10,000/mL had a sensitivity of 87.7% (95%CI:77.2-94.5%), specificity of 74.9% (95%CI:70.6 -78.8%). The median peripheral white blood cell count was 13,150/mm3; C-reactive protein levels were normal in 30.5% of cases. The male: female ratio for urinary tract infection was 3.3:1. Non-Escherichia coli etiologies should be considered in empirical treatment. Fever was the main symptom. Positive nitrite is highly suggestive of UTI but has low sensitivity; whereas pyuria ≥ 10,000/mL revealed good sensitivity, but low specificity. Peripheral white blood cell count and C-reactive protein concentration have limited usefulness to suggest UTI.

Discrimination of skin sensitizers from non-sensitizers by interleukin-1α and interleukin-6 production on cultured human keratinocytes.

PubMed

Jung, Daun; Che, Jeong-Hwan; Lim, Kyung-Min; Chun, Young-Jin; Heo, Yong; Seok, Seung Hyeok

2016-09-01

In vitro testing methods for classifying sensitizers could be valuable alternatives to in vivo sensitization testing using animal models, such as the murine local lymph node assay (LLNA) and the guinea pig maximization test (GMT), but there remains a need for in vitro methods that are more accurate and simpler to distinguish skin sensitizers from non-sensitizers. Thus, the aim of our study was to establish an in vitro assay as a screening tool for detecting skin sensitizers using the human keratinocyte cell line, HaCaT. HaCaT cells were exposed to 16 relevant skin sensitizers and 6 skin non-sensitizers. The highest dose used was the dose causing 75% cell viability (CV75) that we determined by an MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide] assay. The levels of extracellular production of interleukin-1α (IL-1α) and IL-6 were measured. The sensitivity of IL-1α was 63%, specificity was 83% and accuracy was 68%. In the case of IL-6, sensitivity: 69%, specificity: 83% and accuracy: 73%. Thus, this study suggests that measuring extracellular production of pro-inflammatory cytokines IL-1α and IL-6 by human HaCaT cells may potentially classify skin sensitizers from non-sensitizers. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Validity of early parathyroid hormone assay as a diagnostic tool for sub-total thyroidectomy related hypocalcaemia.

PubMed

Riaz, Umbreen; Shah, Syed Aslam; Zahoor, Imran; Riaz, Arsalan; Zubair, Muhammad

2014-07-01

To determine the validity of early (one hour postoperatively) parathyroid hormone (PTH) assay (² 10 pg/ml), keeping gold standard as the serum ionic calcium level, for predicting sub-total thyroidectomy-related hypocalcaemia and to calculate the sensitivity and specificity of latent signs of tetany. Cross-sectional validation study. Department of General Surgery, Pakistan Institute of Medical Sciences, Islamabad from August 2008 to August 2010. Patients undergoing sub-total thyroidectomy were included by convenience sampling. PTH assay was performed 1 hour post sub-total thyroidectomy. Serum calcium levels were performed at 24 and 48 hours, 5th day and 2 weeks after surgery. Cases that developed hypocalcaemia were followed-up for a period of 6 months with monthly calcium level estimation to identify cases of permanent hypocalcaemia. Symptoms and signs of hypocalcaemia manifesting in our patients were recorded. Data was analyzed through SPSS version 10. 2 x 2 tables were used to calculate sensitivity and specificity of PTH in detecting post-thyroidectomy hypocalcaemia. Out of a total of 110 patients included in the study, 16.36% (n=18) developed hypocalcaemia including 1.81% (n=2) cases of permanent hypoparathyroidism. The sensitivity of one hour postoperative PTH assay as a predictive tool for post-thyroidectomy related hypocalcaemia was 94.4% while its specificity was 83.6% with 53% positive predictive value and 98.7% negative predictive value. One hour post sub-total thyroidectomy PTH assay can be helpful in predicting post sub-total thyroidectomy hypocalcaemia. Moreover, it can be useful in safe discharge of day-care thyroidectomy patients.

Investigation of occupational asthma: Do clinicians fail to identify relevant occupational exposures?

PubMed Central

de Olim, Carlo; Bégin, Denis; Boulet, Louis-Philippe; Cartier, André; Gérin, Michel; Lemière, Catherine

2015-01-01

BACKGROUND: Specific inhalation challenges (SIC) enable the identification of the agent responsible of occupational asthma (OA). A clinician may fail to identify a specific agent in the workplace, which may potentially lead to a misdiagnosis. The expert assessment method performed by an occupational hygienist has been used to evaluate occupational exposures in epidemiological studies. OBJECTIVE: The broad aim of the present study was to evaluate the contribution of an expert assessment performed by an occupational hygienist to the diagnosis of OA. The specific aim was to compare work-place exposures identified by an occupational hygienist and by chest physicians in subjects with positive SICs and subjects with asthma, but with a negative SIC. METHODS: SICs were performed in 120 cases: 67 were positive and 53 were negative. A clinician assessed occupational exposures to sensitizers during a routine clinical evaluation preceding the performance of the SIC. An expert assessment of occupational exposures was performed by an occupational hygienist blind to the result of the SIC. RESULTS: The occupational hygienist identified the causal agent in 96.7% of the 61 cases of positive SIC. In 33 (62.3%) cases of negative SICs, the occupational hygienist identified ≥1 sensitizing agent(s) that had not been identified by the clinician. CONCLUSION: The hygienist identified the causal agent in almost all subjects with OA. In contrast, the clinician failed to identify potential exposures to sensitizers in >60% of the negative SIC subjects, which may have resulted in some subjects being misdiagnosed as not having OA. PMID:26422401

Evaluation of IOTA Simple Ultrasound Rules to Distinguish Benign and Malignant Ovarian Tumours

PubMed Central

Kaur, Amarjit; Mohi, Jaswinder Kaur; Sibia, Preet Kanwal; Kaur, Navkiran

2017-01-01

Introduction IOTA stands for International Ovarian Tumour Analysis group. Ovarian cancer is one of the common cancers in women and is diagnosed at later stage in majority. The limiting factor for early diagnosis is lack of standardized terms and procedures in gynaecological sonography. Introduction of IOTA rules has provided some consistency in defining morphological features of ovarian masses through a standardized examination technique. Aim To evaluate the efficacy of IOTA simple ultrasound rules in distinguishing benign and malignant ovarian tumours and establishing their use as a tool in early diagnosis of ovarian malignancy. Materials and Methods A hospital based case control prospective study was conducted. Patients with suspected ovarian pathology were evaluated using IOTA ultrasound rules and designated as benign or malignant. Findings were correlated with histopathological findings. Collected data was statistically analysed using chi-square test and kappa statistical method. Results Out of initial 55 patients, 50 patients were included in the final analysis who underwent surgery. IOTA simple rules were applicable in 45 out of these 50 patients (90%). The sensitivity for the detection of malignancy in cases where IOTA simple rules were applicable was 91.66% and the specificity was 84.84%. Accuracy was 86.66%. Classifying inconclusive cases as malignant, the sensitivity and specificity was 93% and 80% respectively. High level of agreement was found between USG and histopathological diagnosis with Kappa value as 0.323. Conclusion IOTA simple ultrasound rules were highly sensitive and specific in predicting ovarian malignancy preoperatively yet being reproducible, easy to train and use. PMID:28969237

Impact of different study populations on reader behavior and performance metrics: initial results

NASA Astrophysics Data System (ADS)

Gallas, Brandon D.; Pisano, Etta; Cole, Elodia; Myers, Kyle

2017-03-01

The FDA recently completed a study on design methodologies surrounding the Validation of Imaging Premarket Evaluation and Regulation called VIPER. VIPER consisted of five large reader sub-studies to compare the impact of different study populations on reader behavior as seen by sensitivity, specificity, and AUC, the area under the ROC curve (receiver operating characteristic curve). The study investigated different prevalence levels and two kinds of sampling of non-cancer patients: a screening population and a challenge population. The VIPER study compared full-field digital mammography (FFDM) to screenfilm mammography (SFM) for women with heterogeneously dense or extremely dense breasts. All cases and corresponding images were sampled from Digital Mammographic Imaging Screening Trial (DMIST) archives. There were 20 readers (American Board Certified radiologists) for each sub-study, and instead of every reader reading every case (fully-crossed study), readers and cases were split into groups to reduce reader workload and the total number of observations (split-plot study). For data collection, readers first decided whether or not they would recall a patient. Following that decision, they provided an ROC score for how close or far that patient was from the recall decision threshold. Performance results for FFDM show that as prevalence increases to 50%, there is a moderate increase in sensitivity and decrease in specificity, whereas AUC is mainly flat. Regarding precision, the statistical efficiency (ratio of variances) of sensitivity and specificity relative to AUC are 0.66 at best and decrease with prevalence. Analyses comparing modalities and the study populations (screening vs. challenge) are still ongoing.

Impact of Different Study Populations on Reader Behavior and Performance Metrics: Initial Results

PubMed Central

Gallas, Brandon D.; Pisano, Etta; Cole, Elodia; Myers, Kyle

2017-01-01

The FDA recently completed a study on design methodologies surrounding the Validation of Imaging Premarket Evaluation and Regulation called VIPER. VIPER consisted of five large reader sub-studies to compare the impact of different study populations on reader behavior as seen by sensitivity, specificity, and AUC, the area under the ROC curve (receiver operating characteristic curve). The study investigated different prevalence levels and two kinds of sampling of non-cancer patients: a screening population and a challenge population. The VIPER study compared full-field digital mammography (FFDM) to screen-film mammography (SFM) for women with heterogeneously dense or extremely dense breasts. All cases and corresponding images were sampled from Digital Mammographic Imaging Screening Trial (DMIST) archives. There were 20 readers (American Board Certified radiologists) for each sub-study, and instead of every reader reading every case (fully-crossed study), readers and cases were split into groups to reduce reader workload and the total number of observations (split-plot study). For data collection, readers first decided whether or not they would recall a patient. Following that decision, they provided an ROC score for how close or far that patient was from the recall decision threshold. Performance results for FFDM show that as prevalence increases to 50%, there is a moderate increase in sensitivity and decrease in specificity, whereas AUC is mainly flat. Regarding precision, the statistical efficiency (ratio of variances) of sensitivity and specificity relative to AUC are 0.66 at best and decrease with prevalence. Analyses comparing modalities and the study populations (screening vs. challenge) are still ongoing. PMID:28845078

Sensitivity analysis of the add-on price estimate for the silicon web growth process

NASA Technical Reports Server (NTRS)

Mokashi, A. R.

1981-01-01

The web growth process, a silicon-sheet technology option, developed for the flat plate solar array (FSA) project, was examined. Base case data for the technical and cost parameters for the technical and commercial readiness phase of the FSA project are projected. The process add on price, using the base case data for cost parameters such as equipment, space, direct labor, materials and utilities, and the production parameters such as growth rate and run length, using a computer program developed specifically to do the sensitivity analysis with improved price estimation are analyzed. Silicon price, sheet thickness and cell efficiency are also discussed.

Validity of a computerized population registry of dementia based on clinical databases.

PubMed

Mar, J; Arrospide, A; Soto-Gordoa, M; Machón, M; Iruin, Á; Martinez-Lage, P; Gabilondo, A; Moreno-Izco, F; Gabilondo, A; Arriola, L

2018-05-08

The handling of information through digital media allows innovative approaches for identifying cases of dementia through computerized searches within the clinical databases that include systems for coding diagnoses. The aim of this study was to analyze the validity of a dementia registry in Gipuzkoa based on the administrative and clinical databases existing in the Basque Health Service. This is a descriptive study based on the evaluation of available data sources. First, through review of medical records, the diagnostic validity was evaluated in 2 samples of cases identified and not identified as dementia. The sensitivity, specificity and positive and negative predictive value of the diagnosis of dementia were measured. Subsequently, the cases of living dementia in December 31, 2016 were searched in the entire Gipuzkoa population to collect sociodemographic and clinical variables. The validation samples included 986 cases and 327 no cases. The calculated sensitivity was 80.2% and the specificity was 99.9%. The negative predictive value was 99.4% and positive value was 95.1%. The cases in Gipuzkoa were 10,551, representing 65% of the cases predicted according to the literature. Antipsychotic medication were taken by a 40% and a 25% of the cases were institutionalized. A registry of dementias based on clinical and administrative databases is valid and feasible. Its main contribution is to show the dimension of dementia in the health system. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Mortality among PCR negative admitted Ebola suspects during the 2014/15 outbreak in Conakry, Guinea: A retrospective cohort study.

PubMed

Ingelbeen, Brecht; Bah, Elhadj Ibrahima; Decroo, Tom; Balde, Idrissa; Nordenstedt, Helena; van Griensven, Johan; De Weggheleire, Anja

2017-01-01

Non-cases are suspect Ebola Virus Disease (EVD) cases testing negative by EVD RT-PCR after admission to an Ebola Treatment Centre (ETC). Admitting non-cases to an ETC prompts concerns on case- and workload in the ETC, risk for nosocomial EVD infection, and delays in diagnosis and disease-specific treatment. We retrospectively analysed characteristics, outcomes and determinants of death of EVD cases and non-cases admitted to the Conakry ETC in Guinea between 03/2014 and 09/2015. Of the 2362 admitted suspects who underwent full confirmatory PCR testing, 1540 (65.2%) were non-cases; among them 727 needed repeated confirmatory PCR testing resulting in 2.5 days (average) in the ETC isolation ward. Twenty-one patients tested positive on the repeat test, most in a period of flawed sampling for the initial test and none after introduction of PCR confirmation with geneXpert. No readmissions following nosocomial EVD infection were recorded. No combination of symptoms yielded acceptable sensitivity and specificity to allow differentiating confirmed from non-cases. Symptoms as ocular bleeding/redness have high specificity, but limited usefulness as not common. Admission delay and age distribution were not different for both groups. In total, 98 (20.6%) of 475 deaths in the ETC were non-cases. Most died within 24 hours after admission. Living in Conakry (aOR 1.78 (1.08-2.96)) was the strongest risk factor for death. Weeks with higher admission load had lower case fatality among non-cases, probably because more acute (and treatable) illnesses of contacts of known cases were admitted. These findings show high numbers of potentially critically ill non-cases need to be considered when setting up triage and referral of EVD suspect cases. Symptoms and risk factors alone do not allow differentiating the non-cases. Integration of highly-sensitive EVD diagnostic methods with short turnaround time in the triage of peripheral hospitals and dropping the systematic 2nd PCR for symptomatic early presenters could limit delays in access to adapted care of cases and seriously ill non-cases. Whether feasible without compromising outbreak control, and under which conditions, should be further assessed.

Mortality among PCR negative admitted Ebola suspects during the 2014/15 outbreak in Conakry, Guinea: A retrospective cohort study

PubMed Central

Bah, Elhadj Ibrahima; Decroo, Tom; Balde, Idrissa; Nordenstedt, Helena; van Griensven, Johan; De Weggheleire, Anja

2017-01-01

Non-cases are suspect Ebola Virus Disease (EVD) cases testing negative by EVD RT-PCR after admission to an Ebola Treatment Centre (ETC). Admitting non-cases to an ETC prompts concerns on case- and workload in the ETC, risk for nosocomial EVD infection, and delays in diagnosis and disease-specific treatment. We retrospectively analysed characteristics, outcomes and determinants of death of EVD cases and non-cases admitted to the Conakry ETC in Guinea between 03/2014 and 09/2015. Of the 2362 admitted suspects who underwent full confirmatory PCR testing, 1540 (65.2%) were non-cases; among them 727 needed repeated confirmatory PCR testing resulting in 2.5 days (average) in the ETC isolation ward. Twenty-one patients tested positive on the repeat test, most in a period of flawed sampling for the initial test and none after introduction of PCR confirmation with geneXpert. No readmissions following nosocomial EVD infection were recorded. No combination of symptoms yielded acceptable sensitivity and specificity to allow differentiating confirmed from non-cases. Symptoms as ocular bleeding/redness have high specificity, but limited usefulness as not common. Admission delay and age distribution were not different for both groups. In total, 98 (20.6%) of 475 deaths in the ETC were non-cases. Most died within 24 hours after admission. Living in Conakry (aOR 1.78 (1.08–2.96)) was the strongest risk factor for death. Weeks with higher admission load had lower case fatality among non-cases, probably because more acute (and treatable) illnesses of contacts of known cases were admitted. These findings show high numbers of potentially critically ill non-cases need to be considered when setting up triage and referral of EVD suspect cases. Symptoms and risk factors alone do not allow differentiating the non-cases. Integration of highly-sensitive EVD diagnostic methods with short turnaround time in the triage of peripheral hospitals and dropping the systematic 2nd PCR for symptomatic early presenters could limit delays in access to adapted care of cases and seriously ill non-cases. Whether feasible without compromising outbreak control, and under which conditions, should be further assessed. PMID:28665950

Bowel obstruction complicated by ischemia: analysis of CT findings.

PubMed

Cox, Veronica L; Tahvildari, Ali M; Johnson, Benjamin; Wei, Wei; Jeffrey, R Brooke

2018-06-01

To analyze CT signs of bowel ischemia in patients with surgical bowel obstruction, and thereby improve CT diagnosis in this common clinical scenario. Surgical and histopathological findings were used as the reference standard. We retrospectively analyzed CT findings in patients brought to surgery for bowel obstruction over 13 years. Etiology of obstruction (adhesion, hernia, etc.) was recorded. Specific CT features of acute mesenteric ischemia (AMI) were analyzed, including bowel wall thickening, mucosal hypoenhancement, and others. 173 cases were eligible for analysis. 21% of cases were positive for bowel ischemia. Volvulus, internal hernia, and closed-loop obstructions showed ischemia rates of 60%, 43%, and 43%; ischemia rate in obstruction from simple adhesion was 21%. Patients with bowel obstruction related to malignancy were never ischemic. Sensitivities and specificities for CT features predicting ischemia were calculated, with wall thickening, hypoenhancement, and pneumatosis showing high specificity for ischemia (86%-100%). Wall thickening, hypoenhancement, and pneumatosis are highly specific CT signs of ischemia in the setting of obstruction. None of the evaluated CT signs were found to be highly sensitive. Overall frequency of ischemia in surgical bowel obstruction is 21%, and 2-3 times that for complex obstructions (volvulus, closed loop, etc.). Obstructions related to malignancy virtually never become ischemic.

Accuracy of loop-mediated isothermal amplification for diagnosis of human leptospirosis in Thailand.

PubMed

Sonthayanon, Piengchan; Chierakul, Wirongrong; Wuthiekanun, Vanaporn; Thaipadungpanit, Janjira; Kalambaheti, Thareerat; Boonsilp, Siriphan; Amornchai, Premjit; Smythe, Lee D; Limmathurotsakul, Direk; Day, Nicholas P; Peacock, Sharon J

2011-04-01

There is a lack of diagnostic tests for leptospirosis in technology-restricted settings. We developed loop-mediated isothermal amplification (LAMP) specific for the 16S ribosomal RNA gene (rrs) of pathogenic and intermediate group Leptospira species. The lower limit of detection was 10 genomic equivalents/reaction, and analytical specificity was high; we observed positive reactions for pathogenic/intermediate groups and negative reactions for non-pathogenic Leptospira species and other bacterial species. We evaluated this assay in Thailand by using a case-control study of 133 patients with laboratory-proven leptospirosis and 133 patients with other febrile illnesses. Using admission blood, we found that the rrs LAMP showed positive results in 58 of 133 cases (diagnostic sensitivity = 43.6, 95% confidence interval [CI] = 35.0-52.5) and in 22 of 133 controls (diagnostic specificity = 83.5, 95% CI = 76.0-89.3). Sensitivity was high for 39 patients who were culture positive for Leptospira spp. (84.6, 95% CI = 69.5-94.1). The rrs LAMP can provide an admission diagnosis in approximately half of patients with leptospirosis, but its clinical utility is reduced by a lower specificity.

Diagnostic power of laboratory tests for hereditary spherocytosis: a comparison study in 150 patients grouped according to molecular and clinical characteristics

PubMed Central

Bianchi, Paola; Fermo, Elisa; Vercellati, Cristina; Marcello, Anna P.; Porretti, Laura; Cortelezzi, Agostino; Barcellini, Wilma; Zanella, Alberto

2012-01-01

Background The laboratory diagnosis of hereditary spherocytosis commonly relies on NaCl-based or glycerol-based red cell osmotic fragility tests; more recently, an assay directly targeting the hereditary spherocytosis molecular defect (eosin-5′-maleimide-binding test) has been proposed. None of the available tests identifies all cases of hereditary spherocytosis. Design and Methods We compared the performances of the eosin-5′-maleimide-binding test, NaCl-osmotic fragility studies on fresh and incubated blood, the glycerol lysis test, the acidified glycerol lysis test, and the Pink test on a series of 150 patients with hereditary spherocytosis grouped according to clinical phenotype and the defective protein, with the final aim of finding the combination of tests associated with the highest diagnostic power, even in the mildest cases of hereditary spherocytosis. Results The eosin-5′-maleimide-binding test had a sensitivity of 93% and a specificity of 98% for detecting hereditary spherocytosis: the sensitivity was independent of the type and amount of molecular defect and of the clinical phenotype. The acidified glycerol lysis test and Pink test showed comparable sensitivity (95% and 91%). The sensitivity of NaCl osmotic fragility tests, commonly considered the gold standard for the diagnosis of hereditary spherocytosis, was 68% on fresh blood and 81% on incubated blood, and further decreased in compensated cases (53% and 64%, respectively). The combination of the eosin-5′-maleimide-binding test and acidified glycerol lysis test enabled all patients with hereditary spherocytosis to be identified. The eosin-5′-maleimide-binding test showed the greatest disease specificity. Conclusions Each type of test fails to diagnose some cases of hereditary spherocytosis. The association of an eosin-5′-maleimide-binding test and an acidified glycerol lysis test enabled identification of all patients with hereditary spherocytosis in this series and, therefore, represents a currently effective diagnostic strategy for hereditary spherocytosis including mild/compensated cases. PMID:22058213

Factors effecting impact of Aspergillus fumigatus sensitization in cystic fibrosis.

PubMed

Kanthan, Senthooran Kathirgama; Bush, Andrew; Kemp, Michael; Buchdahl, Roger

2007-09-01

The clinical impact of Aspergillus fumigatus (Af) sensitization in cystic fibrosis (CF) is controversial. We examined the effect of Af sensitization (Afs) on pulmonary function and growth using a retrospective cohort analysis over two 5-year study periods: 1996-2000 (19 Afs cases and 19 controls) and 2001-2005 (24 Afs cases and 23 controls). Sensitization was defined as Af specific radioallergosorbent test (RAST) >or= 17.5 iu/ml and total serum IgE level >or=150 iu/ml. We examined the impact of changing treatment schedules over these periods. Afs cases had lower median FEV(1) %predicted (%PR) compared to matched controls 1996: 67 versus 80, P < 0.01; 2001: 78 versus 93, P < 0.01. Afs cases in the 2001 cohort had a higher FEV(1) %PR compared to Afs cases in the 1996 cohort: 78 versus 67, P < 0.01. For the 1996 Afs cohort FEV(1) %PR fell significantly over 5 years but not for the 2001 Afs cohort. Af RAST and total IgE reflected the changes in pulmonary function. Children in the 2001 Afs cohort were prescribed significantly more oral antifungal treatment (odds ratio 4.3, 95%CI 1.2-15.7, P = 0.03). Afs children continue to have poorer lung function compared to controls but this observational, hypothesis generating study, suggests that the use of antifungal treatment is associated with better lung function. (c) 2007 Wiley-Liss, Inc.

Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children.

PubMed

Suri, Devika J; Tanumihardjo, Jacob P; Gannon, Bryan M; Pinkaew, Siwaporn; Kaliwile, Chisela; Chileshe, Justin; Tanumihardjo, Sherry A

2015-11-01

The WHO estimates that 190 million preschool children have vitamin A deficiency (VAD). Serum retinol (SR) concentration is a common indicator of vitamin A (VA) status, but SR is homeostatically controlled and suppressed during inflammation, which may lead to misdiagnosis. The sensitivity and specificity of SR compared with VA total liver reserves (TLRs) were evaluated for VAD in children from Thailand (n = 37) and Zambia (n = 128). SR was adjusted for inflammation in the Zambian children. Each child was classified as VA-deficient or not based on cutoffs of <0.1 μmol VA/g liver with the use of retinol isotope dilution and <0.7 μmol/L for SR concentrations. Four categories of infection status in the Zambian children were based on elevated C-reactive protein (CRP) and α1-acid glycoprotein (AGP). Sensitivity and specificity were calculated with the use of unadjusted and inflammation marker-adjusted SR cutoffs. VAD was 65% and 0% according to TLRs and SR, respectively, in Thai children and 0% and 17%, respectively, in Zambian children. No true positive VAD cases occurred; thus, sensitivity was 0% and indeterminable, respectively; specificity was 100% and 82.8%, respectively. CRP was elevated in 26.6% of Zambian children, whereas 97.7% had elevated AGP, categorizing them as having no infection (2.3%) or in early (26.6%) or late (58.6%) convalescence. With the use of marker-adjusted SR cutoffs of 0.6 μmol/L for late convalescence and 0.5 μmol/L for early convalescence, the adjusted prevalence of SR deficiency was 2.3%, increasing specificity to 97.3%. No cases of VAD were identified by both TLRs and SR (true positives) in Thai or Zambian children. Specificity of SR to evaluate VAD was high, but additional research is needed to investigate sensitivity. Adjusting SR cutoffs for inflammation improved specificity by reducing false positives. SR as a VAD indicator may depend on infection rates, which should be taken into consideration. These studies were registered at clinicaltrials.gov as NCT01061307 (for Thailand) and NCT01814891 (for Zambia). © 2015 American Society for Nutrition.

Diagnostic value of the basophil activation test in evaluating Hymenoptera venom sensitization.

PubMed

Peternelj, Andreja; Silar, Mira; Bajrovic, Nissera; Adamic, Katja; Music, Ema; Kosnik, Mitja; Korosec, Peter

2009-01-01

Diagnosis of allergy to Hymenoptera venom is usually confirmed with skin testing and measurement of specific serum IgE antibody, tests which are sometimes inconclusive. In these cases, additional in vitro tests are necessary. The aim of this study was to show the applicability of the basophil activation test in detecting sensitization to Hymenoptera venom and to compare the test sensitivity and clinical positive-predictive value with skin prick tests and measurement of allergen-specific serum IgE. This prospective study was conducted between June 2004 and December 2007 and included a large group of 204 patients. All patients had a history of at least one systemic allergic reaction of Müller grades II-IV after a Hymenoptera sting. We compared results of the basophil activation test, specific serum IgE and skin prick tests with patients' clinical history and data on culprit insects. The overall clinical sensitivities of the basophil activation test, specific serum IgE and skin prick tests were 90%, 76% and 64%, respectively; the clinical positive-predictive values of the three tests were 79%, 73% and 78% for bee venom, 86%, 59% and 43% for wasp venom; and 84%, 77% and 22% for both venoms. Our results revealed a higher clinical sensitivity and comparable or better clinical positive-predictive value of basophil activation tests than skin prick tests and allergen-specific serum IgE in the detection of allergy to Hymenoptera venom.

Applying Classification Trees to Hospital Administrative Data to Identify Patients with Lower Gastrointestinal Bleeding

PubMed Central

Siddique, Juned; Ruhnke, Gregory W.; Flores, Andrea; Prochaska, Micah T.; Paesch, Elizabeth; Meltzer, David O.; Whelan, Chad T.

2015-01-01

Background Lower gastrointestinal bleeding (LGIB) is a common cause of acute hospitalization. Currently, there is no accepted standard for identifying patients with LGIB in hospital administrative data. The objective of this study was to develop and validate a set of classification algorithms that use hospital administrative data to identify LGIB. Methods Our sample consists of patients admitted between July 1, 2001 and June 30, 2003 (derivation cohort) and July 1, 2003 and June 30, 2005 (validation cohort) to the general medicine inpatient service of the University of Chicago Hospital, a large urban academic medical center. Confirmed cases of LGIB in both cohorts were determined by reviewing the charts of those patients who had at least 1 of 36 principal or secondary International Classification of Diseases, Ninth revision, Clinical Modification (ICD-9-CM) diagnosis codes associated with LGIB. Classification trees were used on the data of the derivation cohort to develop a set of decision rules for identifying patients with LGIB. These rules were then applied to the validation cohort to assess their performance. Results Three classification algorithms were identified and validated: a high specificity rule with 80.1% sensitivity and 95.8% specificity, a rule that balances sensitivity and specificity (87.8% sensitivity, 90.9% specificity), and a high sensitivity rule with 100% sensitivity and 91.0% specificity. Conclusion These classification algorithms can be used in future studies to evaluate resource utilization and assess outcomes associated with LGIB without the use of chart review. PMID:26406318

Sigmoid stenosis caused by diverticulitis vs. carcinoma: usefulness of sonographic features for their differentiation in the emergency setting.

PubMed

Ripollés, Tomás; Martínez-Pérez, María Jesús; Gómez Valencia, Diana Patricia; Vizuete, José; Martín, Gregorio

2015-10-01

To retrospectively evaluate the accuracy of ultrasound as a diagnostic method for differentiating acute diverticulitis from colon cancer in patients with sigmoid colon stenosis. Ultrasound examinations of 91 consecutive patients with sigmoid stenosis (50 diverticulitis and 41 colon cancers) were reviewed by two trained radiologists. Sixty-five (71%) patients presented with acute abdominal symptoms. Thirteen sonographic criteria retrieved from the literature were evaluated to differentiate benign from malignant strictures. A score including all parameters which showed significant differences between benign vs. malignant was built. Sensitivity, specificity, accuracy, and positive or negative predictive values of each sonographic sign, the overall diagnosis, and sonographic score were calculated. Loss of the bowel wall stratification was the most reliable criteria for the diagnosis of malignancy (92% and 94% of sensitivity and specificity, respectively), and the best inter-radiologist agreement (κ = 0.848). Adjacent lymph nodes were the most specific feature (98%) for colon cancer, but its sensitivity was low. Global assessment could differentiate both diseases with high sensitivity (92-94.9%) and specificity (98-100%). Sonographic score >3 enabled differentiation of carcinoma from diverticulitis with 95% sensitivity and 92-94% specificity, with an area under the ROC curve of 0.98-0.987. There were no significant differences in the results between patients with acute and nonacute abdominal symptoms. The combination of several morphological sonographic findings using a score can differentiate most cases of diverticulitis from colon carcinoma in sigmoid strictures.

Reliability of fluorescein dye disappearance test in assessment of adults with nasolacrimal duct obstruction.

PubMed

Kashkouli, Mohsen Bahmani; Mirzajani, Hoora; Jamshidian-Tehrani, Mansooreh; Pakdel, Farzad; Nojomi, Marzieh; Aghaei, Gholam-Hossein

2013-01-01

To evaluate the role of fluorescein dye disappearance test (FDDT) in assessment of adults with primary acquired nasolacrimal duct obstruction (PANDO) and its correlation with age and severity of epiphora. In a prospective, cross-sectional comparative study, FDDT at 2 (2-FDDT), 5 (5-FDDT), and 10 (10-FDDT) minutes were performed in 58 eyes of 58 patients with PANDO (case) and 58 eyes of 58 subjects without epiphora (control) between 2008 and 2010. Exclusion criteria were any disease, trauma, or medications that might have an effect on tear drainage system. Patients with functional or incomplete obstruction and upper lacrimal drainage system obstruction were excluded in the case group. FDDT and severity of epiphora were graded. Case and control groups were matched. 2-FDDT showed a sensitivity of 82.8%, specificity of 91.4%, positive predictive value of 90.6%, and negative predictive value of 84.1%. Sensitivity and negative predictive value decreased to 71.1% and 78.6% in 5-FDDT. 5-FDDT specificity and positive predictive value, however, increased to 94.8% and 93.5%, respectively. There was no statistically significant correlation between severity of epiphora and age with FDDT. FDDT is a simple, reliable, and highly specific test in assessment of adults with PANDO.

Identification of potential serum peptide biomarkers of biliary tract cancer using MALDI MS profiling

PubMed Central

2014-01-01

Background The aim of this discovery study was the identification of peptide serum biomarkers for detecting biliary tract cancer (BTC) using samples from healthy volunteers and benign cases of biliary disease as control groups. This work was based on the hypothesis that cancer-specific exopeptidases exist and that their activities in serum can generate cancer-predictive peptide fragments from circulating proteins during coagulation. Methods This case control study used a semi-automated platform incorporating polypeptide extraction linked to matrix-assisted laser desorption/ionisation time-of-flight mass spectrometry (MALDI-TOF MS) to profile 92 patient serum samples. Predictive models were generated to test a validation serum set from BTC cases and healthy volunteers. Results Several peptide peaks were found that could significantly differentiate BTC patients from healthy controls and benign biliary disease. A predictive model resulted in a sensitivity of 100% and a specificity of 93.8% in detecting BTC in the validation set, whilst another model gave a sensitivity of 79.5% and a specificity of 83.9% in discriminating BTC from benign biliary disease samples in the training set. Discriminatory peaks were identified by tandem MS as fragments of abundant clotting proteins. Conclusions Serum MALDI MS peptide signatures can accurately discriminate patients with BTC from healthy volunteers. PMID:24495412

Noninvasive prenatal testing of trisomies 21 and 18 by massively parallel sequencing of maternal plasma DNA in twin pregnancies.

PubMed

Huang, Xuan; Zheng, Jing; Chen, Min; Zhao, Yangyu; Zhang, Chunlei; Liu, Lifu; Xie, Weiwei; Shi, Shuqiong; Wei, Yuan; Lei, Dongzhu; Xu, Chenming; Wu, Qichang; Guo, Xiaoling; Shi, Xiaomei; Zhou, Yi; Liu, Qiufang; Gao, Ya; Jiang, Fuman; Zhang, Hongyun; Su, Fengxia; Ge, Huijuan; Li, Xuchao; Pan, Xiaoyu; Chen, Shengpei; Chen, Fang; Fang, Qun; Jiang, Hui; Lau, Tze Kin; Wang, Wei

2014-04-01

The objective of this study is to assess the performance of noninvasive prenatal testing for trisomies 21 and 18 on the basis of massively parallel sequencing of cell-free DNA from maternal plasma in twin pregnancies. A double-blind study was performed over 12 months. A total of 189 pregnant women carrying twins were recruited from seven hospitals. Maternal plasma DNA sequencing was performed to detect trisomies 21 and 18. The fetal karyotype was used as gold standard to estimate the sensitivity and specificity of sequencing-based noninvasive prenatal test. There were nine cases of trisomy 21 and two cases of trisomy 18 confirmed by karyotyping. Plasma DNA sequencing correctly identified nine cases of trisomy 21 and one case of trisomy 18. The discordant case of trisomy 18 was an unusual case of monozygotic twin with discordant fetal karyotype (one normal and the other trisomy 18). The sensitivity and specificity of maternal plasma DNA sequencing for fetal trisomy 21 were both 100% and for fetal trisomy 18 were 50% and 100%, respectively. Our study further supported that sequencing-based noninvasive prenatal testing of trisomy 21 in twin pregnancies could be achieved with a high accuracy, which could effectively avoid almost 95% of invasive prenatal diagnosis procedures. © 2013 John Wiley & Sons, Ltd.

Noninvasive detection of intracerebral hemorrhage using near-infrared spectroscopy (NIRS)

NASA Astrophysics Data System (ADS)

Hennes, Hans-Juergen; Lott, Carsten; Windirsch, Michael; Hanley, Daniel F.; Boor, Stephan; Brambrink, Ansgar; Dick, Wolfgang

1998-01-01

Intracerebral Hemorrhage (IH) is an important cause of secondary brain injury in neurosurgical patients. Early identification and treatment improve neurologic outcome. We have tested Near Infrared Spectroscopy (NIRS) as an alternative noninvasive diagnostic tool compared to CT-Scans to detect IH. We prospectively studied 212 patients with neurologic symptoms associated with intracranial pathology before performing a CT-scan. NIRS signals indicated pathologies in 181 cases (sensitivity 0.96; specificity 0.29). In a subgroup of subdural hematomas NIRS detected 45 of 46 hematomas (sensitivity 0.96; specificity 0.79). Identification of intracerebral hemorrhage using NIRS has the potential to allow early treatment, thus possibly avoiding further injury.

Noninvasive detection of intracerebral hemorrhage using near-infrared spectroscopy (NIRS)

NASA Astrophysics Data System (ADS)

Hennes, Hans J.; Lott, C.; Windirsch, Michael; Hanley, Daniel F.; Boor, Stephan; Brambrink, Ansgar; Dick, Wolfgang

1997-12-01

Intracerebral Hemorrhage (IH) is an important cause of secondary brain injury in neurosurgical patients. Early identification and treatment improve neurologic outcome. We have tested Near Infrared Spectroscopy (NIRS) as an alternative noninvasive diagnostic tool compared to CT-Scans to detect IH. We prospectively studied 212 patients with neurologic symptoms associated with intracranial pathology before performing a CT-scan. NIRS signals indicated pathologies in 181 cases (sensitivity 0.96; specificity 0.29). In a subgroup of subdural hematomas NIRS detected 45 of 46 hematomas (sensitivity 0.96; specificity 0.79). Identification of intracerebral hemorrhage using NIRS has the potential to allow early treatment, thus possibly avoiding further injury.

Angiosonography in suspicious breast lesions with non-diagnostic FNAC: comparison with power Doppler US.

PubMed

Caumo, F; Carbognin, G; Casarin, A; Pinali, L; Vasori, S; D'Onofrio, M; Pozzi Mucelli, R

2006-02-01

The purpose of this study was to evaluate the accuracy of angiosonography in comparison with colour Doppler ultrasound (US) in the discrimination of suspicious breast lesions with nondiagnostic fine-needle aspiration cytology (FNAC). Pre-operative Power Doppler US and angiosonography were prospectively performed in 20 suspicious breast lesions with non-diagnostic FNAC. A second-generation US contrast agent was utilised with a high-frequency transducer and a contrast-specific algorithm (low acoustic pressure CnTI). The enhancement characteristics of all lesions were analysed using qualitative and quantitative parameters obtained from time-intensity curves with the different imaging modalities. The final diagnosis was confirmed at pathology in all cases. Microvessel density (MVD) was assessed in the surgical specimen using CD34. The correct assessment of biological behaviour was achieved in all cases by angiosonography (sensitivity of 100%; specificity of 91%) and colour Doppler US (45% sensitivity; 78% specificity). MVD correlated with the biological behaviour. Angiosonography is more accurate than colour Doppler US in the correct assessment of biological behaviour of suspicious breast lesions.

