Expanding Access to Malaria Diagnosis through Retail Shops in Western Kenya: What Do Shop Workers Think?

PubMed

Rusk, Andria; Goodman, Catherine; Naanyu, Violet; Koech, Beatrice; Obala, Andrew; O'Meara, Wendy Prudhomme

2013-01-01

Background. The common symptoms of malaria reduce the specificity of clinical diagnosis. Presumptive treatment is conventional but can lead to overdiagnosis of malaria, delay of appropriate treatment, overprescription of antimalarials, and drug resistance. Routine use of diagnostic tests can address many of these concerns. Though treatment is often procured from retailers, there is low availability of rapid diagnostic tests for malaria (MRDTs), a simple, inexpensive, and accurate diagnostic solution. We know little about the challenges to expanding access to diagnostics through these outlets. Methods. To understand the perceptions of the benefits and challenges to selling rapid diagnostic tests for malaria, we conducted focus group discussions with antimalarial retailers who serve the residents of the Webuye Health and Demographic Surveillance Site in western Kenya. Results. Medicine retailers perceived MRDTs to be beneficial to their customers and businesses but also included cost, fear of the tests, risks of self-treatment, and regulatory concerns among the challenges to using and selling MRDTs. Conclusion. MRDTs represent a viable approach to increase access to malaria diagnostic testing. Medicine retailers are eager for MRDTs to be made available to them. However, certain challenges remain to implementation in retail outlets and should be addressed in advance.

Defining the Needs for Next Generation Assays for Tuberculosis

PubMed Central

Denkinger, Claudia M.; Kik, Sandra V.; Cirillo, Daniela Maria; Casenghi, Martina; Shinnick, Thomas; Weyer, Karin; Gilpin, Chris; Boehme, Catharina C.; Schito, Marco; Kimerling, Michael; Pai, Madhukar

2015-01-01

To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets. PMID:25765104

The Role of Nanoparticle Design in Determining Analytical Performance of Lateral Flow Immunoassays.

PubMed

Zhan, Li; Guo, Shuang-Zhuang; Song, Fayi; Gong, Yan; Xu, Feng; Boulware, David R; McAlpine, Michael C; Chan, Warren C W; Bischof, John C

2017-12-13

Rapid, simple, and cost-effective diagnostics are needed to improve healthcare at the point of care (POC). However, the most widely used POC diagnostic, the lateral flow immunoassay (LFA), is ∼1000-times less sensitive and has a smaller analytical range than laboratory tests, requiring a confirmatory test to establish truly negative results. Here, a rational and systematic strategy is used to design the LFA contrast label (i.e., gold nanoparticles) to improve the analytical sensitivity, analytical detection range, and antigen quantification of LFAs. Specifically, we discovered that the size (30, 60, or 100 nm) of the gold nanoparticles is a main contributor to the LFA analytical performance through both the degree of receptor interaction and the ultimate visual or thermal contrast signals. Using the optimal LFA design, we demonstrated the ability to improve the analytical sensitivity by 256-fold and expand the analytical detection range from 3 log 10 to 6 log 10 for diagnosing patients with inflammatory conditions by measuring C-reactive protein. This work demonstrates that, with appropriate design of the contrast label, a simple and commonly used diagnostic technology can compete with more expensive state-of-the-art laboratory tests.

A weighted generalized score statistic for comparison of predictive values of diagnostic tests.

PubMed

Kosinski, Andrzej S

2013-03-15

Positive and negative predictive values are important measures of a medical diagnostic test performance. We consider testing equality of two positive or two negative predictive values within a paired design in which all patients receive two diagnostic tests. The existing statistical tests for testing equality of predictive values are either Wald tests based on the multinomial distribution or the empirical Wald and generalized score tests within the generalized estimating equations (GEE) framework. As presented in the literature, these test statistics have considerably complex formulas without clear intuitive insight. We propose their re-formulations that are mathematically equivalent but algebraically simple and intuitive. As is clearly seen with a new re-formulation we presented, the generalized score statistic does not always reduce to the commonly used score statistic in the independent samples case. To alleviate this, we introduce a weighted generalized score (WGS) test statistic that incorporates empirical covariance matrix with newly proposed weights. This statistic is simple to compute, always reduces to the score statistic in the independent samples situation, and preserves type I error better than the other statistics as demonstrated by simulations. Thus, we believe that the proposed WGS statistic is the preferred statistic for testing equality of two predictive values and for corresponding sample size computations. The new formulas of the Wald statistics may be useful for easy computation of confidence intervals for difference of predictive values. The introduced concepts have potential to lead to development of the WGS test statistic in a general GEE setting. Copyright © 2012 John Wiley & Sons, Ltd.

A weighted generalized score statistic for comparison of predictive values of diagnostic tests

PubMed Central

Kosinski, Andrzej S.

2013-01-01

Positive and negative predictive values are important measures of a medical diagnostic test performance. We consider testing equality of two positive or two negative predictive values within a paired design in which all patients receive two diagnostic tests. The existing statistical tests for testing equality of predictive values are either Wald tests based on the multinomial distribution or the empirical Wald and generalized score tests within the generalized estimating equations (GEE) framework. As presented in the literature, these test statistics have considerably complex formulas without clear intuitive insight. We propose their re-formulations which are mathematically equivalent but algebraically simple and intuitive. As is clearly seen with a new re-formulation we present, the generalized score statistic does not always reduce to the commonly used score statistic in the independent samples case. To alleviate this, we introduce a weighted generalized score (WGS) test statistic which incorporates empirical covariance matrix with newly proposed weights. This statistic is simple to compute, it always reduces to the score statistic in the independent samples situation, and it preserves type I error better than the other statistics as demonstrated by simulations. Thus, we believe the proposed WGS statistic is the preferred statistic for testing equality of two predictive values and for corresponding sample size computations. The new formulas of the Wald statistics may be useful for easy computation of confidence intervals for difference of predictive values. The introduced concepts have potential to lead to development of the weighted generalized score test statistic in a general GEE setting. PMID:22912343

A new condition for assessing the clinical efficiency of a diagnostic test.

PubMed

Bokhari, Ehsan; Hubert, Lawrence

2015-09-01

When prediction using a diagnostic test outperforms simple prediction using base rates, the test is said to be "clinically efficient," a term first introduced into the literature by Meehl and Rosen (1955) in Psychological Bulletin. This article provides three equivalent conditions for determining the clinical efficiency of a diagnostic test: (a) Meehl-Rosen (Meehl & Rosen, 1955); (b) Dawes (Dawes, 1962); and (c) the Bokhari-Hubert condition, introduced here for the first time. Clinical efficiency is then generalized to situations where misclassification costs are considered unequal (for example, false negatives are more costly than false positives). As an illustration, the clinical efficiency of an actuarial device for predicting violent and dangerous behavior is examined that was developed as part of the MacArthur Violence Risk Assessment Study. (c) 2015 APA, all rights reserved.

Diagnostic Tests to Support Late-Stage Control Programs for Schistosomiasis and Soil-Transmitted Helminthiases.

PubMed

Hawkins, Kenneth R; Cantera, Jason L; Storey, Helen L; Leader, Brandon T; de Los Santos, Tala

2016-12-01

Global efforts to address schistosomiasis and soil-transmitted helminthiases (STH) include deworming programs for school-aged children that are made possible by large-scale drug donations. Decisions on these mass drug administration (MDA) programs currently rely on microscopic examination of clinical specimens to determine the presence of parasite eggs. However, microscopy-based methods are not sensitive to the low-intensity infections that characterize populations that have undergone MDA. Thus, there has been increasing recognition within the schistosomiasis and STH communities of the need for improved diagnostic tools to support late-stage control program decisions, such as when to stop or reduce MDA. Failure to adequately address the need for new diagnostics could jeopardize achievement of the 2020 London Declaration goals. In this report, we assess diagnostic needs and landscape potential solutions and determine appropriate strategies to improve diagnostic testing to support control and elimination programs. Based upon literature reviews and previous input from experts in the schistosomiasis and STH communities, we prioritized two diagnostic use cases for further exploration: to inform MDA-stopping decisions and post-MDA surveillance. To this end, PATH has refined target product profiles (TPPs) for schistosomiasis and STH diagnostics that are applicable to these use cases. We evaluated the limitations of current diagnostic methods with regards to these use cases and identified candidate biomarkers and diagnostics with potential application as new tools. Based on this analysis, there is a need to develop antigen-detecting rapid diagnostic tests (RDTs) with simplified, field-deployable sample preparation for schistosomiasis. Additionally, there is a need for diagnostic tests that are more sensitive than the current methods for STH, which may include either a field-deployable molecular test or a simple, low-cost, rapid antigen-detecting test.

Expanding Access to Malaria Diagnosis through Retail Shops in Western Kenya: What Do Shop Workers Think?

PubMed Central

Koech, Beatrice; Obala, Andrew; O'Meara, Wendy Prudhomme

2013-01-01

Background. The common symptoms of malaria reduce the specificity of clinical diagnosis. Presumptive treatment is conventional but can lead to overdiagnosis of malaria, delay of appropriate treatment, overprescription of antimalarials, and drug resistance. Routine use of diagnostic tests can address many of these concerns. Though treatment is often procured from retailers, there is low availability of rapid diagnostic tests for malaria (MRDTs), a simple, inexpensive, and accurate diagnostic solution. We know little about the challenges to expanding access to diagnostics through these outlets. Methods. To understand the perceptions of the benefits and challenges to selling rapid diagnostic tests for malaria, we conducted focus group discussions with antimalarial retailers who serve the residents of the Webuye Health and Demographic Surveillance Site in western Kenya. Results. Medicine retailers perceived MRDTs to be beneficial to their customers and businesses but also included cost, fear of the tests, risks of self-treatment, and regulatory concerns among the challenges to using and selling MRDTs. Conclusion. MRDTs represent a viable approach to increase access to malaria diagnostic testing. Medicine retailers are eager for MRDTs to be made available to them. However, certain challenges remain to implementation in retail outlets and should be addressed in advance. PMID:23766923

Information theoretic quantification of diagnostic uncertainty.

PubMed

Westover, M Brandon; Eiseman, Nathaniel A; Cash, Sydney S; Bianchi, Matt T

2012-01-01

Diagnostic test interpretation remains a challenge in clinical practice. Most physicians receive training in the use of Bayes' rule, which specifies how the sensitivity and specificity of a test for a given disease combine with the pre-test probability to quantify the change in disease probability incurred by a new test result. However, multiple studies demonstrate physicians' deficiencies in probabilistic reasoning, especially with unexpected test results. Information theory, a branch of probability theory dealing explicitly with the quantification of uncertainty, has been proposed as an alternative framework for diagnostic test interpretation, but is even less familiar to physicians. We have previously addressed one key challenge in the practical application of Bayes theorem: the handling of uncertainty in the critical first step of estimating the pre-test probability of disease. This essay aims to present the essential concepts of information theory to physicians in an accessible manner, and to extend previous work regarding uncertainty in pre-test probability estimation by placing this type of uncertainty within a principled information theoretic framework. We address several obstacles hindering physicians' application of information theoretic concepts to diagnostic test interpretation. These include issues of terminology (mathematical meanings of certain information theoretic terms differ from clinical or common parlance) as well as the underlying mathematical assumptions. Finally, we illustrate how, in information theoretic terms, one can understand the effect on diagnostic uncertainty of considering ranges instead of simple point estimates of pre-test probability.

Diagnostic accuracy and applicability of a PCR system for the detection of Schistosoma mansoni DNA in human urine samples from an endemic area.

PubMed

Enk, Martin Johannes; Oliveira e Silva, Guilherme; Rodrigues, Nilton Barnabé

2012-01-01

Schistosomiasis caused by Schistosoma mansoni, one of the most neglected human parasitoses in Latin America and Africa, is routinely confirmed by microscopic visualization of eggs in stool. The main limitation of this diagnostic approach is its lack of sensitivity in detecting individual low worm burdens and consequently data on infection rates in low transmission settings are little reliable. According to the scientific literature, PCR assays are characterized by high sensitivity and specificity in detecting parasite DNA in biological samples. A simple and cost effective extraction method for DNA of Schistosoma mansoni from urine samples in combination with a conventional PCR assay was developed and applied in an endemic area. This urine based PCR system was tested for diagnostic accuracy among a population of a small village in an endemic area, comparing it to a reference test composed of three different parasitological techniques. The diagnostic parameters revealed a sensitivity of 100%, a specificity of 91.20%, positive and negative predictive values of 86.25% and 100%, respectively, and a test accuracy of 94.33%. Further statistical analysis showed a k index of 0.8806, indicating an excellent agreement between the reference test and the PCR system. Data obtained from the mouse model indicate the infection can be detected one week after cercariae penetration, opening a new perspective for early detection and patient management during this stage of the disease. The data indicate that this innovative PCR system provides a simple to handle and robust diagnostic tool for the detection of S. mansoni DNA from urine samples and a promising approach to overcome the diagnostic obstacles in low transmission settings. Furthermore the principals of this molecular technique, based on the examination of human urine samples may be useful for the diagnosis of other neglected tropical diseases that can be detected by trans-renal DNA.

A Novel Technique for Detecting Antibiotic-Resistant Typhoid from Rapid Diagnostic Tests

PubMed Central

Nic Fhogartaigh, Caoimhe; Dance, David A. B.; Davong, Viengmon; Tann, Pisey; Phetsouvanh, Rattanaphone; Turner, Paul; Newton, Paul N.

2015-01-01

Fluoroquinolone-resistant typhoid is increasing. An antigen-detecting rapid diagnotic test (RDT) can rapidly diagnose typhoid from blood cultures. A simple, inexpensive molecular technique performed with DNA from positive RDTs accurately identified gyrA mutations consistent with phenotypic susceptibility testing results. Field diagnosis combined with centralized molecular resistance testing could improve typhoid management and surveillance in low-resource settings. PMID:25762768

Inventing a new diagnostic test for vaginal infection.

PubMed Central

O'Dowd, T. C.; Bourne, N.

1994-01-01

Bacterial vaginosis, which is underdiagnosed in clinical practice, has a characteristic fishy smell because of production of diamines. This smell is the basis of a visual rapid diagnostic test that is technically simple to perform. The test has been patented in Europe and America, and a licence agreement has been negotiated. This paper describes the process from idea to invention to patenting and licensing. The combined costs of research and patenting were met by a multinational company in return for rights to exploit the patent invention. The process has taken nine years and has needed clinical, scientific, legal, and commercial input to get the test to the marketplace. Images p41-a PMID:8044068

KIDMAP--A Diagnostic Tool for Teachers.

ERIC Educational Resources Information Center

Lee, Yew Jin; Linacre, John M.; Yeoh, Oon Chye

While assessment is the bread and butter of the teaching profession, its practitioners usually do not extend analysis of test responses beyond simple measures such as facility or discrimination indices in classical test theory. Item response theory (IRT) has much to offer but its nonintuitive content and difficulty make it a formidable obstacle in…

Developing a new intelligent system for the diagnosis of tuberculous pleural effusion.

PubMed

Li, Chengye; Hou, Lingxian; Sharma, Bishundat Yanesh; Li, Huaizhong; Chen, ChengShui; Li, Yuping; Zhao, Xuehua; Huang, Hui; Cai, Zhennao; Chen, Huiling

2018-01-01

In countries with high prevalence of tuberculosis (TB), clinicians often diagnose tuberculous pleural effusion (TPE) by using diagnostic tests, which have not only poor sensitivity, but poor availability as well. The aim of our study is to develop a new artificial intelligence based diagnostic model that is accurate, fast, non-invasive and cost effective to diagnose TPE. It is expected that a tool derived based on the model be installed on simple computer devices (such as smart phones and tablets) and be used by clinicians widely. For this study, data of 140 patients whose clinical signs, routine blood test results, blood biochemistry markers, pleural fluid cell type and count, and pleural fluid biochemical tests' results were prospectively collected into a database. An Artificial intelligence based diagnostic model, which employs moth flame optimization based support vector machine with feature selection (FS-MFO-SVM), is constructed to predict the diagnosis of TPE. The optimal model results in an average of 95% accuracy (ACC), 0.9564 the area under the receiver operating characteristic curve (AUC), 93.35% sensitivity, and 97.57% specificity for FS-MFO-SVM. The proposed artificial intelligence based diagnostic model is found to be highly reliable for diagnosing TPE based on simple clinical signs, blood samples and pleural effusion samples. Therefore, the proposed model can be widely used in clinical practice and further evaluated for use as a substitute of invasive pleural biopsies. Copyright © 2017 Elsevier B.V. All rights reserved.

Interpretation of diagnostic data: 3. How to do it with a simple table (part B).

PubMed

1983-10-01

The following guidelines are useful if you want to "do it with a simple table" (Table IV): First, identify the sensitivity and specificity of the sign, symptom or diagnostic test you plan to use. Many are already in the literature, and subspecialists should either know them for their field or be able to track them down for you. Depending on whether you are considering a sign, a symptom or a diagnostic laboratory test, you will want to track down a clinical subspecialist, a radiologist, a pathologist and so on. Start your table with a total of 1000 patients, as shown in location (a + b + c + d) of panel A. Using the information you have about the patient before you apply the diagnostic test, estimate the patient's pretest likelihood (prevalence or prior probability) of the target disorder -- let's say 10%. Take this proportion of the total (100) and place it in location (a + c); the remaining 900 patients go in location (b + d) (panel B). Multiply (a + c) (100) by the sensitivity of the diagnostic test (let's say 83%) and place the result (83) in cell a and the difference (17) in cell c; similarly, multiply (b + d) (900) by the specificity of the diagnostic test (let's say 91%) and place the result (819) in cell d and the difference (81) in cell b (panel C). If (a + b) and (c + d) do not add up to 1000, you will know you have made a mistake. You can now calculate the positive predictive value, a/(a + b), and the negative predictive value, d/(c + d), as shown in panel D. You have now reached a level of understanding a fair bit beyond the rule-in/rule-out strategy discussed in part 1 of our series. Furthermore, you can already do more than most clinicians, so you may want to stop here, at least for a while. On the other hand, you may want to go further and learn how to handle slightly more complex tables with multiple cut-off points. In the next article you will find more powerful ways to take advantage of the degree of positivity and negativity of diagnostic test results.

Added value of cost-utility analysis in simple diagnostic studies of accuracy: (18)F-fluoromethylcholine PET/CT in prostate cancer staging.

PubMed

Gerke, Oke; Poulsen, Mads H; Høilund-Carlsen, Poul Flemming

2015-01-01

Diagnostic studies of accuracy targeting sensitivity and specificity are commonly done in a paired design in which all modalities are applied in each patient, whereas cost-effectiveness and cost-utility analyses are usually assessed either directly alongside to or indirectly by means of stochastic modeling based on larger randomized controlled trials (RCTs). However the conduct of RCTs is hampered in an environment such as ours, in which technology is rapidly evolving. As such, there is a relatively limited number of RCTs. Therefore, we investigated as to which extent paired diagnostic studies of accuracy can be also used to shed light on economic implications when considering a new diagnostic test. We propose a simple decision tree model-based cost-utility analysis of a diagnostic test when compared to the current standard procedure and exemplify this approach with published data from lymph node staging of prostate cancer. Average procedure costs were taken from the Danish Diagnosis Related Groups Tariff in 2013 and life expectancy was estimated for an ideal 60 year old patient based on prostate cancer stage and prostatectomy or radiation and chemotherapy. Quality-adjusted life-years (QALYs) were deduced from the literature, and an incremental cost-effectiveness ratio (ICER) was used to compare lymph node dissection with respective histopathological examination (reference standard) and (18)F-fluoromethylcholine positron emission tomography/computed tomography (FCH-PET/CT). Lower bounds of sensitivity and specificity of FCH-PET/CT were established at which the replacement of the reference standard by FCH-PET/CT comes with a trade-off between worse effectiveness and lower costs. Compared to the reference standard in a diagnostic accuracy study, any imperfections in accuracy of a diagnostic test imply that replacing the reference standard generates a loss in effectiveness and utility. We conclude that diagnostic studies of accuracy can be put to a more extensive use, over and above a mere indication of sensitivity and specificity of an imaging test, and that health economic considerations should be undertaken when planning a prospective diagnostic accuracy study. These endeavors will prove especially fruitful when comparing several imaging techniques with one another, or the same imaging technique using different tracers, with an independent reference standard for the evaluation of results.

Towards improving diagnosis of memory loss in general practice: TIMeLi diagnostic test accuracy study protocol.

PubMed

Creavin, Sam T; Cullum, Sarah J; Haworth, Judy; Wye, Lesley; Bayer, Antony; Fish, Mark; Purdy, Sarah; Ben-Shlomo, Yoav

2016-07-19

People with cognitive problems, and their families, report distress and uncertainty whilst undergoing evaluation for dementia and perceive that traditional diagnostic evaluation in secondary care is insufficiently patient centred. The James Lind Alliance has prioritised research to investigate the role of primary care in supporting a more effective diagnostic pathway, and the topic is also of interest to health commissioners. However, there are very few studies that investigate the accuracy of diagnostic tests for dementia in primary care. We will conduct a prospective diagnostic test accuracy study to evaluate the accuracy of a range of simple tests for diagnosing all-cause-dementia in symptomatic people aged over 70 years who have consulted with their general practitioner (GP). We will invite eligible people to attend a research clinic where they will undergo a range of index tests that a GP could perform in the surgery and also be assessed by a specialist in memory disorders at the same appointment. Participating GPs will request neuroimaging and blood tests and otherwise manage patients in line with their usual clinical practice. The reference standard will be the consensus judgement of three experts (neurologist, psychiatrist and geriatrician) based on information from the specialist assessment, GP records and investigations, but not including items in the index test battery. The target condition will be all-cause dementia but we will also investigate diagnostic accuracy for sub-types where possible. We will use qualitative interviews with patients and focus groups with clinicians to help us understand the acceptability and feasibility of diagnosing dementia in primary care using the tests that we are investigating. Our results will help clinicians decide on which tests to perform in someone where there is concern about possible dementia and inform commissioning of diagnostic pathways.

Defining the needs for next generation assays for tuberculosis.

PubMed

Denkinger, Claudia M; Kik, Sandra V; Cirillo, Daniela Maria; Casenghi, Martina; Shinnick, Thomas; Weyer, Karin; Gilpin, Chris; Boehme, Catharina C; Schito, Marco; Kimerling, Michael; Pai, Madhukar

2015-04-01

To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets. © 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.

Diagnosis of asthma: diagnostic testing.

PubMed

Brigham, Emily P; West, Natalie E

2015-09-01

Asthma is a heterogeneous disease, encompassing both atopic and non-atopic phenotypes. Diagnosis of asthma is based on the combined presence of typical symptoms and objective tests of lung function. Objective diagnostic testing consists of 2 components: (1) demonstration of airway obstruction, and (2) documentation of variability in degree of obstruction. A review of current guidelines and literature was performed regarding diagnostic testing for asthma. Spirometry with bronchodilator reversibility testing remains the mainstay of asthma diagnostic testing for children and adults. Repetition of the test over several time points may be necessary to confirm airway obstruction and variability thereof. Repeated peak flow measurement is relatively simple to implement in a clinical and home setting. Bronchial challenge testing is reserved for patients in whom the aforementioned testing has been unrevealing but clinical suspicion remains, though is associated with low specificity. Demonstration of eosinophilic inflammation, via fractional exhaled nitric oxide measurement, or atopy, may be supportive of atopic asthma, though diagnostic utility is limited particularly in nonatopic asthma. All efforts should be made to confirm the diagnosis of asthma in those who are being presumptively treated but have not had objective measurements of variability in the degree of obstruction. Multiple testing modalities are available for objective confirmation of airway obstruction and variability thereof, consistent with a diagnosis of asthma in the appropriate clinical context. Providers should be aware that both these characteristics may be present in other disease states, and may not be specific to a diagnosis of asthma. © 2015 ARS-AAOA, LLC.

Assessing the value-adding impact of diagnostic-type tests on drug development and marketing.

PubMed

Blair, Edward D

2008-01-01

We explore the cash value of the companion diagnostics opportunity from the perspective of the pharmaceutical partner. Cashflow-based modeling is used to demonstrate the potential financial benefits of key relationships between the pharmaceutical and diagnostics industries. In four scenarios, the uplift in the net present value (NPV) of a proprietary medicine can exceed $US1.8 billion. By simple extrapolation, the uplifted NPV calculations allow realistic and plausible estimates of the companion diagnostic opportunity to be in the region of $US40 billion to $US90 billion. It is expected that such market valuation could drive a macroeconomic change that shifts healthcare practice from reactionary disease-treatment to proactive health maintenance.

[A new system of testing visual performance based on the cylindrical lens screen].

PubMed

Doege, E; Krause, O

1983-09-01

Using a special microoptical screen as a test-picture coating, a method for testing binocular function was developed. It offers the advantage of providing a separate visual impression to each eye from a diagnostic picture without using any device in front of the eyes. The person tested is unaware of this procedure, of which the diagnostic plate gives no hint. In addition to a description of its numerous uses and diagnostic possibilities, fusion pictures suitable for screening tests are described: Each eye is offered a separate impression with a completely different content. If fusion occurs correctly, a third motif with an entirely new meaning emerges. Several years of experience with this effective system (naked-eye tests) resulted in aids which are listed in the final section of the paper: exercise aids used for preparing the persons tested (especially infants) in the waiting room, recognition aids for the examination, and a partially kinetic picture for rapid, simple and very convincing representation of adjusting movements and of the squint position in cases of concomitant squint.

A Paper-Based Device for Performing Loop-Mediated Isothermal Amplification with Real-Time Simultaneous Detection of Multiple DNA Targets.

PubMed

Seok, Youngung; Joung, Hyou-Arm; Byun, Ju-Young; Jeon, Hyo-Sung; Shin, Su Jeong; Kim, Sanghyo; Shin, Young-Beom; Han, Hyung Soo; Kim, Min-Gon

2017-01-01

Paper-based diagnostic devices have many advantages as a one of the multiple diagnostic test platforms for point-of-care (POC) testing because they have simplicity, portability, and cost-effectiveness. However, despite high sensitivity and specificity of nucleic acid testing (NAT), the development of NAT based on a paper platform has not progressed as much as the others because various specific conditions for nucleic acid amplification reactions such as pH, buffer components, and temperature, inhibitions from technical differences of paper-based device. Here, we propose a paper-based device for performing loop-mediated isothermal amplification (LAMP) with real-time simultaneous detection of multiple DNA targets. We determined the optimal chemical components to enable dry conditions for the LAMP reaction without lyophilization or other techniques. We also devised the simple paper device structure by sequentially stacking functional layers, and employed a newly discovered property of hydroxynaphthol blue fluorescence to analyze real-time LAMP signals in the paper device. This proposed platform allowed analysis of three different meningitis DNA samples in a single device with single-step operation. This LAMP-based multiple diagnostic device has potential for real-time analysis with quantitative detection of 10 2 -10 5 copies of genomic DNA. Furthermore, we propose the transformation of DNA amplification devices to a simple and affordable paper system approach with great potential for realizing a paper-based NAT system for POC testing.

A Paper-Based Device for Performing Loop-Mediated Isothermal Amplification with Real-Time Simultaneous Detection of Multiple DNA Targets

PubMed Central

Seok, Youngung; Joung, Hyou-Arm; Byun, Ju-Young; Jeon, Hyo-Sung; Shin, Su Jeong; Kim, Sanghyo; Shin, Young-Beom; Han, Hyung Soo; Kim, Min-Gon

2017-01-01

Paper-based diagnostic devices have many advantages as a one of the multiple diagnostic test platforms for point-of-care (POC) testing because they have simplicity, portability, and cost-effectiveness. However, despite high sensitivity and specificity of nucleic acid testing (NAT), the development of NAT based on a paper platform has not progressed as much as the others because various specific conditions for nucleic acid amplification reactions such as pH, buffer components, and temperature, inhibitions from technical differences of paper-based device. Here, we propose a paper-based device for performing loop-mediated isothermal amplification (LAMP) with real-time simultaneous detection of multiple DNA targets. We determined the optimal chemical components to enable dry conditions for the LAMP reaction without lyophilization or other techniques. We also devised the simple paper device structure by sequentially stacking functional layers, and employed a newly discovered property of hydroxynaphthol blue fluorescence to analyze real-time LAMP signals in the paper device. This proposed platform allowed analysis of three different meningitis DNA samples in a single device with single-step operation. This LAMP-based multiple diagnostic device has potential for real-time analysis with quantitative detection of 102-105 copies of genomic DNA. Furthermore, we propose the transformation of DNA amplification devices to a simple and affordable paper system approach with great potential for realizing a paper-based NAT system for POC testing. PMID:28740546

Evaluation of the accuracy of the EasyTest™ malaria Pf/Pan Ag, a rapid diagnostic test, in Uganda.

PubMed

Chong, Chom-Kyu; Cho, Pyo Yun; Na, Byoung-Kuk; Ahn, Seong Kyu; Kim, Jin Su; Lee, Jin-Soo; Lee, Sung-Keun; Han, Eun-Taek; Kim, Hak-Yong; Park, Yun-Kyu; Cha, Seok Ho; Kim, Tong-Soo

2014-10-01

In recent years, rapid diagnostic tests (RDTs) have been widely used for malaria detection, primarily because of their simple operation, fast results, and straightforward interpretation. The Asan EasyTest™ Malaria Pf/Pan Ag is one of the most commonly used malaria RDTs in several countries, including Korea and India. In this study, we tested the diagnostic performance of this RDT in Uganda to evaluate its usefulness for field diagnosis of malaria in this country. Microscopic and PCR analyses, and the Asan EasyTest™ Malaria Pf/Pan Ag rapid diagnostic test, were performed on blood samples from 185 individuals with suspected malaria in several villages in Uganda. Compared to the microscopic analysis, the sensitivity of the RDT to detect malaria infection was 95.8% and 83.3% for Plasmodium falciparum and non-P. falciparum, respectively. Although the diagnostic sensitivity of the RDT decreased when parasitemia was ≤500 parasites/µl, it showed 96.8% sensitivity (98.4% for P. falciparum and 93.8% for non-P. falciparum) in blood samples with parasitemia ≥100 parasites/µl. The specificity of the RDT was 97.3% for P. falciparum and 97.3% for non-P. falciparum. These results collectively suggest that the accuracy of the Asan EasyTest™ Malaria Pf/Pan Ag makes it an effective point-of-care diagnostic tool for malaria in Uganda.

Evaluation of the Accuracy of the EasyTest™ Malaria Pf/Pan Ag, a Rapid Diagnostic Test, in Uganda

PubMed Central

Chong, Chom-Kyu; Cho, Pyo Yun; Na, Byoung-Kuk; Ahn, Seong Kyu; Kim, Jin Su; Lee, Jin-Soo; Lee, Sung-Keun; Han, Eun-Taek; Kim, Hak-Yong; Park, Yun-Kyu; Cha, Seok Ho

2014-01-01

In recent years, rapid diagnostic tests (RDTs) have been widely used for malaria detection, primarily because of their simple operation, fast results, and straightforward interpretation. The Asan EasyTest™ Malaria Pf/Pan Ag is one of the most commonly used malaria RDTs in several countries, including Korea and India. In this study, we tested the diagnostic performance of this RDT in Uganda to evaluate its usefulness for field diagnosis of malaria in this country. Microscopic and PCR analyses, and the Asan EasyTest™ Malaria Pf/Pan Ag rapid diagnostic test, were performed on blood samples from 185 individuals with suspected malaria in several villages in Uganda. Compared to the microscopic analysis, the sensitivity of the RDT to detect malaria infection was 95.8% and 83.3% for Plasmodium falciparum and non-P. falciparum, respectively. Although the diagnostic sensitivity of the RDT decreased when parasitemia was ≤500 parasites/µl, it showed 96.8% sensitivity (98.4% for P. falciparum and 93.8% for non-P. falciparum) in blood samples with parasitemia ≥100 parasites/µl. The specificity of the RDT was 97.3% for P. falciparum and 97.3% for non-P. falciparum. These results collectively suggest that the accuracy of the Asan EasyTest™ Malaria Pf/Pan Ag makes it an effective point-of-care diagnostic tool for malaria in Uganda. PMID:25352698

PBX 9502 air-gap tests

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

Dickson, Peter; Novak, Alan M.; Foley, Timothy J.

A small number of simple air-gap tests were performed on 1-inch diameter PBX 9502 cylinders to determine an approximate threshold for detonation failure. The primary diagnostics were streak imaging and dent measurements in a steel witness plate. Relight was found to occur, with negligible excess transit time, for air gaps up to 1 mm. Relight did not occur with a 3-mm air gap.

A simple and rapid DNA extraction method for Chlamydia trachomatis detection from urogenital swabs.

PubMed

Butzler, Matthew A; Reed, Jennifer L; McFall, Sally M

2017-11-01

A highly sensitive and specific Chlamydia trachomatis (CT) diagnostic test was developed by combining filtration isolation of nucleic acid (FINA) extraction with quantitative polymerase chain reaction including an internal control to identify test inhibition. A pilot study of 40 clinical specimens yielded 100% sensitivity and specificity. Copyright © 2017 Elsevier Inc. All rights reserved.

Laboratory Tests for Legionnaire's Disease.

PubMed

Dunne, W Michael; Picot, Nathalie; van Belkum, Alex

2017-03-01

Legionella pneumophila is one of the more recently discovered bacterial pathogens of humans. The last 2 decades have seen tremendous progress in the evolution of diagnostic tests, for detection and characterization of this pathogen and for defining the host response to infection. This has generated several diagnostic tools that span the range from simple immunologic assays to modern genome sequencing. This review describes the state of affairs of this continuously evolving field regarding the diagnosis of Legionnaire's disease and covers detection, assessment of antibiotic susceptibility, and epidemiologic characterization of isolates of L pneumophila and other pathogenic species within the genus. Copyright © 2016 Elsevier Inc. All rights reserved.

A Gram Stain Hands-On Workshop Enhances First Year Medical Students' Technique Competency in Comprehension and Memorization.

PubMed

Delfiner, Matthew S; Martinez, Luis R; Pavia, Charles S

2016-01-01

Laboratory diagnostic tests have an essential role in patient care, and the increasing number of medical and health professions schools focusing on teaching laboratory medicine to pre-clinical students reflects this importance. However, data validating the pedagogical methods that best influence students' comprehension and interpretation of diagnostic tests have not been well described. The Gram stain is a simple yet significant and frequently used diagnostic test in the clinical setting that helps classify bacteria into two major groups, Gram positive and negative, based on their cell wall structure. We used this technique to assess which educational strategies may improve students' learning and competency in medical diagnostic techniques. Hence, in this randomized controlled study, we compared the effectiveness of several educational strategies (e.g. workshop, discussion, or lecture) in first year medical students' competency in comprehension and interpretation of the Gram stain procedure. We demonstrated that a hands-on practical workshop significantly enhances students' competency in memorization and overall comprehension of the technique. Interestingly, most students irrespective of their cohort showed difficulty in answering Gram stain-related analytical questions, suggesting that more emphasis should be allocated by the instructors to clearly explain the interpretation of the diagnostic test results to students in medical and health professional schools. This proof of principle study highlights the need of practical experiences on laboratory medical techniques during pre-clinical training to facilitate future medical doctors' and healthcare professionals' basic understanding and competency in diagnostic testing for better patient care.

Sonicated Diagnostic Immunoblot for Bartonellosis

PubMed Central

Mallqui, Vania; Speelmon, Emily C.; Verástegui, Manuela; Maguiña-Vargas, Ciro; Pinell-Salles, Paula; Lavarello, Rosa; Delgado, Jose; Kosek, Margaret; Romero, Sofia; Arana, Yanina; Gilman, Robert H.

2000-01-01

Two simple Bartonella bacilliformis immunoblot preparation methods were developed. Antigen was prepared by two different methods: sonication of whole organisms or glycine extraction. Both methods were then tested for sensitivity and specificity. Well-defined control sera were utilized in the development of these diagnostic immunoblots, and possible cross-reactions were thoroughly examined. Sera investigated for cross-reaction with these diagnostic antigens were drawn from patients with brucellosis, chlamydiosis, Q fever, and cat scratch disease, all of whom were from regions where bartonellosis is not endemic. While both immunoblots yielded reasonable sensitivity and high specificity, we recommend the use of the sonicated immunoblot, which has a higher sensitivity when used to detect acute disease and produces fewer cross-reactions. The sonicated immunoblot reported here is 94% sensitive to chronic bartonellosis and 70% sensitive to acute bartonellosis. In a healthy group, it is 100% specific. This immunoblot preparation requires a simple sonication protocol for the harvesting of B. bacilliformis antigens and is well suited for use in regions of endemicity. PMID:10618267

Gear Damage Detection Integrating Oil Debris and Vibration Measurement Technologies Developed

NASA Technical Reports Server (NTRS)

Gyekeyeski, Andrew L.; Sawicki, Jerzy T.

2001-01-01

The development of highly reliable health-monitoring systems is one technology area recommended for reducing the number of helicopter accidents. Helicopter transmission diagnostics are an important part of a helicopter health-monitoring system because helicopters depend on the power train for propulsion, lift, and flight maneuvering. One technique currently being tested for increasing the reliability and decreasing the false alarm rate of current transmission diagnostic tools is the replacement of simple single-sensor limits with multisensor systems integrating different measurement technologies.

Xylem resistance to embolism: presenting a simple diagnostic test for the open vessel artefact.

PubMed

Torres-Ruiz, José M; Cochard, Hervé; Choat, Brendan; Jansen, Steven; López, Rosana; Tomášková, Ivana; Padilla-Díaz, Carmen M; Badel, Eric; Burlett, Regis; King, Andrew; Lenoir, Nicolas; Martin-StPaul, Nicolas K; Delzon, Sylvain

2017-07-01

Xylem vulnerability to embolism represents an essential trait for the evaluation of the impact of hydraulics in plant function and ecology. The standard centrifuge technique is widely used for the construction of vulnerability curves, although its accuracy when applied to species with long vessels remains under debate. We developed a simple diagnostic test to determine whether the open-vessel artefact influences centrifuge estimates of embolism resistance. Xylem samples from three species with differing vessel lengths were exposed to less negative xylem pressures via centrifugation than the minimum pressure the sample had previously experienced. Additional calibration was obtained from non-invasive measurement of embolism on intact olive plants by X-ray microtomography. Results showed artefactual decreases in hydraulic conductance (k) for samples with open vessels when exposed to a less negative xylem pressure than the minimum pressure they had previously experienced. X-Ray microtomography indicated that most of the embolism formation in olive occurs at xylem pressures below -4.0 MPa, reaching 50% loss of hydraulic conductivity at -5.3 MPa. The artefactual reductions in k induced by centrifugation underestimate embolism resistance data of species with long vessels. A simple test is suggested to avoid this open vessel artefact and to ensure the reliability of this technique in future studies. © 2017 The Authors. New Phytologist © 2017 New Phytologist Trust.

Detection of scabies: A systematic review of diagnostic methods

PubMed Central

Leung, Victor; Miller, Mark

2011-01-01

BACKGROUND: Accurate diagnosis of scabies infection is important for patient treatment and for public health control of scabies epidemics. OBJECTIVE: To systematically review the accuracy and precision of history, physical examination and tests for diagnosing scabies. METHODS: Using a structured search strategy, Medline and Embase databases were searched for English and French language articles that included a diagnosis of scabies. Studies comparing history, physical examination and/or any diagnostic tests with the reference standard of microscopic visualization of mites, eggs or fecal elements obtained from skin scrapings or biopsies were included for analysis. Data were extracted using standard criteria. RESULTS: History and examination of pruritic dermatoses failed to accurately diagnose scabies infection. Dermatoscopy by a trained practitioner has a positive likelihood ratio of 6.5 (95% CI 4.1 to 10.3) and a negative likelihood ratio of 0.1 (95% CI 0.06 to 0.2) for diagnosing scabies. The accuracy of other diagnostic tests could not be calculated from the data in the literature. CONCLUSIONS: In the face of such diagnostic inaccuracy, clinical judgment is still practical in diagnosing scabies. Two tests are used – the burrow ink test and handheld dermatoscopy. The burrow ink test is a simple, rapid, noninvasive test that can be used to screen a large number of patients. Handheld dermatoscopy is an accurate test, but requires special equipment and trained practitioners. Given the morbidity and costs of scabies infection, and that studies to date lack adequate internal and external validity, research to identify or develop accurate diagnostic tests for scabies infection is needed and justifiable. PMID:23205026

Detection of scabies: A systematic review of diagnostic methods.

PubMed

Leung, Victor; Miller, Mark

2011-01-01

Accurate diagnosis of scabies infection is important for patient treatment and for public health control of scabies epidemics. To systematically review the accuracy and precision of history, physical examination and tests for diagnosing scabies. Using a structured search strategy, Medline and Embase databases were searched for English and French language articles that included a diagnosis of scabies. Studies comparing history, physical examination and/or any diagnostic tests with the reference standard of microscopic visualization of mites, eggs or fecal elements obtained from skin scrapings or biopsies were included for analysis. Data were extracted using standard criteria. History and examination of pruritic dermatoses failed to accurately diagnose scabies infection. Dermatoscopy by a trained practitioner has a positive likelihood ratio of 6.5 (95% CI 4.1 to 10.3) and a negative likelihood ratio of 0.1 (95% CI 0.06 to 0.2) for diagnosing scabies. The accuracy of other diagnostic tests could not be calculated from the data in the literature. In the face of such diagnostic inaccuracy, clinical judgment is still practical in diagnosing scabies. Two tests are used - the burrow ink test and handheld dermatoscopy. The burrow ink test is a simple, rapid, noninvasive test that can be used to screen a large number of patients. Handheld dermatoscopy is an accurate test, but requires special equipment and trained practitioners. Given the morbidity and costs of scabies infection, and that studies to date lack adequate internal and external validity, research to identify or develop accurate diagnostic tests for scabies infection is needed and justifiable.

Noninvasive Differentiation between Hepatic Steatosis and Steatohepatitis with MR Imaging Enhanced with USPIOs in Patients with Nonalcoholic Fatty Liver Disease: A Proof-of-Concept Study.

PubMed

Smits, Loek P; Coolen, Bram F; Panno, Maria D; Runge, Jurgen H; Nijhof, Wouter H; Verheij, Joanne; Nieuwdorp, Max; Stoker, Jaap; Beuers, Ulrich H; Nederveen, Aart J; Stroes, Erik S

2016-03-01

To (a) study the optimal timing and dosing for ultrasmall superparamagnetic iron oxide particle (USPIO)-enhanced magnetic resonance (MR) imaging of the liver in nonalcoholic fatty liver disease, (b) evaluate whether hepatic USPIO uptake is decreased in nonalcoholic steatohepatitis (NASH), and (c) study the diagnostic accuracy of USPIO-enhanced MR imaging to distinguish between NASH and simple steatosis. This prospective study was approved by the local institutional review board, and informed consent was obtained from all patients. Quantitative R2* MR imaging of the liver was performed at baseline and 72 hours after USPIO administration in patients with biopsy-proven NASH (n = 13), hepatic steatosis without NASH (n = 11), and healthy control subjects (n = 9). The hepatic USPIO uptake in the liver was quantified by the difference in R2* (ΔR2*) between the contrast material-enhanced images and baseline images. Between-group differences in mean ΔR2* were tested with the Student t test, and diagnostic accuracy was tested by calculating the area under the receiver operating characteristic curve. Patients with NASH had a significantly lower ΔR2* 72 hours after USPIO administration when compared with patients who had simple steatosis and healthy control subjects (mean ± standard deviation for patients with NASH, 37.0 sec(-1) ± 16.1; patients with simple steatosis, 61.0 sec(-1) ± 17.3; and healthy control subjects, 72.2 sec(-1) ± 22.0; P = .006 for NASH vs simple steatosis; P < .001 for NASH vs healthy control subjects). The area under the receiver operating characteristic curve to distinguish NASH from simple steatosis was 0.87 (95% confidence interval: 0.72, 1.00). This proof-of-concept study provides clues that hepatic USPIO uptake in patients with NASH is decreased and that USPIO MR imaging can be used to differentiate NASH from simple steatosis.

[What is hidden behind the Baking Tray Task? Study of sensibility and specificity in right-hemispheric stroke patients].

PubMed

Garcia-Fernandez, Juan; Garcia-Molina, Alberto; Aparicio-Lopez, Celeste; Sanchez-Carrion, Rocío; Ensenat, Antònia; Pena-Casanova, Jordi; Roig-Rovira, Teresa

2015-12-16

Tham and Tegner proposed the Baking Tray Task (BTT) as a fast simple assessment test for detecting spatial negligence. However, very few studies have examined its validity as a diagnostic test. To analyse the diagnostic validity of the BTT by measuring its specificity and sensitivity in a sample of subjects with right hemisphere strokes. Forty-eight patients with right hemisphere vascular lesions were distributed in two groups (negligence group, n = 35; non-negligence group, n = 13) according to the scores obtained in a battery of visuospatial examination tests. The participants' performance on the BTT was compared with that of a healthy control group (n = 12). The results showed a high level of sensitivity of the BTT, but low specificity. The performance on the BTT of eight of the 13 members of the non-negligence group was suggestive of negligence. The BTT has proved to be a sensitive test for the detection of spatial negligence. Yet, based on its low specificity, its use alone as a single diagnostic test is not recommended.

The Buffer Diagnostic Prototype: A fault isolation application using CLIPS

NASA Technical Reports Server (NTRS)

Porter, Ken

1994-01-01

This paper describes problem domain characteristics and development experiences from using CLIPS 6.0 in a proof-of-concept troubleshooting application called the Buffer Diagnostic Prototype. The problem domain is a large digital communications subsystems called the real-time network (RTN), which was designed to upgrade the launch processing system used for shuttle support at KSC. The RTN enables up to 255 computers to share 50,000 data points with millisecond response times. The RTN's extensive built-in test capability but lack of any automatic fault isolation capability presents a unique opportunity for a diagnostic expert system application. The Buffer Diagnostic Prototype addresses RTN diagnosis with a multiple strategy approach. A novel technique called 'faulty causality' employs inexact qualitative models to process test results. Experimental knowledge provides a capability to recognize symptom-fault associations. The implementation utilizes rule-based and procedural programming techniques, including a goal-directed control structure and simple text-based generic user interface that may be reusable for other rapid prototyping applications. Although limited in scope, this project demonstrates a diagnostic approach that may be adapted to troubleshoot a broad range of equipment.

Adoption of recommended practices and basic technologies in a low-income setting

PubMed Central

English, Mike; Gathara, David; Mwinga, Stephen; Ayieko, Philip; Opondo, Charles; Aluvaala, Jalemba; Kihuba, Elesban; Mwaniki, Paul; Were, Fred; Irimu, Grace; Wasunna, Aggrey; Mogoa, Wycliffe; Nyamai, Rachel

2014-01-01

Objective In global health considerable attention is focused on the search for innovations; however, reports tracking their adoption in routine hospital settings from low-income countries are absent. Design and setting We used data collected on a consistent panel of indicators during four separate cross-sectional, hospital surveys in Kenya to track changes over a period of 11 years (2002–2012). Main outcome measures Basic resource availability, use of diagnostics and uptake of recommended practices. Results There appeared little change in availability of a panel of 28 basic resources (median 71% in 2002 to 82% in 2012) although availability of specific feeds for severe malnutrition and vitamin K improved. Use of blood glucose and HIV testing increased but remained inappropriately low throughout. Commonly (malaria) and uncommonly (lumbar puncture) performed diagnostic tests frequently failed to inform practice while pulse oximetry, a simple and cheap technology, was rarely available even in 2012. However, increasing adherence to prescribing guidance occurred during a period from 2006 to 2012 in which efforts were made to disseminate guidelines. Conclusions Findings suggest changes in clinical practices possibly linked to dissemination of guidelines at reasonable scale. However, full availability of basic resources was not attained and major gaps likely exist between the potential and actual impacts of simple diagnostics and technologies representing problems with availability, adoption and successful utilisation. These findings are relevant to debates on scaling up in low-income settings and to those developing novel therapeutic or diagnostic interventions. PMID:24482351

CMOS Cell Sensors for Point-of-Care Diagnostics

PubMed Central

Adiguzel, Yekbun; Kulah, Haluk

2012-01-01

The burden of health-care related services in a global era with continuously increasing population and inefficient dissipation of the resources requires effective solutions. From this perspective, point-of-care diagnostics is a demanded field in clinics. It is also necessary both for prompt diagnosis and for providing health services evenly throughout the population, including the rural districts. The requirements can only be fulfilled by technologies whose productivity has already been proven, such as complementary metal-oxide-semiconductors (CMOS). CMOS-based products can enable clinical tests in a fast, simple, safe, and reliable manner, with improved sensitivities. Portability due to diminished sensor dimensions and compactness of the test set-ups, along with low sample and power consumption, is another vital feature. CMOS-based sensors for cell studies have the potential to become essential counterparts of point-of-care diagnostics technologies. Hence, this review attempts to inform on the sensors fabricated with CMOS technology for point-of-care diagnostic studies, with a focus on CMOS image sensors and capacitance sensors for cell studies. PMID:23112587

CMOS cell sensors for point-of-care diagnostics.

PubMed

Adiguzel, Yekbun; Kulah, Haluk

2012-01-01

The burden of health-care related services in a global era with continuously increasing population and inefficient dissipation of the resources requires effective solutions. From this perspective, point-of-care diagnostics is a demanded field in clinics. It is also necessary both for prompt diagnosis and for providing health services evenly throughout the population, including the rural districts. The requirements can only be fulfilled by technologies whose productivity has already been proven, such as complementary metal-oxide-semiconductors (CMOS). CMOS-based products can enable clinical tests in a fast, simple, safe, and reliable manner, with improved sensitivities. Portability due to diminished sensor dimensions and compactness of the test set-ups, along with low sample and power consumption, is another vital feature. CMOS-based sensors for cell studies have the potential to become essential counterparts of point-of-care diagnostics technologies. Hence, this review attempts to inform on the sensors fabricated with CMOS technology for point-of-care diagnostic studies, with a focus on CMOS image sensors and capacitance sensors for cell studies.

Inventions leading to the development of the diagnostic test kit industry--from the modern pregnancy test to the sandwich assays.

PubMed

Wide, Leif

2005-01-01

The universities are encouraged by the government nowadays to stimulate innovations and also to provide the proper machinery for assisting the protection and commercialisation of innovations. A better understanding of the innovation process may help to create an atmosphere suitable for inventions at the university. Examples can be taken from successful innovations previously made at the university. During the 1960's I made a series of inventions, which ultimately led to the development of the diagnostic test kit industry. The first, which I made as an undergraduate, was a simple and reliable test kit for diagnosis of pregnancy. This was followed by the solid phase radioimmunoassay and a solid phase assay for vitamin B12; next, the dual specific non-competitive sandwich assay and the in-vitro test for diagnosis of allergy, called RAST (Radioallergosorbent test). Organon in Holland with the pregnancy test kit, and Pharmacia in Sweden with test kits for radioimmunoassay, became pioneers among the diagnostic test kit industries. Pharmacia Diagnostics later became one of the leading diagnostic test kit companies in the world and has continued to be so in the field of allergy diagnosis. Each one of these inventions started with a few unique observations leading to a technical development. The pregnancy test as well as the allergy test emerged from the development of assay methods with unique qualities with the subsequent search for appropriate applications. The foreseeing of a commercial value on a future market was a very important step. This was followed by the search for a suitable industry interested to exploit the invention with its new business opportunity i.e. apply for a patent, produce and market the products, which in my case consisted of the necessary reagents and equipments for particular diagnostic tests. Finally, an agreement had to be settled between the entrepreneur and the inventors. This report describes these inventions and particularly discusses some crucial steps of the innovation processes.