Evaluation of a prognostic scoring system for dogs managed with hemodialysis.

PubMed

Perondi, Francesca; Lippi, Ilaria; Ceccherini, Gianila; Marchetti, Veronica; Bernicchi, Lucrezia; Guidi, Grazia

2018-06-24

To investigate prognostic models in a cohort of dogs with acute kidney injury (AKI) and acute on chronic kidney disease (AKI/CKD) managed by hemodialysis. Retrospective study from July 2011 to November 2014. University Veterinary Teaching Hospital. Forty dogs with historical, clinical, imaging, and laboratory findings consistent with AKI or AKI/CKD managed with intermittent hemodialysis were included. Scoring system models previously established by Segev et al for outcome prediction in dogs with AKI were applied to all dogs. Models A, B, and C correctly classified outcomes in 68%, 83%, and 85% of cases, respectively. In our cohort Model A showed sensitivity of 58% and specificity of 86%, Model B showed sensitivity of 79% and specificity of 87%, Model C showed sensitivity of 86% and specificity of 84%. The presence of anuria (P < 0.0002), respiratory complications (P < 0.0001), disseminated intravascular coagulation (DIC) (P = 0.0004), grade of AKI (P = 0.0023), pancreatitis (P = 0.0001), and systemic inflammatory response syndrome (SIRS) (P = 0.0001) was significantly higher in nonsurvivors compared with survivors. In our cohort of patients, Segev's model C showed the best sensitivity and specificity for predicting prognosis, while model A had lower sensitivity. In our cohort of dialysis patients, the presence of respiratory complications, DIC, SIRS, and pancreatitis at hospitalization, were correlated with a poor prognosis. © Veterinary Emergency and Critical Care Society 2018.

Evaluation of the GeneXpert MTB/RIF assay on extrapulmonary and respiratory samples other than sputum: a low burden country experience.

PubMed

Pandey, Sushil; Congdon, Jacob; McInnes, Bradley; Pop, Alina; Coulter, Christopher

2017-01-01

The aim of this study was to assess the performance of the GeneXpert MTB/RIF assay on extrapulmonary (EP) and respiratory (non-sputum) clinical samples of patients suspected of having tuberculosis (TB) from Queensland, Australia. A total of 269 EP and respiratory (non-sputum) clinical samples collected from Qld patients who were suspected of having TB were subjected to the GeneXpert MTB/RIF analysis, Ziehl-Neelsen (ZN) staining, Mycobacterium tuberculosis (MTB) culture and drug susceptibility testing. Phenotypic and genotypic data were compared. The overall performance analysis of the GeneXpert MTB/RIF assay for detection of MTB complex demonstrated sensitivity of 89%, specificity of 95%, PPV of 89% and NPV of 95% using culture as a reference standard. The GeneXpert MTB/RIF analysis of acid-fast bacilli (AFB) smear positive samples and AFB smear negative samples showed sensitivities of 100% and 77%, respectively. Looking at individual EP and respiratory (non-sputum) sample types, the sensitivity ranged from 60% to 100% although the specificity ranged from 33% to 100% with the specificity of lymph node tissue biopsy being the lowest. The GeneXpert MTB/RIF assay detected 11% more TB cases than culture and 27% more cases than ZN microscopy. Due to insufficient numbers of presenting rifampicin resistance cases, performance analysis of the GeneXpert MTB/RIF assay on rifampicin resistance could not be carried out. The GeneXpert MTB/RIF assay is potentially valuable for TB diagnosis in the majority of the EP and respiratory (other than sputum) samples in our setting. Although the GeneXpert MTB/RIF assay provides rapid diagnostic results, the overall sensitivity to rule out the disease is suboptimal for some specimen types. Performance varied according to specimen type and AFB smear status. The sensitivity and specificity of lymph node tissue was 63% and 33%. Care must be taken when using the GeneXpert MTB/RIF assay for detection of MTB in lymph node tissue samples. All samples should be cultured regardless of the GeneXpert MTB/RIF assay result. Copyright © 2016 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.

[Age peculiarities in prostate cancer detection based on the prostate-specific antigen and its alterations control].

PubMed

Ponkratov, S V; Kheyfets, V Kh; Kagan, O F

2017-01-01

Data on epidemiology of a prostate cancer are presented in article, high prevalence and body height of a case rate cause relevance of researches on this oncopathology. It is shown that the number augmentation for the first time of the taped cases is bound including to the program of a screening of inspection of men by determination of level of prostates-specific antigen (PSA). Modern diagnostic methods of identification of modifications of PSA, possessing larger sensitivity and specificity concerning a prostate cancer are lit. The attention to change of level of PSA depending on age is focused that needs to be considered at diagnostics of malignant neoplasms of a prostate.

Development and validation of a case definition for epilepsy for use with administrative health data.

PubMed

Reid, Aylin Y; St Germaine-Smith, Christine; Liu, Mingfu; Sadiq, Shahnaz; Quan, Hude; Wiebe, Samuel; Faris, Peter; Dean, Stafford; Jetté, Nathalie

2012-12-01

The objective of this study was to develop and validate coding algorithms for epilepsy using ICD-coded inpatient claims, physician claims, and emergency room (ER) visits. 720/2049 charts from 2003 and 1533/3252 charts from 2006 were randomly selected for review from 13 neurologists' practices as the "gold standard" for diagnosis. Epilepsy status in each chart was determined by 2 trained physicians. The optimal algorithm to identify epilepsy cases was developed by linking the reviewed charts with three administrative databases (ICD 9 and 10 data from 2000 to 2008) including hospital discharges, ER visits and physician claims in a Canadian health region. Accepting chart review data as the gold standard, we calculated sensitivity, specificity, positive, and negative predictive value for each ICD-9 and ICD-10 administrative data algorithm (case definitions). Of 18 algorithms assessed, the most accurate algorithm to identify epilepsy cases was "2 physician claims or 1 hospitalization in 2 years coded" (ICD-9 345 or G40/G41) and the most sensitive algorithm was "1 physician clam or 1 hospitalization or 1 ER visit in 2 years." Accurate and sensitive case definitions are available for research requiring the identification of epilepsy cases in administrative health data. Copyright © 2012 Elsevier B.V. All rights reserved.

Validity of a PCR assay in CSF for the diagnosis of neurocysticercosis.

PubMed

Carpio, Arturo; Campoverde, Alfredo; Romo, Matthew L; García, Lorena; Piedra, Luis M; Pacurucu, Mónica; López, Nelson; Aguilar, Jenner; López, Sebastian; Vintimilla, Luis C; Toral, Ana M; Peña-Tapia, Pablo

2017-03-01

To prospectively evaluate the validity of a PCR assay in CSF for the diagnosis of neurocysticercosis (NC). We conducted a multicenter, prospective case-control study, recruiting participants from 5 hospitals in Cuenca, Ecuador, from January 2015 to February 2016. Cases fulfilled validated diagnostic criteria for NC. For each case, a neurosurgical patient who did not fulfill the diagnostic criteria for NC was selected as a control. CT and MRI, as well as a CSF sample, were collected from both cases and controls. The diagnostic criteria to identify cases were used as a reference standard. Overall, 36 case and 36 control participants were enrolled. PCR had a sensitivity of 72.2% (95% confidence interval [CI] 54.8%-85.8%) and a specificity of 100.0% (95% CI 90.3%-100.0%). For parenchymal NC, PCR had a sensitivity of 42.9% (95% CI 17.7%-71.1%), and for extraparenchymal NC, PCR had a sensitivity of 90.9% (95% CI 70.8%-98.9%). This study demonstrated the usefulness of this PCR assay in CSF for the diagnosis of NC. PCR may be particularly helpful for diagnosing extraparenchymal NC when neuroimaging techniques have failed. This study provides Class III evidence that CSF PCR can accurately identify patients with extraparenchymal NC.

The sensitivity and specificity of subjective memory complaints and the subjective memory rating scale, deterioration cognitive observee, mini-mental state examination, six-item screener and clock drawing test in dementia screening.

PubMed

Ramlall, S; Chipps, J; Bhigjee, A I; Pillay, B J

2013-01-01

The effectiveness of dementia screening depends on the availability of suitable screening tools with good sensitivity and specificity to confidently distinguish normal age-related cognitive decline from dementia. The aim of this study was to evaluate the discriminant validity of 7 screening measures for dementia. A sample of 140 participants aged ≥60 years living in a residential facility for the aged were assessed clinically and assigned caseness for dementia using the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised diagnostic criteria. Sensitivity and specificity of a selection of the following screening measures were tested using receiver operating characteristic (ROC) analysis for individual and combined tests: the Mini-Mental State Examination (MMSE), Six-Item Screener (SIS), Subjective Memory Complaint, Subjective Memory Complaint Clinical (SMCC), Subjective Memory Rating Scale (SMRS), Deterioration Cognitive Observee (DECO) and the Clock Drawing Test (CDT). Using ROC analyses, the SMCC, MMSE and CDT were found to be 'moderately accurate' in screening for dementia with an area under the curve (AUC) >0.70. The AUCs for the SIS (0.526), SMRS (0.661) and DECO (0.687) classified these measures as being 'less accurate'. At recommended cutoff scores, the SMCC had a sensitivity of 90.9% and specificity of 45.7%; the MMSE had a sensitivity of 63.6% and a specificity of 76.0%, and the CDT had a sensitivity of 44.4% and a specificity of 88.9%. Combining the SMCC and MMSE did not improve their predictive power except for a modest increase when using the sequential rule. The SMCC is composed of valid screening questions that have high sensitivity, are simple to administer and ideal for administration at the community or primary health care level as a first level of 'rule-out' screening. The MMSE can be included at a second stage of screening at the general hospital level and the CDT in specialist clinical settings. Sequential use of the SMCC and MMSE will improve the specificity of the former and the sensitivity of the latter. Copyright © 2013 S. Karger AG, Basel.

Accuracy of MRI findings in chronic lateral ankle ligament injury: comparison with surgical findings.

PubMed

Park, H-J; Cha, S-D; Kim, S S; Rho, M-H; Kwag, H-J; Park, N-H; Lee, S-Y

2012-04-01

To evaluate the accuracy of magnetic resonance imaging (MRI) findings in chronic lateral ankle ligament injury in comparison with that of surgical findings. Forty-eight cases (25 men, 23 women, mean age 36 years) of clinically suspected chronic ankle ligament injury underwent MRI studies and surgery. Sagittal, coronal, and axial, T1-weighted, spin-echo, proton density and T2-weighted, fast spin-echo images with fat saturation were obtained in all patients. MRI examinations were read in consensus by two fellowship-trained academic musculoskeletal radiologists who evaluated the lateral ankle ligaments, including the anterior talofibular ligament (ATFL) and calcaneofibular ligament (CFL) without clinical information. The results of the MRI studies were then compared with the surgical findings. The MRI findings of ATFL injury showed a sensitivity of detection of complete tears of 75% and specificity of 86%. The sensitivity of detection of partial tears was 75% and the specificity was 78%. The sensitivity of detection of sprains was 44% and the specificity was 88%. Regarding the MRI findings of CFL injury, the sensitivity of detection of complete tears was 50% and the specificity was 98%. The sensitivity of detection of partial tear was 83% and the specificity was 93%. The sensitivity of detection of sprains was 100% and the specificity was 90%. Regarding the ATFL, the accuracies of detection were 88, 58, 77, and 85% for no injury, sprain, partial tear, and complete tear, respectively, and for the CFL the accuracies of detection were 90, 90, 92, and 96% for no injury, sprain, partial tear, and complete tear, respectively. The diagnosis of a complete tear of the ATFL on MRI is more sensitive than the diagnosis of a complete tear of the CFL. MRI findings of CFL injury are diagnostically specific but are not sensitive. However, only normal findings and complete tears were statistically significant between ATFL and CFL (p < 0.001). Copyright © 2011 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Evaluation of 5 different labeled polymer immunohistochemical detection systems.

PubMed

Skaland, Ivar; Nordhus, Marit; Gudlaugsson, Einar; Klos, Jan; Kjellevold, Kjell H; Janssen, Emiel A M; Baak, Jan P A

2010-01-01

Immunohistochemical staining is important for diagnosis and therapeutic decision making but the results may vary when different detection systems are used. To analyze this, 5 different labeled polymer immunohistochemical detection systems, REAL EnVision, EnVision Flex, EnVision Flex+ (Dako, Glostrup, Denmark), NovoLink (Novocastra Laboratories Ltd, Newcastle Upon Tyne, UK) and UltraVision ONE (Thermo Fisher Scientific, Fremont, CA) were tested using 12 different, widely used mouse and rabbit primary antibodies, detecting nuclear, cytoplasmic, and membrane antigens. Serial sections of multitissue blocks containing 4% formaldehyde fixed paraffin embedded material were selected for their weak, moderate, and strong staining for each antibody. Specificity and sensitivity were evaluated by subjective scoring and digital image analysis. At optimal primary antibody dilution, digital image analysis showed that EnVision Flex+ was the most sensitive system (P < 0.005), with means of 8.3, 13.4, 20.2, and 41.8 gray scale values stronger staining than REAL EnVision, EnVision Flex, NovoLink, and UltraVision ONE, respectively. NovoLink was the second most sensitive system for mouse antibodies, but showed low sensitivity for rabbit antibodies. Due to low sensitivity, 2 cases with UltraVision ONE and 1 case with NovoLink stained false negatively. None of the detection systems showed any distinct false positivity, but UltraVision ONE and NovoLink consistently showed weak background staining both in negative controls and at optimal primary antibody dilution. We conclude that there are significant differences in sensitivity, specificity, costs, and total assay time in the immunohistochemical detection systems currently in use.

[Husband to wife kidney transplantation in five multiparous women: sensitization or tolerance after pregnancy?].

PubMed

Ortiz-Arroyo, Víctor M; Granados, Julio; Uribe-Uribe, Norma; de Leo, Claudia; Castelán, Natalia; González, Norma; López, Mayra; Alberú, Josefina

2004-01-01

Pregnancy is a known cause of immunological sensitization and it has been reported graft survival to be lower in husband to wife kidney transplantation if the wife had been pregnant (mutual children) as compare to those cases without pregnancies. Previous exposure to husband HLA antigens during pregnancies may lead to specific sensitization to subsequent allografts. To communicate the fate of kidney allograft in husband to wife transplantation when the recipient had been pregnant. From 682 renal transplants performed at INCMNSZ 5 corresponded to husband to wife transplants. All the recipients were multiparous and had received multiple blood transfusions. Pretransplantation lymphocytotoxic cross-match testing were performed by complement dependent citotoxicity with antihuman globulin added (AHG-CDC), being negative in all cases for T and B cells. All the patients received triple-drug immunosuppressive therapy, additionally, anti-IL2R monoclonal antibodies were used in two cases. Two patients developed: accelerated acute rejection (case 1), and acute humoral rejection (case 5), respectively. Graft in these patients were loss to rejection and transplant nephrectomy accomplished. The remaining three patients (cases 2, 3, and 4) has not had any rejection episode, and have had excellent graft outcome at 34, 30, and 21 months posttransplant, respectively. Why under similar conditions some husband to wife kidney transplant recipients developed an adverse humoral immunological events while others maintain excellent long-term graft outcome? Is it possible to speculate that for some women pregnancy is in fact a sensitizing event, while in others it promotes "immunological acceptance"? At present there is no a test that characterized one and other group. Even though pretransplantation cross-match testing by flow cytometry is more sensitive than AHG-CDC, its negative result is by no means an absolute guarantee that an adverse anamnestic immunological event will not occur.

Analysis of the utility of stone gram stain in urolithiasis treated with percutaneous nephrolithotomy.

PubMed

Cockerill, Patrick A; Rivera, Marcelino E; Krambeck, Amy E

2014-06-01

To define the sensitivity and specificity of stone gram stain for infected urolithiasis treated with percutaneous nephrolithotomy (PCNL). PCNL procedures performed at our institution were analyzed between January 2009 and May 2013. Stone fragments were sent in a sterile fashion for aerobic and fungal cultures. A gram stain and fungal smear were performed on the stones and reported within 24 hours of collection. A total of 228 patients underwent 248 PCNLs. Of the 248 stones, 81 (33%) had a positive stone culture. Stone gram stain was positive in 31 cases and negative in 50. There were 167 negative stone cultures, and in these cases, gram stain was positive in 5 and negative in 162. The calculated sensitivity and specificity of stone gram stain were 38% and 97%. The positive and negative predictive values were 86% and 76%, respectively. In the subset of 16 patients with positive stone fungal cultures, fungal smear was performed in 12 and was positive in 4, giving fungal smear a sensitivity of 33%. The results of this study suggest that stone gram stain cannot be relied on to detect a positive stone culture and may fail to detect up to 62% of infected stones. However, when positive, gram stain accurately predicts a positive stone culture in 86% of cases. Copyright © 2014 Elsevier Inc. All rights reserved.

Ultrasound detection of placenta accreta in the first trimester of pregnancy

PubMed Central

Rahimi-Sharbaf, Fatemeh; Jamal, Ashraf; Mesdaghinia, Elaheh; Abedzadeh- Kalahroudi, Masoumeh; Niroomanesh, Shirin; Atoof, Fatemeh

2014-01-01

Background: Placenta accreta is considered a life-threatening condition and the main cause of maternal mortality. Prenatal diagnosis of placenta accreta usually is made by clinical presentation, imaging studies like ultrasound and MRI in the second and third trimester. Objective: To determine accuracy of ultrasound findings for placenta accreta in the first trimester of pregnancy. Materials and Methods: In a longitudinal study 323 high risk patients for placenta accreta were assessed. The eligible women were examined by vaginal and abdominal ultrasound for gestational sac and placental localization and they were followed up until the end of pregnancy. The ultrasound findings were compared with histopathological examinations as a gold standard. The sensitivity, specificity, positive and negative predictive value of ultrasound were estimated for the first trimester and compared with other 2 trimesters in the case of repeated ultrasound examination. Results: Ultrasound examinations in the first trimester revealed that 28 cases had the findings in favor of placenta accreta which ultimately was confirmed in 7 cases. The ultrasound sensitivity and specificity for detecting placenta accreta in the first trimester was 41% [95% CI: 16.2-62.7] and 88% [95% CI: 88.2-94.6] respectively. Conclusion: Ultrasound screening for placenta accreta in the first trimester of pregnancy could not achieve the high sensitivity as second and third trimester of pregnancy. PMID:25071851

Systemic autoimmune rheumatic disease prevalence in Canada: updated analyses across 7 provinces.

PubMed

Broten, Laurel; Aviña-Zubieta, J Antonio; Lacaille, Diane; Joseph, Lawrence; Hanly, John G; Lix, Lisa; O'Donnell, Siobhan; Barnabe, Cheryl; Fortin, Paul R; Hudson, Marie; Jean, Sonia; Peschken, Christine; Edworthy, Steven M; Svenson, Larry; Pineau, Christian A; Clarke, Ann E; Smith, Mark; Bélisle, Patrick; Badley, Elizabeth M; Bergeron, Louise; Bernatsky, Sasha

2014-04-01

To estimate systemic autoimmune rheumatic disease (SARD) prevalence across 7 Canadian provinces using population-based administrative data evaluating both regional variations and the effects of age and sex. Using provincial physician billing and hospitalization data, cases of SARD (systemic lupus erythematosus, scleroderma, primary Sjögren syndrome, polymyositis/dermatomyositis) were ascertained. Three case definitions (rheumatology billing, 2-code physician billing, and hospital diagnosis) were combined to derive a SARD prevalence estimate for each province, categorized by age, sex, and rural/urban status. A hierarchical Bayesian latent class regression model was fit to account for the imperfect sensitivity and specificity of each case definition. The model also provided sensitivity estimates of different case definition approaches. Prevalence estimates for overall SARD ranged between 2 and 5 cases per 1000 residents across provinces. Similar demographic trends were evident across provinces, with greater prevalence in women and in persons over 45 years old. SARD prevalence in women over 45 was close to 1%. Overall sensitivity was poor, but estimates for each of the 3 case definitions improved within older populations and were slightly higher for men compared to women. Our results are consistent with previous estimates and other North American findings, and provide results from coast to coast, as well as useful information about the degree of regional and demographic variations that can be seen within a single country. Our work demonstrates the usefulness of using multiple data sources, adjusting for the error in each, and providing estimates of the sensitivity of different case definition approaches.

Results of the rubella elimination program in Catalonia (Spain), 2002–2011

PubMed Central

Barrabeig, Irene; Torner, Nuria; Martínez, Ana; Carmona, Gloria; Ciruela, Pilar; Batalla, Joan; Costa, Josep; Hernández, Sergi; Salleras, Luis; Domínguez, Angela; Group of Catalonia, the Rubella Surveillance

2013-01-01

Rubella is usually a mild disease with nonspecific symptoms, but can cause congenital rubella syndrome (CRS) when infection occurs during pregnancy. The objective of this study was to evaluate the sensitivity and positive predictive value of different data sources used for surveillance purposes in the Rubella Elimination Program of Catalonia between 2002 and 2011. The Urgent Notification to the Statutory Disease Reporting System, the Individualized Disease Reporting System, screening for other viruses included in the Measles Elimination Program, the Microbiological Reporting System and the Minimum Hospital Discharge Data were evaluated. 100 suspected cases of postnatal rubella and 6 suspected cases of CRS were detected. For postnatal rubella, Urgent Notification had the highest sensitivity (32.5%; 95%CI 18.6–49.1), followed by the Virus screening in Measles Elimination Program (25%; 95%CI 12.7-41.2). Virus screening in the Measles Elimination Program had the highest PPV (76.9%; 95%CI 46.1–94.9), followed by the Individualized Disease Reporting System (57.1%; 95%CI 28.9–82.3). For CRS cases, the Individualized Disease Reporting System had the highest sensitivity (100%, 95%CI 29.2–100) and the highest PPV (60%; 95%CI 14.7–100). Most confirmed postnatal cases (25 cases, 48.1%) were in the 25–44 y age group followed by the 15–24 y age group (11 cases, 21.2%). The highest values of sensitivity and PPV for the detection of confirmed cases corresponded to activities that were specifically introduced in the measles and rubella elimination programs. PMID:23299566

HIV-1 maternal and infant variants show similar sensitivity to broadly neutralizing antibodies, but sensitivity varies by subtype

PubMed Central

Jennifer, Mabuka; Leslie, Goo; Maxwel, Majiwa O.; Ruth, Nduati; Julie, Overbaugh

2014-01-01

Rationale To protect against HIV infection, passively transferred and/or vaccine elicited neutralizing antibodies (NAbs) need to effectively target diverse subtypes that are transmitted globally. These variants are a limited subset of those present during chronic infection and display some unique features. In the case of mother-to-child transmission (MTCT), transmitted variants tend to be resistant to neutralization by maternal autologous NAbs. Method To investigate whether variants transmitted during MTCT are generally resistant to HIV-1 specific NAbs, 107 maternal or infant variants representing the dominant HIV-1 subtypes were tested against six recently identified HIV-1-specific broadly neutralizing monoclonal antibodies (bNAbs), NIH45-46W, VRC01, PGT128, PGT121, PG9, and PGT145. Results Infant and maternal variants did not differ in their neutralization sensitivity to individual bNAbs, nor did viruses from transmitting versus non-transmitting mothers, although there was a trend for viruses from transmitting mothers to be less sensitive overall. No single bNAb neutralized all viruses, but a combination of bNAbs that target distinct epitopes covered 100% of the variants tested. Compared to heterosexually transmitted variants, vertically transmitted variants, were significantly more sensitive to neutralization by PGT128 and PGT121 (p=0.03 in both cases) but there were no differences for the other bNAbs. Overall, subtype A variants were significantly more sensitive to NIH45-46 (p=0.04), VRC01 (p=0.002) and PGT145 (p=0.03) compared to the non-subtype A and less sensitive to PGT121 than subtype Cs (p=0.0001). Conclusion A combination of bNAbs against distinct epitopes may be needed to provide maximum coverage against viruses in different modes of transmission and diverse subtypes. PMID:23856624

[The value of bedside lung ultrasound in emergency-plus protocol for the assessment of lung consolidation and atelectasis in critical patients].

PubMed

Wang, Xiao-ting; Liu, Da-wei; Zhang, Hong-min; He, Huai-wu; Liu, Ye; Chai, Wen-zhao; Du, Wei

2012-12-01

To investigate the effect of the bedside lung ultrasound in emergency(BLUE)-plus lung ultrasound protocol on lung consolidation and atelectasis of critical patients. All patients who need to receive mechanical ventilation for more than 48 hours in ICU from June 2010 to December 2011 in Peking Union Medical College Hospital were included in the study. BLUE-plus and BLUE lung ultrasound, bedside X-ray, lung CT examination were performed on all patients at the same time. The condition of lung consolidation and atelectasis discovered by BLUE-plus lung ultrasound protocol was recorded and compared with bedside X-ray or lung CT. The difference in assessment of lung consolidation and atelectasis between BLUE-plus lung ultrasound protocol and BLUE protocol was compared. A total of 78 patients were finally enrolled in the study. The lung CT found 70 cases (89.74%) had different degrees of lung consolidation and atelectasis. The sensitivity, specificity and diagnostic accuracy of lung consolidation and atelectasis by the bedside chest X-ray were 31.29%, 75.00% and 38.46%, respectively. BLUE-plus lung ultrasound protocol found 68 cases with lung consolidation and atelectasis, and its sensitivity, specificity, and diagnostic accuracy were 95.71%, 87.50% and 94.87%, respectively, which were significantly higher than those of lung CT. BLUE protocol found 48 cases of lung consolidation and atelectasis, and its sensitivity, specificity, and diagnostic accuracy were 65.71%, 75.00% and 66.67%, respectively. The position of lung consolidation and atelectasis which hadn't been found by BLUE protocol was mainly proved to be located in the basement of lung by lung CT. The incidence of lung consolidation and atelectasis in critical patients who received mechanical ventilation is high. The BLUE-plus lung ultrasound protocol has a relatively higher sensitivity, specificity and diagnostic accuracy for consolidation and atelectasis, which can find majority of consolidation and atelectasis. As BLUE-plus lung ultrasound is a bedside noninvasive method allowing immediate assessment of most lung consolidation and atelectasis, it will be likely the alternative of the CT and play a key role in assessment of lung consolidation and atelectasis.

Significance of combined detection of JAK2V617F, MPL and CALR gene mutations in patients with essential thrombocythemia

PubMed Central

Ji, Liying; Qian, Mengyao; Wu, Nana; Wu, Jianmin

2017-01-01

The aim of this study was to analyze the mutation rate of JAK2V617F, MPLW515L/K and CALR genes in adult patients with essential thrombocythemia (ET) and the accuracy of the combined detection by the receiver operating curve. Three hundred and forty-two cases with high-platelets (≥300×109/l) were consecutively selected. The patients were analyzed for routine blood examination, bone marrow biopsy and genetic testing. One hundred and fifty-four cases (45.03%) were diagnosed with ET and 188 cases of secondary thrombocythemia according to the hematopoietic and lymphoid tissue tumor classification standards of 2008. It was found that the mutant type of three genes showed three bands, whereas only one band for wild-type. The JAK2V617F and MPL mutations did not cause a change in the open reading frame and the CALR mutation resulted in its change. The mutation rate of JAK2V617F and CALR in ET group was significantly higher than that in the secondary thrombocythemia group (p<0.05). The positive mutation rate of MPL was only 4.55%. JAK2V617F-positive mutation alone was used to diagnose with ET. The area under the curve (AUC) was 0.721. The sensitivity was 72.4%, the specificity was 79.5% and the cut-off value was 0.25. When CALR-positive mutation alone was used to diagnose ET, the AUC, sensitivity, specificity and cut-off value were 0.664, 68.4, 82.4 and 0.09%, respectively. JAK2V617F combined with CALR mutation were used for diagnosis of ET. The AUC was 0.862, the sensitivity was 85.9%, the specificity was 87.8%, and the cut-off values were 0.21 and 0.07. In conclusion, the positive mutation rate of JAK2V617F and CALR in ET was higher, and the sensitivity, specificity and accuracy of the diagnosis of ET were significantly improved using the detection of JAK2V617F and CALR. PMID:28450924

Significance of combined detection of JAK2V617F, MPL and CALR gene mutations in patients with essential thrombocythemia.

PubMed

Ji, Liying; Qian, Mengyao; Wu, Nana; Wu, Jianmin

2017-03-01

The aim of this study was to analyze the mutation rate of JAK2V617F, MPLW515L/K and CALR genes in adult patients with essential thrombocythemia (ET) and the accuracy of the combined detection by the receiver operating curve. Three hundred and forty-two cases with high-platelets (≥300×10 9 /l) were consecutively selected. The patients were analyzed for routine blood examination, bone marrow biopsy and genetic testing. One hundred and fifty-four cases (45.03%) were diagnosed with ET and 188 cases of secondary thrombocythemia according to the hematopoietic and lymphoid tissue tumor classification standards of 2008. It was found that the mutant type of three genes showed three bands, whereas only one band for wild-type. The JAK2V617F and MPL mutations did not cause a change in the open reading frame and the CALR mutation resulted in its change. The mutation rate of JAK2V617F and CALR in ET group was significantly higher than that in the secondary thrombocythemia group (p<0.05). The positive mutation rate of MPL was only 4.55%. JAK2V617F-positive mutation alone was used to diagnose with ET. The area under the curve (AUC) was 0.721. The sensitivity was 72.4%, the specificity was 79.5% and the cut-off value was 0.25. When CALR-positive mutation alone was used to diagnose ET, the AUC, sensitivity, specificity and cut-off value were 0.664, 68.4, 82.4 and 0.09%, respectively. JAK2V617F combined with CALR mutation were used for diagnosis of ET. The AUC was 0.862, the sensitivity was 85.9%, the specificity was 87.8%, and the cut-off values were 0.21 and 0.07. In conclusion, the positive mutation rate of JAK2V617F and CALR in ET was higher, and the sensitivity, specificity and accuracy of the diagnosis of ET were significantly improved using the detection of JAK2V617F and CALR.

The diagnostic value of narrow-band imaging for early and invasive lung cancer: a meta-analysis.

PubMed

Zhu, Juanjuan; Li, Wei; Zhou, Jihong; Chen, Yuqing; Zhao, Chenling; Zhang, Ting; Peng, Wenjia; Wang, Xiaojing

2017-07-01

This study aimed to compare the ability of narrow-band imaging to detect early and invasive lung cancer with that of conventional pathological analysis and white-light bronchoscopy. We searched the PubMed, EMBASE, Sinomed, and China National Knowledge Infrastructure databases for relevant studies. Meta-disc software was used to perform data analysis, meta-regression analysis, sensitivity analysis, and heterogeneity testing, and STATA software was used to determine if publication bias was present, as well as to calculate the relative risks for the sensitivity and specificity of narrow-band imaging vs those of white-light bronchoscopy for the detection of early and invasive lung cancer. A random-effects model was used to assess the diagnostic efficacy of the above modalities in cases in which a high degree of between-study heterogeneity was noted with respect to their diagnostic efficacies. The database search identified six studies including 578 patients. The pooled sensitivity and specificity of narrow-band imaging were 86% (95% confidence interval: 83-88%) and 81% (95% confidence interval: 77-84%), respectively, and the pooled sensitivity and specificity of white-light bronchoscopy were 70% (95% confidence interval: 66-74%) and 66% (95% confidence interval: 62-70%), respectively. The pooled relative risks for the sensitivity and specificity of narrow-band imaging vs the sensitivity and specificity of white-light bronchoscopy for the detection of early and invasive lung cancer were 1.33 (95% confidence interval: 1.07-1.67) and 1.09 (95% confidence interval: 0.84-1.42), respectively, and sensitivity analysis showed that narrow-band imaging exhibited good diagnostic efficacy with respect to detecting early and invasive lung cancer and that the results of the study were stable. Narrow-band imaging was superior to white light bronchoscopy with respect to detecting early and invasive lung cancer; however, the specificities of the two modalities did not differ significantly.

Evaluation of sensitivity and specificity of cytologic examination: 269 cases (1999-2000).

PubMed

Cohen, Michele; Bohling, Mark W; Wright, James C; Welles, Elizabeth A; Spano, Joseph S

2003-04-01

To determine sensitivity and specificity of cytologic examination used in a clinical setting. Retrospective study. 216 dogs, 44 cats, 4 horses, 2 ferrets, 1 llama, 1 rat, and 1 mouse. Records were reviewed of cases in which a cytologic diagnosis was followed by a surgical biopsy or postmortem examination within 3 days with subsequent histopathologic diagnosis. Diagnoses were compared for agreement at various levels, including complete agreement, partial agreement, no agreement, or no comparison possible because of insufficient or incorrect cytologic specimen. Levels of agreement were compared for different categories of lesions, including neoplastic, inflammatory, dysplastic-hyperplastic-other, and normal tissue. Additionally, levels of agreement for neoplastic lesions were categorized with regard to cell type, degree of malignancy, and location. Sensitivity and specificity of cytologic examination were calculated. At the level of general agreement (complete and partial agreement), the sensitivity of cytologic examination ranged from 33.3 to 66.1%, depending on the location of the lesion. Cytologic examination was most accurate when used to diagnose cutaneous and subcutaneous lesions and least accurate for diagnosis of liver lesions. Cytologic examination was most effective in diagnosis of neoplastic disease and least effective in diagnosis of dysplastic or hyperplastic conditions. Cytologic examination is a valuable diagnostic tool, although our results indicated lower accuracy than previously reported. False-negative results (missing a diagnosis) were far more common than false-positive results (categorizing a healthy animal as diseased): therefore, if the clinical index of suspicion is high, cytologic examination should be repeated or another technique should be selected to rule out the suspected condition.

Use of the International Classification of Diseases, 9th revision, coding in identifying chronic hepatitis B virus infection in health system data: implications for national surveillance.

PubMed

Mahajan, Reena; Moorman, Anne C; Liu, Stephen J; Rupp, Loralee; Klevens, R Monina

2013-05-01

With increasing use electronic health records (EHR) in the USA, we looked at the predictive values of the International Classification of Diseases, 9th revision (ICD-9) coding system for surveillance of chronic hepatitis B virus (HBV) infection. The chronic HBV cohort from the Chronic Hepatitis Cohort Study was created based on electronic health records (EHR) of adult patients who accessed services from 2006 to 2008 from four healthcare systems in the USA. Using the gold standard of abstractor review to confirm HBV cases, we calculated the sensitivity, specificity, positive and negative predictive values using one qualifying ICD-9 code versus using two qualifying ICD-9 codes separated by 6 months or greater. Of 1 652 055 adult patients, 2202 (0.1%) were confirmed as having chronic HBV. Use of one ICD-9 code had a sensitivity of 83.9%, positive predictive value of 61.0%, and specificity and negative predictive values greater than 99%. Use of two hepatitis B-specific ICD-9 codes resulted in a sensitivity of 58.4% and a positive predictive value of 89.9%. Use of one or two hepatitis B ICD-9 codes can identify cases with chronic HBV infection with varying sensitivity and positive predictive values. As the USA increases the use of EHR, surveillance using ICD-9 codes may be reliable to determine the burden of chronic HBV infection and would be useful to improve reporting by state and local health departments.

Reliability of medical records in diagnosing inflammatory breast cancer in Egypt.

PubMed

Le, Lynne; Schairer, Catherine; Hablas, Ahmed; Meza, Jane; Watanabe-Galloway, Shinobu; Ramadan, Mohamed; Merajver, Sofia D; Seifeldin, Ibrahim A; Soliman, Amr S

2017-03-16

Inflammatory breast cancer (IBC) is a rare, aggressive breast cancer diagnosed clinically by the presence of diffuse erythema, peau d'orange, and edema that arise quickly in the affected breast. This study evaluated the validity of medical records in Gharbiah, Egypt in identifying clinical signs/symptoms of IBC. For 34 IBC cases enrolled in a case-control study at the Gharbiah Cancer Society and Tanta Cancer Center, Egypt (2009-2010), we compared signs/symptoms of IBC noted in medical records to those recorded on a standardized form at the time of IBC diagnosis by clinicians participating in the case-control study. We calculated the sensitivity and specificity of medical records as compared to the case-control study for recording these signs/symptoms. We also performed McNemar's tests. In the case-control study, 32 (94.1%) IBC cases presented with peau d'orange, 30 (88.2%) with erythema, and 31 (91.2%) with edema. The sensitivities of the medical records as compared to the case-control study were 0.8, 0.5, and 0.2 for peau d'orange, erythema, and edema, respectively. Corresponding specificities were 1.0, 0.5, and 1.0. p values for McNemar's test were <0.05 for all signs. Medical records had data on the extent and duration of signs for at most 27% of cases for which this information was recorded in the case-control study. Twenty-three of the 34 cases (67.6%) had confirmed diagnosis of IBC in their medical records. Medical records lacked information on signs/symptoms of IBC, especially erythema and edema, when compared to the case-control study. Deficient medical records could have implications for diagnosis and treatment of IBC and proper documentation of cases in cancer registries.

Validation of the Cepstral Spectral Index of Dysphonia (CSID) as a Screening Tool for Voice Disorders: Development of Clinical Cutoff Scores.

PubMed

Awan, Shaheen N; Roy, Nelson; Zhang, Dong; Cohen, Seth M

2016-03-01

The purposes of this study were to (1) evaluate the performance of the Cepstral Spectral Index of Dysphonia (CSID--a multivariate estimate of dysphonia severity) as a potential screening tool for voice disorder identification and (2) identify potential clinical cutoff scores to classify voice-disordered cases versus controls. Subjects were 332 men and women (116 men, 216 women) comprised of subjects who presented to a physician with a voice-related complaint and a group of non-voice-related control subjects. Voice-disordered cases versus controls were initially defined via three reference standards: (1) auditory-perceptual judgment (dysphonia +/-); (2) Voice Handicap Index (VHI) score (VHI +/-); and (3) laryngoscopic description (laryngoscopic +/-). Speech samples were analyzed using the Analysis of Dysphonia in Speech and Voice program. Cepstral and spectral measures were combined into a CSID multivariate formula which estimated dysphonia severity for Rainbow Passage samples (i.e., the CSIDR). The ability of the CSIDR to accurately classify cases versus controls in relation to each reference standard was evaluated via a combination of logistic regression and receiver operating characteristic (ROC) analyses. The ability of the CSIDR to discriminate between cases and controls was represented by the "area under the ROC curve" (AUC). ROC classification of dysphonia-positive cases versus controls resulted in a strong AUC = 0.85. A CSIDR cutoff of ≈24 achieved the best balance between sensitivity and specificity, whereas a more liberal cutoff score of ≈19 resulted in higher sensitivity while maintaining respectable specificity which may be preferred for screening purposes. Weaker but adequate AUCs = 0.75 and 0.73 were observed for the classification of VHI-positive and laryngoscopic-positive cases versus controls, respectively. Logistic regression analyses indicated that subject age may be a significant covariate in the discrimination of dysphonia-positive and VHI-positive cases versus controls. The CSIDR can provide a strong level of accuracy for the classification of voice-disordered cases versus controls, particularly when auditory-perceptual judgment is used as the reference standard. Although users often focus on a cutoff score that achieves a balance between sensitivity and specificity, more liberal cutoffs for screening purposes versus conservative cutoffs when cost or risk of further evaluation is deemed to be high should also be considered. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Utility of 99mTc-Hynic-TOC in 131I Whole-Body Scan Negative Thyroid Cancer Patients with Elevated Serum Thyroglobulin Levels

PubMed Central

Shinto, Ajit S.; Kamaleshwaran, K. K.; Mallia, Madhav; Korde, Aruna; Samuel, Grace; Banerjee, Sharmila; Velayutham, Pavanasam; Damodharan, Suresh; Sairam, Madhu

2015-01-01

Several studies have reported on the expression of somatostatin receptors (SSTRs) in patients with differentiated thyroid cancer (DTC). The aim of this study was to evaluate the imaging abilities of a recently developed Technetium-99m labeled somatostatin analog, 99mTc-Hynic-TOC, in terms of precise localization of the disease. The study population consisted of 28 patients (16 men, 12 women; age range: 39-72 years) with histologically confirmed DTC, who presented with recurrent or persistent disease as indicated by elevated serum thyroglobulin (Tg) levels after initial treatment (serum Tg > 10 ng/ml off T4 suppression for 4-6 weeks). All patients were negative on the Iodine-131 posttherapy whole-body scans. Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG PET) was performed in all patients. SSTR scintigraphy was true positive in 23 cases (82.1%), true negative in two cases (7.1%) and false negative in three cases (10.7%) which resulted in a sensitivity of 88.46%, specificity of 100% and an accuracy of 89.2%. Sensitivity of 99mTc-Hynic-TOC scan was higher (93.7%) for patients with advanced stages, that is stages III and IV. 18F-FDG showed a sensitivity of 93.7%, a specificity of 50% and an accuracy of 89.3%. 18F-FDG PET was found to be more sensitive, with lower specificity due to false positive results in 2 patients. Analysis on a lesion basis demonstrated substantial agreement between the two imaging techniques with a Cohen's kappa of 0.66. Scintigraphy with 99mTc-Hynic-TOC might be a promising tool for treatment planning; it is easy to perform and showed sufficient accuracy for localization diagnostics in thyroid cancer patients with recurrent or metastatic disease. PMID:26097420

Utility of (99m)Tc-Hynic-TOC in 131I Whole-Body Scan Negative Thyroid Cancer Patients with Elevated Serum Thyroglobulin Levels.

PubMed

Shinto, Ajit S; Kamaleshwaran, K K; Mallia, Madhav; Korde, Aruna; Samuel, Grace; Banerjee, Sharmila; Velayutham, Pavanasam; Damodharan, Suresh; Sairam, Madhu

2015-01-01

Several studies have reported on the expression of somatostatin receptors (SSTRs) in patients with differentiated thyroid cancer (DTC). The aim of this study was to evaluate the imaging abilities of a recently developed Technetium-99m labeled somatostatin analog, (99m)Tc-Hynic-TOC, in terms of precise localization of the disease. The study population consisted of 28 patients (16 men, 12 women; age range: 39-72 years) with histologically confirmed DTC, who presented with recurrent or persistent disease as indicated by elevated serum thyroglobulin (Tg) levels after initial treatment (serum Tg > 10 ng/ml off T4 suppression for 4-6 weeks). All patients were negative on the Iodine-131 posttherapy whole-body scans. Fluorine-18 fluorodeoxyglucose positron emission tomography ((18)F-FDG PET) was performed in all patients. SSTR scintigraphy was true positive in 23 cases (82.1%), true negative in two cases (7.1%) and false negative in three cases (10.7%) which resulted in a sensitivity of 88.46%, specificity of 100% and an accuracy of 89.2%. Sensitivity of (99m)Tc-Hynic-TOC scan was higher (93.7%) for patients with advanced stages, that is stages III and IV. (18)F-FDG showed a sensitivity of 93.7%, a specificity of 50% and an accuracy of 89.3%. (18)F-FDG PET was found to be more sensitive, with lower specificity due to false positive results in 2 patients. Analysis on a lesion basis demonstrated substantial agreement between the two imaging techniques with a Cohen's kappa of 0.66. Scintigraphy with (99m)Tc-Hynic-TOC might be a promising tool for treatment planning; it is easy to perform and showed sufficient accuracy for localization diagnostics in thyroid cancer patients with recurrent or metastatic disease.

A Multiplexed Serum Biomarker Immunoassay Panel Discriminates Clinical Lung Cancer Patients from High-Risk Individuals Found to be Cancer-Free by CT Screening

PubMed Central

Bigbee, William L.; Gopalakrishnan, Vanathi; Weissfeld, Joel L.; Wilson, David O.; Dacic, Sanja; Lokshin, Anna E.; Siegfried, Jill M.

2012-01-01

Introduction Clinical decision-making in the setting of CT screening could benefit from accessible biomarkers that help predict the level of lung cancer risk in high-risk individuals with indeterminate pulmonary nodules. Methods To identify candidate serum biomarkers, we measured 70 cancer-related proteins by Luminex xMAP® multiplexed immunoassays in a training set of sera from 56 patients with biopsy-proven primary non small cell lung cancer and 56 age-, sex- and smoking-matched CT-screened controls. Results We identified a panel of 10 serum biomarkers – prolactin, transthyretin, thrombospondin-1, E-selectin, C-C motif chemokine 5, macrophage migration inhibitory factor, plasminogen activator inhibitor, receptor tyrosine-protein kinase, Cyfra 21.1, and serum amyloid A – that distinguished lung cancer from controls with an estimated balanced accuracy (average of sensitivity and specificity) of 76.0%±3.8% from 20-fold internal cross-validation. We then iteratively evaluated this model in independent test and verification case/control studies confirming the initial classification performance of the panel. The classification performance of the 10-biomarker panel was also analytically validated using ELISAs in a second independent case/control population further validating the robustness of the panel. Conclusions The performance of this 10-biomarker panel based model was 77.1% sensitivity/76.2% specificity in cross-validation in the expanded training set, 73.3% sensitivity/93.3% specificity (balanced accuracy 83.3%) in the blinded verification set with the best discriminative performance in Stage I/II cases: 85% sensitivity (balanced accuracy 89.2%). Importantly, the rate of misclassification of CT-screened controls was not different in most control subgroups with or without airflow obstruction or emphysema or pulmonary nodules. These biomarkers have potential to aid in the early detection of lung cancer and more accurate interpretation of indeterminate pulmonary nodules detected by screening CT. PMID:22425918

Performance of the G4 Xpert® MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampin resistance: a retrospective case-control study of analytical and clinical samples from high- and low-tuberculosis prevalence settings.

PubMed

Dharan, Nila J; Blakemore, Robert; Sloutsky, Alex; Kaur, Devinder; Alexander, Richard C; Ghajar, Minoo; Musser, Kimberlee A; Escuyer, Vincent E; Rowlinson, Marie-Claire; Crowe, Susanne; Laniado-Laborin, Rafael; Valli, Eloise; Nabeta, Pamela; Johnson, Pamela; Alland, David

2016-12-20

The Xpert ® MTB/RIF (Xpert) assay is a rapid PCR-based assay for the detection of Mycobacterium tuberculosis complex DNA (MTBc) and mutations associated with rifampin resistance (RIF). An updated version introduced in 2011, the G4 Xpert, included modifications to probe B and updated analytic software. An analytical study was performed to assess Xpert detection of mutations associated with rifampin resistance in rifampin-susceptible and -resistant isolates. A clinical study was performed in which specimens from US and non-US persons suspected of tuberculosis (TB) were tested to determine Xpert performance characteristics. All specimens underwent smear microscopy, mycobacterial culture, conventional drug-susceptibility testing and Xpert testing; DNA from isolates with discordant rifampin resistance results was sequenced. Among 191 laboratory-prepared isolates in the analytical study, Xpert sensitivity for detection of rifampin resistance associated mutations was 97.7% and specificity was 90.8%, which increased to 99.0% after DNA sequencing analysis of the discordant samples. Of the 1,096 subjects in the four clinical studies, 49% were from the US. Overall, Xpert detected MTBc in 439 of 468 culture-positive specimens for a sensitivity of 93.8% (95% confidence interval [CI]: 91.2%-95.7%) and did not detect MTBc in 620 of 628 culture-negative specimens for a specificity of 98.7% (95% CI: 97.5%-99.4%). Sensitivity was 99.7% among smear-positive cases, and 76.1% among smear-negative cases. Non-determinate MTBc detection and false-positive RIF resistance results were low (1.2 and 0.9%, respectively). The updated Xpert assay retained the high sensitivity and specificity of the previous assay versions and demonstrated low rates of non-determinate and RIF resistance false positive results.

Uroplakin II (UPII), GATA3, and p40 are Highly Sensitive Markers for the Differential Diagnosis of Invasive Urothelial Carcinoma.

PubMed

Hoang, Laura L; Tacha, David; Bremer, Ryan E; Haas, Thomas S; Cheng, Liang

2015-01-01

Distinguishing between invasive urothelial carcinoma from other genitourinary lesions such as prostatic and renal carcinomas can be difficult, and may require highly sensitive immunohistochemical markers. GATA-binding protein 3 (GATA3) has been reported in a high percentage of urothelial and breast carcinomas. Mouse monoclonal uroplakin II (UPII) and p40 antibodies have recently been developed and demonstrated high specificity in urothelial carcinoma. This study evaluated the immunohistochemical staining sensitivities of UPII, GATA3, p40, and p63 in the detection of invasive urothelial carcinoma. UPII, GATA3, and p40 were further tested for specificity in lung, breast, colon, kidney, and prostate cancers. In all invasive urothelial carcinoma cases, UPII, GATA3, p40, and p63 exhibited sensitivities of 77.7%, 83.5%, 85.4%, and 80.6%, respectively. The combination of UPII, GATA3, and p40 antibodies stained 94.2% (97/103) of all invasive urothelial carcinoma cases, including 92.2% (71/77) of grade 2-3 urothelial carcinomas. In addition, GATA3 and UPII showed negative staining in lung squamous cell carcinomas and p40 showed negative staining in breast infiltrating ductal carcinomas. The combination of UPII, GATA3, and p40 showed negative staining in lung adenocarcinoma, colon adenocarcinoma, and renal carcinomas. In conclusion, UPII, GATA3, and p40, when used in combination, are highly sensitive in the differential diagnosis of invasive urothelial carcinoma.

Using administrative databases in the surveillance of depressive disorders--case definitions.

PubMed

Alaghehbandan, Reza; Macdonald, Don; Barrett, Brendan; Collins, Kayla; Chen, Yue

2012-12-01

The objective of this study was to assess the usefulness of provincial administrative databases in carrying out surveillance on depressive disorders. Electronic medical records (EMRs) at 3 family practice clinics in St. John's, NL, Canada, were audited; 253 depressive disorder cases and 257 patients not diagnosed with a depressive disorder were selected. The EMR served as the "gold standard," which then was compared to these same patients investigated through the use of various case definitions applied against the provincial hospital and physician administrative databases. Variables used in the development of the case definitions were depressive disorder diagnoses (either in hospital or physician claims data), date of diagnosis, and service provider type [general practitioner (GP) vs. psychiatrist]. Of the 120 case definitions investigated, 26 were found to have a kappa statistic greater than 0.6, of which 5 case definitions were considered the most appropriate for surveillance of depressive disorders. Of the 5 definitions, the following case definition, with a 77.5% sensitivity and 93% specificity, was found to be the most valid ([ ≥1 hospitalizations OR ≥1 psychiatrist visit related to depressive disorders any time] OR ≥2 GP visits related to depressive disorders within the first 2 years of diagnosis). This study found that provincial administrative databases may be useful for carrying out surveillance on depressive disorders among the adult population. The approach used in this study was simple and resulted in rather reasonable sensitivity and specificity.

Herpes simplex keratitis in South India: clinico-virological correlation.

PubMed

Pramod, N P; Rajendran, P; Kannan, K A; Thyagarajan, S P

1999-01-01

A retrospective cross-section study to analyze the prevalence of herpes simplex virus-induced keratitis (HSK) among 3,000 patients attending a corneal clinic in South India between 1995 and 1997, and to evaluate laboratory techniques for detecting HSK. The clinico-virological correlation was studied using herpes simplex virus (HSV) isolation on the Vero cell line, HSV-specific antigen detection by indirect immunofluorescence (IF) microscopy, and serum anti-HSV IgG quantitation, IgM estimation, and tear secretory IgA (sIgA) detection by ELISA. HSK had a prevalence of 7.8% (234 patients) in this study. A virological correlation could be obtained in 44.4% of the cases that had epithelial manifestations and in 14.8% of the cases that had only stromal disease. In 161 cases where both culture and IF microscopy were used, IF detected 27 cases (26.8%) more than cell culture. The difference in sensitivity between cell culture and IF was found to be statistically significant (McNemar's test, P < .05). An elevation in IgG titer was seen in 17 (30.4%) cases. IgM was detected in only 2 cases of the 62 (3.2%) analyzed. Of the 138 cases analyzed, sIgA was positive in 28 (20.3%) cases. A proved diagnosis could be made in 58% of cases when the specimen was collected during the first week after disease onset, and in only 5% when the time interval increased to 4 weeks. HSV antigen detection by indirect IF is a rapid and sensitive diagnostic tool for HSK. Tear secretory IgA (sIgA) is a specific marker for acute herpetic keratitis, and the detection of HSV-specific tear sIgA is a valuable adjunct to virus isolation and antigen detection in the laboratory diagnosis of HSK. For a successful diagnosis, the specimen should be collected as soon as possible after HSK onset.

Evaluation of serological and molecular tests used to identify Toxoplasma gondii infection in pregnant women attended in a public health service in São Paulo state, Brazil.

PubMed

Murata, Fernando Henrique Antunes; Ferreira, Marina Neves; Pereira-Chioccola, Vera Lucia; Spegiorin, Lígia Cosentino Junqueira Franco; Meira-Strejevitch, Cristina da Silva; Gava, Ricardo; Silveira-Carvalho, Aparecida Perpétuo; de Mattos, Luiz Carlos; Brandão de Mattos, Cinara Cássia

2017-09-01

Toxoplasmosis during pregnancy can have severe consequences. The use of sensitive and specific serological and molecular methods is extremely important for the correct diagnosis of the disease. We compared the ELISA and ELFA serological methods, conventional PCR (cPCR), Nested PCR and quantitative PCR (qPCR) in the diagnosis of Toxoplasma gondii infection in pregnant women without clinical suspicion of toxoplasmosis (G1=94) and with clinical suspicion of toxoplasmosis (G2=53). The results were compared using the Kappa index, and the sensitivity, specificity, positive predictive value and negative predictive value were calculated. The results of the serological methods showed concordance between the ELISA and ELFA methods even though ELFA identified more positive cases than ELISA. Molecular methods were discrepant with cPCR using B22/23 primers having greater sensitivity and lower specificity compared to the other molecular methods. Copyright © 2017 Elsevier Inc. All rights reserved.

Liver Rapid Reference Set Application (#1): David Lubman - Univ of Michigan (2009) — EDRN Public Portal

Cancer.gov

We are requesting the reference set, which includes 50 HCC cases and 50 cirrhotic controls. In our preliminary study, AFP had a AUROC of 0.66 while the AUROC for the 5 glycoproteins was 0.81. The sensitivity and specificity for the 5 glycoproteins was 79% and 72% at the point that maximizes sensitivity+specificity in the ROC curve, and it was 79% and 35%, respectively, for AFP at the same point in the ROC curve. The reference set will allow us to determine the best performance of the 5 glycoproteins by themselves or whether their combination has a better sensitivity and/or specificity and AUROC. While a direct comparison with AFP will be made, the reference set will not allow a robust comparison due to the low sample size. If the glycoproteins are complementary or have better performance than AFP, then the next step would be to test them in the entire phase 2 hepatocellular carcinoma set.

Liver Rapid Reference Set Application ( #2): Lubman - Univ of Michigan (2010) — EDRN Public Portal

Cancer.gov

We are requesting the reference set, which includes 50 HCC cases and 50 cirrhotic controls. In our preliminary study, AFP had a AUROC of 0.66 while the AUROC for the 5 glycoproteins was 0.81. The sensitivity and specificity for the 5 glycoproteins was 79% and 72% at the point that maximizes sensitivity+specificity in the ROC curve, and it was 79% and 35%, respectively, for AFP at the same point in the ROC curve. The reference set will allow us to determine the best performance of the 5 glycoproteins by themselves or whether their combination has a better sensitivity and/or specificity and AUROC. While a direct comparison with AFP will be made, the reference set will not allow a robust comparison due to the low sample size. If the glycoproteins are complementary or have better performance than AFP, then the next step would be to test them in the entire phase 2 hepatocellular carcinoma set.

Expression of dog1 in low-grade fibromyxoid sarcoma: A study of 19 cases and review of the literature.

PubMed

Vallejo-Benítez, Ana; Rodríguez-Zarco, Enrique; Carrasco, Sara Pabón; Pereira-Gallardo, Sofia; Brugal Molina, Javier; García-Escudero, Antonio; Robles Frías, Antonio; Marcilla, David; González-Cámpora, Ricardo

2017-10-01

DOG1 is a highly-sensitive marker often included in the immunohistochemical panel for the diagnosis of gastrointestinal stromal tumors (GISTs). Recent research has shown that DOG1 may also be expressed by low-grade fibromyxoid sarcomas (LGFMSs); this may give rise to diagnostic error when the sarcoma is located in the abdominal cavity. This paper reports on immnohistochemical expression of DOG1 in 19 LGFMSs using two different monoclonal antibodies: K9 (Leica, Novocastra Laboratories, Newcastle upon Tyne, UK) and SP31 (Thermo Scientific, Freemont, USA). All LGFMSs displayed the standard histological pattern of alternating myxoid and fibrous areas, low cellularity and bland spindle-cell morphology. Positive staining for MUC4 was observed in 18/19 cases (94.7%), while there was rearrangement of the FUS gene in 14/19 (73.7%) cases and of the EWR1 gene in 2/19 (10.5%). The sarcoma staining negative for MUC4 displayed FUS gene rearrangement. Whole-section immunohistochemistry revealed positive staining for DOG1 in 8/19 cases (42.1%), though only with clone K9. Cytoplasmic as well as membrane staining was observed in all cases; staining was focal (10-30%) and of varying intensity (1+ to 2+). In conclusion, DOG1 clone K9 exhibited low sensitivity (42.1%) for the diagnosis of LGFMS, although higher than clone SP31. Since the two clones display similar sensitivity and specificity for GIST diagnosis, SP31 would appear to be more specific for this purpose, since no reaction was observed here with LGFMS, a GIST-mimicking lesion. Copyright © 2017 Elsevier Inc. All rights reserved.

Recognizing ovarian cancer from co-registered ultrasound and photoacoustic images

NASA Astrophysics Data System (ADS)

Alqasemi, Umar; Kumavor, Patrick; Aguirre, Andres; Zhu, Quing

2013-03-01

Unique features in co-registered ultrasound and photoacoustic images of ex vivo ovarian tissue are introduced, along with the hypotheses of how these features may relate to the physiology of tumors. The images are compressed with wavelet transform, after which the mean Radon transform of the photoacoustic image is computed and fitted with a Gaussian function to find the centroid of the suspicious area for shift-invariant recognition process. In the next step, 24 features are extracted from a training set of images by several methods; including features from the Fourier domain, image statistics, and the outputs of different composite filters constructed from the joint frequency response of different cancerous images. The features were chosen from more than 400 training images obtained from 33 ex vivo ovaries of 24 patients, and used to train a support vector machine (SVM) structure. The SVM classifier was able to exclusively separate the cancerous from the non-cancerous cases with 100% sensitivity and specificity. At the end, the classifier was used to test 95 new images, obtained from 37 ovaries of 20 additional patients. The SVM classifier achieved 76.92% sensitivity and 95.12% specificity. Furthermore, if we assume that recognizing one image as a cancerous case is sufficient to consider the ovary as malignant, then the SVM classifier achieves 100% sensitivity and 87.88% specificity.

Screening for HIV-related PTSD: sensitivity and specificity of the 17-item Posttraumatic Stress Diagnostic Scale (PDS) in identifying HIV-related PTSD among a South African sample.

PubMed

Martin, L; Fincham, D; Kagee, A

2009-11-01

The identification of HIV-positive patients who exhibit criteria for Posttraumatic Stress Disorder (PTSD) and related trauma symptomatology is of clinical importance in the maintenance of their overall wellbeing. This study assessed the sensitivity and specificity of the 17-item Posttraumatic Stress Diagnostic Scale (PDS), a self-report instrument, in the detection of HIV-related PTSD. An adapted version of the PTSD module of the Composite International Diagnostic Interview (CIDI) served as the gold standard. 85 HIV-positive patients diagnosed with HIV within the year preceding data collection were recruited by means of convenience sampling from three HIV clinics within primary health care facilities in the Boland region of South Africa. A significant association was found between the 17-item PDS and the adapted PTSD module of the CIDI. A ROC curve analysis indicated that the 17-item PDS correctly discriminated between PTSD caseness and non-caseness 74.9% of the time. Moreover, a PDS cut-off point of > or = 15 yielded adequate sensitivity (68%) and 1-specificity (65%). The 17-item PDS demonstrated a PPV of 76.0% and a NPV of 56.7%. The 17-item PDS can be used as a brief screening measure for the detection of HIV-related PTSD among HIV-positive patients in South Africa.

Validity of Race, Ethnicity, and National Origin in Population-based Cancer Registries and Rapid Case Ascertainment Enhanced With a Spanish Surname List.

PubMed

Clarke, Lisa C; Rull, Rudolph P; Ayanian, John Z; Boer, Robert; Deapen, Dennis; West, Dee W; Kahn, Katherine L

2016-01-01

Accurate information regarding race, ethnicity, and national origins is critical for identifying disparities in the cancer burden. To examine the use of a Spanish surname list to improve the quality of race-related information obtained from rapid case ascertainment (RCA) and to estimate the accuracy of race-related information obtained from cancer registry records collected by routine reporting. Self-reported survey responses of 3954 participants from California enrolled in the Cancer Care Outcomes Research and Surveillance Consortium. Sensitivity, specificity, positive predictive value, and percent agreement. We used logistic regression to identify predictors of underreporting and overreporting of a race/ethnicity. Use of the Spanish surname list increased the sensitivity of RCA for Latino ethnicity from 37% to 83%. Sensitivity for cancer registry records collected by routine reporting was ≥95% for whites, blacks, and Asians, and specificity was high for all groups (86%-100%). However, patterns of misclassification by race/ethnicity were found that could lead to biased cancer statistics for specific race/ethnicities. Discordance between self-reported and registry-reported race/ethnicity was more likely for women, Latinos, and Asians. Methods to improve race and ethnicity data, such as using Spanish surnames in RCA and instituting data collection guidelines for hospitals, are needed to ensure minorities are accurately represented in clinical and epidemiological research.

Clinical Evaluation and Management of Patients with Suspected Fungus Sensitivity.

PubMed

Larenas-Linnemann, Desiree; Baxi, Sachin; Phipatanakul, Wanda; Portnoy, Jay M

2016-01-01

Fungus-sensitized patients usually present with symptoms that are similar to symptoms presented by those who are sensitized to other aeroallergens. Therefore, diagnosis and management should follow the same pathways used for patients with allergic conditions in general. The physician should consider that a relationship between fungal exposure and symptoms is not necessarily caused by an IgE-mediated mechanism, even when specific fungal IgE is detected. Until recently, IgE-mediated allergy has been documented only for a limited number of fungi. We propose a series of questions to be used to identify symptoms that occur in situations with high fungal exposure and a limited skin-prick-test panel (Alternaria, Cladosporium, Penicillium, Aspergillus, Candida) that can be amplified only in cases of high suspicion of other fungal exposure (eg, postfloods). We also review in vitro testing for fungi-specific IgE. Treatment includes environmental control, medical management, and, when appropriate, specific immunotherapy. Low-quality evidence exists supporting the use of subcutaneous immunotherapy for Alternaria to treat allergic rhinitis and asthma, and very low quality evidence supports the use of subcutaneous immunotherapy for Cladosporium and sublingual immunotherapy for Alternaria. As is the case for many allergens, evidence for immunotherapy with other fungal extracts is lacking. The so-called toxic mold syndrome is also briefly discussed. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

IMRT QA: Selecting gamma criteria based on error detection sensitivity

DOE Office of Scientific and Technical Information (OSTI.GOV)

Steers, Jennifer M.; Fraass, Benedick A., E-mail: benedick.fraass@cshs.org

Purpose: The gamma comparison is widely used to evaluate the agreement between measurements and treatment planning system calculations in patient-specific intensity modulated radiation therapy (IMRT) quality assurance (QA). However, recent publications have raised concerns about the lack of sensitivity when employing commonly used gamma criteria. Understanding the actual sensitivity of a wide range of different gamma criteria may allow the definition of more meaningful gamma criteria and tolerance limits in IMRT QA. We present a method that allows the quantitative determination of gamma criteria sensitivity to induced errors which can be applied to any unique combination of device, delivery technique,more » and software utilized in a specific clinic. Methods: A total of 21 DMLC IMRT QA measurements (ArcCHECK®, Sun Nuclear) were compared to QA plan calculations with induced errors. Three scenarios were studied: MU errors, multi-leaf collimator (MLC) errors, and the sensitivity of the gamma comparison to changes in penumbra width. Gamma comparisons were performed between measurements and error-induced calculations using a wide range of gamma criteria, resulting in a total of over 20 000 gamma comparisons. Gamma passing rates for each error class and case were graphed against error magnitude to create error curves in order to represent the range of missed errors in routine IMRT QA using 36 different gamma criteria. Results: This study demonstrates that systematic errors and case-specific errors can be detected by the error curve analysis. Depending on the location of the error curve peak (e.g., not centered about zero), 3%/3 mm threshold = 10% at 90% pixels passing may miss errors as large as 15% MU errors and ±1 cm random MLC errors for some cases. As the dose threshold parameter was increased for a given %Diff/distance-to-agreement (DTA) setting, error sensitivity was increased by up to a factor of two for select cases. This increased sensitivity with increasing dose threshold was consistent across all studied combinations of %Diff/DTA. Criteria such as 2%/3 mm and 3%/2 mm with a 50% threshold at 90% pixels passing are shown to be more appropriately sensitive without being overly strict. However, a broadening of the penumbra by as much as 5 mm in the beam configuration was difficult to detect with commonly used criteria, as well as with the previously mentioned criteria utilizing a threshold of 50%. Conclusions: We have introduced the error curve method, an analysis technique which allows the quantitative determination of gamma criteria sensitivity to induced errors. The application of the error curve method using DMLC IMRT plans measured on the ArcCHECK® device demonstrated that large errors can potentially be missed in IMRT QA with commonly used gamma criteria (e.g., 3%/3 mm, threshold = 10%, 90% pixels passing). Additionally, increasing the dose threshold value can offer dramatic increases in error sensitivity. This approach may allow the selection of more meaningful gamma criteria for IMRT QA and is straightforward to apply to other combinations of devices and treatment techniques.« less

Bench study of the accuracy of a commercial AED arrhythmia analysis algorithm in the presence of electromagnetic interferences.

PubMed

Jekova, Irena; Krasteva, Vessela; Ménétré, Sarah; Stoyanov, Todor; Christov, Ivaylo; Fleischhackl, Roman; Schmid, Johann-Jakob; Didon, Jean-Philippe

2009-07-01

This paper presents a bench study on a commercial automated external defibrillator (AED). The objective was to evaluate the performance of the defibrillation advisory system and its robustness against electromagnetic interferences (EMI) with central frequencies of 16.7, 50 and 60 Hz. The shock advisory system uses two 50 and 60 Hz band-pass filters, an adaptive filter to identify and suppress 16.7 Hz interference, and a software technique for arrhythmia analysis based on morphology and frequency ECG parameters. The testing process includes noise-free ECG strips from the internationally recognized MIT-VFDB ECG database that were superimposed with simulated EMI artifacts and supplied to the shock advisory system embedded in a real AED. Measurements under special consideration of the allowed variation of EMI frequency (15.7-17.4, 47-52, 58-62 Hz) and amplitude (1 and 8 mV) were performed to optimize external validity. The accuracy was reported using the American Heart Association (AHA) recommendations for arrhythmia analysis performance. In the case of artifact-free signals, the AHA performance goals were exceeded for both sensitivity and specificity: 99% for ventricular fibrillation (VF), 98% for rapid ventricular tachycardia (VT), 90% for slow VT, 100% for normal sinus rhythm, 100% for asystole and 99% for other non-shockable rhythms. In the presence of EMI, the specificity for some non-shockable rhythms (NSR, N) may be affected in some specific cases of a low signal-to-noise ratio and extreme frequencies, leading to a drop in the specificity with no more than 7% point. The specificity for asystole and the sensitivity for VF and rapid VT in the presence of any kind of 16.7, 50 or 60 Hz EMI simulated artifact were shown to reach the equivalence of sensitivity required for non-noisy signals. In conclusion, we proved that the shock advisory system working in a real AED operates accurately according to the AHA recommendations without artifacts and in the presence of EMI. The results may be affected for specificity in the case of a low signal-to-noise ratio or in some extreme frequency setting.

Computer-aided interpretation approach for optical tomographic images

NASA Astrophysics Data System (ADS)

Klose, Christian D.; Klose, Alexander D.; Netz, Uwe J.; Scheel, Alexander K.; Beuthan, Jürgen; Hielscher, Andreas H.

2010-11-01

A computer-aided interpretation approach is proposed to detect rheumatic arthritis (RA) in human finger joints using optical tomographic images. The image interpretation method employs a classification algorithm that makes use of a so-called self-organizing mapping scheme to classify fingers as either affected or unaffected by RA. Unlike in previous studies, this allows for combining multiple image features, such as minimum and maximum values of the absorption coefficient for identifying affected and not affected joints. Classification performances obtained by the proposed method were evaluated in terms of sensitivity, specificity, Youden index, and mutual information. Different methods (i.e., clinical diagnostics, ultrasound imaging, magnet resonance imaging, and inspection of optical tomographic images), were used to produce ground truth benchmarks to determine the performance of image interpretations. Using data from 100 finger joints, findings suggest that some parameter combinations lead to higher sensitivities, while others to higher specificities when compared to single parameter classifications employed in previous studies. Maximum performances are reached when combining the minimum/maximum ratio of the absorption coefficient and image variance. In this case, sensitivities and specificities over 0.9 can be achieved. These values are much higher than values obtained when only single parameter classifications were used, where sensitivities and specificities remained well below 0.8.

A comprehensive evaluation of the accuracy of cervical pre-cancer detection methods in a high-risk area in East Congo

PubMed Central

Hovland, S; Arbyn, M; Lie, A K; Ryd, W; Borge, B; Berle, E J; Skomedal, H; Kadima, T M; Kyembwa, L; Billay, E M; Mukwege, D; Chirimwami, R B; Mvula, T M; Snijders, P J; Meijer, C J L M; Karlsen, F

2010-01-01

Background: Given the high burden of cervical cancer in low-income settings, there is a need for a convenient and affordable method for detecting and treating pre-cancerous lesions. Methods: Samples for comparing the accuracy of cytology, virology and histology were collected. Identification of HPV E6/E7 mRNA was performed using PreTect HPV-Proofer. HPV DNA detection was performed by GP5+/6+ PCR, followed by reverse line blot (RLB) for typing. Results: A total of 343 women, aged 25–60 years, attending gynaecological polyclinics in DR Congo were included for sample enrolment. The test positivity rate was conventional and liquid-based cytology (LBC) at cutoff ASCUS+ of 6.9 and 6.6%, respectively; PreTect HPV-Proofer of 7.3% and consensus DNA PCR for 14 HR types of 18.5%. Sixteen cases of CIN2+ lesions were identified. Of these, conventional cytology identified 66.7% with a specificity of 96.2%, LBC identified 73.3% with a specificity of 96.9%, all at cutoff ASCUS+. HR-HPV DNA detected all CIN2+ cases with a specificity of 85.9%, whereas PreTect HPV-Proofer gave a sensitivity of 81.3% and a specificity of 96.6%. Conclusion: Both HPV detection assays showed a higher sensitivity for CIN2+ than did cytological methods. Detecting E6/E7 mRNA from only a subset of HR HPVs, as is the case with PreTect HPV-Proofer, resulted in a similar specificity to cytology and a significantly higher specificity than consensus HR HPV DNA (P<0.0001). PMID:20197765

Development of loop-mediated isothermal amplification with Plasmodium falciparum unique genes for molecular diagnosis of human malaria.

PubMed

Zhang, Yijing; Yao, Yi; Du, Weixing; Wu, Kai; Xu, Wenyue; Lin, Min; Tan, Huabing; Li, Jian

2017-07-01

In order to achieve better outcomes for treatment and in the prophylaxis of malaria, it is imperative to develop a sensitive, specific, and accurate assay for early diagnosis of Plasmodium falciparum infection, which is the major cause of malaria. In this study, we aimed to develop a loop-mediated isothermal amplification (LAMP) assay with P. falciparum unique genes for sensitive, specific, and accurate detection of P. falciparum infection. The unique genes of P. falciparum were randomly selected from PlasmoDB. The LAMP primers of the unique genes were designed using PrimerExplorer V4. LAMP assays with primers from unique genes of P. falciparum and conserved 18S rRNA gene were developed and their sensitivity was assessed. The specificity of the most sensitive LAMP assay was further examined using genomic DNA from Plasmodium vivax, Plasmodium yoelii and Toxoplasma gondii. Finally, the unique gene-based LAMP assay was validated using clinical samples of P. falciparum infection cases. A total of 31 sets of top-scored LAMP primers from nine unique genes were selected from the pools of designed primers. The LAMP assay with PF3D7_1253300-5 was the most sensitive with the detection limit 5 parasites/μl, and it displayed negative LAMP assay with the genomic DNA samples of P. vivax, P. yoelii, and T. gondii. The LAMP assay with PF3D7_0112300 (18S rRNA) was less sensitive with the detection limit 50 parasites/μl, and it displayed negative LAMP assay with the genomic DNA samples of P. yoelii and T. gondii, but displayed positive LAMP detection with P. vivax. The positive detection rate of the LAMP assay with PF3D7_1253300-5 was 90% (27/30), higher than that (80%, 24/30) of the positive rate of PF3D7_0112300 (18S rRNA) in examining clinical samples of P. falciparum infection cases. The LAMP assay with the primer set PF3D7_1253300-5 was more sensitive, specific, and accurate than those with PF3D7_0112300 (18S rRNA) in examining P. falciparum infection, and therefore it is a promising tool for diagnosis of P. falciparum infection.

Fever screening during the influenza (H1N1-2009) pandemic at Narita International Airport, Japan.

PubMed

Nishiura, Hiroshi; Kamiya, Kazuko

2011-05-03

Entry screening tends to start with a search for febrile international passengers, and infrared thermoscanners have been employed for fever screening in Japan. We aimed to retrospectively assess the feasibility of detecting influenza cases based on fever screening as a sole measure. Two datasets were collected at Narita International Airport during the 2009 pandemic. The first contained confirmed influenza cases (n = 16) whose diagnosis took place at the airport during the early stages of the pandemic, and the second contained a selected and suspected fraction of passengers (self-reported or detected by an infrared thermoscanner; n = 1,049) screened from September 2009 to January 2010. The sensitivity of fever (38.0 °C) for detecting H1N1-2009 was estimated, and the diagnostic performances of the infrared thermoscanners in detecting hyperthermia at cut-off levels of 37.5 °C, 38.0 °C and 38.5 °C were also estimated. The sensitivity of fever for detecting H1N1-2009 cases upon arrival was estimated to be 22.2% (95% confidence interval: 0, 55.6) among nine confirmed H1N1-2009 cases, and 55.6% of the H1N1-2009 cases were under antipyretic medications upon arrival. The sensitivity and specificity of the infrared thermoscanners in detecting hyperthermia ranged from 50.8-70.4% and 63.6-81.7%, respectively. The positive predictive value appeared to be as low as 37.3-68.0%. The sensitivity of entry screening is a product of the sensitivity of fever for detecting influenza cases and the sensitivity of the infrared thermoscanners in detecting fever. Given the additional presence of confounding factors and unrestricted medications among passengers, reliance on fever alone is unlikely to be feasible as an entry screening measure.

Fever screening during the influenza (H1N1-2009) pandemic at Narita International Airport, Japan

PubMed Central

2011-01-01

Background Entry screening tends to start with a search for febrile international passengers, and infrared thermoscanners have been employed for fever screening in Japan. We aimed to retrospectively assess the feasibility of detecting influenza cases based on fever screening as a sole measure. Methods Two datasets were collected at Narita International Airport during the 2009 pandemic. The first contained confirmed influenza cases (n = 16) whose diagnosis took place at the airport during the early stages of the pandemic, and the second contained a selected and suspected fraction of passengers (self-reported or detected by an infrared thermoscanner; n = 1,049) screened from September 2009 to January 2010. The sensitivity of fever (38.0°C) for detecting H1N1-2009 was estimated, and the diagnostic performances of the infrared thermoscanners in detecting hyperthermia at cut-off levels of 37.5°C, 38.0°C and 38.5°C were also estimated. Results The sensitivity of fever for detecting H1N1-2009 cases upon arrival was estimated to be 22.2% (95% confidence interval: 0, 55.6) among nine confirmed H1N1-2009 cases, and 55.6% of the H1N1-2009 cases were under antipyretic medications upon arrival. The sensitivity and specificity of the infrared thermoscanners in detecting hyperthermia ranged from 50.8-70.4% and 63.6-81.7%, respectively. The positive predictive value appeared to be as low as 37.3-68.0%. Conclusions The sensitivity of entry screening is a product of the sensitivity of fever for detecting influenza cases and the sensitivity of the infrared thermoscanners in detecting fever. Given the additional presence of confounding factors and unrestricted medications among passengers, reliance on fever alone is unlikely to be feasible as an entry screening measure. PMID:21539735

Sensitivity and specificity of bone marrow hemophagocytosis in hemophagocytic lymphohistiocytosis.