Clinical review: Distinguishing constitutional delay of growth and puberty from isolated hypogonadotropic hypogonadism: critical appraisal of available diagnostic tests.

PubMed

Harrington, Jennifer; Palmert, Mark R

2012-09-01

Determining the etiology of delayed puberty during initial evaluation can be challenging. Specifically, clinicians often cannot distinguish constitutional delay of growth and puberty (CDGP) from isolated hypogonadotropic hypogonadism (IHH), with definitive diagnosis of IHH awaiting lack of spontaneous puberty by age 18 yr. However, the ability to make a timely, correct diagnosis has important clinical implications. The aim was to describe and evaluate the literature regarding the ability of diagnostic tests to distinguish CDGP from IHH. A PubMed search was performed using key words "puberty, delayed" and "hypogonadotropic hypogonadism," and citations within retrieved articles were reviewed to identify studies that assessed the utility of basal and stimulation tests in the diagnosis of delayed puberty. Emphasis was given to a test's ability to distinguish prepubertal adolescents with CDGP from those with IHH. Basal gonadotropin and GnRH stimulation tests have limited diagnostic specificity, with overlap in gonadotropin levels between adolescents with CDGP and IHH. Stimulation tests using more potent GnRH agonists and/or human chorionic gonadotropin may have better discriminatory value, but small study size, lack of replication of diagnostic thresholds, and prolonged protocols limit clinical application. A single inhibin B level in two recent studies demonstrated good differentiation between groups. Distinguishing IHH from CDGP is an important clinical issue. Basal inhibin B may offer a simple, discriminatory test if results from recent studies are replicated. However, current literature does not allow for recommendation of any diagnostic test for routine clinical use, making this an important area for future investigation.

Malaria rapid diagnostic tests in elimination settings—can they find the last parasite?

PubMed Central

McMorrow, M. L.; Aidoo, M.; Kachur, S. P.

2016-01-01

Rapid diagnostic tests (RDTs) for malaria have improved the availability of parasite-based diagnosis throughout the malaria-endemic world. Accurate malaria diagnosis is essential for malaria case management, surveillance, and elimination. RDTs are inexpensive, simple to perform, and provide results in 15–20 min. Despite high sensitivity and specificity for Plasmodium falciparum infections, RDTs have several limitations that may reduce their utility in low-transmission settings: they do not reliably detect low-density parasitaemia (≤200 parasites/μL), many are less sensitive for Plasmodium vivax infections, and their ability to detect Plasmodium ovale and Plasmodium malariae is unknown. Therefore, in elimination settings, alternative tools with higher sensitivity for low-density infections (e.g. nucleic acid-based tests) are required to complement field diagnostics, and new highly sensitive and specific field-appropriate tests must be developed to ensure accurate diagnosis of symptomatic and asymptomatic carriers. As malaria transmission declines, the proportion of low-density infections among symptomatic and asymptomatic persons is likely to increase, which may limit the utility of RDTs. Monitoring malaria in elimination settings will probably depend on the use of more than one diagnostic tool in clinical-care and surveillance activities, and the combination of tools utilized will need to be informed by regular monitoring of test performance through effective quality assurance. PMID:21910780

Students' Visual Learning Disabilities and Under-Achievement in Selected Science Subjects.

ERIC Educational Resources Information Center

Rochford, Kevin

Two experiments were conducted to assess the performance of freshmen chemistry students with poor spatial visualization skills. In the first experiment, 31 chemistry students with academically deficient backgrounds completed a diagnostic test of their ability to visualize and interpret pictorial representations of simple molecular structures. At…

Current and state-of-the-art approaches for detecting mycotoxins in commodities

USDA-ARS?s Scientific Manuscript database

The tools that have been applied to detection of mycotoxins in commodities are numerous and powerful. These include everything from simple to use diagnostic test strips to complex, instrument intensive, methods such as ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS). This wi...

Waiting for the evidence: VEMP testing and the ability to differentiate utricular versus saccular function.

PubMed

Welgampola, Miriam S; Carey, John P

2010-08-01

The advent of cervical vestibular evoked myogenic potentials (CVEMPs) marked a milestone in clinical vestibular testing because they provided a simple means of assessing human otolith function. The availability of air-conducted (AC) sound and bone-conducted vibration (BCV) to evoke CVEMPs and development of a new technique of recording ocular vestibular-evoked myogenic potentials (OVEMPs) have increased the complexity of this simple test, yet extended its diagnostic capabilities. Here we highlight the evidence-based assumptions that guide interpretation of AC sound- and BCV-evoked VEMPs and the gaps in VEMP research thus far. Copyright (c) 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

Simple exercise test score versus cardiac stress test for the prediction of coronary artery disease in patients with type 2 diabetes.

PubMed

Pikto-Pietkiewicz, Witold; Przewłocka, Monika; Chybowska, Barbara; Cyciwa, Alona; Pasierski, Tomasz

2014-01-01

Type 2 diabetes markedly increases the risk of coronary heart disease (CHD), and screening for CHD is suggested by the guidelines. The aim of the study was to compare the diagnostic usefulness of the simple exercise test score, incorporating the clinical data and cardiac stress test results, with the standard stress test in patients with type 2 diabetes. A total of 62 consecutive patients (aged 65.4 ±8.5 years; 32 men) with type 2 diabetes and clinical symptoms suggesting CHD underwent a stress test followed by coronary angiography. The simple score was calculated for all patients. Significant coronary stenosis was observed in 41 patients (66.1%). Stress test results were positive in 36 patients (58.1%). The mean simple score was high (65.5 ±14.3 points). A positive linear relationship was observed between the score and the prevalence of CHD (R2 = 0.19; P <0.001) as well as its severity (R² = 0.23; P <0.001). The area under the receiver-operating characteristic curve for the simple score was 0.74 (95% confidence interval [CI], 0.62-0.86). At the original cut-off value of 60 points, the score had a similar prognostic value to that of the standard stress test. However, in a multivariate analysis, only the simple score (odds ratio [OR], 1.46; 95% CI, 1.11-1.94; P <0.01 for an increase in the score by 1 point) and male sex (OR, 1.57; 95% CI, 1.24-1.98; P <0.001) remained independent predictors of CHD. In patients with type 2 diabetes, the simple score correlated with the prevalence and severity of CHD. However, the cut-off value of 60 points was inadequate in the population of diabetic patients with high risk of CHD. The simple score used instead of or together with the stress test was a better predictor of CHD than the stress test alone.

A simple sandwich ELISA (WELYSSA) for the detection of lyssavirus nucleocapsid in rabies suspected specimens using mouse monoclonal antibodies.

PubMed

Xu, Gelin; Weber, Patrick; Hu, Qiaoling; Xue, Honggang; Audry, Laurent; Li, Chengping; Wu, Jie; Bourhy, Herve

2007-10-01

Monoclonal antibody (MAb)-based capture enzyme-linked immunosorbent assays (ELISA) were developed for the diagnosis of rabies-suspect specimens. A combination of four mouse monoclonal antibodies directed against the rabies virus nucleocapsid was selected and used for the detection. The test was optimized and standardized so that maximum concordance could be maintained with the standard procedures of rabies diagnosis recommended by the WHO expert committee. Using prototype viruses from the different genotypes of lyssavirus and from various geographic origins and phylogenetic lineages, this paper presents a reliable, rapid and transferable diagnostic method, named WELYSSA that readily permits the detection of lyssaviruses belonging to the 7 genotypes of lyssavirus circulating in Europe, Africa, Asia and Oceania. The threshold of detection of lyssavirus nucleocapsids is low (0.8 ng/ml). With a panel of 1030 specimens received for rabies diagnostic testing, this test was found to be highly specific (0.999) and sensitive (0.970) when compared to other recommended rabies diagnostic methods.

[Comparison of simple pooling and bivariate model used in meta-analyses of diagnostic test accuracy published in Chinese journals].

PubMed

Huang, Yuan-sheng; Yang, Zhi-rong; Zhan, Si-yan

2015-06-18

To investigate the use of simple pooling and bivariate model in meta-analyses of diagnostic test accuracy (DTA) published in Chinese journals (January to November, 2014), compare the differences of results from these two models, and explore the impact of between-study variability of sensitivity and specificity on the differences. DTA meta-analyses were searched through Chinese Biomedical Literature Database (January to November, 2014). Details in models and data for fourfold table were extracted. Descriptive analysis was conducted to investigate the prevalence of the use of simple pooling method and bivariate model in the included literature. Data were re-analyzed with the two models respectively. Differences in the results were examined by Wilcoxon signed rank test. How the results differences were affected by between-study variability of sensitivity and specificity, expressed by I2, was explored. The 55 systematic reviews, containing 58 DTA meta-analyses, were included and 25 DTA meta-analyses were eligible for re-analysis. Simple pooling was used in 50 (90.9%) systematic reviews and bivariate model in 1 (1.8%). The remaining 4 (7.3%) articles used other models pooling sensitivity and specificity or pooled neither of them. Of the reviews simply pooling sensitivity and specificity, 41(82.0%) were at the risk of wrongly using Meta-disc software. The differences in medians of sensitivity and specificity between two models were both 0.011 (P<0.001, P=0.031 respectively). Greater differences could be found as I2 of sensitivity or specificity became larger, especially when I2>75%. Most DTA meta-analyses published in Chinese journals(January to November, 2014) combine the sensitivity and specificity by simple pooling. Meta-disc software can pool the sensitivity and specificity only through fixed-effect model, but a high proportion of authors think it can implement random-effect model. Simple pooling tends to underestimate the results compared with bivariate model. The greater the between-study variance is, the more likely the simple pooling has larger deviation. It is necessary to increase the knowledge level of statistical methods and software for meta-analyses of DTA data.

Creation of a simple natural language processing tool to support an imaging utilization quality dashboard.

PubMed

Swartz, Jordan; Koziatek, Christian; Theobald, Jason; Smith, Silas; Iturrate, Eduardo

2017-05-01

Testing for venous thromboembolism (VTE) is associated with cost and risk to patients (e.g. radiation). To assess the appropriateness of imaging utilization at the provider level, it is important to know that provider's diagnostic yield (percentage of tests positive for the diagnostic entity of interest). However, determining diagnostic yield typically requires either time-consuming, manual review of radiology reports or the use of complex and/or proprietary natural language processing software. The objectives of this study were twofold: 1) to develop and implement a simple, user-configurable, and open-source natural language processing tool to classify radiology reports with high accuracy and 2) to use the results of the tool to design a provider-specific VTE imaging dashboard, consisting of both utilization rate and diagnostic yield. Two physicians reviewed a training set of 400 lower extremity ultrasound (UTZ) and computed tomography pulmonary angiogram (CTPA) reports to understand the language used in VTE-positive and VTE-negative reports. The insights from this review informed the arguments to the five modifiable parameters of the NLP tool. A validation set of 2,000 studies was then independently classified by the reviewers and by the tool; the classifications were compared and the performance of the tool was calculated. The tool was highly accurate in classifying the presence and absence of VTE for both the UTZ (sensitivity 95.7%; 95% CI 91.5-99.8, specificity 100%; 95% CI 100-100) and CTPA reports (sensitivity 97.1%; 95% CI 94.3-99.9, specificity 98.6%; 95% CI 97.8-99.4). The diagnostic yield was then calculated at the individual provider level and the imaging dashboard was created. We have created a novel NLP tool designed for users without a background in computer programming, which has been used to classify venous thromboembolism reports with a high degree of accuracy. The tool is open-source and available for download at http://iturrate.com/simpleNLP. Results obtained using this tool can be applied to enhance quality by presenting information about utilization and yield to providers via an imaging dashboard. Copyright © 2017 Elsevier B.V. All rights reserved.

Our experiences with the use of atopy patch test in the diagnosis of cow's milk hypersensitivity.

PubMed

Pustisek, Nives; Jaklin-Kekez, Alemka; Frkanec, Ruza; Sikanić-Dugić, Nives; Misak, Zrinjka; Jadresin, Oleg; Kolacek, Sanja

2010-01-01

Atopy patch test has been recognized as a diagnostic tool for the verification of food allergies in infants and small children suffering from atopic dermatitis. The test also has a role in the diagnosis of food allergies characterized by clinical signs associated with the digestive system. Yet, in spite of numerous studies, the test itself has hitherto not been standardized. Our study enlisted 151 children less than two years of age, who exhibited suspect skin and/or gastrointestinal manifestations of food allergy to cow's milk, and in whom tests failed to prove early type of allergic reaction. Atopy patch test was positive in 28% of the children with atopic dermatitis, 43% of the children with suspect gastrointestinal manifestation and 32% of the children with skin and gastrointestinal manifestations of food allergy. In our experience, atopy patch test is an excellent addition to the hitherto used tests for the diagnosis of food allergies. It targets specifically delayed type hypersensitivity reactions, which are difficult to confirm with other diagnostic tools. It is furthermore simple to perform, noninvasive and produces a minimum of undesired side effects. For these reasons, it should become part of the routine diagnostic toolset for food allergies to cow's milk in infants and children, and applied before a food challenge test.

Diagnostic performance of serological tests to detect antibodies against acute scrub typhus infection in central India.

PubMed

Pote, Kiran; Narang, Rahul; Deshmukh, Pradeep

2018-01-01

Differentiating scrub typhus from other acute febrile illness is difficult due to non specificity of clinical symptoms and relative absence of eschar in Indian population. The diagnosis thus relies mainly on laboratory tests. Antibody based serological tests are mainstay of scrub typhus diagnosis. Here, we evaluated the diagnostic performance of IgM ELISA, IgM IFA and ICT to detect antibodies against O. tsutsugamushi in acute serum of febrile patients. The serum samples from 600 randomly selected patients suffering from acute undifferentiated fever were tested by all the three tests mentioned above. We used latent class analysis to generate unbiased results as all the tests for scrub typhus diagnosis are imperfect and none of them can be considered as reference standard. We found that IgM ELISA with cutoff titer 0.5 OD has high diagnostic accuracy (sensitivity 99.9% and specificity 99.15) than IgM IFA (sensitivity 96.8% and specificity 99.7%) for scrub typhus diagnosis. ICT used in our study had very high specificity 100% but low sensitivity (38%) which would limit its use for acute serum samples. ICT being a screening or point of care test, has to be more sensitive while some compromise with specificity is affordable. Hence, optimal cutoff for ICT should be evaluated under different settings. IgM ELISA being simple and affordable could be an alternative diagnostic test to IgM IFA which is subjective and costly.

Interpretation of diagnostic data: 4. How to do it with a more complex table.

PubMed

1983-10-15

A more complex table is especially useful when a diagnostic test produces a wide range of results and your patient's levels are near one of the extremes. The following guidelines will be useful: Identify the several cut-off points that could be used. Fill in a complex table along the lines of Table I, showing the numbers of patients at each level who have and do not have the target disorder. Generate a simple table for each cut-off point, as in Table II, and determine the sensitivity (TP rate) and specificity (TN rate) at each of them. Select the cut-off point that makes the most sense for your patient's test result and proceed as in parts 2 and 3 of our series. Alternatively, construct an ROC curve by plotting the TP and FP rates that attend each cut-off point. If you keep your tables and ROC curves close at hand, you will gradually accumulate a set of very useful guides. However, if you looked very hard at what was happening, you will probably have noticed that they are not very useful for patients whose test results fall in the middle zones, or for those with just one positive result of two tests; the post-test likelihood of disease in these patients lurches back and forth past 50%, depending on where the cut-off point is. We will show you how to tackle this problem in part 5 of our series. It involves some maths, but you will find that its very powerful clinical application can be achieved with a simple nomogram or with some simple calculations.

Self-powered integrated microfluidic point-of-care low-cost enabling (SIMPLE) chip

PubMed Central

Yeh, Erh-Chia; Fu, Chi-Cheng; Hu, Lucy; Thakur, Rohan; Feng, Jeffrey; Lee, Luke P.

2017-01-01

Portable, low-cost, and quantitative nucleic acid detection is desirable for point-of-care diagnostics; however, current polymerase chain reaction testing often requires time-consuming multiple steps and costly equipment. We report an integrated microfluidic diagnostic device capable of on-site quantitative nucleic acid detection directly from the blood without separate sample preparation steps. First, we prepatterned the amplification initiator [magnesium acetate (MgOAc)] on the chip to enable digital nucleic acid amplification. Second, a simplified sample preparation step is demonstrated, where the plasma is separated autonomously into 224 microwells (100 nl per well) without any hemolysis. Furthermore, self-powered microfluidic pumping without any external pumps, controllers, or power sources is accomplished by an integrated vacuum battery on the chip. This simple chip allows rapid quantitative digital nucleic acid detection directly from human blood samples (10 to 105 copies of methicillin-resistant Staphylococcus aureus DNA per microliter, ~30 min, via isothermal recombinase polymerase amplification). These autonomous, portable, lab-on-chip technologies provide promising foundations for future low-cost molecular diagnostic assays. PMID:28345028

Opportunities for Improved Serodiagnosis of Human Tuberculosis, Bovine Tuberculosis, and Paratuberculosis

PubMed Central

Wadhwa, Ashutosh; Hickling, Graham J.; Eda, Shigetoshi

2012-01-01

Mycobacterial infections—tuberculosis (TB), bovine tuberculosis (bTB), and Johne's disease (JD)—are major infectious diseases of both human and animals. Methods presently in use for diagnosis of mycobacterial infections include bacterial culture, nucleic acid amplification, tuberculin skin test, interferon-γ assay, and serology. Serological tests have several advantages over other methods, including short turn-around time, relatively simple procedures, and low cost. However, current serodiagnostic methods for TB, bTB and JD exhibit low sensitivity and/or specificity. Recent studies that have aimed to develop improved serodiagnostic tests have mostly focused on identifying useful species-specific protein antigens. A review of recent attempts to improve diagnostic test performance indicates that the use of multiple antigens can improve the accuracy of serodiagnosis of these mycobacterial diseases. Mycobacteria also produce a variety of species-specific nonprotein molecules; however, only a few such molecules (e.g., cord factor and lipoarabinomannan) have so far been evaluated for their effectiveness as diagnostic antigens. For TB and bTB, there has been recent progress in developing laboratory-free diagnostic methods. New technologies such as microfluidics and “Lab-on-Chip” are examples of promising new technologies that can underpin development of laboratory-free diagnostic devices for these mycobacterial infections. PMID:22720192

[Microbiology--laboratory examinations for bacterias].

PubMed

Hen, Renjun; Imafuku, Yuji; Yoshida, Hiroshi

2002-11-01

As it has been required to identify pathogenic microbes in shorter times, simple and rapid methods have been developed and used. Here, we summarized the present situation of rapid diagnostic testing in clinical microbiology in Japan, and also presented our results on PBP2' detection. The rapid test kits available in Japan for E. coli, Helicobacter pylori, Salmonella, Streptococcus and Staphylococcus aureus were described. Rapid examination methods are based mainly on immunologic reactions, which included slide agglutination using latex particle, immunochromatography and ELISA. Times required for the identification are 10 to 15 minutes. Moreover, rapid test kits employing PCR are also marketed. Further, we evaluated MRSA-LA "Seiken" which is a rapid detection kit for PBP2' produced by MRSA. The test was shown to be highly sensitive and specific. For the rapid identification of pathogenic microbes, simple and rapid test kits described here will be used more in clinical diagnosis.

Diagnostic reasoning by hospital pharmacists: assessment of attitudes, knowledge, and skills.

PubMed

Chernushkin, Kseniya; Loewen, Peter; de Lemos, Jane; Aulakh, Amneet; Jung, Joanne; Dahri, Karen

2012-07-01

Hospital pharmacists participate in activities that may be considered diagnostic. Two reasoning approaches to diagnosis have been described: non-analytic and analytic. Of the 6 analytic traditions, the probabilistic tradition has been shown to improve diagnostic accuracy and reduce unnecessary testing. To the authors' knowledge, pharmacists' attitudes toward having a diagnostic role and their diagnostic knowledge and skills have never been studied. To describe pharmacists' attitudes toward the role of diagnosis in pharmacotherapeutic problem-solving and to characterize the extent of pharmacists' knowledge and skills related to diagnostic literacy. Pharmacists working within Lower Mainland Pharmacy Services (British Columbia) who spent at least 33% of their time in direct patient care were invited to participate in a prospective observational survey. The survey sought information about demographic characteristics and attitudes toward diagnosis. Diagnostic knowledge and skills were tested by means of 3 case scenarios. The analysis included simple descriptive statistics and inferential statistics to evaluate relationships between responses and experience and training. Of 266 pharmacists invited to participate, 94 responded. The attitudes section of the survey was completed by 90 pharmacists; of these, 80 (89%) agreed with the definition of "diagnosis" proposed in the survey, and 83 (92%) agreed that it is important for pharmacists to have diagnosis-related skills. Respondents preferred an analytic to a non-analytic approach to diagnostic decision-making. The probabilistic tradition was not the preferred method in any of the 3 cases. In evaluating 5 clinical scenarios that might require diagnostic skills, on average 84% of respondents agreed that they should be involved in assessing such problems. Respondents' knowledge of and ability to apply probabilistic diagnostic tools were highest for test sensitivity (average of 61% of respondents with the correct answers) and lower for test specificity (average of 48% with correct answers) and likelihood ratios (average of 39% with correct answers). Respondents to this survey strongly believed that diagnostic skills were important for solving drug-related problems, but they demonstrated low levels of knowledge and ability to apply concepts of probabilistic diagnostic reasoning. Opportunities to expand pharmacists' knowledge of diagnostic reasoning exist, and the findings reported here indicate that pharmacists would consider such professional development valuable.

A simple diagnostic model for ruling out pneumoconiosis among construction workers.

PubMed

Suarthana, Eva; Moons, Karel G M; Heederik, Dick; Meijer, Evert

2007-09-01

Construction workers exposed to silica-containing dust are at risk of developing silicosis even at low exposure levels. Health surveillance among these workers is commonly advised but the exact diagnostic work-up is not specified and therefore may result in unnecessary chest x ray investigations. To develop a simple diagnostic model to estimate the probability of an individual worker having pneumoconiosis from questionnaire and spirometry results, in order to accurately rule out workers without pneumoconiosis. The study was performed using cross-sectional data of 1291 Dutch natural stone and construction workers with potentially high quartz dust exposure. A multivariable logistic regression model was developed using chest x ray with ILO profusion category > or =1/1 as the reference standard. The model's calibration was evaluated with the Hosmer-Lemeshow test; the discriminative ability was determined by calculating the area under the receiver operating characteristic curve (ROC area). Internal validity of the final model was assessed by a bootstrapping procedure. For clinical application, the diagnostic model was transformed into an easy-to-use score chart. Age 40 years or older, current smoker, high-exposure job, working 15 years or longer in the construction industry, "feeling unhealthy" and FEV1 were independent predictors in the diagnostic model. The model showed good calibration (a non-significant Hosmer-Lemeshow test) and discriminative ability (ROC area 0.81, 95% CI 0.74 to 0.85). Internal validity was reasonable; the optimism corrected ROC area was 0.76. By using a cut-off point with a high negative predictive value the occupational physician can efficiently detect a large proportion of workers with a low probability of having pneumoconiosis and exclude them from unnecessary x ray investigations. This diagnostic model is an efficient and effective instrument to rule out pneumoconiosis among construction workers. Its use in health surveillance among these workers can reduce the number of redundant x ray investigations.

Lessons learned developing a diagnostic tool for HIV-associated dementia feasible to implement in resource-limited settings: pilot testing in Kenya.

PubMed

Kwasa, Judith; Cettomai, Deanna; Lwanya, Edwin; Osiemo, Dennis; Oyaro, Patrick; Birbeck, Gretchen L; Price, Richard W; Bukusi, Elizabeth A; Cohen, Craig R; Meyer, Ana-Claire L

2012-01-01

To conduct a preliminary evaluation of the utility and reliability of a diagnostic tool for HIV-associated dementia (HAD) for use by primary health care workers (HCW) which would be feasible to implement in resource-limited settings. In resource-limited settings, HAD is an indication for anti-retroviral therapy regardless of CD4 T-cell count. Anti-retroviral therapy, the treatment for HAD, is now increasingly available in resource-limited settings. Nonetheless, HAD remains under-diagnosed likely because of limited clinical expertise and availability of diagnostic tests. Thus, a simple diagnostic tool which is practical to implement in resource-limited settings is an urgent need. A convenience sample of 30 HIV-infected outpatients was enrolled in Western Kenya. We assessed the sensitivity and specificity of a diagnostic tool for HAD as administered by a primary HCW. This was compared to an expert clinical assessment which included examination by a physician, neuropsychological testing, and in selected cases, brain imaging. Agreement between HCW and an expert examiner on certain tool components was measured using Kappa statistic. The sample was 57% male, mean age was 38.6 years, mean CD4 T-cell count was 323 cells/µL, and 54% had less than a secondary school education. Six (20%) of the subjects were diagnosed with HAD by expert clinical assessment. The diagnostic tool was 63% sensitive and 67% specific for HAD. Agreement between HCW and expert examiners was poor for many individual items of the diagnostic tool (K = .03-.65). This diagnostic tool had moderate sensitivity and specificity for HAD. However, reliability was poor, suggesting that substantial training and formal evaluations of training adequacy will be critical to enable HCW to reliably administer a brief diagnostic tool for HAD.

2D imaging X-ray diagnostic for measuring the current density distribution in a wide-area electron beam produced in a multiaperture diode with plasma cathode

NASA Astrophysics Data System (ADS)

Kurkuchekov, V.; Kandaurov, I.; Trunev, Y.

2018-05-01

A simple and inexpensive X-ray diagnostic tool was designed for measuring the cross-sectional current density distribution in a low-relativistic pulsed electron beam produced in a source based on an arc-discharge plasma cathode and multiaperture diode-type electron optical system. The beam parameters were as follows: Uacc = 50–110 kV, Ibeam = 20–100 A, τbeam = 0.1–0.3 ms. The beam effective diameter was ca. 7 cm. Based on a pinhole camera, the diagnostic allows one to obtain a 2D profile of electron beam flux distribution on a flat metal target in a single shot. The linearity of the diagnostic system response to the electron flux density was established experimentally. Spatial resolution of the diagnostic was also estimated in special test experiments. The optimal choice of the main components of the diagnostic technique is discussed.

Clinical reasoning in the real world is mediated by bounded rationality: implications for diagnostic clinical practice guidelines.

PubMed

Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-04-20

Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. FOUR MAIN THEMES WERE IDENTIFIED: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration.

Clinical Reasoning in the Real World Is Mediated by Bounded Rationality: Implications for Diagnostic Clinical Practice Guidelines

PubMed Central

Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-01-01

Background Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. Method This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. Results Four main themes were identified: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Discussion Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration. PMID:20421920

Isotope-selective sensor for medical diagnostics based on PAS

NASA Astrophysics Data System (ADS)

Wolff, M.; Groninga, H. G.; Harde, H.

2005-06-01

Development of new optical sensor technologies has a major impact on the progression of diagnostic methods. Of the permanently increasing number of non-invasive 13C-breath tests, the Urea Breath Test for detection of Helicobacter pylori is the most prominent. However, many recent developments go beyond gastroenterological applications. We present a new detection scheme for breath analysis that employs an especially compact and simple set-up based on Photoacoustic Spectroscopy. Using a wavelength-modulated DFB-diode laser and taking advantage of acoustical resonances of the sample cell, we performed very sensitive isotope-selective measurements on CO2. Detection limits for 13CO2 of a few ppm and for the variation of the 13CO2 concentration of approximately 1% were achieved.

Clinical approaches to infertility in the bitch.

PubMed

Wilborn, Robyn R; Maxwell, Herris S

2012-05-01

When presented with the apparently infertile bitch, the practitioner must sort through a myriad of facts, historical events, and diagnostic tests to uncover the etiology of the problem. Many bitches that present for infertility are reproductively normal and are able to conceive with appropriate intervention and breeding management. An algorithmic approach is helpful in cases of infertility, where simple questions lead to the next appropriate step. Most bitches can be categorized as either cyclic or acyclic, and then further classified based on historical data and diagnostic testing. Each female has a unique set of circumstances that can affect her reproductive potential. By utilizing all available information and a logical approach, the clinician can narrow the list of differentials and reach a diagnosis more quickly.

Loopback Tester: a synchronous communications circuit diagnostic device

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

Maestas, J.H.

1986-07-01

The Loopback Tester is an Intel SBC 86/12A Single Board Computer and an Intel SBC 534 Communications Expansion Board configured and programmed to perform various basic or less. These tests include: (1) Data Communications Equipment (DCE) transmit timing detection (2) data rate measurement (3) instantaneous loopback indication and (4) bit error rate testing. It requires no initial setup after plug in, and can be used to locate the source of communications loss in a circuit. It can also be used to determine when crypto variable mismatch problems are the source of communications loss. This report discusses the functionality of themore » Loopback Tester as a diagnostic device. It also discusses the hardware and software which implements this simple yet reliable device.« less

[Express diagnostics of bovine leucosis by immune sensor based on surface plasmon resonance].

PubMed

Pyrohova, L V; Starodub, M F; Artiukh, V P; Nahaieva, L I; Dobrosol, H I

2002-01-01

An immune sensor based on the surface plasmon resonance (SPR) was developed for express diagnostics of bovine leucosis. The sensor was used for detection of the level of antibodies against bovine leukaemia virus (BLV) in the blood serum. The industrially manufactured BLV antigen for screening test in the agar gel immunodiffusion (AGID) required the additional purification in order to be used in immune sensor analysis. It was shown that immune sensor analysis was more sensitive, rapid and simple in comparison with the traditional AGID test. It was stated that the developed immune sensor was capable to be used for performance of bovine leucosis screening at the farms and the minimal dilution of the serum should be 1:500.

Simple ultrasound rules to distinguish between benign and malignant adnexal masses before surgery: prospective validation by IOTA group

PubMed Central

Ameye, Lieveke; Fischerova, Daniela; Epstein, Elisabeth; Melis, Gian Benedetto; Guerriero, Stefano; Van Holsbeke, Caroline; Savelli, Luca; Fruscio, Robert; Lissoni, Andrea Alberto; Testa, Antonia Carla; Veldman, Joan; Vergote, Ignace; Van Huffel, Sabine; Bourne, Tom; Valentin, Lil

2010-01-01

Objectives To prospectively assess the diagnostic performance of simple ultrasound rules to predict benignity/malignancy in an adnexal mass and to test the performance of the risk of malignancy index, two logistic regression models, and subjective assessment of ultrasonic findings by an experienced ultrasound examiner in adnexal masses for which the simple rules yield an inconclusive result. Design Prospective temporal and external validation of simple ultrasound rules to distinguish benign from malignant adnexal masses. The rules comprised five ultrasonic features (including shape, size, solidity, and results of colour Doppler examination) to predict a malignant tumour (M features) and five to predict a benign tumour (B features). If one or more M features were present in the absence of a B feature, the mass was classified as malignant. If one or more B features were present in the absence of an M feature, it was classified as benign. If both M features and B features were present, or if none of the features was present, the simple rules were inconclusive. Setting 19 ultrasound centres in eight countries. Participants 1938 women with an adnexal mass examined with ultrasound by the principal investigator at each centre with a standardised research protocol. Reference standard Histological classification of the excised adnexal mass as benign or malignant. Main outcome measures Diagnostic sensitivity and specificity. Results Of the 1938 patients with an adnexal mass, 1396 (72%) had benign tumours, 373 (19.2%) had primary invasive tumours, 111 (5.7%) had borderline malignant tumours, and 58 (3%) had metastatic tumours in the ovary. The simple rules yielded a conclusive result in 1501 (77%) masses, for which they resulted in a sensitivity of 92% (95% confidence interval 89% to 94%) and a specificity of 96% (94% to 97%). The corresponding sensitivity and specificity of subjective assessment were 91% (88% to 94%) and 96% (94% to 97%). In the 357 masses for which the simple rules yielded an inconclusive result and with available results of CA-125 measurements, the sensitivities were 89% (83% to 93%) for subjective assessment, 50% (42% to 58%) for the risk of malignancy index, 89% (83% to 93%) for logistic regression model 1, and 82% (75% to 87%) for logistic regression model 2; the corresponding specificities were 78% (72% to 83%), 84% (78% to 88%), 44% (38% to 51%), and 48% (42% to 55%). Use of the simple rules as a triage test and subjective assessment for those masses for which the simple rules yielded an inconclusive result gave a sensitivity of 91% (88% to 93%) and a specificity of 93% (91% to 94%), compared with a sensitivity of 90% (88% to 93%) and a specificity of 93% (91% to 94%) when subjective assessment was used in all masses. Conclusions The use of the simple rules has the potential to improve the management of women with adnexal masses. In adnexal masses for which the rules yielded an inconclusive result, subjective assessment of ultrasonic findings by an experienced ultrasound examiner was the most accurate diagnostic test; the risk of malignancy index and the two regression models were not useful. PMID:21156740

A simple pore water hydrogen diffusion syringe sampler

USGS Publications Warehouse

Vroblesky, D.A.; Chapelle, F.H.; Bradley, P.M.

2007-01-01

Molecular hydrogen (H2) is an important intermediate product and electron donor in microbial metabolism. Concentrations of dissolved H 2 are often diagnostic of the predominant terminal electron-accepting processes in ground water systems or aquatic sediments. H2 concentrations are routinely measured in ground water monitoring wells but are rarely measured in saturated aquatic sediments due to a lack of simple and practical sampling methods. This report describes the design and development (including laboratory and field testing) of a simple, syringe-based H 2 sampler in (1) saturated, riparian sediments, (2) surface water bed sediments, and (3) packed intervals of a fractured bedrock borehole that are inaccessible by standard pumped methods. ?? 2007 National Ground Water Association.

Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithms in Dar es Salaam, Tanzania

PubMed Central

2009-01-01

Background Suitable algorithms based on a combination of two or more simple rapid HIV assays have been shown to have a diagnostic accuracy comparable to double enzyme-linked immunosorbent assay (ELISA) or double ELISA with Western Blot strategies. The aims of this study were to evaluate the performance of five simple rapid HIV assays using whole blood samples from HIV-infected patients, pregnant women, voluntary counseling and testing attendees and blood donors, and to formulate an alternative confirmatory strategy based on rapid HIV testing algorithms suitable for use in Tanzania. Methods Five rapid HIV assays: Determine™ HIV-1/2 (Inverness Medical), SD Bioline HIV 1/2 3.0 (Standard Diagnostics Inc.), First Response HIV Card 1–2.0 (PMC Medical India Pvt Ltd), HIV1/2 Stat-Pak Dipstick (Chembio Diagnostic System, Inc) and Uni-Gold™ HIV-1/2 (Trinity Biotech) were evaluated between June and September 2006 using 1433 whole blood samples from hospital patients, pregnant women, voluntary counseling and testing attendees and blood donors. All samples that were reactive on all or any of the five rapid assays and 10% of non-reactive samples were tested on a confirmatory Inno-Lia HIV I/II immunoblot assay (Immunogenetics). Results Three hundred and ninety samples were confirmed HIV-1 antibody positive, while 1043 were HIV negative. The sensitivity at initial testing of Determine, SD Bioline and Uni-Gold™ was 100% (95% CI; 99.1–100) while First Response and Stat-Pak had sensitivity of 99.5% (95% CI; 98.2–99.9) and 97.7% (95% CI; 95.7–98.9), respectively, which increased to 100% (95% CI; 99.1–100) on repeat testing. The initial specificity of the Uni-Gold™ assay was 100% (95% CI; 99.6–100) while specificities were 99.6% (95% CI; 99–99.9), 99.4% (95% CI; 98.8–99.7), 99.6% (95% CI; 99–99.9) and 99.8% (95% CI; 99.3–99.9) for Determine, SD Bioline, First Response and Stat-Pak assays, respectively. There was no any sample which was concordantly false positive in Uni-Gold™, Determine and SD Bioline assays. Conclusion An alternative confirmatory HIV testing strategy based on initial testing on either SD Bioline or Determine assays followed by testing of reactive samples on the Determine or SD Bioline gave 100% sensitivity (95% CI; 99.1–100) and 100% specificity (95% CI; 96–99.1) with Uni-Gold™ as tiebreaker for discordant results. PMID:19226452

Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithms in Dar es Salaam, Tanzania.

PubMed

Lyamuya, Eligius F; Aboud, Said; Urassa, Willy K; Sufi, Jaffer; Mbwana, Judica; Ndugulile, Faustin; Massambu, Charles

2009-02-18

Suitable algorithms based on a combination of two or more simple rapid HIV assays have been shown to have a diagnostic accuracy comparable to double enzyme-linked immunosorbent assay (ELISA) or double ELISA with Western Blot strategies. The aims of this study were to evaluate the performance of five simple rapid HIV assays using whole blood samples from HIV-infected patients, pregnant women, voluntary counseling and testing attendees and blood donors, and to formulate an alternative confirmatory strategy based on rapid HIV testing algorithms suitable for use in Tanzania. Five rapid HIV assays: Determine HIV-1/2 (Inverness Medical), SD Bioline HIV 1/2 3.0 (Standard Diagnostics Inc.), First Response HIV Card 1-2.0 (PMC Medical India Pvt Ltd), HIV1/2 Stat-Pak Dipstick (Chembio Diagnostic System, Inc) and Uni-Gold HIV-1/2 (Trinity Biotech) were evaluated between June and September 2006 using 1433 whole blood samples from hospital patients, pregnant women, voluntary counseling and testing attendees and blood donors. All samples that were reactive on all or any of the five rapid assays and 10% of non-reactive samples were tested on a confirmatory Inno-Lia HIV I/II immunoblot assay (Immunogenetics). Three hundred and ninety samples were confirmed HIV-1 antibody positive, while 1043 were HIV negative. The sensitivity at initial testing of Determine, SD Bioline and Uni-Gold was 100% (95% CI; 99.1-100) while First Response and Stat-Pak had sensitivity of 99.5% (95% CI; 98.2-99.9) and 97.7% (95% CI; 95.7-98.9), respectively, which increased to 100% (95% CI; 99.1-100) on repeat testing. The initial specificity of the Uni-Gold assay was 100% (95% CI; 99.6-100) while specificities were 99.6% (95% CI; 99-99.9), 99.4% (95% CI; 98.8-99.7), 99.6% (95% CI; 99-99.9) and 99.8% (95% CI; 99.3-99.9) for Determine, SD Bioline, First Response and Stat-Pak assays, respectively. There was no any sample which was concordantly false positive in Uni-Gold, Determine and SD Bioline assays. An alternative confirmatory HIV testing strategy based on initial testing on either SD Bioline or Determine assays followed by testing of reactive samples on the Determine or SD Bioline gave 100% sensitivity (95% CI; 99.1-100) and 100% specificity (95% CI; 96-99.1) with Uni-Gold as tiebreaker for discordant results.

Sensitivity of influenza rapid diagnostic tests to H5N1 and 2009 pandemic H1N1 viruses.

PubMed

Sakai-Tagawa, Yuko; Ozawa, Makoto; Tamura, Daisuke; Le, Mai thi Quynh; Nidom, Chairul A; Sugaya, Norio; Kawaoka, Yoshihiro

2010-08-01

Simple and rapid diagnosis of influenza is useful for making treatment decisions in the clinical setting. Although many influenza rapid diagnostic tests (IRDTs) are available for the detection of seasonal influenza virus infections, their sensitivity for other viruses, such as H5N1 viruses and the recently emerged swine origin pandemic (H1N1) 2009 virus, remains largely unknown. Here, we examined the sensitivity of 20 IRDTs to various influenza virus strains, including H5N1 and 2009 pandemic H1N1 viruses. Our results indicate that the detection sensitivity to swine origin H1N1 viruses varies widely among IRDTs, with some tests lacking sufficient sensitivity to detect the early stages of infection when the virus load is low.

IOTA simple rules in differentiating between benign and malignant ovarian tumors.

PubMed

Tantipalakorn, Charuwan; Wanapirak, Chanane; Khunamornpong, Surapan; Sukpan, Kornkanok; Tongsong, Theera

2014-01-01

To evaluate the diagnostic performance of IOTA simple rules in differentiating between benign and malignant ovarian tumors. A study of diagnostic performance was conducted on women scheduled for elective surgery due to ovarian masses between March 2007 and March 2012. All patients underwent ultrasound examination for IOTA simple rules within 24 hours of surgery. All examinations were performed by the authors, who had no any clinical information of the patients, to differentiate between benign and malignant adnexal masses using IOTA simple rules. Gold standard diagnosis was based on pathological or operative findings. A total of 398 adnexal masses, in 376 women, were available for analysis. Of them, the IOTA simple rules could be applied in 319 (80.1%) including 212 (66.5%) benign tumors and 107 (33.6%) malignant tumors. The simple rules yielded inconclusive results in 79 (19.9%) masses. In the 319 masses for which the IOTA simple rules could be applied, sensitivity was 82.9% and specificity 95.3%. The IOTA simple rules have high diagnostic performance in differentiating between benign and malignant adnexal masses. Nevertheless, inconclusive results are relatively common.

Enhancing Pre-Service Elementary Teachers' Conceptual Understanding of Solution Chemistry with Conceptual Change Text

ERIC Educational Resources Information Center

Calik, Muammer; Ayas, Alipasa; Coll, Richard Kevin

2007-01-01

This paper reports on the use of a constructivist-based pedagogy to enhance understanding of some features of solution chemistry. Pre-service science teacher trainees' prior knowledge about the dissolution of salts and sugar in water were elicited by the use of a simple diagnostic tool. The test revealed widespread alternative conceptions. These…

Transtracheal aspiration in the diagnosis of pulmonary blastomycosis (17 cases: 2000–2005)

PubMed Central

McMillan, Chantal J.; Taylor, Susan M.

2008-01-01

Blastomyces dermatitidis is a common etiologic agent of fungal pneumonia in dogs. Definitive diagnosis is based on cytologic demonstration of the organism in affected tissues. Fluid obtained through transtracheal aspiration has previously been reported to have a low diagnostic yield for B. dermatitidis organisms. This retrospective study identified B. dermatitidis organisms in 76% of samples when transtracheal aspiration was performed in 17 nonsedated dogs with pulmonary blastomycosis. Transtracheal aspiration is a noninvasive and simple procedure that should be considered as an early diagnostic test whenever blastomycosis is a differential diagnosis in dogs with pulmonary disease. PMID:18320978

SMS messages increase adherence to rapid diagnostic test results among malaria patients: results from a pilot study in Nigeria.

PubMed

Modrek, Sepideh; Schatzkin, Eric; De La Cruz, Anna; Isiguzo, Chinwoke; Nwokolo, Ernest; Anyanti, Jennifer; Ujuju, Chinazo; Montagu, Dominic; Liu, Jenny

2014-02-25

The World Health Organization now recommends parasitological confirmation for malaria case management. Rapid diagnostic tests (RDTs) for malaria are an accurate and simple diagnostic to confirm parasite presence in blood. However, where they have been deployed, adherence to RDT results has been poor, especially when the test result is negative. Few studies have examined adherence to RDTs distributed or purchased through the private sector. The Rapid Examination of Malaria and Evaluation of Diagnostic Information (REMEDI) study assessed the acceptability of and adherence to RDT results for patients seeking care from private sector drug retailers in two cities in Oyo State in south-west Nigeria. In total, 465 adult participants were enrolled upon exit from a participating drug shop having purchased anti-malaria drugs for themselves. Participants were given a free RDT and the appropriate treatment advice based on their RDT result. Short Message Service (SMS) text messages reiterating the treatment advice were sent to a randomly selected half of the participants one day after being tested. Participants were contacted via phone four days after the RDT was conducted to assess adherence to the RDT information and treatment advice. Adherence to RDT results was 14.3 percentage points (P-val <0.001) higher in the treatment group who were sent the SMS. The higher adherence in the treatment group was robust to several specification tests and the estimated difference in adherence ranged from 9.7 to 16.1 percentage points. Further, the higher adherence to the treatment advice was specific to the treatment advice for anti-malarial drugs and not other drugs purchased to treat malaria symptoms in the RDT-negative participants who bought both anti-malarial and symptom drugs. There was no difference in adherence for the RDT-positive participants who were sent the SMS. SMS text messages substantially increased adherence to RDT results for patients seeking care for malaria from privately owned drug retailers in Nigeria and may be a simple and cost-effective means for boosting adherence to RDT results if and when RDTs are introduced as a commercial retail product.

Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance.

PubMed

Rennie, Waverly; Phetsouvanh, Rattanaxay; Lupisan, Socorro; Vanisaveth, Viengsay; Hongvanthong, Bouasy; Phompida, Samlane; Alday, Portia; Fulache, Mila; Lumagui, Richard; Jorgensen, Pernille; Bell, David; Harvey, Steven

2007-01-01

The usefulness of rapid diagnostic tests (RDT) in malaria case management depends on the accuracy of the diagnoses they provide. Despite their apparent simplicity, previous studies indicate that RDT accuracy is highly user-dependent. As malaria RDTs will frequently be used in remote areas with little supervision or support, minimising mistakes is crucial. This paper describes the development of new instructions (job aids) to improve health worker performance, based on observations of common errors made by remote health workers and villagers in preparing and interpreting RDTs, in the Philippines and Laos. Initial preparation using the instructions provided by the manufacturer was poor, but improved significantly with the job aids (e.g. correct use both of the dipstick and cassette increased in the Philippines by 17%). However, mistakes in preparation remained commonplace, especially for dipstick RDTs, as did mistakes in interpretation of results. A short orientation on correct use and interpretation further improved accuracy, from 70% to 80%. The results indicate that apparently simple diagnostic tests can be poorly performed and interpreted, but provision of clear, simple instructions can reduce these errors. Preparation of appropriate instructions and training as well as monitoring of user behaviour are an essential part of rapid test implementation.

Current and future molecular diagnostics in colorectal cancer and colorectal adenoma.

PubMed

Tsang, Andy Hin-Fung; Cheng, Ka-Ho; Wong, Apple Siu-Ping; Ng, Simon Siu-Man; Ma, Brigette Buig-Yue; Chan, Charles Ming-Lok; Tsui, Nancy Bo-Yin; Chan, Lawrence Wing-Chi; Yung, Benjamin Yat-Ming; Wong, Sze-Chuen Cesar

2014-04-14

Colorectal cancer (CRC) is one of the most prevalent cancers in developed countries. On the other hand, CRC is also one of the most curable cancers if it is detected in early stages through regular colonoscopy or sigmoidoscopy. Since CRC develops slowly from precancerous lesions, early detection can reduce both the incidence and mortality of the disease. Fecal occult blood test is a widely used non-invasive screening tool for CRC. Although fecal occult blood test is simple and cost-effective in screening CRC, there is room for improvement in terms of the accuracy of the test. Genetic dysregulations have been found to play an important role in CRC development. With better understanding of the molecular basis of CRC, there is a growing expectation on the development of diagnostic tests based on more sensitive and specific molecular markers and those tests may provide a breakthrough to the limitations of current screening tests for CRC. In this review, the molecular basis of CRC development, the characteristics and applications of different non-invasive molecular biomarkers, as well as the technologies available for the detection were discussed. This review intended to provide a summary on the current and future molecular diagnostics in CRC and its pre-malignant state, colorectal adenoma.

Current and future molecular diagnostics in colorectal cancer and colorectal adenoma

PubMed Central

Tsang, Andy Hin-Fung; Cheng, Ka-Ho; Wong, Apple Siu-Ping; Ng, Simon Siu-Man; Ma, Brigette Buig-Yue; Chan, Charles Ming-Lok; Tsui, Nancy Bo-Yin; Chan, Lawrence Wing-Chi; Yung, Benjamin Yat-Ming; Wong, Sze-Chuen Cesar

2014-01-01

Colorectal cancer (CRC) is one of the most prevalent cancers in developed countries. On the other hand, CRC is also one of the most curable cancers if it is detected in early stages through regular colonoscopy or sigmoidoscopy. Since CRC develops slowly from precancerous lesions, early detection can reduce both the incidence and mortality of the disease. Fecal occult blood test is a widely used non-invasive screening tool for CRC. Although fecal occult blood test is simple and cost-effective in screening CRC, there is room for improvement in terms of the accuracy of the test. Genetic dysregulations have been found to play an important role in CRC development. With better understanding of the molecular basis of CRC, there is a growing expectation on the development of diagnostic tests based on more sensitive and specific molecular markers and those tests may provide a breakthrough to the limitations of current screening tests for CRC. In this review, the molecular basis of CRC development, the characteristics and applications of different non-invasive molecular biomarkers, as well as the technologies available for the detection were discussed. This review intended to provide a summary on the current and future molecular diagnostics in CRC and its pre-malignant state, colorectal adenoma. PMID:24744577

The Zombie Plot: A Simple Graphic Method for Visualizing the Efficacy of a Diagnostic Test.

PubMed

Richardson, Michael L

2016-08-09

One of the most important jobs of a radiologist is to pick the most appropriate imaging test for a particular clinical situation. Making a proper selection sometimes requires statistical analysis. The objective of this article is to introduce a simple graphic technique, an ROC plot that has been divided into zones of mostly bad imaging efficacy (ZOMBIE, hereafter referred to as the "zombie plot"), that transforms information about imaging efficacy from the numeric domain into the visual domain. The numeric rationale for the use of zombie plots is given, as are several examples of the clinical use of these plots. Two online calculators are described that simplify the process of producing a zombie plot.

Diagnostic performance characteristics of a rapid field test for anthrax in cattle.

PubMed

Muller, Janine; Gwozdz, Jacek; Hodgeman, Rachel; Ainsworth, Catherine; Kluver, Patrick; Czarnecki, Jill; Warner, Simone; Fegan, Mark

2015-07-01

Although diagnosis of anthrax can be made in the field with a peripheral blood smear, and in the laboratory with bacterial culture or molecular based tests, these tests require either considerable experience or specialised equipment. Here we report on the evaluation of the diagnostic sensitivity and specificity of a simple and rapid in-field diagnostic test for anthrax, the anthrax immunochromatographic test (AICT). The AICT detects the protective antigen (PA) component of the anthrax toxin present within the blood of an animal that has died from anthrax. The test provides a result in 15min and offers the advantage of avoiding the necessity for on-site necropsy and subsequent occupational risks and environmental contamination. The specificity of the test was determined by testing samples taken from 622 animals, not infected with Bacillus anthracis. Diagnostic sensitivity was estimated on samples taken from 58 animals, naturally infected with B. anthracis collected over a 10-year period. All samples used to estimate the diagnostic sensitivity and specificity of the AICT were also tested using the gold standard of bacterial culture. The diagnostic specificity of the test was estimated to be 100% (99.4-100%; 95% CI) and the diagnostic sensitivity was estimated to be 93.1% (83.3-98.1%; 95% CI) (Clopper-Pearson method). Four samples produced false negative AICT results. These were among 9 samples, all of which tested positive for B. anthracis by culture, where there was a time delay between collection and testing of >48h and/or the samples were collected from animals that were >48h post-mortem. A statistically significant difference (P<0.001; Fishers exact test) was found between the ability of the AICT to detect PA in samples from culture positive animals <48h post-mortem, 49 of 49, Se=100% (92.8-100%; 95% CI) compared with samples tested >48h post-mortem 5 of 9 Se=56% (21-86.3%; 95% CI) (Clopper-Pearson method). Based upon these results a post hoc cut-off for use of the AICT of 48h post-mortem was applied, Se=100% (92.8-100%; 95% CI) and Sp=100% (99.4-100%; 95% CI). The high diagnostic sensitivity and specificity and the simplicity of the AICT enables it to be used for active surveillance in areas with a history of anthrax, or used as a preliminary tool in investigating sudden, unexplained death in cattle. Copyright © 2015 Elsevier B.V. All rights reserved.