PubMed

Goel, Suman; Polski, Jacek M; Imran, Hamayun

2012-01-01

Hemophagocytic lymphohistiocytosis (HLH) is a potentially fatal disease characterized by abnormal activation of T-lymphocytes and macrophages. The diagnosis of HLH can be established if there is a family history of HLH, or evidence of genetic defects, or if 5 of 8 clinicopathologic criteria are fulfilled. This case-control study aimed to examine the extent of hemophagocytosis on the bone marrow examination of patients fulfilling diagnostic criteria for HLH. Hemophagocytosis in 6 bone marrow aspirates from 3 HLH patients was compared with 20 random control bone marrows. Macrophages with hemophagocytosis were counted using a Miller ocular disc in fields corresponding to 9,000 nucleated cells. Mean hemophagocytosis count in the HLH cases was estimated at 0.082% (range 0-0.31%), whereas in the controls it was 0.009% (range 0-0.04%). The sensitivity of hemophagocytosis was 83% with a specificity of only 60%. This demonstrates that rare hemophagocytosis can be seen in bone marrow aspirates from patients without a clinical diagnosis of HLH. It also shows that hemophagocytosis has too low a specificity to be a screening test for HLH. While the hemophagocytosis counts are significantly higher in HLH cases than in controls, overlap of the counts precludes using hemophagocytosis as a reliable indicator of HLH. A rise in the hemophagocytosis count threshold of 0.05-0.13% would increase the specificity to 100%. We suggest that the diagnostic scheme for HLH needs revision, and can be improved by addressing minimum hemophagocytosis count threshold.

Diagnostic value of secreted frizzled-related protein 2 gene promoter hypermethylation in stool for colorectal cancer: A meta-analysis.

PubMed

Zhou, Zhiran; Zhang, Huitian; Lei, Yunxia

2016-10-01

To evaluate the diagnostic value of secreted frizzled-related protein 2 (SFRP2) gene promoter hypermethylation in stool for colorectal cancer (CRC). Open published diagnostic study of SFRP2 gene promoter hypermethylation in stool for CRC detection was electronic searched in the databases of PubMed, EMBASE, Cochrane Library, Web of Science, and China National Knowledge Infrastructure. The data of true positive, false positive false negative, and true negative identified by stool SFRP2 gene hypermethylation was extracted and pooled for diagnostic sensitivity, specificity, and summary receiver operating characteristic (SROC) curve. According to the inclusion and exclusion criteria, we finally included nine publications with 792 cases in the meta-analysis. Thus, the diagnostic sensitivity was aggregated through random effect model. The pooled sensitivity was 0.82 with the corresponding 95% confidence interval (95% CI) of 0.79-0.85; the pooled specificity and its corresponding 95% CI were 0.47 and 0.40-0.53 by the random effect model; we pooled the SROC curve by sensitivity versus specificity according to data published in the nine studies. The area under the SROC curve was 0.70 (95% CI: 0.65-0.73). SFRP2 gene promoter hypermethylation in stool can was a potential biomarker for CRC diagnosis with relative high sensitivity.

[Two cases of royal jelly allergy provoked the symptoms at the time of their first intake].

PubMed

Harada, Susumu; Moriyama, Tatsuya; Tanaka, Akira

2011-06-01

Two young women were suffered from several symptoms after the intake of royal jelly at their first time. According to the positive skin prick test reactions of raw royal jelly, royal jelly allergy was diagnosed. As the reasons why the symptoms appeared at the time of their first intake, we guessed the possibility that 1) they had been sensitized for royal jelly formerly, or 2) their symptoms were induced by the cross-reactivity between royal jelly and other allergens such as bee, honey and pollens. As to our cases, no related allergens were found in one case, but in another case co-existence of mugwort allergy was suspected from the results of both skin prick test and specific IgE titers. Originally royal jelly allergy has been regarded as class 1 allergic reaction developed by the sensitization of itself. But we speculated the possibility that there can also be cases of class 2 royal jelly allergy by the mechanism of cross-reaction with pollens.

Percutaneous CT-guided sacroiliac joint sampling for infection: aspiration, biopsy, and technique.

PubMed

Knipp, David; Simeone, F Joseph; Nelson, Sandra B; Huang, Ambrose J; Chang, Connie Y

2018-04-01

To evaluate methods of CT-guided sacroiliac joint sampling in patients with suspected infection. All CT-guided sacroiliac joint sampling procedures for suspected infection were reviewed for sampling type (aspiration, lavage aspiration, biopsy), microbiology results, and clinical and imaging follow-up. The primary gold standard was anatomic pathology. If pathology was not available, then positive blood culture with the same organism as SIJ sampling, imaging and clinical follow-up, or clinical follow-up only were used. Anterior and posterior joint distention was evaluated by MRI within 7 days of the procedure. A total of 34 patients (age 39 ± 20 (range, 6-75) years; 21 F, 13 M) were included. Aspiration samples only were obtained in 13/34 (38%) cases, biopsy samples only in 9/34 (26%) cases, and both samples in 12/34 (35%) cases. There was an overall 54% sensitivity and 86% specificity. For the aspiration samples, sensitivity and specificity were 60 and 81%, respectively, compared to 45 and 90% for the biopsy samples. In cases with both samples, biopsy did not add additional microbial information. Seventeen (17/34, 50%) patients had an MRI. The anterior joint was more distended than the posterior joint in 15/17 (88%) of patients, and this difference was significant (P = 0.0003). All of these 17 patients had an attempted aspiration by a posterior approach; 6/17 (35%) resulted in a successful aspiration. Aspiration of the sacroiliac joint has a higher sensitivity than biopsy and should always be attempted first. MRI may be helpful for procedure planning.

Diagnostic Accuracy of Ascites Fluid Gross Appearance in Detection of Spontaneous Bacterial Peritonitis

PubMed Central

Aminiahidashti, Hamed; Hosseininejad, Seyed Mohammad; Montazer, Hosein; Bozorgi, Farzad; Goli Khatir, Iraj; Jahanian, Fateme; Raee, Behnaz

2014-01-01

Introduction: Spontaneous bacterial peritonitis (SBP) as a monomicrobial infection of ascites fluid is one of the most important causes of morbidity and mortality in cirrhotic patients. This study was aimed to determine the diagnostic accuracy of ascites fluid color in detection of SBP in cirrhotic cases referred to the emergency department. Methods: Cirrhotic patients referred to the ED for the paracentesis of ascites fluid were enrolled. For all studied patients, the results of laboratory analysis and gross appearance of ascites fluid registered and reviewed by two emergency medicine specialists. The sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ration of the ascites fluid gross appearance in detection of SBP were measured with 95% confidence interval. Results: The present project was performed in 80 cirrhotic patients with ascites (52.5 female). The mean of the subjects’ age was 56.25±12.21 years (35-81). Laboratory findings revealed SBP in 23 (29%) cases. Fifty nine (73%) cases had transparent ascites fluid appearance of whom 17 (29%) ones suffered from SBP. From 21 (26%) cases with opaque ascites appearance, 15 (71%) had SBP. The sensitivity and specificity of the ascites fluid appearance in detection of SBP were 46.88% (Cl: 30.87-63.55) and 87.50% (95% Cl: 75.3-94.14), respectively. Conclusion: It seems that the gross appearance of ascites fluid had poor diagnostic accuracy in detection of SBP and considering its low sensitivity, it could not be used as a good screening tool for this propose. PMID:26495366

Arterial spin labeling-based Z-maps have high specificity and positive predictive value for neurodegenerative dementia compared to FDG-PET.

PubMed

Fällmar, David; Haller, Sven; Lilja, Johan; Danfors, Torsten; Kilander, Lena; Tolboom, Nelleke; Egger, Karl; Kellner, Elias; Croon, Philip M; Verfaillie, Sander C J; van Berckel, Bart N M; Ossenkoppele, Rik; Barkhof, Frederik; Larsson, Elna-Marie

2017-10-01

Cerebral perfusion analysis based on arterial spin labeling (ASL) MRI has been proposed as an alternative to FDG-PET in patients with neurodegenerative disease. Z-maps show normal distribution values relating an image to a database of controls. They are routinely used for FDG-PET to demonstrate disease-specific patterns of hypometabolism at the individual level. This study aimed to compare the performance of Z-maps based on ASL to FDG-PET. Data were combined from two separate sites, each cohort consisting of patients with Alzheimer's disease (n = 18 + 7), frontotemporal dementia (n = 12 + 8) and controls (n = 9 + 29). Subjects underwent pseudocontinuous ASL and FDG-PET. Z-maps were created for each subject and modality. Four experienced physicians visually assessed the 166 Z-maps in random order, blinded to modality and diagnosis. Discrimination of patients versus controls using ASL-based Z-maps yielded high specificity (84%) and positive predictive value (80%), but significantly lower sensitivity compared to FDG-PET-based Z-maps (53% vs. 96%, p < 0.001). Among true-positive cases, correct diagnoses were made in 76% (ASL) and 84% (FDG-PET) (p = 0.168). ASL-based Z-maps can be used for visual assessment of neurodegenerative dementia with high specificity and positive predictive value, but with inferior sensitivity compared to FDG-PET. • ASL-based Z-maps yielded high specificity and positive predictive value in neurodegenerative dementia. • ASL-based Z-maps had significantly lower sensitivity compared to FDG-PET-based Z-maps. • FDG-PET might be reserved for ASL-negative cases where clinical suspicion persists. • Findings were similar at two study sites.

Allergy to kiwi: is component-resolved diagnosis in routine clinical practice really impossible?

PubMed

Asero, R

2012-04-01

Kiwi allergy is frequent and can be the result of sensitization to a number of allergens showing different physicochemical characteristics. Component-resolved diagnosis of kiwi allergy is still unavailable in routine clinical practice. To investigate whether component resolved-diagnosis of kiwi allergy can be, at least in part, carried out by a proper combination of routinely available diagnostic tools. 63 adults with plant food allergy were studied 36 were kiwi-allergic while 27 were kiwi-tolerant and served as controls. Patients and controls underwent SPT with commercial peach and kiwi extracts, and with aprofilin-enriched date palm pollen extract (all by ALK-Abellò), and the measurement of IgE to birch, kiwi, and natural rubber latex. The in-vitro test showed poor sensitivity and specificity, as it scored positive in about 50% of patients and controls irrespective of clinical allergy to kiwi. The kiwi SPT showed overall poor sensitivity; however, it scored negative in all subjects with pollen food-allergy syndrome, was weakly positive in some lipid transfer protein-hypersensitive/kiwi tolerant subjects and in one latex-sensitized subject, and strongly positive in all subjects with primary kiwi sensitization. SPT with this commercial kiwi extract sensitively and specifically detects patients reacting to specific kiwi allergens. This can be useful to detect patients that are at risk of potentially severe reactions, particularly in case of co-sensitization to labile allergens, while we wait that the whole spectrum of kiwi allergens becomes available for routine in-vitro testing.

Diagnostic accuracy of mammography readers and their memory performance have no correlation with each other.

PubMed

Kok, P; Pitman, A G; Cawson, J N; Gledhill, S; Kremer, S; Lawson, J; Mehta, K; Mercuri, V; Shnier, D; Taft, R; Zentner, L

2010-08-01

The study aims to determine if any association exists between visual memory performance and diagnostic accuracy performance in a group of radiologist mammogram readers. One hundred proven mammograms (23 with cancers) were grouped into 5 sets of 20 cases, with sets being of equal difficulty. Pairs of sets were presented in 5 reads (40 cases per read, order random) to a panel of 8 radiologist readers (either present or past screening readers, with experience range from <1 year to >20 years). The readers were asked to either 'clear' or 'call back' cases depending on need for further workup, and at post-baseline reads to indicate whether each case was 'new' or 'old' (i.e. remembered from prior read). Two sets were presented only at baseline (40 cases per reader), and were used to calculate the reader's false recollection rate. Three sets were repeated post-baseline once or twice (100 cases per reader). Reading conditions were standardised. Memory performance differed markedly between readers. The number of correctly remembered cases (of 100 'old' cases) had a median of 10.5 and range of 0-58. The observed number of false recollections (of 40 'totally new' cases) had a median of 2 and range of 0-17. Diagnostic performance measures were mean (range): sensitivity 0.68 (0.54-0.81); specificity 0.82 (0.74-0.91); positive predictive value (PPV) 0.55 (0.50-0.65); negative predictive value (NPV) 0.89 (0.86-0.93) and accuracy 0.78 (0.76-0.83). Confidence intervals (CIs; 95%) for each reader overlapped for all the diagnostic parameters, indicating a lack of statistically significant difference between the readers at the 5% level. The most sensitive and the most specific reader showed a trend away from each other on sensitivity, specificity, NPV and PPV; their accuracies were 0.76 and 0.82, respectively, and their accuracy 95% CIs overlapped considerably. Correlation analysis by reader showed no association between observed memory performance and any of the diagnostic accuracy measures in our group of readers. In particular, there was no correlation between diagnostic accuracy and memory performance. There was no association between visual memory performance and diagnostic accuracy as a screening mammographer in our group of eight representative readers. Whether a radiologist has a good or a bad visual memory for cases, and in particular mammograms, should not impact on his or her performance as a radiologist and mammogram reader.

An automated quantitative DNA image cytometry system detects abnormal cells in cervical cytology with high sensitivity.

PubMed

Wong, O G; Ho, M W; Tsun, O K; Ng, A K; Tsui, E Y; Chow, J N; Ip, P P; Cheung, A N

2018-03-26

To evaluate the performance of an automated DNA-image-cytometry system as a tool to detect cervical carcinoma. Of 384 liquid-based cervical cytology samples with available biopsy follow-up were analyzed by both the Imager System and a high-risk HPV test (Cobas). The sensitivity and specificity of Imager System for detecting biopsy proven high-grade squamous intraepithelial lesion (HSIL, cervical intraepithelial neoplasia [CIN]2-3) and carcinoma were 89.58% and 56.25%, respectively, compared to 97.22% and 23.33% of HPV test but additional HPV 16/18 genotyping increased the specificity to 69.58%. The sensitivity and specificity of the Imager System for predicting HSIL+ (CIN2-3+) lesions among atypical squamous cells of undetermined significance samples were 80.00% and 70.53%, respectively, compared to 100% and 11.58% of HPV test whilst the HPV 16/18 genotyping increased the specificity to 77.89%. Among atypical squamous cells-cannot exclude HSIL, the sensitivity and specificity of Imager System for predicting HSIL+ (CIN2-3+) lesions upon follow up were 82.86% and 33.33%%, respectively, compared to 97.14% and 4.76% of HPV test and the HPV 16/18 genotyping increased the specificity to 19.05%. Among low-grade squamous intraepithelial lesion cases, the sensitivity and specificity of the Imager System for predicting HSIL+ (CIN2-3+) lesions were 66.67% and 35.71%%, respectively, compared to 66.67% and 29.76% of HPV test while HPV 16/18 genotyping increased the specificity to 79.76%. The overall results of imager and high-risk HPV test agreed in 69.43% (268) of all samples. The automated imager system and HPV 16/18 genotyping can enhance the specificity of detecting HSIL+ (CIN2-3+) lesions. © 2018 John Wiley & Sons Ltd.

Fliposomes: pH-triggered conformational flip of new trans-2-aminocyclohexanol-based amphiphiles causes instant cargo release in liposomes.

PubMed

Liu, Xin; Zheng, Yu; Samoshina, Nataliya M; Franz, Andreas H; Guo, Xin; Samoshin, Vyacheslav V

2012-12-01

A new type of pH-sensitive liposomes (fliposomes) was designed based on the amphiphiles that are able to perform a pH-triggered conformational flip (flipids). This flip disrupts the liposome membrane and causes rapid release of the liposome cargo, specifically in response to lowered pH. The flipids (1) and (2) are equipped with a trans-2-aminocyclohexanol conformational switch. pH-sensitive fliposomes containing one or both of these flipids, as well as POPC and PEG ceramide, were constructed and characterized. These compositions were stable at 4°C and pH 7.4 for several months. Fliposomes loaded with ANTS/DPX performed an unusually quick content release within a few seconds at pH below 8.5 (in case of 2) and 6.0 (in case of 1). This difference in pH sensitivity demonstrates a potential for the custom design of flipids by variation of the amino group to target areas with specific pH values. The pH titration curves for the fliposome leakage parallel the curves for the acid-induced conformational flip of 1 and 2 studied by ¹H NMR. A plausible mechanism of pH sensitivity starts with an acid-triggered conformational flip of 1 or 2, which changes the molecular size and shape, shortens the lipid tails, and perturbs the liposome membrane, resulting in the content leakage.

Multiplexed detection of anthrax-related toxin genes.

PubMed

Moser, Michael J; Christensen, Deanna R; Norwood, David; Prudent, James R

2006-02-01

Simultaneous analysis of three targets in three colors on any real-time polymerase chain reaction (PCR) instrument would increase the flexibility of real-time PCR. For the detection of Bacillus strains that can cause inhalation anthrax-related illness, this ability would be valuable because two plasmids confer virulence, and internal positive controls are needed to monitor the testing in cases lacking target-specific signals. Using a real-time PCR platform called MultiCode-RTx, multiple assays were developed that specifically monitor the presence of Bacillus anthracis-specific virulence plasmid-associated genes. In particular for use on LightCycler-1, two triplex RTx systems demonstrated high sensitivity with limits of detection nearing single-copy levels for both plasmids. Specificity was established using a combination of Ct values and correct amplicon melting temperatures. All reactions were further verified by detection of an internal positive control. For these two triplex RTx assays, the analytical detection limit was one to nine plasmid copy equivalents, 100% analytical specificity with a 95% confidence interval (CI) of 9%, and 100% analytical sensitivity with a CI of 2%. Although further testing using clinical or environmental samples will be required to assess diagnostic sensitivity and specificity, the RTx platform achieves similar results to those of probe-based real-time systems.

Evaluation of highly conserved hsp65-specific nested PCR primers for diagnosing Mycobacterium tuberculosis.

PubMed

Priyadarshini, P; Tiwari, K; Das, A; Kumar, D; Mishra, M N; Desikan, P; Nath, G

2017-02-01

To evaluate the sensitivity and specificity of a new nested set of primers designed for the detection of Mycobacterium tuberculosis complex targeting a highly conserved heat shock protein gene (hsp65). The nested primers were designed using multiple sequence alignment assuming the nucleotide sequence of the M. tuberculosis H37Rv hsp65 genome as base. Multidrug-resistant Mycobacterium species along with other non-mycobacterial and fungal species were included to evaluate the specificity of M. tuberculosis hsp65 gene-specific primers. The sensitivity of the primers was determined using serial 10-fold dilutions, and was 100% as shown by the bands in the case of M. tuberculosis complex. None of the other non M. tuberculosis complex bacterial and fungal species yielded any band on nested polymerase chain reaction (PCR). The first round of amplification could amplify 0.3 ng of the template DNA, while nested PCR could detect 0.3 pg. The present hsp65-specific primers have been observed to be sensitive, specific and cost-effective, without requiring interpretation of biochemical tests, real-time PCR, sequencing or high-performance liquid chromatography. These primer sets do not have the drawbacks associated with those protocols that target insertion sequence 6110, 16S rDNA, rpoB, recA and MPT 64.

The hospital anxiety and depression rating scale: A cross-sectional study of psychometrics and case finding abilities in general practice

PubMed Central

Olssøn, Ingrid; Mykletun, Arnstein; Dahl, Alv A

2005-01-01

Background General practitioners' (GPs) diagnostic skills lead to underidentification of generalized anxiety disorders (GAD) and major depressive episodes (MDE). Supplement of brief questionnaires could improve the diagnostic accuracy of GPs for these common mental disorders. The aims of this study were to examine the usefulness of The Hospital Anxiety and Depression Rating Scale (HADS) for GPs by: 1) Examining its psychometrics in the GPs' setting; 2) Testing its case-finding properties compared to patient-rated GAD and MDE (DSM-IV); and 3) Comparing its case finding abilities to that of the GPs using Clinical Global Impression-Severity (CGI-S) rating. Methods In a cross-sectional survey study 1,781 patients in three consecutive days in September 2001 attended 141 GPs geographically spread in Norway. Sensitivity, specificity, optimal cut off score, and Area under the curve (AUC) for the HADS and the CGI-S were calculated with Generalized Anxiety Questionnaire (GAS-Q) as reference standard for GAD, and Depression Screening Questionnaire (DSQ) for MDE. Results The HADS-A had optimal cut off ≥8 (sensitivity 0.89, specificity 0.75), AUC 0.88 and 76% of patients were correctly classified in relation to GAD. The HADS-D had by optimal cut off ≥8 (sensitivity 0.80 and specificity 0.88) AUC 0.93 and 87% of the patients were correctly classified in relation to MDE. Proportions of the total correctly classified at the CGI-S optimal cut-off ≥3 were 83% of patients for GAD and 81% for MDE. Conclusion The results indicate that addition of the patients' HADS scores to GPs' information could improve their diagnostic accuracy of GAD and MDE. PMID:16351733

PIVKA-II is a useful tool for diagnostic characterization of ultrasound-detected liver nodules in cirrhotic patients

PubMed Central

Saitta, Carlo; Raffa, Giuseppina; Alibrandi, Angela; Brancatelli, Santa; Lombardo, Daniele; Tripodi, Gianluca; Raimondo, Giovanni; Pollicino, Teresa

2017-01-01

Abstract Protein induced by vitamin K absence-II (PIVKA-II) is a potential screening marker for hepatocellular carcinoma (HCC). Limited data are available about its utility in discriminating neoplastic from regenerative nodules at ultrasonography (US) evaluation in cirrhotic patients. Aim of this study was to investigate the diagnostic utility of PIVKA-II in cases showing liver nodules of uncertain diagnosis at US. Ninety cirrhotics with US evidence of liver nodule(s) were enrolled. All patients underwent blood sampling within 1 week of US and were thereafter followed up. HCC was confirmed in 40/90 cases, and in all cases it was in a very early/early stage. All sera were tested for PIVKA-II and alpha-fetoprotein (AFP) at the end of follow-up. PIVKA-II at a cut off of 60 mAU/mL was significantly associated with HCC at both univariate and multivariate analysis (P = .016 and P = .032, respectively). AFP at a cut off of 6.5 ng/mL was not associated with HCC at univariate analysis (P = .246). ROC curves showed that PIVKA-II had 60% sensitivity, 88% specificity, 80% positive predictive value (PPV), and 73% negative predictive value (NPV), whereas AFP had 67% sensitivity, 68% specificity, 63% PPV, and 72% NPV. AUROC curves showed that the combination of both biomarkers increased the diagnostic accuracy for HCC (AUC 0.76; sensitivity 70%, specificity 94%, PPV 91%, and NPV 79%). In conclusion, PIVKA-II is a useful tool for the diagnostic definition of US-detected liver nodules in cirrhotic patients, and it provides high diagnostic accuracy for HCC when combined with AFP. PMID:28658121

Diagnostic and prognostic value of human prion detection in cerebrospinal fluid.

PubMed

Foutz, Aaron; Appleby, Brian S; Hamlin, Clive; Liu, Xiaoqin; Yang, Sheng; Cohen, Yvonne; Chen, Wei; Blevins, Janis; Fausett, Cameron; Wang, Han; Gambetti, Pierluigi; Zhang, Shulin; Hughson, Andrew; Tatsuoka, Curtis; Schonberger, Lawrence B; Cohen, Mark L; Caughey, Byron; Safar, Jiri G

2017-01-01

Several prion amplification systems have been proposed for detection of prions in cerebrospinal fluid (CSF), most recently, the measurements of prion seeding activity with second-generation real-time quaking-induced conversion (RT-QuIC). The objective of this study was to investigate the diagnostic performance of the RT-QuIC prion test in the broad phenotypic spectrum of prion diseases. We performed CSF RT-QuIC testing in 2,141 patients who had rapidly progressive neurological disorders, determined diagnostic sensitivity and specificity in 272 cases that were autopsied, and evaluated the impact of mutations and polymorphisms in the PRNP gene, and type 1 or type 2 human prions on diagnostic performance. The 98.5% diagnostic specificity and 92% sensitivity of CSF RT-QuIC in a blinded retrospective analysis matched the 100% specificity and 95% sensitivity of a blind prospective study. The CSF RT-QuIC differentiated 94% of cases of sporadic Creutzfeldt-Jakob disease (sCJD) MM1 from the sCJD MM2 phenotype, and 80% of sCJD VV2 from sCJD VV1. The mixed prion type 1-2 and cases heterozygous for codon 129 generated intermediate CSF RT-QuIC patterns, whereas genetic prion diseases revealed distinct profiles for each PRNP gene mutation. The diagnostic performance of the improved CSF RT-QuIC is superior to surrogate marker tests for prion diseases such as 14-3-3 and tau proteins, and together with PRNP gene sequencing the test allows the major prion subtypes to be differentiated in vivo. This differentiation facilitates prediction of the clinicopathological phenotype and duration of the disease-two important considerations for envisioned therapeutic interventions. ANN NEUROL 2017;81:79-92. © 2016 American Neurological Association.

Diagnostic and Prognostic Value of Human Prion Detection in Cerebrospinal Fluid

PubMed Central

Foutz, Aaron; Appleby, Brian S.; Hamlin, Clive; Liu, Xiaoqin; Yang, Sheng; Cohen, Yvonne; Chen, Wei; Blevins, Janis; Fausett, Cameron; Wang, Han; Gambetti, Pierluigi; Zhang, Shulin; Hughson, Andrew; Tatsuoka, Curtis; Schonberger, Lawrence B.; Cohen, Mark L.; Caughey, Byron; Safar, Jiri G.

2016-01-01

Objective Several prion amplification systems have been proposed for detection of prions in cerebrospinal fluid (CSF), most recently, the measurements of prion seeding activity with second-generation real-time quaking-induced conversion (RT-QuIC). The objective of this study was to investigate the diagnostic performance of the RT-QuIC prion test in the broad phenotypic spectrum of prion diseases. Methods We performed CSF RT-QuIC testing in 2,141 patients who had rapidly progressive neurological disorders, determined diagnostic sensitivity and specificity in 272 cases which were autopsied, and evaluated the impact of mutations and polymorphisms in the PRNP gene, and Type 1 or Type 2 of human prions on diagnostic performance. Results The 98.5% diagnostic specificity and 92% sensitivity of CSF RT-QuIC in a blinded retrospective analysis matched the 100% specificity and 95% sensitivity of a blind prospective study. The CSF RT-QuIC differentiated 94% of cases of sporadic Creutzfeldt-Jakob disease (sCJD) MM1 from the sCJD MM2 phenotype, and 80% of sCJD VV2 from sCJD VV1. The mixed prion type 1–2 and cases heterozygous for codon 129 generated intermediate CSF RT-QuIC patterns, while genetic prion diseases revealed distinct profiles for each PRNP gene mutation. Interpretation The diagnostic performance of the improved CSF RT-QuIC is superior to surrogate marker tests for prion diseases such as 14-3-3 and Tau proteins and together with PRNP gene sequencing, the test allows the major prion subtypes to be differentiated in vivo. This differentiation facilitates prediction of the clinicopathological phenotype and duration of the disease—two important considerations for envisioned therapeutic interventions. PMID:27893164

Accuracy of diagnosis codes to identify febrile young infants using administrative data.

PubMed

Aronson, Paul L; Williams, Derek J; Thurm, Cary; Tieder, Joel S; Alpern, Elizabeth R; Nigrovic, Lise E; Schondelmeyer, Amanda C; Balamuth, Fran; Myers, Angela L; McCulloh, Russell J; Alessandrini, Evaline A; Shah, Samir S; Browning, Whitney L; Hayes, Katie L; Feldman, Elana A; Neuman, Mark I

2015-12-01

Administrative data can be used to determine optimal management of febrile infants and aid clinical practice guideline development. Determine the most accurate International Classification of Diseases, Ninth Revision (ICD-9) diagnosis coding strategies for identification of febrile infants. Retrospective cross-sectional study. Eight emergency departments in the Pediatric Health Information System. Infants aged <90 days evaluated between July 1, 2012 and June 30, 2013 were randomly selected for medical record review from 1 of 4 ICD-9 diagnosis code groups: (1) discharge diagnosis of fever, (2) admission diagnosis of fever without discharge diagnosis of fever, (3) discharge diagnosis of serious infection without diagnosis of fever, and (4) no diagnosis of fever or serious infection. The ICD-9 diagnosis code groups were compared in 4 case-identification algorithms to a reference standard of fever ≥100.4°F documented in the medical record. Algorithm predictive accuracy was measured using sensitivity, specificity, and negative and positive predictive values. Among 1790 medical records reviewed, 766 (42.8%) infants had fever. Discharge diagnosis of fever demonstrated high specificity (98.2%, 95% confidence interval [CI]: 97.8-98.6) but low sensitivity (53.2%, 95% CI: 50.0-56.4). A case-identification algorithm of admission or discharge diagnosis of fever exhibited higher sensitivity (71.1%, 95% CI: 68.2-74.0), similar specificity (97.7%, 95% CI: 97.3-98.1), and the highest positive predictive value (86.9%, 95% CI: 84.5-89.3). A case-identification strategy that includes admission or discharge diagnosis of fever should be considered for febrile infant studies using administrative data, though underclassification of patients is a potential limitation. © 2015 Society of Hospital Medicine.

Accuracy of Diagnosis Codes to Identify Febrile Young Infants Using Administrative Data

PubMed Central

Aronson, Paul L.; Williams, Derek J.; Thurm, Cary; Tieder, Joel S.; Alpern, Elizabeth R.; Nigrovic, Lise E.; Schondelmeyer, Amanda C.; Balamuth, Fran; Myers, Angela L.; McCulloh, Russell J.; Alessandrini, Evaline A.; Shah, Samir S.; Browning, Whitney L.; Hayes, Katie L.; Feldman, Elana A.; Neuman, Mark I.

2015-01-01

Background Administrative data can be used to determine optimal management of febrile infants and aid clinical practice guideline development. Objective Determine the most accurate International Classification of Diseases, 9th revision (ICD-9) diagnosis coding strategies for identification of febrile infants. Design Retrospective cross-sectional study. Setting Eight emergency departments in the Pediatric Health Information System. Patients Infants age < 90 days evaluated between July 1, 2012 and June 30, 2013 were randomly selected for medical record review from one of four ICD-9 diagnosis code groups: 1) discharge diagnosis of fever, 2) admission diagnosis of fever without discharge diagnosis of fever, 3) discharge diagnosis of serious infection without diagnosis of fever, and 4) no diagnosis of fever or serious infection. Exposure The ICD-9 diagnosis code groups were compared in four case-identification algorithms to a reference standard of fever ≥ 100.4°F documented in the medical record. Measurements Algorithm predictive accuracy was measured using sensitivity, specificity, negative and positive predictive values. Results Among 1790 medical records reviewed, 766 (42.8%) infants had fever. Discharge diagnosis of fever demonstrated high specificity (98.2%, 95% confidence interval [CI]: 97.8-98.6) but low sensitivity (53.2%, 95% CI: 50.0-56.4). A case-identification algorithm of admission or discharge diagnosis of fever exhibited higher sensitivity (71.1%, 95% CI: 68.2-74.0), similar specificity (97.7%, 95% CI: 97.3-98.1), and the highest positive predictive value (86.9%, 95% CI: 84.5-89.3). Conclusions A case-identification strategy that includes admission or discharge diagnosis of fever should be considered for febrile infant studies using administrative data, though under-classification of patients is a potential limitation. PMID:26248691

Immune biosensors based on the SPR and TIRE: efficiency of their application for bacteria determination

NASA Astrophysics Data System (ADS)

Starodub, N. F.; Ogorodniichuk, J.; Lebedeva, T.; Shpylovyy, P.

2013-11-01

In this work we have designed high-specific biosensors for Salmonella typhimurium detection based on the surface plasmon resonance (SPR) and total internal reflection ellipsometry (TIRE). It has been demonstrated high selectivity and sensitivity of analysis. As a registering part for our experiments the Spreeta (USA) and "Plasmonotest" (Ukraine) with flowing cell have been applied among of SPR device. Previous researches confirmed an efficiency of SPR biosensors using for detecting of specific antigen-antibody interactions therefore this type of reactions with some previous preparations of surface binding layer was used as reactive part. It has been defined that in case with Spreeta sensitivity was on the level 103 - 107 cells/ml. Another biosensor based on the SPR has shown the sensitivity within 101 - 106 cells/ml. Maximal sensitivity was on the level of several cells in 10 ml (up to the fact that less than 5 cells) which has been obtained using the biosensor based on TIRE.

Rheumatoid arthritis prevalence in Quebec.

PubMed

Bernatsky, Sasha; Dekis, Alaa; Hudson, Marie; Pineau, Christian A; Boire, Gilles; Fortin, Paul R; Bessette, Louis; Jean, Sonia; Chetaille, Ann L; Belisle, Patrick; Bergeron, Louise; Feldman, Debbie Ehrmann; Joseph, Lawrence

2014-12-19

To estimate rheumatoid arthritis (RA) prevalence in Quebec using administrative health data, comparing across regions. Cases of RA were ascertained from physician billing and hospitalization data, 1992-2008. We used three case definitions: 1) ≥ 2 billing diagnoses, submitted by any physician, ≥ 2 months apart, but within 2 years; 2) ≥ 1 diagnosis, by a rheumatologist; 3) ≥1 hospitalization diagnosis (all based on ICD-9 code 714, and ICD-10 code M05). We combined data across these three case definitions, using Bayesian hierarchical latent class models to estimate RA prevalence, adjusting for the imperfect sensitivity and specificity of the data. We compared urban versus rural regions. Using our case definitions and no adjustment for error, we defined 75,760 cases for an over-all RA prevalence of 9.9 per thousand residents. After adjusting for the imperfect sensitivity and specificity of our case definition algorithms, we estimated Quebec RA prevalence at 5.6 per 1000 females and 4.1 per 1000 males. The adjusted RA prevalence estimates for older females were the highest for any demographic group (9.9 cases per 1,000), and were similar in rural and urban regions. In younger males and females, and in older males, RA prevalence estimates were lower in rural versus urban areas. Without adjustment for error inherent in administrative databases, RA prevalence in Quebec was approximately 1%, while adjusted estimates are approximately half that. The lower prevalence in rural areas, seen for most demographic groups, may suggest either true regional variations in RA risk, or under-ascertainment of cases in rural Quebec.

Accuracy of clinical diagnosis versus the World Health Organization case definition in the Amoy Garden SARS cohort.

PubMed

Wong, W N; Sek, Antonio C H; Lau, Rick F L; Li, K M; Leung, Joe K S; Tse, M L; Ng, Andy H W; Stenstrom, Robert

2003-11-01

To compare the diagnostic accuracy of emergency department (ED) physicians with the World Health Organization (WHO) case definition in a large community-based SARS (severe acute respiratory syndrome) cohort. This was a cohort study of all patients from Hong Kong's Amoy Garden complex who presented to an ED SARS screening clinic during a 2-month outbreak. Clinical findings and WHO case definition criteria were recorded, along with ED diagnoses. Final diagnoses were established independently based on relevant diagnostic tests performed after the ED visit. Emergency physician diagnostic accuracy was compared with that of the WHO SARS case definition. Sensitivity, specificity, predictive values and likelihood ratios were calculated using standard formulae. During the study period, 818 patients presented with SARS-like symptoms, including 205 confirmed SARS, 35 undetermined SARS and 578 non-SARS. Sensitivity, specificity and accuracy were 91%, 96% and 94% for ED clinical diagnosis, versus 42%, 86% and 75% for the WHO case definition. Positive likelihood ratios (LR+) were 21.1 for physician judgement and 3.1 for the WHO criteria. Negative likelihood ratios (LR-) were 0.10 for physician judgement and 0.67 for the WHO criteria, indicating that clinician judgement was a much more powerful predictor than the WHO criteria. Physician clinical judgement was more accurate than the WHO case definition. Reliance on the WHO case definition as a SARS screening tool may lead to an unacceptable rate of misdiagnosis. The SARS case definition must be revised if it is to be used as a screening tool in emergency departments and primary care settings.

Proteomic Approach for Diagnostic Applications in Head and Neck Cancer — EDRN Public Portal

Cancer.gov

To evaluate the test characteristics of a panel of biomarkers for identifying patients with early stage head and neck squamous cell carcinoma (HNSCC). The primary endpoints are sensitivity, specificity and accuracy of the marker panel. This study of the test characteristics of a modeling strategy for diagnosing HNSCC uses a case-control design, with several types of cases and several types of controls.

Toxoplasmosis masking non-Hodgkin's lymphoma: a case report.

PubMed

Mighell, A; Carton, A; Carey, P; High, A

1995-12-01

A 39-year-old female with persistent cervical lymphadenopathy is reported. Initial investigations resulted in a diagnosis of toxoplasmosis, but subsequently the patient proved to have high grade immunoblastic non-Hodgkin's lymphoma. This paper highlights the difficulties in accurately diagnosing some cases of either toxoplasmosis or lymphoma, and briefly mentions some of the ongoing technical advances which will increase diagnostic specificity and sensitivity by early detection of genetic mutations.

Nasal potential difference outcomes support diagnostic decisions in cystic fibrosis.

PubMed

Tridello, Gloria; Menin, Laura; Pintani, Emily; Bergamini, Gabriella; Assael, Baroukh Maurice; Melotti, Paola

2016-09-01

When cystic fibrosis (CF) is suspected Nasal Potential Difference (NPD) measurements are proposed to support controversial diagnosis: we investigated appropriate outcomes at the CF Centre of Verona. NPD were measured in 196 subjects: 50 non-CF, 65 classical CF (the reference group) and 81 with uncertain CF (case group). Discriminating power was determined by comparison between several outcomes from the CF reference group versus non-CF: basal, amiloride, 0Cl, isoproterenol, ATP, Delta-amiloride, Delta-0Cl, Delta-isoproterenol, Delta-ATP, Delta-isoproterenol+Delta-0Cl, Wilschanski Index (WI) and Sermet score (SS). The most appropriate cut-off values for variables with the best discriminating power were then applied to the case group. Descriptive statistics, logistic regression models and ROC curve analysis were applied. WI and SS were the most powerful in discriminating CF from non-CF subjects. In the reference group sensitivity of the 0.82 WI cut-off was 98%, specificity 96%; both sensitivity and specificity of the -0.44 SS cut-off value were 100%. For the case group, WI and SS were, respectively, consistent with CF diagnosis in 94% and 92% of the cases. Formulae have the highest discriminating power and can support the diagnosis in uncertain cases; they should be utilized for standardized interpretation of NPD for diagnosis and possibly for clinical research. Copyright © 2016. Published by Elsevier B.V.

3T MRI evaluation of large nerve perineural spread of head and neck cancers.

PubMed

Baulch, Justin; Gandhi, Mitesh; Sommerville, Jennifer; Panizza, Ben

2015-10-01

Accurate definition of the presence and extent of large nerve perineural spread (PNS) is a vital component in planning appropriate surgery and radiotherapy for head and neck cancers. Our research aimed to define the sensitivity and specificity of 3T MRI in detecting the presence and extent of large nerve PNS, compared with histologic evaluation. Retrospective review of surgically proven cases of large nerve PNS in patients with preoperative 3T MRI performed as high resolution neurogram. 3T MRI had a sensitivity of 95% and a specificity of 84%, detecting PNS in 36 of 38 nerves and correctly identifying uninvolved nerves in 16 of 19 cases. It correctly identified the zonal extent of spread in 32 of 36 cases (89%), underestimating the extent in three cases and overestimating the extent in one case. Targeted 3T MRI is highly accurate in defining the presence and extent of large nerve PNS in head and neck cancers. However, there is still a tendency to undercall the zonal extent due to microscopic, radiologically occult involvement. Superficial large nerve involvement also remains a difficult area of detection for radiologists and should be included as a 'check area' for review. Further research is required to define the role radiation-induced neuritis plays in the presence of false-positive PNS on MRI. © 2015 The Royal Australian and New Zealand College of Radiologists.

Tumor-associated autoantibodies are useful biomarkers in immunodiagnosis of α-fetoprotein-negative hepatocellular carcinoma.

PubMed

Wang, Ting; Liu, Mei; Zheng, Su-Jun; Bian, Dan-Dan; Zhang, Jin-Yan; Yao, Jia; Zheng, Qing-Fen; Shi, A-Meng; Li, Wen-Han; Li, Lu; Chen, Yu; Wang, Jin-Hai; Duan, Zhong-Ping; Dong, Lei

2017-05-21

To determine the prevalence and diagnostic value of autoantibodies in α-fetoprotein (AFP)-negative hepatocellular carcinoma (HCC). Fifty-six serum samples from AFP-negative HCC cases, 86 from AFP-positive HCC cases, 168 from chronic liver disease cases, and 59 from normal human controls were included in this study. Autoantibodies to nucleophosmin (NPM)1, 14-3-3zeta and mouse double minute 2 homolog (MDM2) proteins in AFP-negative HCC serum were evaluated by enzyme-linked immunosorbent assay. Partially positive sera were further evaluated by western blotting. Immunohistochemistry was used to detect the expression of three tumor-associated antigens (TAAs) in AFP-negative HCC and normal control tissues. The frequency of autoantibodies to the three TAAs in AFP-negative HCC sera was 21.4%, 19.6% and 19.6%, which was significantly higher than in the chronic liver disease cases and normal human controls ( P < 0.01) as well as AFP-positive HCC cases. The sensitivity of the three autoantibodies for diagnosis of AFP-negative HCC ranged from 19.6% to 21.4%, and the specificity was approximately 95%. When the three autoantibodies were combined, the sensitivity reached 30.4% and the specificity reached 91.6%. Autoantibodies to NPM1, 14-3-3zeta and MDM2 may be useful biomarkers for immunodiagnosis of AFP-negative HCC.

Tumor-associated autoantibodies are useful biomarkers in immunodiagnosis of α-fetoprotein-negative hepatocellular carcinoma

PubMed Central

Wang, Ting; Liu, Mei; Zheng, Su-Jun; Bian, Dan-Dan; Zhang, Jin-Yan; Yao, Jia; Zheng, Qing-Fen; Shi, A-Meng; Li, Wen-Han; Li, Lu; Chen, Yu; Wang, Jin-Hai; Duan, Zhong-Ping; Dong, Lei

2017-01-01

AIM To determine the prevalence and diagnostic value of autoantibodies in α-fetoprotein (AFP)-negative hepatocellular carcinoma (HCC). METHODS Fifty-six serum samples from AFP-negative HCC cases, 86 from AFP-positive HCC cases, 168 from chronic liver disease cases, and 59 from normal human controls were included in this study. Autoantibodies to nucleophosmin (NPM)1, 14-3-3zeta and mouse double minute 2 homolog (MDM2) proteins in AFP-negative HCC serum were evaluated by enzyme-linked immunosorbent assay. Partially positive sera were further evaluated by western blotting. Immunohistochemistry was used to detect the expression of three tumor-associated antigens (TAAs) in AFP-negative HCC and normal control tissues. RESULTS The frequency of autoantibodies to the three TAAs in AFP-negative HCC sera was 21.4%, 19.6% and 19.6%, which was significantly higher than in the chronic liver disease cases and normal human controls (P < 0.01) as well as AFP-positive HCC cases. The sensitivity of the three autoantibodies for diagnosis of AFP-negative HCC ranged from 19.6% to 21.4%, and the specificity was approximately 95%. When the three autoantibodies were combined, the sensitivity reached 30.4% and the specificity reached 91.6%. CONCLUSION Autoantibodies to NPM1, 14-3-3zeta and MDM2 may be useful biomarkers for immunodiagnosis of AFP-negative HCC. PMID:28596685

Xpert(®) MTB/RIF for improved case detection of extra-pulmonary TB in a tertiary care setting in urban India.

PubMed

Nataraj, G; Kanade, S; Mehta, P

2016-07-01

Department of microbiology at a tertiary care hospital, Mumbai, India. To determine 1) the sensitivity and specificity of the Xpert(®) MTB/RIF assay in comparison with microscopy and culture in extra-pulmonary tuberculosis (EPTB), and 2) the number of additional cases of EPTB and rifampicin (RMP) resistance detected using this assay. The study was conducted from July 2013 to April 2015. All consecutive patients with clinically suspected EPTB referred for microscopic examination to the Department of Microbiology that were sufficient in specimen volume were included in the study. Of the 728 specimens included in the study, respectively 5.5%, 23.5% and 20.9% were positive on smear, culture and Xpert. Compared to culture, Xpert had a sensitivity of 84.2% (95%CI 81.4-86.6) and specificity of 98.2% (95%CI 90-104). All specimens with high and medium load on assay were positive on culture; 28 (18.4%) specimens were RMP-resistant and 124 (81.6%) were Xpert-susceptible. No additional RMP-resistant cases were detected using Xpert as compared to phenotypic drug susceptibility testing. The ability of the Xpert assay to rapidly detect a significantly greater number of bacteriologically confirmed EPTB cases, including RMP-resistant cases, makes it an important diagnostic tool in a TB-endemic country.

Morin Stain Detects Aluminum-Containing Macrophages in Macrophagic Myofasciitis and Vaccination Granuloma With High Sensitivity and Specificity.

PubMed

Chkheidze, Rati; Burns, Dennis K; White, Charles L; Castro, Diana; Fuller, Julie; Cai, Chunyu

2017-04-01

Macrophagic myofasciitis (MMF) is an inflammatory condition associated with the intramuscular (i.m.) injection of aluminum adjuvant-containing vaccines. It is clinically characterized by myalgia, weakness, and chronic fatigue and histologically by aggregates of cohesive macrophages with abundant basophilic, periodic acid-Schiff (PAS)-positive, diastase-resistant granules that percolate through the peri- and endomysium without eliciting substantial myofiber damage. The definitive diagnosis of MMF requires demonstration of aluminum within these macrophages. We evaluated the Morin stain, a simple, 2-step histochemical stain for aluminum, as a confirmatory diagnostic tool for MMF. Among 2270 muscle biopsies processed at UTSW between 2010 and 2015, a total of 12 MMF cases and 1 subcutaneous vaccination granuloma case were identified (11 pediatric, 2 adults). With the Morin stain, all 13 cases showed strong granular reactivity within the cytoplasm of macrophages but not in myofibers or connective tissue. Three cases of inflammatory myopathy with abundant macrophages (IMAM), 8 cases of granulomatous inflammation and 23 other deltoid muscle biopsies used as controls were all negative. Morin stain could be used in both formalin-fixed paraffin-embedded and cryostat sections. Thus, Morin stain detects aluminum with high sensitivity and specificity in human muscle and soft tissue and may improve the diagnostic yield of MMF and vaccination granuloma. © 2017 American Association of Neuropathologists, Inc.

A novel approach for medical research on lymphomas

PubMed Central

Conte, Cécile; Palmaro, Aurore; Grosclaude, Pascale; Daubisse-Marliac, Laetitia; Despas, Fabien; Lapeyre-Mestre, Maryse

2018-01-01

Abstract The use of claims database to study lymphomas in real-life conditions is a crucial issue in the future. In this way, it is essential to develop validated algorithms for the identification of lymphomas in these databases. The aim of this study was to assess the validity of diagnosis codes in the French health insurance database to identify incident cases of lymphomas according to results of a regional cancer registry, as the gold standard. Between 2010 and 2013, incident lymphomas were identified in hospital data through 2 algorithms of selection. The results of the identification process and characteristics of incident lymphomas cases were compared with data from the Tarn Cancer Registry. Each algorithm's performance was assessed by estimating sensitivity, predictive positive value, specificity (SPE), and negative predictive value. During the period, the registry recorded 476 incident cases of lymphomas, of which 52 were Hodgkin lymphomas and 424 non-Hodgkin lymphomas. For corresponding area and period, algorithm 1 provides a number of incident cases close to the Registry, whereas algorithm 2 overestimated the number of incident cases by approximately 30%. Both algorithms were highly specific (SPE = 99.9%) but moderately sensitive. The comparative analysis illustrates that similar distribution and characteristics are observed in both sources. Given these findings, the use of claims database can be consider as a pertinent and powerful tool to conduct medico-economic or pharmacoepidemiological studies in lymphomas. PMID:29480830

Image-guided fine-needle aspiration of retroperitoneal masses: The role of the cytopathologist.

PubMed

Mehdi, Ghazala; Maheshwari, Veena; Afzal, Sheerin; Ansari, Hena A; Ahmad, Ibne

2013-01-01

Retroperitoneal tumors constitute a difficult diagnostic category as they are not easily accessible. The advent of image-guided fine-needle aspiration (FNA) has resolved this problem significantly. We present a short study based on guided aspiration of retroperitoneal tumors, in which we have tried to assess the role of image-guided fine-needle aspiration cytology as a tool for pre-operative diagnosis. The study was conducted on patients diagnosed with retroperitoneal masses. FNA was performed under image guidance with the help of ultrasonography and/or computed tomography; smears were prepared and meticulously screened according to a fixed protocol. The results were analyzed to determine sensitivity, specificity, and diagnostic efficacy of cytopathological diagnosis using image-guided FNA techniques. We assessed 38 patients with retroperitoneal masses. In all cases, adequate cellular material was obtained. No major complications were encountered. Statistical analysis was carried out in 35 cases; sensitivity, specificity, and diagnostic accuracy were 100% in these cases. FNA under image guidance should be considered a first-line diagnostic approach for retroperitoneal and other abdominal tumors, although caution should be exercised in case selection. In areas where advanced tests are not available, the cytotechnologist and cytopathologist have a very important role to play in ensuring accurate diagnoses.

Lichtheimia Infection in a Lymphoma Patient: Case Report and a Brief Review of the Available Diagnostic Tools.

PubMed

Zimmerli, Stefan; Bialek, Ralf; Blau, Igor W; Christe, Andreas; Lass-Flörl, Cornelia; Presterl, Elisabeth

2016-08-01

We describe the case of a patient with a T-lymphoblastic lymphoma whose disseminated mucormycosis was diagnosed with delay, and we address the diagnostic and therapeutic decision-making process and review the diagnostic workup of patients with potential IFD. The diagnosis was delayed despite a suggestive radiological presentation of the patient's pulmonary lesion. The uncommon risk profile (T-lymphoblastic lymphoma, short neutropenic phases) wrongly led to a low level of suspicion. The diagnosis was also hampered by the lack of indirect markers for infections caused by Mucorales, the low sensitivity of both fungal culture and panfungal PCR, and the limited availability of species-specific PCR. A high level of suspicion of IFD is needed, and aggressive diagnostic procedures should be promptly initiated even in apparently low-risk patients with uncommon presentations. The extent of the analytical workup should be decided on a case-by-case base. Diagnostic tests such as the galactomannan and β-D-glucan test and/or PCR on biological material followed by sequencing should be chosen according to their availability and after evaluation of their specificity and sensitivity. In high-risk patients, preemptive therapy with a broad-spectrum mould-active antifungal agent should be started before definitive diagnostic findings become available.

Characterization of human papillomavirus antibodies in individuals with head and neck cancer

PubMed Central

Lang Kuhs, Krystle A.; Pawlita, Michael; Gibson, Sandra P.; Schmitt, Nicole C.; Trivedi, Sumita; Argiris, Athanassios; Kreimer, Aimée R.; Ferris, Robert L.; Waterboer, Tim

2016-01-01

BACKGROUND Human papillomavirus type 16 (HPV16) E6 antibodies are a promising biomarker of oropharyngeal cancer (OPC); however, seropositivity among non-OPC cases is not well characterized. METHODS Pre-treatment sera from 260 (38 OPC, 222 non-OPC) incident head and neck cancers diagnosed at the University of Pittsburgh between 2003 and 2006 were tested for HPV16 (L1,E1,E2,E4,E6,E7) and non-HPV16 E6 (HPV6,11,18,33) antibodies. Sensitivity and specificity of HPV16 E6 antibodies for HPV-driven tumors was evaluated among tumors with known HPV status (n=25). RESULTS 63.2% of OPC versus 27.5% of non-OPC cases were HPV16 seropositive; HPV16 E6 seroprevalence was 60.5% and 6.3% respectively, odds ratio 22.8 (95% confidence interval [CI] 9.8–53.1). Sensitivity and specificity of HPV16 E6 antibodies for HPV-driven OPC was 100% [95%CI:50%–100%; n=6] and 100% [95%CI:60%–100%, n=4] compared to 0% (n=2) and 0% (n=13) for non-OPC cases. CONCLUSIONS HPV16 antibodies were significantly more common in OPC versus non-OPC cases, particularly HPV16 E6 antibodies. PMID:27010729

A practical approach to the diagnosis of systemic amyloidoses.

PubMed

Fernández de Larrea, Carlos; Verga, Laura; Morbini, Patrizia; Klersy, Catherine; Lavatelli, Francesca; Foli, Andrea; Obici, Laura; Milani, Paolo; Capello, Gian Luca; Paulli, Marco; Palladini, Giovanni; Merlini, Giampaolo

2015-04-02

Accurate diagnosis of systemic amyloidosis is necessary both for assessing the prognosis and for delineating the appropriate treatment. It is based on histologic evidence of amyloid deposits and characterization of the amyloidogenic protein. We prospectively evaluated the diagnostic performance of immunoelectron microscopy (IEM) of abdominal fat aspirates from 745 consecutive patients with suspected systemic amyloidoses. All cases were extensively investigated with clinical and laboratory data, with a follow-up of at least 18 months. The 423 (56.8%) cases with confirmed systemic forms were used to estimate the diagnostic performance of IEM. Compared with Congo-red-based light microscopy, IEM was equally sensitive (75% to 80%) but significantly more specific (100% vs 80%; P < .001). In amyloid light-chain (AL) amyloidosis, κ cases were more difficult to diagnose (sensitivity 71%), whereas the analysis of abdominal aspirate was informative in only 40% of patients with transthyretin amyloidosis. We found a high prevalence (20%) of a monoclonal component in patients with non-AL amyloidosis, highlighting the risk of misdiagnosis and the need for unequivocal amyloid typing. Notably, IEM identified correctly the specific form of amyloidosis in >99% of the cases. IEM of abdominal fat aspirates is an effective tool in the routine diagnosis of systemic amyloidoses. © 2015 by The American Society of Hematology.

Characterization of human papillomavirus antibodies in individuals with head and neck cancer.

PubMed

Lang Kuhs, Krystle A; Pawlita, Michael; Gibson, Sandra P; Schmitt, Nicole C; Trivedi, Sumita; Argiris, Athanassios; Kreimer, Aimée R; Ferris, Robert L; Waterboer, Tim

2016-06-01

Human papillomavirus type 16 (HPV16) E6 antibodies are a promising biomarker of oropharyngeal cancer (OPC); however, seropositivity among non-OPC cases is not well characterized. Pre-treatment sera from 260 (38 OPC, 222 non-OPC) incident head and neck cancers diagnosed at the University of Pittsburgh between 2003 and 2006 were tested for HPV16 (L1,E1,E2,E4,E6,E7) and non-HPV16 E6 (HPV6,11,18,33) antibodies. Sensitivity and specificity of HPV16 E6 antibodies for HPV-driven tumors was evaluated among tumors with known HPV status (n=25). 63.2% of OPC versus 27.5% of non-OPC cases were HPV16 seropositive; HPV16 E6 seroprevalence was 60.5% and 6.3% respectively, odds ratio 22.8 (95% confidence interval [CI] 9.8-53.1). Sensitivity and specificity of HPV16 E6 antibodies for HPV-driven OPC was 100% [95% CI: 50-100%; n=6] and 100% [95% CI: 60-100%, n=4] compared to 0% (n=2) and 0% (n=13) for non-OPC cases. HPV16 antibodies were significantly more common in OPC versus non-OPC cases, particularly HPV16 E6 antibodies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Component-resolved diagnostics in vernal conjunctivitis.

PubMed

Armentia, Alicia; Sanchís, Eugenia; Montero, Javier A

2016-10-01

Conventional diagnostic tests in allergy are insufficient to clarify the cause of vernal conjunctivitis. Component-resolved diagnostic (CRD) by microarray allergen assay may be useful in detecting allergens that might be involved in the inflammatory process. In a recent trial in patients suffered from eosinophilic esophagitis, after 2 years of the CRD-guided exclusion diet and specific immunotherapy, significant clinical improvement was observed, and 68% of patients were discharged (cure based on negative biopsy, no symptoms, and no medication intake). Our new objective was to evaluate IgE-mediated hypersensitivity by CRD in tears and serum from patients with vernal conjunctivitis and treat patients with identified triggering allergens by specific immunotherapy. Twenty-five patients with vernal conjunctivitis were evaluated. The identified triggering allergens were n Lol p 1 (11 cases), n Cyn d 1 (eight cases), group 4 and 6 grasses (six cases) and group 5 of grasses (five cases). Prick test and pollen IgE were positive in one case. Clinical improvement was observed in 13/25 vernal conjunctivitis patients after 1-year specific immunotherapy. CRD seems to be a more sensitive diagnostic tool compared with prick test and IgE detection. Specific CRD-led immunotherapy may achieve clinical improvements in vernal conjunctivitis patients.

Validating malignant melanoma ICD-9-CM codes in Umbria, ASL Napoli 3 Sud and Friuli Venezia Giulia administrative healthcare databases: a diagnostic accuracy study.

PubMed

Orso, Massimiliano; Serraino, Diego; Abraha, Iosief; Fusco, Mario; Giovannini, Gianni; Casucci, Paola; Cozzolino, Francesco; Granata, Annalisa; Gobbato, Michele; Stracci, Fabrizio; Ciullo, Valerio; Vitale, Maria Francesca; Eusebi, Paolo; Orlandi, Walter; Montedori, Alessandro; Bidoli, Ettore

2018-04-20

To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying subjects with melanoma. A diagnostic accuracy study comparing melanoma ICD-9-CM codes (index test) with medical chart (reference standard). Case ascertainment was based on neoplastic lesion of the skin and a histological diagnosis from a primary or metastatic site positive for melanoma. Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli Venezia Giulia (FVG) Region. 112, 130 and 130 cases (subjects with melanoma) were randomly selected from Umbria, NA and FVG, respectively; 94 non-cases (subjects without melanoma) were randomly selected from each unit. Sensitivity and specificity for ICD-9-CM code 172.x located in primary position. The most common melanoma subtype was malignant melanoma of skin of trunk, except scrotum (ICD-9-CM code: 172.5), followed by malignant melanoma of skin of lower limb, including hip (ICD-9-CM code: 172.7). The mean age of the patients ranged from 60 to 61 years. Most of the diagnoses were performed in surgical departments.The sensitivities were 100% (95% CI 96% to 100%) for Umbria, 99% (95% CI 94% to 100%) for NA and 98% (95% CI 93% to 100%) for FVG. The specificities were 88% (95% CI 80% to 93%) for Umbria, 77% (95% CI 69% to 85%) for NA and 79% (95% CI 71% to 86%) for FVG. The case definition for melanoma based on clinical or instrumental diagnosis, confirmed by histological examination, showed excellent sensitivities and good specificities in the three operative units. Administrative databases from the three operative units can be used for epidemiological and outcome research of melanoma. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Validating malignant melanoma ICD-9-CM codes in Umbria, ASL Napoli 3 Sud and Friuli Venezia Giulia administrative healthcare databases: a diagnostic accuracy study

PubMed Central

Orso, Massimiliano; Serraino, Diego; Fusco, Mario; Giovannini, Gianni; Casucci, Paola; Cozzolino, Francesco; Granata, Annalisa; Gobbato, Michele; Stracci, Fabrizio; Ciullo, Valerio; Vitale, Maria Francesca; Orlandi, Walter; Montedori, Alessandro; Bidoli, Ettore

2018-01-01

Objectives To assess the accuracy of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes in identifying subjects with melanoma. Design A diagnostic accuracy study comparing melanoma ICD-9-CM codes (index test) with medical chart (reference standard). Case ascertainment was based on neoplastic lesion of the skin and a histological diagnosis from a primary or metastatic site positive for melanoma. Setting Administrative databases from Umbria Region, Azienda Sanitaria Locale (ASL) Napoli 3 Sud (NA) and Friuli Venezia Giulia (FVG) Region. Participants 112, 130 and 130 cases (subjects with melanoma) were randomly selected from Umbria, NA and FVG, respectively; 94 non-cases (subjects without melanoma) were randomly selected from each unit. Outcome measures Sensitivity and specificity for ICD-9-CM code 172.x located in primary position. Results The most common melanoma subtype was malignant melanoma of skin of trunk, except scrotum (ICD-9-CM code: 172.5), followed by malignant melanoma of skin of lower limb, including hip (ICD-9-CM code: 172.7). The mean age of the patients ranged from 60 to 61 years. Most of the diagnoses were performed in surgical departments. The sensitivities were 100% (95% CI 96% to 100%) for Umbria, 99% (95% CI 94% to 100%) for NA and 98% (95% CI 93% to 100%) for FVG. The specificities were 88% (95% CI 80% to 93%) for Umbria, 77% (95% CI 69% to 85%) for NA and 79% (95% CI 71% to 86%) for FVG. Conclusions The case definition for melanoma based on clinical or instrumental diagnosis, confirmed by histological examination, showed excellent sensitivities and good specificities in the three operative units. Administrative databases from the three operative units can be used for epidemiological and outcome research of melanoma. PMID:29678984

Multidetector-Row Computed Tomography in the Evaluation of Transjugular Intrahepatic Portosystemic Shunt Performed with Expanded-Polytetrafluoroethylene-Covered Stent-Graft

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fanelli, Fabrizio, E-mail: fabrizio.fanelli@uniroma1.it; Bezzi, Mario; Bruni, Antonio

2011-02-15

We assessed, in a prospective study, the efficacy of multidetector spiral computed tomography (MDCT) in the evaluation of transjugular intrahepatic portosystemic shunt (TIPS) patency in patients treated with the Viatorr (Gore, Flagstaff, AZ) expanded-polytetrafluoroethylene (e-PTFE)-covered stent-graft. Eighty patients who underwent TIPS procedure using the Viatorr self-expanding e-PTFE stent-graft were evaluated at follow-up of 1, 3, 6, and 12 months with clinical and laboratory tests as well as ultrasound-color Doppler (USCD) imaging. In case of varices, upper gastrointestinal endoscopy was also performed. In addition, the shunt was evaluated using MDCT at 6 and 12 months. In all cases of abnormal findingsmore » and discrepancy between MDCT and USCD, invasive control venography was performed. MDCT images were acquired before and after injection of intravenous contrast media on the axial plane and after three-dimensional reconstruction using different algorithms. MDCT was successfully performed in all patients. No artefacts correlated to the Viatorr stent-graft were observed. A missing correlation between UCSD and MDCT was noticed in 20 of 80 (25%) patients. Invasive control venography confirmed shunt patency in 16 (80%) cases and shunt malfunction in 4 (20%) cases. According to these data, MDCT sensitivity was 95.2%; specificity was 96.6%; and positive (PPV) and negative predictive values (NPV) were 90.9 and 98.2%, respectively. USCD sensitivity was 90%; specificity was 75%; and PPV and NPV were 54.5 and 95.7%, respectively. A high correlation (K value = 0.85) between MDCT and invasive control venography was observed. On the basis of these results, MDCT shows superior sensitivity and specificity compared with USCD in those patients in whom TIPS was performed with the Viatorr stent-graft. MDCT can be considered a valid tool in the follow-up of these patients.« less

Extraction and Refinement Strategy for detection of autism in 18-month-olds: a guarantee of higher sensitivity and specificity in the process of mass screening.

PubMed

Honda, Hideo; Shimizu, Yasuo; Nitto, Yukari; Imai, Miho; Ozawa, Takeshi; Iwasa, Mitsuaki; Shiga, Keiko; Hira, Tomoko

2009-08-01

For early detection of autism, it is difficult to maintain an efficient level of sensitivity and specificity based on observational data from a single screening. The Extraction and Refinement (E&R) Strategy utilizes a public children's health surveillance program to produce maximum efficacy in early detection of autism. In the extraction stage, all cases at risk of childhood problems, including developmental abnormality, are identified; in the refinement stage, cases without problems are excluded, leaving only cases with conclusive diagnoses. The city of Yokohama, Japan, conducts a routine child health surveillance program for children at 18 months in which specialized public health nurses administer YACHT-18 (Young Autism and other developmental disorders CHeckup Tool), a screening instrument to identify children at risk for developmental disorders. Children who screen positive undergo further observation, and those without disorders are subsequently excluded. To study the efficacy of early detection procedures for developmental disorders, including autism, 2,814 children born in 1988, examined at 18 months of age, and not already receiving treatment for diseases or disorders were selected. In the extraction stage, 402 (14.3%) children were identified for follow-up. In the refinement stage, 19 (.7%) of these were referred to the Yokohama Rehabilitation Center and diagnosed with developmental disorders. The extraction stage produced four false negatives, bringing total diagnoses of developmental disorders to 23 (.8%) - including 5 with autistic disorder and 9 with pervasive developmental disorder - not otherwise specified (PDDNOS). Sensitivity was 60% for autistic disorder and 82.6% for developmental disorders. Specificity for developmental disorders rose to 100% with the E&R Strategy. Picture cards used in YACHT-18 provided a finer screen that excluded some false positive cases. An extraction and refinement methodology utilizing child health surveillance programs achieve high efficacy for early detection of autism.

Utility of nested polymerase chain reaction over the microscopy and immuno-chromatographic test in the detection of Plasmodium species and their clinical spectrum.

PubMed

Ranjan, P; Ghoshal, U

2016-09-01

Though demonstration of Plasmodium parasite in peripheral blood on microscopy remains gold standard, it may miss some patients resulting in delay in instituting life-saving therapy. Studies on polymerase chain reaction (PCR), a highly sensitive and specific technique that also discriminates among different species of malaria parasite, are scanty. Hence, we aimed to evaluate the role of PCR in diagnosis and species identification of Plasmodium. Of 2186 febrile patients with clinical suspicion of malaria screened between July 2013 to February 2015, 561 patients fulfilled inclusion criteria. Microscopy, rapid diagnostic test (RDT) and PCR were performed to identify the parasite. Plasmodium was detected in 64/561 (11.40 %), 92/561 (16.40 %) and 78/561 (13.90 %) cases using microscopy, RDT and PCR, respectively. Of 78 positive cases by PCR, 47 (60.25 %) were confirmed as Plasmodium falciparum (P. falciparum), 28 (35.89 %) were Plasmodium vivax (P. vivax) and 3 (3.84 %) had mixed infections. Sensitivity and specificity of microscopy and RDT were 82.10 %, 100 % and 98.70 %, 96.90 %, respectively (p = 0.139). Of total 93 patients, 67 (72.04 %) were classified as complicated and 26 (27.96 %) were as uncomplicated. Creatinine (p = <0.001), conjugated bilirubin (p = 0.003) and total bilirubin (p = <0.001) level was elevated in complicated malaria along with renal (65 %) and liver dysfunction (25 %). In the present study, P. falciparum was responsible for 40/67 (59.70 %) cases of complicated malaria; P. vivax was also found in 17/67 (25.37 %) complicated cases using PCR. The findings highlight the alarming number of complicated vivax malaria in addition to falciparum. Moreover, PCR proved to be highly sensitive and specific test for detecting Plasmodium species.

Accuracy of line probe assays for the diagnosis of pulmonary and multidrug-resistant tuberculosis: a systematic review and meta-analysis

PubMed Central

Cudahy, Patrick G.T; Schumacher, Samuel G.; Steingart, Karen R.; Pai, Madhukar; Denkinger, Claudia M.

2017-01-01

Only 25% of multidrug-resistant tuberculosis (MDR-TB) cases are currently diagnosed. Line probe assays (LPAs) enable rapid drug-susceptibility testing for rifampicin (RIF) and isoniazid (INH) resistance and Mycobacterium tuberculosis detection. Genotype MTBDRplusV1 was WHO-endorsed in 2008 but newer LPAs have since been developed. This systematic review evaluated three LPAs: Hain Genotype MTBDRplusV1, MTBDRplusV2 and Nipro NTM+MDRTB. Study quality was assessed with QUADAS-2. Bivariate random-effects meta-analyses were performed for direct and indirect testing. Results for RIF and INH resistance were compared to phenotypic and composite (incorporating sequencing) reference standards. M. tuberculosis detection results were compared to culture. 74 unique studies were included. For RIF resistance (21 225 samples), pooled sensitivity and specificity (with 95% confidence intervals) were 96.7% (95.6–97.5%) and 98.8% (98.2–99.2%). For INH resistance (20 954 samples), pooled sensitivity and specificity were 90.2% (88.2–91.9%) and 99.2% (98.7–99.5%). Results were similar for direct and indirect testing and across LPAs. Using a composite reference standard, specificity increased marginally. For M. tuberculosis detection (3451 samples), pooled sensitivity was 94% (89.4–99.4%) for smear-positive specimens and 44% (20.2–71.7%) for smear-negative specimens. In patients with pulmonary TB, LPAs have high sensitivity and specificity for RIF resistance and high specificity and good sensitivity for INH resistance. This meta-analysis provides evidence for policy and practice. PMID:28100546

Validation of asthma recording in electronic health records: a systematic review

PubMed Central

Nissen, Francis; Quint, Jennifer K; Wilkinson, Samantha; Mullerova, Hana; Smeeth, Liam; Douglas, Ian J

2017-01-01

Objective To describe the methods used to validate asthma diagnoses in electronic health records and summarize the results of the validation studies. Background Electronic health records are increasingly being used for research on asthma to inform health services and health policy. Validation of the recording of asthma diagnoses in electronic health records is essential to use these databases for credible epidemiological asthma research. Methods We searched EMBASE and MEDLINE databases for studies that validated asthma diagnoses detected in electronic health records up to October 2016. Two reviewers independently assessed the full text against the predetermined inclusion criteria. Key data including author, year, data source, case definitions, reference standard, and validation statistics (including sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) were summarized in two tables. Results Thirteen studies met the inclusion criteria. Most studies demonstrated a high validity using at least one case definition (PPV >80%). Ten studies used a manual validation as the reference standard; each had at least one case definition with a PPV of at least 63%, up to 100%. We also found two studies using a second independent database to validate asthma diagnoses. The PPVs of the best performing case definitions ranged from 46% to 58%. We found one study which used a questionnaire as the reference standard to validate a database case definition; the PPV of the case definition algorithm in this study was 89%. Conclusion Attaining high PPVs (>80%) is possible using each of the discussed validation methods. Identifying asthma cases in electronic health records is possible with high sensitivity, specificity or PPV, by combining multiple data sources, or by focusing on specific test measures. Studies testing a range of case definitions show wide variation in the validity of each definition, suggesting this may be important for obtaining asthma definitions with optimal validity. PMID:29238227

Accuracy of frozen section in the diagnosis of ovarian tumours.

PubMed

Toneva, F; Wright, H; Razvi, K

2012-07-01

The purpose of our retrospective study was to assess the accuracy of intraoperative frozen section diagnosis compared to final paraffin diagnosis in ovarian tumours at a gynaecological oncology centre in the UK. We analysed 66 cases and observed that frozen section consultation agreed with final paraffin diagnosis in 59 cases, which provided an accuracy of 89.4%. The overall sensitivity and specificity for all tumours were 85.4% and 100%, respectively. The positive predictive value (PPV) and negative predictive value (NPV) were 100% and 89.4%, respectively. Of the seven cases with discordant results, the majority were large, mucinous tumours, which is in line with previous studies. Our study demonstrated that despite its limitations, intraoperative frozen section has a high accuracy and sensitivity for assessing ovarian tumours; however, care needs to be taken with large, mucinous tumours.

[Sorting role of p16(INK4a)/Ki-67 double immunostaining in the cervical cytology specimens of ASCUS and LSIL cases].

PubMed

Yu, J; Zhu, H T; Zhao, J J; Su, J Z; Xia, Y D

2017-05-08

Objective: To investigate the sorting effect of p16(INK4a)/Ki-67 double immunostaining method in patients with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) cytology results. Methods: Four-hundred and twenty cases collected during April 2014 to February 2015 of cervical cytology of ASCUS ( n =318) and LSIL ( n =102) were selected, and residual liquid-based cytology specimens were used for p16(INK4a)/Ki-67 double immunostaining. The sensitivity and specificity of the detection of cervical precancerous lesions and cervical cancer were calculated, and the results were compared with high risk HPV. Taking histological follow-up as the gold standard, the test was considered positive when at least one cell exhibited p16(INK4a)/Ki-67 co-staining, without requirement of adjunct morphologic interpretation of positive cells. Results: Further screening CIN2+ in cytology ASCUS and LSIL group , the sensitivity of p16(INK4a)/Ki-67 double immunostaining was slightly lower than high risk HPV (84.2% vs . 94.7%), while the specificity was higher (84.0% vs . 53.9%). For ASCUS patients, the sensitivity of p16(INK4a)/Ki-67 double immunostaining and high risk HPV was 82.6% and 91.3%, and the specificity was 88.8% and 63.7%, respectively. For LSIL patients, the sensitivity of p16(INK4a)/Ki-67 double immunostaining and high risk HPV was 86.7% and 100.0%, and the specificity was 67.8% and 20.7%, respectively. For patients younger and older than 30 years, specificity of p16(INK4a)/Ki-67 double immunostaining was both higher than that of high risk HPV (80.8% vs . 42.3%; 84.6% vs . 56.9%). Conclusions: p16(INK4a)/Ki-67 double immunostaining can effectively identify the high risk population in ASCUS or LSIL, with higher specificity than high risk HPV test. p16(INK4a)/Ki-67 double immunostaining may benefit patients younger than 30 years of age as a preliminary or potential cytology-combining screening tool.

The use of administrative health care databases to identify patients with rheumatoid arthritis

PubMed Central

Hanly, John G; Thompson, Kara; Skedgel, Chris

2015-01-01

Objective To validate and compare the decision rules to identify rheumatoid arthritis (RA) in administrative databases. Methods A study was performed using administrative health care data from a population of 1 million people who had access to universal health care. Information was available on hospital discharge abstracts and physician billings. RA cases in health administrative databases were matched 1:4 by age and sex to randomly selected controls without inflammatory arthritis. Seven case definitions were applied to identify RA cases in the health administrative data, and their performance was compared with the diagnosis by a rheumatologist. The validation study was conducted on a sample of individuals with administrative data who received a rheumatologist consultation at the Arthritis Center of Nova Scotia. Results We identified 535 RA cases and 2,140 non-RA, noninflammatory arthritis controls. Using the rheumatologist’s diagnosis as the gold standard, the overall accuracy of the case definitions for RA cases varied between 68.9% and 82.9% with a kappa statistic between 0.26 and 0.53. The sensitivity and specificity varied from 20.7% to 94.8% and 62.5% to 98.5%, respectively. In a reference population of 1 million, the estimated annual number of incident cases of RA was between 176 and 1,610 and the annual number of prevalent cases was between 1,384 and 5,722. Conclusion The accuracy of case definitions for the identification of RA cases from rheumatology clinics using administrative health care databases is variable when compared to a rheumatologist’s assessment. This should be considered when comparing results across studies. This variability may also be used as an advantage in different study designs, depending on the relative importance of sensitivity and specificity for identifying the population of interest to the research question. PMID:27790047

Sensitivity and specificity of radiographic methods for predicting insertion torque of dental implants.

PubMed

Cortes, Arthur Rodriguez Gonzalez; Eimar, Hazem; Barbosa, Jorge de Sá; Costa, Claudio; Arita, Emiko Saito; Tamimi, Faleh

2015-05-01

Subjective radiographic classifications of alveolar bone have been proposed and correlated with implant insertion torque (IT). The present diagnostic study aims to identify quantitative bone features influencing IT and to use these findings to develop an objective radiographic classification for predicting IT. Demographics, panoramic radiographs (taken at the beginning of dental treatment), and cone-beam computed tomographic scans (taken for implant surgical planning) of 25 patients receiving 31 implants were analyzed. Bone samples retrieved from implant sites were assessed with dual x-ray absorptiometry, microcomputed tomography, and histology. Odds ratio, sensitivity, and specificity of all variables to predict high peak IT were assessed. A ridge cortical thickness >0.75 mm and a normal appearance of the inferior mandibular cortex were the most sensitive variables for predicting high peak IT (87.5% and 75%, respectively). A classification based on the combination of both variables presented high sensitivity (90.9%) and specificity (100%) for predicting IT. Within the limitations of this study, the results suggest that it is possible to predict IT accurately based on radiographic findings of the patient. This could be useful in the treatment plan of immediate loading cases.

Optimization and validation of CEDIA drugs of abuse immunoassay tests in serum on Hitachi 912.