Improving validation methods for molecular diagnostics: application of Bland-Altman, Deming and simple linear regression analyses in assay comparison and evaluation for next-generation sequencing

PubMed Central

Misyura, Maksym; Sukhai, Mahadeo A; Kulasignam, Vathany; Zhang, Tong; Kamel-Reid, Suzanne; Stockley, Tracy L

2018-01-01

Aims A standard approach in test evaluation is to compare results of the assay in validation to results from previously validated methods. For quantitative molecular diagnostic assays, comparison of test values is often performed using simple linear regression and the coefficient of determination (R2), using R2 as the primary metric of assay agreement. However, the use of R2 alone does not adequately quantify constant or proportional errors required for optimal test evaluation. More extensive statistical approaches, such as Bland-Altman and expanded interpretation of linear regression methods, can be used to more thoroughly compare data from quantitative molecular assays. Methods We present the application of Bland-Altman and linear regression statistical methods to evaluate quantitative outputs from next-generation sequencing assays (NGS). NGS-derived data sets from assay validation experiments were used to demonstrate the utility of the statistical methods. Results Both Bland-Altman and linear regression were able to detect the presence and magnitude of constant and proportional error in quantitative values of NGS data. Deming linear regression was used in the context of assay comparison studies, while simple linear regression was used to analyse serial dilution data. Bland-Altman statistical approach was also adapted to quantify assay accuracy, including constant and proportional errors, and precision where theoretical and empirical values were known. Conclusions The complementary application of the statistical methods described in this manuscript enables more extensive evaluation of performance characteristics of quantitative molecular assays, prior to implementation in the clinical molecular laboratory. PMID:28747393

Are the classic diagnostic methods in mycology still state of the art?

PubMed

Wiegand, Cornelia; Bauer, Andrea; Brasch, Jochen; Nenoff, Pietro; Schaller, Martin; Mayser, Peter; Hipler, Uta-Christina; Elsner, Peter

2016-05-01

The diagnostic workup of cutaneous fungal infections is traditionally based on microscopic KOH preparations as well as culturing of the causative organism from sample material. Another possible option is the detection of fungal elements by dermatohistology. If performed correctly, these methods are generally suitable for the diagnosis of mycoses. However, the advent of personalized medicine and the tasks arising therefrom require new procedures marked by simplicity, specificity, and swiftness. The additional use of DNA-based molecular techniques further enhances sensitivity and diagnostic specificity, and reduces the diagnostic interval to 24-48 hours, compared to weeks required for conventional mycological methods. Given the steady evolution in the field of personalized medicine, simple analytical PCR-based systems are conceivable, which allow for instant diagnosis of dermatophytes in the dermatology office (point-of-care tests). © 2016 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

Vesical schistosomiasis with terminal hematuria in sub-Saharan patients.

PubMed

Pereira, J; Calleja, E; Marne, C; Borque, A

2014-03-01

To know the characteristics of vesical schistosomiasis caused by schistosoma hematobium in immigrant patients. The retrospective study of 41 cases microbiologically diagnosed in our hospital over the last 16 years is presented. Data was collected on origin, age, presentation form, diagnostic tests and treatment. All were African patients whose ages ranged from 4 to 32 years and who had terminal macroscopic hematuria. Most of the patients (85%) were men. In all of the cases, diagnosis was by a urinary microbiological study and in one case, cystoscopy with a biopsy of a typical vesical lesion. Terminal hematuria is the most representative clinical sign. They were treated with praziquantel. The epidemiology and intermittent terminal hematuria in African patients should lead to the suspicion of vesical schistosomiasis as the first diagnostic option. Urinary microbiological study is a rapid, non-invasive, test with high diagnostic yield that would avoid performing invasive studies. Its simple treatment assures high level of compliance and consequent efficacy. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

Equipment-free nucleic acid extraction and amplification on a simple paper disc for point-of-care diagnosis of rotavirus A.

PubMed

Ye, Xin; Xu, Jin; Lu, Lijuan; Li, Xinxin; Fang, Xueen; Kong, Jilie

2018-08-14

The use of paper-based methods for clinical diagnostics is a rapidly expanding research topic attracting a great deal of interest. Some groups have attempted to realize an integrated nucleic acid test on a single microfluidic paper chip, including extraction, amplification, and readout functions. However, these studies were not able to overcome complex modification and fabrication requirements, long turn-around times, or the need for sophisticated equipment like pumps, thermal cyclers, or centrifuges. Here, we report an extremely simple paper-based test for the point-of-care diagnosis of rotavirus A, one of the most common pathogens that causes pediatric gastroenteritis. This paper-based test could perform nucleic acid extraction within 5 min, then took 25 min to amplify the target sequence, and the result was visible to the naked eye immediately afterward or quantitative by the UV-Vis absorbance. This low-cost method does not require extra equipment and is easy to use either in a lab or at the point-of-care. The detection limit for rotavirus A was found to be 1 × 10 3 copies/mL. In addition, 100% sensitivity and specificity were achieved when testing 48 clinical stool samples. In conclusion, the present paper-based test fulfills the main requirements for a point-of-care diagnostic tool, and has the potential to be applied to disease prevention, control, and precision diagnosis. Copyright © 2018 Elsevier B.V. All rights reserved.

Tips and tricks in the dermoscopy of pigmented lesions

PubMed Central

2012-01-01

Dermoscopy is a useful, widely used tool for examining pigmented lesions, especially helpful in cases of an uncertain nature. Nevertheless, doctors may experience diagnostic difficulties while using this method. An example of this may be found in the examination of subcorneal hematoma, dark nevi with black lamella or lesions of acral volar skin. In such cases, a few diagnostic tricks have proven to be helpful in achieving diagnostic accuracy. This paper reviews various methods of performing dermoscopy, suggesting a number of simple, yet helpful tests. These include the adhesive tape test, the skin scraping test and the ink furrow test. The adhesive tape test is helpful in differentiating between dark melanocytic nevi and melanoma. Hematoma may be more easily differentiated with the use of the so-called skin scraping test. The confirmation of benign and melanocytic lesions of acral volar skin, on the other hand, is more accurate when using the ink furrow test. These methods have been discussed here based upon a series of literature reviews, the authors’ own experience and, also, iconography. The present article describes novel methods used in dermoscopy, helping to bring about a faster, more accurate diagnostics of those lesions which have proven to be more difficult to recognize. Helpful tricks, such as have been known to professional literature, as well as the authors’ own experience (for instance, applying urea cream to hyperkeratotic lesions or using photographs of skin lesions taken with the aid of a mobile phone camera – all prior to surgery) will surely be considered beneficial to the practitioner, be it dermatologist or any other physician. PMID:22916721

A Simple, Inexpensive Device for Nucleic Acid Amplification without Electricity—Toward Instrument-Free Molecular Diagnostics in Low-Resource Settings

PubMed Central

LaBarre, Paul; Hawkins, Kenneth R.; Gerlach, Jay; Wilmoth, Jared; Beddoe, Andrew; Singleton, Jered; Boyle, David; Weigl, Bernhard

2011-01-01

Background Molecular assays targeted to nucleic acid (NA) markers are becoming increasingly important to medical diagnostics. However, these are typically confined to wealthy, developed countries; or, to the national reference laboratories of developing-world countries. There are many infectious diseases that are endemic in low-resource settings (LRS) where the lack of simple, instrument-free, NA diagnostic tests is a critical barrier to timely treatment. One of the primary barriers to the practicality and availability of NA assays in LRS has been the complexity and power requirements of polymerase chain reaction (PCR) instrumentation (another is sample preparation). Methodology/Principal Findings In this article, we investigate the hypothesis that an electricity-free heater based on exothermic chemical reactions and engineered phase change materials can successfully incubate isothermal NA amplification assays. We assess the heater's equivalence to commercially available PCR instruments through the characterization of the temperature profiles produced, and a minimal method comparison. Versions of the prototype for several different isothermal techniques are presented. Conclusions/Significance We demonstrate that an electricity-free heater based on exothermic chemical reactions and engineered phase change materials can successfully incubate isothermal NA amplification assays, and that the results of those assays are not significantly different from ones incubated in parallel in commercially available PCR instruments. These results clearly suggest the potential of the non-instrumented nucleic acid amplification (NINA) heater for molecular diagnostics in LRS. When combined with other innovations in development that eliminate power requirements for sample preparation, cold reagent storage, and readout, the NINA heater will comprise part of a kit that should enable electricity-free NA testing for many important analytes. PMID:21573065

Development of Simple Designs of Multitip Probe Diagnostic Systems for RF Plasma Characterization

PubMed Central

Naz, M. Y.; Shukrullah, S.; Ghaffar, A.; Rehman, N. U.

2014-01-01

Multitip probes are very useful diagnostics for analyzing and controlling the physical phenomena occurring in low temperature discharge plasmas. However, DC biased probes often fail to perform well in processing plasmas. The objective of the work was to deduce simple designs of DC biased multitip probes for parametric study of radio frequency plasmas. For this purpose, symmetric double probe, asymmetric double probe, and symmetric triple probe diagnostic systems and their driving circuits were designed and tested in an inductively coupled plasma (ICP) generated by a 13.56 MHz radio frequency (RF) source. Using I-V characteristics of these probes, electron temperature, electron number density, and ion saturation current was measured as a function of input power and filling gas pressure. An increasing trend was noticed in electron temperature and electron number density for increasing input RF power whilst a decreasing trend was evident in these parameters when measured against filling gas pressure. In addition, the electron energy probability function (EEPF) was also studied by using an asymmetric double probe. These studies confirmed the non-Maxwellian nature of the EEPF and the presence of two groups of the energetic electrons at low filling gas pressures. PMID:24683326

Assessing stakeholder perceptions of the acceptability and feasibility of national scale-up for a dual HIV/syphilis rapid diagnostic test in Malawi.

PubMed

Maddox, Brandy L Peterson; Wright, Shauntā S; Namadingo, Hazel; Bowen, Virginia B; Chipungu, Geoffrey A; Kamb, Mary L

2017-12-01

The WHO recommends pregnant women receive both HIV and syphilis testing at their first antenatal care visit, as untreated maternal infections can lead to severe, adverse pregnancy outcomes. One strategy for increasing testing for both HIV and syphilis is the use of point-of-care (rapid) diagnostic tests that are simple, proven effective and inexpensive. In Malawi, pregnant women routinely receive HIV testing, but only 10% are tested for syphilis at their first antenatal care visit. This evaluation explores stakeholder perceptions of a novel, dual HIV/syphilis rapid diagnostic test and potential barriers to national scale-up of the dual test in Malawi. During June and July 2015, we conducted 15 semistructured interviews with 25 healthcare workers, laboratorians, Ministry of Health leaders and partner agency representatives working in prevention of mother-to-child transmission in Malawi. We asked stakeholders about the importance of a dual rapid diagnostic test, concerns using and procuring the dual test and recommendations for national expansion. Stakeholders viewed the test favourably, citing the importance of a dual rapid test in preventing missed opportunities for syphilis diagnosis and treatment, improving infant outcomes and increasing syphilis testing coverage. Primary technical concerns were about the additional procedural steps needed to perform the test, the possibility that testers may not adhere to required waiting times before interpreting results and difficulty reading and interpreting test results. Stakeholders thought national scale-up would require demonstration of cost-savings, uniform coordination, revisions to testing guidelines and algorithms, training of testers and a reliable supply chain. Stakeholders largely support implementation of a dual HIV/syphilis rapid diagnostic test as a feasible alternative to current antenatal testing. Scale-up will require addressing perceived barriers; negotiating changes to existing algorithms and guidelines; and Ministry of Health approval and funding to support training of staff and procurement of supplies. © Article author(s) (or their employer(s) unless otherwise stated in the text of thearticle) 2017. All rights reserved. No commercial use is permitted unless otherwiseexpressly granted.

Prospective survey of veterinary practitioners’ primary assessment of equine colic: clinical features, diagnoses, and treatment of 120 cases of large colon impaction

PubMed Central

2014-01-01

Background Large colon impactions are a common cause of colic in the horse. There are no scientific reports on the clinical presentation, diagnostic tests and treatments used in first opinion practice for large colon impaction cases. The aim of this study was to describe the presentation, diagnostic approach and treatment at the primary assessment of horses with large colon impactions. Methods Data were collected prospectively from veterinary practitioners on the primary assessment of equine colic cases over a 12 month period. Inclusion criteria were a diagnosis of primary large colon impaction and positive findings on rectal examination. Data recorded for each case included history, signalment, clinical and diagnostic findings, treatment on primary assessment and final case outcome. Case outcomes were categorised into three groups: simple medical (resolved with single treatment), complicated medical (resolved with multiple medical treatments) and critical (required surgery, were euthanased or died). Univariable analysis using one-way ANOVA and Tukey’s post-hoc test, Kruskal Wallis with Dunn’s post-hoc test and Chi squared analysis were used to compare between different outcome categories. Results 1032 colic cases were submitted by veterinary practitioners: 120 cases met the inclusion criteria for large colon impaction. Fifty three percent of cases were categorised as simple medical, 36.6% as complicated medical, and 9.2% as critical. Most cases (42.1%) occurred during the winter. Fifty nine percent of horses had had a recent change in management, 43% of horses were not ridden, and 12.5% had a recent / current musculoskeletal injury. Mean heart rate was 43bpm (range 26-88) and most cases showed mild signs of pain (67.5%) and reduced gut sounds (76%). Heart rate was significantly increased and gut sounds significantly decreased in critical compared to simple medical cases (p<0.05). Fifty different treatment combinations were used, with NSAIDs (93%) and oral fluids (71%) being administered most often. Conclusions Large colon impactions typically presented with mild signs of colic; heart rate and gut sounds were the most useful parameters to distinguish between simple and critical cases at the primary assessment. The findings of seasonal incidence and associated management factors are consistent with other studies. Veterinary practitioners currently use a wide range of different treatment combinations for large colon impactions. PMID:25238179

Virtual Resting Pd/Pa From Coronary Angiography and Blood Flow Modelling: Diagnostic Performance Against Fractional Flow Reserve.

PubMed

Papafaklis, Michail I; Muramatsu, Takashi; Ishibashi, Yuki; Bourantas, Christos V; Fotiadis, Dimitrios I; Brilakis, Emmanouil S; Garcia-Garcia, Héctor M; Escaned, Javier; Serruys, Patrick W; Michalis, Lampros K

2018-03-01

Fractional flow reserve (FFR) has been established as a useful diagnostic tool. The distal coronary pressure to aortic pressure (Pd/Pa) ratio at rest is a simpler physiologic index but also requires the use of the pressure wire, whereas recently proposed virtual functional indices derived from coronary imaging require complex blood flow modelling and/or are time-consuming. Our aim was to test the diagnostic performance of virtual resting Pd/Pa using routine angiographic images and a simple flow model. Three-dimensional quantitative coronary angiography (3D-QCA) was performed in 139 vessels (120 patients) with intermediate lesions assessed by FFR. The resting Pd/Pa for each lesion was assessed by computational fluid dynamics. The discriminatory power of virtual resting Pd/Pa against FFR (reference: ≤0.80) was high (area under the receiver operator characteristic curve [AUC]: 90.5% [95% CI: 85.4-95.6%]). Diagnostic accuracy, sensitivity and specificity for the optimal virtual resting Pd/Pa cut-off (≤0.94) were 84.9%, 90.4% and 81.6%, respectively. Virtual resting Pd/Pa demonstrated superior performance (p<0.001) versus 3D-QCA %area stenosis (AUC: 77.5% [95% CI: 69.8-85.3%]). There was a good correlation between virtual resting Pd/Pa and FFR (r=0.69, p<0.001). Virtual resting Pd/Pa using routine angiographic data and a simple flow model provides fast functional assessment of coronary lesions without requiring the pressure-wire and hyperaemia induction. The high diagnostic performance of virtual resting Pd/Pa for predicting FFR shows promise for using this simple/fast virtual index in clinical practice. Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Behçet syndrome.

PubMed

Altiner, Ahmet; Mandal, Rajni

2010-11-15

We present a 34-year-old man with a two-year history of aphthous stomatitis, who later developed painful, erythematous nodules on his lower extremities. A pathergy test was positive, and the diagnosis of Behçet syndrome (BS) was made. It is important for the dermatologist to recognize the wide variety of cutaneous manifestations of this disorder. A pathergy test is a simple diagnostic tool that may assist in making a diagnosis. Case reports of other unusual skin manifestations in BS also are reviewed.

The population impact of screening for Down syndrome: audit of 19 326 invasive diagnostic tests in England and Wales in 2008.

PubMed

Morris, Joan K; Waters, Jonathan J; de Souza, E

2012-06-01

Pregnant women who receive a high screening risk result for Down, Edwards or Patau syndrome are offered diagnostic tests that carry a risk of miscarriage. This study determined how many women had such tests per syndrome diagnosis. The number of tests per Down, Edwards or Patau syndrome diagnosis adjusted for maternal and gestational age at diagnosis was calculated using routine data from 18 (95%) cytogenetic laboratories in England and Wales in 2008. There were 19,326 tests that identified 1118 diagnoses of Down syndrome and 615 of Edwards and Patau syndromes. There were eight chorionic villus samplings (CVS) per syndrome diagnosis compared with 16 amniocenteses (gestational age adjusted). The lowest number of tests per diagnosis (three for CVSs and for amniocentesis) resulted from an abnormal ultrasound scan. Among pregnant women, 2.9% had an invasive diagnostic test. If a CVS and an amniocentesis increase the risk of a miscarriage by 1% and 0.5%, respectively, approximately one miscarriage for every 14 Down, Edwards or Patau syndrome diagnosis would have occurred. A simple measurement of the population impact of screening for Down syndrome can be calculated using data already collected. Annual estimates should be produced to monitor the national fetal anomaly screening programme. © 2012 John Wiley & Sons, Ltd. © 2012 John Wiley & Sons, Ltd.

Digital PCR on a SlipChip.

PubMed

Shen, Feng; Du, Wenbin; Kreutz, Jason E; Fok, Alice; Ismagilov, Rustem F

2010-10-21

This paper describes a SlipChip to perform digital PCR in a very simple and inexpensive format. The fluidic path for introducing the sample combined with the PCR mixture was formed using elongated wells in the two plates of the SlipChip designed to overlap during sample loading. This fluidic path was broken up by simple slipping of the two plates that removed the overlap among wells and brought each well in contact with a reservoir preloaded with oil to generate 1280 reaction compartments (2.6 nL each) simultaneously. After thermal cycling, end-point fluorescence intensity was used to detect the presence of nucleic acid. Digital PCR on the SlipChip was tested quantitatively by using Staphylococcus aureus genomic DNA. As the concentration of the template DNA in the reaction mixture was diluted, the fraction of positive wells decreased as expected from the statistical analysis. No cross-contamination was observed during the experiments. At the extremes of the dynamic range of digital PCR the standard confidence interval determined using a normal approximation of the binomial distribution is not satisfactory. Therefore, statistical analysis based on the score method was used to establish these confidence intervals. The SlipChip provides a simple strategy to count nucleic acids by using PCR. It may find applications in research applications such as single cell analysis, prenatal diagnostics, and point-of-care diagnostics. SlipChip would become valuable for diagnostics, including applications in resource-limited areas after integration with isothermal nucleic acid amplification technologies and visual readout.

Identification of facilitators and barriers to residents' use of a clinical reasoning tool.

PubMed

DiNardo, Deborah; Tilstra, Sarah; McNeil, Melissa; Follansbee, William; Zimmer, Shanta; Farris, Coreen; Barnato, Amber E

2018-03-28

While there is some experimental evidence to support the use of cognitive forcing strategies to reduce diagnostic error in residents, the potential usability of such strategies in the clinical setting has not been explored. We sought to test the effect of a clinical reasoning tool on diagnostic accuracy and to obtain feedback on its usability and acceptability. We conducted a randomized behavioral experiment testing the effect of this tool on diagnostic accuracy on written cases among post-graduate 3 (PGY-3) residents at a single internal medical residency program in 2014. Residents completed written clinical cases in a proctored setting with and without prompts to use the tool. The tool encouraged reflection on concordant and discordant aspects of each case. We used random effects regression to assess the effect of the tool on diagnostic accuracy of the independent case sets, controlling for case complexity. We then conducted audiotaped structured focus group debriefing sessions and reviewed the tapes for facilitators and barriers to use of the tool. Of 51 eligible PGY-3 residents, 34 (67%) participated in the study. The average diagnostic accuracy increased from 52% to 60% with the tool, a difference that just met the test for statistical significance in adjusted analyses (p=0.05). Residents reported that the tool was generally acceptable and understandable but did not recognize its utility for use with simple cases, suggesting the presence of overconfidence bias. A clinical reasoning tool improved residents' diagnostic accuracy on written cases. Overconfidence bias is a potential barrier to its use in the clinical setting.

Bias in logistic regression due to imperfect diagnostic test results and practical correction approaches.

PubMed

Valle, Denis; Lima, Joanna M Tucker; Millar, Justin; Amratia, Punam; Haque, Ubydul

2015-11-04

Logistic regression is a statistical model widely used in cross-sectional and cohort studies to identify and quantify the effects of potential disease risk factors. However, the impact of imperfect tests on adjusted odds ratios (and thus on the identification of risk factors) is under-appreciated. The purpose of this article is to draw attention to the problem associated with modelling imperfect diagnostic tests, and propose simple Bayesian models to adequately address this issue. A systematic literature review was conducted to determine the proportion of malaria studies that appropriately accounted for false-negatives/false-positives in a logistic regression setting. Inference from the standard logistic regression was also compared with that from three proposed Bayesian models using simulations and malaria data from the western Brazilian Amazon. A systematic literature review suggests that malaria epidemiologists are largely unaware of the problem of using logistic regression to model imperfect diagnostic test results. Simulation results reveal that statistical inference can be substantially improved when using the proposed Bayesian models versus the standard logistic regression. Finally, analysis of original malaria data with one of the proposed Bayesian models reveals that microscopy sensitivity is strongly influenced by how long people have lived in the study region, and an important risk factor (i.e., participation in forest extractivism) is identified that would have been missed by standard logistic regression. Given the numerous diagnostic methods employed by malaria researchers and the ubiquitous use of logistic regression to model the results of these diagnostic tests, this paper provides critical guidelines to improve data analysis practice in the presence of misclassification error. Easy-to-use code that can be readily adapted to WinBUGS is provided, enabling straightforward implementation of the proposed Bayesian models.

The role of STK 11 gene testing in individuals with oral pigmentation.

PubMed

Duong, Bich-Thu; Winship, Ingrid

2017-05-01

Peutz-Jeghers syndrome (PJS) is a rare, autosomal dominant condition characterised by mucocutaneous pigmented lesions, gastrointestinal polyposis and a significant risk of cancer. Laugier-Hunziker syndrome (LHS) is a benign condition with similar dermatological features, but with no systemic complications. STK 11 gene testing allows clinicians to differentiate between these two disorders. This case report compares the dermatological similarities in four individuals with PJS or LHS and illustrates the potential benefit of genetic testing. There is > 90% likelihood of identifying a mutation in STK 11 if a patient fulfils the diagnostic criteria for PJS. Lifelong risk management is advised for these individuals with confirmed PJS. Diagnostic confirmation is important to provide rational management, in particular, endoscopic cancer surveillance, and psychological support. STK 11 testing can confirm those at risk of PJS, who require lifelong surveillance, and possibly release those with a simple dermatosis, such as LHS, from invasive and thus potentially harmful surveillance. © 2016 The Australasian College of Dermatologists.

Use of electronic data and existing screening tools to identify clinically significant obstructive sleep apnea.

PubMed

Severson, Carl A; Pendharkar, Sachin R; Ronksley, Paul E; Tsai, Willis H

2015-01-01

To assess the ability of electronic health data and existing screening tools to identify clinically significant obstructive sleep apnea (OSA), as defined by symptomatic or severe OSA. The present retrospective cohort study of 1041 patients referred for sleep diagnostic testing was undertaken at a tertiary sleep centre in Calgary, Alberta. A diagnosis of clinically significant OSA or an alternative sleep diagnosis was assigned to each patient through blinded independent chart review by two sleep physicians. Predictive variables were identified from online questionnaire data, and diagnostic algorithms were developed. The performance of electronically derived algorithms for identifying patients with clinically significant OSA was determined. Diagnostic performance of these algorithms was compared with versions of the STOP-Bang questionnaire and adjusted neck circumference score (ANC) derived from electronic data. Electronic questionnaire data were highly sensitive (>95%) at identifying clinically significant OSA, but not specific. Sleep diagnostic testing-determined respiratory disturbance index was very specific (specificity ≥95%) for clinically relevant disease, but not sensitive (<35%). Derived algorithms had similar accuracy to the STOP-Bang or ANC, but required fewer questions and calculations. These data suggest that a two-step process using a small number of clinical variables (maximizing sensitivity) and objective diagnostic testing (maximizing specificity) is required to identify clinically significant OSA. When used in an online setting, simple algorithms can identify clinically relevant OSA with similar performance to existing decision rules such as the STOP-Bang or ANC.

Screening for physical inactivity among adults: the value of distance walked in the six-minute walk test. A cross-sectional diagnostic study.

PubMed

Sperandio, Evandro Fornias; Arantes, Rodolfo Leite; da Silva, Rodrigo Pereira; Matheus, Agatha Caveda; Lauria, Vinícius Tonon; Bianchim, Mayara Silveira; Romiti, Marcello; Gagliardi, Antônio Ricardo de Toledo; Dourado, Victor Zuniga

2016-01-01

Accelerometry provides objective measurement of physical activity levels, but is unfeasible in clinical practice. Thus, we aimed to identify physical fitness tests capable of predicting physical inactivity among adults. Diagnostic test study developed at a university laboratory and a diagnostic clinic. 188 asymptomatic subjects underwent assessment of physical activity levels through accelerometry, ergospirometry on treadmill, body composition from bioelectrical impedance, isokinetic muscle function, postural balance on a force platform and six-minute walk test. We conducted descriptive analysis and multiple logistic regression including age, sex, oxygen uptake, body fat, center of pressure, quadriceps peak torque, distance covered in six-minute walk test and steps/day in the model, as predictors of physical inactivity. We also determined sensitivity (S), specificity (Sp) and area under the curve of the main predictors by means of receiver operating characteristic curves. The prevalence of physical inactivity was 14%. The mean number of steps/day (≤ 5357) was the best predictor of physical inactivity (S = 99%; Sp = 82%). The best physical fitness test was a distance in the six-minute walk test and ≤ 96% of predicted values (S = 70%; Sp = 80%). Body fat > 25% was also significant (S = 83%; Sp = 51%). After logistic regression, steps/day and distance in the six-minute walk test remained predictors of physical inactivity. The six-minute walk test should be included in epidemiological studies as a simple and cheap tool for screening for physical inactivity.

Heavy Metal Pad Shielding during Fluoroscopic Interventions

PubMed Central

Dromi, Sergio; Wood, Bradford J.; Oberoi, Jay; Neeman, Ziv

2008-01-01

Significant direct and scatter radiation doses to patient and physician may result from routine interventional radiology practice. A lead-free disposable tungsten antimony shielding pad was tested in phantom patients during simulated diagnostic angiography procedures. Although the exact risk of low doses of ionizing radiation is unknown, dramatic dose reductions can be seen with routine use of this simple, sterile pad made from lightweighttungsten antimony material. PMID:16868175

Improving validation methods for molecular diagnostics: application of Bland-Altman, Deming and simple linear regression analyses in assay comparison and evaluation for next-generation sequencing.

PubMed

Misyura, Maksym; Sukhai, Mahadeo A; Kulasignam, Vathany; Zhang, Tong; Kamel-Reid, Suzanne; Stockley, Tracy L

2018-02-01

A standard approach in test evaluation is to compare results of the assay in validation to results from previously validated methods. For quantitative molecular diagnostic assays, comparison of test values is often performed using simple linear regression and the coefficient of determination (R 2 ), using R 2 as the primary metric of assay agreement. However, the use of R 2 alone does not adequately quantify constant or proportional errors required for optimal test evaluation. More extensive statistical approaches, such as Bland-Altman and expanded interpretation of linear regression methods, can be used to more thoroughly compare data from quantitative molecular assays. We present the application of Bland-Altman and linear regression statistical methods to evaluate quantitative outputs from next-generation sequencing assays (NGS). NGS-derived data sets from assay validation experiments were used to demonstrate the utility of the statistical methods. Both Bland-Altman and linear regression were able to detect the presence and magnitude of constant and proportional error in quantitative values of NGS data. Deming linear regression was used in the context of assay comparison studies, while simple linear regression was used to analyse serial dilution data. Bland-Altman statistical approach was also adapted to quantify assay accuracy, including constant and proportional errors, and precision where theoretical and empirical values were known. The complementary application of the statistical methods described in this manuscript enables more extensive evaluation of performance characteristics of quantitative molecular assays, prior to implementation in the clinical molecular laboratory. © 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.

Use of Malachite Green-Loop Mediated Isothermal Amplification for Detection of Plasmodium spp. Parasites

PubMed Central

Lucchi, Naomi W.; Ljolje, Dragan; Silva-Flannery, Luciana; Udhayakumar, Venkatachalam

2016-01-01

Malaria elimination efforts are hampered by the lack of sensitive tools to detect infections with low-level parasitemia, usually below the threshold of standard diagnostic methods, microscopy and rapid diagnostic tests. Isothermal nucleic acid amplification assays such as the loop-mediated isothermal amplification (LAMP), are well suited for field use as they do not require thermal cyclers to run the test. However, the use of specialized equipment, as described by many groups, reduces the versatility of the LAMP technique as a simple tool for use in endemic countries. In this study, the use of the malachite green (MG) dye, as a visual endpoint readout, together with a simple mini heat block was evaluated for the detection of malaria parasites. The assay was performed for 1 hour at 63°C and the results scored by 3 independent human readers. The limit of detection of the assay was determined using well-quantified Plasmodium spp. infected reference samples and its utility in testing clinical samples was determined using 190 pre-treatment specimens submitted for reference diagnosis of imported malaria in the United States. Use of a simplified boil and spin methods of DNA extraction from whole blood and filter paper was also investigated. We demonstrate the accurate and sensitive detection of malaria parasites using this assay with a detection limit ranging between 1–8 parasites/μL, supporting its applicability for the detection of infections with low parasite burden. This assay is compatible with the use of a simple boil and spin sample preparation method from both whole blood and filter papers without a loss of sensitivity. The MG-LAMP assay described here has great potential to extend the reach of molecular tools to settings where they are needed. PMID:26967908

Battery operated preconcentration-assisted lateral flow assay.

PubMed

Kim, Cheonjung; Yoo, Yong Kyoung; Han, Sung Il; Lee, Junwoo; Lee, Dohwan; Lee, Kyungjae; Hwang, Kyo Seon; Lee, Kyu Hyoung; Chung, Seok; Lee, Jeong Hoon

2017-07-11

Paper-based analytical devices (e.g. lateral flow assays) are highly advantageous as portable diagnostic systems owing to their low costs and ease of use. Because of their low sensitivity and detection limits for biomolecules, these devices have several limitations in applications for real-field diagnosis. Here, we demonstrate a paper-based preconcentration enhanced lateral flow assay using a commercial β-hCG-based test. Utilizing a simple 9 V battery operation with a low power consumption of approximately 81 μW, we acquire a 25-fold preconcentration factor, demonstrating a clear sensitivity enhancement in the colorimetric lateral flow assay; consequently, clear colors are observed in a rapid kit test line, which cannot be monitored without preconcentration. This device can also facilitate a semi-quantitative platform using the saturation value and/or color intensity in both paper-based colorimetric assays and smartphone-based diagnostics.

Challenges to Laser-Based Imaging Techniques in Gas Turbine Combustor Systems for Aerospace Applications

NASA Technical Reports Server (NTRS)

Locke, Randy J.; Anderson, Robert C.; Zaller, Michelle M.; Hicks, Yolanda R.

1998-01-01

Increasingly severe constraints on emissions, noise and fuel efficiency must be met by the next generation of commercial aircraft powerplants. At NASA Lewis Research Center (LeRC) a cooperative research effort with industry is underway to design and test combustors that will meet these requirements. To accomplish these tasks, it is necessary to gain both a detailed understanding of the combustion processes and a precise knowledge of combustor and combustor sub-component performance at close to actual conditions. To that end, researchers at LeRC are engaged in a comprehensive diagnostic investigation of high pressure reacting flowfields that duplicate conditions expected within the actual engine combustors. Unique, optically accessible flame-tubes and sector rig combustors, designed especially for these tests. afford the opportunity to probe these flowfields with the most advanced, laser-based optical diagnostic techniques. However, these same techniques, tested and proven on comparatively simple bench-top gaseous flame burners, encounter numerous restrictions and challenges when applied in these facilities. These include high pressures and temperatures, large flow rates, liquid fuels, remote testing, and carbon or other material deposits on combustor windows. Results are shown that document the success and versatility of these nonintrusive optical diagnostics despite the challenges to their implementation in realistic systems.

Diagnostic accuracy of the Thessaly test, standardised clinical history and other clinical examination tests (Apley's, McMurray's and joint line tenderness) for meniscal tears in comparison with magnetic resonance imaging diagnosis.

PubMed

Blyth, Mark; Anthony, Iain; Francq, Bernard; Brooksbank, Katriona; Downie, Paul; Powell, Andrew; Jones, Bryn; MacLean, Angus; McConnachie, Alex; Norrie, John

2015-08-01

Reliable non-invasive diagnosis of meniscal tears is difficult. Magnetic resonance imaging (MRI) is often used but is expensive and incidental findings are problematic. There are a number of physical examination tests for the diagnosis of meniscal tears that are simple, cheap and non-invasive. To determine the diagnostic accuracy of the Thessaly test and to determine if the Thessaly test (alone or in combination with other physical tests) can obviate the need for further investigation by MRI or arthroscopy for patients with a suspected meniscal tear. Single-centre prospective diagnostic accuracy study. Although the study was performed in a secondary care setting, it was designed to replicate the results that would have been achieved in a primary care setting. Two cohorts of patients were recruited: patients with knee pathology (n = 292) and a control cohort with no knee pathology (n = 75). Sensitivity, specificity and diagnostic accuracy of the Thessaly test in determining the presence of meniscal tears. Participants were assessed by both a primary care clinician and a musculoskeletal clinician. Both clinicians performed the Thessaly test, McMurray's test, Apley's test, joint line tenderness test and took a standardised clinical history from the patient. The Thessaly test had a sensitivity of 0.66, a specificity of 0.39 and a diagnostic accuracy of 54% when utilised by primary care clinicians. This compared with a sensitivity of 0.62, a specificity of 0.55 and diagnostic accuracy of 59% when used by musculoskeletal clinicians. The diagnostics accuracy of the other tests when used by primary care clinicians was 54% for McMurray's test, 53% for Apley's test, 54% for the joint line tenderness test and 55% for clinical history. For primary care clinicians, age and past history of osteoarthritis were both significant predictors of MRI diagnosis of meniscal tears. For musculoskeletal clinicians age and a positive diagnosis of meniscal tears on clinical history taking were significant predictors of MRI diagnosis. No physical tests were significant predictors of MRI diagnosis in our multivariate models. The specificity of MRI diagnosis was tested in subgroup of patients who went on to have a knee arthroscopy and was found to be low [0.53 (95% confidence interval 0.28 to 0.77)], although the sensitivity was 1.0. The Thessaly test was no better at diagnosing meniscal tears than other established physical tests. The sensitivity, specificity and diagnostic accuracy of all physical tests was too low to be of routine clinical value as an alternative to MRI. Caution needs to be exercised in the indiscriminate use of MRI scanning in the identification of meniscal tears in the diagnosis of the painful knee, due to the low specificity seen in the presence of concomitant knee pathology. Further research is required to determine the true diagnostic accuracy and cost-effectiveness of MRI for the detection of meniscal tears. Current Controlled Trial ISRCTN43527822. The National Institute for Health Research Health Technology Assessment programme.

Validity of the Hum Test, a Simple and Reliable Alternative to the Weber Test.

PubMed

Ahmed, Omar H; Gallant, Sara C; Ruiz, Ryan; Wang, Binhuan; Shapiro, William H; Voigt, Erich P

2018-06-01

To compare the diagnostic performance of the Hum Test against the Weber Test using pure tone audiometry (PTA) as the "gold standard" comparator. 29 participants with normal hearing of ages 18 to 35 without any history of hearing abnormalities or otologic conditions were enrolled. Subjects underwent three tests (Hum Test, Weber Test, and PTA) across two conditions: with an ear plug in one ear (side randomized) and without ear plugs. When examining the ability of the Hum Test to detect simulated conductive hearing loss (CHL), the test had a sensitivity of 89.7% and specificity of 100% with high pitched humming and 93.1% and 100%, respectively, with low pitched humming. The Weber Test had a sensitivity and specificity of 96.6% and 100%, respectively. McNemar's test demonstrated agreement between the Hum Test, performed with either high pitched ( P = .32) or low pitched ( P = .56) humming, and the Weber Test. Receiver operating characteristic (ROC) curves for the Hum Test (both high and low pitched) and Weber test were compared and demonstrated no statistically significant difference. The Hum Test is comparable to the Weber Test with regards to its sensitivity, specificity, and diagnostic accuracy in assessing new onset unilateral CHL in previously normal hearing subjects.

Persistent digestive disorders in the tropics: causative infectious pathogens and reference diagnostic tests

PubMed Central

2013-01-01

Background Persistent digestive disorders account for considerable disease burden in the tropics. Despite advances in understanding acute gastrointestinal infections, important issues concerning epidemiology, diagnosis, treatment and control of most persistent digestive symptomatologies remain to be elucidated. Helminths and intestinal protozoa are considered to play major roles, but the full extent of the aetiologic spectrum is still unclear. We provide an overview of pathogens causing digestive disorders in the tropics and evaluate available reference tests. Methods We searched the literature to identify pathogens that might give rise to persistent diarrhoea, chronic abdominal pain and/or blood in the stool. We reviewed existing laboratory diagnostic methods for each pathogen and stratified them by (i) microscopy; (ii) culture techniques; (iii) immunological tests; and (iv) molecular methods. Pathogen-specific reference tests providing highest diagnostic accuracy are described in greater detail. Results Over 30 pathogens may cause persistent digestive disorders. Bacteria, viruses and parasites are important aetiologic agents of acute and long-lasting symptomatologies. An integrated approach, consisting of stool culture, microscopy and/or specific immunological techniques for toxin, antigen and antibody detection, is required for accurate diagnosis of bacteria and parasites. Molecular techniques are essential for sensitive diagnosis of many viruses, bacteria and intestinal protozoa, and are increasingly utilised as adjuncts for helminth identification. Conclusions Diagnosis of the broad spectrum of intestinal pathogens is often cumbersome. There is a need for rapid diagnostic tests that are simple and affordable for resource-constrained settings, so that the management of patients suffering from persistent digestive disorders can be improved. PMID:23347408

Dilution testing using rapid diagnostic tests in a HIV diagnostic algorithm: a novel alternative for confirmation testing in resource limited settings.

PubMed

Shanks, Leslie; Siddiqui, M Ruby; Abebe, Almaz; Piriou, Erwan; Pearce, Neil; Ariti, Cono; Masiga, Johnson; Muluneh, Libsework; Wazome, Joseph; Ritmeijer, Koert; Klarkowski, Derryck

2015-05-14

Current WHO testing guidelines for resource limited settings diagnose HIV on the basis of screening tests without a confirmation test due to cost constraints. This leads to a potential risk of false positive HIV diagnosis. In this paper, we evaluate the dilution test, a novel method for confirmation testing, which is simple, rapid, and low cost. The principle of the dilution test is to alter the sensitivity of a rapid diagnostic test (RDT) by dilution of the sample, in order to screen out the cross reacting antibodies responsible for falsely positive RDT results. Participants were recruited from two testing centres in Ethiopia where a tiebreaker algorithm using 3 different RDTs in series is used to diagnose HIV. All samples positive on the initial screening RDT and every 10th negative sample underwent testing with the gold standard and dilution test. Dilution testing was performed using Determine™ rapid diagnostic test at 6 different dilutions. Results were compared to the gold standard of Western Blot; where Western Blot was indeterminate, PCR testing determined the final result. 2895 samples were recruited to the study. 247 were positive for a prevalence of 8.5 % (247/2895). A total of 495 samples underwent dilution testing. The RDT diagnostic algorithm misclassified 18 samples as positive. Dilution at the level of 1/160 was able to correctly identify all these 18 false positives, but at a cost of a single false negative result (sensitivity 99.6 %, 95 % CI 97.8-100; specificity 100 %, 95 % CI: 98.5-100). Concordance between the gold standard and the 1/160 dilution strength was 99.8 %. This study provides proof of concept for a new, low cost method of confirming HIV diagnosis in resource-limited settings. It has potential for use as a supplementary test in a confirmatory algorithm, whereby double positive RDT results undergo dilution testing, with positive results confirming HIV infection. Negative results require nucleic acid testing to rule out false negative results due to seroconversion or misclassification by the lower sensitivity dilution test. Further research is needed to determine if these results can be replicated in other settings. ClinicalTrials.gov, NCT01716299 .

"Chair Stand Test" as Simple Tool for Sarcopenia Screening in Elderly Women.

PubMed

Pinheiro, P A; Carneiro, J A O; Coqueiro, R S; Pereira, R; Fernandes, M H

2016-01-01

To investigate the association between sarcopenia and "chair stand test" performance, and evaluate this test as a screening tool for sarcopenia in community-dwelling elderly women. Cross-sectional Survey. 173 female individuals, aged ≥ 60 years and living in the urban area of the municipality of Lafaiete Coutinho, Bahia's inland, Brazil. The association between sarcopenia (defined by muscle mass, strength and/or performance loss) and performance in the "chair stand test" was tested by binary logistic regression technique. The ROC curve parameters were used to evaluate the diagnostic power of the test in sarcopenia screening. The significance level was set at 5 %. The model showed that the time spent for the "chair stand test" was positively associated (OR = 1.08; 95% CI = 1.01 - 1.16, p = 0.024) to sarcopenia, indicating that, for each 1 second increment in the test performance, the sarcopenia's probability increased by 8% in elderly women. The cut-off point that showed the best balance between sensitivity and specificity was 13 seconds. The performance of "chair stand test" showed predictive ability for sarcopenia, being an effective and simple screening tool for sarcopenia in elderly women. This test could be used for screening sarcopenic elderly women, allowing early interventions.

Solar thermal polymerase chain reaction for smartphone-assisted molecular diagnostics.

PubMed

Jiang, Li; Mancuso, Matthew; Lu, Zhengda; Akar, Gunkut; Cesarman, Ethel; Erickson, David

2014-02-20

Nucleic acid-based diagnostic techniques such as polymerase chain reaction (PCR) are used extensively in medical diagnostics due to their high sensitivity, specificity and quantification capability. In settings with limited infrastructure and unreliable electricity, however, access to such devices is often limited due to the highly specialized and energy-intensive nature of the thermal cycling process required for nucleic acid amplification. Here we integrate solar heating with microfluidics to eliminate thermal cycling power requirements as well as create a simple device infrastructure for PCR. Tests are completed in less than 30 min, and power consumption is reduced to 80 mW, enabling a standard 5.5 Wh iPhone battery to provide 70 h of power to this system. Additionally, we demonstrate a complete sample-to-answer diagnostic strategy by analyzing human skin biopsies infected with Kaposi's Sarcoma herpesvirus (KSHV/HHV-8) through the combination of solar thermal PCR, HotSHOT DNA extraction and smartphone-based fluorescence detection. We believe that exploiting the ubiquity of solar thermal energy as demonstrated here could facilitate broad availability of nucleic acid-based diagnostics in resource-limited areas.

Solar thermal polymerase chain reaction for smartphone-assisted molecular diagnostics

NASA Astrophysics Data System (ADS)

Jiang, Li; Mancuso, Matthew; Lu, Zhengda; Akar, Gunkut; Cesarman, Ethel; Erickson, David

2014-02-01

Nucleic acid-based diagnostic techniques such as polymerase chain reaction (PCR) are used extensively in medical diagnostics due to their high sensitivity, specificity and quantification capability. In settings with limited infrastructure and unreliable electricity, however, access to such devices is often limited due to the highly specialized and energy-intensive nature of the thermal cycling process required for nucleic acid amplification. Here we integrate solar heating with microfluidics to eliminate thermal cycling power requirements as well as create a simple device infrastructure for PCR. Tests are completed in less than 30 min, and power consumption is reduced to 80 mW, enabling a standard 5.5 Wh iPhone battery to provide 70 h of power to this system. Additionally, we demonstrate a complete sample-to-answer diagnostic strategy by analyzing human skin biopsies infected with Kaposi's Sarcoma herpesvirus (KSHV/HHV-8) through the combination of solar thermal PCR, HotSHOT DNA extraction and smartphone-based fluorescence detection. We believe that exploiting the ubiquity of solar thermal energy as demonstrated here could facilitate broad availability of nucleic acid-based diagnostics in resource-limited areas.

An Integrated Quantum Dot Barcode Smartphone Optical Device for Wireless Multiplexed Diagnosis of Infected Patients

NASA Astrophysics Data System (ADS)

Ming, Kevin

Integrating mobile-cellular devices with multiplex molecular diagnostics can potentially provide the most powerful platform for tracking, managing and preventing the transmission of infectious diseases. With over 6.9 billion subscriptions globally, handheld mobile-cellular devices can be programmed to spatially map, temporally track, and transmit information on infections over wide geographical space and boundaries. Current cell phone diagnostic technologies have poor limit of detection, dynamic range, and cannot detect multiple pathogen targets simultaneously, limiting their utility to single infections with high load. Here we combined recent advances in quantum dot barcode technology for molecular detection with smartphones to engineer a simple and low-cost chip-based wireless multiplex diagnostic device. We validated our device using a variety of synthetic genomic targets for the respiratory virus and blood-borne pathogens, and demonstrated that it could detect clinical samples after simple amplification. More importantly, we confirmed that the device is capable of detecting patients infected with a single or multiple infectious pathogens (e.g., HIV and hepatitis B) in a single test. This device advances the capacity for global surveillance of infectious diseases and has the potential to accelerate knowledge exchange-transfer of emerging or exigent disease threats with healthcare and military organizations in real-time.

Moving toward rapid and low-cost point-of-care molecular diagnostics with a repurposed 3D printer and RPA.

PubMed

Chan, Kamfai; Wong, Pui-Yan; Parikh, Chaitanya; Wong, Season

2018-03-15

Traditionally, the majority of nucleic acid amplification-based molecular diagnostic tests are done in centralized settings. In recent years, point-of-care tests have been developed for use in low-resource settings away from central laboratories. While most experts agree that point-of-care molecular tests are greatly needed, their availability as cost-effective and easy-to-operate tests remains an unmet goal. In this article, we discuss our efforts to develop a recombinase polymerase amplification reaction-based test that will meet these criteria. First, we describe our efforts in repurposing a low-cost 3D printer as a platform that can carry out medium-throughput, rapid, and high-performing nucleic acid extraction. Next, we address how these purified templates can be rapidly amplified and analyzed using the 3D printer's heated bed or the deconstructed, low-cost thermal cycler we have developed. In both approaches, real-time isothermal amplification and detection of template DNA or RNA can be accomplished using a low-cost portable detector or smartphone camera. Last, we demonstrate the capability of our technologies using foodborne pathogens and the Zika virus. Our low-cost approach does not employ complicated and high-cost components, making it suitable for resource-limited settings. When integrated and commercialized, it will offer simple sample-to-answer molecular diagnostics. Copyright © 2018 Elsevier Inc. All rights reserved.

Urinary free cortisol in the diagnosis of Cushing's syndrome: how useful?

PubMed

Odeniyi, I A; Ifedayo, A O; Fasanmade, O A; Olufemi, A F

2013-01-01

Cushing's syndrome results from chronic exposure to excessive circulating levels of glucocorticoids. To confirm the clinical suspicion, biochemical tests are needed. These biochemical tests include the measurement of excess total endogenous cortisol secretion assessed by 24-hour urinary free cortisol (UFC), loss of the normal feedback of the hypothalamo-pituitary-adrenal axis assessed by suppressibility after dexamethasone testing, and disturbance of the normal circadian rhythm of cortisol secretion assessed by midnight serum or salivary cortisol. We searched the Medline, Pubmed, journal articles, WHO publications and reputable textbooks relating to Cushing's syndrome using publications from 1995 to 2011. UFC has been the classic screening test used to confirm hypercortisolemia as the first step in diagnostic work-up of Cushing's syndrome. Its long-term use in clinical practice has led to emergence of significant evidence regarding the utility of UFC in the diagnosis of Cushing's syndrome. UFC would have been a simple diagnostic tool to use but for the drawbacks in the sample collection, different laboratory methods of assay, not easily determined normal range. UFC use as a screening test is not strongly favoured because cortisol is not uniformly secreted during the day, and the increased prevalence of mild, preclinical or cyclic Cushing's syndrome. A very high level of UFC negates the need for other test procedures in patients with obvious symptoms and signs of Cushing's syndrome. We therefore suggest that UFC should be used with other screening tests for Cushing's syndrome to increase diagnostic yield.

Strategies to diagnose ovarian cancer: new evidence from phase 3 of the multicentre international IOTA study.

PubMed

Testa, A; Kaijser, J; Wynants, L; Fischerova, D; Van Holsbeke, C; Franchi, D; Savelli, L; Epstein, E; Czekierdowski, A; Guerriero, S; Fruscio, R; Leone, F P G; Vergote, I; Bourne, T; Valentin, L; Van Calster, B; Timmerman, D

2014-08-12

To compare different ultrasound-based international ovarian tumour analysis (IOTA) strategies and risk of malignancy index (RMI) for ovarian cancer diagnosis using a meta-analysis approach of centre-specific data from IOTA3. This prospective multicentre diagnostic accuracy study included 2403 patients with 1423 benign and 980 malignant adnexal masses from 2009 until 2012. All patients underwent standardised transvaginal ultrasonography. Test performance of RMI, subjective assessment (SA) of ultrasound findings, two IOTA risk models (LR1 and LR2), and strategies involving combinations of IOTA simple rules (SRs), simple descriptors (SDs) and LR2 with and without SA was estimated using a meta-analysis approach. Reference standard was histology after surgery. The areas under the receiver operator characteristic curves of LR1, LR2, SA and RMI were 0.930 (0.917-0.942), 0.918 (0.905-0.930), 0.914 (0.886-0.936) and 0.875 (0.853-0.894). Diagnostic one-step and two-step strategies using LR1, LR2, SR and SD achieved summary estimates for sensitivity 90-96%, specificity 74-79% and diagnostic odds ratio (DOR) 32.8-50.5. Adding SA when IOTA methods yielded equivocal results improved performance (DOR 57.6-75.7). Risk of Malignancy Index had sensitivity 67%, specificity 91% and DOR 17.5. This study shows all IOTA strategies had excellent diagnostic performance in comparison with RMI. The IOTA strategy chosen may be determined by clinical preference.