PubMed

Kirschbaum, Katrin M; Musshoff, Frank; Schmithausen, Ricarda; Stockhausen, Sarah; Madea, Burkhard

2011-10-10

Due to sensitive limits of detection of chromatographic methods and low limit values regarding the screening of drugs under the terms of impairment in safe driving (§ 24a StVG, Street Traffic Law in Germany), preliminary immunoassay (IA) tests should be able to detect also low concentrations of legal and illegal drugs in serum in forensic cases. False-negatives should be avoided, the rate of false-positive samples should be low due to cost and time. An optimization of IA cutoff values and a validation of the assay is required for each laboratory. In a retrospective study results for serum samples containing amphetamine, methylenedioxy derivatives, cannabinoids, benzodiazepines, cocaine (metabolites), methadone and opiates obtained with CEDIA drugs of abuse reagents on a Hitachi 912 autoanalyzer were compared with quantitative results of chromatographic methods (gas or liquid chromatography coupled with mass spectrometry (GC/MS or LC/MS)). Firstly sensitivity, specificity, positive and negative predictive values and overall misclassification rates were evaluated by contingency tables and compared to ROC-analyses and Youden-Indices. Secondly ideal cutoffs were statistically calculated on the basis of sensitivity and specificity as decisive statistical criteria with focus on a high sensitivity (low rates of false-negatives), i.e. using the Youden-Index. Immunoassay (IA) and confirmatory results were available for 3014 blood samples. Sensitivity was 90% or more for nearly all analytes: amphetamines (IA cutoff 9.5 ng/ml), methylenedioxy derivatives (IA cutoff 5.5 ng/ml), cannabinoids (IA cutoff 14.5 ng/ml), benzodiazepines (IA cutoff >0 ng/ml). Test of opiates showed a sensitivity of 86% for a IA cutoff value of >0 ng/ml. Values for specificity ranged between 33% (methadone, IA cutoff 10 ng/ml) and 90% (cocaine, IA cutoff 20 ng/ml). Lower cutoff values as recommended by ROC analyses were chosen for most tests to decrease the rate of false-negatives. Analyses enabled the definition of cutoff values with good values for sensitivity. Small rates of false-positives can be accepted in forensic cases. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The Diagnostic Utility of Bact/ALERT and Nested PCR in the Diagnosis of Tuberculous Meningitis.

PubMed

Sastry, Apurba Sankar; Bhat K, Sandhya; Kumudavathi

2013-01-01

The early laboratory diagnosis of Tuberculous Meningitis (TBM) is crucial, to start the antitubercular chemotherapy and to prevent its complications. However, the conventional methods are either less sensitive or time consuming. Hence, the diagnostic potentials of BacT/ALERT and Polymerase Chain Reaction (PCR) was evaluated in this study. The study group comprised of 62 cases and 33 controls. The cases were divided according to Ahuja's criteria into the confirmed (two cases), highly probable (19 cases), probable (26 cases) and the possible (15 cases) subgroups. Ziehl Neelsen's (ZN) and Auramine Phenol (AP) staining, Lowenstein Jensen (LJ) medium culture, BacT/ALERT and nested Polymerase Chain Reaction (PCR) which targeted IS6110 were carried out on all the patients. The sensitivity of the LJ culture was 3.22%. BacT/ALERT showed a sensitivity and a specificity of 25.80% and 100% and those of nested PCR were found to be 40.32% and 96.97% respectively. The mean detection time of growth of the LJ culture was 31.28 days, whereas that of BacT/ALERT was 20.68 days. The contamination rate in the LJ culture and BacT/ALERT were 7.2% and 5.8% respectively. Nested PCR was found to be more sensitive, followed by BacT/ALERT as compared to the LJ culture and smear microscopy. As both false negative and false positive results have been reported for nested PCR, so it should not be used alone as a criterion for initiating or terminating the therapy, but it should be supported by clinical, radiological, cytological and other microbiological findings.

Evaluation of a commercial rubella IgM assay for use on oral fluid samples for diagnosis and surveillance of congenital rubella syndrome and postnatal rubella.

PubMed

Vijaylakshmi, P; Muthukkaruppan, V R; Rajasundari, A; Korukluoglu, G; Nigatu, W; L A Warrener; Samuel, D; Brown, D W G

2006-12-01

Clinical diagnosis (surveillance) of rubella is unreliable and laboratory confirmation is essential. Detection of virus specific IgM in serum is the most commonly used method. However, the use of serum necessitates the drawing of blood, either through venipuncture or finger/heel prick, which can be difficult in young babies. Oral fluid samples have proved useful as an alternative, less invasive sample for virus specific IgM detection however until recently no commercial rubella IgM tests were available, restricting the usefulness of this approach. To evaluate the performance of the Microimmune Rubella IgM capture EIA using oral fluid samples from outbreaks as well as in cases of suspected congenital rubella syndrome (CRS). Paired serum and oral fluids were collected from cases during a rubella outbreak in three provinces in Turkey. Matched serum and oral fluid samples were collected from children with suspected CRS in an active surveillance programme at the Aravind Eye Hospital in South India. Serum samples were collected as part of the measles surveillance programme in Ethiopia. On serum samples the sensitivity and specificity of the Microimmune Rubella IgM capture EIA compared to Behring Enzygnost rubella IgM test was 96.9% (62/64; 95% CI 94.2-100%) and 100% (53/53; 95% CI 93.2-100%). On oral fluids compared to matched Behring results on serum the sensitivity was 95.5% (42/44; 95% CI 84.5-99.4%). The sensitivity and specificity of Microimmune Rubella IgM capture EIA on oral fluids from suspected CRS cases compared to serum results using Behring Enzygnost IgM assay was 100% (95% CI 84.5-100%) and 100% (95% CI 95.8-100.0%) respectively. Microimmune Rubella IgM capture EIA has adequate performance for diagnosis and surveillance of rubella in outbreak using either serum or oral fluid specimens.

First case of symmetric drug-related intertriginous and flexural exanthema (sdrife) due to rivastigmine?

PubMed

Allain-Veyrac, Gwenaëlle; Lebreton, Anne; Collonnier, Catherine; Jolliet, Pascale

2011-06-01

The term 'baboon syndrome' was introduced in 1984 to describe a special form of systemic, contact-type dermatitis that occurs after ingestion or systemic absorption of a contact allergen in individuals previously sensitized by topical exposure to the same allergen in the same areas. Its clinical picture presents as an erythema of the buttocks and upper inner thighs resembling the red bottom of baboons. This reaction was originally observed with mercury, nickel, and ampicillin. In 2004, some authors proposed the acronym SDRIFE standing for 'symmetric drug-related intertriginous and flexural exanthema' specifically for cases elicited by systemically administered drugs. Since 1984, about 100 cases have been reported in the literature; for most of the concerned drugs, previous skin sensitization or possible cross-sensitization has not been shown. We report the first case of SDRIFE due to rivastigmine, with the exception of an erythematous maculopapular eruption due to rivastigmine that was previously reported. Rivastigmine is a reversible and noncompetitive acetylcholinesterase inhibitor used for the treatment of Alzheimer disease. SDRIFE is an important condition to keep in mind in order to avoid a misdiagnosis when dealing with other exanthematous disorders and to prevent re-exposure to the responsible allergen in the future.

Desensitization protocol enabling pediatric crossmatch-positive renal transplantation: successful HLA-antibody-incompatible renal transplantation of two highly sensitized children.

PubMed

Adamusiak, Anna M; Stojanovic, Jelena; Shaw, Olivia; Vaughan, Robert; Sebire, Neil J; Drage, Martin; Kessaris, Nicos; Marks, Stephen D; Mamode, Nizam

2017-02-01

Renal transplantation improves quality of life (QoL) and survival in children requiring renal replacement therapy (RRT). Sensitization with development of a broad-spectrum of anti-HLA antibodies as a result of previous transplantation or after receiving blood products is an increasing problem. There are no published reports of desensitization protocols in children allowing renal transplantation from HLA-antibody-incompatible living donors. We adopted our well-established adult desensitization protocol for this purpose and undertook HLA antibody-incompatible living donor renal transplants in two children: a 14-year-old girl and a 13-year-old boy. After 2 and 1.5 years of follow-up, respectively, both patients have stable renal allograft function despite a rise in donor-specific antibodies in one case. HLA-incompatible transplantation should be considered in selected cases for sensitized children.

Case-finding for common mental disorders of anxiety and depression in primary care: an external validation of routinely collected data.

PubMed

John, Ann; McGregor, Joanne; Fone, David; Dunstan, Frank; Cornish, Rosie; Lyons, Ronan A; Lloyd, Keith R

2016-03-15

The robustness of epidemiological research using routinely collected primary care electronic data to support policy and practice for common mental disorders (CMD) anxiety and depression would be greatly enhanced by appropriate validation of diagnostic codes and algorithms for data extraction. We aimed to create a robust research platform for CMD using population-based, routinely collected primary care electronic data. We developed a set of Read code lists (diagnosis, symptoms, treatments) for the identification of anxiety and depression in the General Practice Database (GPD) within the Secure Anonymised Information Linkage Databank at Swansea University, and assessed 12 algorithms for Read codes to define cases according to various criteria. Annual incidence rates were calculated per 1000 person years at risk (PYAR) to assess recording practice for these CMD between January 1(st) 2000 and December 31(st) 2009. We anonymously linked the 2799 MHI-5 Caerphilly Health and Social Needs Survey (CHSNS) respondents aged 18 to 74 years to their routinely collected GP data in SAIL. We estimated the sensitivity, specificity and positive predictive value of the various algorithms using the MHI-5 as the gold standard. The incidence of combined depression/anxiety diagnoses remained stable over the ten-year period in a population of over 500,000 but symptoms increased from 6.5 to 20.7 per 1000 PYAR. A 'historical' GP diagnosis for depression/anxiety currently treated plus a current diagnosis (treated or untreated) resulted in a specificity of 0.96, sensitivity 0.29 and PPV 0.76. Adding current symptom codes improved sensitivity (0.32) with a marginal effect on specificity (0.95) and PPV (0.74). We have developed an algorithm with a high specificity and PPV of detecting cases of anxiety and depression from routine GP data that incorporates symptom codes to reflect GP coding behaviour. We have demonstrated that using diagnosis and current treatment alone to identify cases for depression and anxiety using routinely collected primary care data will miss a number of true cases given changes in GP recording behaviour. The Read code lists plus the developed algorithms will be applicable to other routinely collected primary care datasets, creating a platform for future e-cohort research into these conditions.

Antigen detection systems

USDA-ARS?s Scientific Manuscript database

Infectious agents or their constituent parts (antigens or nucleic acids) can be detected in fresh, frozen, or fixed tissues or other specimens, using a variety of direct or indirect assays. The assays can be modified to yield the greatest sensitivity and specificity but in most cases a particular m...

Robustness Regions for Dichotomous Decisions.

ERIC Educational Resources Information Center

Vijn, Pieter; Molenaar, Ivo W.

1981-01-01

In the case of dichotomous decisions, the total set of all assumptions/specifications for which the decision would have been the same is the robustness region. Inspection of this (data-dependent) region is a form of sensitivity analysis which may lead to improved decision making. (Author/BW)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dondi, M.; Franchi, R.; Levorato, M.

One-hundred five hypertensive patients underwent conventional renal scintigraphy followed 2 or 3 days later by Captopril-enhanced renal scintigraphy, performed 1 hr after premedication with 50 mg of Captopril per os. All patients were then submitted to renal arteriography, performed within 15-30 days. Fifty-five patients had no renal artery stenosis, 29 had unilateral disease, and 21 bilateral. Overall, 34/37 patients were diagnosed by the provocative test as having at least one renal artery affected by a stenosis greater than 50%. Of those with no stenosis (n = 55) or stenosis less than 50% (n = 13) only two cases were falselymore » positive. Thus sensitivity was 92% and specificity 97%. For single kidney identification with stenosis greater than 50%, sensitivity of renal scintigraphy after Captopril administration was 94% and specificity 98%. Captopril enhanced renal scintigraphy is thus suggested as the first test to be performed in hypertensive patients referred for renal scintigraphic studies. Only those cases with equivocal results require a baseline study for better assessment.« less

Biomarkers for diagnosis of neonatal sepsis: a literature review.

PubMed

Sharma, Deepak; Farahbakhsh, Nazanin; Shastri, Sweta; Sharma, Pradeep

2018-06-01

Sepsis is an important cause of mortality and morbidity in neonatal populations. There has been constant search of an ideal sepsis biomarker that have high sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), so that both the diagnosis and exclusion of neonatal sepsis can be made at the earliest possible and appropriate antibiotics can be started to neonate. Ideal sepsis biomarker will help in guiding us when not to start antibiotics in case of suspect sepsis and total duration of antibiotics course in case of proven sepsis. There are numerous sepsis biomarkers that have been evaluated for early detection of neonatal sepsis but till date there is no single ideal biomarker that fulfills all essential criteria's for being an ideal biomarker. The most commonly used biomarkers are C-reactive protein (CRP) and procalcitonin (PCT), but both have shown varied sensitivity, specificity, PPV and NPV in different studies. We conducted literature search for various neonatal sepsis biomarkers and this review article will cover briefly all the markers with current available evidence.

Syncope or seizure? The diagnostic value of the EEG and hyperventilation test in transient loss of consciousness.

PubMed Central

Hoefnagels, W A; Padberg, G W; Overweg, J; Roos, R A; van Dijk, J G; Kamphuisen, H A

1991-01-01

In a prospective study of consecutive patients (age 15 or over) with transient loss of consciousness 45 patients had a history of seizure and 74 patients had a history of syncope. All patients had an EEG, ECG, laboratory tests and a hyperventilation test and were followed for an average of 14.5 months. Epileptiform activity in the interictal EEG had a sensitivity of 0.40 and a specificity of 0.95 for the diagnosis of a seizure. Epileptiform activity nearly doubled the probability of a seizure in doubtful cases. If no epileptiform activity was found, this probability remained substantially the same. The hyperventilation test had a sensitivity of 0.57 and a specificity of 0.84 for the diagnosis of syncope. A positive test increased the probability of syncope half as much in doubtful cases. A negative test did not exclude syncope. Laboratory tests were not helpful except for an ECG which was helpful in elderly patients. PMID:1800665

Study on validity of a rapid diagnostic test kit versus light microscopy for malaria diagnosis in Ahmedabad city, India.

PubMed

Vyas, S; Puwar, B; Patel, V; Bhatt, G; Kulkarni, S; Fancy, M

2014-05-01

Light microscopy of blood smears for diagnosis of malaria in the field has several limitations, notably delays in diagnosis. This study in Ahmedabad in Gujarat State, India, evaluated the diagnostic performance of a rapid diagnostic test for malaria (SD Bioline Malaria Ag P.f/Pan) versus blood smear examination as the gold standard. All fever cases presenting at 13 urban health centres were subjected to rapid diagnostic testing and thick and thin blood smears. A total of 677 cases with fever were examined; 135 (20.0%) tested positive by rapid diagnostic test and 86 (12.7%) by blood smear. The sensitivity of the rapid diagnostic test for malaria was 98.8%, specificity was 91.5%, positive predictive value 63.0% and negative predictive value 99.8%. For detection of Plasmodium falciparum the sensitivity of rapid diagnostic test was 100% and specificity was 97.3%. The results show the acceptability of the rapid test as an alternative to light microscopy in the field setting.

Video Head Impulse Test for Early Diagnosis of Vestibular Neuritis Among Acute Vertigo.

PubMed

Guan, Qiongfeng; Zhang, Lisan; Hong, Wenke; Yang, Yi; Chen, Zhaoying; Lu, Peilin; Zhang, Dan; Hu, Xingyue

2017-09-01

This study assesses the value of the video head impulse test (vHIT) for early diagnosis of vestibular neuritis (VN) among acute vertigo. Thirty-three cases of vestibular neuritis (VN), 96 patients with other acute vertigo (AV), and 50 cases of normal controls used vHIT to quantitatively test a pair of horizontal vestibulo-ocular reflection (VOR) gains, two pairs of vertical VOR gains, and the corresponding three pairs of VOR gain asymmetry. The peculiarity of VOR gains in VN and the differences between VN and other AV, normal controls by vHIT, were collected and analyzed. There were statistically significant differences in the three pairs of VOR gains asymmetry between VN and other AV, and normal controls (P<0.01). The sensitivity was 87.9% and specificity was 94.3% in differentiating VN from normal and other acute vertigo by vHIT. This study shows vHIT has advantages in the diagnosis of VN in acute vertigo with good sensitivity and specificity and indicates a widespread clinical application.

Clinical Performance of Aspergillus PCR for Testing Serum and Plasma: a Study by the European Aspergillus PCR Initiative.

PubMed

White, P Lewis; Barnes, Rosemary A; Springer, Jan; Klingspor, Lena; Cuenca-Estrella, Manuel; Morton, C Oliver; Lagrou, Katrien; Bretagne, Stéphane; Melchers, Willem J G; Mengoli, Carlo; Donnelly, J Peter; Heinz, Werner J; Loeffler, Juergen

2015-09-01

Aspergillus PCR testing of serum provides technical simplicity but with potentially reduced sensitivity compared to whole-blood testing. With diseases for which screening to exclude disease represents an optimal strategy, sensitivity is paramount. The associated analytical study confirmed that DNA concentrations were greater in plasma than those in serum. The aim of the current investigation was to confirm analytical findings by comparing the performance of Aspergillus PCR testing of plasma and serum in the clinical setting. Standardized Aspergillus PCR was performed on plasma and serum samples concurrently obtained from hematology patients in a multicenter retrospective anonymous case-control study, with cases diagnosed according to European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) consensus definitions (19 proven/probable cases and 42 controls). Clinical performance and clinical utility (time to positivity) were calculated for both kinds of samples. The sensitivity and specificity for Aspergillus PCR when testing serum were 68.4% and 76.2%, respectively, and for plasma, they were 94.7% and 83.3%, respectively. Eighty-five percent of serum and plasma PCR results were concordant. On average, plasma PCR was positive 16.8 days before diagnosis and was the earliest indicator of infection in 13 cases, combined with other biomarkers in five cases. On average, serum PCR was positive 10.8 days before diagnosis and was the earliest indicator of infection in six cases, combined with other biomarkers in three cases. These results confirm the analytical finding that the sensitivity of Aspergillus PCR using plasma is superior to that using serum. PCR positivity occurs earlier when testing plasma and provides sufficient sensitivity for the screening of invasive aspergillosis while maintaining methodological simplicity. Copyright © 2015 White et al.

Evaluation of the IS6110 PCR assay for the rapid diagnosis of tuberculous meningitis

PubMed Central

Deshpande, Poonam S; Kashyap, Rajpal S; Ramteke, Sonali S; Nagdev, Khushboo J; Purohit, Hemant J; Taori, Girdhar M; Daginawala, Hatim F

2007-01-01

Background Tuberculous meningitis (TBM) is one of the common clinical manifestations of extra-pulmonary tuberculosis. It is difficult to diagnose due to a lack of rapid, sensitive, and specific tests. Newer methods, which are easy and reliable, are required to diagnose TBM at an early stage. Thus our aim was to evaluate the polymerase chain reaction (PCR) technique, using primers directed against the IS6110 gene, for the detection of Mycobacterium tuberculosis in the CSF, for the diagnosis of TBM patients. Methods An in-house IS6110 PCR method using a specific pair of primers designed to amplify the insertion sequence, IS6110, in the M. tuberculosis genome was used to analyze CSF. A total of 80 CSF samples from different groups of patients were studied (confirmed TBM n = 35, clinically suspected TBM n = 16, non-TBM infectious meningitis n = 12, non infectious neurological diseases n = 17). Results PCR gave a sensitivity of 91.4% and specificity of 75.9% for the diagnosis of TBM in patients with TBM confirmed by culture. In 16 clinically diagnosed, but unconfirmed, TBM cases PCR was positive in 10 (62.5%) cases. There were seven (24.1%) PCR-positive cases among the 29 patients with non-TBM and non-infectious neurological disease. Conclusion We conclude that the performance of an in-house IS6110 PCR assay is valuable in the rapid diagnosis of tuberculous meningitis. PMID:17976247

Head impact exposure sustained by football players on days of diagnosed concussion.

PubMed

Beckwith, Jonathan G; Greenwald, Richard M; Chu, Jeffrey J; Crisco, Joseph J; Rowson, Steven; Duma, Stefan M; Broglio, Steven P; McAllister, Thomas W; Guskiewicz, Kevin M; Mihalik, Jason P; Anderson, Scott; Schnebel, Brock; Brolinson, P Gunnar; Collins, Michael W

2013-04-01

This study compares the frequency and severity of head impacts sustained by football players on days with and without diagnosed concussion and to identify the sensitivity and specificity of single-impact severity measures to diagnosed injury. One thousand two hundred eight players from eight collegiate football teams and six high school football teams wore instrumented helmets to measure head impacts during all team sessions, of which 95 players were diagnosed with concussion. Eight players sustained two injuries and one sustained three, providing 105 injury cases. Measures of head kinematics (peak linear and rotational acceleration, Gadd severity index, head injury criteria (HIC15), and change in head velocity (Δv)) and the number of head impacts sustained by individual players were compared between days with and without diagnosed concussion. Receiver operating characteristic curves were generated to evaluate the sensitivity and specificity of each kinematic measure to diagnosed concussion using only those impacts that directly preceded diagnosis. Players sustained a higher frequency of impacts and impacts with more severe kinematic properties on days of diagnosed concussion than on days without diagnosed concussion. Forty-five injury cases were immediately diagnosed after head impact. For these cases, peak linear acceleration and HIC15 were most sensitive to immediately diagnosed concussion (area under the curve = 0.983). Peak rotational acceleration was less sensitive to diagnosed injury than all other kinematic measures (P = 0.01), which are derived from linear acceleration (peak linear, HIC15, Gadd severity index, and Δv). Players sustained more impacts and impacts of higher severity on days of diagnosed concussion than on days without diagnosed concussion. In addition, of historical measures of impact severity, those associated with peak linear acceleration are the best predictors of immediately diagnosed concussion.

Head Impact Exposure Sustained by Football Players on Days of Diagnosed Concussion

PubMed Central

Beckwith, Jonathan G.; Greenwald, Richard M.; Chu, Jeffrey J.; Crisco, Joseph J.; Rowson, Steven; Duma, Stefan M.; Broglio, Steven P.; McAllister, Thomas W.; Guskiewicz, Kevin M.; Mihalik, Jason P.; Anderson, Scott; Schnebel, Brock; Brolinson, P. Gunnar; Collins, Michael W.

2012-01-01

Purpose This study compares the frequency and severity of head impacts sustained by football players on days with and without diagnosed concussion and to identify the sensitivity and specificity of single impact severity measures to diagnosed injury. Methods 1,208 players from eight collegiate and six high school football teams wore instrumented helmets to measure head impacts during all team sessions, of which 95 players were diagnosed with concussion. Eight players sustained two injuries and one three, providing 105 injury cases. Measures of head kinematics (peak linear and rotational acceleration, Gadd Severity Index (GSI), Head Injury Criteria (HIC15), change in head velocity (Δv)) and the number of head impacts sustained by individual players were compared between days with and without diagnosed concussion. Receiver operator characteristic curves were generated to evaluate the sensitivity and specificity of each kinematic measure to diagnosed concussion using only those impacts that directly preceded diagnosis. Results Players sustained a higher frequency of impacts and impacts with more severe kinematic properties on days of diagnosed concussion than on days without diagnosed concussion. Forty-five injury cases were immediately diagnosed following head impact. For these cases, peak linear acceleration and HIC15 were most sensitive to immediately diagnosed concussion (AUC = 0.983). Peak rotational acceleration was less sensitive to diagnosed injury than all other kinematic measures (p = 0.01) which are derived from linear acceleration (peak linear, HIC15, GSI, and Δv). Conclusions Players sustain more impacts and impacts of higher severity on days of diagnosed concussion than on days without diagnosed concussion. Additionally, of historical measures of impact severity, those associated with peak linear acceleration are the best predictors of immediately diagnosed concussion. PMID:23135363

Improved detection of Burkholderia pseudomallei from non-blood clinical specimens using enrichment culture and PCR: narrowing diagnostic gap in resource-constrained settings.

PubMed

Tellapragada, Chaitanya; Shaw, Tushar; D'Souza, Annet; Eshwara, Vandana Kalwaje; Mukhopadhyay, Chiranjay

2017-07-01

To evaluate the diagnostic utility of enrichment culture and PCR for improved case detection rates of non-bacteraemic form of melioidosis in limited resource settings. Clinical specimens (n = 525) obtained from patients presenting at a tertiary care hospital of South India with clinical symptoms suggestive of community-acquired pneumonia, lower respiratory tract infections, superficial or internal abscesses, chronic skin ulcers and bone or joint infections were tested for the presence of Burkholderia pseudomallei using conventional culture (CC), enrichment culture (EC) and PCR. Sensitivity, specificity, positive and negative predictive values of CC and PCR were initially deduced using EC as the gold standard method. Further, diagnostic accuracies of all the three methods were analysed using Bayesian latent class modelling (BLCM). Detection rates of B. pseudomallei using CC, EC and PCR were 3.8%, 5.3% and 6%, respectively. Diagnostic sensitivities and specificities of CC and PCR were 71.4, 98.4% and 100 and 99.4%, respectively in comparison with EC as the gold standard test. With Bayesian latent class modelling, EC and PCR demonstrated sensitivities of 98.7 and 99.3%, respectively, while CC showed a sensitivity of 70.3% for detection of B. pseudomallei. An increase of 1.6% (95% CI: 1.08-4.32%) in the case detection rate of melioidosis was observed in the study population when EC and/or PCR were used in adjunct to the conventional culture technique. Our study findings underscore the diagnostic superiority of enrichment culture and/or PCR over conventional microbiological culture for improved case detection of melioidosis from non-blood clinical specimens. © 2017 John Wiley & Sons Ltd.

Accuracy of non-invasive prenatal testing using cell-free DNA for detection of Down, Edwards and Patau syndromes: a systematic review and meta-analysis.

PubMed

Taylor-Phillips, Sian; Freeman, Karoline; Geppert, Julia; Agbebiyi, Adeola; Uthman, Olalekan A; Madan, Jason; Clarke, Angus; Quenby, Siobhan; Clarke, Aileen

2016-01-18

To measure test accuracy of non-invasive prenatal testing (NIPT) for Down, Edwards and Patau syndromes using cell-free fetal DNA and identify factors affecting accuracy. Systematic review and meta-analysis of published studies. PubMed, Ovid Medline, Ovid Embase and the Cochrane Library published from 1997 to 9 February 2015, followed by weekly autoalerts until 1 April 2015. English language journal articles describing case-control studies with ≥ 15 trisomy cases or cohort studies with ≥ 50 pregnant women who had been given NIPT and a reference standard. 41, 37 and 30 studies of 2012 publications retrieved were included in the review for Down, Edwards and Patau syndromes. Quality appraisal identified high risk of bias in included studies, funnel plots showed evidence of publication bias. Pooled sensitivity was 99.3% (95% CI 98.9% to 99.6%) for Down, 97.4% (95.8% to 98.4%) for Edwards, and 97.4% (86.1% to 99.6%) for Patau syndrome. The pooled specificity was 99.9% (99.9% to 100%) for all three trisomies. In 100,000 pregnancies in the general obstetric population we would expect 417, 89 and 40 cases of Downs, Edwards and Patau syndromes to be detected by NIPT, with 94, 154 and 42 false positive results. Sensitivity was lower in twin than singleton pregnancies, reduced by 9% for Down, 28% for Edwards and 22% for Patau syndrome. Pooled sensitivity was also lower in the first trimester of pregnancy, in studies in the general obstetric population, and in cohort studies with consecutive enrolment. NIPT using cell-free fetal DNA has very high sensitivity and specificity for Down syndrome, with slightly lower sensitivity for Edwards and Patau syndrome. However, it is not 100% accurate and should not be used as a final diagnosis for positive cases. CRD42014014947. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Validity of a PCR assay in CSF for the diagnosis of neurocysticercosis

PubMed Central

Campoverde, Alfredo; Romo, Matthew L.; García, Lorena; Piedra, Luis M.; Pacurucu, Mónica; López, Nelson; Aguilar, Jenner; López, Sebastian; Vintimilla, Luis C.; Toral, Ana M.; Peña-Tapia, Pablo

2017-01-01

Objective: To prospectively evaluate the validity of a PCR assay in CSF for the diagnosis of neurocysticercosis (NC). Methods: We conducted a multicenter, prospective case-control study, recruiting participants from 5 hospitals in Cuenca, Ecuador, from January 2015 to February 2016. Cases fulfilled validated diagnostic criteria for NC. For each case, a neurosurgical patient who did not fulfill the diagnostic criteria for NC was selected as a control. CT and MRI, as well as a CSF sample, were collected from both cases and controls. The diagnostic criteria to identify cases were used as a reference standard. Results: Overall, 36 case and 36 control participants were enrolled. PCR had a sensitivity of 72.2% (95% confidence interval [CI] 54.8%–85.8%) and a specificity of 100.0% (95% CI 90.3%–100.0%). For parenchymal NC, PCR had a sensitivity of 42.9% (95% CI 17.7%–71.1%), and for extraparenchymal NC, PCR had a sensitivity of 90.9% (95% CI 70.8%–98.9%). Conclusions: This study demonstrated the usefulness of this PCR assay in CSF for the diagnosis of NC. PCR may be particularly helpful for diagnosing extraparenchymal NC when neuroimaging techniques have failed. Classification of evidence: This study provides Class III evidence that CSF PCR can accurately identify patients with extraparenchymal NC. PMID:28105460

Comparison of the performance of rapid prescreening, 10% random review, and clinical risk criteria as methods of internal quality control in cervical cytopathology.

PubMed

Tavares, Suelene B N; Alves de Sousa, Nadja L; Manrique, Edna J C; Pinheiro de Albuquerque, Zair B; Zeferino, Luiz C; Amaral, Rita G

2008-06-25

Rapid prescreening (RPS) is an internal quality-control (IQC) method that is used both to reduce errors in the laboratory and to measure the sensitivity of routine screening (RS). Little direct comparison data are available comparing RPS with other more widely used IQC methods. The authors compared the performance of RPS, 10% random review of negative smears (R-10%), and directed rescreening of negative smears based on clinical risk criteria (RCRC) over 1 year in a community clinic setting. In total, 6,135 smears were evaluated. The sensitivity of RS alone was 71.3%. RPS detected significantly more (132 cases) false-negative (FN) cases than either R-10% (7 cases) or RCRC (32 cases). RPS significantly improved the overall sensitivity of the laboratory (71.3-92.2%; P = .001); neither R-10% nor RCRC significantly changed the sensitivity of RS. RPS was not as specific as the other methods, although nearly 68% of all abnormalities detected by RPS were verified as real. RPS of 100% of smears required the same amount of time as RCRC but required twice as much time as R-10%. The current results demonstrated that RPS is a much more effective IQC method than either R-10% or RCRC. RPS detects significantly more errors and can improve the overall sensitivity of a laboratory with either a modest increase or no increase in overall time spent on IQC. R-10% is an insensitive IQC method, and neither R-10% nor RCRC can significantly improve the overall sensitivity of a laboratory. (c) 2008 American Cancer Society.

Early diagnosis of typhoid fever by nested PCR for flagellin gene of Salmonella enterica serotype Typhi.

PubMed

Khan, S; Harish, B N; Menezes, G A; Acharya, N S; Parija, S C

2012-11-01

Typhoid fever caused by Salmonella Typhi continues to be a major health problem in spite of the use of antibiotics and the development of newer antibacterial drugs. Inability to make an early laboratory diagnosis and resort to empirical therapy, often lead to increased morbidity and mortality in cases of typhoid fever. This study was aimed to optimize a nested PCR for early diagnosis of typhoid fever and using it as a diagnostic tool in culture negative cases of suspected typhoid fever. Eighty patients with clinical diagnosis of typhoid fever and 40 controls were included in the study. The blood samples collected were subjected to culture, Widal and nested PCR targeting the flagellin gene of S. Typhi. The sensitivity of PCR on blood was found to be 100 per cent whereas the specificity was 76.9 per cent. The positive predictive value (PPV) of PCR was calculated to be 76.9 per cent with an accuracy of 86 per cent. None of the 40 control samples gave a positive PCR. Due to its high sensitivity and specificity nested PCR can be used as a useful tool to diagnose clinically suspected, culture negative cases of typhoid fever.

99mtechnetium-dimercapto-succinic acid renal scanning and excretory urography in diagnosis of renal scars in children

DOE Office of Scientific and Technical Information (OSTI.GOV)

McLorie, G.A.; Aliabadi, H.; Churchill, B.M.

1989-09-01

We compared the ability of excretory urography (without tomography) and 99mtechnetium-dimercapto-succinic acid renal scanning to detect renal scars in 32 children with primary vesicoureteral reflux. These children did not have hydronephrosis, renal failure or urinary tract obstruction. In all cases both studies were conducted within a 10-month period. The findings from both modalities were in agreement for 51 of the 64 renal units evaluated (80%). Evaluation of the excretory urogram indicated 6 cases of diffuse and 2 of focal scarring that were not detected by evaluation of the renal scan. The sensitivity of excretory urography to detect renal scars wasmore » 84% and the specificity was 83%. The 99mtechnetium-dimercapto-succinic acid renal scan showed 5 cases of focal renal scarring not detected by excretory urography. The sensitivity of the renal scan to detect renal scars was 77% and the specificity was 75%. We conclude that neither study alone could effectively replace the other for the detection of renal scars, and recommend that both be included in the initial evaluation and followup of patients with renal scars.« less

Height velocity and IGF-I assessment in the diagnosis of childhood onset GH insufficiency: do we still need a second GH stimulation test?

PubMed

Cianfarani, Stefano; Tondinelli, Tiziana; Spadoni, Gian Luigi; Scirè, Giuseppe; Boemi, Sergio; Boscherini, Brunetto

2002-08-01

The diagnosis of GH insufficiency (GHI) in childhood is not straightforward. Our aim was to test the sensitivity and specificity of height velocity (HV), IGF-I, IGFBP-3 and GH stimulation tests alone or in combination in the diagnosis of GHI. A retrospective review of patients with GHI and idiopathic short stature (ISS) diagnosed in our centre and followed up to the completion of linear growth. Thirty-three GHI children and 56 children with ISS were evaluated. GHI diagnosis was based on fulfilment of anthropometric, endocrine and neuroradiological criteria: stature < or = -2 z-score, delayed bone age (at least 1 year), GH peak response to at least two different provocative tests < 10 micro g/l (20 mU/l), brain MRI positive for hypothalamus-pituitary abnormalities, catch-up growth during the first year of GH replacement therapy > or = 75th centile, peak GH response to a third provocative test after growth completion < 10 micro g/l (20 mU/l). Children with anthropometry resembling that of GHI but with peak GH responses > 10 micro g/l (20 mU/l) were diagnosed as ISS. All subjects underwent standard anthropometry. GH secretory status was assessed by clonidine, arginine and GHRH plus arginine stimulation tests. IGF-I and IGFBP-3 circulating levels were measured by immunoradiometric assay (IRMA). The following cut-off values were chosen to discriminate between GHI and nonGHI short children: HV < 25th centile over the 6-12 months prior to the initiation of GH therapy, peak GH responses < 10 or < 7 micro g/l (< 20 or < 14 mU/l) and IGF-I and IGFBP-3-values < -1.9 z-score. Sensitivity (true positive ratio) and specificity (true negative ratio) were evaluated. Taking 10 micro g/l (20 mU/l) as the cut-off value, sensitivity was 100% and specificity 57% for GH provocative tests, whereas taking 7 as the cut-off value, sensitivity was 66% and specificity rose to 78%. Sensitivity was 73% for IGF-I and 30% for IGFBP-3 measurement, whilst specificity was 95% for IGF-I and 98% for IGFBP-3 evaluation. HV assessment revealed a sensitivity of 82% and a specificity of 43%. When HV and IGF-I evaluations were used in combination, sensitivity reached 95% and specificity 96%. When both HV and IGF-I are normal (26% of our subjects) GHI may be ruled out, whereas when both the indices are subnormal (23%) GHI is so highly likely that the child may undergo only one GH provocative test and brain MRI and, thereafter, may begin GH therapy without any further test. In case of discrepancy, when IGF-I is normal and HV < 25th centile (44% of children), due to the relatively low sensitivity of IGF-I assessment and low specificity of HV, the patient should undergo GH tests and brain MRI. Finally, in the rare case of HV > 25th centile and subnormal IGF-I-values (7%), due to the high specificity of IGF-I measurement, the child should undergo one provocative test and brain MRI for the high suspicion of GHI. Our results suggest that a simple assessment of HV and basal IGF-I may exclude or, in association with only one stimulation test, confirm the diagnosis of GH insufficiency in more than half of patients with short stature.

Systematic review of validated case definitions for diabetes in ICD-9-coded and ICD-10-coded data in adult populations.

PubMed

Khokhar, Bushra; Jette, Nathalie; Metcalfe, Amy; Cunningham, Ceara Tess; Quan, Hude; Kaplan, Gilaad G; Butalia, Sonia; Rabi, Doreen

2016-08-05

With steady increases in 'big data' and data analytics over the past two decades, administrative health databases have become more accessible and are now used regularly for diabetes surveillance. The objective of this study is to systematically review validated International Classification of Diseases (ICD)-based case definitions for diabetes in the adult population. Electronic databases, MEDLINE and Embase, were searched for validation studies where an administrative case definition (using ICD codes) for diabetes in adults was validated against a reference and statistical measures of the performance reported. The search yielded 2895 abstracts, and of the 193 potentially relevant studies, 16 met criteria. Diabetes definition for adults varied by data source, including physician claims (sensitivity ranged from 26.9% to 97%, specificity ranged from 94.3% to 99.4%, positive predictive value (PPV) ranged from 71.4% to 96.2%, negative predictive value (NPV) ranged from 95% to 99.6% and κ ranged from 0.8 to 0.9), hospital discharge data (sensitivity ranged from 59.1% to 92.6%, specificity ranged from 95.5% to 99%, PPV ranged from 62.5% to 96%, NPV ranged from 90.8% to 99% and κ ranged from 0.6 to 0.9) and a combination of both (sensitivity ranged from 57% to 95.6%, specificity ranged from 88% to 98.5%, PPV ranged from 54% to 80%, NPV ranged from 98% to 99.6% and κ ranged from 0.7 to 0.8). Overall, administrative health databases are useful for undertaking diabetes surveillance, but an awareness of the variation in performance being affected by case definition is essential. The performance characteristics of these case definitions depend on the variations in the definition of primary diagnosis in ICD-coded discharge data and/or the methodology adopted by the healthcare facility to extract information from patient records. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cell-free mitochondrial DNA copy number variation in head and neck squamous cell carcinoma: A study of non-invasive biomarker from Northeast India.