Surface electromyography as a screening method for evaluation of dysphagia and odynophagia

PubMed Central

Vaiman, Michael; Eviatar, Ephraim

2009-01-01

Objective Patients suspected of having swallowing disorders, could highly benefit from simple diagnostic screening before being referred to specialist evaluations. The article analyzes various instrumental methods of dysphagia assessment, introduces surface electromyography (sEMG) to carry out rapid assessment of such patients, and debates proposed suggestions for sEMG screening protocol in order to identify abnormal deglutition. Data sources Subject related books and articles from 1813 to 2007 were obtained through library search, MEDLINE (1949–2007) and EMBASE (1975–2007). Methods Specifics steps for establishing the protocol for applying the technique for screening purposes (e.g., evaluation of specific muscles), the requirements for diagnostic sEMG equipment, the sEMG technique itself, and defining the tests suitable for assessing deglutition (e.g., saliva, normal, and excessive swallows and uninterrupted drinking of water) are presented in detail. SEMG is compared with other techniques in terms of cost, timing, involvement of radiation, etc. Results According to the published data, SEMG of swallowing is a simple and reliable method for screening and preliminary differentiation among dysphagia and odynophagia of various origins. This noninvasive radiation-free examination has a low level of discomfort, and is simple, time-saving and inexpensive to perform. The major weakness of the method seems to be inability for precise diagnostic of neurologically induced dysphagia. Conclusion With standardization of the technique and an established normative database, sEMG might serve as a reliable screening method for optimal patient management but cannot serve for proper investigation of neurogenic dysphagia. PMID:19232090

Improved Analytical Sensitivity of Lateral Flow Assay using Sponge for HBV Nucleic Acid Detection.

PubMed

Tang, Ruihua; Yang, Hui; Gong, Yan; Liu, Zhi; Li, XiuJun; Wen, Ting; Qu, ZhiGuo; Zhang, Sufeng; Mei, Qibing; Xu, Feng

2017-05-02

Hepatitis B virus (HBV) infection is a serious public health problem, which can be transmitted through various routes (e.g., blood donation) and cause hepatitis, liver cirrhosis and liver cancer. Hence, it is necessary to do diagnostic screening for high-risk HBV patients in these transmission routes. Nowadays, protein-based technologies have been used for HBV testing, which however involve the issues of large sample volume, antibody instability and poor specificity. Nucleic acid hybridization-based lateral flow assay (LFA) holds great potential to address these limitations due to its low-cost, rapid, and simple features, but the poor analytical sensitivity of LFA restricts its application. In this study, we developed a low-cost, simple and easy-to-use method to improve analytical sensitivity by integrating sponge shunt into LFA to decrease the fluid flow rate. The thickness, length and hydrophobicity of the sponge shunt were sequentially optimized, and achieved 10-fold signal enhancement in nucleic acid testing of HBV as compared to the unmodified LFA. The enhancement was further confirmed by using HBV clinical samples, where we achieved the detection limit of 10 3 copies/ml as compared to 10 4 copies/ml in unmodified LFA. The improved LFA holds great potential for diseases diagnostics, food safety control and environment monitoring at point-of-care.

Competitive Reporter Monitored Amplification (CMA) - Quantification of Molecular Targets by Real Time Monitoring of Competitive Reporter Hybridization

PubMed Central

Ullrich, Thomas; Ermantraut, Eugen; Schulz, Torsten; Steinmetzer, Katrin

2012-01-01

Background State of the art molecular diagnostic tests are based on the sensitive detection and quantification of nucleic acids. However, currently established diagnostic tests are characterized by elaborate and expensive technical solutions hindering the development of simple, affordable and compact point-of-care molecular tests. Methodology and Principal Findings The described competitive reporter monitored amplification allows the simultaneous amplification and quantification of multiple nucleic acid targets by polymerase chain reaction. Target quantification is accomplished by real-time detection of amplified nucleic acids utilizing a capture probe array and specific reporter probes. The reporter probes are fluorescently labeled oligonucleotides that are complementary to the respective capture probes on the array and to the respective sites of the target nucleic acids in solution. Capture probes and amplified target compete for reporter probes. Increasing amplicon concentration leads to decreased fluorescence signal at the respective capture probe position on the array which is measured after each cycle of amplification. In order to observe reporter probe hybridization in real-time without any additional washing steps, we have developed a mechanical fluorescence background displacement technique. Conclusions and Significance The system presented in this paper enables simultaneous detection and quantification of multiple targets. Moreover, the presented fluorescence background displacement technique provides a generic solution for real time monitoring of binding events of fluorescently labelled ligands to surface immobilized probes. With the model assay for the detection of human immunodeficiency virus type 1 and 2 (HIV 1/2), we have been able to observe the amplification kinetics of five targets simultaneously and accommodate two additional hybridization controls with a simple instrument set-up. The ability to accommodate multiple controls and targets into a single assay and to perform the assay on simple and robust instrumentation is a prerequisite for the development of novel molecular point of care tests. PMID:22539973

Photoacoustic sensor for medical diagnostics

NASA Astrophysics Data System (ADS)

Wolff, Marcus; Groninga, Hinrich G.; Harde, Hermann

2004-03-01

The development of new optical sensor technologies has a major impact on the progress of diagnostic methods. Of the permanently increasing number of non-invasive breath tests, the 13C-Urea Breath Test (UBT) for the detection of Helicobacter pylori is the most prominent. However, many recent developments, like the detection of cancer by breath test, go beyond gastroenterological applications. We present a new detection scheme for breath analysis that employs an especially compact and simple set-up. Photoacoustic Spectroscopy (PAS) represents an offset-free technique that allows for short absorption paths and small sample cells. Using a single-frequency diode laser and taking advantage of acoustical resonances of the sample cell, we performed extremely sensitive and selective measurements. The smart data processing method contributes to the extraordinary sensitivity and selectivity as well. Also, the reasonable acquisition cost and low operational cost make this detection scheme attractive for many biomedical applications. The experimental set-up and data processing method, together with exemplary isotope-selective measurements on carbon dioxide, are presented.

'Nano-immuno test' for the detection of live Mycobacterium avium subspecies paratuberculosis bacilli in the milk samples using magnetic nano-particles and chromogen.

PubMed

Singh, Manju; Singh, Shoor Vir; Gupta, Saurabh; Chaubey, Kundan Kumar; Stephan, Bjorn John; Sohal, Jagdip Singh; Dutta, Manali

2018-04-26

Early rapid detection of Mycobacterium avium subspecies paratuberculosis (MAP) bacilli in milk samples is the major challenge since traditional culture method is time consuming and laboratory dependent. We report a simple, sensitive and specific nano-technology based 'Nano-immuno test' capable of detecting viable MAP bacilli in the milk samples within 10 h. Viable MAP bacilli were captured by MAP specific antibody-conjugated magnetic nano-particles using resazurin dye as chromogen. Test was optimized using true culture positive (10-bovine and 12-goats) and true culture negative (16-bovine and 25-goats) raw milk samples. Domestic livestock species in India are endemically infected with MAP. After successful optimization, sensitivity and specificity of the 'nano-immuno test' in goats with respect to milk culture was 91.7% and 96.0%, respectively. Whereas, it was 90.0% (sensitivity) and 92.6% (specificity) with respect to IS900 PCR. In bovine milk samples, sensitivity and specificity of 'nano-immuno test' with respect to milk culture was 90.0% and 93.7%, respectively. However, with respect to IS900 PCR, the sensitivity and specificity was 88.9% and 94.1%, respectively. Test was validated with field raw milk samples (goats-258 and bovine-138) collected from domestic livestock species to detect live/viable MAP bacilli. Of 138 bovine raw milk samples screened by six diagnostic tests, 81 (58.7%) milk samples were positive for MAP infection in one or more than one diagnostic tests. Of 81 (58.7%) positive bovine raw milk samples, only 24 (17.4%) samples were detected positive for the presence of viable MAP bacilli. Of 258 goats raw milk samples screened by six diagnostic tests, 141 (54.6%) were positive for MAP infection in one or more than one test. Of 141 (54.6%) positive raw milk samples from goats, only 48 (34.0%) were detected positive for live MAP bacilli. Simplicity and efficiency of this novel 'nano-immuno test' makes it suitable for wide-scale screening of milk samples in the field. Standardization, validation and re-usability of functionalized nano-particles and the test was successfully achieved in field samples. Test was highly specific, simple to perform and easy to read by naked eyes and does not require laboratory support in the performance of test. Test has potential to be used as screening test to estimate bio-load of MAP in milk samples at National level.

Laboratory diagnosis of invasive candidiasis.

PubMed Central

Jones, J M

1990-01-01

Severe infections due to Candida species have become more frequent during the past two decades because of the increasing numbers of immunosuppressed patients being treated in our hospitals. Distinguishing colonization from invasive disease requires knowledge of the pathogenetic mechanisms leading to invasion. To assist the clinician in therapeutic decisions, clinical microbiologists should identify to species Candida organisms isolated from immunosuppressed patients. Quantitative or semiquantitative cultures of urine, burn tissues, intravascular catheter tips, and bronchoalveolar lavage specimens may provide useful information. Immunofluorescent staining of certain specimens can enhance diagnostic yield. The lysis-centrifugation blood culture technique offers some advantages over traditional broth techniques in detecting Candida fungemia. Antibody testing is of limited diagnostic value in highly immunosuppressed patients. Developing simple and reliable tests for detecting antigens or metabolites of Candida spp. in the sera of infected patients has proven difficult. Methods for typing Candida albicans are evolving. Typing should prove useful for studying the epidemiology of candidiasis in hospitalized patients. Images PMID:2404567

Fast and efficient detection of tuberculosis antigens using liposome encapsulated secretory proteins of Mycobacterium tuberculosis.

PubMed

Tiwari, Dileep; Haque, Shafiul; Tiwari, Ram P; Jawed, Arshad; Govender, Thavendran; Kruger, Hendrik G

2017-04-01

A rapid and efficient diagnostic test was developed for the detection of Mycobacterium tuberculosis antigens in serum samples of active tuberculosis (TB) and extrapulmonary TB patients via a liposomal agglutination-based method. A rapid card test has been developed to facilitate the recognition of high-affinity binding rabbit raised purified culture filtrate protein antibodies coupled on the surface of activated liposomal preparation. In the presence of TB antigens, the polyclonal antibodies bound to the liposomal particles demonstrate a visible agglutination reaction. The developed assay was simple, rapid, reliable, sensitive, and specific as a diagnostic test for the detection of antigens in serum samples of clinically confirmed cases of TB within 4-5 minutes' duration. The test was evaluated at different hospitals, medical colleges, and pathology centers, and involved 1483 participants. This investigation was conducted to detect the presence of these antigens during the period of active growth of the microorganism in serum samples for pulmonary TB and processed tissue biopsy for other extrapulmonary TB. Results obtained using this test were compared with acid-fast bacilli smear and culture results. Our study demonstrated that the newly developed liposome tuberculosis antigen card test detected antigens in our study population with approximately 97.48% sensitivity and 95.79% specificity. This is the first study to report the liposomal encapsulation of culture filtrate proteins from M. tuberculosis for diagnostic application. Copyright © 2015. Published by Elsevier B.V.

Studies on the diagnostic value of an immunofluorescence test for EB virus-specific IgM.

PubMed

Edwards, J M; McSwiggan, D A

1974-08-01

A modification of the test for EB virus/IgM introduced by Schmitz and Scherer (1972) is described. It is simple and gives reproducible results.EB virus/IgM was demonstrated in all but one case of infectious mononucleosis and in students with minor illness shown to have acquired EB virus/IgG recently. Unlike the EB virus/IgG, the IgM disappears within a few months. Although the Paul-Bunnell-Davidsohn test is still the test of choice for the diagnosis of infectious mononucleosis, the EB virus/IgM test could be useful to establish a diagnosis of current or recent EB virus infection where the Paul-Bunnell-Davidsohn test was negative or equivocal.

The use of a pocket-sized ultrasound device improves physical examination: results of an in- and outpatient cohort study.

PubMed

Colli, Agostino; Prati, Daniele; Fraquelli, Mirella; Segato, Sergio; Vescovi, Pier Paolo; Colombo, Fabrizio; Balduini, Carlo; Della Valle, Serena; Casazza, Giovanni

2015-01-01

The performance of pocket mobile ultrasound devices (PUDs) is comparable with that of standard ultrasonography, whereas the accuracy of a physical examination is often poor requiring further tests to assess diagnostic hypotheses. Adding the use of PUD to physical examination could lead to an incremental benefit. We assessed whether the use of PUD in the context of physical examination can reduce the prescription of additional tests when used by physicians in different clinical settings. We conducted a cohort impact study in four hospital medical wards, one gastroenterological outpatient clinic, and 90 general practices in the same geographical area. The study involved 135 physicians who used PUD, after a short predefined training course, to examine 1962 consecutive patients with one of 10 diagnostic hypotheses: ascites, pleural effusion, pericardial effusion, urinary retention, urinary stones, gallstones, biliary-duct dilation, splenomegaly, abdominal mass, abdominal aortic aneurysm. According to the physicians' judgment, PUD examination could rule out or in the diagnostic hypothesis or require further testing; the concordance with the final diagnosis was assessed. The main outcome was the proportion of cases in which additional tests were required after PUD. The PUD diagnostic accuracy was assessed in patients submitted to further testing. The 1962 patients included 37% in-patients, 26% gastroenterology outpatients, 37% from general practices. Further testing after PUD examination was deemed unnecessary in 63%. Only 5% of patients with negative PUD not referred for further testing were classified false negatives with respect to the final diagnosis. In patients undergoing further tests, the sensitivity was 91%, and the specificity 83%. After a simple and short training course, a PUD examination can be used in addition to a physical examination to improve the answer to ten common clinical questions concerning in- and outpatients, and can reduce the need for further testing.

Rapid Diagnosis of Tuberculosis from Analysis of Urine Volatile Organic Compounds

PubMed Central

Lim, Sung H.; Martino, Raymond; Anikst, Victoria; Xu, Zeyu; Mix, Samantha; Benjamin, Robert; Schub, Herbert; Eiden, Michael; Rhodes, Paul A.; Banaei, Niaz

2017-01-01

The World Health Organization has called for simple, sensitive, and non-sputum diagnostics for tuberculosis. We report development of a urine tuberculosis test using a colorimetric sensor array (CSA). The sensor comprised of 73 different indicators captures high-dimensional, spatiotemporal signatures of volatile chemicals emitted by human urine samples. The sensor responses to 63 urine samples collected from 22 tuberculosis cases and 41 symptomatic controls were measured under five different urine test conditions. Basified testing condition yielded the best accuracy with 85.5% sensitivity and 79.5% specificity. The CSA urine assay offers desired features needed for tuberculosis diagnosis in endemic settings. PMID:29057329

A novel diagnostic biomarker panel for obesity-related nonalcoholic steatohepatitis (NASH).

PubMed

Younossi, Zobair M; Jarrar, Mohammed; Nugent, Clare; Randhawa, Manpreet; Afendy, Mariam; Stepanova, Maria; Rafiq, Nila; Goodman, Zachary; Chandhoke, Vikas; Baranova, Ancha

2008-11-01

Within the spectrum of nonalcoholic fatty liver disease (NAFLD), only patients with nonalcoholic steatohepatitis (NASH) show convincing evidence for progression. To date, liver biopsy remains the gold standard for the diagnosis of NASH; however, liver biopsy is expensive and associated with a small risk, emphasizing the urgent need for noninvasive diagnostic biomarkers. Recent findings suggest a role for apoptosis and adipocytokines in the pathogenesis of NASH. The aim of this study was to develop a noninvasive diagnostic biomarker for NASH. The study included 101 patients with liver biopsies who were tested with enzyme-linked immunosorbent assay (ELISA)-based assays. Of these, 69 were included in the biomarker development set and 32 were included in the biomarker validation set. Clinical data and serum samples were collected at the time of biopsy. Fasting serum samples were assayed for adiponectin, resistin, insulin, glucose, TNF-alpha, IL-6, IL-8, cytokeratin CK-18 (M65 antigen), and caspase-cleaved CK-18 (M30 antigen). Data analysis revealed that the levels of M30 antigen (cleaved CK-18) predicted histological NASH with 70% sensitivity and 83.7% specificity and area under the curve (AUC) = 0.711, p < 10(-4), whereas the predictive value of the levels of intact CK-18 (M65) was higher (63.6% sensitivity and 89.4% specificity and AUC = 0.814, p < 10(-4)). Histological NASH could be predicted by a combination of Cleaved CK-18, a product of the subtraction of Cleaved CK-18 level from intact CK-18 level, serum adiponectin, and serum resistin with a sensitivity of 95.45% sensitivity, specificity of 70.21%, and AUC of 0.908 (p < 10(-4)). Blinded validation of this model confirmed its reliability for separating NASH from simple steatosis. Four ELISA-based tests were combined to form a simple diagnostic biomarker for NASH.

The investigation and differential diagnosis of Asperger syndrome in adults.

PubMed

Lehnhardt, Fritz-Georg; Gawronski, Astrid; Pfeiffer, Kathleen; Kockler, Hanna; Schilbach, Leonhard; Vogeley, Kai

2013-11-08

As a result of the increased public interest in autism spectrum disorders (ASD), certain core manifestations of ASD--impaired social interaction and communication, bizarre interests--are now commonly recognized as being typical of autism, not only in children, but in adults as well. More often than before, general practitioners, neurologists, and psychiatrists find themselves being asked whether a patient is suffering from previously unrecognized Asperger syndrome (AS). The prevalence of ASD is estimated at 1%, and the ratio of diagnosed to undiagnosed cases at about 3:2. Little is known about the diagnostic evaluation of AS in adulthood. We selectively searched the Medline database for pertinent literature, paying special attention to diagnostic manuals and to the guideline of the United Kingdom's National Institute for Health and Care Excellence (NICE). Centrally important aspects of the diagnosis of AS include an assessment of the patient's ability to assume the emotional perspectives of others, non-verbal modes of expression, repetitive behavior patterns, and childhood social behavioral history. The autism quotient (AQ) is now established as a simple but nonspecific screening test. Up to 70% of all affected adults have comorbid disturbances, most often depression and anxiety disorders. The differential diagnosis includes personality disorders, anxiety disorders, obsessive-compulsive disorder, and attention deficit-hyperactivity disorder. The diagnostic assessment should proceed in stepwise fashion, starting from simple screening in primary care and then moving on to evaluation of the suspected diagnosis by a mental health care specialist, followed by extensive further investigation in an outpatient clinic specifically devoted to patients with autism spectrum disorders. The diagnostic assessment of autism in adults requires knowledge of the core and accompanying manifestations of autism and of their differential diagnoses. More research is needed for the development of further screening tests and the precise determination of diagnosis rates, differential diagnoses, nd comorbidities.

Global Foot-and-Mouth Disease Research Update and Gap Analysis: 4 - Diagnostics.

PubMed

Knight-Jones, T J D; Robinson, L; Charleston, B; Rodriguez, L L; Gay, C G; Sumption, K J; Vosloo, W

2016-06-01

This study assessed knowledge gaps in foot-and-mouth disease (FMD) research in the field of diagnostics. The study took the form of a literature review (2011-15) combined with research updates collected in 2014 from 33 institutes from around the world. Findings were used to identify priority areas for future FMD research. Molecular and genetic technologies, including sequencing, are developing at an increasing rate both in terms of capability and affordability. These advances potentiate progress in many other fields of research, from vaccine development to epidemiology. The development of RT-LAMP represents an important breakthrough allowing greater use and access to molecular diagnostics. It is now possible to determine virus serotype using PCR, although only for certain virus pools, continued progress is needed to cover the global spectrum of FMD viruses. Progress has also been made in the development of pen-side rapid diagnostics, some with the ability to determine serotype. However, further advances in pen-side serotype or strain determination would benefit both FMD-free countries and endemic countries with limited access to well-resourced laboratories. Novel sampling methods that show promise include air sampling and baited ropes, the latter may aid sampling in wildlife and swine. Studies of infrared thermography for the early detection of FMD have not been encouraging, although investigations are ongoing. Multiplex tests have been developed that are able to simultaneously screen for multiple pathogens with similar clinical signs. Crucial for assessing FMDV freedom, tests exist to detect animals that have been infected with FMDV regardless of vaccination status; however, limitations exist, particularly when testing previously vaccinated animals. Novel vaccines are being developed with complementary DIVA tests for this purpose. Research is also needed to improve the current imprecise approaches to FMD vaccine matching. The development of simple, affordable tests increases access to FMD diagnostics, greatly benefiting regions with limited laboratory capacity. © 2016 Blackwell Verlag GmbH.

Multi-site evaluation of the LN34 pan-lyssavirus real-time RT-PCR assay for post-mortem rabies diagnostics

PubMed Central

Dettinger, Lisa; Powell, James W.; Seiders, Melanie; Condori, Rene Edgar Condori; Griesser, Richard; Okogi, Kenneth; Carlos, Maria; Pesko, Kendra; Breckenridge, Mike; Simon, Edson Michael M.; Chu, Maria Yna Joyce V.; Davis, April D.; Brunt, Scott J.; Orciari, Lillian; Yager, Pamela; Carson, William C.; Hartloge, Claire; Saliki, Jeremiah T.; Deldari, Mojgan; Hsieh, Kristina; Wadhwa, Ashutosh; Wilkins, Kimberly; Rabideau, Patricia; Gruhn, Nina; Cadet, Rolain; Isloor, Shrikrishna; Nath, Sujith S.; Joseph, Tomy; Gao, Jinxin; Wallace, Ryan; Reynolds, Mary; Olson, Victoria A.

2018-01-01

Rabies is a fatal zoonotic disease that requires fast, accurate diagnosis to prevent disease in an exposed individual. The current gold standard for post-mortem diagnosis of human and animal rabies is the direct fluorescent antibody (DFA) test. While the DFA test has proven sensitive and reliable, it requires high quality antibody conjugates, a skilled technician, a fluorescence microscope and diagnostic specimen of sufficient quality. The LN34 pan-lyssavirus real-time RT-PCR assay represents a strong candidate for rabies post-mortem diagnostics due to its ability to detect RNA across the diverse Lyssavirus genus, its high sensitivity, its potential for use with deteriorated tissues, and its simple, easy to implement design. Here, we present data from a multi-site evaluation of the LN34 assay in 14 laboratories. A total of 2,978 samples (1,049 DFA positive) from Africa, the Americas, Asia, Europe, and the Middle East were tested. The LN34 assay exhibited low variability in repeatability and reproducibility studies and was capable of detecting viral RNA in fresh, frozen, archived, deteriorated and formalin-fixed brain tissue. The LN34 assay displayed high diagnostic specificity (99.68%) and sensitivity (99.90%) when compared to the DFA test, and no DFA positive samples were negative by the LN34 assay. The LN34 assay produced definitive findings for 80 samples that were inconclusive or untestable by DFA; 29 were positive. Five samples were inconclusive by the LN34 assay, and only one sample was inconclusive by both tests. Furthermore, use of the LN34 assay led to the identification of one false negative and 11 false positive DFA results. Together, these results demonstrate the reliability and robustness of the LN34 assay and support a role for the LN34 assay in improving rabies diagnostics and surveillance. PMID:29768505

ROC-ing along: Evaluation and interpretation of receiver operating characteristic curves.

PubMed

Carter, Jane V; Pan, Jianmin; Rai, Shesh N; Galandiuk, Susan

2016-06-01

It is vital for clinicians to understand and interpret correctly medical statistics as used in clinical studies. In this review, we address current issues and focus on delivering a simple, yet comprehensive, explanation of common research methodology involving receiver operating characteristic (ROC) curves. ROC curves are used most commonly in medicine as a means of evaluating diagnostic tests. Sample data from a plasma test for the diagnosis of colorectal cancer were used to generate a prediction model. These are actual, unpublished data that have been used to describe the calculation of sensitivity, specificity, positive predictive and negative predictive values, and accuracy. The ROC curves were generated to determine the accuracy of this plasma test. These curves are generated by plotting the sensitivity (true-positive rate) on the y axis and 1 - specificity (false-positive rate) on the x axis. Curves that approach closest to the coordinate (x = 0, y = 1) are more highly predictive, whereas ROC curves that lie close to the line of equality indicate that the result is no better than that obtained by chance. The optimum sensitivity and specificity can be determined from the graph as the point where the minimum distance line crosses the ROC curve. This point corresponds to the Youden index (J), a function of sensitivity and specificity used commonly to rate diagnostic tests. The area under the curve is used to quantify the overall ability of a test to discriminate between 2 outcomes. By following these simple guidelines, interpretation of ROC curves will be less difficult and they can then be interpreted more reliably when writing, reviewing, or analyzing scientific papers. Copyright © 2016 Elsevier Inc. All rights reserved.

'Multiple-test' approach to the laboratory diagnosis of tuberculosis -perception of medical doctors from Ujjain, India.

PubMed

Purohit, Manju Raj; Sharma, Megha; Rosales-Klintz, Senia; Lundborg, Cecilia Stålsby

2015-08-11

Delay in diagnosis is one of the most important factors for the control of tuberculosis (TB) in endemic countries like India. As laboratory diagnosis is the mainstay for identification of active disease, we aim to explore and understand the opinions of medical doctors about the laboratory diagnosis of TB in Ujjain, India. Sixteen qualified specialist medical doctors from Ujjain were purposefully selected for the study. Individual interviews with the doctors (13 men and 3 women), were conducted. As one interview could not be completed, data from 15 interviews were analyzed using manifest and latent content analysis. Based on perception of the doctors, the theme; 'challenges and need for the laboratory diagnosis of TB' emerged from the following subthemes: (i) Relationship between basic element of the TB diseases process such as 'Symptoms prior to diagnoses' and 'Clinical characteristics of TB', which were not specific enough to diagnose TB (ii) The prevailing conditions such as lack of explicit diagnostic tools, lead to the doctors using the 'multiple tests' or 'empiric treatment' approach (iii) The doctors proposed that there is a need for access to a rapid, single and simple diagnostic test, and a need for awareness and knowledge of the practitioners regarding specific TB investigations, and early referral to improve the situation at resource-limited settings. The medical specialists use a 'multiple test' or 'empiric treatment' approach to diagnose TB. According to the participants, there is a low dependence and uptake of the available laboratory TB investigations by medical practitioners. There is an urgent need to have a specific, simple and reliable test, and a protocol, to improve diagnosis of TB and to prevent development of resistant TB.

A novel metric that quantifies risk stratification for evaluating diagnostic tests: The example of evaluating cervical-cancer screening tests across populations.

PubMed

Katki, Hormuzd A; Schiffman, Mark

2018-05-01

Our work involves assessing whether new biomarkers might be useful for cervical-cancer screening across populations with different disease prevalences and biomarker distributions. When comparing across populations, we show that standard diagnostic accuracy statistics (predictive values, risk-differences, Youden's index and Area Under the Curve (AUC)) can easily be misinterpreted. We introduce an intuitively simple statistic for a 2 × 2 table, Mean Risk Stratification (MRS): the average change in risk (pre-test vs. post-test) revealed for tested individuals. High MRS implies better risk separation achieved by testing. MRS has 3 key advantages for comparing test performance across populations with different disease prevalences and biomarker distributions. First, MRS demonstrates that conventional predictive values and the risk-difference do not measure risk-stratification because they do not account for test-positivity rates. Second, Youden's index and AUC measure only multiplicative relative gains in risk-stratification: AUC = 0.6 achieves only 20% of maximum risk-stratification (AUC = 0.9 achieves 80%). Third, large relative gains in risk-stratification might not imply large absolute gains if disease is rare, demonstrating a "high-bar" to justify population-based screening for rare diseases such as cancer. We illustrate MRS by our experience comparing the performance of cervical-cancer screening tests in China vs. the USA. The test with the worst AUC = 0.72 in China (visual inspection with acetic acid) provides twice the risk-stratification (i.e. MRS) of the test with best AUC = 0.83 in the USA (human papillomavirus and Pap cotesting) because China has three times more cervical precancer/cancer. MRS could be routinely calculated to better understand the clinical/public-health implications of standard diagnostic accuracy statistics. Published by Elsevier Inc.

A standard test case suite for two-dimensional linear transport on the sphere: results from a collection of state-of-the-art schemes

NASA Astrophysics Data System (ADS)

Lauritzen, P. H.; Ullrich, P. A.; Jablonowski, C.; Bosler, P. A.; Calhoun, D.; Conley, A. J.; Enomoto, T.; Dong, L.; Dubey, S.; Guba, O.; Hansen, A. B.; Kaas, E.; Kent, J.; Lamarque, J.-F.; Prather, M. J.; Reinert, D.; Shashkin, V. V.; Skamarock, W. C.; Sørensen, B.; Taylor, M. A.; Tolstykh, M. A.

2013-09-01

Recently, a standard test case suite for 2-D linear transport on the sphere was proposed to assess important aspects of accuracy in geophysical fluid dynamics with a "minimal" set of idealized model configurations/runs/diagnostics. Here we present results from 19 state-of-the-art transport scheme formulations based on finite-difference/finite-volume methods as well as emerging (in the context of atmospheric/oceanographic sciences) Galerkin methods. Discretization grids range from traditional regular latitude-longitude grids to more isotropic domain discretizations such as icosahedral and cubed-sphere tessellations of the sphere. The schemes are evaluated using a wide range of diagnostics in idealized flow environments. Accuracy is assessed in single- and two-tracer configurations using conventional error norms as well as novel diagnostics designed for climate and climate-chemistry applications. In addition, algorithmic considerations that may be important for computational efficiency are reported on. The latter is inevitably computing platform dependent, The ensemble of results from a wide variety of schemes presented here helps shed light on the ability of the test case suite diagnostics and flow settings to discriminate between algorithms and provide insights into accuracy in the context of global atmospheric/ocean modeling. A library of benchmark results is provided to facilitate scheme intercomparison and model development. Simple software and data-sets are made available to facilitate the process of model evaluation and scheme intercomparison.

A standard test case suite for two-dimensional linear transport on the sphere: results from a collection of state-of-the-art schemes

NASA Astrophysics Data System (ADS)

Lauritzen, P. H.; Ullrich, P. A.; Jablonowski, C.; Bosler, P. A.; Calhoun, D.; Conley, A. J.; Enomoto, T.; Dong, L.; Dubey, S.; Guba, O.; Hansen, A. B.; Kaas, E.; Kent, J.; Lamarque, J.-F.; Prather, M. J.; Reinert, D.; Shashkin, V. V.; Skamarock, W. C.; Sørensen, B.; Taylor, M. A.; Tolstykh, M. A.

2014-01-01

Recently, a standard test case suite for 2-D linear transport on the sphere was proposed to assess important aspects of accuracy in geophysical fluid dynamics with a "minimal" set of idealized model configurations/runs/diagnostics. Here we present results from 19 state-of-the-art transport scheme formulations based on finite-difference/finite-volume methods as well as emerging (in the context of atmospheric/oceanographic sciences) Galerkin methods. Discretization grids range from traditional regular latitude-longitude grids to more isotropic domain discretizations such as icosahedral and cubed-sphere tessellations of the sphere. The schemes are evaluated using a wide range of diagnostics in idealized flow environments. Accuracy is assessed in single- and two-tracer configurations using conventional error norms as well as novel diagnostics designed for climate and climate-chemistry applications. In addition, algorithmic considerations that may be important for computational efficiency are reported on. The latter is inevitably computing platform dependent. The ensemble of results from a wide variety of schemes presented here helps shed light on the ability of the test case suite diagnostics and flow settings to discriminate between algorithms and provide insights into accuracy in the context of global atmospheric/ocean modeling. A library of benchmark results is provided to facilitate scheme intercomparison and model development. Simple software and data sets are made available to facilitate the process of model evaluation and scheme intercomparison.

The 'ABC' of examining foot radiographs.

PubMed

Pearse, Eyiyemi O; Klass, Benjamin; Bendall, Stephen P

2005-11-01

We report a simple systematic method of assessing foot radiographs that improves diagnostic accuracy and can reduce the incidence of inappropriate management of serious forefoot and midfoot injuries, particularly the Lisfranc-type injury. Five recently appointed senior house officers (SHOs), with no casualty or Orthopaedic experience prior to their appointment, were shown a set of 10 foot radiographs and told the history and examination findings recorded in the casualty notes of each patient within 6 weeks of taking up their posts. They were informed that the radiographs might or might not demonstrate an abnormality. They were asked to make a diagnosis and decide on a management plan. The test was repeated after they were taught the 'ABC' method of evaluating foot radiographs. Diagnostic accuracy improved after SHOs were taught a systematic method of assessing foot radiographs. The proportion of correct diagnoses increased from 0.64 to 0.78 and the probability of recognising Lisfranc injuries increased from 0 to 0.6. The use of this simple method of assessing foot radiographs can reduce the incidence of inappropriate management of serious foot injuries by casualty SHOs, in particular the Lisfranc type injury.

A lab-on-chip for malaria diagnosis and surveillance

PubMed Central

2014-01-01

Background Access to timely and accurate diagnostic tests has a significant impact in the management of diseases of global concern such as malaria. While molecular diagnostics satisfy this need effectively in developed countries, barriers in technology, reagent storage, cost and expertise have hampered the introduction of these methods in developing countries. In this study a simple, lab-on-chip PCR diagnostic was created for malaria that overcomes these challenges. Methods The platform consists of a disposable plastic chip and a low-cost, portable, real-time PCR machine. The chip contains a desiccated hydrogel with reagents needed for Plasmodium specific PCR. Chips can be stored at room temperature and used on demand by rehydrating the gel with unprocessed blood, avoiding the need for sample preparation. These chips were run on a custom-built instrument containing a Peltier element for thermal cycling and a laser/camera setup for amplicon detection. Results This diagnostic was capable of detecting all Plasmodium species with a limit of detection for Plasmodium falciparum of 2 parasites/μL of blood. This exceeds the sensitivity of microscopy, the current standard for diagnosis in the field, by ten to fifty-fold. In a blind panel of 188 patient samples from a hyper-endemic region of malaria transmission in Uganda, the diagnostic had high sensitivity (97.4%) and specificity (93.8%) versus conventional real-time PCR. The test also distinguished the two most prevalent malaria species in mixed infections, P. falciparum and Plasmodium vivax. A second blind panel of 38 patient samples was tested on a streamlined instrument with LED-based excitation, achieving a sensitivity of 96.7% and a specificity of 100%. Conclusions These results describe the development of a lab-on-chip PCR diagnostic from initial concept to ready-for-manufacture design. This platform will be useful in front-line malaria diagnosis, elimination programmes, and clinical trials. Furthermore, test chips can be adapted to detect other pathogens for a differential diagnosis in the field. The flexibility, reliability, and robustness of this technology hold much promise for its use as a novel molecular diagnostic platform in developing countries. PMID:24885206

Inability of keratinocytes lacking their specific transglutaminase to form cross-linked envelopes: absence of envelopes as a simple diagnostic test for lamellar ichthyosis.

PubMed

Jeon, S; Djian, P; Green, H

1998-01-20

Epidermal keratinocytes, late in their terminal differentiation, form cross-linked envelopes resistant to ionic detergent and reducing agent. Because the cross-linking process is catalyzed by the keratinocyte transglutaminase, the absence of active transglutaminase should result in failure of the keratinocyte to form a cross-linked envelope. Three keratinocyte strains bearing mutations in the keratinocyte transglutaminase were examined: two contained no detectable transglutaminase mRNA and none contained active enzyme. All three were unable to form cross-linked envelopes, either spontaneously in stratified cultures or upon induction with Ca2+. Although stratum corneum of normal humans and scales from patients with different ichthyotic diseases contain cross-linked envelopes, those from patients with transglutaminase-negative lamellar ichthyosis do not. Therefore, the disease due to the absence of transglutaminase may be readily distinguished from other ichthyotic disease by a simple test for cross-linked envelopes.

A CLIPS based personal computer hardware diagnostic system

NASA Technical Reports Server (NTRS)

Whitson, George M.

1991-01-01

Often the person designated to repair personal computers has little or no knowledge of how to repair a computer. Described here is a simple expert system to aid these inexperienced repair people. The first component of the system leads the repair person through a number of simple system checks such as making sure that all cables are tight and that the dip switches are set correctly. The second component of the system assists the repair person in evaluating error codes generated by the computer. The final component of the system applies a large knowledge base to attempt to identify the component of the personal computer that is malfunctioning. We have implemented and tested our design with a full system to diagnose problems for an IBM compatible system based on the 8088 chip. In our tests, the inexperienced repair people found the system very useful in diagnosing hardware problems.

A multispectral imaging approach for diagnostics of skin pathologies

NASA Astrophysics Data System (ADS)

Lihacova, Ilze; Derjabo, Aleksandrs; Spigulis, Janis

2013-06-01

Noninvasive multispectral imaging method was applied for different skin pathology such as nevus, basal cell carcinoma, and melanoma diagnostics. Developed melanoma diagnostic parameter, using three spectral bands (540 nm, 650 nm and 950 nm), was calculated for nevus, melanoma and basal cell carcinoma. Simple multispectral diagnostic device was established and applied for skin assessment. Development and application of multispectral diagnostics method described further in this article.

Dimensional indicators of generalized anxiety disorder severity for DSM-V.

PubMed

Niles, Andrea N; Lebeau, Richard T; Liao, Betty; Glenn, Daniel E; Craske, Michelle G

2012-03-01

For DSM-V, simple dimensional measures of disorder severity will accompany diagnostic criteria. The current studies examine convergent validity and test-retest reliability of two potential dimensional indicators of worry severity for generalized anxiety disorder (GAD): percent of the day worried and number of worry domains. In study 1, archival data from diagnostic interviews from a community sample of individuals diagnosed with one or more anxiety disorders (n = 233) were used to assess correlations between percent of the day worried and number of worry domains with other measures of worry severity (clinical severity rating (CSR), age of onset, number of comorbid disorders, Penn state worry questionnaire (PSWQ)) and DSM-IV criteria (excessiveness, uncontrollability and number of physical symptoms). Both measures were significantly correlated with CSR and number of comorbid disorders, and with all three DSM-IV criteria. In study 2, test-retest reliability of percent of the day worried and number of worry domains were compared to test-retest reliability of DSM-IV diagnostic criteria in a non-clinical sample of undergraduate students (n = 97) at a large west coast university. All measures had low test-retest reliability except percent of the day worried, which had moderate test-retest reliability. Findings suggest that these two indicators capture worry severity, and percent of the day worried may be the most reliable existing indicator. These measures may be useful as dimensional measures for DSM-V. Copyright © 2012 Elsevier Ltd. All rights reserved.

Application of MALDI-TOF mass spectrometry in clinical diagnostic microbiology.

PubMed

De Carolis, Elena; Vella, Antonietta; Vaccaro, Luisa; Torelli, Riccardo; Spanu, Teresa; Fiori, Barbara; Posteraro, Brunella; Sanguinetti, Maurizio

2014-09-12

Matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) has recently emerged as a powerful technique for identification of microorganisms, changing the workflow of well-established laboratories so that its impact on microbiological diagnostics has been unparalleled. In comparison with conventional identification methods that rely on biochemical tests and require long incubation procedures, MALDI-TOF MS has the advantage of identifying bacteria and fungi directly from colonies grown on culture plates in a few minutes and with simple procedures. Numerous studies on different systems available demonstrate the reliability and accuracy of the method, and new frontiers have been explored besides microbial species level identification, such as direct identification of pathogens from positive blood cultures, subtyping, and drug susceptibility detection.

Strategies to diagnose ovarian cancer: new evidence from phase 3 of the multicentre international IOTA study

PubMed Central

Testa, A; Kaijser, J; Wynants, L; Fischerova, D; Van Holsbeke, C; Franchi, D; Savelli, L; Epstein, E; Czekierdowski, A; Guerriero, S; Fruscio, R; Leone, F P G; Vergote, I; Bourne, T; Valentin, L; Van Calster, B; Timmerman, D

2014-01-01

Background: To compare different ultrasound-based international ovarian tumour analysis (IOTA) strategies and risk of malignancy index (RMI) for ovarian cancer diagnosis using a meta-analysis approach of centre-specific data from IOTA3. Methods: This prospective multicentre diagnostic accuracy study included 2403 patients with 1423 benign and 980 malignant adnexal masses from 2009 until 2012. All patients underwent standardised transvaginal ultrasonography. Test performance of RMI, subjective assessment (SA) of ultrasound findings, two IOTA risk models (LR1 and LR2), and strategies involving combinations of IOTA simple rules (SRs), simple descriptors (SDs) and LR2 with and without SA was estimated using a meta-analysis approach. Reference standard was histology after surgery. Results: The areas under the receiver operator characteristic curves of LR1, LR2, SA and RMI were 0.930 (0.917–0.942), 0.918 (0.905–0.930), 0.914 (0.886–0.936) and 0.875 (0.853–0.894). Diagnostic one-step and two-step strategies using LR1, LR2, SR and SD achieved summary estimates for sensitivity 90–96%, specificity 74–79% and diagnostic odds ratio (DOR) 32.8–50.5. Adding SA when IOTA methods yielded equivocal results improved performance (DOR 57.6–75.7). Risk of Malignancy Index had sensitivity 67%, specificity 91% and DOR 17.5. Conclusions: This study shows all IOTA strategies had excellent diagnostic performance in comparison with RMI. The IOTA strategy chosen may be determined by clinical preference. PMID:24937676

Asay window: A new spall diagnostic

NASA Astrophysics Data System (ADS)

McCluskey, Craig W.; Wilke, Mark D.; Anderson, William W.; Byers, Mark E.; Holtkamp, David B.; Rigg, Paulo A.; Furnish, Michael D.; Romero, Vincent T.

2006-11-01

By changing from the metallic foil of the Asay foil diagnostic, which can detect ejecta from a shocked surface, to a lithium fluoride (LiF) or polymethyl methacrylate (PMMA) window, it is possible to detect multiple spall layers and interlayer rubble. Past experiments to demonstrate this diagnostic have used high explosives (HEs) to shock metals to produce multiple spall layers. Because the exact characteristics of HE-induced spall layers cannot be predetermined, two issues exist in the quantitative interpretation of the data. First, to what level of fidelity is the Asay window method capable of providing quantitative information about spall layers, possibly separated by rubble, and second, contingent on the first, can an analytic technique be developed to convert the data to a meaningful description of spall from a given experiment? In this article, we address the first issue. A layered projectile fired from a gas gun was used to test the new diagnostic's accuracy and repeatability. We impacted a LiF or PMMA window viewed by a velocity interferometer system for any reflector (VISAR) probe with a projectile consisting of four thin stainless steel disks spaced apart 200μm with either vacuum or polyethylene. The window/surface interface velocity measured with a VISAR probe was compared with calculations. The good agreement observed between the adjusted calculation and the measured data indicates that, in principle and given enough prior information, it is possible to use the Asay window data to model a density distribution from spalled material with simple hydrodynamic models and only simple adjustments to nominal predictions.

Residual gas analyzer mass spectrometry for human breath analysis: a new tool for the non-invasive diagnosis of Helicobacter pylori infection.

PubMed

Maity, Abhijit; Banik, Gourab D; Ghosh, Chiranjit; Som, Suman; Chaudhuri, Sujit; Daschakraborty, Sunil B; Ghosh, Shibendu; Ghosh, Barnali; Raychaudhuri, Arup K; Pradhan, Manik

2014-03-01

A residual gas analyzer (RGA) coupled with a high vacuum chamber is described for the non-invasive diagnosis of the Helicobacter pylori (H. pylori) infection through ¹³C-urea breath analysis. The present RGA-based mass spectrometry (MS) method is capable of measuring high-precision ¹³CO₂ isotope enrichments in exhaled breath samples from individuals harboring the H. pylori infection. The system exhibited 100% diagnostic sensitivity, and 93% specificity alongside positive and negative predictive values of 95% and 100%, respectively, compared with invasive endoscopy-based biopsy tests. A statistically sound diagnostic cut-off value for the presence of H. pylori was determined to be 3.0‰ using a receiver operating characteristic curve analysis. The diagnostic accuracy and validity of the results are also supported by optical off-axis integrated cavity output spectroscopy measurements. The δ¹³(DOB)C‰ values of both methods correlated well (R² = 0.9973 at 30 min). The RGA-based instrumental setup described here is simple, robust, easy-to-use and more portable and cost-effective compared to all other currently available detection methods, thus making it a new point-of-care medical diagnostic tool for the purpose of large-scale screening of the H. pylori infection in real time. The RGA-MS technique should have broad applicability for ¹³C-breath tests in a wide range of biomedical research and clinical diagnostics for many other diseases and metabolic disorders.

Rapid clinical diagnosis of Legionnaires' disease during the "herald wave" of the swine influenza (H1N1) pandemic: the Legionnaires' disease triad.

PubMed

Cunha, Burke A; Mickail, Nardeen; Syed, Uzma; Strollo, Stephanie; Laguerre, Marianne

2010-01-01

In adults hospitalized with atypical community-acquired pneumonia (CAP), Legionnaires' disease is not uncommon. Legionnaire's disease can be differentiated from typical CAPs and from other atypical CAPs based on its characteristic pattern of extrapulmonary organ involvement. The first clinically useful diagnostic weighted point score system for the clinical diagnosis of Legionnaires' disease was developed by the Infectious Disease Division at Winthrop-University Hospital in the 1980s. It has proven to be diagnostically accurate and useful for more than two decades, but was time-consuming. Because Legionella spp. diagnostic tests are time-dependent and problematic, a need was perceived for a rapid, simple way to render a clinical, syndromic diagnosis of Legionnaires' disease pending Legionella test results. During the "herald wave" of the swine influenza (H1N1) pandemic in the New York area, our hospital, like others, was inundated with patients who presented to the Emergency Department with influenza-like illnesses (ILIs) for H1N1 testing/evaluation. Most patients with ILIs did not have swine influenza. Hospitalized patients with ILIs who tested positive with rapid influenza diagnostic tests (RIDTs) were placed on influenza precautions and treated with oseltamivir. Unfortunately, approximately 30% of adult patients admitted with an ILI had negative RIDTs. Because the definitive laboratory diagnosis of H1N1 pneumonia by reverse transcription-polymerase chain reaction(RT-PCR), testing was restricted by health departments, resulted in clinical and infection control dilemmas in determining which RIDT-negative patients did, in fact, have H1N1 pneumonia. Accordingly, a diagnostic weighted point score system was developed for H1N1 pneumonia patients, based on RT-PCR positivity by the Infectious Disease Division at Winthrop-University Hospital. This diagnostic point score system for hospitalized adults with negative RIDTs was time-consuming. As the pandemic progressed, a simplified diagnostic swine influenza (H1N1) triad was developed for the rapid clinical diagnosis of probable H1N1 pneumonia, which also differentiated it from its mimics as well as from bacterial pneumonia, eg, Legionnaires' disease. During the "herald wave" of the H1N1 pandemic, we noticed an unexplained increase in Legionnaires' disease CAPs. Because clinical resources were stressed to the maximum during the pandemic, it was critically important to rapidly identify patients rapidly with Legionnaire's disease who did not require influenza precautions or oseltamivir, but who did require anti-Legionella antimicrobial therapy. Based on the Winthrop-University Hospital Infectious Disease Division's diagnostic weighted point score system for Legionnaires' disease (modified), key indicators were identified and became the basis for the diagnostic Legionnaires' disease triad. The diagnostic Legionnaires' disease triad was used to make a clinical diagnosis of Legionnaires' disease until the results of Legionella diagnostic tests were reported. The diagnostic Legionnaires' disease triad diagnosed Legionnaires' disease in hospitalized adults with CAPs with extrapulmonary findings (atypical CAP) and relative bradycardia, accompanied by any three (ie, a triad) of the following: otherwise unexplained relative lymphopenia, early/mildly elevated serum transaminases (SGOT/SGPT), highly increased ferritin levels (> or =2 x n), or hypophosphatemia. The diagnostic Legionnaires' disease triad provides clinicians with a rapid way to clinically diagnose Legionnaires' disease, pending Legionella test results. The accuracy of the diagnostic Legionnaires' disease triad was confirmed in our 9 cases of Legionnaires' disease by subsequent Legionella diagnostic testing. The diagnostic Legionnaires' disease triad is particularly useful in situations where a rapid clinical syndromic diagnosis is needed, ie, during an H1N1 pandemic. Copyright 2010 Elsevier Inc. All rights reserved.

Evaluation of the rapid plasma reagin "teardrop" card test for screening of syphilis in field conditions.

PubMed

Van Dyck, E; Van de Velden, L; Ndoye, I; Piot, P; Meheus, A

1993-01-01

The availability of simple diagnostic methods may contribute to more efficient control of sexually transmitted diseases (STDs) in developing countries. For the detection of syphilis, a simple rapid plasma reagin (RPR) "teardrop" assay for finger-prick blood samples was developed in 1962. The reliability of this test is compared with RPR, Treponema pallidum hemagglutination assay (TPHA), and fluorescent treponemal antibody absorption (FTA-Abs) assays performed on venous blood samples. To evaluate the potential usefulness of the finger-stick RPR teardrop assay for diagnosis of syphilis in settings with poor medical resources. Pregnant women evaluated at two health centers in Pikine, Senegal were tested for STDs. The RPR teardrop assay was performed on plasma from blood samples obtained by finger prick, and standard RPR, TPHA, and FTA-Abs procedures were performed on serum obtained by vein puncture. The sensitivity and specificity of the finger-prick RPR teardrop assay were 69.7% and 96.5%, respectively, and its reactivity was correlated with RPR serum antibody titer. The finger-prick RPR teardrop assay is not a reliable alternative to the classic serum RPR test.

Solar thermal polymerase chain reaction for smartphone-assisted molecular diagnostics

PubMed Central

Jiang, Li; Mancuso, Matthew; Lu, Zhengda; Akar, Gunkut; Cesarman, Ethel; Erickson, David

2014-01-01

Nucleic acid-based diagnostic techniques such as polymerase chain reaction (PCR) are used extensively in medical diagnostics due to their high sensitivity, specificity and quantification capability. In settings with limited infrastructure and unreliable electricity, however, access to such devices is often limited due to the highly specialized and energy-intensive nature of the thermal cycling process required for nucleic acid amplification. Here we integrate solar heating with microfluidics to eliminate thermal cycling power requirements as well as create a simple device infrastructure for PCR. Tests are completed in less than 30 min, and power consumption is reduced to 80 mW, enabling a standard 5.5 Wh iPhone battery to provide 70 h of power to this system. Additionally, we demonstrate a complete sample-to-answer diagnostic strategy by analyzing human skin biopsies infected with Kaposi's Sarcoma herpesvirus (KSHV/HHV-8) through the combination of solar thermal PCR, HotSHOT DNA extraction and smartphone-based fluorescence detection. We believe that exploiting the ubiquity of solar thermal energy as demonstrated here could facilitate broad availability of nucleic acid-based diagnostics in resource-limited areas. PMID:24553130

A simple Lagrangian forecast system with aviation forecast potential

NASA Technical Reports Server (NTRS)

Petersen, R. A.; Homan, J. H.

1983-01-01

A trajectory forecast procedure is developed which uses geopotential tendency fields obtained from a simple, multiple layer, potential vorticity conservative isentropic model. This model can objectively account for short-term advective changes in the mass field when combined with fine-scale initial analyses. This procedure for producing short-term, upper-tropospheric trajectory forecasts employs a combination of a detailed objective analysis technique, an efficient mass advection model, and a diagnostically proven trajectory algorithm, none of which require extensive computer resources. Results of initial tests are presented, which indicate an exceptionally good agreement for trajectory paths entering the jet stream and passing through an intensifying trough. It is concluded that this technique not only has potential for aiding in route determination, fuel use estimation, and clear air turbulence detection, but also provides an example of the types of short range forecasting procedures which can be applied at local forecast centers using simple algorithms and a minimum of computer resources.

Diagnostic performance of serological tests for swine brucellosis in the presence of false positive serological reactions.

PubMed

Dieste-Pérez, L; Blasco, J M; de Miguel, M J; Moriyón, I; Muñoz, P M

2015-04-01

Swine brucellosis caused by Brucella suis biovar 2 is an emerging disease in Europe. Currently used diagnostic tests for swine brucellosis detect antibodies to the O-polysaccharide (O-PS) of Brucella smooth lipopolysaccharide (S-LPS) but their specificity is compromised by false-positive serological reactions (FPSRs) when bacteria carrying cross-reacting O-PS infect pigs. FPSRs occur throughout Europe, and the only tool available for a specific B. suis diagnosis is the intradermal test with Brucella protein extracts free of O-PS or S-LPS. Using sera of 162 sows naturally infected by B. suis biovar 2, 406 brucellosis-free sows, and 218 pigs of brucellosis-free farms affected by FPSR, we assessed the diagnostic performance of an indirect ELISA with rough LPS (thus devoid of O-PS) and of gel immunodiffusion, counterimmunoelectrophoresis, latex agglutination and indirect ELISA with O-PS free proteins in comparison with several S-LPS tests (Rose Bengal, complement fixation, gel immunodiffusion and indirect ELISA). When adjusted to 100% specificity, the sensitivity of the rough LPS ELISA was very low (30%), and adoption of other cut-offs resulted in poor specificity/sensitivity ratios. Although their specificity was 100%, the sensitivity of protein tests (ELISA, latex agglutination, counterimmunoelectrophoresis, and gel immunodiffusion) was only moderate (45, 58, 61 and 63%, respectively). Among S-LPS tests, gel immunodiffusion was the only test showing acceptable sensitivity/specificity (68 and 100%, respectively). Despite these shortcomings, and when the purpose is to screen out FPSR at herd level, gel immunodiffusion tests may offer a technically simple and practical alternative to intradermal testing. Copyright © 2015 Elsevier B.V. All rights reserved.

Mining Peripheral Arterial Disease Cases from Narrative Clinical Notes Using Natural Language Processing

PubMed Central

Afzal, Naveed; Sohn, Sunghwan; Abram, Sara; Scott, Christopher G.; Chaudhry, Rajeev; Liu, Hongfang; Kullo, Iftikhar J.; Arruda-Olson, Adelaide M.

2016-01-01

Objective Lower extremity peripheral arterial disease (PAD) is highly prevalent and affects millions of individuals worldwide. We developed a natural language processing (NLP) system for automated ascertainment of PAD cases from clinical narrative notes and compared the performance of the NLP algorithm to billing code algorithms, using ankle-brachial index (ABI) test results as the gold standard. Methods We compared the performance of the NLP algorithm to 1) results of gold standard ABI; 2) previously validated algorithms based on relevant ICD-9 diagnostic codes (simple model) and 3) a combination of ICD-9 codes with procedural codes (full model). A dataset of 1,569 PAD patients and controls was randomly divided into training (n= 935) and testing (n= 634) subsets. Results We iteratively refined the NLP algorithm in the training set including narrative note sections, note types and service types, to maximize its accuracy. In the testing dataset, when compared with both simple and full models, the NLP algorithm had better accuracy (NLP: 91.8%, full model: 81.8%, simple model: 83%, P<.001), PPV (NLP: 92.9%, full model: 74.3%, simple model: 79.9%, P<.001), and specificity (NLP: 92.5%, full model: 64.2%, simple model: 75.9%, P<.001). Conclusions A knowledge-driven NLP algorithm for automatic ascertainment of PAD cases from clinical notes had greater accuracy than billing code algorithms. Our findings highlight the potential of NLP tools for rapid and efficient ascertainment of PAD cases from electronic health records to facilitate clinical investigation and eventually improve care by clinical decision support. PMID:28189359

Dissolvable fluidic time delays for programming multi-step assays in instrument-free paper diagnostics.

PubMed

Lutz, Barry; Liang, Tinny; Fu, Elain; Ramachandran, Sujatha; Kauffman, Peter; Yager, Paul

2013-07-21

Lateral flow tests (LFTs) are an ingenious format for rapid and easy-to-use diagnostics, but they are fundamentally limited to assay chemistries that can be reduced to a single chemical step. In contrast, most laboratory diagnostic assays rely on multiple timed steps carried out by a human or a machine. Here, we use dissolvable sugar applied to paper to create programmable flow delays and present a paper network topology that uses these time delays to program automated multi-step fluidic protocols. Solutions of sucrose at different concentrations (10-70% of saturation) were added to paper strips and dried to create fluidic time delays spanning minutes to nearly an hour. A simple folding card format employing sugar delays was shown to automate a four-step fluidic process initiated by a single user activation step (folding the card); this device was used to perform a signal-amplified sandwich immunoassay for a diagnostic biomarker for malaria. The cards are capable of automating multi-step assay protocols normally used in laboratories, but in a rapid, low-cost, and easy-to-use format.

Dissolvable fluidic time delays for programming multi-step assays in instrument-free paper diagnostics

PubMed Central

Lutz, Barry; Liang, Tinny; Fu, Elain; Ramachandran, Sujatha; Kauffman, Peter; Yager, Paul

2013-01-01

Lateral flow tests (LFTs) are an ingenious format for rapid and easy-to-use diagnostics, but they are fundamentally limited to assay chemistries that can be reduced to a single chemical step. In contrast, most laboratory diagnostic assays rely on multiple timed steps carried out by a human or a machine. Here, we use dissolvable sugar applied to paper to create programmable flow delays and present a paper network topology that uses these time delays to program automated multi-step fluidic protocols. Solutions of sucrose at different concentrations (10-70% of saturation) were added to paper strips and dried to create fluidic time delays spanning minutes to nearly an hour. A simple folding card format employing sugar delays was shown to automate a four-step fluidic process initiated by a single user activation step (folding the card); this device was used to perform a signal-amplified sandwich immunoassay for a diagnostic biomarker for malaria. The cards are capable of automating multi-step assay protocols normally used in laboratories, but in a rapid, low-cost, and easy-to-use format. PMID:23685876

A tuberculosis biomarker database: the key to novel TB diagnostics.

PubMed

Yerlikaya, Seda; Broger, Tobias; MacLean, Emily; Pai, Madhukar; Denkinger, Claudia M

2017-03-01

New diagnostic innovations for tuberculosis (TB), including point-of-care solutions, are critical to reach the goals of the End TB Strategy. However, despite decades of research, numerous reports on new biomarker candidates, and significant investment, no well-performing, simple and rapid TB diagnostic test is yet available on the market, and the search for accurate, non-DNA biomarkers remains a priority. To help overcome this 'biomarker pipeline problem', FIND and partners are working on the development of a well-curated and user-friendly TB biomarker database. The web-based database will enable the dynamic tracking of evidence surrounding biomarker candidates in relation to target product profiles (TPPs) for needed TB diagnostics. It will be able to accommodate raw datasets and facilitate the verification of promising biomarker candidates and the identification of novel biomarker combinations. As such, the database will simplify data and knowledge sharing, empower collaboration, help in the coordination of efforts and allocation of resources, streamline the verification and validation of biomarker candidates, and ultimately lead to an accelerated translation into clinically useful tools. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Video instrumentation for radionuclide angiocardiography.

NASA Technical Reports Server (NTRS)

Kriss, J. P.

1973-01-01

Two types of videoscintiscopes for performing radioisotopic angiocardiography with a scintillation camera are described, and use of these instruments in performing clinical studies is illustrated. Radionuclide angiocardiography is a simple, quick and accurate procedure recommended as a screening test for patients with a variety of congenital and acquired cardiovascular lesions. When performed in conjunction with coronary arterial catheterization, dynamic radionuclide angiography may provide useful information about regional myocardial perfusion. Quantitative capabilities greatly enhance the potential of this diagnostic tool.

Machine learning-based in-line holographic sensing of unstained malaria-infected red blood cells.

PubMed

Go, Taesik; Kim, Jun H; Byeon, Hyeokjun; Lee, Sang J

2018-04-19

Accurate and immediate diagnosis of malaria is important for medication of the infectious disease. Conventional methods for diagnosing malaria are time consuming and rely on the skill of experts. Therefore, an automatic and simple diagnostic modality is essential for healthcare in developing countries that lack the expertise of trained microscopists. In the present study, a new automatic sensing method using digital in-line holographic microscopy (DIHM) combined with machine learning algorithms was proposed to sensitively detect unstained malaria-infected red blood cells (iRBCs). To identify the RBC characteristics, 13 descriptors were extracted from segmented holograms of individual RBCs. Among the 13 descriptors, 10 features were highly statistically different between healthy RBCs (hRBCs) and iRBCs. Six machine learning algorithms were applied to effectively combine the dominant features and to greatly improve the diagnostic capacity of the present method. Among the classification models trained by the 6 tested algorithms, the model trained by the support vector machine (SVM) showed the best accuracy in separating hRBCs and iRBCs for training (n = 280, 96.78%) and testing sets (n = 120, 97.50%). This DIHM-based artificial intelligence methodology is simple and does not require blood staining. Thus, it will be beneficial and valuable in the diagnosis of malaria. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Waist-to-Height Ratio: a simple, effective and practical screening tool for childhood obesity and metabolic syndrome.

PubMed

Zhou, Dan; Yang, Min; Yuan, Zhe-Ping; Zhang, Dan-Dan; Liang, Li; Wang, Chun-Lin; Zhang, Shuai; Zhu, Hong-Hong; Lai, Mao-De; Zhu, Yi-Min

2014-10-01

This study aimed to evaluate the diagnostic value of Waist-to-Height Ratio in early detection of obesity and metabolic syndrome in Chinese children and adolescents. A cross-sectional study was conducted in six cities in China in 2010 with 16,914 children and adolescents aged 7-17 years. Participants were randomly divided into the training and testing sets. Diagnostic values were estimated using sensitivity, specificity and areas under receiver operating characteristic curves. The coefficients of variation of Waist-to-Height Ratio among age groups were lower than that of body mass index and waist circumstance. The area under receiver operating characteristic curve of Waist-to-Height Ratio was 0.968 in boys and 0.949 in girls for general obesity evaluation, and 0.983 in boys and 0.984 in girls for central obesity. The optimal cut-offs of Waist-to-Height Ratio were 0.47 in boys and 0.45 in girls in the training set and validated in the testing set. For metabolic syndrome evaluation, the sensitivity and specificity were 0.858 and 0.825 in boys, 0.864 and 0.812 in girls under the suggested cut-offs. Waist-to-Height Ratio was a simple, effective and practical tool for mass screening childhood obesity and metabolic syndrome in China. It will have potential values in public health practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Sensitive and affordable diagnostic assay for the quantitative detection of anaplastic lymphoma kinase (ALK) alterations in patients with non-small cell lung cancer.

PubMed

Dama, Elisa; Tillhon, Micol; Bertalot, Giovanni; de Santis, Francesca; Troglio, Flavia; Pessina, Simona; Passaro, Antonio; Pece, Salvatore; de Marinis, Filippo; Dell'Orto, Patrizia; Viale, Giuseppe; Spaggiari, Lorenzo; Di Fiore, Pier Paolo; Bianchi, Fabrizio; Barberis, Massimo; Vecchi, Manuela

2016-06-14

Accurate detection of altered anaplastic lymphoma kinase (ALK) expression is critical for the selection of lung cancer patients eligible for ALK-targeted therapies. To overcome intrinsic limitations and discrepancies of currently available companion diagnostics for ALK, we developed a simple, affordable and objective PCR-based predictive model for the quantitative measurement of any ALK fusion as well as wild-type ALK upregulation. This method, optimized for low-quantity/-quality RNA from FFPE samples, combines cDNA pre-amplification with ad hoc generated calibration curves. All the models we derived yielded concordant predictions when applied to a cohort of 51 lung tumors, and correctly identified all 17 ALK FISH-positive and 33 of the 34 ALK FISH-negative samples. The one discrepant case was confirmed as positive by IHC, thus raising the accuracy of our test to 100%. Importantly, our method was accurate when using low amounts of input RNA (10 ng), also in FFPE samples with limited tumor cellularity (5-10%) and in FFPE cytology specimens. Thus, our test is an easily implementable diagnostic tool for the rapid, efficacious and cost-effective screening of ALK status in patients with lung cancer.

Mammalian milk allergy: clinical suspicion, cross-reactivities and diagnosis.

PubMed

Järvinen, Kirsi M; Chatchatee, Pantipa

2009-06-01

Cow's milk allergy affects 2-3% of young children, the economic impact of which necessitates search for simple diagnostic tools and affordable milk substitutes. This review examines recent studies on the diagnosis of cow's milk allergy as well as on the allergenicity of milk from other mammalian species. Resolution of symptoms during strict milk avoidance and their re-appearance during the double-blind, placebo-controlled milk challenge remains the gold standard for the diagnosis of cow's milk allergy. Allergic eosinophilic esophagitis/gastroenteritis requires confirmatory endoscopic biopsy. There are increasing data in various populations on cut-off points based on positive predictive values for skin prick test and milk-specific IgE measurements to aid in the diagnosis of cow's milk allergy and to decrease the number of unnecessary food challenges. For non-IgE-mediated manifestations, noninvasive diagnostic tests are still largely lacking. The significant homology between milk from cow, sheep and goat results in clinical cross-reactivity. However, mare's or donkey's milk may be tolerated by some individuals. Data have been accumulating on the utility of diagnostic tools for mostly IgE-mediated milk allergy and allergenicity of milk from other mammalian species, although further studies are sought.

[Rate of human papillomavirus infection in rural areas diagnosed by direct visualization with acetic acid and lugol].

PubMed

José Daniel, Flores-Alatriste; Karla Georgina, Saldivar-Gutiérrez; Josué Sarmiento-Ángeles; Jaime Claudio, Granados-Marin; Marco Antonio, Olaya-Rivera; Stark, Carlotta; Hugo, Flores-Navarro; Jaroslav, Stern-Colin

2015-07-01

Infection by HPV is a major global health problem and the main risk factor for cervical cancer with high morbidity and mortality. Simple diagnostic methods, such as visual inspection with the naked eye of the cervix with acetic acid application 5% (VAT) or solution of iodine (tincture of iodine) are simple to detect early lesions, sensitivity varies from 87 to 99% and specificity varies from 23 to 87%. To find the proportion of infection by human papillomavirus in a population of extreme poverty. Linear, observational and descriptive pilot study was done in patients of marginalized communities in extreme poverty in Chiapas (Mexico), from 1 to 30 November 2013. The existence of acetowhite lesions suggestive of virus was verified human papillomavirus, and medical history of all patients was formed for the incidence of risk factors. 214 women with age limits of 19 and 78 years, median age of 37 years were studied. Of the total, 66 (31%) had acetowhite lesions consistent with human papillomavirus at the time of the study. Marginalized populations have a higher risk of infection with human papillomavirus, consequently high rate of progression to cervical cancer due to sociodemographic characteristics, risk factors and lack of resources in health. Diagnostic tests like the simple display with acetic acid are ideal for people such as this.

Clinical importance of personality difficulties: diagnostically sub-threshold personality disorders.

PubMed

Karukivi, Max; Vahlberg, Tero; Horjamo, Kalle; Nevalainen, Minna; Korkeila, Jyrki

2017-01-14

Current categorical classification of personality disorders has been criticized for overlooking the dimensional nature of personality and that it may miss some sub-threshold personality disturbances of clinical significance. We aimed to evaluate the clinical importance of these conditions. For this, we used a simple four-level dimensional categorization based on the severity of personality disturbance. The sample consisted of 352 patients admitted to mental health services. All underwent diagnostic assessments (SCID-I and SCID-II) and filled in questionnaires concerning their social situation and childhood adversities, and other validated tools, including the Beck Depression Inventory (BDI), Alcohol Use Disorders Identification Test (AUDIT), health-related quality of life (15D), and the five-item Mental Health Index (MHI-5). The patients were categorized into four groups according to the level of personality disturbance: 0 = No personality disturbance, 1 = Personality difficulty (one criterion less than threshold for one or more personality disorders), 2 = Simple personality disorder (one personality disorder), and 3 = Complex/Severe personality disorder (two or more personality disorders or any borderline and antisocial personality disorder). The proportions of the groups were as follows: no personality disturbance 38.4% (n = 135), personality difficulty 14.5% (n = 51), simple personality disorder 19.9% (n = 70), and complex/severe personality disorder 24.4% (n = 86). Patients with no personality disturbance were significantly differentiated (p < 0.05) from the other groups regarding the BDI, 15D, and MHI-5 scores as well as the number of Axis I diagnoses. Patients with complex/severe personality disorders stood out as being worst off. Social dysfunction was related to the severity of the personality disturbance. Patients with a personality difficulty or a simple personality disorder had prominent symptoms and difficulties, but the differences between these groups were mostly non-significant. An elevated severity level of personality disturbance is associated with an increase in psychiatric morbidity and social dysfunction. Diagnostically sub-threshold personality difficulties are of clinical significance and the degree of impairment corresponds to actual personality disorders. Since these two groups did not significantly differ from each other, our findings also highlight the complexity related to the use of diagnostic thresholds for separate personality disorders.

Draw your assay: Fabrication of low-cost paper-based diagnostic and multi-well test zones by drawing on a paper.

PubMed

Oyola-Reynoso, Stephanie; Heim, Andrew P; Halbertsma-Black, Julian; Zhao, C; Tevis, Ian D; Çınar, Simge; Cademartiri, Rebecca; Liu, Xinyu; Bloch, Jean-Francis; Thuo, Martin M

2015-11-01

Interest in low-cost diagnostic devices has recently gained attention, in part due to the rising cost of healthcare and the need to serve populations in resource-limited settings. A major challenge in the development of such devices is the need for hydrophobic barriers to contain polar bio-fluid analytes. Key approaches in lowering the cost in diagnostics have centered on (i) development of low-cost fabrication techniques/processes, (ii) use of affordable materials, or, (iii) minimizing the need for high-tech tools. This communication describes a simple, low-cost, adaptable, and portable method for patterning paper and subsequent use of the patterned paper in diagnostic tests. Our approach generates hydrophobic regions using a ball-point pen filled with a hydrophobizing molecule suspended in a solvent carrier. An empty ball-point pen was filled with a solution of trichloro perfluoroalkyl silane in hexanes (or hexadecane), and the pen used to draw lines on Whatman® chromatography 1 paper. The drawn regions defined the test zones since the trichloro silane reacts with the paper to give a hydrophobic barrier. The formation of the hydrophobic barriers is reaction kinetic and diffusion-limited, ensuring well defined narrow barriers. We performed colorimetric glucose assays and enzyme-linked immuno-sorbent assay (ELISA) using the created test zones. To demonstrate the versatility of this approach, we fabricated multiple devices on a single piece of paper and demonstrated the reproducibility of assays on these devices. The overall cost of devices fabricated by drawing are relatively lower (

Application of loop-mediated isothermal amplification (LAMP) assays for the detection of bovine herpesvirus 1.

PubMed

Socha, W; Rola, J; Urban-Chmiel, R; Żmudziński, J F

2017-09-26

Bovine herpesvirus-1 (BoHV-1), a causative agent of Infectious Bovine Rhinotracheitis (IBR), is responsible for high economic losses in cattle farming industry. The use of testing methods that allow early detection of BoHV-1-infected animals is a key element of each program of IBR eradication. The aim of the study was to design and evaluate two variants of LAMP isothermal tests with SYBR Green fluorescence probes, specific to the genes encoding gD and gE glycoproteins of BoHV-1. LAMP gE BoHV-1 assay was able to distinguish between gE- and gE+ strains of the virus. Both LAMP gD and gE assays were specific to BoHV-1 and did not react with other related to BoHV-1 alphaherpesviruses. Sensitivity of LAMP gD was 2x104 copies of the viral genome whereas for LAMP gE it was 2x105. Diagnostic sensitivity calculated for LAMP gD was 64.7% whereas for LAMP gE it was 80%. Diagnostic specificity for LAMP gD and LAMP gE was 78.9% and 89.3%, respectively. LAMP assay can be a rapid and simple method of diagnosis of acute BoHV-1 infections and discrimination of gE- strains. However, relatively low diagnostic sensitivity of the method can limit its use in routine diagnostics.

Production and Evaluation of a Purified Adenovirus Group-Specific (Hexon) Antigen for Use in the Diagnostic Complement Fixation Test

PubMed Central

Dowdle, W. R.; Lambriex, M.; Hierholzer, J. C.

1971-01-01

A simple procedure for the production of large volumes of purified adenovirus group-specific complement-fixing (CF) (hexon) antigen by selective adsorption to and elution from CaHPO4 is described. Results of immunodiffusion tests, electrophoresis, electron microscopy, and tests for hemagglutination and infectivity indicate that the purified antigen consisted of a single virus component (hexon). The purified product contained little host materials. Unlike the crude virus harvest usually employed for serodiagnostic CF tests, the purified antigen demonstrated no anticomplementary activity and did not develop such activity during storage. The purified antigen was equal to or slightly more sensitive than crude virus harvests for serodiagnosis of adenovirus infections. Images PMID:4325021

Analysis of psycho-physiological features of a subject in simple tests with the registration of electroencephalograms

NASA Astrophysics Data System (ADS)

Runnova, Anastasiya; Zhuravlev, Maxim; Kulanin, Roman; Protasov, Pavel; Efremova, Tatiana

2018-04-01

In this paper we found a correlation between the characteristics of a person revealed in classical psychological testing on the basis of Schulte tables, and its neurophysiological features of the functioning of the brain obtained from the time-frequency analysis of EEG. The results obtained are interesting from the point of view of the choice of training strategies for a particular individual. We believe that the obtained results are of interest for fundamental science and applied works of psychological testing and diagnostics. The study of such forming strategies on EEG data can be automated and do not require the work of highly skilled psychologists.

Interaction Between a Steady Detonation Wave in Nitromethane and Geometrical Complex Confinement Defects

NASA Astrophysics Data System (ADS)

Crouzet, B.; Soulard, L.; Carion, N.; Manczur, P.

2007-12-01

Two copper cylinder expansion tests were carried out on nitromethane. They differ from the classical cylinder test in that the liner includes evenly-spaced protruding circular defects. The aim is to study how a detonation front propagating in the liquid explosive interacts with the confining material defects. The subsequent motion of the metal, accelerated by the expanding detonation products, is measured using a range of diagnostic techniques: electrical probes, a rapid framing camera, a glass block associated with a streak camera and velocity laser interferometers. The different experimental records have been examined in the light of previous classical cylinder test measurements, simple 2D theoretical shock polar analysis results and 2D numerical simulations.

Functional electrospun nanofibers for multimodal sensitive detection of biogenic amines in food via a simple dipstick assay.

PubMed

Yurova, Nadezhda S; Danchuk, Alexandra; Mobarez, Sarah N; Wongkaew, Nongnoot; Rusanova, Tatiana; Baeumner, Antje J; Duerkop, Axel

2018-01-01

Electrospun nanofibers (ENFs) are promising materials for rapid diagnostic tests like lateral flow assays and dipsticks because they offer an immense surface area while excluding minimal volume, a variety of functional surface groups, and can entrap functional additives within their interior. Here, we show that ENFs on sample pads are superior in comparison to standard polymer membranes for the optical detection of biogenic amines (BAs) in food using a dipstick format. Specifically, cellulose acetate (CA) fibers doped with 2 mg/mL of the chromogenic and fluorogenic amine-reactive chameleon dye Py-1 were electrospun into uniform anionic mats. Those extract cationic BAs from real samples and Py-1 transduces BA concentrations into a change of color, reflectance, and fluorescence. Dropping a BA sample onto the nanofiber mat converts the weakly fluorescent pyrylium dye Py-1 into a strongly red emitting pyridinium dye. For the first time, a simple UV lamp excites fluorescence and a digital camera acts as detector. The intensity ratio of the red to the blue channel of the digital image is dependent on the concentration of most relevant BAs indicating food spoilage from 10 to 250 μM. This matches the permitted limits for BAs in foods and no false positive signals arise from secondary and tertiary amines. BA detection in seafood samples was also demonstrated successfully. The nanofiber mat dipsticks were up to sixfold more sensitive than those using a polymer membrane with the same dye embedded. Hence, nanofiber-based tests are not only superior to polymer-based dipstick assays, but will also improve the performance of established tests related to food safety, medical diagnostics, and environmental testing. Graphical Absract ᅟ.

Emergency physician perceptions of medically unnecessary advanced diagnostic imaging.

PubMed

Kanzaria, Hemal K; Hoffman, Jerome R; Probst, Marc A; Caloyeras, John P; Berry, Sandra H; Brook, Robert H

2015-04-01

The objective was to determine emergency physician (EP) perceptions regarding 1) the extent to which they order medically unnecessary advanced diagnostic imaging, 2) factors that contribute to this behavior, and 3) proposed solutions for curbing this practice. As part of a larger study to engage physicians in the delivery of high-value health care, two multispecialty focus groups were conducted to explore the topic of decision-making around resource utilization, after which qualitative analysis was used to generate survey questions. The survey was extensively pilot-tested and refined for emergency medicine (EM) to focus on advanced diagnostic imaging (i.e., computed tomography [CT] or magnetic resonance imaging [MRI]). The survey was then administered to a national, purposive sample of EPs and EM trainees. Simple descriptive statistics to summarize physician responses are presented. In this study, 478 EPs were approached, of whom 435 (91%) completed the survey; 68% of respondents were board-certified, and roughly half worked in academic emergency departments (EDs). Over 85% of respondents believe too many diagnostic tests are ordered in their own EDs, and 97% said at least some (mean = 22%) of the advanced imaging studies they personally order are medically unnecessary. The main perceived contributors were fear of missing a low-probability diagnosis and fear of litigation. Solutions most commonly felt to be "extremely" or "very" helpful for reducing unnecessary imaging included malpractice reform (79%), increased patient involvement through education (70%) and shared decision-making (56%), feedback to physicians on test-ordering metrics (55%), and improved education of physicians on diagnostic testing (50%). Overordering of advanced imaging may be a systemic problem, as many EPs believe a substantial proportion of such studies, including some they personally order, are medically unnecessary. Respondents cited multiple complex factors with several potential high-yield solutions that must be addressed simultaneously to curb overimaging. © 2015 by the Society for Academic Emergency Medicine.

Fecal immunochemical test for predicting mucosal healing in ulcerative colitis patients: A systematic review and meta-analysis.

PubMed

Dai, Cong; Jiang, Min; Sun, Ming-Jun; Cao, Qin

2018-05-01

Fecal immunochemical test (FIT) is a promising marker for assessment of inflammatory bowel disease activity. However, the utility of FIT for predicting mucosal healing (MH) of ulcerative colitis (UC) patients has yet to be clearly demonstrated. The objective of our study was to perform a diagnostic test accuracy test meta-analysis evaluating the diagnostic accuracy of FIT in predicting MH of UC patients. We systematically searched the databases from inception to November 2017 that evaluated MH in UC. The methodological quality of each study was assessed according to the Quality Assessment of Diagnostic Accuracy Studies checklist. The extracted data were pooled using a summary receiver operating characteristic curve model. Random-effects model was used to summarize the diagnostic odds ratio, sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio. Six studies comprising 625 UC patients were included in the meta-analysis. The pooled sensitivity and specificity values for predicting MH in UC were 0.77 (95% confidence interval [CI], 0.72-0.81) and 0.81 (95% CI, 0.76-0.85), respectively. The FIT level had a high rule-in value (positive likelihood ratio, 3.79; 95% CI, 2.85-5.03) and a moderate rule-out value (negative likelihood ratio, 0.26; 95% CI, 0.16-0.43) for predicting MH in UC. The results of the receiver operating characteristic curve analysis (area under the curve, 0.88; standard error of the mean, 0.02) and diagnostic odds ratio (18.08; 95% CI, 9.57-34.13) also revealed improved discrimination for identifying MH in UC with FIT concentration. Our meta-analysis has found that FIT is a simple, reliable non-invasive marker for predicting MH in UC patients. © 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

A concise evidence-based physical examination for diagnosis of acromioclavicular joint pathology: a systematic review.

PubMed

Krill, Michael K; Rosas, Samuel; Kwon, KiHyun; Dakkak, Andrew; Nwachukwu, Benedict U; McCormick, Frank

2018-02-01

The clinical examination of the shoulder joint is an undervalued diagnostic tool for evaluating acromioclavicular (AC) joint pathology. Applying evidence-based clinical tests enables providers to make an accurate diagnosis and minimize costly imaging procedures and potential delays in care. The purpose of this study was to create a decision tree analysis enabling simple and accurate diagnosis of AC joint pathology. A systematic review of the Medline, Ovid and Cochrane Review databases was performed to identify level one and two diagnostic studies evaluating clinical tests for AC joint pathology. Individual test characteristics were combined in series and in parallel to improve sensitivities and specificities. A secondary analysis utilized subjective pre-test probabilities to create a clinical decision tree algorithm with post-test probabilities. The optimal special test combination to screen and confirm AC joint pathology combined Paxinos sign and O'Brien's Test, with a specificity of 95.8% when performed in series; whereas, Paxinos sign and Hawkins-Kennedy Test demonstrated a sensitivity of 93.7% when performed in parallel. Paxinos sign and O'Brien's Test demonstrated the greatest positive likelihood ratio (2.71); whereas, Paxinos sign and Hawkins-Kennedy Test reported the lowest negative likelihood ratio (0.35). No combination of special tests performed in series or in parallel creates more than a small impact on post-test probabilities to screen or confirm AC joint pathology. Paxinos sign and O'Brien's Test is the only special test combination that has a small and sometimes important impact when used both in series and in parallel. Physical examination testing is not beneficial for diagnosis of AC joint pathology when pretest probability is unequivocal. In these instances, it is of benefit to proceed with procedural tests to evaluate AC joint pathology. Ultrasound-guided corticosteroid injections are diagnostic and therapeutic. An ultrasound-guided AC joint corticosteroid injection may be an appropriate new standard for treatment and surgical decision-making. II - Systematic Review.

Development of a clinical diagnostic matrix for characterizing inherited epidermolysis bullosa.

PubMed

Yenamandra, V K; Moss, C; Sreenivas, V; Khan, M; Sivasubbu, S; Sharma, V K; Sethuraman, G

2017-06-01

Accurately diagnosing the subtype of epidermolysis bullosa (EB) is critical for management and genetic counselling. Modern laboratory techniques are largely inaccessible in developing countries, where the diagnosis remains clinical and often inaccurate. To develop a simple clinical diagnostic tool to aid in the diagnosis and subtyping of EB. We developed a matrix indicating presence or absence of a set of distinctive clinical features (as rows) for the nine most prevalent EB subtypes (as columns). To test an individual patient, presence or absence of these features was compared with the findings expected in each of the nine subtypes to see which corresponded best. If two or more diagnoses scored equally, the diagnosis with the greatest number of specific features was selected. The matrix was tested using findings from 74 genetically characterized patients with EB aged > 6 months by an investigator blinded to molecular diagnosis. For concordance, matrix diagnoses were compared with molecular diagnoses. Overall, concordance between the matrix and molecular diagnoses for the four major types of EB was 91·9%, with a kappa coefficient of 0·88 [95% confidence interval (CI) 0·81-0·95; P < 0·001]. The matrix achieved a 75·7% agreement in classifying EB into its nine subtypes, with a kappa coefficient of 0·73 (95% CI 0·69-0·77; P < 0·001). The matrix appears to be simple, valid and useful in predicting the type and subtype of EB. An electronic version will facilitate further testing. © 2016 British Association of Dermatologists.

Rapid identification of pneumococci, enterococci, beta-haemolytic streptococci and S. aureus from positive blood cultures enabling early reports.

PubMed

Larsson, Marie C; Karlsson, Ewa; Woksepp, Hanna; Frölander, Kerstin; Mårtensson, Agneta; Rashed, Foad; Annika, Wistedt; Schön, Thomas; Serrander, Lena

2014-03-19

The aim of this study was to evaluate diagnostic tests in order to introduce a diagnostic strategy to identify the most common gram-positive bacteria (pneumococci, enterococci, β-haemolytic streptococci and S. aureus) found in blood cultures within 6 hours after signalling growth. The tube coagulase test was optimized and several latex agglutination tests were compared and evaluated before a validation period of 11 months was performed on consecutive positive blood culture patient samples from Kalmar County Hospital, Sweden. During the validation period 150 (91%) of a total of 166 gram-positive cocci (119 in clusters, 45 in chains or pairs and 2 undefined morphology) were correctly identified as S. aureus, CoNS, Pneumococci, Enterococci or group A streptococci (GAS), group B streptococci (GBS), group G streptococci (GGS) within 6 hours with a minimal increase in work-load and costs. The remaining samples (9%) were correctly identified during the next day. No samples were incorrectly grouped with this diagnostic strategy and no patient came to risk by early reporting. A simple strategy gives reliable and cost-effective reporting of >90% of the most common gram-positive cocci within 6 hours after a blood cultures become positive. The high specificity of the tests used makes preliminary reports reliable. The reports can be used to indicate the focus of infection and not the least, support faster administration of proper antimicrobial treatment for patients with serious bacterial infections.

Water-loss (intracellular) dehydration assessed using urinary tests: how well do they work? Diagnostic accuracy in older people.

PubMed

Hooper, Lee; Bunn, Diane K; Abdelhamid, Asmaa; Gillings, Rachel; Jennings, Amy; Maas, Katie; Millar, Sophie; Twomlow, Elizabeth; Hunter, Paul R; Shepstone, Lee; Potter, John F; Fairweather-Tait, Susan J

2016-07-01

Water-loss dehydration (hypertonic, hyperosmotic, or intracellular dehydration) is due to insufficient fluid intake and is distinct from hypovolemia due to excess fluid losses. Water-loss dehydration is associated with poor health outcomes such as disability and mortality in older people. Urine specific gravity (USG), urine color, and urine osmolality have been widely advocated for screening for dehydration in older adults. We assessed the diagnostic accuracy of urinary measures to screen for water-loss dehydration in older people. This was a diagnostic accuracy study of people aged ≥65 y taking part in the DRIE (Dehydration Recognition In our Elders; living in long-term care) or NU-AGE (Dietary Strategies for Healthy Ageing in Europe; living in the community) studies. The reference standard was serum osmolality, and index tests included USG, urine color, urine osmolality, urine cloudiness, additional dipstick measures, ability to provide a urine sample, and the volume of a random urine sample. Minimum useful diagnostic accuracy was set at sensitivity and specificity ≥70% or a receiver operating characteristic plot area under the curve ≥0.70. DRIE participants (women: 67%; mean age: 86 y; n = 162) had more limited cognitive and functional abilities than did NU-AGE participants (women: 64%; mean age: 70 y; n = 151). Nineteen percent of DRIE participants and 22% of NU-AGE participants were dehydrated (serum osmolality >300 mOsm/kg). Neither USG nor any other potential urinary tests were usefully diagnostic for water-loss dehydration. Although USG, urine color, and urinary osmolality have been widely advocated for screening for dehydration in older adults, we show, in the largest study to date to our knowledge, that their diagnostic accuracy is too low to be useful, and these measures should not be used to indicate hydration status in older people (either alone or as part of a wider tranche of tests). There is a need to develop simple, inexpensive, and noninvasive tools for the assessment of dehydration in older people. The DRIE study was registered at www.researchregister.org.uk as 122273. The NU-AGE trial was registered at clinicialtrials.gov as NCT01754012. © 2016 American Society for Nutrition.

Rapid non-invasive tests for diagnostics of infectious diseases

NASA Astrophysics Data System (ADS)

Malamud, Daniel

2014-06-01

A rapid test for an infectious disease that can be used at point-of-care at a physician's office, a pharmacy, or in the field is critical for the prompt and appropriate therapeutic intervention. Ultimately by treating infections early on will decrease transmission of the pathogen. In contrast to metabolic diseases or cancer where multiple biomarkers are required, infectious disease targets (e.g. antigen, antibody, nucleic acid) are simple and specific for the pathogen causing the disease. Our laboratory has focused on three major infectious disease; HIV, Tuberculosis, and Malaria. These diseases are pandemic in much of the world thus putting natives, tourists and military personnel at risk for becoming infected, and upon returning to the U.S., transmitting these diseases to their contacts. Our devices are designed to detect antigens, antibodies or nucleic acids in blood or saliva samples in less than 30 minutes. An overview describing the current status of each of the three diagnostic platforms is presented. These microfluidic point-of-care devices will be relatively inexpensive, disposable, and user friendly.

Enhancements to the Engine Data Interpretation System (EDIS)

NASA Technical Reports Server (NTRS)

Hofmann, Martin O.

1993-01-01

The Engine Data Interpretation System (EDIS) expert system project assists the data review personnel at NASA/MSFC in performing post-test data analysis and engine diagnosis of the Space Shuttle Main Engine (SSME). EDIS uses knowledge of the engine, its components, and simple thermodynamic principles instead of, and in addition to, heuristic rules gathered from the engine experts. EDIS reasons in cooperation with human experts, following roughly the pattern of logic exhibited by human experts. EDIS concentrates on steady-state static faults, such as small leaks, and component degradations, such as pump efficiencies. The objective of this contract was to complete the set of engine component models, integrate heuristic rules into EDIS, integrate the Power Balance Model into EDIS, and investigate modification of the qualitative reasoning mechanisms to allow 'fuzzy' value classification. The results of this contract is an operational version of EDIS. EDIS will become a module of the Post-Test Diagnostic System (PTDS) and will, in this context, provide system-level diagnostic capabilities which integrate component-specific findings provided by other modules.

Enhancements to the Engine Data Interpretation System (EDIS)

NASA Technical Reports Server (NTRS)

Hofmann, Martin O.

1993-01-01

The Engine Data Interpretation System (EDIS) expert system project assists the data review personnel at NASA/MSFC in performing post-test data analysis and engine diagnosis of the Space Shuttle Main Engine (SSME). EDIS uses knowledge of the engine, its components, and simple thermodynamic principles instead of, and in addition to, heuristic rules gathered from the engine experts. EDIS reasons in cooperation with human experts, following roughly the pattern of logic exhibited by human experts. EDIS concentrates on steady-state static faults, such as small leaks, and component degradations, such as pump efficiencies. The objective of this contract was to complete the set of engine component models, integrate heuristic rules into EDIS, integrate the Power Balance Model into EDIS, and investigate modification of the qualitative reasoning mechanisms to allow 'fuzzy' value classification. The result of this contract is an operational version of EDIS. EDIS will become a module of the Post-Test Diagnostic System (PTDS) and will, in this context, provide system-level diagnostic capabilities which integrate component-specific findings provided by other modules.

Metabolic emergencies and the emergency physician.

PubMed

Fletcher, Janice Mary

2016-02-01

Fifty percent of inborn errors of metabolism are present in later childhood and adulthood, with crises commonly precipitated by minor viral illnesses or increased protein ingestion. Many physicians only consider IEM after more common conditions (such as sepsis) have been considered. In view of the large number of inborn errors, it might appear that their diagnosis requires precise knowledge of a large number of biochemical pathways and their interrelationship. As a matter of fact, an adequate diagnostic approach can be based on the proper use of only a few screening tests. A detailed history of antecedent events, together with these simple screening tests, can be diagnostic, leading to life-saving, targeted treatments for many disorders. Unrecognised, IEM can lead to significant mortality and morbidity. Advice is available 24/7 through the metabolic service based at the major paediatric hospital in each state and Starship Children's Health in New Zealand. © 2016 The Author. Journal of Paediatrics and Child Health © 2016 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Mitochondrial DNA Mutation Associated with Leber's Hereditary Optic Neuropathy

NASA Astrophysics Data System (ADS)

Wallace, Douglas C.; Singh, Gurparkash; Lott, Marie T.; Hodge, Judy A.; Schurr, Theodore G.; Lezza, Angela M. S.; Elsas, Louis J.; Nikoskelainen, Eeva K.

1988-12-01

Leber's hereditary optic neuropathy is a maternally inherited disease resulting in optic nerve degeneration and cardiac dysrhythmia. A mitochondrial DNA replacement mutation was identified that correlated with this disease in multiple families. This mutation converted a highly conserved arginine to a histidine at codon 340 in the NADH dehydrogenase subunit 4 gene and eliminated an Sfa NI site, thus providing a simple diagnostic test. This finding demonstrated that a nucleotide change in a mitochondrial DNA energy production gene can result in a neurological disease.

Elongated uvula and diagnostic utility of spirometry in upper airway obstruction

PubMed Central

Paliwal, Rajiv; Patel, Satish; Patel, Purvesh; Soni, Hiren

2010-01-01

Elongated uvula is relatively an uncommon condition. Upper airway obstruction is often a missed complication of such a rare condition. Clinical presentations of upper airway obstruction often mimic asthma. Hence it is very easily mis-diagnosed as asthma. Spirometry offers a very simple test to diagnose upper airway obstruction very early and easily. Once diagnosed, the management of elongated uvula, almost exclusively, is surgical excision leading to total cure. Here is a case report of such a rare condition. PMID:20539769

Rare Cell Separation and Analysis by Magnetic Sorting

PubMed Central

Zborowski, Maciej; Chalmers, Jeffrey J.

2011-01-01

Summary The separation and or isolation of rare cells using magnetic forces is commonly used and growing in use ranging from simple sample prep for further studies to a FDA approved, clinical diagnostic test. This grown is the result of both the demand to obtain homogeneous rare cells for molecular analysis and the dramatic increases in the power of permanent magnets that even allow the separation of some unlabeled cells based on intrinsic magnetic moments, such as malaria parasite-infected red blood cells. PMID:21812408

A Community-Based IoT Personalized Wireless Healthcare Solution Trial.

PubMed

Catherwood, Philip A; Steele, David; Little, Mike; Mccomb, Stephen; Mclaughlin, James

2018-01-01

This paper presents an advanced Internet of Things point-of-care bio-fluid analyzer; a LoRa/Bluetooth-enabled electronic reader for biomedical strip-based diagnostics system for personalized monitoring. We undertake test simulations (technology trial without patient subjects) to demonstrate potential of long-range analysis, using a disposable test 'key' and companion Android app to form a diagnostic platform suitable for remote point-of-care screening for urinary tract infection (UTI). The 868 MHz LoRaWAN-enabled personalized monitor demonstrated sound potential with UTI test results being correctly diagnosed and transmitted to a remote secure cloud server in every case. Tests ranged over distances of 1.1-6.0 Km with radio path losses from 119-141 dB. All tests conducted were correctly and robustly received at the base station and relayed to the secure server for inspection. The UTI test strips were visually inspected for correct diagnosis based on color change and verified as 100% accurate. Results from testing across a number of regions indicate that such an Internet of Things medical solution is a robust and simple way to deliver next generation community-based smart diagnostics and disease management to best benefit patients and clinical staff alike. This significant step can be applied to any type of home or region, particularly those lacking suitable mobile signals, broadband connections, or even landlines. It brings subscription-free long-range bio-telemetry to healthcare providers and offers savings on regular clinician home visits or frequent clinic visits by the chronically ill. This paper highlights practical hurdles in establishing an Internet of Medical Things network, assisting informed deployment of similar future systems.

A Community-Based IoT Personalized Wireless Healthcare Solution Trial

PubMed Central

Steele, David; Little, Mike; Mccomb, Stephen; Mclaughlin, James

2018-01-01

This paper presents an advanced Internet of Things point-of-care bio-fluid analyzer; a LoRa/Bluetooth-enabled electronic reader for biomedical strip-based diagnostics system for personalized monitoring. We undertake test simulations (technology trial without patient subjects) to demonstrate potential of long-range analysis, using a disposable test ‘key’ and companion Android app to form a diagnostic platform suitable for remote point-of-care screening for urinary tract infection (UTI). The 868 MHz LoRaWAN-enabled personalized monitor demonstrated sound potential with UTI test results being correctly diagnosed and transmitted to a remote secure cloud server in every case. Tests ranged over distances of 1.1–6.0 Km with radio path losses from 119–141 dB. All tests conducted were correctly and robustly received at the base station and relayed to the secure server for inspection. The UTI test strips were visually inspected for correct diagnosis based on color change and verified as 100% accurate. Results from testing across a number of regions indicate that such an Internet of Things medical solution is a robust and simple way to deliver next generation community-based smart diagnostics and disease management to best benefit patients and clinical staff alike. This significant step can be applied to any type of home or region, particularly those lacking suitable mobile signals, broadband connections, or even landlines. It brings subscription-free long-range bio-telemetry to healthcare providers and offers savings on regular clinician home visits or frequent clinic visits by the chronically ill. This paper highlights practical hurdles in establishing an Internet of Medical Things network, assisting informed deployment of similar future systems. PMID:29888145

Updates on chikungunya epidemiology, clinical disease, and diagnostics.

PubMed

Sam, I-Ching; Kümmerer, Beate M; Chan, Yoke-Fun; Roques, Pierre; Drosten, Christian; AbuBakar, Sazaly

2015-04-01

Chikungunya virus (CHIKV) is an Aedes-borne alphavirus, historically found in Africa and Asia, where it caused sporadic outbreaks. In 2004, CHIKV reemerged in East Africa and spread globally to cause epidemics, including, for the first time, autochthonous transmission in Europe, the Middle East, and Oceania. The epidemic strains were of the East/Central/South African genotype. Strains of the Asian genotype of CHIKV continued to cause outbreaks in Asia and spread to Oceania and, in 2013, to the Americas. Acute disease, mainly comprising fever, rash, and arthralgia, was previously regarded as self-limiting; however, there is growing evidence of severe but rare manifestations, such as neurological disease. Furthermore, CHIKV appears to cause a significant burden of long-term morbidity due to persistent arthralgia. Diagnostic assays have advanced greatly in recent years, although there remains a need for simple, accurate, and affordable tests for the developing countries where CHIKV is most prevalent. This review focuses on recent important work on the epidemiology, clinical disease and diagnostics of CHIKV.

Screening and syndromic approaches to identify gonorrhea and chlamydial infection among women.

PubMed

Sloan, N L; Winikoff, B; Haberland, N; Coggins, C; Elias, C

2000-03-01

The standard diagnostic tools to identify sexually transmitted infections are often expensive and have laboratory and infrastructure requirements that make them unavailable to family planning and primary health-care clinics in developing countries. Therefore, inexpensive, accessible tools that rely on symptoms, signs, and/or risk factors have been developed to identify and treat reproductive tract infections without the need for laboratory diagnostics. Studies were reviewed that used standard diagnostic tests to identify gonorrhea and cervical chlamydial infection among women and that provided adequate information about the usefulness of the tools for screening. Aggregation of the studies' results suggest that risk factors, algorithms, and risk scoring for syndromic management are poor indicators of gonorrhea and chlamydial infection in samples of both low and high prevalence and, consequently, are not effective mechanisms with which to identify or manage these conditions. The development and evaluation of other approaches to identify gonorrhea and chlamydial infections, including inexpensive and simple laboratory screening tools, periodic universal treatment, and other alternatives must be given priority.

Silk-based blood stabilization for diagnostics.

PubMed

Kluge, Jonathan A; Li, Adrian B; Kahn, Brooke T; Michaud, Dominique S; Omenetto, Fiorenzo G; Kaplan, David L

2016-05-24

Advanced personalized medical diagnostics depend on the availability of high-quality biological samples. These are typically biofluids, such as blood, saliva, or urine; and their collection and storage is critical to obtain reliable results. Without proper temperature regulation, protein biomarkers in particular can degrade rapidly in blood samples, an effect that ultimately compromises the quality and reliability of laboratory tests. Here, we present the use of silk fibroin as a solid matrix to encapsulate blood analytes, protecting them from thermally induced damage that could be encountered during nonrefrigerated transportation or freeze-thaw cycles. Blood samples are recovered by simple dissolution of the silk matrix in water. This process is demonstrated to be compatible with a number of immunoassays and provides enhanced sample preservation in comparison with traditional air-drying paper approaches. Additional processing can remediate interactions with conformational structures of the silk protein to further enhance blood stabilization and recovery. This approach can provide expanded utility for remote collection of blood and other biospecimens empowering new modalities of temperature-independent remote diagnostics.

Advanced Imaging Adds Little Value in the Diagnosis of Femoroacetabular Impingement Syndrome.

PubMed

Cunningham, Daniel J; Paranjape, Chinmay S; Harris, Joshua D; Nho, Shane J; Olson, Steven A; Mather, Richard C

2017-12-20

Femoroacetabular impingement (FAI) syndrome is an increasingly recognized source of hip pain and disability in young active adults. In order to confirm the diagnosis, providers often supplement physical examination maneuvers and radiographs with intra-articular hip injection, magnetic resonance imaging (MRI), or magnetic resonance arthrography (MRA). Since diagnostic imaging represents the fastest rising cost segment in U.S. health care, there is a need for value-driven diagnostic algorithms. The purpose of this study was to identify cost-effective diagnostic strategies for symptomatic FAI, comparing history and physical examination (H&P) alone (utilizing only radiographic imaging) with supplementation with injection, MRI, or MRA. A simple-chain decision model run as a cost-utility analysis was constructed to assess the diagnostic value of the MRI, MRA, and injection that are added to the H&P and radiographs in diagnosing symptomatic FAI. Strategies were compared using the incremental cost-utility ratio (ICUR) with a willingness to pay (WTP) of $100,000/QALY (quality-adjusted life year). Direct costs were measured using the Humana database (PearlDiver). Diagnostic test accuracy, treatment outcome probabilities, and utilities were extracted from the literature. H&P with and without supplemental diagnostic injection was the most cost-effective. Adjunct injection was preferred in situations with a WTP of >$60,000/QALY, low examination sensitivity, and high FAI prevalence. With low disease prevalence and low examination sensitivity, as may occur in a general practitioner's office, H&P with injection was the most cost-effective strategy, whereas in the reciprocal scenario, H&P with injection was only favored at exceptionally high WTP (∼$990,000). H&P and radiographs with supplemental diagnostic injection are preferred over advanced imaging, even with reasonable deviations from published values of disease prevalence, test sensitivity, and test specificity. Providers with low examination sensitivity in situations with low disease prevalence may benefit most from including injection in their diagnostic strategy. Providers with high examination sensitivity in situations with high disease prevalence may not benefit from including injection in their diagnostic strategy. Providers should not routinely rely on advanced imaging to diagnose FAI syndrome, although advanced imaging may have a role in challenging clinical scenarios. Economic and Decision Analysis Level IV. See Instructions for Authors for a complete description of levels of evidence.

Improved Specificity for Detection of Mycobacterium bovis in Fresh Tissues Using IS6110 Real-time PCR

USDA-ARS?s Scientific Manuscript database

Background: Culture of M. bovis from diagnostic specimens is the gold standard for bovine tuberculosis diagnostics in the US. Detection of M. bovis by PCR in tissue homogenates may provide a simple, rapid method to complement diagnostic culture. A significant impediment to PCR based assays on tissue...

Application of diagnostic tests for mycoplasmal infections of desert and gopher tortoises with management recommendations

USGS Publications Warehouse

Brown, D.R.; Schumacher, Isabella M.; Mclaughlin, Grace S.; Wendland, L.D.; Brown, Mary E.; Klein, P.A.; Jacobson, E.R.