PubMed

Kumar, Manish; Srivastava, Shilpee; Singh, Seram Anil; Das, Anup Kumar; Das, Ganesh Chandra; Dhar, Bishal; Ghosh, Sankar Kumar; Mondal, Rosy

2017-10-01

Head and neck squamous cell carcinoma is the most commonly diagnosed cancer worldwide. The lifestyle, food habits, and customary practices manifest the Northeast Indian population toward higher susceptibility to develop head and neck squamous cell carcinoma. Here, we have investigated the association of smoke and smokeless tobacco, and alcohol with copy number variation of cell-free mitochondrial DNA and cell-free nuclear DNA in cases and controls. Cell-free DNA from plasma was isolated from 50 head and neck squamous cell carcinoma cases and 50 controls with informed written consent using QIAamp Circulating Nucleic Acid Kit. Real-time polymerase chain reaction was done for copy number variation in cell-free mitochondrial DNA and cell-free nuclear DNA. Receiver operating characteristic curve analysis was performed to evaluate the diagnostic application between the two study groups using clinicopathological parameters. The levels of cell-free nuclear DNA and cell-free mitochondrial DNA of cases in association with smoke and smokeless tobacco, alcohol with smoking (p < 0.05) were significantly higher (p < 0.01 and p < 0.001, respectively) than controls. Using receiver operating characteristic curve analysis between head and neck squamous cell carcinoma cases and controls, we distinguished cell-free mitochondrial DNA (cutoff: 19.84 raw Ct; sensitivity: 84%; specificity: 100%; p < 0.001) and cell-free nuclear DNA (cutoff: 463,282 genomic equivalent/mL; sensitivity: 53%; specificity: 87%; p < 0.001). The copy number variation in cases (cell-free nuclear DNA: 5451.66 genomic equivalent/mL and cell-free mitochondrial DNA: 29,103,476.15 genomic equivalent/mL) and controls (cell-free nuclear DNA: 1650.9 genomic equivalent/mL and cell-free mitochondrial DNA: 9,189,312.54 genomic equivalent/mL), respectively. Our result indicates that the cell-free mitochondrial DNA content is highly associated with smoke and smokeless tobacco, betel quid chewing, and alcohol which shows greater promises, holding the key characteristics of diagnostic biomarkers, that is, minimal invasiveness, high specificity, and sensitivity.

Musculoskeletal impairment survey in Rwanda: Design of survey tool, survey methodology, and results of the pilot study (a cross sectional survey)

PubMed Central

Atijosan, Oluwarantimi; Kuper, Hannah; Rischewski, Dorothea; Simms, Victoria; Lavy, Christopher

2007-01-01

Background Musculoskeletal impairment (MSI) is an important cause of morbidity and mortality worldwide, especially in developing countries. Prevalence studies for MSI in the developing world have used varying methodologies and are seldom directly comparable. This study aimed to develop a new tool to screen for and diagnose MSI and to pilot test the methodology for a national survey in Rwanda. Methods A 7 question screening tool to identify cases of MSI was developed through literature review and discussions with healthcare professionals. To validate the tool, trained rehabilitation technicians screened 93 previously identified gold standard 'cases' and 86 'non cases'. Sensitivity, specificity and positive predictive value were calculated. A standardised examination protocol was developed to determine the aetiology and diagnosis of MSI for those who fail the screening test. For the national survey in Rwanda, multistage cluster random sampling, with probability proportional to size procedures will be used for selection of a cross-sectional, nationally representative sample of the population. Households to be surveyed will be chosen through compact segment sampling and all individuals within chosen households will be screened. A pilot survey of 680 individuals was conducted using the protocol. Results: The screening tool demonstrated 99% sensitivity and 97% specificity for MSI, and a positive predictive value of 98%. During the pilot study 468 out of 680 eligible subjects (69%) were screened. 45 diagnoses were identified in 38 persons who were cases of MSI. The subjects were grouped into categories based on diagnostic subgroups of congenital (1), traumatic (17), infective (2) neurological (6) and other acquired(19). They were also separated into mild (42.1%), moderate (42.1%) and severe (15.8%) cases, using an operational definition derived from the World Health Organisation's International Classification of Functioning, Disability and Health. Conclusion: The screening tool had good sensitivity and specificity and was appropriate for use in a national survey. The pilot study showed that the survey protocol was appropriate for measuring the prevalence of MSI in Rwanda. This survey is an important step to building a sound epidemiological understanding of MSI, to enable appropriate health service planning. PMID:17391509

Validation of two case definitions to identify pressure ulcers using hospital administrative data

PubMed Central

Ho, Chester; Jiang, Jason; Eastwood, Cathy A; Wong, Holly; Weaver, Brittany; Quan, Hude

2017-01-01

Objective Pressure ulcer development is a quality of care indicator, as pressure ulcers are potentially preventable. Yet pressure ulcer is a leading cause of morbidity, discomfort and additional healthcare costs for inpatients. Methods are lacking for accurate surveillance of pressure ulcer in hospitals to track occurrences and evaluate care improvement strategies. The main study aim was to validate hospital discharge abstract database (DAD) in recording pressure ulcers against nursing consult reports, and to calculate prevalence of pressure ulcers in Alberta, Canada in DAD. We hypothesised that a more inclusive case definition for pressure ulcers would enhance validity of cases identified in administrative data for research and quality improvement purposes. Setting A cohort of patients with pressure ulcers were identified from enterostomal (ET) nursing consult documents at a large university hospital in 2011. Participants There were 1217 patients with pressure ulcers in ET nursing documentation that were linked to a corresponding record in DAD to validate DAD for correct and accurate identification of pressure ulcer occurrence, using two case definitions for pressure ulcer. Results Using pressure ulcer definition 1 (7 codes), prevalence was 1.4%, and using definition 2 (29 codes), prevalence was 4.2% after adjusting for misclassifications. The results were lower than expected. Definition 1 sensitivity was 27.7% and specificity was 98.8%, while definition 2 sensitivity was 32.8% and specificity was 95.9%. Pressure ulcer in both DAD and ET consultation increased with age, number of comorbidities and length of stay. Conclusion DAD underestimate pressure ulcer prevalence. Since various codes are used to record pressure ulcers in DAD, the case definition with more codes captures more pressure ulcer cases, and may be useful for monitoring facility trends. However, low sensitivity suggests that this data source may not be accurate for determining overall prevalence, and should be cautiously compared with other prevalence studies. PMID:28851785

Diagnostic utility of attenuation measurement (Hounsfield units) in computed tomography stonogram in predicting the radio-opacity of urinary calculi in plain abdominal radiographs.

PubMed

Chua, Michael E; Gatchalian, Glenn T; Corsino, Michael Vincent; Reyes, Buenaventura B

2012-10-01

(1) To determine the best cut-off level of Hounsfield units (HU) in the CT stonogram that would predict the appearance of a urinary calculi in plain KUB X-ray; (2) to estimate the sensitivity and specificity of the best cut-off HU; and (3) to determine whether stone size and location affect the in vivo predictability. A prospective cross-sectional study of patients aged 18-85 diagnosed with urolithiases on CT stonogram with concurrent plain KUB radiograph was conducted. Appearance of stones was recorded, and significant difference between radiolucent and radio-opaque CT attenuation level was determined using ANOVA. Receiver operating characteristics (ROC) curve determined the best HU cut-off value. Stone size and location were used for factor variability analysis. A total of 184 cases were included in this study, and the average urolithiasis size on CT stonogram was 0.84 cm (0.3-4.9 cm). On KUB X-ray, 34.2 % of the urolithiases were radiolucent and 65.8 % were radio-opaque. Mean value of CT Hounsfield unit for radiolucent stones was 358.25 (±156), and that for radio-opaque stones was 816.51 (±274). ROC curve determined the best cut-off value of HU at 498.5, with the sensitivity of 89.3 % and specificity of 87.3 %. For >4 mm stones, the sensitivity was 91.3 % and the specificity was 81.8 %. On the other hand, for =<4 mm stones, the sensitivity was 60 % and the specificity was 89.5 %. Based on the constructed ROC curve, a threshold value of 498.5 HU in CT stonogram was established as cut-off in determining whether a calculus is radio-opaque or radiolucent. The determined overall sensitivity and specificity of the set cut-off HU value are optimal. Stone size but not location affects the sensitivity and specificity.

Sensitivity and specificity of antibodies against HPV16 E6 and other early proteins for the detection of HPV16-driven oropharyngeal squamous cell carcinoma.

PubMed

Holzinger, Dana; Wichmann, Gunnar; Baboci, Lorena; Michel, Angelika; Höfler, Daniela; Wiesenfarth, Manuel; Schroeder, Lea; Boscolo-Rizzo, Paolo; Herold-Mende, Christel; Dyckhoff, Gerhard; Boehm, Andreas; Del Mistro, Annarosa; Bosch, Franz X; Dietz, Andreas; Pawlita, Michael; Waterboer, Tim

2017-06-15

To determine the sensitivity and specificity of HPV16 serology as diagnostic marker for HPV16-driven oropharyngeal squamous cell carcinoma (OPSCC), 214 HNSCC patients from Germany and Italy with fresh-frozen tumor tissues and sera collected before treatment were included in this study. Hundred and twenty cancer cases were from the oropharynx and 94 were from head and neck cancer regions outside the oropharynx (45 oral cavity, 12 hypopharynx and 35 larynx). Serum antibodies to early (E1, E2, E6 and E7) and late (L1) HPV16 proteins were analyzed by multiplex serology and were compared to tumor HPV RNA status as the gold standard. A tumor was defined as HPV-driven in the presence of HPV16 DNA and HPV16 transformation-specific RNA transcript patterns (E6*I, E1 ∧ E4 and E1C). Of 120 OPSCC, 66 (55%) were HPV16-driven. HPV16 E6 seropositivity was the best predictor of HPV16-driven OPSCC (diagnostic accuracy 97% [95%CI 92-99%], Cohen's kappa 0.93 [95%CI 0.8-1.0]). Of the 66 HPV-driven OPSCC, 63 were HPV16 E6 seropositive, compared to only one (1.8%) among the 54 non-HPV-driven OPSCC, resulting in a sensitivity of 96% (95%CI 88-98) and a specificity of 98% (95%CI 90-100). Of 94 HNSCC outside the oropharynx, six (6%) were HPV16-driven. In these patients, HPV16 E6 seropositivity had lower sensitivity (50%, 95%CI 19-81), but was highly specific (100%, 95%CI 96-100). In conclusion, HPV16 E6 seropositivity appears to be a highly reliable diagnostic marker for HPV16-driven OPSCC with very high sensitivity and specificity, but might be less sensitive for HPV16-driven HNSCC outside the oropharynx. © 2017 UICC.

A highly sensitive and specific combined clinical and sonographic score to diagnose appendicitis.

PubMed

Reddy, Swathi B; Kelleher, Michael; Bokhari, S A Jamal; Davis, Kimberly A; Schuster, Kevin M

2017-10-01

Computed tomography (CT) scanning reduces the negative appendectomy rate however it exposes the patient to ionizing radiation. Ultrasound (US) does not carry this risk but may be nondiagnostic. We hypothesized that a clinical-US scoring system would improve diagnostic accuracy. We conducted a retrospective review of all patients (age, >15 years) who presented through the emergency department with suspected appendicitis and underwent initial US. A US score was developed using odds ratios for appendicitis given appendiceal diameter, compressibility, hyperemia, free fluid, and focal or diffuse tenderness. The US score was then combined with the Alvarado score. Final diagnosis of appendicitis was assigned by pathology reports. Three hundred patients who underwent US as initial imaging were identified. Thirty-two patients with evident nonappendiceal pathology on US were excluded. In 114 (38%), the appendix was not visualized and partially visualized in 36 (12%). Fifty-seven (21.3%) had an appendectomy with 1 (1.7%) negative. Six nonvisualized appendicies underwent appendectomy, with no negative cases. Sensitivity and specificity for the sonographic score were 86% and 90%, respectively, at a score of 1.5. The combined score demonstrated 98% sensitivity and 82% specificity at 6.5, and 95% sensitivity, and 87% specificity at a score of 7.5. Sensitivity and specificity were confirmed by bootstrap resampling for validation. Area under receiver operating characteristic (ROC) curves for our new US score were similar to the ROC curve for the Alvarado score (91.9 and 91.1, p = 0.8). The combined US and Alvarado score yielded an area under the ROC curve of 97.1, significantly better than either score alone (p = 0.017 and p < 0.001, respectively). Our scoring system based entirely on US findings was highly sensitive and specific for appendicitis, and it significantly improved when combined with the Alvarado score. After prospective evaluation, the combined US-Alvarado score might replace the need for computed tomography imaging in a majority of patients. Diagnostic Test, Level III.

The role of nerve monitoring to predict postoperative recurrent laryngeal nerve function in thyroid and parathyroid surgery.

PubMed

Eid, Issam; Miller, Frank R; Rowan, Stephanie; Otto, Randal A

2013-10-01

To determine the role and efficacy of intraoperative recurrent laryngeal nerve (RLN) stimulation in the prediction of early and permanent postoperative nerve function in thyroid and parathyroid surgery. A retrospective review of thyroid and parathyroid surgeries was performed with calculation of sensitivity and specificity of the response of intraoperative stimulation for different pathological groups. Normal electromyography (EMG) response with 0.5 mAmp stimulation was considered a positive stimulation response with postoperative function determined by laryngoscopy. No EMG response at >1-2 mAmps was considered a negative response. The rates of early and permanent paralysis, as well as sensitivity, specificity, and positive and negative predictive values for postoperative nerve function were calculated for separate pathological groups. The number of nerves at risk analyzed was 909. The overall early and permanent paralysis rates were 3.1% and 1.2%, respectively, with the highest rate being for Grave's disease cases. The overall sensitivity was 98.4%. The specificity was lower at 62.5% but acceptable in thyroid carcinoma and Grave's disease patients. The majority of nerves with a positive stimulation result and postoperative paralysis on laryngoscopy recovered function in 3 to 12 weeks, showing positive stimulation to be a good predictor of eventual recovery. Stimulation of the RLN during thyroid and parathyroid surgery is a useful tool in predicting postoperative RLN function. The sensitivity of stimulation is high, showing positive stimulation to be an excellent predictor of normal nerve function. Negative stimulation is more predictive of paralysis in cases of thyroid carcinoma and Grave's disease. 2b. Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Is Routine Use of High Resolution Computerized Tomography of Temporal Bone in Patients of Atticoantral Chronic Suppurative Otitis Media without Intracranial Complications Justified?

PubMed

Bathla, Meeta; Doshi, Hiren; Kansara, Atul

2018-03-01

Role of high resolution computerized tomography (HRCT) of temporal bone is established in cases of atticoantral chronic suppurative otitis media (CSOM) with intracranial complications. Routine use of HRCT in management of patients of atticoantral CSOM without intracranial complications has been an issue of debate. The aim of this study was to evaluate the routine use of HRCT of temporal bone in such cases. This study was a prospective study done at LG hospital, AMC MET Medical College, Ahmedabad to evaluate and compare the temporal bone findings in HRCT and intraoperative findings in 100 patients with atticoantral CSOM. All patients underwent HRCT screening followed by surgical exploration of middle ear cleft. In extent of disease HRCT showed very high sensitivity and specificity for epitympanum (100, 94%) and mesotympanum (98, 98%) areas. It gave valuable information of disease extent in hidden areas like sinus tympani and facial recess of mesotympanum. HRCT satisfactorily delineated malleus and incus erosion but had 75% sensitivity for detecting erosion of stapes suprastructure, though specificity was of 97%. For bony anatomical landmarks HRCT showed very high sensitivity and specificity for detecting erosion of lateral semicircular canal, tegmen tympani and sinus plate. Detection of facial canal erosion on HRCT had moderate sensitivity of 75%. We concluded that routine use of HRCT is justified as a reliable preoperative tool in patients with atticoantral CSOM without intracranial complications and it helps to plan type of surgical intervention. HRCT has limited role to distinguish between granulations and cholesteatoma and also to delineate stapes supra structure and facial nerve canal.

HPV-testing versus HPV-cytology co-testing to predict the outcome after conization.

PubMed

Bruhn, Laerke Valsøe; Andersen, Sisse Josephine; Hariri, Jalil

2018-06-01

The purpose of this study was to determine the feasibility of human Papillomavirus (HPV) testing alone as a prognostic tool to predict recurrent disease within a three-year follow-up period after treatment for cervical intraepithelial neoplasia (CIN)2 + . Retrospectively, 128 women with histologically verified CIN2 + who had a conization performed at Southern Jutland Hospital in Denmark between 1 January 2013 and 31 December 2013 were included. Histology, cytology and HPV test results were obtained for a three-year follow-up period. 4.7% (6/128) of the cases developed recurrent disease during follow-up. Of the cases without free margins, recurrent dysplasia was detected normal in 10.4% (5/48), whereas in the group with free margins it was 1.3% (1/80). The post-conization HPV test was negative in 67.2% (86/128) and Pap smear normal in 93.7% (120/128). Combining resection margins, cytology and HPV had sensitivity for prediction of recurrent dysplasia of 100%. Specificity was 45.8%, positive predictive value (PPV) 8.5% and negative predictive value (NPV) 100%. Using HPV test alone as a predictor of recurrent dysplasia gave a sensitivity of 83.3%, specificity 69.7%, PPV 11.9% and NPV 98.8%. Combining resection margin and HPV test had a sensitivity of 100%, specificity 45.9%, PPV 8.3% and NPV 100%. HPV test at six months control post-conization gave an NPV of 98.8% and can be used as a solitary test to identify women at risk for recurrent disease three years after treatment for precursor lesions. Using both resection margin and HPV test had a sensitivity of 100% and NPV 100%. Adding cytology did not increase the predictive value. © 2018 Nordic Federation of Societies of Obstetrics and Gynecology.

Reformatted images improve the detection rate of acute traumatic subdural hematomas on brain CT compared with axial images alone.

PubMed

Amrhein, Timothy J; Mostertz, William; Matheus, Maria Gisele; Maass-Bolles, Genevieve; Sharma, Komal; Collins, Heather R; Kranz, Peter G

2017-02-01

Subdural hematomas (SDHs) comprise a significant percentage of missed intracranial hemorrhage on axial brain CT. SDH detection rates could be improved with the addition of reformatted images. Though performed at some centers, the potential additional diagnostic sensitivity of reformatted images has not yet been investigated. The purpose of our study is to determine if the addition of coronal and sagittal reformatted images to an axial brain CT increases the sensitivity and specificity for detection of acute traumatic SDH. We retrospectively reviewed consecutive brain CTs acquired for acute trauma that contained new SDHs. An equivalent number of normal brain CTs served as control. Paired sets of images were created for each case: (1) axial images only ("axial only") and (2) axial, coronal, sagittal images ("reformat added"). Three readers interpreted both the axial only and companion reformat added for each case, separated by 1 month. Reading times and SDH detection rates were compared. One hundred SDH and 100 negative examinations were collected. Sensitivity and specificity for the axial-only scans were 75.7 and 94.3 %, respectively, compared with 88.3 and 98.3 % for reformat added. There was a 24.3 % false negative (missed SDH) rate with axial-only scans versus 11.7 % with reformat added (p = <0.001). Median reader interpretation times were longer with the addition of reformatted images (125 versus 89 s), but this difference was not significant (p = 0.23). The addition of coronal and sagittal images in trauma brain CT resulted in improved sensitivity and specificity as well as a reduction in SDH false negatives by greater than 50 %. Reformatted images substantially reduce the number of missed SDHs compared with axial images alone.

Outcomes and reliability of the flow coupler in postoperative monitoring of head and neck free flaps.

PubMed

Fujiwara, Rance J T; Dibble, Jacqueline M; Larson, Scott V; Pierce, Matthew L; Mehra, Saral

2018-04-01

To assess the accuracy and reliability of the flow coupler relative to the implantable arterial Doppler probe in postoperative monitoring of head and neck free flaps. Retrospective single-institution study, April 2015 to March 2017. Both the venous flow coupler and arterial Doppler were employed in 120 consecutive head and neck free flap cases. When Doppler signal loss occurred, flaps were evaluated by physical exam to determine whether signal loss was a true positive necessitating operating room takeback. Sensitivity, specificity, and false positive rate (FPR) were recorded for each device. Logistic regression was conducted to identify user trends over time. Eleven of 120 patients (9.2%) required takeback, 10 from venous thrombosis and one from arterial thrombosis. Permanent signal loss (PSL) occurred in the flow coupler in all takebacks; PSL occurred in the arterial Doppler only in the case of arterial thrombosis. Salvage rate was 9/11 (81.8%). For the flow coupler, sensitivity was 100%, specificity 86.4%, and FPR 13.6%. For the arterial probe, sensitivity was 9.1%, specificity 97.1%, and FPR 2.9%. A 4.1% decrease in false positives with each additional flow coupler use was observed. Monitoring the vein via flow coupler has high sensitivity in identifying vascular compromise compared to the arterial probe, especially for venous thrombosis. There is moderate FPR; this decreases with increased usage and, when supplemented with physical examination, does not result in unnecessary takebacks. The flow coupler can be a valuable tool in postoperative monitoring of head and neck free flaps. 4. Laryngoscope, 128:812-817, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Diagnostic performance of major depression disorder case-finding instruments used among mothers of young children in the United States: A systematic review.

PubMed

Owora, Arthur H; Carabin, Hélène; Reese, Jessica; Garwe, Tabitha

2016-09-01

Growing recognition of the interrelated negative outcomes associated with major depression disorder (MDD) among mothers and their children has led to renewed public health interest in the early identification and treatment of maternal MDD. Healthcare providers, however, remain unsure of the validity of existing case-finding instruments. We conducted a systematic review to identify the most valid maternal MDD case-finding instrument used in the United States. We identified articles reporting the sensitivity and specificity of MDD case-finding instruments based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) by systematically searching through three electronic bibliographic databases, PubMed, PsycINFO, and EMBASE, from 1994 to 2014. Study eligibility and quality were evaluated using the Standards for the Reporting of Diagnostic Accuracy studies and Quality Assessment of Diagnostic Accuracy Studies guidelines respectively. Overall, we retrieved 996 unduplicated articles and selected 74 for full-text review. Of these, 14 articles examining 21 different instruments were included in the systematic review. The 10 item Edinburgh Postnatal Depression Scale and Postpartum Depression Screening Scale had the most stable (lowest variation) and highest diagnostic performance during the antepartum and postpartum periods (sensitivity range: 0.63-0.94 and 0.67-0.95; specificity range: 0.83-0.98 and 0.68-0.97 respectively). Greater variation in diagnostic performance was observed among studies with higher MDD prevalence. Factors that explain greater variation in instrument diagnostic performance in study populations with higher MDD prevalence were not examined. Findings suggest that the diagnostic performance of maternal MDD case-finding instruments is peripartum period-specific. Published by Elsevier B.V.

Increasing role of arthropod bites in tularaemia transmission in Poland - case reports and diagnostic methods.

PubMed

Formińska, Kamila; Zasada, Aleksandra A; Rastawicki, Waldemar; Śmietańska, Karolina; Bander, Dorota; Wawrzynowicz-Syczewska, Marta; Yanushevych, Mariya; Niścigórska-Olsen, Jolanta; Wawszczak, Marek

2015-01-01

The study describes four cases of tularaemia - one developed after contact with rabbits and three developed after an arthropod bite. Due to non-specific clinical symptoms, accurate diagnosis of tularaemia may be difficult. The increasing contribution of the arthropod vectors in the transmission of the disease indicates that special effort should be made to apply sensitive and specific diagnostic methods for tularaemia, and to remind health-care workers about this route of Francisella tularensis infections. The advantages and disadvantages of various diagnostic methods - molecular, serological and microbiological culture - are discussed. The PCR as a rapid and proper diagnostic method for ulceroglandular tularaemia is presented.

Using a bayesian latent class model to evaluate the utility of investigating persons with negative polymerase chain reaction results for pertussis.

PubMed

Tarr, Gillian A M; Eickhoff, Jens C; Koepke, Ruth; Hopfensperger, Daniel J; Davis, Jeffrey P; Conway, James H

2013-07-15

Pertussis remains difficult to control. Imperfect sensitivity of diagnostic tests and lack of specific guidance regarding interpretation of negative test results among patients with compatible symptoms may contribute to its spread. In this study, we examined whether additional pertussis cases could be identified if persons with negative pertussis test results were routinely investigated. We conducted interviews among 250 subjects aged ≤18 years with pertussis polymerase chain reaction (PCR) results reported from 2 reference laboratories in Wisconsin during July-September 2010 to determine whether their illnesses met the Centers for Disease Control and Prevention's clinical case definition (CCD) for pertussis. PCR validity measures were calculated using the CCD as the standard for pertussis disease. Two Bayesian latent class models were used to adjust the validity measures for pertussis detectable by 1) culture alone and 2) culture and/or more sensitive measures such as serology. Among 190 PCR-negative subjects, 54 (28%) had illnesses meeting the CCD. In adjusted analyses, PCR sensitivity and the negative predictive value were 1) 94% and 99% and 2) 43% and 87% in the 2 types of models, respectively. The models suggested that public health follow-up of reported pertussis patients with PCR-negative results leads to the detection of more true pertussis cases than follow-up of PCR-positive persons alone. The results also suggest a need for a more specific pertussis CCD.

Diagnostic value of CT-localizer and axial low-dose computed tomography for the detection of drug body packing.

PubMed

Aissa, Joel; Kohlmeier, Antonia; Rubbert, Christian; Hohn, Ulrich; Blondin, Dirk; Schleich, Christoph; Kröpil, Patric; Boos, Johannes; Antoch, Gerald; Miese, Falk

2016-01-01

The purpose of this study was to assess the diagnostic performance of CT-localizers in the detection of intracorporal containers. This study was approved by the research ethics committee of our clinic. From March 2012 to March 2013, 108 subjects were referred to our institute with suspected body packing. The CT-localizer and the axial CT-images were compared by two blinded observers retrospectively. Presence of body packs was assessed in consensus. Sensitivity and specificity, PPV and NPV of the CT-localizer were calculated. Packets were detected in the CT-localizer of 19 suspects. In 28 of 108 cases packs were detected in axial CT-images. Sensitivity of CT-localizer for detection of packs was 0.68, and specificity was 1.00. There were no cases rated as false positive. The PPV was 1.0 and the NPV was 0.89. The omission of the axial CT-images would have led to a mean radiation dose reduction of 1.94 ± 0.5 mSv. The value of CT-localizers lies in their high PPV. Localizers are limited by low sensitivity, compared to axial CT-images in screening of potential body packers. However, in positive cases their high PPV may possibly allow to omit the complete axial abdominal CT to achieve even lower radiation exposure. Copyright © 2015 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Accuracy of non-invasive prenatal testing using cell-free DNA for detection of Down, Edwards and Patau syndromes: a systematic review and meta-analysis

PubMed Central

Taylor-Phillips, Sian; Freeman, Karoline; Geppert, Julia; Agbebiyi, Adeola; Uthman, Olalekan A; Madan, Jason; Clarke, Angus; Quenby, Siobhan; Clarke, Aileen

2016-01-01

Objective To measure test accuracy of non-invasive prenatal testing (NIPT) for Down, Edwards and Patau syndromes using cell-free fetal DNA and identify factors affecting accuracy. Design Systematic review and meta-analysis of published studies. Data sources PubMed, Ovid Medline, Ovid Embase and the Cochrane Library published from 1997 to 9 February 2015, followed by weekly autoalerts until 1 April 2015. Eligibility criteria for selecting studies English language journal articles describing case–control studies with ≥15 trisomy cases or cohort studies with ≥50 pregnant women who had been given NIPT and a reference standard. Results 41, 37 and 30 studies of 2012 publications retrieved were included in the review for Down, Edwards and Patau syndromes. Quality appraisal identified high risk of bias in included studies, funnel plots showed evidence of publication bias. Pooled sensitivity was 99.3% (95% CI 98.9% to 99.6%) for Down, 97.4% (95.8% to 98.4%) for Edwards, and 97.4% (86.1% to 99.6%) for Patau syndrome. The pooled specificity was 99.9% (99.9% to 100%) for all three trisomies. In 100 000 pregnancies in the general obstetric population we would expect 417, 89 and 40 cases of Downs, Edwards and Patau syndromes to be detected by NIPT, with 94, 154 and 42 false positive results. Sensitivity was lower in twin than singleton pregnancies, reduced by 9% for Down, 28% for Edwards and 22% for Patau syndrome. Pooled sensitivity was also lower in the first trimester of pregnancy, in studies in the general obstetric population, and in cohort studies with consecutive enrolment. Conclusions NIPT using cell-free fetal DNA has very high sensitivity and specificity for Down syndrome, with slightly lower sensitivity for Edwards and Patau syndrome. However, it is not 100% accurate and should not be used as a final diagnosis for positive cases. Trial registration number CRD42014014947. PMID:26781507

Norm Acquisition, Rational Judgment and Moral Particularism

ERIC Educational Resources Information Center

Westphal, Kenneth R.

2012-01-01

Moral particularism, defined as the view that moral judgment does not require moral principles, has become prominent both in moral philosophy and in philosophy of education. This article re-examines Nussbaum's case for particularism, based on Sophocles' "Antigone", because her stress on sensitive appreciation of circumstantial specifics is…

Depression Case Finding in Individuals with Dementia: A Systematic Review and Meta-Analysis.

PubMed

Goodarzi, Zahra S; Mele, Bria S; Roberts, Derek J; Holroyd-Leduc, Jayna

2017-05-01

To compare the diagnostic accuracy of depression case finding tools with a criterion standard in the outpatient setting among adults with dementia. Systematic review and meta-analysis. Studies of older outpatients with dementia. Elderly outpatients (clinic and long-term care) with dementia (N = 3,035). Prevalence of major depression and diagnostic accuracy measures including sensitivity, specificity, and likelihood ratios. From the 11,539 citations, 20 studies were included for qualitative synthesis and 15 for a meta-analysis. Tools included were the Montgomery Åsberg Depression Rating Scale, Cornell Scale for Depression in Dementia (CSDD), Geriatric Depression Scale (GDS), Center for Epidemiologic Studies Depression Scale (CES-D), Hamilton Depression Rating Scale (HDRS), Single Question, Nijmegen Observer-Rated Depression Scale, and Even Briefer Assessment Scale-Depression. The pooled prevalence of depression in individuals with dementia was 30.3% (95% CI = 22.1-38.5). The average age was 75.2 (95% CI = 71.7-78.7), and mean Mini-Mental State Examination scores ranged from 11.2 to 24. The diagnostic accuracy of the individual tools was pooled for the best-reported cutoffs and for each cutoff, if available. The CSDD had a sensitivity of 0.84 (95% CI = 0.73-0.91) and a specificity of 0.80 (95% CI = 0.65-0.90), the 30-item GDS (GDS-30) had a sensitivity of 0.62 (95% CI = 0.45-0.76) and a specificity 0.81 (95% CI = 0.75-0.85), and the HDRS had a sensitivity of 0.86 (95% CI = 0.63-0.96) and a specificity of 0.84 (95% CI = 0.76-0.90). Summary statistics for all tools across best-reported cutoffs had significant heterogeneity. There are many validated tools for the detection of depression in individuals with dementia. Tools that incorporate a physician interview with patient and collateral histories, the CSDD and HDRS, have higher sensitivities, which would ensure fewer false-negatives. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Comparison of clinical and analytical performance of the Abbott Realtime High Risk HPV test to the performance of hybrid capture 2 in population-based cervical cancer screening.

PubMed

Poljak, Mario; Ostrbenk, Anja; Seme, Katja; Ucakar, Veronika; Hillemanns, Peter; Bokal, Eda Vrtacnik; Jancar, Nina; Klavs, Irena

2011-05-01

The clinical performance of the Abbott RealTime High Risk HPV (human papillomavirus) test (RealTime) and that of the Hybrid Capture 2 HPV DNA test (hc2) were prospectively compared in the population-based cervical cancer screening setting. In women >30 years old (n = 3,129), the clinical sensitivity of RealTime for detection of cervical intraepithelial neoplasia of grade 2 (CIN2) or worse (38 cases) and its clinical specificity for lesions of less than CIN2 (3,091 controls) were 100% and 93.3%, respectively, and those of hc2 were 97.4% and 91.8%, respectively. A noninferiority score test showed that the clinical specificity (P < 0.0001) and clinical sensitivity (P = 0.011) of RealTime were noninferior to those of hc2 at the recommended thresholds of 98% and 90%. In the total study population (women 20 to 64 years old; n = 4,432; 57 cases, 4,375 controls), the clinical sensitivity and specificity of RealTime were 98.2% and 89.5%, and those of hc2 were 94.7% and 87.7%, respectively. The analytical sensitivity and analytical specificity of RealTime in detecting targeted HPV types evaluated with the largest sample collection to date (4,479 samples) were 94.8% and 99.8%, and those of hc2 were 93.4% and 97.8%, respectively. Excellent analytical agreement between the two assays was obtained (kappa value, 0.84), while the analytical accuracy of RealTime was significantly higher than that of hc2. RealTime demonstrated high intralaboratory reproducibility and interlaboratory agreement with 500 samples retested 61 to 226 days after initial testing in two different laboratories. RealTime can be considered to be a reliable and robust HPV assay clinically comparable to hc2 for the detection of CIN2+ lesions in a population-based cervical cancer screening setting.

Methods to increase reporting of childhood sexual abuse in surveys: the sensitivity and specificity of face-to-face interviews versus a sealed envelope method in Ugandan primary school children.

PubMed

Barr, Anna Louise; Knight, Louise; Franҫa-Junior, Ivan; Allen, Elizabeth; Naker, Dipak; Devries, Karen M

2017-02-23

Underreporting of childhood sexual abuse is a major barrier to obtaining reliable prevalence estimates. We tested the sensitivity and specificity of the face-to-face-interview (FTFI) method by comparing the number of disclosures of forced sex against a more confidential mode of data collection, the sealed-envelope method (SEM). We also report on characteristics of individuals associated with non-disclosure in FTFIs. Secondary analysis of data from a cross-sectional survey conducted in 2014, with n = 3843 children attending primary school in Luwero District, Uganda. Sensitivity and specificity were calculated, and mixed effects logistic regression models tested factors associated with disclosure in one or both modes. In the FTFI, 1.1% (n = 42) of children reported ever experiencing forced sex, compared to 7.0% (n = 268) in the SEM. The FTFI method demonstrated low sensitivity (13.1%, 95%CI 9.3-17.7%) and high specificity (99.8%, 95%CI 99.6-99.9%) in detecting cases of forced sex, when compared to the SEM. Boys were less likely than girls to disclose in the FTFI, however there was no difference in prevalence by sex using the SEM (aOR = 0.91, 95%CI 0.7-1.2; P = 0.532). Disclosing experience of other forms of sexual violence was associated with experience of forced sex for both modes of disclosure. The SEM method was superior to FTFIs in identifying cases of forced sex amongst primary school children, particularly for boys. Reporting of other forms of sexual violence in FTFIs may indicate experience of forced sex. Future survey research, and efforts to estimate prevalence of sexual violence, should make use of more confidential disclosure methods to detect childhood sexual abuse.

Comparison of radiologist performance with photon-counting full-field digital mammography to conventional full-field digital mammography.

PubMed

Cole, Elodia B; Toledano, Alicia Y; Lundqvist, Mats; Pisano, Etta D

2012-08-01

The purpose of this study was to assess the performance of a MicroDose photon-counting full-field digital mammography (PCM) system in comparison to full-field digital mammography (FFDM) for area under the receiver-operating characteristic (ROC) curve (AUC), sensitivity, specificity, and feature analysis of standard-view mammography for women presenting for screening mammography, diagnostic mammography, or breast biopsy. A total of 133 women were enrolled in this study at two European medical centers, with 67 women who had a pre-existing 10-36 months FFDM enrolled prospectively into the study and 66 women who underwent breast biopsy and had screening PCM and diagnostic FFDM, including standard craniocaudal and mediolateral oblique views of the breast with the lesion, enrolled retrospectively. The case mix consisted of 49 cancers, 17 biopsy-benign cases, and 67 normal cases. Sixteen radiologists participated in the reader study and interpreted all 133 cases in both conditions, separated by washout period of ≥4 weeks. ROC curve and free-response ROC curve analyses were performed for noninferiority of PCM compared to FFDM using a noninferiority margin Δ value of 0.10. Feature analysis of the 66 cases with lesions was conducted with all 16 readers at the conclusion of the blinded reads. Mean glandular dose was recorded for all cases. The AUC for PCM was 0.947 (95% confidence interval [CI], 0.920-0.974) and for FFDM was 0.931 (95% CI, 0.898-0.964). Sensitivity per case for PCM was 0.936 (95% CI, 0.897-0.976) and for FFDM was 0.908 (95% CI, 0.856-0.960). Specificity per case for PCM was 0.764 (95% CI, 0.688-0.841) and for FFDM was 0.749 (95% CI, 0.668-0.830). Free-response ROC curve figures of merit were 0.920 (95% CI, 0.881-0.959) and 0.903 (95% CI, 0.858-0.948) for PCM and FFDM, respectively. Sensitivity per lesion was 0.903 (95% CI, 0.846-0.960) and 0.883 (95% CI, 0.823-0.944) for PCM and FFDM, respectively. The average false-positive marks per image of noncancer cases were 0.265 (95% CI, 0.171-0.359) and 0.281 (95% CI, 0.188-0.374) for PCM and FFDM, respectively. Noninferiority P values for AUC, sensitivity (per case and per lesion), specificity, and average false-positive marks per image were all statistically significant (P < .001). The noninferiority P value for free-response ROC was <.025, from the 95% CI for the difference. Feature analysis resulted in PCM being preferred to FFDM by the readers for ≥70% of the cases. The average mean glandular dose for PCM was 0.74 mGy (95% CI, 0.722-0.759 mGy) and for FFDM was 1.23 mGy (95% CI, 1.199-1.262 mGy). In this study, radiologist performance with PCM was not inferior to that with conventional FFDM at an average 40% lower mean glandular dose. Copyright © 2012 AUR. Published by Elsevier Inc. All rights reserved.

Evaluation of the IgE cross-reactions among vespid venoms. A possible approach for the choice of immunotherapy.