2002-01-01

Mycoplasmosis is a transmissible upper respiratory tract disease that has affected plans for management and conservation of wild desert and gopher tortoises in the United States. Although impact of mycoplasmosis on populations of desert and gopher tortoises is unknown, increased prevalence of seropositive animals as well as field observations of clinically ill tortoises have occurred in association with declining populations. In order to help in the identification of potentially infected animals, three tests have been developed to diagnose mycoplasmal infections of tortoises: 1) direct mycoplasmal culture; 2) detection of mycolplasmal chromosomal DNA by polymerase chain reaction (PCR); and 3) detection of anti-Mycoplasma antibodies in tortoise plasma by enzyme-linked immunosorbent assay (ELISA). Each test provides different, complementary information that collectively can be used to define tortoise mycoplasmal infection status. The types of samples required, the predictive value, interpretation, and cost vary among tests. These assays have been used for epidemiological surveys and in decision making for relocation, repatriation, or captive management of tortoises to minimize the risk of outbreaks of mycoplasmal respiratory disease and spread of the causative agent of this disease. Certain features of mycoplasmal infections of tortoises and other animals create a diagnostic dilemma. Multiple Mycoplasma species can cause respiratory disease with identical clinical presentations. Further, individual strains of a given species may vary with respect to their virulence potential, and some species may be commensals rather than pathogens. Current diagnostic tests may not differentiate among mycoplasmal species or strains or permit determination of pathogenicity of individual isolates. Thus, the information provided by testing is not a simple 'positive' vs. 'negative' issue. While these tests provide much needed information on the exposure of tortoise populations to Mycoplasma species, they do not provide a complete picture of the overall health status of individual tortoises or populations. Unfortunately, test results are often used to make life and death decisions concerning disposition of tortoises being displaced by land development without a complete understanding of the limitations of the diagnostic tests or any consideration of other infectious agents that might be present.

Evaluation of the Illumigene Malaria LAMP: A Robust Molecular Diagnostic Tool for Malaria Parasites

PubMed Central

Lucchi, Naomi W.; Gaye, Marie; Diallo, Mammadou Alpha; Goldman, Ira F.; Ljolje, Dragan; Deme, Awa Bineta; Badiane, Aida; Ndiaye, Yaye Die; Barnwell, John W.; Udhayakumar, Venkatachalam; Ndiaye, Daouda

2016-01-01

Isothermal nucleic acid amplification assays such as the loop mediated isothermal amplification (LAMP), are well suited for field use as they do not require thermal cyclers to amplify the DNA. To further facilitate the use of LAMP assays in remote settings, simpler sample preparation methods and lyophilized reagents are required. The performance of a commercial malaria LAMP assay (Illumigene Malaria LAMP) was evaluated using two sample preparation workflows (simple filtration prep (SFP)) and gravity-driven filtration prep (GFP)) and pre-dispensed lyophilized reagents. Laboratory and clinical samples were tested in a field laboratory in Senegal and the results independently confirmed in a reference laboratory in the U.S.A. The Illumigene Malaria LAMP assay was easily implemented in the clinical laboratory and gave similar results to a real-time PCR reference test with limits of detection of ≤2.0 parasites/μl depending on the sample preparation method used. This assay reliably detected Plasmodium sp. parasites in a simple low-tech format, providing a much needed alternative to the more complex molecular tests for malaria diagnosis. PMID:27827432

Design and development of a simple UV fluorescence multi-spectral imaging system

NASA Astrophysics Data System (ADS)

Tovar, Carlos; Coker, Zachary; Yakovlev, Vladislav V.

2018-02-01

Healthcare access in low-resource settings is compromised by the availability of affordable and accurate diagnostic equipment. The four primary poverty-related diseases - AIDS, pneumonia, malaria, and tuberculosis - account for approximately 400 million annual deaths worldwide as of 2016 estimates. Current diagnostic procedures for these diseases are prolonged and can become unreliable under various conditions. We present the development of a simple low-cost UV fluorescence multi-spectral imaging system geared towards low resource settings for a variety of biological and in-vitro applications. Fluorescence microscopy serves as a useful diagnostic indicator and imaging tool. The addition of a multi-spectral imaging modality allows for the detection of fluorophores within specific wavelength bands, as well as the distinction between fluorophores possessing overlapping spectra. The developed instrument has the potential for a very diverse range of diagnostic applications in basic biomedical science and biomedical diagnostics and imaging. Performance assessment of the microscope will be validated with a variety of samples ranging from organic compounds to biological samples.

[In defence of the diagnosis of simple schizophrenia: reflections on a case presentation].

PubMed

Martínez Serrano, José; Medina Garrido, María L; Consuegra Sánchez, Rosario; Del Cerro Oñate, Matias; López-Mesa, José L; González Matás, Juana

2012-01-01

Since the first case descriptions of dementia praecox (Diem, 1903), the diagnosis of simple schizophrenia has continued to be controversial. The questioning of its descriptive validity and its reliability, as well as its infrequent use, has led to it being eliminated as a sub-type of schizophrenia in the DSM-III. Criteria for the diagnosis of «simple deteriorative disorder» are currently included in the DSM-IV-TR as a disorder requiring more studies for its possible inclusion. An attempt is made, using a clinical case, to perform a historical review of the concept of simple schizophrenia, and at the same what has led to the reflection on the possible reasons for the controversy, and a potential route to resolve it. Using a controversial clinical case, which meets ICD-10 clinical criteria for simple schizophrenia (and those of the DSM-IV-TR for the simple deteriorative disorder), we reflect on the symptoms and diagnostic difficulties. A literature review and update on the subjects was also performed. Our patient highlights, by the absence in the clinical picture of the most obvious positive psychotic symptoms, the tendency by psychiatrists to identify the diagnosis of schizophrenia with the presence of the same, at least at some time during its evolution. The use of neuroimaging tests was useful to assess the level of deterioration and prognosis of the patient. Considering simple schizophrenia in the differential diagnosis of other chronic deteriorative disorders could increase its recognition in the initial phases. The use of neuropsychological function tests, and looking for typical deteriorative patterns of the schizophrenia spectrum, could help to increase the reliability of the diagnosis. Copyright © 2011 SEP y SEPB. Published by Elsevier Espana. All rights reserved.

Mining peripheral arterial disease cases from narrative clinical notes using natural language processing.

PubMed

Afzal, Naveed; Sohn, Sunghwan; Abram, Sara; Scott, Christopher G; Chaudhry, Rajeev; Liu, Hongfang; Kullo, Iftikhar J; Arruda-Olson, Adelaide M

2017-06-01

Lower extremity peripheral arterial disease (PAD) is highly prevalent and affects millions of individuals worldwide. We developed a natural language processing (NLP) system for automated ascertainment of PAD cases from clinical narrative notes and compared the performance of the NLP algorithm with billing code algorithms, using ankle-brachial index test results as the gold standard. We compared the performance of the NLP algorithm to (1) results of gold standard ankle-brachial index; (2) previously validated algorithms based on relevant International Classification of Diseases, Ninth Revision diagnostic codes (simple model); and (3) a combination of International Classification of Diseases, Ninth Revision codes with procedural codes (full model). A dataset of 1569 patients with PAD and controls was randomly divided into training (n = 935) and testing (n = 634) subsets. We iteratively refined the NLP algorithm in the training set including narrative note sections, note types, and service types, to maximize its accuracy. In the testing dataset, when compared with both simple and full models, the NLP algorithm had better accuracy (NLP, 91.8%; full model, 81.8%; simple model, 83%; P < .001), positive predictive value (NLP, 92.9%; full model, 74.3%; simple model, 79.9%; P < .001), and specificity (NLP, 92.5%; full model, 64.2%; simple model, 75.9%; P < .001). A knowledge-driven NLP algorithm for automatic ascertainment of PAD cases from clinical notes had greater accuracy than billing code algorithms. Our findings highlight the potential of NLP tools for rapid and efficient ascertainment of PAD cases from electronic health records to facilitate clinical investigation and eventually improve care by clinical decision support. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Rolling element bearings diagnostics using the Symbolic Aggregate approXimation

NASA Astrophysics Data System (ADS)

Georgoulas, George; Karvelis, Petros; Loutas, Theodoros; Stylios, Chrysostomos D.

2015-08-01

Rolling element bearings are a very critical component in various engineering assets. Therefore it is of paramount importance the detection of possible faults, especially at an early stage, that may lead to unexpected interruptions of the production or worse, to severe accidents. This research work introduces a novel, in the field of bearing fault detection, method for the extraction of diagnostic representations of vibration recordings using the Symbolic Aggregate approXimation (SAX) framework and the related intelligent icons representation. SAX essentially transforms the original real valued time-series into a discrete one, which is then represented by a simple histogram form summarizing the occurrence of the chosen symbols/words. Vibration signals from healthy bearings and bearings with three different fault locations and with three different severity levels, as well as loading conditions, are analyzed. Considering the diagnostic problem as a classification one, the analyzed vibration signals and the resulting feature vectors feed simple classifiers achieving remarkably high classification accuracies. Moreover a sliding window scheme combined with a simple majority voting filter further increases the reliability and robustness of the diagnostic method. The results encourage the potential use of the proposed methodology for the diagnosis of bearing faults.

β-trace protein as a diagnostic marker for perilymphatic fluid fistula: a prospective controlled pilot study to test a sample collection technique.

PubMed

Bachmann-Harildstad, Gregor; Stenklev, Niels Christian; Myrvoll, Elin; Jablonski, Greg; Klingenberg, Olav

2011-01-01

The diagnosis of perilymphatic fluid (PLF) fistula is still challenging. Perilymphatic fluid fistula is one possible complication after stapedotomy or cochlear implant surgery. We have performed a prospective diagnostic pilot study to further investigate β-trace protein (β-TP) as a marker for PLF fistula. In this pilot study, we tested the sensitivity of the β-TP marker using a simple method for sample collection from the tympanic cavity. Prospective controlled diagnostic study. Two-center tertiary referral hospitals. A total of 35 adult patients undergoing ear surgery were included. Subjects were divided into 2 groups: 1) 19 patients undergoing stapedotomy were investigated for PLF fistula in samples obtained from the tympanic cavity and 2) 16 patients undergoing myringoplasty were investigated for PLF fistula in samples from the tympanic cavity. This group served as the control. Mean age +/- SD at surgery was 49.9 +/- 8.0 years in the study group and 39.69 +/- 15.47 years in the control group. β-Trace protein (prostaglandin D synthase) in tympanic cavity samples and serum samples was analyzed. The samples were collected by gradually filling the tympanic cavity with 100 to 200 μl sodium chloride and by immediately collecting a volume of 60 to 100 μl in a mucus specimen set container. The concentration of β-TP was quantified using laser nephelometry. The median β-TP in the study group was 0.8 mg/L (range, 0.05-4.5 mg/L). In the control group, the median β-TP value was 0.16 mg/L (range, 0.01-0.36 mg/L). Thirty-five percent of the values in the study group were below the highest value in the negative control group. The β-TP values of the tympanic cavity samples were significantly higher in the study group than in controls (p = 0.0001). The serum values were 0.55 +/- 0.18 and 0.53 +/- 0.11 mg/L, respectively. It may be feasible to test for PLF fistula using β-TP in samples from the tympanic cavity. Our results, however, suggest a relative low diagnostic sensitivity, given a cutoff that is set to obtain a high specificity when using a simple sample collection method. Furthermore, the test does not permit the distinction between PLF fistula and cerebrospinal fluid fistula. Further studies should focus on minimal dilution at sampling and on minimizing sample volumes.

Invasive and non-invasive diagnosis of cirrhosis and portal hypertension

PubMed Central

Kim, Moon Young; Jeong, Woo Kyoung; Baik, Soon Koo

2014-01-01

With advances in the management and treatment of advanced liver disease, including the use of antiviral therapy, a simple, one stage description for advanced fibrotic liver disease has become inadequate. Although refining the diagnosis of cirrhosis to reflect disease heterogeneity is essential, current diagnostic tests have not kept pace with the progression of this new paradigm. Liver biopsy and hepatic venous pressure gradient measurement are the gold standards for the estimation of hepatic fibrosis and portal hypertension (PHT), respectively, and they have diagnostic and prognostic value. However, they are invasive and, as such, cannot be used repeatedly in clinical practice. The ideal noninvasive test should be safe, easy to perform, inexpensive, reproducible as well as to give numerical and accurate results in real time. It should be predictive of long term outcomes related with fibrosis and PHT to allow prognostic stratification. Recently, many types of noninvasive alternative tests have been developed and are under investigation. In particular, imaging and ultrasound based tests, such as transient elastography, have shown promising results. Although most of these noninvasive tests effectively identify severe fibrosis and PHT, the methods available for diagnosing moderate disease status are still insufficient, and further investigation is essential to predict outcomes and individualize therapy in this field. PMID:24764667

A new method to address verification bias in studies of clinical screening tests: cervical cancer screening assays as an example.

PubMed

Xue, Xiaonan; Kim, Mimi Y; Castle, Philip E; Strickler, Howard D

2014-03-01

Studies to evaluate clinical screening tests often face the problem that the "gold standard" diagnostic approach is costly and/or invasive. It is therefore common to verify only a subset of negative screening tests using the gold standard method. However, undersampling the screen negatives can lead to substantial overestimation of the sensitivity and underestimation of the specificity of the diagnostic test. Our objective was to develop a simple and accurate statistical method to address this "verification bias." We developed a weighted generalized estimating equation approach to estimate, in a single model, the accuracy (eg, sensitivity/specificity) of multiple assays and simultaneously compare results between assays while addressing verification bias. This approach can be implemented using standard statistical software. Simulations were conducted to assess the proposed method. An example is provided using a cervical cancer screening trial that compared the accuracy of human papillomavirus and Pap tests, with histologic data as the gold standard. The proposed approach performed well in estimating and comparing the accuracy of multiple assays in the presence of verification bias. The proposed approach is an easy to apply and accurate method for addressing verification bias in studies of multiple screening methods. Copyright © 2014 Elsevier Inc. All rights reserved.

A simple semi-rapid HIV-1&2 confirmatory immunoassay using magnetic particles.

PubMed

Sommerfelt, Maja A; Ohlsson, Irene; Flolid, Irene; Thorstensson, Rigmor; Sørensen, Birger

2004-02-01

The Bionor HIV-1&2 Confirmatory Test is a semi-rapid simple immunoassay based on magnetic particles for the confirmation of serological status to human immunodeficiency virus (HIV). The specificity and sensitivity of this assay was evaluated by comparison with the Diagnostic Biotechnology HIV-1 Western blot (WB) 2.2 and the HIV-2/SBL-6669 WB. Bionor's confirmatory test demonstrated 98% specificity when testing sero-negative blood donors and false positive sera in screening tests compared to 81.5 and 71.6%, respectively, using the HIV-1 WB. The sensitivity of this assay for HIV-1 antibody positive sera was 97.9% compared to the WB which was 99.5%. When testing confirmed HIV-2 antibody positive samples, 2/100 scored negative using this confirmatory test similar to other HIV-2 peptide-based line immunoassays available commercially, whilst 8/100 were indeterminate reacting to HIV-2 membrane antigens only. Bionor's confirmatory test detected HIV-1 seropositivity earlier than the WB in longitudinal seroconversion panels and could discriminate between HIV-1 and -2 infection. The number of indeterminate responses was generally reduced significantly using Bionor's confirmatory test compared to the HIV-1 WB. The greater specificity, speed and ease of interpretation of Bionor's confirmatory test renders it an attractive and cost effective alternative to the WB for confirming HIV serological status worldwide.

Inability of keratinocytes lacking their specific transglutaminase to form cross-linked envelopes: Absence of envelopes as a simple diagnostic test for lamellar ichthyosis

PubMed Central

Jeon, Saewha; Djian, Philippe; Green, Howard

1998-01-01

Epidermal keratinocytes, late in their terminal differentiation, form cross-linked envelopes resistant to ionic detergent and reducing agent. Because the cross-linking process is catalyzed by the keratinocyte transglutaminase, the absence of active transglutaminase should result in failure of the keratinocyte to form a cross-linked envelope. Three keratinocyte strains bearing mutations in the keratinocyte transglutaminase were examined: two contained no detectable transglutaminase mRNA and none contained active enzyme. All three were unable to form cross-linked envelopes, either spontaneously in stratified cultures or upon induction with Ca2+. Although stratum corneum of normal humans and scales from patients with different ichthyotic diseases contain cross-linked envelopes, those from patients with transglutaminase-negative lamellar ichthyosis do not. Therefore, the disease due to the absence of transglutaminase may be readily distinguished from other ichthyotic diseases by a simple test for cross-linked envelopes. PMID:9435253

Evaluation of commercially available techniques and development of simplified methods for measuring grille airflows in HVAC systems

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

Walker, Iain S.; Wray, Craig P.; Guillot, Cyril

2003-08-01

In this report, we discuss the accuracy of flow hoods for residential applications, based on laboratory tests and field studies. The results indicate that commercially available hoods are often inadequate to measure flows in residential systems, and that there can be a wide range of performance between different flow hoods. The errors are due to poor calibrations, sensitivity of existing hoods to grille flow non-uniformities, and flow changes from added flow resistance. We also evaluated several simple techniques for measuring register airflows that could be adopted by the HVAC industry and homeowners as simple diagnostics that are often as accuratemore » as commercially available devices. Our test results also show that current calibration procedures for flow hoods do not account for field application problems. As a result, organizations such as ASHRAE or ASTM need to develop a new standard for flow hood calibration, along with a new measurement standard to address field use of flow hoods.« less

The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study

PubMed Central

Ferrando, Carlos; Romero, Carolina; Tusman, Gerardo; Suarez-Sipmann, Fernando; Canet, Jaume; Dosdá, Rosa; Valls, Paola; Villena, Abigail; Serralta, Ferran; Jurado, Ana; Carrizo, Juan; Navarro, Jose; Parrilla, Cristina; Romero, Jose E; Pozo, Natividad; Soro, Marina; Villar, Jesús; Belda, Francisco Javier

2017-01-01

Objective To assess the diagnostic accuracy of peripheral capillary oxygen saturation (SpO2) while breathing room air for 5 min (the ‘Air-Test’) in detecting postoperative atelectasis. Design Prospective cohort study. Diagnostic accuracy was assessed by measuring the agreement between the index test and the reference standard CT scan images. Setting Postanaesthetic care unit in a tertiary hospital in Spain. Participants Three hundred and fifty patients from 12 January to 7 February 2015; 170 patients scheduled for surgery under general anaesthesia who were admitted into the postsurgical unit were included. Intervention The Air-Test was performed in conscious extubated patients after a 30 min stabilisation period during which they received supplemental oxygen therapy via a venturi mask. The Air-Test was defined as positive when SpO2 was ≤96% and negative when SpO2 was ≥97%. Arterial blood gases were measured in all patients at the end of the Air-Test. In the subsequent 25 min, the presence of atelectasis was evaluated by performing a CT scan in 59 randomly selected patients. Main outcome measures The primary study outcome was assessment of the accuracy of the Air-Test for detecting postoperative atelectasis compared with the reference standard. The secondary outcome was the incidence of positive Air-Test results. Results The Air-Test diagnosed postoperative atelectasis with an area under the receiver operating characteristic curve of 0.90 (95% CI 0.82 to 0.98) with a sensitivity of 82.6% and a specificity of 87.8%. The presence of atelectasis was confirmed by CT scans in all patients (30/30) with positive and in 5 patients (17%) with negative Air-Test results. Based on the Air-Test, postoperative atelectasis was present in 36% of the patients (62 out of 170). Conclusion The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis. Trial Registration NCT02650037. PMID:28554935

Voltage verification unit

DOEpatents

Martin, Edward J [Virginia Beach, VA

2008-01-15

A voltage verification unit and method for determining the absence of potentially dangerous potentials within a power supply enclosure without Mode 2 work is disclosed. With this device and method, a qualified worker, following a relatively simple protocol that involves a function test (hot, cold, hot) of the voltage verification unit before Lock Out/Tag Out and, and once the Lock Out/Tag Out is completed, testing or "trying" by simply reading a display on the voltage verification unit can be accomplished without exposure of the operator to the interior of the voltage supply enclosure. According to a preferred embodiment, the voltage verification unit includes test leads to allow diagnostics with other meters, without the necessity of accessing potentially dangerous bus bars or the like.

Quantitative diagnostics of soft tissue through viscoelastic characterization using time-based instrumented palpation.

PubMed

Palacio-Torralba, Javier; Hammer, Steven; Good, Daniel W; Alan McNeill, S; Stewart, Grant D; Reuben, Robert L; Chen, Yuhang

2015-01-01

Although palpation has been successfully employed for centuries to assess soft tissue quality, it is a subjective test, and is therefore qualitative and depends on the experience of the practitioner. To reproduce what the medical practitioner feels needs more than a simple quasi-static stiffness measurement. This paper assesses the capacity of dynamic mechanical palpation to measure the changes in viscoelastic properties that soft tissue can exhibit under certain pathological conditions. A diagnostic framework is proposed to measure elastic and viscous behaviors simultaneously using a reduced set of viscoelastic parameters, giving a reliable index for quantitative assessment of tissue quality. The approach is illustrated on prostate models reconstructed from prostate MRI scans. The examples show that the change in viscoelastic time constant between healthy and cancerous tissue is a key index for quantitative diagnostics using point probing. The method is not limited to any particular tissue or material and is therefore useful for tissue where defining a unique time constant is not trivial. The proposed framework of quantitative assessment could become a useful tool in clinical diagnostics for soft tissue. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Diagnostic criteria for Patulous Eustachian Tube: A proposal by the Japan Otological Society.

PubMed

Kobayashi, Toshimitsu; Morita, Masahiro; Yoshioka, Satoshi; Mizuta, Kunihiro; Ohta, Shigeto; Kikuchi, Toshiaki; Hayashi, Tatsuya; Kaneko, Akihiro; Yamaguchi, Nobumasa; Hashimoto, Sho; Kojima, Hiromi; Murakami, Shingo; Takahashi, Haruo

2018-02-01

Patulous Eustachian Tube (PET) is of increasing importance in otology. However, despite the abundance of diseases requiring a differential diagnosis from PET, such as superior semicircular canal dehiscence syndrome, perilymphatic fistula, acute low-tone sensorineural hearing loss, etc., there are currently no established diagnostic criteria for PET. In view of these circumstances, the Japan Otological Society (JOS) Eustachian Tube Committee proposed the diagnostic criteria for Patulous Eustachian Tube in 2012, in order to promote clinical research on PET. A revision was made in 2016, maintaining the original concept that the criteria should be very simple, avoid any contamination of "Definite PET" with uncertain cases. Moreover, it was also intended to minimize the number of cases that could be accidentally excluded even in the presence of some suspected findings ("Possible PET"). The criteria can be used by all otolaryngologists even without using the Eustachian tube function test apparatus. However, the use of such an apparatus may increase the chances of detecting "Definite PET". The algorithm for the diagnosis of PET using the criteria has also been described. The JOS diagnostic criteria for Patulous Eustachian Tube will further promote international scientific communication on PET. Copyright © 2017 Elsevier B.V. All rights reserved.

Sensitive and affordable diagnostic assay for the quantitative detection of anaplastic lymphoma kinase (ALK) alterations in patients with non-small cell lung cancer

PubMed Central

Dama, Elisa; Tillhon, Micol; Bertalot, Giovanni; de Santis, Francesca; Troglio, Flavia; Pessina, Simona; Passaro, Antonio; Pece, Salvatore; de Marinis, Filippo; Dell'Orto, Patrizia; Viale, Giuseppe; Spaggiari, Lorenzo; Di Fiore, Pier Paolo; Bianchi, Fabrizio; Barberis, Massimo; Vecchi, Manuela

2016-01-01

Accurate detection of altered anaplastic lymphoma kinase (ALK) expression is critical for the selection of lung cancer patients eligible for ALK-targeted therapies. To overcome intrinsic limitations and discrepancies of currently available companion diagnostics for ALK, we developed a simple, affordable and objective PCR-based predictive model for the quantitative measurement of any ALK fusion as well as wild-type ALK upregulation. This method, optimized for low-quantity/−quality RNA from FFPE samples, combines cDNA pre-amplification with ad hoc generated calibration curves. All the models we derived yielded concordant predictions when applied to a cohort of 51 lung tumors, and correctly identified all 17 ALK FISH-positive and 33 of the 34 ALK FISH-negative samples. The one discrepant case was confirmed as positive by IHC, thus raising the accuracy of our test to 100%. Importantly, our method was accurate when using low amounts of input RNA (10 ng), also in FFPE samples with limited tumor cellularity (5–10%) and in FFPE cytology specimens. Thus, our test is an easily implementable diagnostic tool for the rapid, efficacious and cost-effective screening of ALK status in patients with lung cancer. PMID:27206799

Diagnosis of sputum-scarce HIV-associated pulmonary tuberculosis in Lima, Peru

PubMed Central

Vargas, Daniel; García, Luis; Gilman, Robert H; Evans, Carlton; Ticona, Eduardo; Ñavincopa, Marcos; Luo, Robert F; Caviedes, Luz; Hong, Clemens; Escombe, Rod; Moore, David A J

2010-01-01

Sputum induction, bronchoalveolar lavage, or gastric aspiration are often needed to produce adequate diagnostic respiratory samples from people with HIV in whom tuberculosis is suspected. Since these procedures are rarely appropriate in less-developed countries, we compared the performances of a simple string test and the gold-standard sputum induction. 160 HIV-positive adults under investigation for tuberculosis, and 52 asymptomatic HIV-positive control patients underwent the string test followed by sputum induction. The string test detected tuberculosis in 14 patients in whom this disease was suspected; sputum induction detected only eight of them (McNemar's test, p=0·03). These preliminary data suggest that the string test is safe and effective for retrieval of useful clinical specimens for diagnosis of pulmonary tuberculosis, and is at least as sensitive as sputum induction. PMID:15639297

Diagnostic Value of Run Chart Analysis: Using Likelihood Ratios to Compare Run Chart Rules on Simulated Data Series

PubMed Central

Anhøj, Jacob

2015-01-01

Run charts are widely used in healthcare improvement, but there is little consensus on how to interpret them. The primary aim of this study was to evaluate and compare the diagnostic properties of different sets of run chart rules. A run chart is a line graph of a quality measure over time. The main purpose of the run chart is to detect process improvement or process degradation, which will turn up as non-random patterns in the distribution of data points around the median. Non-random variation may be identified by simple statistical tests including the presence of unusually long runs of data points on one side of the median or if the graph crosses the median unusually few times. However, there is no general agreement on what defines “unusually long” or “unusually few”. Other tests of questionable value are frequently used as well. Three sets of run chart rules (Anhoej, Perla, and Carey rules) have been published in peer reviewed healthcare journals, but these sets differ significantly in their sensitivity and specificity to non-random variation. In this study I investigate the diagnostic values expressed by likelihood ratios of three sets of run chart rules for detection of shifts in process performance using random data series. The study concludes that the Anhoej rules have good diagnostic properties and are superior to the Perla and the Carey rules. PMID:25799549

[Coma in the emergency room].

PubMed

Braun, M; Ploner, C J; Lindner, T; Möckel, M; Schmidt, W U

2017-06-01

Coma of unknown origin (CUO) is a frequent unspecific emergency symptom associated with a high mortality. A fast diagnostic work-up is essential given the wide spectrum of underlying diagnoses that are made up of approximately 50% primary central nervous system (CNS) pathologies and approximately 50% extracerebral, almost exclusively internal medical causes. Despite the high mortality associated with this symptom, there are currently no generally accepted management guidelines for adult patients presenting with CUO. We propose an interdisciplinary standard operating procedure (SOP) for patients with acute CUO as has been established in our maximum care hospital. The SOP is triggered by simple triage criteria that are sufficient to identify CUO patients before arrival in hospital. The in-hospital response team is led by a neurologist. Collaboration with nursing staff, internal medicine, anesthesiology, neurosurgery and trauma surgery is organized along structured pathways that include standardized laboratory tests, including cerebrospinal fluid (CSF), toxicology, computed tomography (CT) and CT angiography imaging (CTA). Our data suggest that neurologists and internists need to be placed at the beginning of the diagnostic work-up. Imaging should not just be carried out depending on the clinical syndrome because sensitivity, specificity and inter-rater reliability of the latter are not sufficient and because in many cases, multiple pathologies can be detected that could each explain CUO alone. Clinical examination, imaging and laboratory testing should be regarded as components of an integrative diagnostic approach and the final aetiological classification should only be made after the diagnostic work-up is complete.

Value of bacterial culture of vaginal swabs in diagnosis of vaginal infections.

PubMed

Nenadić, Dane; Pavlović, Miloš D

2015-06-01

Vaginal and cervical swab culture is still very common procedure in our country's everyday practice whereas simple and rapid diagnostic methods have been very rarely used. The aim of this study was to show that the employment of simple and rapid diagnostic tools [vaginal fluid wet mount microscopy (VFWMM), vaginal pH and potassium hydroxide (KOH) test] offers better assessment of vaginal environment than standard microbiologic culture commonly used in Serbia. This prospective study included 505 asymptomatic pregnant women undergoing VFWMM, test with 10% KOH, determination of vaginal pH and standard culture of cervicovaginal swabs. Combining findings from the procedures was used to make diagnoses of bacterial vaginosis (BV) and vaginitis. In addition, the number of polymorphonuclear leukocytes (PMN) was determined in each sample and analyzed along with other findings. Infections with Candida albicans and Trichomonas vaginalis were confirmed or excluded by microscopic examination. In 36 (6%) patients cervicovaginal swab cultures retrieved several aerobes and facultative anaerobes, whereas in 52 (11%) women Candida albicans was isolated. Based on VFWMM findings and clinical criteria 96 (19%) women had BV, 19 (4%) vaginitis, and 72 (14%) candidiasis. Of 115 women with BV and vaginitis, pH 4.5 was found in 5, and of 390 with normal findings 83 (21%) had vaginal pH 4.5. Elevated numbers of PMN were found in 154 (30%) women--in 83 (54%) of them VFWMM was normal. Specificity and sensitivity of KOH test and vaginal pH determination in defining pathological vaginal flora were 95% and 81%, and 79% and 91%, respectively. Cervicovaginal swab culture is expensive but almost non-informative test in clinical practice. The use of simpler and rapid methods as vaginal fluid wet mount microscopy, KOH test and vaginal pH offers better results in diagnosis, and probably in the treatment and prevention of sequels of vaginal infections.

Suboptimal performance of simple noninvasive tests for advanced fibrosis in Chinese patients with nonalcoholic fatty liver disease.

PubMed

Xun, Yun Hao; Fan, Jian Gao; Zang, Guo Qing; Liu, Hong; Jiang, Yan Ming; Xiang, Jing; Huang, Qian; Shi, Jun Ping

2012-11-01

To evaluate the diagnostic accuracy of some noninvasive fibrosis models in Chinese patients with nonalcoholic fatty liver disease (NAFLD). Consecutive biopsy-proven NAFLD patients were recruited from a single center from January 2005 to December 2010. Advanced fibrosis (stage 3 and 4) was defined using Kleiner criteria. The area under the receiver operating characteristic curve (AUROC) was used to compare the diagnostic accuracy of the NAFLD fibrosis score (NFS), FIB-4 index, aspartate transaminase (AST)/platelet ratio index (APRI), AST/alanine transaminase (ALT) ratio (AAR) and body mass index (BMI)-AAR-Diabetes (BARD) score. Of the patients with NAFLD, 79.6% were males with a mean age of 37.1 years, mean BMI of 26.1 kg/m(2) and 41.4% of them had nonalcoholic steatohepatitis, and 24 (15.8%) had advanced fibrosis. The AUROC of the FIB-4 index, APRI, AAR, NFS and BARD score for advanced fibrosis were 0.756, 0.742, 0.670, 0.653 and 0.642 (P < 0.05 for all), respectively. A concordant negative predictive value of approximately 90% was indicated whereas the positive predictive values were modest for all tests, and only the FIB-4 index yielded a higher positive likelihood ratio of 7.65. Using these cut-off values of tests for excluding advanced fibrosis could reduce the use of liver biopsy in 56.6-74.3% of the patients, with a minor false negative rate of 5.3-9.9%. Although slightly less accurate than liver biopsy, simple noninvasive tests can reliably exclude advanced fibrosis in Chinese NAFLD patients in our center. FIB-4 index performs better than the other tests under examination. © 2012 The Authors. Journal of Digestive Diseases © 2012 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Simple and robust diagnosis of early, small and AFP-negative primary hepatic carcinomas: an integrative approach of serum fluorescence and conventional blood tests.

PubMed

Wang, Ting; Zhang, Kun-He; Hu, Piao-Ping; Huang, Zeng-Yong; Zhang, Pan; Wan, Qin-Si; Huang, De-Qiang; Lv, Nong-Hua

2016-09-27

The diagnosis of early, small and alpha-fetoprotein (AFP)-negative primary hepatic carcinomas (PHCs) remains a significant challenge. We developed a simple and robust approach to noninvasively detect these PHCs. A rapid, high-throughput and single-tube method was firstly developed to measure serum autofluorescence and cell-free DNA (cfDNA)-related fluorescence using a real-time PCR system, and both types of serum fluorescence were measured and routine laboratory data were collected in 1229 subjects, including 353 PHC patients, 331 liver cirrhosis (LC) patients, 213 chronic hepatitis (CH) patients and 332 normal controls (NC). The results showed that fluorescence indicators of PHC differed from those of NC, CH and LC to various extents, and all of them were not associated with age, gender, or AFP level. The logistic regression models established with the fluorescence indicators alone and combined with AFP, hepatic function tests and blood cell analyses were valuable for distinguishing early, small, AFP-negative and all PHC from LC, CH, NC and all non-PHC, with areas under the receiver operating characteristic curves 0.857-0.993 and diagnostic accuracies 80.2-97.7%. Conclusively, serum autofluorescence and cfDNA-related fluorescence are able to be rapidly and simultaneously measured by our simple method and valuable for diagnosing early, small and AFP-negative PHCs, especially integrating with AFP and conventional blood tests.

Sensitive and less invasive confirmatory diagnosis of visceral leishmaniasis in Sudan using loop-mediated isothermal amplification (LAMP)

PubMed Central

Mukhtar, Maowia; Ali, Sababil S.; Boshara, Salah A.; Albertini, Audrey; Monnerat, Séverine; Bessell, Paul; Mori, Yasuyoshi; Kubota, Yutaka; Ndung’u, Joseph M.

2018-01-01

Background Confirmatory diagnosis of visceral leishmaniasis (VL), as well as diagnosis of relapses and test of cure, usually requires examination by microscopy of samples collected by invasive means, such as splenic, bone marrow or lymph node aspirates. This causes discomfort to patients, with risks of bleeding and iatrogenic infections, and requires technical expertise. Molecular tests have great potential for diagnosis of VL using peripheral blood, but require well-equipped facilities and trained personnel. More user-friendly, and field-amenable options are therefore needed. One method that could meet these requirements is loop-mediated isothermal amplification (LAMP) using the Loopamp Leishmania Detection Kit, which comes as dried down reagents that can be stored at room temperature, and allows simple visualization of results. Methodology/Principal findings The Loopamp Leishmania Detection Kit (Eiken Chemical Co., Japan), was evaluated in the diagnosis of VL in Sudan. A total of 198 VL suspects were tested by microscopy of lymph node aspirates (the reference test), direct agglutination test-DAT (in house production) and rK28 antigen-based rapid diagnostic test (OnSite Leishmania rK39-Plus, CTK Biotech, USA). LAMP was performed on peripheral blood (whole blood and buffy coat) previously processed by: i) a direct boil and spin method, and ii) the QIAamp DNA Mini Kit (QIAgen). Ninety seven of the VL suspects were confirmed as cases by microscopy of lymph node aspirates. The sensitivity and specificity for each of the tests were: rK28 RDT 98.81% and 100%; DAT 88.10% and 78.22%; LAMP-boil and spin 97.65% and 99.01%; LAMP-QIAgen 100% and 99.01%. Conclusions/Significance Due to its simplicity and high sensitivity, rK28 RDT can be used first in the diagnostic algorithm for primary VL diagnosis, the excellent performance of LAMP using peripheral blood indicates that it can be also included in the algorithm for diagnosis of VL as a simple test when parasitological confirmatory diagnosis is required in settings that are lower than the reference laboratory, avoiding the need for invasive lymph node aspiration. PMID:29444079

Single-particle imaging for biosensor applications

NASA Astrophysics Data System (ADS)

Yorulmaz, Mustafa; Isil, Cagatay; Seymour, Elif; Yurdakul, Celalettin; Solmaz, Berkan; Koc, Aykut; Ünlü, M. Selim

2017-10-01

Current state-of-the-art technology for in-vitro diagnostics employ laboratory tests such as ELISA that consists of a multi-step test procedure and give results in analog format. Results of these tests are interpreted by the color change in a set of diluted samples in a multi-well plate. However, detection of the minute changes in the color poses challenges and can lead to false interpretations. Instead, a technique that allows individual counting of specific binding events would be useful to overcome such challenges. Digital imaging has been applied recently for diagnostics applications. SPR is one of the techniques allowing quantitative measurements. However, the limit of detection in this technique is on the order of nM. The current required detection limit, which is already achieved with the analog techniques, is around pM. Optical techniques that are simple to implement and can offer better sensitivities have great potential to be used in medical diagnostics. Interference Microscopy is one of the tools that have been investigated over years in optics field. More of the studies have been performed in confocal geometry and each individual nanoparticle was observed separately. Here, we achieve wide-field imaging of individual nanoparticles in a large field-of-view ( 166 μm × 250 μm) on a micro-array based sensor chip in fraction of a second. We tested the sensitivity of our technique on dielectric nanoparticles because they exhibit optical properties similar to viruses and cells. We can detect non-resonant dielectric polystyrene nanoparticles of 100 nm. Moreover, we perform post-processing applications to further enhance visibility.

The evolving threat of influenza viruses of animal origin and the challenges in developing appropriate diagnostics.

PubMed

Mak, Polly W Y; Jayawardena, Shanthi; Poon, Leo L M

2012-11-01

An H1N1 subtype of swine origin caused the first influenza pandemic in this century. This pandemic strain was a reassortant of avian, swine, and human influenza viruses. Many diagnostic laboratories were overwhelmed by the testing demands related to this pandemic. Nevertheless, there remains the threat of other animal influenza viruses, such as highly pathogenic H5N1. As a part of pandemic preparedness, it is essential to identify the diagnostic challenges that will accompany the next pandemic. We discuss the natural reservoir of influenza viruses and the possible role of livestock in the emergence of pandemic strains. The current commonly used molecular tests for influenza diagnosis or surveillance are also briefly reviewed. Some of these approaches are also used to detect animal viruses. Unfortunately, owing to a lack of systematic surveillance of animal influenza viruses, established tests may not be able to detect pandemic strains that have yet to emerge from the animal reservoir. Thus, multiple strategies need to be developed for better identification of influenza viruses. In addition, molecular assays for detection of mutations associated with antiviral resistance and for viral segment reassortments should also be encouraged. Influenza viruses are highly dynamic viruses. Regular and systematic influenza surveillance in both humans and animals is essential to provide a more comprehensive picture of the prevalent influenza viruses. To better prepare for the next pandemic, we should develop some simple and easy-to-use tests for characterizing newly emerging influenza viruses. © 2012 American Association for Clinical Chemistry

Family practitioners' diagnostic decision-making processes regarding patients with respiratory tract infections: an observational study.

PubMed

Fischer, Thomas; Fischer, Susanne; Himmel, Wolfgang; Kochen, Michael M; Hummers-Pradier, Eva

2008-01-01

The influence of patient characteristics on family practitioners' (FPs') diagnostic decision making has mainly been investigated using indirect methods such as vignettes or questionnaires. Direct observation-borrowed from social and cultural anthropology-may be an alternative method for describing FPs' real-life behavior and may help in gaining insight into how FPs diagnose respiratory tract infections, which are frequent in primary care. To clarify FPs' diagnostic processes when treating patients suffering from symptoms of respiratory tract infection. This direct observation study was performed in 30 family practices using a checklist for patient complaints, history taking, physical examination, and diagnoses. The influence of patients' symptoms and complaints on the FPs' physical examination and diagnosis was calculated by logistic regression analyses. Dummy variables based on combinations of symptoms and complaints were constructed and tested against saturated (full) and backward regression models. In total, 273 patients (median age 37 years, 51% women) were included. The median number of symptoms described was 4 per patient, and most information was provided at the patients' own initiative. Multiple logistic regression analysis showed a strong association between patients' complaints and the physical examination. Frequent diagnoses were upper respiratory tract infection (URTI)/common cold (43%), bronchitis (26%), sinusitis (12%), and tonsillitis (11%). There were no significant statistical differences between "simple heuristic'' models and saturated regression models in the diagnoses of bronchitis, sinusitis, and tonsillitis, indicating that simple heuristics are probably used by the FPs, whereas "URTI/common cold'' was better explained by the full model. FPs tended to make their diagnosis based on a few patient symptoms and a limited physical examination. Simple heuristic models were almost as powerful in explaining most diagnoses as saturated models. Direct observation allowed for the study of decision making under real conditions, yielding both quantitative data and "qualitative'' information about the FPs' performance. It is important for investigators to be aware of the specific disadvantages of the method (e.g., a possible observer effect).

Neural net diagnostics for VLSI test

NASA Technical Reports Server (NTRS)

Lin, T.; Tseng, H.; Wu, A.; Dogan, N.; Meador, J.

1990-01-01

This paper discusses the application of neural network pattern analysis algorithms to the IC fault diagnosis problem. A fault diagnostic is a decision rule combining what is known about an ideal circuit test response with information about how it is distorted by fabrication variations and measurement noise. The rule is used to detect fault existence in fabricated circuits using real test equipment. Traditional statistical techniques may be used to achieve this goal, but they can employ unrealistic a priori assumptions about measurement data. Our approach to this problem employs an adaptive pattern analysis technique based on feedforward neural networks. During training, a feedforward network automatically captures unknown sample distributions. This is important because distributions arising from the nonlinear effects of process variation can be more complex than is typically assumed. A feedforward network is also able to extract measurement features which contribute significantly to making a correct decision. Traditional feature extraction techniques employ matrix manipulations which can be particularly costly for large measurement vectors. In this paper we discuss a software system which we are developing that uses this approach. We also provide a simple example illustrating the use of the technique for fault detection in an operational amplifier.

Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

PubMed Central

Carnero-Pardo, Cristobal; Gurpegui, Manuel; Sanchez-Cantalejo, Emilio; Frank, Ana; Mola, Santiago; Barquero, M Sagrario; Montoro-Rios, M Teresa

2006-01-01

Background Available screening tests for dementia are of limited usefulness because they are influenced by the patient's culture and educational level. The Eurotest, an instrument based on the knowledge and handling of money, was designed to overcome these limitations. The objective of this study was to evaluate the diagnostic accuracy of the Eurotest in identifying dementia in customary clinical practice. Methods A cross-sectional, multi-center, naturalistic phase II study was conducted. The Eurotest was administered to consecutive patients, older than 60 years, in general neurology clinics. The patients' condition was classified as dementia or no dementia according to DSM-IV diagnostic criteria. We calculated sensitivity (Sn), specificity (Sp) and area under the ROC curves (aROC) with 95% confidence intervals. The influence of social and educational factors on scores was evaluated with multiple linear regression analysis, and the influence of these factors on diagnostic accuracy was evaluated with logistic regression. Results Sixteen neurologists recruited a total of 516 participants: 101 with dementia, 380 without dementia, and 35 who were excluded. Of the 481 participants who took the Eurotest, 38.7% were totally or functionally illiterate and 45.5% had received no formal education. Mean time needed to administer the test was 8.2+/-2.0 minutes. The best cut-off point was 20/21, with Sn = 0.91 (0.84–0.96), Sp = 0.82 (0.77–0.85), and aROC = 0.93 (0.91–0.95). Neither the scores on the Eurotest nor its diagnostic accuracy were influenced by social or educational factors. Conclusion This naturalistic and pragmatic study shows that the Eurotest is a rapid, simple and useful screening instrument, which is free from educational influences, and has appropriate internal and external validity. PMID:16606455

[Peripheral lymphadenopathy in childhood--recommendations for diagnostic evaluation].

PubMed

Benesch, M; Kerbl, R; Wirnsberger, A; Stünzner, D; Mangge, H; Schenkeli, R; Deutsch, J

2000-01-01

Enlargement of peripheral lymph nodes most commonly caused by a local inflammatory process is frequently seen in childhood. The aim of the present study was to analyze the most common causes of peripheral lymphadenopathy and to develop a simple algorithm for the primary diagnostic evaluation of peripheral lymph node enlargement in this age group. Between April and September 1999 87 unselected children (median age: 5 1/2 years) with peripheral lymphadenopathy were referred to the Department of Pediatrics, University of Graz, for further investigation. EBV infection was diagnosed in 20 (23.0%) children. 19 (21.8%) patients had acute bacterial lymphadenitis. In 21 (24.1%) patients lymph node enlargement was classified as "post/parainfectious (viral)". Four patients each had toxoplasmosis and cat scratch disease. In 11 (12.6%) patients neither physical nor laboratory examinations revealed pathologic results. Among the remaining 8 children sarcoidosis and Hodgkin disease was diagnosed in one patient each. Small, soft, mobile, nontender, cervical, axillary or inguinal lymph nodes do not require further investigations. In case of enlarged, tender lymph nodes with overlying skin erythema and fever diagnostic evaluation should include complete blood count, erythrocyte sedimentation rate and/or c-reactive protein level, supplemented by appropriate antibody testing (EBV, CMV, Toxoplasma gondii, Bartonella henselae). Firm, enlarged, painless lymph nodes which are matted together and fixed to the skin or underlying tissues necessitate a more detailed diagnostic evaluation in order to exclude malignant or granulomatous diseases. Our study demonstrated that primary diagnostic evaluation of childhood peripheral lymphadenopathy is mainly based on clinical grounds. In most cases a small number of additionally performed laboratory tests allow to correctly identify the cause of the peripheral lymph node enlargement.

Current diagnostic procedures for diagnosing vertigo and dizziness

PubMed Central

Walther, Leif Erik

2017-01-01

Vertigo is a multisensory syndrome that otolaryngologists are confronted with every day. With regard to the complex functions of the sense of orientation, vertigo is considered today as a disorder of the sense of direction, a disturbed spatial perception of the body. Beside the frequent classical syndromes for which vertigo is the leading symptom (e.g. positional vertigo, vestibular neuritis, Menière’s disease), vertigo may occur as main or accompanying symptom of a multitude of ENT-related diseases involving the inner ear. It also concerns for example acute and chronic viral or bacterial infections of the ear with serous or bacterial labyrinthitis, disorders due to injury (e.g. barotrauma, fracture of the oto-base, contusion of the labyrinth), chronic-inflammatory bone processes as well as inner ear affections in the perioperative course. In the last years, diagnostics of vertigo have experienced a paradigm shift due to new diagnostic possibilities. In the diagnostics of emergency cases, peripheral and central disorders of vertigo (acute vestibular syndrome) may be differentiated with simple algorithms. The introduction of modern vestibular test procedures (video head impulse test, vestibular evoked myogenic potentials) in the clinical practice led to new diagnostic options that for the first time allow a complex objective assessment of all components of the vestibular organ with relatively low effort. Combined with established methods, a frequency-specific assessment of the function of vestibular reflexes is possible. New classifications allow a clinically better differentiation of vertigo syndromes. Modern radiological procedures such as for example intratympanic gadolinium application for Menière’s disease with visualization of an endolymphatic hydrops also influence current medical standards. Recent methodical developments significantly contributed to the possibilities that nowadays vertigo can be better and more quickly clarified in particular in otolaryngology. PMID:29279722

'It puts life in us and we feel big': shifts in the local health care system during the introduction of rapid diagnostic tests for malaria into drug shops in Uganda.

PubMed

Hutchinson, Eleanor; Chandler, Clare; Clarke, Siân; Lal, Sham; Magnussen, Pascal; Kayendeke, Miriam; Nabirye, Christine; Kizito, James; Mbonye, Anthony

2015-01-01

This paper is an analysis of the social interaction between drug sellers, their clients and local health care workers within a medical trial that introduced rapid diagnostic tests for malaria into private sector drug shops in Mukono District, Uganda. It locates the introduction of a new technology to test blood and a system of referral within the context of local concerns about the choice and evaluation of treatment; and the socially legitimated statuses, roles and hierarchies within the local health care system. Based on the multi-layered interpretation of 21 focus group discussions, we describe three key aspects of the trial central to local interpretation: openly testing blood, supervisory visits to drug shops and a new referral form. Each had the potential to shift drug shop vendors from outsider to insider of the formal health service. The responses of the different groups of participants reflect their situation within the health care system. The clients and patients welcomed the local availability of new diagnostic technology and the apparent involvement of the government in securing good quality health services for them from providers with often uncertain credentials. The drug shop vendors welcomed the authorization to openly test blood, enabling the demonstration of a new skill and newfound legitimacy as a health worker rather than simple drug seller. Formal sector health workers were less enthusiastic about the trial, raising concerns about professional hierarchies and the maintenance of a boundary around the formal health service to ensure the exclusion of those they considered untrained, unprofessional and untrustworthy personnel.

‘It puts life in us and we feel big’: shifts in the local health care system during the introduction of rapid diagnostic tests for malaria into drug shops in Uganda

PubMed Central

Hutchinson, Eleanor; Chandler, Clare; Clarke, Siân; Lal, Sham; Magnussen, Pascal; Kayendeke, Miriam; Nabirye, Christine; Kizito, James; Mbonye, Anthony

2015-01-01

This paper is an analysis of the social interaction between drug sellers, their clients and local health care workers within a medical trial that introduced rapid diagnostic tests for malaria into private sector drug shops in Mukono District, Uganda. It locates the introduction of a new technology to test blood and a system of referral within the context of local concerns about the choice and evaluation of treatment; and the socially legitimated statuses, roles and hierarchies within the local health care system. Based on the multi-layered interpretation of 21 focus group discussions, we describe three key aspects of the trial central to local interpretation: openly testing blood, supervisory visits to drug shops and a new referral form. Each had the potential to shift drug shop vendors from outsider to insider of the formal health service. The responses of the different groups of participants reflect their situation within the health care system. The clients and patients welcomed the local availability of new diagnostic technology and the apparent involvement of the government in securing good quality health services for them from providers with often uncertain credentials. The drug shop vendors welcomed the authorization to openly test blood, enabling the demonstration of a new skill and newfound legitimacy as a health worker rather than simple drug seller. Formal sector health workers were less enthusiastic about the trial, raising concerns about professional hierarchies and the maintenance of a boundary around the formal health service to ensure the exclusion of those they considered untrained, unprofessional and untrustworthy personnel. PMID:25632175

Biomarkers for early diagnosis of Alzheimer disease: 'ALZheimer ASsociated gene'--a new blood biomarker?

PubMed

Jellinger, Kurt A; Janetzky, Bernd; Attems, Johannes; Kienzl, Elisabeth

2008-08-01

Simple, non-invasive tests for an early detection of degenerative dementia by use of biomarkers are urgently required. However, up to the present, no validated extracerebral diagnostic markers (plasma/serum, platelets, urine, connective tissue) for the early diagnosis of Alzheimer disease (AD) are available. In disease stages with evident cognitive disturbances, the clinical diagnosis of probable AD is made with around 90% accuracy using modern clinical, neuropsychological and imaging methods. Diagnostic sensitivity and specificity even in early disease stages are improved by CSF markers, in particular combined tau and amyloid beta peptides (Abeta) and plasma markers (eg, Abeta-42/Abeta-40 ratio). Recently, a novel gene/protein--ALZAS (Alzheimer Associated Protein)--with a 79 amino acid sequence, containing the amyloid beta-42 fragment (Abeta-42), the amyloid precursor protein (APP) transmembrane signal and a 12 amino acid C-terminal, not present in any other known APP alleles, has been discovered on chromosome 21 within the APP region. Reverse transcriptase-PCR revealed the expression of the transcript of this protein in the cortex and hippocampal regions as well as in lymphocytes of human AD patients. The expression of ALZAS is mirrored by a specific autoimmune response in AD patients, directed against the ct-12 end of the ALZAS-peptide but not against the Abeta-sequence. ELISA studies of plasma detected highest titers of ALZAS in patients with mild cognitive impairment (presymptomatic AD), but only moderately increased titers in autopsy-confirmed AD, whereas low or undetectable ct-12 titers were found in cognitively intact age-matched subjects and young controls. The antigen, ALZAS protein, was detected in plasma in later clinical stages of AD. It is suggested that ALZAS represents an indicator in a dynamic equilibrium between both peripheral and brain degenerative changes in AD and may become a useful "non-invasive" diagnostic marker via a simple blood test.

Erythema nodosum leprosum as the presenting feature in multibacillary leprosy.

PubMed

Prabhu, Smitha; Shenoi, S D; Pai, Sathish B; Sripathi, H

2009-06-15

Leprosy is an ancient disease that has survived into the modern ages despite an intense effort to eliminate it worldwide. Here we report a case of a 32-year-old woman who had recurrent painful nodules of six months duration. Because of a lack of lesions suggestive of leprosy, she was initially diagnosed to have cutaneous vasculitis and erythema nodosum. However, because of the persistent nature of her condition she was later detected to have leprosy and erythema nodosum leprosum (ENL) with the aid of simple diagnostic tests.

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

Maestas, J.H.

The Loopback Tester is an Intel SBC 86/12A Single Board Computer and an Intel SBC 534 Communications Expansion Board configured and programmed to perform various basic or less. These tests include: (1) Data Communications Equipment (DCE) transmit timing detection (2) data rate measurement (3) instantaneous loopback indication and (4) bit error rate testing. It requires no initial setup after plug in, and can be used to locate the source of communications loss in a circuit. It can also be used to determine when crypto variable mismatch problems are the source of communications loss. This report discusses the functionality of themore » Loopback Tester as a diagnostic device. It also discusses the hardware and software which implements this simple yet reliable device.« less

[Celiac disease in disguise].

PubMed

de Gottardi, A; de Saussure, P

2005-09-07

Contrarily to a widely prevalent opinion, celiac disease frequently affects adults, and only rarely reveals itself by the classical triad of diarrhea--weight loss--nutritional deficiency. In addition to isolated deficiencies, most frequently iron and calcium-vitamin D, celiac disease is commonly associated with atypical, sometimes very commonplace manifestations, such as abdominal symptoms reminiscent of those of irritable bowel syndrome, or type I diabetes. The diagnostic process is now made easier by the availability of antitransglutaminase antibodies dosage, a simple, trustworthy, sensitive and specific test. This review article discusses the many clinical pictures which should prompt the clinician to rule out celiac disease, and provides practical guidelines as to the use and interpretation of serologic tests.

Rapid Immuno-Chromatographic Assay for the Detection of Antibodies to HIV Compare with Elisa among Voluntary and Replacement Blood Donor of Mymensingh Medical College Hospital.

PubMed

Chakrabarty, P; Rudra, S; Hossain, M A; Begum, S A; Mirza, T T; Rudra, M

2015-04-01

Suitable algorithms based on a combination of two or more simple rapid HIV assays have been shown to have a diagnostic accuracy comparable to double enzyme-linked immunosorbent assay (ELISA) or double ELISA with Western Blot strategies. The aims of this study were to evaluate the performance of five simple rapid HIV assays using whole blood samples from voluntary and replacement blood donors & HIV-infected patients (positive samples from BSMMU, Dhaka). Five rapid HIV assays: Determine™ HIV-1/2 (Inverness Medical), SD Bioline HIV 1/2 3.0 (Standard Diagnostics Inc.), First Response HIV Card 1-2.0 (PMC Medical India Pvt Ltd.), HIV1/2 Stat-Pak Dipstick (Chembio Diagnostic System, Inc) and Uni-Gold™ HIV-1/2 (Biotech) were evaluated between 1st February to 30th June, 2013 using 400 whole blood samples from voluntary and replacement blood donors. All samples that were reactive on all or any of the five rapid assays and 10% of non-reactive samples were tested on a confirmatory Inno-Lia HIV I/II immunoblot assay (Immunogenetics). Only 01 sample including ten positive samples from BSMMU were confirmed HIV-1 antibody positive, while 399 were HIV negative. The sensitivity at initial testing of Determine, SD Bioline and Uni-Gold™ was 100% (95% CI; 99.1-100) while First Response and Stat-Pak had sensitivity of 99.5% (95% CI; 98.2-99.9) and 97.7% (95% CI; 95.7-98.9) respectively, which increased to 100% (95% CI; 99.1-100) on repeat testing. The initial specificity of the Uni-Gold™ assay was 100% (95% CI; 99.6-100) while specificities were 99.6% (95% CI; 99-99.9), 99.4% (95% CI; 98.8-99.7), 99.6% (95% CI; 99-99.9) and 99.8% (95% CI; 99.3-99.9) for Determine, SD Bioline, First Response and Stat-Pak assays, respectively. There was no any sample which was concordantly false positive in Uni-Gold™, Determine and SD Bioline assays. An alternative confirmatory HIV testing strategy based on initial testing on either SD Bioline or Determine assays followed by testing of reactive samples on the Determine or SD Bioline gave 100% sensitivity (95% CI; 99.1-100) and 100% specificity (95% CI; 96-99.1) with Uni-Gold™ as tiebreaker for discordant results.

Clinical and public health implications of acute and early HIV detection and treatment: a scoping review.

PubMed

Rutstein, Sarah E; Ananworanich, Jintanat; Fidler, Sarah; Johnson, Cheryl; Sanders, Eduard J; Sued, Omar; Saez-Cirion, Asier; Pilcher, Christopher D; Fraser, Christophe; Cohen, Myron S; Vitoria, Marco; Doherty, Meg; Tucker, Joseph D

2017-06-28

The unchanged global HIV incidence may be related to ignoring acute HIV infection (AHI). This scoping review examines diagnostic, clinical, and public health implications of identifying and treating persons with AHI. We searched PubMed, in addition to hand-review of key journals identifying research pertaining to AHI detection and treatment. We focused on the relative contribution of AHI to transmission and the diagnostic, clinical, and public health implications. We prioritized research from low- and middle-income countries (LMICs) published in the last fifteen years. Extensive AHI research and limited routine AHI detection and treatment have begun in LMIC. Diagnostic challenges include ease-of-use, suitability for application and distribution in LMIC, and throughput for high-volume testing. Risk score algorithms have been used in LMIC to screen for AHI among individuals with behavioural and clinical characteristics more often associated with AHI. However, algorithms have not been implemented outside research settings. From a clinical perspective, there are substantial immunological and virological benefits to identifying and treating persons with AHI - evading the irreversible damage to host immune systems and seeding of viral reservoirs that occurs during untreated acute infection. The therapeutic benefits require rapid initiation of antiretrovirals, a logistical challenge in the absence of point-of-care testing. From a public health perspective, AHI diagnosis and treatment is critical to: decrease transmission via viral load reduction and behavioural interventions; improve pre-exposure prophylaxis outcomes by avoiding treatment initiation for HIV-seronegative persons with AHI; and, enhance partner services via notification for persons recently exposed or likely transmitting. There are undeniable clinical and public health benefits to AHI detection and treatment, but also substantial diagnostic and logistical barriers to implementation and scale-up. Effective early ART initiation may be critical for HIV eradication efforts, but widespread use in LMIC requires simple and accurate diagnostic tools. Implementation research is critical to facilitate sustainable integration of AHI detection and treatment into existing health systems and will be essential for prospective evaluation of testing algorithms, point-of-care diagnostics, and efficacious and effective first-line regimens.

Clinical and public health implications of acute and early HIV detection and treatment: a scoping review

PubMed Central

Rutstein, Sarah E.; Ananworanich, Jintanat; Fidler, Sarah; Johnson, Cheryl; Sanders, Eduard J.; Sued, Omar; Saez-Cirion, Asier; Pilcher, Christopher D.; Fraser, Christophe; Cohen, Myron S.; Vitoria, Marco; Doherty, Meg; Tucker, Joseph D.

2017-01-01

Abstract Introduction: The unchanged global HIV incidence may be related to ignoring acute HIV infection (AHI). This scoping review examines diagnostic, clinical, and public health implications of identifying and treating persons with AHI. Methods: We searched PubMed, in addition to hand-review of key journals identifying research pertaining to AHI detection and treatment. We focused on the relative contribution of AHI to transmission and the diagnostic, clinical, and public health implications. We prioritized research from low- and middle-income countries (LMICs) published in the last fifteen years. Results and Discussion: Extensive AHI research and limited routine AHI detection and treatment have begun in LMIC. Diagnostic challenges include ease-of-use, suitability for application and distribution in LMIC, and throughput for high-volume testing. Risk score algorithms have been used in LMIC to screen for AHI among individuals with behavioural and clinical characteristics more often associated with AHI. However, algorithms have not been implemented outside research settings. From a clinical perspective, there are substantial immunological and virological benefits to identifying and treating persons with AHI – evading the irreversible damage to host immune systems and seeding of viral reservoirs that occurs during untreated acute infection. The therapeutic benefits require rapid initiation of antiretrovirals, a logistical challenge in the absence of point-of-care testing. From a public health perspective, AHI diagnosis and treatment is critical to: decrease transmission via viral load reduction and behavioural interventions; improve pre-exposure prophylaxis outcomes by avoiding treatment initiation for HIV-seronegative persons with AHI; and, enhance partner services via notification for persons recently exposed or likely transmitting. Conclusions: There are undeniable clinical and public health benefits to AHI detection and treatment, but also substantial diagnostic and logistical barriers to implementation and scale-up. Effective early ART initiation may be critical for HIV eradication efforts, but widespread use in LMIC requires simple and accurate diagnostic tools. Implementation research is critical to facilitate sustainable integration of AHI detection and treatment into existing health systems and will be essential for prospective evaluation of testing algorithms, point-of-care diagnostics, and efficacious and effective first-line regimens. PMID:28691435

Noninvasive Tests Do Not Accurately Differentiate Nonalcoholic Steatohepatitis From Simple Steatosis: A Systematic Review and Meta-analysis.

PubMed

Verhaegh, Pauline; Bavalia, Roisin; Winkens, Bjorn; Masclee, Ad; Jonkers, Daisy; Koek, Ger

2018-06-01

Nonalcoholic fatty liver disease is a rapidly increasing health problem. Liver biopsy analysis is the most sensitive test to differentiate between nonalcoholic steatohepatitis (NASH) and simple steatosis (SS), but noninvasive methods are needed. We performed a systematic review and meta-analysis of noninvasive tests for differentiating NASH from SS, focusing on blood markers. We performed a systematic search of the PubMed, Medline and Embase (1990-2016) databases using defined keywords, limited to full-text papers in English and human adults, and identified 2608 articles. Two independent reviewers screened the articles and identified 122 eligible articles that used liver biopsy as reference standard. If at least 2 studies were available, pooled sensitivity (sens p ) and specificity (spec p ) values were determined using the Meta-Analysis Package for R (metafor). In the 122 studies analyzed, 219 different blood markers (107 single markers and 112 scoring systems) were identified to differentiate NASH from simple steatosis, and 22 other diagnostic tests were studied. Markers identified related to several pathophysiological mechanisms. The markers analyzed in the largest proportions of studies were alanine aminotransferase (sens p , 63.5% and spec p , 74.4%) within routine biochemical tests, adiponectin (sensp, 72.0% and spec p , 75.7%) within inflammatory markers, CK18-M30 (sens p , 68.4% and spec p , 74.2%) within markers of cell death or proliferation and homeostatic model assessment of insulin resistance (sens p , 69.0% and spec p , 72.7%) within the metabolic markers. Two scoring systems could also be pooled: the NASH test (differentiated NASH from borderline NASH plus simple steatosis with 22.9% sens p and 95.3% spec p ) and the GlycoNASH test (67.1% sens p and 63.8% spec p ). In the meta-analysis, we found no test to differentiate NASH from SS with a high level of pooled sensitivity and specificity (≥80%). However, some blood markers, when included in scoring systems in single studies, identified patients with NASH with ≥80% sensitivity and specificity. Replication studies and more standardized study designs are urgently needed. At present, no marker or scoring system can be recommended for use in clinical practice to differentiate NASH from simple steatosis. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

A Simple, Evidence-Based Approach to Help Guide Diagnosis of Heart Failure with Preserved Ejection Fraction.

PubMed

Reddy, Yogesh N V; Carter, Rickey E; Obokata, Masaru; Redfield, Margaret M; Borlaug, Barry A

2018-05-23

Background -Diagnosis of heart failure with preserved ejection fraction (HFpEF) is challenging in euvolemic patients with dyspnea, and no evidence-based criteria are available. We sought to develop and then validate non-invasive diagnostic criteria that could be used to estimate the likelihood that HFpEF is present among patients with unexplained dyspnea in order to guide further testing. Methods -Consecutive patients with unexplained dyspnea referred for invasive hemodynamic exercise testing were retrospectively evaluated. Diagnosis of HFpEF (case) or non-cardiac dyspnea (control) was ascertained by invasive hemodynamic exercise testing. Logistic regression was performed to evaluate the ability of clinical findings to discriminate cases from controls. A scoring system was developed and then validated in a separate test cohort. Results -The derivation cohort included 414 consecutive patients (267 HFpEF and 147 controls, HFpEF prevalence 64%). The test cohort included 100 consecutive patients (61 HFpEF, prevalence 61%). Obesity, atrial fibrillation, age>60 years, treatment with 2 or more antihypertensives, echocardiographic E/e' ratio>9 and echocardiographic pulmonary artery systolic pressure>35 mmHg were selected as the final set of predictive variables. A weighted score based on these six variables was used to create a composite score (H 2 FPEF score) ranging from 0-9. The odds of HFpEF doubled for each 1 unit score increase [OR 1.98 [1.74-2.30], p<0.0001], with an AUC of 0.841 (p<0.0001). The H 2 FPEF score was superior to a currently-used algorithm based upon expert consensus (increase in AUC of +0.169 [+0.120 to +0.217], p<0.0001). Performance in the independent test cohort was maintained [AUC 0.886, p<0.0001]. Conclusions -The H 2 FPEF score, which relies upon simple clinical characteristics and echocardiography, enables discrimination of HFpEF from non-cardiac causes of dyspnea, and can assist in determination of the need for further diagnostic testing in the evaluation of patients with unexplained exertional dyspnea.

Systematic review of the accuracy of the ParaSight-F test in the diagnosis of Plasmodium falciparum malaria.

PubMed

Cruciani, Mario; Nardi, Stefano; Malena, Marina; Bosco, Oliviero; Serpelloni, Giovanni; Mengoli, Carlo

2004-07-01

The Parasight-F test is a device for the rapid diagnosis of Plasmodium falciparum malaria. In a number of field studies rather wide disparities in the performance of the test have been reported. To provide an evaluation of the quality of available reports and an overall summary of diagnostic accuracy of the Parasight-F test, we have performed a systematic review. Systematic review and meta-analysis of controlled studies evaluating the diagnostic accuracy of Parasight-F test in comparison with light microscopy. 15,359 subjects (4,119 with falciparum malaria) studied with the Parasight-F test as reported in 32 studies from 29 publications. Summary receiving operator characteristic (SROC) curve as well as odds ratio calculated by the fixed effect model and the random effect model. Based on pooled data, the predictive values were calculated for a range of P. falciparum prevalence through a Bayesian approach. Overall, the Parasight-F test demonstrated 0.90 (95%, confidence intervals 0.88-0.93) sensitivity and 0.94 (0.92-0.96) specificity. Both sensitivity and specificity were significantly higher in the non-resident than in the resident population. The post-test probability indicates that in settings of low malaria prevalence, a negative test almost absolutely excludes infection, while in settings of high prevalence, the same result still gives a substantial chance of infection being present. The Parasight-F test is a simple and accurate test for the diagnosis of P. falciparum infection. The test could be of particular value in the diagnosis of malaria in travelers returning from endemic areas.

Cost-effectiveness analysis of malaria rapid diagnostic test incentive schemes for informal private healthcare providers in Myanmar.

PubMed

Chen, Ingrid T; Aung, Tin; Thant, Hnin Nwe Nwe; Sudhinaraset, May; Kahn, James G

2015-02-05

The emergence of artemisinin-resistant Plasmodium falciparum parasites in Southeast Asia threatens global malaria control efforts. One strategy to counter this problem is a subsidy of malaria rapid diagnostic tests (RDTs) and artemisinin-based combination therapy (ACT) within the informal private sector, where the majority of malaria care in Myanmar is provided. A study in Myanmar evaluated the effectiveness of financial incentives vs information, education and counselling (IEC) in driving the proper use of subsidized malaria RDTs among informal private providers. This cost-effectiveness analysis compares intervention options. A decision tree was constructed in a spreadsheet to estimate the incremental cost-effectiveness ratios (ICERs) among four strategies: no intervention, simple subsidy, subsidy with financial incentives, and subsidy with IEC. Model inputs included programmatic costs (in dollars), malaria epidemiology and observed study outcomes. Data sources included expenditure records, study data and scientific literature. Model outcomes included the proportion of properly and improperly treated individuals with and without P. falciparum malaria, and associated disability-adjusted life years (DALYs). Results are reported as ICERs in US dollars per DALY averted. One-way sensitivity analysis assessed how outcomes depend on uncertainty in inputs. ICERs from the least to most expensive intervention are: $1,169/DALY averted for simple subsidy vs no intervention, $185/DALY averted for subsidy with financial incentives vs simple subsidy, and $200/DALY averted for a subsidy with IEC vs subsidy with financial incentives. Due to decreasing ICERs, each strategy was also compared to no intervention. The subsidy with IEC was the most favourable, costing $639/DALY averted compared with no intervention. One-way sensitivity analysis shows that ICERs are most affected by programme costs, RDT uptake, treatment-seeking behaviour, and the prevalence and virulence of non-malarial fevers. In conclusion, private provider subsidies with IEC or a combination of IEC and financial incentives may be a good investment for malaria control.

Development and utilization of new diagnostics for dense-phase pneumatic transport. Quarterly technical progress report, October 1-December 31, 1989

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

Louge, M. Y.; Jenkins, J. T.

The main objective of this work is to develop probes for local measurements of solid velocity and holdup in dense gas-solid flows. In particular, capacitance probes are designed to measure local, time-dependent particle concentrations. In addition, a new optical fiber probe based on laser-induced-phosphorescence is developed to measure particle velocities. The principles for the capacitance and optical diagnostics were given in our first and second quarterly reports. In this reporting period, we have demonstrated with success the feasibility of the optical fiber probe. Another objective of this work is to develop a model of dense-phase conveying and to test thismore » model in a setup that incorporates our diagnostics. In this period, as a prelude to these modeling efforts scheduled for the third year of the contract, we have carried out additional computer simulations of rapid granular flows to verify the theories of Jenkins and Richman (1988) on the anisotropy of the second moment in simple shear. 2 refs., 5 figs.« less

Asymptomatic malaria parasitaemia using rapid diagnostic test in unbooked pregnant women in rural Ondo-south district, Nigeria.

PubMed

Nwaneri, D U; Adeleye, O A; Ande, A B

2013-03-01

Malaria is a major contributor of maternal and peri-natal morbidity and mortality. The disease may be asymptomatic despite sequestration of parasitized red blood cells in the placental micro-circulation with antecedent complications. In such condition, it may also be difficult to identify the malaria parasite by the peripheral blood film microscopy, thus the need for use of simple but reliable tool for malaria parasite diagnosis. To determine the prevalence of asymptomatic malaria parasitaemia using the Rapid Diagnostic Test in pregnant unbooked women seen in a primary health centre during a malaria control campaign programme in rural Ondo-south, District Nigeria. Prevalence of asymptomatic malaria parasitaemia was 25.9%. Only 3 (3.5%) of the 85 women had the long lasting insecticide-treated nets. There was no significant association between malaria parasitaemia, and the age group, parity and gestation age. Given the high prevalence of asymptomatic malaria in pregnancy, routine screening for malaria at booking and scaling-up of other malaria control strategies such as the use of long lasting insecticidal-treated nets and intermittent preventive therapy for pregnant women are recommended.

An exo probe-based recombinase polymerase amplification assay for the rapid detection of porcine parvovirus.

PubMed

Wang, Jian-Chang; Liu, Li-Bing; Han, Qing-An; Wang, Jin-Feng; Yuan, Wan-Zhe

2017-10-01

Recombinase polymerase amplification (RPA), an isothermal amplification technology, has been developed as an alternative to PCR in pathogen detection. A real-time RPA assay (rt-RPA) was developed to detect the porcine parvovirus (PPV) using primers and exo probe specific for the VP2 gene. The amplification was performed at 39°C for 20min. There was no cross-reaction with other pathogens tested. Using the recombinant plasmid pPPV-VP2 as template, the analytical sensitivity was 103 copies. The assay performance was evaluated by testing 115 field samples by rt-RPA and a real-time PCR assay. The diagnostic agreement between assays was 100%, and PPV DNA was detected in 94 samples. The R 2 value of rt-RPA and real-time PCR was 0.909 by linear regression analysis. The developed rt-RPA assay provides a useful alternative tool for rapid, simple and reliable detection of PPV in diagnostic laboratories and at point-of-care, especially in remote and rural areas. Copyright © 2017 Elsevier B.V. All rights reserved.

A new simple and rapid LC-ESI-MS/MS method for quantification of plasma oxysterols as dimethylaminobutyrate esters. Its successful use for the diagnosis of Niemann-Pick type C disease.

PubMed

Boenzi, Sara; Deodato, Federica; Taurisano, Roberta; Martinelli, Diego; Verrigni, Daniela; Carrozzo, Rosalba; Bertini, Enrico; Pastore, Anna; Dionisi-Vici, Carlo; Johnson, David W

2014-11-01

Two oxysterols, cholestan-3β,5α,6β-triol (C-triol) and 7-ketocholesterol (7-KC), have been recently proposed as diagnostic markers of Niemann-Pick type C (NP-C) disease, representing a potential alternative diagnostic tool to the more invasive and time consuming filipin test in cultured fibroblasts. Usually, the oxysterols are detected and quantified by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method using atmospheric pressure chemical ionization (APCI) or electro-spray-ionization (ESI) sources, after a variety of derivatization procedures to enhance sensitivity. We developed a sensitive LC-MS/MS method to quantify the oxysterols in plasma as dimethylaminobutyrate ester, suitable for ESI analysis. This method, with an easy liquid-phase extraction and a short derivatization procedure, has been validated to demonstrate specificity, linearity, recovery, lowest limit of quantification, accuracy and precision. The assay was linear over a concentration range of 0.5-200ng/mL for C-triol and 1.0-200ng/mL for 7-KC. Intra-day and inter-day coefficients of variation (CV%) were <15% for both metabolites. Receiver operating characteristic analysis estimates that the area under curve was 0.998 for C-triol, and 0.972 for 7-KC, implying a significant discriminatory power for the method in this patient population of both oxysterols. In summary, our method provides a simple, rapid and non-invasive diagnostic tool for the biochemical diagnosis of NP-C disease. Copyright © 2014 Elsevier B.V. All rights reserved.

Body image drawings dissociate ethnic differences and anorexia in adolescent girls.

PubMed

Goldzak-Kunik, Galit; Leshem, Micah

2017-01-01

To distinguish between ethnic differences among segregated schoolgirls and restrictive anorexia nervosa using a simple culture-fair test of body image (BI) figure drawings. Several responses to BI figure drawings by 178 adolescent schoolgirls from three ethnically distinct and segregated schools and communities in Israel, Jewish secular (JS), Jewish Haredi (H), and Christian Arab (C), and a group of 14 severely restricting anorexic girls (AN). BI evaluations were analyzed by MANCOVA, followed by paired or Student-t tests for comparisons between responses and groups respectively. Pearson r served for correlations and the Fisher Z for differences between slopes. Despite the total ethnic segregation among the schoolgirls, there are commonalities; all prefer a thinner ideal BI, and are similarly dissatisfied with their BI. However, ethnic differences also emerge: C underestimate their BI and how others view them, and H true and Ideal BI evaluations correlate, unlike the other groups. Despite this variability, and in stark contrast, the anorexic girls show a gross misperception of their BI, even in comparison to girls equated for BMI. The findings show that figure drawings evaluation of BI is a simple and robust instrument dissociating clinical and ethnic responses. Clinicians may consider body figure drawings as a simple, supportive, diagnostic for first-line recognition for risk of AN in adolescent girls.

Contribution of diagnostic tests for the etiological assessment of uveitis, data from the ULISSE study (Uveitis: Clinical and medicoeconomic evaluation of a standardized strategy of the etiological diagnosis).

PubMed

Grumet, Pierre; Kodjikian, Laurent; de Parisot, Audrey; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Labetoulle, Marc; Broussolle, Christiane; Jamilloux, Yvan; Decullier, Evelyne; Sève, Pascal

2018-04-01

ULISSE is the only study that prospectively assessed the efficiency of a standardized strategy, compared to an open strategy for the etiologic diagnosis of uveitis. Our aim was to evaluate the diagnostic yield of the tests prescribed in the ULISSE study to clarify their relevance. ULISSE is a non-inferiority, prospective, multicenter and cluster randomized study. The standardized strategy is a two-steps strategy: in the first step, common standard tests were performed, and in the second step, tests were guided by the clinical and anatomic type of uveitis. We reported the relevance of the diagnostic tests used in the standardized strategy, as well as the profitability of the tests that were prescribed to more than twenty patients in each group. Based on diagnostic criteria, either an ophthalmologist, or an internist, established the profitability of a test by considering whether the test lead to a diagnosis or not. Among the 676 patients included (standardized 303; open 373), a diagnosis was made for 152 (50.4%) in the standardized group and 203 (54.4%) in the open group. The most common entities were HLA-B27 associated uveitis (22%), spondyloarthritis (11%), sarcoidosis (18%), tuberculosis (10.7%) and herpes virus infections (8.5%). Among the first step's systematic tests, tuberculin skin test was the most contributive investigation (17.1%), followed by chest X-ray (8.4%), C reactive protein and ESR (6.6% and 5.1%), complete blood count (2.2%) and VDRL (2.0%). The second step's most often contributive tests were: HLA B27 (56.3%), chest-CT (30.3%) and angiotensin converting enzyme (ACE) (16.5%). HLA B27 and ACE were significantly more contributive in the standardized group than in the open group. Immunological tests were never contributive. Among the free investigations, or among the investigations guided by clinical or paraclinical findings, the most often contributive tests were: Quantiferon® (24%), electrophoresis of serum protein (7.8%) and sacroiliac imagery (46.4%). Intracellular serologies (1.7%), serum calcium (2.1%) and hepatic tests (3.3%) were exceptionally contributive. Among the third intention tests, labial salivary gland biopsies were contributive in 17.9% of cases, but the profitability of other invasive investigations (anterior chamber tap, vitrectomy, bronchoscopy and lumbar puncture) or specialized imagery (18F-FDG PET, Brain MRI) could not be determined since these test were rarely performed. Only a few diagnostic tests are useful for the etiological assessment of uveitis. They are often cheap, simple, more often guided by the clinical findings, and lead to an etiological diagnosis in most patients. On the other hand, some tests are never or exceptionally contributive, such as immunological tests or intracellular serologies. Further studies are required to evaluate the profitability of third intention imagery and invasive investigations. Copyright © 2018 Elsevier B.V. All rights reserved.

Contribution of a new electrophysiologic test to Morton's neuroma diagnosis.

PubMed

Pardal-Fernández, José Manuel; Palazón-García, Elena; Hernández-Fernández, Francisco; de Cabo, Carlos

2014-06-01

Morton's neuroma causes metatarsalgia due to the interdigital neuropathy. The small nerve diameter compromises their evaluation in image studies. To overcome this problem we propose a new electrophysiological test. We conducted a prospective case-control study performing a orthodromic electroneurography using subdermal electrodes in controls and patients to assess the validity. Additionally all patients were tested with magnetic resonance. Some patients required surgery and subsequent histological evaluation. The new ENG procedure showed higher sensitivity and specificity. Methodological standardization was easy and the test was well tolerated by the subjects. Our test demonstrated remarkable diagnostic efficiency, and also was able to identify symptomatic patients undetected by magnetic resonance, which underlines the lack of correlation between the size and intensity of the lesion. This new electrophysiological method appears to be a highly sensitivity, well-tolerated, simple and low-cost for Morton's neuroma diagnosis. Copyright © 2014 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Comparison of Effectiveness in Differentiating Benign from Malignant Ovarian Masses between IOTA Simple Rules and Subjective Sonographic Assessment.

PubMed

Tongsong, Theera; Tinnangwattana, Dangcheewan; Vichak-Ururote, Linlada; Tontivuthikul, Paponrad; Charoenratana, Cholaros; Lerthiranwong, Thitikarn

2016-01-01

To compare diagnostic performance in differentiating benign from malignant ovarian masses between IOTA (the International Ovarian Tumor Analysis) simple rules and subjective sonographic assessment. Women scheduled for elective surgery because of ovarian masses were recruited into the study and underwent ultrasound examination within 24 hours of surgery to apply the IOTA simple rules by general gynecologists and to record video clips for subjective assessment by an experienced sonographer. The diagnostic performance of the IOTA rules and subjective assessment for differentiation between benign and malignant masses was compared. The gold standard diagnosis was pathological or operative findings. A total of 150 ovarian masses were covered, comprising 105 (70%) benign and 45 (30%) malignant. Of them, the IOTA simple rules could be applied in 119 (79.3%) and were inconclusive in 31 (20.7%) whereas subjective assessment could be applied in all cases (100%). The sensitivity and the specificity of the IOTA simple rules and subjective assessment were not significantly different, 82.9% vs 86.7% and 94.0% vs 94.3% respectively. The agreement of the two methods in prediction was high with a Kappa index of 0.835. Both techniques had a high diagnostic performance in differentiation between benign and malignant ovarian masses but the IOTA rules had a relatively high rate of inconclusive results. The IOTA rules can be used as an effective screening technique by general gynecologists but when the results are inconclusive they should consult experienced sonographers.

Evaluation of latex agglutination test (KAtex) for early diagnosis of kala-azar.

PubMed

Ahsan, M M; Islam, M N; Mollah, A H; Hoque, M A; Hossain, M A; Begum, Z; Islam, M T

2010-07-01

Kala-azar is one of the major public health problem in Bangladesh. But the diagnosis of the problem often is difficult, unusual and time consuming, a simple, noninvasive, easy to perform, reliable and rapid diagnostic test has been a long-felt need of the clinicians. Therefore, the present study was conducted to see the sensitivity and specificity of Latex Agglutination test (KAtex) to detect leishmanial antigen from urine of kala-azar cases. The study was carried out in the department of Paediatrics, Mymensingh Medical College and Hospital, Bangladesh during July to December, 2008. A total of 100 urine samples were collected of which 50 were confirmed kala-azar cases and 50 were age and sex matched controls. Out of 50 kala-azar cases 47 showed positive result of KAtex. The test was also positive in 01 out of 30 healthy controls. None of the febrile controls was positive by KAtex. The sensitivity, specificity, positive predictive value and negative predictive value of the test using presence of LD bodies in splenic and/or bone marrow aspirate as gold standard were 94%, 98%, 97.91% and 94.23% respectively. KAtex is simple, noninvasive, easy to perform, rapid and reliable test for diagnosing kala-azar in endemic area and useful for small, less equipped laboratories as well as for the laboratories with better facilities.

PrimaTB STAT-PAK Assay, a Novel, Rapid Lateral-Flow Test for Tuberculosis in Nonhuman Primates▿

PubMed Central

Lyashchenko, Konstantin P.; Greenwald, Rena; Esfandiari, Javan; Greenwald, David; Nacy, Carol A.; Gibson, Susan; Didier, Peter J.; Washington, Marc; Szczerba, Peter; Motzel, Sherri; Handt, Larry; Pollock, John M.; McNair, James; Andersen, Peter; Langermans, Jan A. M.; Verreck, Frank; Ervin, Sean; Ervin, Frank; McCombs, Candace

2007-01-01

Tuberculosis (TB) is the most important zoonotic bacterial disease in nonhuman primates (NHP). The current diagnostic method, the intradermal palpebral tuberculin test, has serious shortcomings. We characterized antibody responses in NHP against Mycobacterium tuberculosis to identify immunodominant antigens and develop a rapid serodiagnostic test for TB. A total of 422 NHP were evaluated, including 243 rhesus (Macaca mulatta), 46 cynomolgus (Macaca fascicularis), and 133 African green (Cercopithecus aethiops sabaeus) monkeys at five collaborative centers. Of those, 50 monkeys of the three species were experimentally inoculated with M. tuberculosis. Antibody responses were monitored every 2 to 4 weeks for up to 8 months postinfection by MultiAntigen Print ImmunoAssay with a panel of 12 recombinant antigens. All of the infected monkeys produced antibodies at various levels and with different antigen recognition patterns. ESAT-6 and MPB83 were the most frequently recognized proteins during infection. A combination of selected antigens which detected antibodies in all of the infected monkeys was designed to develop the PrimaTB STAT-PAK assay by lateral-flow technology. Serological evaluation demonstrated high diagnostic sensitivity (90%) and specificity (99%). The highest rate of TB detection was achieved when the skin test was combined with the PrimaTB STAT-PAK kit. This novel immunoassay provides a simple, rapid, and accurate test for TB in NHP. PMID:17652522

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

H5N1-SeroDetect EIA and rapid test: a novel differential diagnostic assay for serodiagnosis of H5N1 infections and surveillance.

PubMed

Khurana, Surender; Sasono, Pretty; Fox, Annette; Nguyen, Van Kinh; Le, Quynh Mai; Pham, Quang Thai; Nguyen, Tran Hien; Nguyen, Thanh Liem; Horby, Peter; Golding, Hana

2011-12-01

Continuing evolution of highly pathogenic (HP) H5N1 influenza viruses in wild birds with transmission to domestic poultry and humans poses a pandemic threat. There is an urgent need for a simple and rapid serological diagnostic assay which can differentiate between antibodies to seasonal and H5N1 strains and that could provide surveillance tools not dependent on virus isolation and nucleic acid technologies. Here we describe the establishment of H5N1 SeroDetect enzyme-linked immunosorbent assay (ELISA) and rapid test assays based on three peptides in HA2 (488-516), PB1-F2 (2-75), and M2e (2-24) that are highly conserved within H5N1 strains. These peptides were identified by antibody repertoire analyses of H5N1 influenza survivors in Vietnam using whole-genome-fragment phage display libraries (GFPDLs). To date, both platforms have demonstrated high levels of sensitivity and specificity in detecting H5N1 infections (clade 1 and clade 2.3.4) in Vietnamese patients as early as 7 days and up to several years postinfection. H5N1 virus-uninfected individuals in Vietnam and the United States, including subjects vaccinated with seasonal influenza vaccines or with confirmed seasonal virus infections, did not react in the H5N1-SeroDetect assays. Moreover, sera from individuals vaccinated with H5N1 subunit vaccine with moderate anti-H5N1 neutralizing antibody titers did not react positively in the H5N1-SeroDetect ELISA or rapid test assays. The simple H5N1-SeroDetect ELISA and rapid tests could provide an important tool for large-scale surveillance for potential exposure to HP H5N1 strains in both humans and birds.

Diagnostic accuracy, incremental yield and prognostic value of Determine TB-LAM for routine diagnostic testing for tuberculosis in HIV-infected patients requiring acute hospital admission in South Africa: a prospective cohort.

PubMed

Lawn, Stephen D; Kerkhoff, Andrew D; Burton, Rosie; Schutz, Charlotte; Boulle, Andrew; Vogt, Monica; Gupta-Wright, Ankur; Nicol, Mark P; Meintjes, Graeme

2017-03-21

We previously reported that one-third of HIV-positive adults requiring medical admission to a South African district hospital had laboratory-confirmed tuberculosis (TB) and that almost two-thirds of cases could be rapidly diagnosed using Xpert MTB/RIF-testing of concentrated urine samples obtained on the first day of admission. Implementation of urine-based, routine, point-of-care TB screening is an attractive intervention that might be facilitated by use of a simple, low-cost diagnostic tool, such as the Determine TB-LAM lateral-flow rapid test for HIV-associated TB. Sputum, urine and blood samples were systematically obtained from unselected HIV-positive adults within 24 hours of admission to a South African township hospital. Additional clinical samples were obtained during hospitalization as clinically indicated. TB was defined by the detection of Mycobacterium tuberculosis in any sample using Xpert MTB/RIF or liquid culture. The diagnostic yield, accuracy and prognostic value of urine-lipoarabinomannan (LAM) testing were determined, but urine-LAM results did not inform treatment decisions. Consecutive HIV-positive adult acute medical admissions not already receiving TB treatment (n = 427) were enrolled regardless of clinical presentation or symptoms. TB was diagnosed in 139 patients (TB prevalence 32.6%; median CD4 count 80 cells/μL). In the first 24 hours of admission, sputum (spot and/or induced) samples were obtained from 37.0% of patients and urine samples from 99.5% of patients (P < 0.001). The diagnostic yields from these specimens were 19.4% (n = 27/139) for sputum-microscopy, 26.6% (n = 37/139) for sputum-Xpert, 38.1% (n = 53/139) for urine-LAM and 52.5% (n = 73/139) for sputum-Xpert/urine-LAM combined (P < 0.01). Corresponding yields among patients with CD4 counts <100 cells/μL were 18.9%, 24.3%, 55.4% and 63.5%, respectively (P < 0.01). The diagnostic yield of urine-LAM was unrelated to respiratory symptoms, and LAM assay specificity (using a grade-2 cut-off) was 98.9% (274/277; 95% confidence interval [CI] 96.9-99.8). Among TB cases, positive urine-LAM status was strongly associated with mortality at 90 days (adjusted hazard ratio 4.20; 95% CI 1.50-11.75). Routine testing for TB in newly admitted HIV-positive adults using Determine TB-LAM to test urine provides major incremental diagnostic yield with very high specificity when used in combination with sputum testing and has important utility among those without respiratory TB symptoms and/or unable to produce sputum. The assay also rapidly identifies individuals with a poor prognosis.

Salivary diagnostics and its impact in dentistry, research, education, and the professional community.

PubMed

Slavkin, H C; Fox, C H; Meyer, D M

2011-10-01

Oral fluid-based (salivary) tests have the potential to create practical, point-of-care clinical instruments that are convenient, practical, and comfortable to use in dentistry and medicine. Currently, there are no simple, accurate, and inexpensive sampling, screening, or detection methods to support definitive diagnostic platforms across dental and medical disciplines. Though the benefits from advancing screening and detection technologies seem eminent, analytical, chemical, molecular, genetic, and protein markers are still under development. Clinical applications in patient care must be validated independently to ensure that they are clinically accurate, reliable, precise, and uniformly consistent for screening and detecting specific diseases or conditions. As technology designed to improve patient care through risk assessment, prevention, and disease management is transferred into clinical practice, dentistry may need to reassess its role in general health care. © International & American Associations for Dental Research

A telehealth system for automated diagnosis of asthma and chronical obstructive pulmonary disease.

PubMed

Gurbeta, Lejla; Badnjevic, Almir; Maksimovic, Mirjana; Omanovic-Miklicanin, Enisa; Sejdic, Ervin

2018-05-18

This paper presents the development and real-time testing of an automated expert diagnostic telehealth system for the diagnosis of 2 respiratory diseases, asthma and Chronic Obstructive Pulmonary Disease (COPD). The system utilizes Android, Java, MATLAB, and PHP technologies and consists of a spirometer, mobile application, and expert diagnostic system. To evaluate the effectiveness of the system, a prospective study was carried out in 3 remote primary healthcare institutions, and one hospital in Bosnia and Herzegovina healthcare system. During 6 months, 780 patients were assessed and diagnosed with an accuracy of 97.32%. The presented approach is simple to use and offers specialized consultations for patients in remote, rural, and isolated communities, as well as old and less physically mobile patients. While improving the quality of care delivered to patients, it was also found to be very beneficial in terms of healthcare.

Multi-scale silica structures for improved point of care detection

NASA Astrophysics Data System (ADS)

Lin, Sophia; Lin, Lancy; Cho, Eunbyul; Pezzani, Gaston A. O.; Khine, Michelle

2017-03-01

The need for sensitive, portable diagnostic tests at the point of care persists. We report on a simple method to obtain improved detection of biomolecules by a two-fold mechanism. Silica (SiO2) is coated on pre-stressed thermoplastic shrink-wrap film. When the film retracts, the resulting micro- and nanostructures yield far-field fluorescence signal enhancements over their planar or wrinkled counterparts. Because the film shrinks by 95% in surface area, there is also a 20x concentration effect. The SiO2 structured substrate is therefore used for improved detection of labeled proteins and DNA hybridization via both fluorescent and bright field. Through optical characterization studies, we attribute the fluorescence signal enhancements of 100x to increased surface density and light scattering from the rough SiO2 structures. Combining with our open channel self-wicking microfluidics, we can achieve extremely low cost yet sensitive point of care diagnostics.

Circulating tumor DNA as a liquid biopsy target for detection of pancreatic cancer

PubMed Central

Takai, Erina; Yachida, Shinichi

2016-01-01

Most pancreatic cancer patients present with advanced metastatic disease, resulting in extremely poor 5-year survival, mainly because of the lack of a reliable modality for early detection and limited therapeutic options for advanced disease. Therefore, there is a need for minimally-invasive diagnostic tools for detecting pancreatic cancer at an early stage, when curative surgery and also novel therapeutic approaches including precision medicine may be feasible. The “liquid biopsy” addresses these unmet clinical needs based on the concept that simple peripheral blood sampling and detection of circulating tumor DNA (ctDNA) could provide diagnostic information. In this review, we provide an overview of the current status of blood-based tests for diagnosis of pancreatic cancer and the potential utility of ctDNA for precision medicine. We also discuss challenges that remain to be addressed in developing practical ctDNA-based liquid biopsy approaches for early diagnosis of pancreatic cancer. PMID:27784960

Circulating tumor DNA as a liquid biopsy target for detection of pancreatic cancer.

PubMed

Takai, Erina; Yachida, Shinichi

2016-10-14

Most pancreatic cancer patients present with advanced metastatic disease, resulting in extremely poor 5-year survival, mainly because of the lack of a reliable modality for early detection and limited therapeutic options for advanced disease. Therefore, there is a need for minimally-invasive diagnostic tools for detecting pancreatic cancer at an early stage, when curative surgery and also novel therapeutic approaches including precision medicine may be feasible. The "liquid biopsy" addresses these unmet clinical needs based on the concept that simple peripheral blood sampling and detection of circulating tumor DNA (ctDNA) could provide diagnostic information. In this review, we provide an overview of the current status of blood-based tests for diagnosis of pancreatic cancer and the potential utility of ctDNA for precision medicine. We also discuss challenges that remain to be addressed in developing practical ctDNA-based liquid biopsy approaches for early diagnosis of pancreatic cancer.

Magnetic bead-quantum dot assay for detection of a biomarker for traumatic brain injury

NASA Astrophysics Data System (ADS)

Kim, Chloe; Searson, Peter C.

2015-10-01

Current diagnostic methods for traumatic brain injury (TBI), which accounts for 15% of all emergency room visits, are limited to neuroimaging modalities. The challenges of accurate diagnosis and monitoring of TBI have created the need for a simple and sensitive blood test to detect brain-specific biomarkers. Here we report on an assay for detection of S100B, a putative biomarker for TBI, using antibody-conjugated magnetic beads for capture of the protein, and antibody-conjugated quantum dots for optical detection. From Western Blot, we show efficient antigen capture and concentration by the magnetic beads. Using magnetic bead capture and quantum dot detection in serum samples, we show a wide detection range and detection limit below the clinical cut-off level.Current diagnostic methods for traumatic brain injury (TBI), which accounts for 15% of all emergency room visits, are limited to neuroimaging modalities. The challenges of accurate diagnosis and monitoring of TBI have created the need for a simple and sensitive blood test to detect brain-specific biomarkers. Here we report on an assay for detection of S100B, a putative biomarker for TBI, using antibody-conjugated magnetic beads for capture of the protein, and antibody-conjugated quantum dots for optical detection. From Western Blot, we show efficient antigen capture and concentration by the magnetic beads. Using magnetic bead capture and quantum dot detection in serum samples, we show a wide detection range and detection limit below the clinical cut-off level. Electronic supplementary information (ESI) available. See DOI: 10.1039/c5nr05608j

Accurate screening for insulin resistance in PCOS women using fasting insulin concentrations.

PubMed

Lunger, Fabian; Wildt, Ludwig; Seeber, Beata

2013-06-01

The aims of this cross-sectional study were to evaluate the relative agreement of both static and dynamic methods of diagnosing IR in women with polycystic ovary syndrome (PCOS) and to suggest a simple screening method for IR. All participants underwent serial blood draws for hormonal profiling and lipid assessment, a 3 h, 75 g load oral glucose tolerance test (OGTT) with every 15 min measurements of glucose and insulin, and an ACTH stimulation test. The prevalence of IR ranged from 12.2% to 60.5%, depending on the IR index used. Based on largest area under the curve on receiver operating curve (ROC) analyses, the dynamic indices outperformed the static indices with glucose to insulin ratio and fasting insulin (fInsulin) demonstrating the best diagnostic properties. Applying two cut-offs representing fInsulin extremes (<7 and >13 mIU/l, respectively) gave the diagnosis in 70% of the patients with high accuracy. Currently utilized indices for assessing IR give highly variable results in women with PCOS. The most accurate indices based on dynamic testing can be time-consuming and labor-intensive. We suggest the use of fInsulin as a simple screening test, which can reduce the number of OGTTs needed to routinely assess insulin resistance in women with PCOS.

A simple micro-photometric method for urinary iodine determination.

PubMed

Grimm, Gabriele; Lindorfer, Heidelinde; Kieweg, Heidi; Marculescu, Rodrig; Hoffmann, Martha; Gessl, Alois; Sager, Manfred; Bieglmayer, Christian

2011-10-01

Urinary iodide concentration (UIC) is useful to evaluate nutritional iodine status. In clinical settings UIC helps to exclude blocking of the thyroid gland by excessive endogenous iodine, if diagnostic or therapeutic administration of radio-iodine is indicated. Therefore, this study established a simple test for the measurement of UIC. UIC was analyzed in urine samples of 200 patients. Samples were pre-treated at 95°C for 45 min with ammonium persulfate in a thermal cycler, followed by a photometric Sandell-Kolthoff reaction (SK) carried out in microtiter plates. For method comparison, UIC was analyzed in 30 samples by inductivity coupled plasma mass spectro-metry (ICP-MS) as a reference method. Incubation conditions were optimized concerning recovery. The photometric test correlated well to the reference method (SK=0.91*ICP-MS+1, r=0.962) and presented with a functional sensitivity of 20 μg/L. UIC of patient samples ranged from <20 to 750 μg/L (median 110 μg/L); 90% of the urine samples had iodide concentrations below 210 μg/L. The modified SK-test takes approximately 90 min for analyses of 20 urine samples compared with 27 h for ICP-MS. The photometric test provides satisfactory results and can be performed with the basic equipment of a clinical laboratory.

Efficient statistical tests to compare Youden index: accounting for contingency correlation.

PubMed

Chen, Fangyao; Xue, Yuqiang; Tan, Ming T; Chen, Pingyan

2015-04-30

Youden index is widely utilized in studies evaluating accuracy of diagnostic tests and performance of predictive, prognostic, or risk models. However, both one and two independent sample tests on Youden index have been derived ignoring the dependence (association) between sensitivity and specificity, resulting in potentially misleading findings. Besides, paired sample test on Youden index is currently unavailable. This article develops efficient statistical inference procedures for one sample, independent, and paired sample tests on Youden index by accounting for contingency correlation, namely associations between sensitivity and specificity and paired samples typically represented in contingency tables. For one and two independent sample tests, the variances are estimated by Delta method, and the statistical inference is based on the central limit theory, which are then verified by bootstrap estimates. For paired samples test, we show that the estimated covariance of the two sensitivities and specificities can be represented as a function of kappa statistic so the test can be readily carried out. We then show the remarkable accuracy of the estimated variance using a constrained optimization approach. Simulation is performed to evaluate the statistical properties of the derived tests. The proposed approaches yield more stable type I errors at the nominal level and substantially higher power (efficiency) than does the original Youden's approach. Therefore, the simple explicit large sample solution performs very well. Because we can readily implement the asymptotic and exact bootstrap computation with common software like R, the method is broadly applicable to the evaluation of diagnostic tests and model performance. Copyright © 2015 John Wiley & Sons, Ltd.

Rapid screening test for gestational diabetes: public health need, market requirement, initial product design, and experimental results

NASA Astrophysics Data System (ADS)

Weigl, Bernhard H.; Zwisler, Greg; Peck, Roger; Abu-Haydar, Elizabeth

2013-03-01

Gestational diabetes is a global epidemic where many urban areas in Southeast Asia have found prevalence rates as high as 20%, exceeding the highest prevalence rates in the developed world. It can have serious and life-threatening consequences for mothers and babies. We are developing two variants of a new, simple, low-cost rapid test for screening for gestational diabetes mellitus for use primarily in low-resource settings. The pair of assays, both semiquantitative rapid diagnostic strip tests for glycated albumin, require neither fasting nor an oral glucose challenge test. One variant is an extremely simple strip test to estimate the level of total glycated albumin in blood. The other, which is slightly more complex and expensive, is a test that determines the ratio of glycated albumin to total albumin. The screening results can be used to refer women to receive additional care during delivery to avoid birth complications as well as counseling on diet and exercise during and after pregnancy. Results with the latter test may also be used to start treatment with glucose-lowering drugs. Both assays will be read visually. We present initial results of a preliminary cost-performance comparison model evaluating the proposed test versus existing alternatives. We also evaluated user needs and schematic paper microfluidics-based designs aimed at overcoming the challenge of visualizing relatively narrow differences between normal and elevated levels of glycated albumin in blood.