PubMed

Caruso, B; Bonadonna, P; Severino, M G; Manfredi, M; Dama, A; Schiappoli, M; Rizzotti, P; Senna, G; Passalacqua, G

2007-05-01

Hymenoptera venom allergy can be effectively cured with specific immunotherapy, thus the correct identification of the allergen is essential. In the case of multiple skin and serum positivities it is important to know if a cross-reaction among venoms is present. We studied by CAP-inhibition assays the degree of cross-reactivity between Vespula vulgaris and Polistes dominulus. Serum samples were obtained from consecutive patients with a clinical history of grade III-IV reactions to hymenoptera sting and with nondiscriminative skin/CAP positivity to both Vespula and Polistes. Inhibition assays were carried out with a CAP method, incubating the sera separately with both venoms and subsequently measuring the specific immunoglobulin E (IgE) to venoms themselves. Forty-five patients (33 male, mean age 40 years, age range 12-74, total serum IgE 242 +/- 168 kU/l) were included. Their specific IgE to Vespula and Polistes were 12.03 +/- 5.70 kU/l and 10.7 +/- 2.0 kU/l (P = NS), respectively. At the CAP-inhibition assays, in 25 patients a >75% heterologous inhibition by P. dominulus venom against V. vulgaris-specific IgE was found. In six subjects V. vulgaris venom effectively inhibited the P. dominulus-specific IgE. In the remaining 14 cases the CAP-inhibition test provided intermediate and not discriminative results. In 31/45 patients, the double sensitizations to venoms were probably the result of cross-reactions and the CAP-inhibition allowed identifying the true double sensitizations. This approach may be helpful for the correct prescription of immunotherapy in the case of V. vulgaris and P. dominulus double positivity.

Management of neonatal sepsis at Muhimbili National Hospital in Dar es Salaam: diagnostic accuracy of C-reactive protein and newborn scale of sepsis and antimicrobial resistance pattern of etiological bacteria.

PubMed

Mkony, Martha Franklin; Mizinduko, Mucho Michael; Massawe, Augustine; Matee, Mecky

2014-12-05

We determined the accuracy of Rubarth's newborn scale of sepsis and C- reactive protein in diagnosing neonatal sepsis and assessed antimicrobial susceptibility pattern of etiological bacteria. This cross sectional study was conducted at Muhimbili National Hospital in Dar es Salaam, Tanzania between July 2012 and March 2013. Neonates suspected to have sepsis underwent physical examination using Rubarth's newborn scale of sepsis (RNSOS). Blood was taken for culture and antimicrobial sensitivity testing, full blood picture and C - reactive protein (CRP) performed 12 hours apart. The efficacy of RNSOS and serial CRP was assessed by calculating sensitivity, specificity, negative and positive predictive values, receiver operating characteristics (ROC) analysis as well as likelihood ratios (LHR) with blood culture result used as a gold standard. Out of 208 blood samples, 19.2% had a positive blood culture. Single CRP had sensitivity and specificity of 87.5% and 70.9% respectively, while RNSOS had sensitivity of 65% and specificity of 79.7%. Serial CRP had sensitivity of 69.0% and specificity of 92.9%. Combination of CRP and RNSOS increased sensitivity to 95.6% and specificity of 56.4%. Combination of two CRP and RNSOS decreased sensitivity to 89.1% but increased specificity to 74%. ROC for CRP was 0.86; and for RNSOS was 0.81. For CRP the LHR for positive test was 3 while for negative test was 0.18, while for RNSOS the corresponding values were 3.24 and for negative test was 0.43. Isolated bacteria were Klebsiella spp 14 (35%), Escherichia coli 12 (22.5%), Coagulase negative staphlococci 9 (30%), Staphylococcus aureus 4 (10%), and Pseudomonas spp 1 (2.5%). The overall resistance to the WHO recommended first line antibiotics was 100%, 92% and 42% for cloxacillin, ampicillin and gentamicin, respectively. For the second line drugs resistance was 45%, 40%, and 7% for ceftriaxone, vancomycin and amikacin respectively. Single CRP in combination with RNSOS can be used for rapid identification of neonates with sepsis due to high sensitivity (95.6%) but cannot exclude those without sepsis due to low specificity (56.4%). Serial CRP done 12hrs apart can be used to exclude non-cases. This study demonstrated very high levels of resistance to the first-line antibiotics.

The predictive value of 201Tl rest-redistribution and 18F-fluorodeoxyglucose SPECT for wall motion recovery after recent reperfused myocardial infarction.

PubMed

González, Patricio; Massardo, Teresa; Coll, Claudia; Humeres, Pamela; Sierralta, Paulina; Jofré, M Josefina; Yovanovich, Jorge; Aramburu, Ivonne; Brugère, Solange; Chamorro, Hernán

2004-04-01

201Tl and 18F-FDG are useful for acute myocardial infarction (MI) assessment. The goal of this study was to compare their predictive value for wall motion recovery in the culprit area after a recent reperfused MI using SPECT technique. Forty-one patients (mean age: 56 +/- 12 years) were included, 81% of them male; all were studied within 1-24 days post MI. They underwent angioplasty in 27 cases (12 primary); bypass grafting in 10 cases and successful thrombolysis in 4. SPECT 201Tl injected at rest and redistribution (R-R) and also 18F-FDG, were performed on different days. Processed tomograms were interpreted blinded to clinical or angiographic data. Segmental wall motion assessed with echocardiography at baseline was compared with the 3 month follow up. Sensitivity [Confidence Interval] for 201Tl R-R was 74.6% [60.5-84.5], for FDG it was 82.1% [70.8-90.4]; specificities were 73% [64.3-80.5] and 54.8% [45.6-63.7], respectively. 18F-FDG tended to be more sensitive than 201Tl R-R, but the latter was more specific (p < 0.0004). Both 201Tl RR and 18F-FDG presented high negative predictive value (p: ns). In recent MI, SPECT 201Tl R-R is a valuable and widely available technique for viability detection, with similar sensitivity and significant better specificity than SPECT 18F-FDG.

Screening instruments for a population of older adults: The 10-item Kessler Psychological Distress Scale (K10) and the 7-item Generalized Anxiety Disorder Scale (GAD-7).

PubMed

Vasiliadis, Helen-Maria; Chudzinski, Veronica; Gontijo-Guerra, Samantha; Préville, Michel

2015-07-30

Screening tools that appropriately detect older adults' mental disorders are of great public health importance. The present study aimed to establish cutoff scores for the 10-item Kessler Psychological Distress (K10) and the 7-item Generalized Anxiety Disorder (GAD-7) scales when screening for depression and anxiety. We used data from participants (n = 1811) in the Enquête sur la Santé des Aînés-Service study. Depression and anxiety were measured using DSM-V and DSM-IV criteria. Receiver operating characteristic (ROC) curve analysis provided an area under the curve (AUC) of 0.767 and 0.833 for minor and for major depression when using K10. A cutoff of 19 was found to balance sensitivity (0.794) and specificity (0.664) for minor depression, whereas a cutoff of 23 was found to balance sensitivity (0.692) and specificity (0.811) for major depression. When screening for an anxiety with GAD-7, ROC analysis yielded an AUC of 0.695; a cutoff of 5 was found to balance sensitivity (0.709) and specificity (0.568). No significant differences were found between subgroups of age and gender. Both K10 and GAD-7 were able to discriminate between cases and non-cases when screening for depression and anxiety in an older adult population of primary care service users. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Sensitivity and Specificity of an Adult Stroke Screening Tool in Childhood Ischemic Stroke.

PubMed

Neville, Kerri; Lo, Warren

2016-05-01

There are frequent delays in the diagnosis of acute pediatric ischemic stroke. A screening tool that could increase the suspicion of acute ischemic stroke could aid early recognition and might improve initial care. An earlier study reported that children with acute ischemic stroke have signs that can be recognized with two adult stroke scales. We tested the hypothesis that an adult stroke scale could distinguish children with acute ischemic stroke from children with acute focal neurological deficits not due to stroke. We retrospectively applied an adult stroke scale to the recorded examinations of 53 children with acute symptomatic acute ischemic stroke and 53 age-matched control subjects who presented with focal neurological deficits. We examined the sensitivity and specificity of the stroke scale and the occurrence of acute seizures as predictors of stroke status. The total stroke scale did not differentiate children with acute ischemic stroke from those who had acute deficits from nonstroke causes; however, the presence of arm weakness was significantly associated with stroke cases. Acute seizures were significantly associated with stroke cases. An adult stroke scale is not sensitive or specific to distinguish children with acute ischemic stroke from those with nonstroke focal neurological deficits. The development of a pediatric acute ischemic stroke screening tool should include arm weakness and perhaps acute seizures as core elements. Such a scale must account for the limitations of language in young or intellectually disabled children. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison the Serum STREM1 Levels Between Children with Upper and Lower UTI.

PubMed

Ehsanipour, Fahime; Noorbakhsh, Samileh; Zarabi, Vida; Movahedi, Zahra; Rahimzadeh, Nahid

2017-01-01

Pyelonephritis is the most common and important infection among Iranian pediatric population. Differentiation between upper and lower Urinary Tract Infection (UTI) is often difficult based on clinical data. Therefore, definite diagnosis is helpful for choosing appropriate antibiotic and decision for hospital admission. The main purpose of this study was todetermine the diagnostic value of serum STREM-1 level in children suspicious to UTI and differentiation of upper UTI and lower UTI. This prospective cross sectional study (2010-2011) was performed to evaluate and compare the serum level of STREM- 1 (pg. /ml) in 36 diagnosed UTI patients (24 upper and 12 lower UTI) with 25 normal children (without UTI) in Rasoul Akram hospital, Tehran, Iran. The mean age of studied children was 3.64 years; 24 male and 37 female. Urinary analysis and urine culture were performed for all UTI cases and only the positive cultured cases with the same microorganism were enrolled in the study. Distinguishing the upper from lower UTI was done on the basis of clinical manifestation and laboratory tests and confirmed by Imaging studies (ultra sonography /or DMSA scan). Blood sampling was taken from all children and centrifuged .The level of STREM-1 (pg /ml) in all sera was determined by Enzyme immunoassay technique (Human TREM-1 immunoassay Sandwich test, Quantikine, R&D systems, Minneapolis; USA). Cut-off levels for STREM-1 were illustrated by ROC curve. The p<0.05 was considered as significant for differences between groups. The mean of STREM -1level had significant difference between overall cases of UTI (427.72pg/ml) and controls (124.24 pg. /ml; P =0.000) ; with cutoff point 111.5 pg./ml ; it had 83.3% sensitivity; and 60 % specificity to distinguish UTI from control. Serum STREM -1 level had no significantly difference between the upper and lower UTI (500pg/ml vs. 283 pg. /ml, P value=0.1) with cutoff point 132 pg./ml it had 83.3% sensitivity ; and 60 % specificity to distinguish upper UTI from lower UTI. Our study demonstrates that even low amount of serum STREM-1 (111.5 pg./ml) has 83.3% sensitivity ; and 60 % specificity to distinguish the UTI from normal cases (P value =0.000) but higher level (132 pg./ml) was needed for definite diagnosis (83.3% sensitivity; 60 % specificity) of upper and lower UTI. It is concluded that serum STREM-1 level test is a valuable tool for early diagnosis of the normal cases with false positive urine culture, or in highly suspicious upper UTI cases with false negative urine culture. Indeed higher titer of this biomarker could be helpful for discriminating the upper from lower UTI. Therefore adding this new biologic marker (STREM-1) to previous ones (CRP, PCT) is suggested to prevent the unnecessary hospital admission and empiric antibiotic therapy. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Rapid antigen detection test for group A streptococcus in children with pharyngitis.

PubMed

Cohen, Jérémie F; Bertille, Nathalie; Cohen, Robert; Chalumeau, Martin

2016-07-04

Group A streptococcus (GAS) accounts for 20% to 40% of cases of pharyngitis in children; the remaining cases are caused by viruses. Compared with throat culture, rapid antigen detection tests (RADTs) offer diagnosis at the point of care (within five to 10 minutes). To determine the diagnostic accuracy of RADTs for diagnosing GAS in children with pharyngitis. To assess the relative diagnostic accuracy of the two major types of RADTs (enzyme immunoassays (EIA) and optical immunoassays (OIA)) by indirect and direct comparison. We searched CENTRAL, MEDLINE, EMBASE, Web of Science, CDSR, DARE, MEDION and TRIP (January 1980 to July 2015). We also conducted related citations tracking via PubMed, handsearched reference lists of included studies and relevant review articles, and screened all articles citing included studies via Google Scholar. We included studies that compared RADT for GAS pharyngitis with throat culture on a blood agar plate in a microbiology laboratory in children seen in ambulatory care. Two review authors independently screened titles and abstracts for relevance, assessed full texts for inclusion, and carried out data extraction and quality assessment using the QUADAS-2 tool. We used bivariate meta-analysis to estimate summary sensitivity and specificity, and to investigate heterogeneity across studies. We compared the accuracy of EIA and OIA tests using indirect and direct evidence. We included 98 unique studies in the review (116 test evaluations; 101,121 participants). The overall methodological quality of included studies was poor, mainly because many studies were at high risk of bias regarding patient selection and the reference standard used (in 73% and 43% of test evaluations, respectively). In studies in which all participants underwent both RADT and throat culture (105 test evaluations; 58,244 participants; median prevalence of participants with GAS was 29.5%), RADT had a summary sensitivity of 85.6%; 95% confidence interval (CI) 83.3 to 87.6 and a summary specificity of 95.4%; 95% CI 94.5 to 96.2. There was substantial heterogeneity in sensitivity across studies; specificity was more stable. There was no evidence of a trade-off between sensitivity and specificity. Heterogeneity in accuracy was not explained by study-level characteristics such as whether an enrichment broth was used before plating, mean age and clinical severity of participants, and GAS prevalence. The sensitivity of EIA and OIA tests was comparable (summary sensitivity 85.4% versus 86.2%). Sensitivity analyses showed that summary estimates of sensitivity and specificity were stable in low risk of bias studies. In a population of 1000 children with a GAS prevalence of 30%, 43 patients with GAS will be missed. Whether or not RADT can be used as a stand-alone test to rule out GAS will depend mainly on the epidemiological context. The sensitivity of EIA and OIA tests seems comparable. RADT specificity is sufficiently high to ensure against unnecessary use of antibiotics. Based on these results, we would expect that amongst 100 children with strep throat, 86 would be correctly detected with the rapid test while 14 would be missed and not receive antibiotic treatment.

Robust Detection of Rare Species Using Environmental DNA: The Importance of Primer Specificity

PubMed Central

Wilcox, Taylor M.; McKelvey, Kevin S.; Young, Michael K.; Jane, Stephen F.; Lowe, Winsor H.; Whiteley, Andrew R.; Schwartz, Michael K.

2013-01-01

Environmental DNA (eDNA) is being rapidly adopted as a tool to detect rare animals. Quantitative PCR (qPCR) using probe-based chemistries may represent a particularly powerful tool because of the method’s sensitivity, specificity, and potential to quantify target DNA. However, there has been little work understanding the performance of these assays in the presence of closely related, sympatric taxa. If related species cause any cross-amplification or interference, false positives and negatives may be generated. These errors can be disastrous if false positives lead to overestimate the abundance of an endangered species or if false negatives prevent detection of an invasive species. In this study we test factors that influence the specificity and sensitivity of TaqMan MGB assays using co-occurring, closely related brook trout (Salvelinus fontinalis) and bull trout (S. confluentus) as a case study. We found qPCR to be substantially more sensitive than traditional PCR, with a high probability of detection at concentrations as low as 0.5 target copies/µl. We also found that number and placement of base pair mismatches between the Taqman MGB assay and non-target templates was important to target specificity, and that specificity was most influenced by base pair mismatches in the primers, rather than in the probe. We found that insufficient specificity can result in both false positive and false negative results, particularly in the presence of abundant related species. Our results highlight the utility of qPCR as a highly sensitive eDNA tool, and underscore the importance of careful assay design. PMID:23555689

Robust detection of rare species using environmental DNA: the importance of primer specificity.

PubMed

Wilcox, Taylor M; McKelvey, Kevin S; Young, Michael K; Jane, Stephen F; Lowe, Winsor H; Whiteley, Andrew R; Schwartz, Michael K

2013-01-01

Environmental DNA (eDNA) is being rapidly adopted as a tool to detect rare animals. Quantitative PCR (qPCR) using probe-based chemistries may represent a particularly powerful tool because of the method's sensitivity, specificity, and potential to quantify target DNA. However, there has been little work understanding the performance of these assays in the presence of closely related, sympatric taxa. If related species cause any cross-amplification or interference, false positives and negatives may be generated. These errors can be disastrous if false positives lead to overestimate the abundance of an endangered species or if false negatives prevent detection of an invasive species. In this study we test factors that influence the specificity and sensitivity of TaqMan MGB assays using co-occurring, closely related brook trout (Salvelinus fontinalis) and bull trout (S. confluentus) as a case study. We found qPCR to be substantially more sensitive than traditional PCR, with a high probability of detection at concentrations as low as 0.5 target copies/µl. We also found that number and placement of base pair mismatches between the Taqman MGB assay and non-target templates was important to target specificity, and that specificity was most influenced by base pair mismatches in the primers, rather than in the probe. We found that insufficient specificity can result in both false positive and false negative results, particularly in the presence of abundant related species. Our results highlight the utility of qPCR as a highly sensitive eDNA tool, and underscore the importance of careful assay design.

Plagiarism in submitted manuscripts: incidence, characteristics and optimization of screening-case study in a major specialty medical journal.

PubMed

Higgins, Janet R; Lin, Feng-Chang; Evans, James P

2016-01-01

Plagiarism is common and threatens the integrity of the scientific literature. However, its detection is time consuming and difficult, presenting challenges to editors and publishers who are entrusted with ensuring the integrity of published literature. In this study, the extent of plagiarism in manuscripts submitted to a major specialty medical journal was documented. We manually curated submitted manuscripts and deemed an article contained plagiarism if one sentence had 80 % of the words copied from another published paper. Commercial plagiarism detection software was utilized and its use was optimized. In 400 consecutively submitted manuscripts, 17 % of submissions contained unacceptable levels of plagiarized material with 82 % of plagiarized manuscripts submitted from countries where English was not an official language. Using the most commonly employed commercial plagiarism detection software, sensitivity and specificity were studied with regard to the generated plagiarism score. The cutoff score maximizing both sensitivity and specificity was 15 % (sensitivity 84.8 % and specificity 80.5 %). Plagiarism was a common occurrence among manuscripts submitted for publication to a major American specialty medical journal and most manuscripts with plagiarized material were submitted from countries in which English was not an official language. The use of commercial plagiarism detection software can be optimized by selecting a cutoff score that reflects desired sensitivity and specificity.

Improved cardiovascular diagnostic accuracy by pocket size imaging device in non-cardiologic outpatients: the NaUSiCa (Naples Ultrasound Stethoscope in Cardiology) study

PubMed Central

2010-01-01

Miniaturization has evolved in the creation of a pocket-size imaging device which can be utilized as an ultrasound stethoscope. This study assessed the additional diagnostic power of pocket size device by both experts operators and trainees in comparison with physical examination and its appropriateness of use in comparison with standard echo machine in a non-cardiologic population. Three hundred four consecutive non cardiologic outpatients underwent a sequential assessment including physical examination, pocket size imaging device and standard Doppler-echo exam. Pocket size device was used by both expert operators and trainees (who received specific training before the beginning of the study). All the operators were requested to give only visual, qualitative insights on specific issues. All standard Doppler-echo exams were performed by expert operators. One hundred two pocket size device exams were performed by experts and two hundred two by trainees. The time duration of the pocket size device exam was 304 ± 117 sec. Diagnosis of cardiac abnormalities was made in 38.2% of cases by physical examination and in 69.7% of cases by physical examination + pocket size device (additional diagnostic power = 31.5%, p < 0.0001). The overall K between pocket size device and standard Doppler-echo was 0.67 in the pooled population (0.84 by experts and 0.58 by trainees). K was suboptimal for trainees in the eyeball evaluation of ejection fraction, left atrial dilation and right ventricular dilation. Overall sensitivity was 91% and specificity 76%. Sensitivity and specificity were lower in trainees than in experts. In conclusion, pocket size device showed a relevant additional diagnostic value in comparison with physical examination. Sensitivity and specificity were good in experts and suboptimal in trainees. Specificity was particularly influenced by the level of experience. Training programs are needed for pocket size device users. PMID:21110840

Bias-Corrected Targeted Next-Generation Sequencing for Rapid, Multiplexed Detection of Actionable Alterations in Cell-Free DNA from Advanced Lung Cancer Patients.

PubMed

Paweletz, Cloud P; Sacher, Adrian G; Raymond, Chris K; Alden, Ryan S; O'Connell, Allison; Mach, Stacy L; Kuang, Yanan; Gandhi, Leena; Kirschmeier, Paul; English, Jessie M; Lim, Lee P; Jänne, Pasi A; Oxnard, Geoffrey R

2016-02-15

Tumor genotyping is a powerful tool for guiding non-small cell lung cancer (NSCLC) care; however, comprehensive tumor genotyping can be logistically cumbersome. To facilitate genotyping, we developed a next-generation sequencing (NGS) assay using a desktop sequencer to detect actionable mutations and rearrangements in cell-free plasma DNA (cfDNA). An NGS panel was developed targeting 11 driver oncogenes found in NSCLC. Targeted NGS was performed using a novel methodology that maximizes on-target reads, and minimizes artifact, and was validated on DNA dilutions derived from cell lines. Plasma NGS was then blindly performed on 48 patients with advanced, progressive NSCLC and a known tumor genotype, and explored in two patients with incomplete tumor genotyping. NGS could identify mutations present in DNA dilutions at ≥ 0.4% allelic frequency with 100% sensitivity/specificity. Plasma NGS detected a broad range of driver and resistance mutations, including ALK, ROS1, and RET rearrangements, HER2 insertions, and MET amplification, with 100% specificity. Sensitivity was 77% across 62 known driver and resistance mutations from the 48 cases; in 29 cases with common EGFR and KRAS mutations, sensitivity was similar to droplet digital PCR. In two cases with incomplete tumor genotyping, plasma NGS rapidly identified a novel EGFR exon 19 deletion and a missed case of MET amplification. Blinded to tumor genotype, this plasma NGS approach detected a broad range of targetable genomic alterations in NSCLC with no false positives including complex mutations like rearrangements and unexpected resistance mutations such as EGFR C797S. Through use of widely available vacutainers and a desktop sequencing platform, this assay has the potential to be implemented broadly for patient care and translational research. ©2015 American Association for Cancer Research.

Bias-corrected targeted next-generation sequencing for rapid, multiplexed detection of actionable alterations in cell-free DNA from advanced lung cancer patients

PubMed Central

Paweletz, Cloud P.; Sacher, Adrian G.; Raymond, Chris K.; Alden, Ryan S.; O'Connell, Allison; Mach, Stacy L.; Kuang, Yanan; Gandhi, Leena; Kirschmeier, Paul; English, Jessie M.; Lim, Lee P.; Jänne, Pasi A.; Oxnard, Geoffrey R.

2015-01-01

Purpose Tumor genotyping is a powerful tool for guiding non-small cell lung cancer (NSCLC) care, however comprehensive tumor genotyping can be logistically cumbersome. To facilitate genotyping, we developed a next-generation sequencing (NGS) assay using a desktop sequencer to detect actionable mutations and rearrangements in cell-free plasma DNA (cfDNA). Experimental Design An NGS panel was developed targeting 11 driver oncogenes found in NSCLC. Targeted NGS was performed using a novel methodology that maximizes on-target reads, and minimizes artifact, and was validated on DNA dilutions derived from cell lines. Plasma NGS was then blindly performed on 48 patients with advanced, progressive NSCLC and a known tumor genotype, and explored in two patients with incomplete tumor genotyping. Results NGS could identify mutations present in DNA dilutions at ≥0.4% allelic frequency with 100% sensitivity/specificity. Plasma NGS detected a broad range of driver and resistance mutations, including ALK, ROS1, and RET rearrangements, HER2 insertions, and MET amplification, with 100% specificity. Sensitivity was 77% across 62 known driver and resistance mutations from the 48 cases; in 29 cases with common EGFR and KRAS mutations, sensitivity was similar to droplet digital PCR. In two cases with incomplete tumor genotyping, plasma NGS rapidly identified a novel EGFR exon 19 deletion and a missed case of MET amplification. Conclusion Blinded to tumor genotype, this plasma NGS approach detected a broad range of targetable genomic alterations in NSCLC with no false positives including complex mutations like rearrangements and unexpected resistance mutations such as EGFR C797S. Through use of widely available vacutainers and a desktop sequencing platform, this assay has the potential to be implemented broadly for patient care and translational research. PMID:26459174

Helicobacter pylori diagnostic tests in children: review of the literature from 1999 to 2009.

PubMed

Guarner, Jeannette; Kalach, Nicolas; Elitsur, Yoram; Koletzko, Sibylle

2010-01-01

The array of tests that can be used for diagnosis of Helicobacter pylori infection is large, and it can be confusing to define which test to use particularly in children where results may not be comparable to those obtained in adult patients. Using PubMed, we reviewed the English literature from January 1999 to May 2009 to identify articles that determined sensitivity and specificity of H. pylori invasive and non-invasive diagnostic tests in children. We excluded articles that presented a review of the literature, abstracts, case reports, or series where children's results could not be separated from adult populations. Of the tissue based methods, rapid urease tests have better sensitivity than histology to detect presence of H. pylori; however, histology can detect the pathology associated with disease including gastritis, intestinal metaplasia, and other conditions that could be the cause of the child's symptoms. Culture of gastric tissues or stool has 100% specificity but sensitivity is low. Of the serologic tests, immunoblot has the best sensitivity. The urea breath tests have >75% sensitivity for detection of H. pylori before and after treatment. Immunoassays in stool using monoclonal antibodies have >95% sensitivity for detection of H. pylori before and after treatment. PCR testing can be performed in tissue and stool samples and can detect genes associated to antibiotic resistance. In summary, the current commercial non-invasive tests have adequate sensitivity and specificity for detecting the presence of H. pylori; however, endoscopy with histopathology is the only method that can detect H. pylori and lesions associated with the infection.

Histopathology of valves in infective endocarditis, diagnostic criteria and treatment considerations.

PubMed

Brandão, Tatiana J D; Januario-da-Silva, Carolina A; Correia, Marcelo G; Zappa, Monica; Abrantes, Jaime A; Dantas, Angela M R; Golebiovski, Wilma; Barbosa, Giovanna Ianini F; Weksler, Clara; Lamas, Cristiane C

2017-04-01

Infective endocarditis (IE) is a severe disease. Pathogen isolation is fundamental so as to treat effectively and reduce morbidity and mortality. Blood and valve culture and histopathology (HP) are routinely employed for this purpose. Valve HP is the gold standard for diagnosis. To determine the sensitivity and specificity of clinical criteria for IE (the modified Duke and the St Thomas' minor modifications, STH) of blood and valve culture compared to valve HP, and to evaluate antibiotic treatment duration. Prospective case series of patients, from 2006 to 2014 with surgically treated IE. Statistical analysis was done by the R software. There were 136 clinically definite episodes of IE in 133 patients. Mean age ± SD was 43 ± 15.6 years and IE was left sided in 81.6 %. HP was definite in 96 valves examined, which were used as gold standard. Sensitivity of blood culture was 61 % (CI 0.51, 0.71) and of valve culture 15 % (CI 0.07, 0.26). The modified Duke criteria were 65 % (CI 0.55, 0.75) sensitive and 33 % specific, while the STH's sensitivity was 72 % (CI 0.61, 0.80) with similar specificity. In multivariate analysis and logistic regression, the only variable with statistical significance was duration of antibiotic therapy postoperatively. Valve HP had high sensitivity and valve culture low sensitivity in the diagnosis of IE. The STH's criteria were more sensitive than the modified Duke criteria. Valve HP should guide duration of postoperative antibiotic treatment.

Evaluation of a Rapid Diagnostic Test for Yaws Infection in a Community Surveillance Setting

PubMed Central

Marks, Michael; Goncalves, Adriana; Vahi, Ventis; Sokana, Oliver; Puiahi, Elliot; Zhang, Zaixing; Dalipanda, Tenneth; Bottomley, Christian; Mabey, David; Solomon, Anthony W.

2014-01-01

Yaws is a non-venereal treponemal infection caused by Treponema pallidum ssp. pertenue. The WHO has launched a worldwide control programme, which aims to eradicate yaws by 2020. The development of a rapid diagnostic test (RDT) for serological diagnosis in the isolated communities affected by yaws is a key requirement for the successful implementation of the WHO strategy. We conducted a study to evaluate the utility of the DPP test in screening for yaws, utilizing samples collected as part of a community prevalence survey conducted in the Solomon Islands. 415 serum samples were tested using both traditional syphilis serology (TPPA and quantitative RPR) and the Chembio DPP Syphilis Screen and Confirm RDT. We calculated the sensitivity and specificity of the RDT as compared to gold standard serology. The sensitivity of the RDT against TPPA was 58.5% and the specificity was 97.6%. The sensitivity of the RDT against RPR was 41.7% and the specificity was 95.2%. The sensitivity of the DPP was strongly related to the RPR titre with a sensitivity of 92.0% for an RPR titre of >1/16. Wider access to DPP testing would improve our understanding of worldwide yaws case reporting and the test may play a key role in assessing patients presenting with yaws like lesions in a post-mass drug administration (MDA) setting. PMID:25211018

Evaluation of a rapid diagnostic test for yaws infection in a community surveillance setting.

PubMed

Marks, Michael; Goncalves, Adriana; Vahi, Ventis; Sokana, Oliver; Puiahi, Elliot; Zhang, Zaixing; Dalipanda, Tenneth; Bottomley, Christian; Mabey, David; Solomon, Anthony W

2014-09-01

Yaws is a non-venereal treponemal infection caused by Treponema pallidum ssp. pertenue. The WHO has launched a worldwide control programme, which aims to eradicate yaws by 2020. The development of a rapid diagnostic test (RDT) for serological diagnosis in the isolated communities affected by yaws is a key requirement for the successful implementation of the WHO strategy. We conducted a study to evaluate the utility of the DPP test in screening for yaws, utilizing samples collected as part of a community prevalence survey conducted in the Solomon Islands. 415 serum samples were tested using both traditional syphilis serology (TPPA and quantitative RPR) and the Chembio DPP Syphilis Screen and Confirm RDT. We calculated the sensitivity and specificity of the RDT as compared to gold standard serology. The sensitivity of the RDT against TPPA was 58.5% and the specificity was 97.6%. The sensitivity of the RDT against RPR was 41.7% and the specificity was 95.2%. The sensitivity of the DPP was strongly related to the RPR titre with a sensitivity of 92.0% for an RPR titre of >1/16. Wider access to DPP testing would improve our understanding of worldwide yaws case reporting and the test may play a key role in assessing patients presenting with yaws like lesions in a post-mass drug administration (MDA) setting.

Comparison of performance of the test of memory malingering and word memory test in a criminal forensic sample.

PubMed

Fazio, Rachel L; Sanders, James Forrest; Denney, Robert L

2015-06-01

Compared with the amount of neuropsychological literature surrounding response bias in civil litigation, there is little regarding criminal cases. This study adds to the criminal forensic neuropsychological literature by comparing the Test of Memory Malingering (TOMM) and the Word Memory Test (WMT) in a criminal forensic setting utilizing a criterion-groups design. Subjects were classified into two groups based on their performance on at least two other freestanding performance validity tests. The WMT demonstrated good sensitivity (95.1%) but poor specificity (68.4%) when Genuine Memory Impaired Profiles (GMIPs) were not considered. Inclusion of GMIPs reduced the sensitivity to 56.1% but increased the specificity to 94.7%. The TOMM evidenced better sensitivity but poorer specificity than the WMT with GMIPs. Conjoint use of the tests was also considered. Receiver operating characteristics and other classification statistics for each measure are presented. Results support the use of these measures in a criminal forensic population. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Polymerase chain reaction in the detection of tumor cells: new approaches in diagnosis and follow-up of patients with thyroid cancer.

PubMed

Bojunga, Jörg; Kusterer, Klaus; Schumm-Draeger, Petra-Maria; Usadel, Klaus-Henning

2002-12-01

Thyroid cancers are the most common endocrine malignancies and are being diagnosed with increasing frequency. In addition to other measures, diagnosis is based on fine-needle aspiration cytology examination. Recently, new assays using reverse transcription-polymerase chain reaction (PCR) are being tested to improve sensitivity and specificity of primary diagnosis and detection of recurrent thyroid cancer. In the preoperative diagnosis of thyroid cancer, several tissue- and/or tumor-specific mRNA have been described and in several cases, a higher sensitivity and specificity could be achieved using molecular techniques compared to conventional methods. In the postoperative follow-up of patients with thyroid cancer, conflicting data have been published and the use of PCR techniques revealed several problems of the molecular approach, which are based on some technical as well as biologic limitations. Despite these problems, which are discussed in detail in this review, molecular techniques may nevertheless improve the sensitivity and accuracy of fine-needle aspiration of thyroid nodules, fine-needle aspiration of metastases, and detection of recurrent disease in peripheral blood samples.

Diagnosing periprosthetic infection: false-positive intraoperative Gram stains.

PubMed

Oethinger, Margret; Warner, Debra K; Schindler, Susan A; Kobayashi, Hideo; Bauer, Thomas W

2011-04-01

Intraoperative Gram stains have a reported low sensitivity but high specificity when used to help diagnose periprosthetic infections. In early 2008, we recognized an unexpectedly high frequency of apparent false-positive Gram stains from revision arthroplasties. The purpose of this report is to describe the cause of these false-positive test results. We calculated the sensitivity and specificity of all intraoperative Gram stains submitted from revision arthroplasty cases during a 3-month interval using microbiologic cultures of the same samples as the gold standard. Methods of specimen harvesting, handling, transport, distribution, specimen processing including tissue grinding/macerating, Gram staining, and interpretation were studied. After a test modification, results of specimens were prospectively collected for a second 3-month interval, and the sensitivity and specificity of intraoperative Gram stains were calculated. The retrospective review of 269 Gram stains submitted from revision arthroplasties indicated historic sensitivity and specificity values of 23% and 92%, respectively. Systematic analysis of all steps of the procedure identified Gram-stained but nonviable bacteria in commercial broth reagents used as diluents for maceration of periprosthetic membranes before Gram staining and culture. Polymerase chain reaction and sequencing showed mixed bacterial DNA. Evaluation of 390 specimens after initiating standardized Millipore filtering of diluent fluid revealed a reduced number of positive Gram stains, yielding 9% sensitivity and 99% specificity. Clusters of false-positive Gram stains have been reported in other clinical conditions. They are apparently rare related to diagnosing periprosthetic infections but have severe consequences if used to guide treatment. Even occasional false-positive Gram stains should prompt review of laboratory methods. Our observations implicate dead bacteria in microbiologic reagents as potential sources of false-positive Gram stains.

Sensitivity and Specificity of Cetuximab-IRDye800CW to Identify Regional Metastatic Disease in Head and Neck Cancer.

PubMed

Rosenthal, Eben L; Moore, Lindsay S; Tipirneni, Kiranya; de Boer, Esther; Stevens, Todd M; Hartman, Yolanda E; Carroll, William R; Zinn, Kurt R; Warram, Jason M

2017-08-15

Purpose: Comprehensive cervical lymphadenectomy can be associated with significant morbidity and poor quality of life. This study evaluated the sensitivity and specificity of cetuximab-IRDye800CW to identify metastatic disease in patients with head and neck cancer. Experimental Design: Consenting patients scheduled for curative resection were enrolled in a clinical trial to evaluate the safety and specificity of cetuximab-IRDye800CW. Patients ( n = 12) received escalating doses of the study drug. Where indicated, cervical lymphadenectomy accompanied primary tumor resection, which occurred 3 to 7 days following intravenous infusion of cetuximab-IRDye800CW. All 471 dissected lymph nodes were imaged with a closed-field, near-infrared imaging device during gross processing of the fresh specimens. Intraoperative imaging of exposed neck levels was performed with an open-field fluorescence imaging device. Blinded assessments of the fluorescence data were compared to histopathology to calculate sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV). Results: Of the 35 nodes diagnosed pathologically positive, 34 were correctly identified with fluorescence imaging, yielding a sensitivity of 97.2%. Of the 435 pathologically negative nodes, 401 were correctly assessed using fluorescence imaging, yielding a specificity of 92.7%. The NPV was determined to be 99.7%, and the PPV was 50.7%. When 37 fluorescently false-positive nodes were sectioned deeper (1 mm) into their respective blocks, metastatic cancer was found in 8.1% of the recut nodal specimens, which altered staging in two of those cases. Conclusions: Fluorescence imaging of lymph nodes after systemic cetuximab-IRDye800CW administration demonstrated high sensitivity and was capable of identifying additional positive nodes on deep sectioning. Clin Cancer Res; 23(16); 4744-52. ©2017 AACR . ©2017 American Association for Cancer Research.

Sensitivity and specificity of the Distress Thermometer and a two-item depression screen (Patient Health Questionnaire-2) with a 'help' question for psychological distress and psychiatric morbidity in patients with advanced cancer.

PubMed

Ryan, Dermot Anthony; Gallagher, Pamela; Wright, Shelagh; Cassidy, Eugene M

2012-12-01

Brief screening tools may help clinicians in busy settings detect patients who are experiencing severe psychological distress. This study examined the performance of the Distress Thermometer (DT) and a two-item depression screen [the Patient Health Questionnaire-2 (PHQ-2)] with a 'help' question in screening for distress and psychiatric morbidity among patients with advanced cancer. Two hundred and five patients with advanced cancer completed the DT, the PHQ-2 and 'help' question and the Hospital Anxiety and Depression Scale and were interviewed using the Structured Clinical Interview for DSM-IV (SCID). The performance of the screening tools was examined against the Hospital Anxiety and Depression Scale and the SCID. Overall, discrimination levels were comparable for the DT [area under the curve (AUC) 0.80-0.81] and the PHQ-2 (AUC 0.73-0.85). The DT performed best in detecting cases of distress and mood, anxiety or adjustment disorders (sensitivity 100%), but it had poor specificity (49-60%). The best performance in terms of combined sensitivity and specificity was the PHQ depression item versus the SCID (sensitivity 88%, specificity 73%). The inclusion of the 'help' question with the PHQ-2 resulted in high levels of specificity (≥89%), but there was a significant drop in sensitivity (≤54%). Ultra-brief screening tools offer an efficient means of identifying patients with advanced cancer with severe distress or psychiatric morbidity but are less effective at identifying non-distressed individuals. Used in conjunction with a 'help' question, these tools can help clinicians identify patients who are both distressed and likely to accept professional support. Copyright © 2011 John Wiley & Sons, Ltd.