Laboratory Diagnosis of Tuberculosis in Resource-Poor Countries: Challenges and Opportunities

PubMed Central

Parsons, Linda M.; Somoskövi, Ákos; Gutierrez, Cristina; Lee, Evan; Paramasivan, C. N.; Abimiku, Alash'le; Spector, Steven; Roscigno, Giorgio; Nkengasong, John

2011-01-01

Summary: With an estimated 9.4 million new cases globally, tuberculosis (TB) continues to be a major public health concern. Eighty percent of all cases worldwide occur in 22 high-burden, mainly resource-poor settings. This devastating impact of tuberculosis on vulnerable populations is also driven by its deadly synergy with HIV. Therefore, building capacity and enhancing universal access to rapid and accurate laboratory diagnostics are necessary to control TB and HIV-TB coinfections in resource-limited countries. The present review describes several new and established methods as well as the issues and challenges associated with implementing quality tuberculosis laboratory services in such countries. Recently, the WHO has endorsed some of these novel methods, and they have been made available at discounted prices for procurement by the public health sector of high-burden countries. In addition, international and national laboratory partners and donors are currently evaluating other new diagnostics that will allow further and more rapid testing in point-of-care settings. While some techniques are simple, others have complex requirements, and therefore, it is important to carefully determine how to link these new tests and incorporate them within a country's national diagnostic algorithm. Finally, the successful implementation of these methods is dependent on key partnerships in the international laboratory community and ensuring that adequate quality assurance programs are inherent in each country's laboratory network. PMID:21482728

Role of ascitic fluid adenosine deaminase (ADA) and serum CA-125 in the diagnosis of tuberculous peritonitis.

PubMed

Ali, N; Nath, N C; Parvin, R; Rahman, A; Bhuiyan, T M; Rahman, M; Mohsin M N

2014-12-01

This cross sectional study was carried out in the department of gastroenterology, BIRDEM, Dhaka from January 2010 to May 2011 to determine the role of ascitic fluid ADA and serum CA-125 in the diagnosis of clinically suspected tubercular peritonitis. Total 30 patients (age 39.69 ± 21.26, 18M/12F) with clinical suspicion of tuberculosis peritonitis were included in this study after analyzing selection criteria. Laparoscopic peritoneal biopsy with 'histopathological diagnosis' was considered gold standard against which accuracics of two biomarkers (ADA & CA-125) were compared. Cut off value of ADA and CA-125 are 24 u/l, 35 U/ml respectively. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of ADA as a diagnostic modality in tuberculos peritonitis were 87.5%, 83.33%, 95.45%, 62.5% and 86.67% respectively where as CA-125 was found to have 83.33% sensitivity, 50% specificity, 86.9% positive predictive value, 42.85% negative predictive value and 76.6% accuracy. Both biomarkers are simple, non-invasive, rapid and relatively cheap diagnostic test where as laparoscopy is an invasive procedure, costly & requires trained staff and not without risk and also not feasible in all the centre in our country. So ascitic fluid ADA and serum CA-125 are important diagnostic test for peritoneal tuberculosis.

FNA diagnostic value in patients with neck masses in two teaching hospitals in Iran.

PubMed

Saatian, Minoo; Badie, Banafsheh Moradmand; Shahriari, Sogol; Fattahi, Fahimeh; Rasoolinejad, Mehrnaz

2011-01-01

The FNA (fine needle aspiration) procedure is simple, inexpensive, available and a safe method for the diagnosis of a neck mass. FNA has numerous advantages over open surgical biopsies as an initial diagnostic tool; therefore we decided to compare the accuracy of this method with open biopsy. This retrospective as well as descriptive study comparing preoperative FNA results with existing data in the Pathology Department in Bu-Ali and Amir Alam Hospitals. Our study included 100 patients with neck masses of which 22 were thyroid masses, 31 were salivary gland masses, and 47 were other masses. Age ranged from 3 years to 80 years with the mean age of 42.6 years. There were 59 men and 41 women. The Sensitivity was 72%, Specificity 87%, PPV 85%, NPV 75% and diagnostic Accuracy 79%. In this study we had also 26% false negative and 15% false positive. FNA is a valuable diagnostic tool in the management of neck masses; also it has been used for staging and planning of treatment for the wide and metastatic malignancy. This technique reduces the need for more invasive and costly procedures. According to the high sensitivity and high accuracy in this study, FNA can be used as the first step of diagnoses test in neck masses.

Important hemoprotozoan diseases of livestock: Challenges in current diagnostics and therapeutics: An update

PubMed Central

Maharana, Biswa Ranjan; Tewari, Anup Kumar; Saravanan, Buddhi Chandrasekaran; Sudhakar, Naduvanahalli Rajanna

2016-01-01

Hemoprotozoan parasites pose a serious threat to the livestock population in terms of mortality, reduced milk yield and lowered draft power. Diagnosis of these diseases often poses a challenging task. Needless to say that impact of disease in health and productivity is huge though a fair economic assessment on the quantum of economic loss associated is yet to be worked out from India. The diagnosis of hemoprotozoan infections largely depends on various laboratory-based diagnostic methods as the clinical manifestations are often inconspicuous and non-specific. Traditional diagnostic methods rely on microscopical demonstration of infective stages in blood or tissue fluids. However, it is laborious, lesser sensitive, and cannot differentiate between morphologically similar organisms. Recent development in the technologies has opened new avenues for improvement in the accurate diagnosis of parasitic infections. Serological tests are simple, fast but lack specificity. With advent of molecular techniques, as DNA hybridization assays, polymerase chain reaction and its modifications ensure the detection of infection in the latent phase of the disease. Nucleic acid-based assays are highly sensitive, free from immunocompetence and can differentiate between morphologically similar parasites. With the advent of newer diagnostics complemented with traditional ones will be of huge help for targeted selective treatment with better chemotherapeutic agents. PMID:27284225

The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study.

PubMed

Ferrando, Carlos; Romero, Carolina; Tusman, Gerardo; Suarez-Sipmann, Fernando; Canet, Jaume; Dosdá, Rosa; Valls, Paola; Villena, Abigail; Serralta, Ferran; Jurado, Ana; Carrizo, Juan; Navarro, Jose; Parrilla, Cristina; Romero, Jose E; Pozo, Natividad; Soro, Marina; Villar, Jesús; Belda, Francisco Javier

2017-05-29

To assess the diagnostic accuracy of peripheral capillary oxygen saturation (SpO 2 ) while breathing room air for 5 min (the 'Air-Test') in detecting postoperative atelectasis. Prospective cohort study. Diagnostic accuracy was assessed by measuring the agreement between the index test and the reference standard CT scan images. Postanaesthetic care unit in a tertiary hospital in Spain. Three hundred and fifty patients from 12 January to 7 February 2015; 170 patients scheduled for surgery under general anaesthesia who were admitted into the postsurgical unit were included. The Air-Test was performed in conscious extubated patients after a 30 min stabilisation period during which they received supplemental oxygen therapy via a venturi mask. The Air-Test was defined as positive when SpO 2 was ≤96% and negative when SpO 2 was ≥97%. Arterial blood gases were measured in all patients at the end of the Air-Test. In the subsequent 25 min, the presence of atelectasis was evaluated by performing a CT scan in 59 randomly selected patients. The primary study outcome was assessment of the accuracy of the Air-Test for detecting postoperative atelectasis compared with the reference standard. The secondary outcome was the incidence of positive Air-Test results. The Air-Test diagnosed postoperative atelectasis with an area under the receiver operating characteristic curve of 0.90 (95% CI 0.82 to 0.98) with a sensitivity of 82.6% and a specificity of 87.8%. The presence of atelectasis was confirmed by CT scans in all patients (30/30) with positive and in 5 patients (17%) with negative Air-Test results. Based on the Air-Test, postoperative atelectasis was present in 36% of the patients (62 out of 170). The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis. NCT02650037. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Noninvasive Diagnosis of Visceral Leishmaniasis: Development and Evaluation of Two Urine-Based Immunoassays for Detection of Leishmania donovani Infection in India

PubMed Central

Ejazi, Sarfaraz Ahmad; Bhattacharya, Pradyot; Bakhteyar, Md. Asjad Karim; Mumtaz, Aquil Ahmad; Pandey, Krishna; Das, Vidya Nand Ravi; Das, Pradeep; Rahaman, Mehebubar; Goswami, Rama Prosad; Ali, Nahid

2016-01-01

Background Visceral Leishmaniasis (VL), a severe parasitic disease, could be fatal if diagnosis and treatment is delayed. Post kala-azar dermal leishmaniasis (PKDL), a skin related outcome, is a potential reservoir for the spread of VL. Diagnostic tests available for VL such as tissue aspiration are invasive and painful although they are capable of evaluating the treatment response. Serological tests although less invasive than tissue aspiration are incompetent to assess cure. Parasitological examination of slit-skin smear along with the clinical symptoms is routinely used for diagnosis of PKDL. Therefore, a noninvasive test with acceptable sensitivity and competency, additionally, to decide cure would be an asset in disease management and control. Methodology/principal findings We describe here, the development of antibody-capture ELISA and field adaptable dipstick test as noninvasive diagnostic tools for VL and PKDL and as a test of cure in VL treatment. Sensitivity and specificity of urine-ELISA were 97.94% (95/97) and 100% (75/75) respectively, for VL. Importantly, dipstick test demonstrated 100% sensitivity (97/97) and specificity (75/75) in VL diagnosis. Degree of agreement of the two methods with tissue aspiration was 98.83% (κ = 0.97) and 100% (κ = 1), for ELISA and dipstick test, respectively. Both the tests had 100% positivity for PKDL (14/14) cases. ELISA and dipstick test illustrated treatment efficacy in about 90% (16/18) VL cases when eventually turned negative after six months of treatment. Conclusions/significance ELISA and dipstick test found immensely effective for diagnosis of VL and PKDL through urine samples thus, may substitute the existing invasive diagnostics. Utility of these tests as indirect methods of monitoring parasite clearance can define infected versus cured. Urine-based dipstick test is simple, sensitive and above all noninvasive method that may help not only in active VL case detection but also to ascertain treatment response. It can therefore, be deployed widely for interventions in disease management of VL particularly in poor resource outskirts. PMID:27741241

Diagnostic value of two commercial chromatographic "patient-side" tests in the diagnosis of acute canine leptospirosis.

PubMed

Gloor, C I; Schweighauser, A; Francey, T; Rodriguez-Campos, S; Vidondo, B; Bigler, B; Schuller, S

2017-03-01

To determine the diagnostic performance of two patient-side tests (RDT-1: Test-it™ and RDT-2 Witness®Lepto) in the early diagnosis of canine leptospirosis. Retrospective study of 108 dogs with leptospirosis and 53 controls. Leptospirosis was diagnosed based on compatible clinical and clinicopathologic signs and either a single microscopic agglutination test titre_ >800 (n=49), seroconversion (n=53), positive urine real time PCR (RT-PCR) (n=1), evidence of spirochaetes in silver-stained tissues (n=1) or a combination of these (n=4). Leptospirosis was excluded in dogs with a convincing alternative diagnosis and single microscopic agglutination testing titres _<200 (n=46) or lack of seroconversion (n=7). Indices of diagnostic accuracy of the rapid diagnostic tests were calculated by comparing admission rapid diagnostic test results to the final disease status. Rapid diagnostic test-1 was performed in 118 dogs, rapid diagnostic test-2 in 69 dogs and both tests in 26 dogs. Weak positive results occurred frequently representing 22·6% (rapid diagnostic test-1) and 32·3% (rapid diagnostic test-2) of all positive tests in dogs with leptospirosis. If weak positive rapid diagnostic tests were considered positive, rapid diagnostic test-1 and rapid diagnostic test-2 had sensitivities of 82 and 76%, specificities of 91 and 100%, positive predictive values of 94% and 100% and negative predictive values of 73% and 74%, respectively. There were some technical problems with rapid diagnostic test-1. The diagnostic performance of the rapid diagnostic tests is similar to that reported for the microscopic agglutination test. Both can support a diagnosis of leptospirosis with high specificity but leptospirosis cannot be excluded based on a negative admission test result. Both RDTs are useful in conjunction with other confirmatory tests. © 2017 British Small Animal Veterinary Association.

Morse Code, Scrabble, and the Alphabet

ERIC Educational Resources Information Center

Richardson, Mary; Gabrosek, John; Reischman, Diann; Curtiss, Phyliss

2004-01-01

In this paper we describe an interactive activity that illustrates simple linear regression. Students collect data and analyze it using simple linear regression techniques taught in an introductory applied statistics course. The activity is extended to illustrate checks for regression assumptions and regression diagnostics taught in an…

Rapid and simple detection of foot-and-mouth disease virus: Evaluation of a cartridge-based molecular detection system for use in basic laboratories.

PubMed

Goller, K V; Dill, V; Madi, M; Martin, P; Van der Stede, Y; Vandenberge, V; Haas, B; Van Borm, S; Koenen, F; Kasanga, C J; Ndusilo, N; Beer, M; Liu, L; Mioulet, V; Armson, B; King, D P; Fowler, V L

2018-04-01

Highly contagious transboundary animal diseases such as foot-and-mouth disease (FMD) are major threats to the productivity of farm animals. To limit the impact of outbreaks and to take efficient steps towards a timely control and eradication of the disease, rapid and reliable diagnostic systems are of utmost importance. Confirmatory diagnostic assays are typically performed by experienced operators in specialized laboratories, and access to this capability is often limited in the developing countries with the highest disease burden. Advances in molecular technologies allow implementation of modern and reliable techniques for quick and simple pathogen detection either in basic laboratories or even at the pen-side. Here, we report on a study to evaluate a fully automated cartridge-based real-time RT-PCR diagnostic system (Enigma MiniLab ® ) for the detection of FMD virus (FMDV). The modular system integrates both nucleic acid extraction and downstream real-time RT-PCR (rRT-PCR). The analytical sensitivity of this assay was determined using serially diluted culture grown FMDV, and the performance of the assay was evaluated using a selected range of FMDV positive and negative clinical samples of bovine, porcine and ovine origin. The robustness of the assay was evaluated in an international inter-laboratory proficiency test and by deployment into an African laboratory. It was demonstrated that the system is easy to use and can detect FMDV with high sensitivity and specificity, roughly on par with standard laboratory methods. This cartridge-based automated real-time RT-PCR system for the detection of FMDV represents a reliable and easy to use diagnostic tool for the early and rapid disease detection of acutely infected animals even in remote areas. This type of system could be easily deployed for routine surveillance within endemic regions such as Africa or could alternatively be used in the developed world. © 2017 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.

Rocket Engine Oscillation Diagnostics

NASA Technical Reports Server (NTRS)

Nesman, Tom; Turner, James E. (Technical Monitor)

2002-01-01

Rocket engine oscillating data can reveal many physical phenomena ranging from unsteady flow and acoustics to rotordynamics and structural dynamics. Because of this, engine diagnostics based on oscillation data should employ both signal analysis and physical modeling. This paper describes an approach to rocket engine oscillation diagnostics, types of problems encountered, and example problems solved. Determination of design guidelines and environments (or loads) from oscillating phenomena is required during initial stages of rocket engine design, while the additional tasks of health monitoring, incipient failure detection, and anomaly diagnostics occur during engine development and operation. Oscillations in rocket engines are typically related to flow driven acoustics, flow excited structures, or rotational forces. Additional sources of oscillatory energy are combustion and cavitation. Included in the example problems is a sampling of signal analysis tools employed in diagnostics. The rocket engine hardware includes combustion devices, valves, turbopumps, and ducts. Simple models of an oscillating fluid system or structure can be constructed to estimate pertinent dynamic parameters governing the unsteady behavior of engine systems or components. In the example problems it is shown that simple physical modeling when combined with signal analysis can be successfully employed to diagnose complex rocket engine oscillatory phenomena.

A comparative study of electrical probe techniques for plasma diagnostics

NASA Technical Reports Server (NTRS)

Szuszczewicz, E. P.

1972-01-01

Techniques for using electrical probes for plasma diagnostics are reviewed. Specific consideration is given to the simple Langmuir probe, the symmetric double probe of Johnson and Malter, the variable-area probe of Fetz and Oeschsner, and a floating probe technique. The advantages and disadvantages of each technique are discussed.

40 CFR 85.2223 - On-board diagnostic test report.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 18 2010-07-01 2010-07-01 false On-board diagnostic test report. 85... Tests § 85.2223 On-board diagnostic test report. (a) Motorists whose vehicles fail the on-board diagnostic test described in § 85.2222 shall be provided with the on-board diagnostic test results, including...

40 CFR 85.2223 - On-board diagnostic test report.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 18 2011-07-01 2011-07-01 false On-board diagnostic test report. 85... Tests § 85.2223 On-board diagnostic test report. (a) Motorists whose vehicles fail the on-board diagnostic test described in § 85.2222 shall be provided with the on-board diagnostic test results, including...

A simple and robust classification tree for differentiation between benign and malignant lesions in MR-mammography.

PubMed

Baltzer, Pascal A T; Dietzel, Matthias; Kaiser, Werner A

2013-08-01

In the face of multiple available diagnostic criteria in MR-mammography (MRM), a practical algorithm for lesion classification is needed. Such an algorithm should be as simple as possible and include only important independent lesion features to differentiate benign from malignant lesions. This investigation aimed to develop a simple classification tree for differential diagnosis in MRM. A total of 1,084 lesions in standardised MRM with subsequent histological verification (648 malignant, 436 benign) were investigated. Seventeen lesion criteria were assessed by 2 readers in consensus. Classification analysis was performed using the chi-squared automatic interaction detection (CHAID) method. Results include the probability for malignancy for every descriptor combination in the classification tree. A classification tree incorporating 5 lesion descriptors with a depth of 3 ramifications (1, root sign; 2, delayed enhancement pattern; 3, border, internal enhancement and oedema) was calculated. Of all 1,084 lesions, 262 (40.4 %) and 106 (24.3 %) could be classified as malignant and benign with an accuracy above 95 %, respectively. Overall diagnostic accuracy was 88.4 %. The classification algorithm reduced the number of categorical descriptors from 17 to 5 (29.4 %), resulting in a high classification accuracy. More than one third of all lesions could be classified with accuracy above 95 %. • A practical algorithm has been developed to classify lesions found in MR-mammography. • A simple decision tree consisting of five criteria reaches high accuracy of 88.4 %. • Unique to this approach, each classification is associated with a diagnostic certainty. • Diagnostic certainty of greater than 95 % is achieved in 34 % of all cases.

Advances in Candida detection platforms for clinical and point-of-care applications

PubMed Central

Safavieh, Mohammadali; Coarsey, Chad; Esiobu, Nwadiuto; Memic, Adnan; Vyas, Jatin Mahesh; Shafiee, Hadi; Asghar, Waseem

2016-01-01

Invasive candidiasis remains one of the most serious community and healthcare-acquired infections worldwide. Conventional Candida detection methods based on blood and plate culture are time-consuming and require at least 2–4 days to identify various Candida species. Despite considerable advances for candidiasis detection, the development of simple, compact and portable point-of-care diagnostics for rapid and precise testing that automatically performs cell lysis, nucleic acid extraction, purification and detection still remains a challenge. Here, we systematically review most prominent conventional and nonconventional techniques for the detection of various Candida species, including Candida staining, blood culture, serological testing and nucleic acid-based analysis. We also discuss the most advanced lab on a chip devices for candida detection. PMID:27093473

Multiple-taper spectral analysis: A stand-alone C-subroutine

NASA Astrophysics Data System (ADS)

Lees, Jonathan M.; Park, Jeffrey

1995-03-01

A simple set of subroutines in ANSI-C are presented for multiple taper spectrum estimation. The multitaper approach provides an optimal spectrum estimate by minimizing spectral leakage while reducing the variance of the estimate by averaging orthogonal eigenspectrum estimates. The orthogonal tapers are Slepian nπ prolate functions used as tapers on the windowed time series. Because the taper functions are orthogonal, combining them to achieve an average spectrum does not introduce spurious correlations as standard smoothed single-taper estimates do. Furthermore, estimates of the degrees of freedom and F-test values at each frequency provide diagnostics for determining levels of confidence in narrow band (single frequency) periodicities. The program provided is portable and has been tested on both Unix and Macintosh systems.

A TeGM6-4r antigen-based immunochromatographic test (ICT) for animal trypanosomosis.

PubMed

Nguyen, Thu-Thuy; Ruttayaporn, Ngasaman; Goto, Yasuyuki; Kawazu, Shin-ichiro; Sakurai, Tatsuya; Inoue, Noboru

2015-11-01

Animal trypanosomosis is a disease that is distributed worldwide which results in huge economic losses due to reduced animal productivity. Endemic regions are often located in the countryside where laboratory diagnosis is costly or inaccessible. The establishment of simple, effective, and accurate field tests is therefore of great interest to the farming and veterinary sectors. Our study aimed to develop a simple, rapid, and sensitive immunochromatographic test (ICT) for animal trypanosomosis utilizing the recombinant tandem repeat antigen TeGM6-4r, which is conserved amongst salivarian trypanosome species. In the specificity analysis, TeGM6-4r/ICT detected all of Trypanosoma evansi-positive controls from experimentally infected water buffaloes. As expected, uninfected controls tested negative. All sera samples collected from Tanzanian and Ugandan cattle that were Trypanosoma congolense- and/or Trypanosoma vivax-positive by microscopic examination of the buffy coat were found to be positive by the newly developed TeGM6-4r/ICT, which was comparable to results from TeGM6-4r/ELISA (kappa coefficient [κ] = 0.78). TeGM6/ICT also showed substantial agreement with ELISA using Trypanosoma brucei brucei (κ = 0.64) and T. congolense (κ = 0.72) crude antigen, suggesting the high potential of TeGM6-4r/ICT as a field diagnostic test, both for research purposes and on-site diagnosis of animal trypanosomosis.

Protocol for the use of a rapid real-time PCR method for the detection of HIV-1 proviral DNA using double-stranded primer.

PubMed

Pau, Chou-Pong; Wells, Susan K; Granade, Timothy C

2012-01-01

This chapter describes a real-time PCR method for the detection of HIV-1 proviral DNA in whole blood samples using a novel double-stranded primer system. The assay utilizes a simple commercially available DNA extraction method and a rapid and easy-to-perform real-time PCR protocol to consistently detect a minimum of four copies of HIV-1 group M proviral DNA in as little as 90 min after sample (whole blood) collection. Co-amplification of the human RNase P gene serves as an internal control to monitor the efficiency of both the DNA extraction and amplification. Once the assay is validated properly, it may be suitable as an alternative confirmation test for HIV-1 infections in a variety of HIV testing venues including the mother-to-child transmission testing sites, clinics, and diagnostic testing centers.

Simple Approaches to Minimally-Instrumented, Microfluidic-Based Point-of-Care Nucleic Acid Amplification Tests

PubMed Central

Mauk, Michael G.; Song, Jinzhao; Liu, Changchun; Bau, Haim H.

2018-01-01

Designs and applications of microfluidics-based devices for molecular diagnostics (Nucleic Acid Amplification Tests, NAATs) in infectious disease testing are reviewed, with emphasis on minimally instrumented, point-of-care (POC) tests for resource-limited settings. Microfluidic cartridges (‘chips’) that combine solid-phase nucleic acid extraction; isothermal enzymatic nucleic acid amplification; pre-stored, paraffin-encapsulated lyophilized reagents; and real-time or endpoint optical detection are described. These chips can be used with a companion module for separating plasma from blood through a combined sedimentation-filtration effect. Three reporter types: Fluorescence, colorimetric dyes, and bioluminescence; and a new paradigm for end-point detection based on a diffusion-reaction column are compared. Multiplexing (parallel amplification and detection of multiple targets) is demonstrated. Low-cost detection and added functionality (data analysis, control, communication) can be realized using a cellphone platform with the chip. Some related and similar-purposed approaches by others are surveyed. PMID:29495424

Rapid Detection of Prunus Necrotic Ringspot Virus by Reverse Transcription-cross-priming Amplification Coupled with Nucleic Acid Test Strip Cassette.

PubMed

Huo, Ya-Yun; Li, Gui-Fen; Qiu, Yan-Hong; Li, Wei-Min; Zhang, Yong-Jiang

2017-11-23

Prunus necrotic ringspot virus (PNRSV) is one of the most devastating viruses to Prunus spp. In this study, we developed a diagnostic system RT-CPA-NATSC, wherein reverse transcription-cross-priming amplification (RT-CPA) is coupled with nucleic acid test strip cassette (NATSC), a vertical flow (VF) visualization, for PNRSV detection. The RT-CPA-NATSC assay targets the encoding gene of the PNRSV coat protein with a limit of detection of 72 copies per reaction and no cross-reaction with the known Prunus pathogenic viruses and viroids, demonstrating high sensitivity and specificity. The reaction is performed on 60 °C and can be completed less than 90 min with the prepared template RNA. Field sample test confirmed the reliability of RT-CPA-NATSC, indicating the potential application of this simple and rapid detection method in routine test of PNRSV.

42 CFR 415.180 - Teaching setting requirements for the interpretation of diagnostic radiology and other diagnostic...

Code of Federal Regulations, 2011 CFR

2011-10-01

... interpretation of diagnostic radiology and other diagnostic tests. 415.180 Section 415.180 Public Health CENTERS... for the interpretation of diagnostic radiology and other diagnostic tests. (a) General rule. Physician fee schedule payment is made for the interpretation of diagnostic radiology and other diagnostic tests...

42 CFR 415.180 - Teaching setting requirements for the interpretation of diagnostic radiology and other diagnostic...

Code of Federal Regulations, 2010 CFR

2010-10-01

... interpretation of diagnostic radiology and other diagnostic tests. 415.180 Section 415.180 Public Health CENTERS... for the interpretation of diagnostic radiology and other diagnostic tests. (a) General rule. Physician fee schedule payment is made for the interpretation of diagnostic radiology and other diagnostic tests...

Diagnostic Accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex Scores in Predicting the Presence of Esophageal Varices in Liver Cirrhosis

PubMed Central

Deng, Han; Qi, Xingshun; Guo, Xiaozhong

2015-01-01

Abstract Aspartate aminotransferase-to-platelet ratio (APRI), aspartate aminotransferase-to-alanine aminotransferase ratio (AAR), FIB-4, FI, King, Lok, Forns, and FibroIndex scores may be simple and convenient noninvasive diagnostic tests, because they are based on the regular laboratory tests and demographic data. This study aimed to systematically evaluate their diagnostic accuracy for the prediction of varices in liver cirrhosis. All relevant papers were searched via PubMed, EMBASE, CNKI, and Wanfang databases. The area under the summary receiver operating characteristic curve (AUSROC), sensitivity, specificity, positive and negative likelihood ratio (PLR and NLR), and diagnostic odds ratio (DOR) were calculated. Overall, 12, 4, 5, 0, 0, 4, 3, and 1 paper was identified to explore the diagnostic accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex scores, respectively. The AUSROCs of APRI, AAR, FIB-4, Lok, and Forns scores for the prediction of varices were 0.6774, 0.7275, 0.7755, 0.7885, and 0.7517, respectively; and those for the prediction of large varices were 0.7278, 0.7448, 0.7095, 0.7264, and 0.6530, respectively. The diagnostic threshold effects of FIB-4 and Forns scores for the prediction of varices were statistically significant. The sensitivities/specificities/PLRs/NLRs/DORs of APRI, AAR, and Lok scores for the prediction of varices were 0.60/0.67/1.77/0.58/3.13, 0.64/0.63/1.97/0.54/4.18, and 0.74/0.68/2.34/0.40/5.76, respectively. The sensitivities/specificities/PLRs/NLRs/DORs of APRI, AAR, FIB-4, Lok, and Forns scores for the prediction of large varices were 0.65/0.66/2.15/0.47/4.97, 0.68/0.58/2.07/0.54/3.93, 0.62/0.64/2.02/0.56/3.57, 0.78/0.63/2.09/0.37/5.55, and 0.65/0.61/1.62/0.59/2.75, respectively. APRI, AAR, FIB-4, Lok, and Forns scores had low to moderate diagnostic accuracy in predicting the presence of varices in liver cirrhosis. PMID:26496312

A simple and cost-effective molecular diagnostic system and DNA probes synthesized by light emitting diode photolithography

NASA Astrophysics Data System (ADS)

Oleksandrov, Sergiy; Kwon, Jung Ho; Lee, Ki-chang; Sujin-Ku; Paek, Mun Cheol

2014-09-01

This work introduces a novel chip to be used in the future as a simple and cost-effective method for creating DNA arrays using light emission diode (LED) photolithography. The DNA chip platform contains 24 independent reaction sites, which allows for the testing of a corresponding amount of patients' samples in hospital. An array of commercial UV LEDs and lens systems was combined with a microfluidic flow system to provide patterning of 24 individual reaction sites, each with 64 independent probes. Using the LED array instead of conventional laser exposure systems or micro-mirror systems significantly reduces the cost of equipment. The microfluidic system together with microfluidic flow cells drastically reduces the amount of used reagents, which is important due to the high cost of commercial reagents. The DNA synthesis efficiency was verified by fluorescence labeling and conventional hybridization.

Defining microchannels and valves on a hydrophobic paper by low-cost inkjet printing of aqueous or weak organic solutions.

PubMed

Cai, Longfei; Zhong, Minghua; Li, Huolin; Xu, Chunxiu; Yuan, Biyu

2015-07-01

We describe a simple and cost-effective strategy for rapid fabrication of microfluidic paper-based analytical devices and valves by inkjet printing. NaOH aqueous solution was printed onto a hydrophobic filter paper, which was previously obtained by soaking in a trimethoxyoctadecylsilane-heptane solution, allowing selective wet etching of hydrophobic cellulose to create hydrophilic-hydrophobic contrast with a relatively good resolution. Hexadecyltrimethylammonium bromide (CTMAB)-ethanol solution was printed onto hydrophobic paper to fabricate temperature-controlled valves. At low temperature, CTMAB deposited on the paper is insoluble in aqueous fluid, thus the paper remains hydrophobic. At high temperature, CTMAB becomes soluble so the CTMAB-deposited channel becomes hydrophilic, allowing the wicking of aqueous solution through the valve. We believe that this strategy will be very attractive for the development of simple micro analytical devices for point-of-care applications, including diagnostic testing, food safety control, and environmental monitoring.

Colorimetric Detection of Plasmodium vivax in Urine Using MSP10 Oligonucleotides and Gold Nanoparticles

PubMed Central

Alnasser, Yossef; Ferradas, Cusi; Clark, Taryn; Calderon, Maritza; Gurbillon, Alejandro; Gamboa, Dionicia; McKakpo, Uri S.; Quakyi, Isabella A.; Bosompem, Kwabena M.; Sullivan, David J.; Vinetz, Joseph M.; Gilman, Robert H.

2016-01-01

Plasmodium vivax is the most prevalent cause of human malaria in the world and can lead to severe disease with high potential for relapse. Its genetic and geographic diversities make it challenging to control. P. vivax is understudied and to achieve control of malaria in endemic areas, a rapid, accurate, and simple diagnostic tool is necessary. In this pilot study, we found that a colorimetric system using AuNPs and MSP10 DNA detection in urine can provide fast, easy, and inexpensive identification of P. vivax. The test exhibited promising sensitivity (84%), high specificity (97%), and only mild cross-reactivity with P. falciparum (21%). It is simple to use, with a visible color change that negates the need for a spectrometer, making it suitable for use in austere conditions. Using urine eliminates the need for finger-prick, increasing both the safety profile and patient acceptance of this model. PMID:27706158

Determination of Urine Albumin by New Simple High-Performance Liquid Chromatography Method.

PubMed

Klapkova, Eva; Fortova, Magdalena; Prusa, Richard; Moravcova, Libuse; Kotaska, Karel

2016-11-01

A simple high-performance liquid chromatography (HPLC) method was developed for the determination of albumin in patients' urine samples without coeluting proteins and was compared with the immunoturbidimetric determination of albumin. Urine albumin is important biomarker in diabetic patients, but part of it is immuno-nonreactive. Albumin was determined by high-performance liquid chromatography (HPLC), UV detection at 280 nm, Zorbax 300SB-C3 column. Immunoturbidimetric analysis was performed using commercial kit on automatic biochemistry analyzer COBAS INTEGRA ® 400, Roche Diagnostics GmbH, Manheim, Germany. The HLPC method was fully validated. No significant interference with other proteins (transferrin, α-1-acid glycoprotein, α-1-antichymotrypsin, antitrypsin, hemopexin) was found. The results from 301 urine samples were compared with immunochemical determination. We found a statistically significant difference between these methods (P = 0.0001, Mann-Whitney test). New simple HPLC method was developed for the determination of urine albumin without coeluting proteins. Our data indicate that the HPLC method is highly specific and more sensitive than immunoturbidimetry. © 2016 Wiley Periodicals, Inc.

Proposal of a punch biopsy protocol as a pre-requisite for the establishment of a tissue bank from resected esophageal tumors.

PubMed

Bonavina, Luigi; Laface, Letizia; Picozzi, Stefano; Nencioni, Marco; Siboni, Stefano; Bona, Davide; Sironi, Andrea; Sorba, Francesca; Clemente, Claudio

2010-09-01

With the development of tissue banking, a need for homogeneous methods of collection, processing, and storage of tissue has emerged. We describe the implementation of a biological bank in a high-volume, tertiary care University referral center for esophageal cancer surgery. We also propose an original punch biopsy technique of the surgical specimen. The method proved to be simple, reproducible, and not expensive. Unified standards for specimen collection are necessary to improve results of specimen-based diagnostic testing and research in surgical oncology.

[Detection of the level of antibodies against bovine leucosis virus in the cow milk by immune sensor].

PubMed

Pyrohova, L V; Starodub, M F; Nahaeva, L I

2005-01-01

An immune sensor based on the surface plasmon resonance (SPR) was developed for express diagnostics of bovine leucosis. Sensor used for detection of the level of antibodies against bovine leukaemia virus (BLV) in the milk serum. It was shown that immune sensor analysis is more sensitive, rapid and simple in comparison with the traditional AGID test. It was stated that the developed immune sensor may be used for performance of screening of bovine leucosis at the farms and the minimal dilution of the milk serum should be 1:20.

An evaluation of consensus techniques for diagnostic interpretation

NASA Astrophysics Data System (ADS)

Sauter, Jake N.; LaBarre, Victoria M.; Furst, Jacob D.; Raicu, Daniela S.

2018-02-01

Learning diagnostic labels from image content has been the standard in computer-aided diagnosis. Most computer-aided diagnosis systems use low-level image features extracted directly from image content to train and test machine learning classifiers for diagnostic label prediction. When the ground truth for the diagnostic labels is not available, reference truth is generated from the experts diagnostic interpretations of the image/region of interest. More specifically, when the label is uncertain, e.g. when multiple experts label an image and their interpretations are different, techniques to handle the label variability are necessary. In this paper, we compare three consensus techniques that are typically used to encode the variability in the experts labeling of the medical data: mean, median and mode, and their effects on simple classifiers that can handle deterministic labels (decision trees) and probabilistic vectors of labels (belief decision trees). Given that the NIH/NCI Lung Image Database Consortium (LIDC) data provides interpretations for lung nodules by up to four radiologists, we leverage the LIDC data to evaluate and compare these consensus approaches when creating computer-aided diagnosis systems for lung nodules. First, low-level image features of nodules are extracted and paired with their radiologists semantic ratings (1= most likely benign, , 5 = most likely malignant); second, machine learning multi-class classifiers that handle deterministic labels (decision trees) and probabilistic vectors of labels (belief decision trees) are built to predict the lung nodules semantic ratings. We show that the mean-based consensus generates the most robust classi- fier overall when compared to the median- and mode-based consensus. Lastly, the results of this study show that, when building CAD systems with uncertain diagnostic interpretation, it is important to evaluate different strategies for encoding and predicting the diagnostic label.

IS THE IMMUNOCROMATOGRAPHIC FECAL ANTIGEN TEST EFFECTIVE FOR PRIMARY DIAGNOSIS OF HELICOBACTER PYLORI INFECTION IN DYSPEPTIC PATIENTS?

PubMed

Dalla Nora, Magali; Hörner, Rosmari; De Carli, Diego Michelon; Rocha, Marta Pires da; Araujo, Amanda Faria de; Fagundes, Renato Borges

2016-01-01

The diagnosis of H. pylori infection can be performed by non-invasive and invasive methods.The identification through a fecal antigen test is a non-invasive, simple, and relatively inexpensive test. To determine the diagnostic performance of fecal antigen test in the identification of H. pylori infection. H. pylori antigens were identified in the stools of dyspeptic patients undergoing upper gastrointestinal endoscopy. For the identification of H. pylori antigen, we use ImmunoCard STAT! HpSA with immunochromatography technique. Histopathology plus urease test were the gold standard. We studied 163 patients, 51% male, mean age of 56.7± 8.5years. H. pylori infection was present in 49%. Fecal test presented: sensitivity 67.5% (CI95% 60.6-72.9); specificity 85.5% (CI95% 78.9-90.7); positive predictive value 81.8% (CI95% 73.4-88.4) and negative predictive value 73,2% (CI95% 67.5-77.6); Positive likelihood ratio was 4.7 (CI95% 2.9-7.9) and Negative Likelihood Ratio 0.4 (CI95% 0.3-0.5). The prevalence odds ratio for a positive test was 12.3 (CI95% 5.7-26.3).The index kappa between FAT and histology/urease test was 0.53 (CI95% 0.39-0.64). Immunochromatographic FAT is less expensive than the other methods and readily accepted by the patients but its diagnostic performance does not recommend its use in the primary diagnosis, when the patient may have an active infection.

Photoacoustic sensor for VOCs: first step towards a lung cancer breath test

NASA Astrophysics Data System (ADS)

Wolff, Marcus; Groninga, Hinrich G.; Dressler, Matthias; Harde, Hermann

2005-08-01

Development of new optical sensor technologies has a major impact on the progression of diagnostic methods. Specifically, the optical analysis of breath is an extraordinarily promising technique. Spectroscopic sensors for the non-invasive 13C-breath tests (the Urea Breath Test for detection of Helicobacter pylori is most prominent) are meanwhile well established. However, recent research and development go beyond gastroenterological applications. Sensitive and selective detection of certain volatile organic compounds (VOCs) in a patient's breath, could enable the diagnosis of diseases that are very difficult to diagnose with contemporary techniques. For instance, an appropriate VOC biomarker for early-stage bronchial carcinoma (lung cancer) is n-butane (C4H10). We present a new optical detection scheme for VOCs that employs an especially compact and simple set-up based on photoacoustic spectroscopy (PAS). This method makes use of the transformation of absorbed modulated radiation into a sound wave. Employing a wavelength-modulated distributed feedback (DFB) diode laser and taking advantage of acoustical resonances of the sample cell, we performed very sensitive and selective measurements on butane. A detection limit for butane in air in the ppb range was achieved. In subsequent research the sensitivity will be successively improved to match the requirements of the medical application. Upon optimization, our photoacoustic sensor has the potential to enable future breath tests for early-stage lung cancer diagnostics.

Fluorescence detection of dental calculus

NASA Astrophysics Data System (ADS)

Gonchukov, S.; Biryukova, T.; Sukhinina, A.; Vdovin, Yu

2010-11-01

This work is devoted to the optimization of fluorescence dental calculus diagnostics in optical spectrum. The optimal wavelengths for fluorescence excitation and registration are determined. Two spectral ranges 620 - 645 nm and 340 - 370 nm are the most convenient for supra- and subgingival calculus determination. The simple implementation of differential method free from the necessity of spectrometer using was investigated. Calculus detection reliability in the case of simple implementation is higher than in the case of spectra analysis at optimal wavelengths. The use of modulated excitation light and narrowband detection of informative signal allows us to decrease essentially its diagnostic intensity even in comparison with intensity of the low level laser dental therapy.

Clinical Application of the UK Working Party's Criteria for the Diagnosis of Atopic Dermatitis in the Chinese Population by Age Group.

PubMed

Wang, Li; Li, Lin-Feng

2016-12-05

Atopic dermatitis (AD) is a common inflammatory skin disease with an increasingly significant prevalence. The prevalence of AD depends greatly on how its diagnosis is done. The UK Working Party's diagnostic criteria for AD are simple and easy to apply without invasive laboratory tests. This study assessed the clinical utility of these criteria in China. Data were collected from 6208 patients at 31 tertiary hospitals in 13 Chinese provinces/municipalities from March 2014 to May 2014. . The agreement between the UK diagnostic criteria and the clinical records for AD was assessed by Cohen's kappa. The overall agreement between the UK diagnostic criteria and clinical diagnosis was fair (kappa = 0.40). A slightly better agreement was found in patients aged between 4 and 9 years (kappa = 0.48), while fair agreement was found in the group <4 years and the group ≥10 years (kappa = 0.27 and 0.39, respectively). Using the UK party's criteria as the standard, the sensitivity, specificity, positive predictive value, and negative predictive value of the clinical diagnosis of AD were 62.3%, 89.2%, 38.0%, and 95.7%, respectively. Our study indicates a modest ability among Chinese dermatologists to apply the UK Working Party's diagnostic criteria for AD, especially in patients aged <4 years and ≥10 years. Since there is no gold standard for AD diagnosis, it is important to determine how AD is identified when evaluating a diagnostic tool.

Comparative study of indirect immunofluorescence, enzyme-linked immunosorbent assay, and the Tzanck smear test for the diagnosis of pemphigus.

PubMed

Zhou, Tingting; Fang, Siyue; Li, Chunlei; Hua, Hong

2016-11-01

Pemphigus is one of the potentially fatal autoimmune blistering diseases. An early and accurate diagnosis is important for prognosis and therapy. It may be difficult to diagnosis based on clinical grounds alone. Direct and indirect immunofluorescence, enzyme-linked immunosorbent assay, the Tzanck smear test, or histopathology are all available for the diagnosis of pemphigus. However, there are no generally accepted diagnostic criteria for the diagnosis of this condition at present. To evaluate the diagnostic value of indirect immunofluorescence, enzyme-linked immunosorbent assay, and the Tzanck smear test for the diagnosis of pemphigus in dental clinics. A single-center retrospective study was conducted, and the clinical data of 33 patients with pemphigus and 61 controls were collected and analyzed from the Department of Oral Medicine, Peking University School of Stomatology, during 2010-2014. The sensitivities and specificities of indirect immunofluorescence, enzyme-linked immunosorbent assay, and the Tzanck smear test were calculated and compared in two groups. Sensitivities for the Tzanck smear test, indirect immunofluorescence, and enzyme-linked immunosorbent assay were 96.7%, 84.8%, and 84.8%, respectively, whereas the specificities of these tests were 60%, 91.8%, and 96.7%, respectively. The serial tests for the Tzanck smear test and enzyme-linked immunosorbent assay showed 82% sensitivity and 98.7% specificity. The serial test for the Tzanck smear test and enzyme-linked immunosorbent assay may represent a simple, rapid, and reliable way to definitive diagnosis of pemphigus. It is recommended as a common test for the diagnosis of pemphigus in dental clinics. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A.D.A.M. test (Antibiofilm Dressing's Activity Measurement) - Simple method for evaluating anti-biofilm activity of drug-saturated dressings against wound pathogens.

PubMed

Junka, Adam F; Żywicka, Anna; Szymczyk, Patrycja; Dziadas, Mariusz; Bartoszewicz, Marzena; Fijałkowski, Karol

2017-12-01

In the present article, we propose a simple Antibiofilm Dressing's Activity Measurement (A.D.A.M.) test that allows to check in vitro a dressing's suitability against biofilm-related wound infections. To perform the test, three agar discs are covered with biofilm formed by the tested pathogen after which they are assembled one over another in the form of an agar plug and placed in the well of a 24-well plate. The top disc is covered with the analyzed dressing and the entire set is incubated for 24h. During this time, the investigated antimicrobial substance is released from the dressing and penetrates to subsequent biofilm-covered agar discs. Biofilm reduction is measured using 2,3,5-triphenyl-2H-tetrazolium chloride (TTC) spectrometric assay and the results are compared to untreated control samples (agar plug covered with biofilm and without the dressing/or with a passive dressing placed on the top disc). Furthermore, in order to standardize the differences in penetrability of the drugs released from active dressings the results can be expressed as a dimensionless value referred to as the Penetrability Index. In summary, A.D.A.M. test is simple, cheap, can be performed practically in every clinical laboratory and takes no more time than routine microbiological diagnostics. Apart from measuring the released drug's activity, the A.D.A.M. test allows to assess drug penetrability (across three agar discs), reflecting real wound conditions, where microbes are frequently hidden under the necrotic tissue or cloth. In conclusion, the A.D.A.M. test produces a high volume of data that, when analyzed, can provide a researcher with a valuable hint concerning the applicability of active dressings against specific biofilm pathogens in a particular setting. Copyright © 2017 Elsevier B.V. All rights reserved.

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... in the 80000 series of the Current Procedural Terminology published by the American Medical... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Procedural Terminology published by the American Medical Association. (3) Levels of supervision. Except where... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

A Broad-Spectrum Infection Diagnostic that Detects Pathogen-Associated Molecular Patterns (PAMPs) in Whole Blood.

PubMed

Cartwright, Mark; Rottman, Martin; Shapiro, Nathan I; Seiler, Benjamin; Lombardo, Patrick; Gamini, Nazita; Tomolonis, Julie; Watters, Alexander L; Waterhouse, Anna; Leslie, Dan; Bolgen, Dana; Graveline, Amanda; Kang, Joo H; Didar, Tohid; Dimitrakakis, Nikolaos; Cartwright, David; Super, Michael; Ingber, Donald E

2016-07-01

Blood cultures, and molecular diagnostic tests that directly detect pathogen DNA in blood, fail to detect bloodstream infections in most infected patients. Thus, there is a need for a rapid test that can diagnose the presence of infection to triage patients, guide therapy, and decrease the incidence of sepsis. An Enzyme-Linked Lectin-Sorbent Assay (ELLecSA) that uses magnetic microbeads coated with an engineered version of the human opsonin, Mannose Binding Lectin, containing the Fc immunoglobulin domain linked to its carbohydrate recognition domain (FcMBL) was developed to quantify pathogen-associated molecular patterns (PAMPs) in whole blood. This assay was tested in rats and pigs to explore whether it can detect infections and monitor disease progression, and in prospectively enrolled, emergency room patients with suspected sepsis. These results were also compared with data obtained from non-infected patients with or without traumatic injuries. The FcMBL ELLecSA was able to detect PAMPS present on, or released by, 85% of clinical isolates representing 47 of 55 different pathogen species, including the most common causes of sepsis. The PAMP assay rapidly (<1h) detected the presence of active infection in animals, even when blood cultures were negative and bacteriocidal antibiotics were administered. In patients with suspected sepsis, the FcMBL ELLecSA detected infection in 55 of 67 patients with high sensitivity (>81%), specificity (>89%), and diagnostic accuracy of 0·87. It also distinguished infection from trauma-related inflammation in the same patient cohorts with a higher specificity than the clinical sepsis biomarker, C-reactive Protein. The FcMBL ELLecSA-based PAMP assay offers a rapid, simple, sensitive and specific method for diagnosing infections, even when blood cultures are negative and antibiotic therapy has been initiated. It may help to triage patients with suspected systemic infections, and serve as a companion diagnostic to guide administration of emerging dialysis-like sepsis therapies. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Preliminary Aerodynamic Investigation of Fan Rotor Blade Morphing

NASA Technical Reports Server (NTRS)

Tweedt, Daniel L.

2012-01-01

Various new technologies currently under development may enable controlled blade shape variability, or so-called blade morphing, to be practically employed in aircraft engine fans and compressors in the foreseeable future. The current study is a relatively brief, preliminary computational fluid dynamics investigation aimed at partially demonstrating and quantifying the aerodynamic potential of fan rotor blade morphing. The investigation is intended to provide information useful for near-term planning, as well as aerodynamic solution data sets that can be subsequently analyzed using advanced acoustic diagnostic tools, for the purpose of making fan noise comparisons. Two existing fan system models serve as baselines for the investigation: the Advanced Ducted Propulsor fan with a design tip speed of 806 ft/sec and a pressure ratio of 1.294, and the Source Diagnostic Test fan with a design tip speed of 1215 ft/sec and a pressure ratio of 1.470. Both are 22-in. sub-scale, low-noise research fan/nacelle models that have undergone extensive experimental testing in the 9- by 15-foot Low Speed Wind Tunnel at the NASA Glenn Research Center. The study, restricted to fan rotor blade morphing only, involves a fairly simple blade morphing technique. Specifically, spanwise-linear variations in rotor blade-section setting angle are applied to alter the blade shape; that is, the blade is linearly retwisted from hub to tip. Aerodynamic performance comparisons are made between morphed-blade and corresponding baseline configurations on the basis of equal fan system thrust, where rotor rotational speed for the morphed-blade fan is varied to change the thrust level for that configuration. The results of the investigation confirm that rotor blade morphing could be a useful technology, with the potential to enable significant improvements in fan aerodynamic performance. Even though the study is very limited in scope and confined to simple geometric perturbations of two existing fan systems, the aerodynamic effectiveness of blade morphing is demonstrated by the configurations analyzed. In particular, for the Advanced Ducted Propulsor fan it is demonstrated that the performance levels of the original variable-pitch baseline design can be achieved using blade morphing instead of variable pitch, and for the Source Diagnostic Test fan the performance at important off-design operating points is substantially increased with blade morphing.

Rapid and sensitive detection of Yersinia pestis using amplification of plague diagnostic bacteriophages monitored by real-time PCR.

PubMed

Sergueev, Kirill V; He, Yunxiu; Borschel, Richard H; Nikolich, Mikeljon P; Filippov, Andrey A

2010-06-28

Yersinia pestis, the agent of plague, has caused many millions of human deaths and still poses a serious threat to global public health. Timely and reliable detection of such a dangerous pathogen is of critical importance. Lysis by specific bacteriophages remains an essential method of Y. pestis detection and plague diagnostics. The objective of this work was to develop an alternative to conventional phage lysis tests--a rapid and highly sensitive method of indirect detection of live Y. pestis cells based on quantitative real-time PCR (qPCR) monitoring of amplification of reporter Y. pestis-specific bacteriophages. Plague diagnostic phages phiA1122 and L-413C were shown to be highly effective diagnostic tools for the detection and identification of Y. pestis by using qPCR with primers specific for phage DNA. The template DNA extraction step that usually precedes qPCR was omitted. phiA1122-specific qPCR enabled the detection of an initial bacterial concentration of 10(3) CFU/ml (equivalent to as few as one Y. pestis cell per 1-microl sample) in four hours. L-413C-mediated detection of Y. pestis was less sensitive (up to 100 bacteria per sample) but more specific, and thus we propose parallel qPCR for the two phages as a rapid and reliable method of Y. pestis identification. Importantly, phiA1122 propagated in simulated clinical blood specimens containing EDTA and its titer rise was detected by both a standard plating test and qPCR. Thus, we developed a novel assay for detection and identification of Y. pestis using amplification of specific phages monitored by qPCR. The method is simple, rapid, highly sensitive, and specific and allows the detection of only live bacteria.

Improved DNA hybridization parameters by Twisted Intercalating Nucleic Acid (TINA).

PubMed

Schneider, Uffe Vest

2012-01-01

This thesis establishes oligonucleotide design rules and applications of a novel group of DNA stabilizing molecules collectively called Twisted Intercalating Nucleic Acid - TINA. Three peer-reviewed publications form the basis for the thesis. One publication describes an improved and rapid method for determination of DNA melting points and two publications describe the effects of positioning TINA molecules in parallel triplex helix and antiparallel duplex helix forming DNA structures. The third publication establishes that TINA molecules containing oligonucleotides improve an antiparallel duplex hybridization based capture assay's analytical sensitivity compared to conventionel DNA oligonucleotides. Clinical microbiology is traditionally based on pathogenic microorganisms' culture and serological tests. The introduction of DNA target amplification methods like PCR has improved the analytical sensitivity and total turn around time involved in clinical diagnostics of infections. Due to the relatively weak hybridization between the two strands of double stranded DNA, a number of nucleic acid stabilizing molecules have been developed to improve the sensitivity of DNA based diagnostics through superior binding properties. A short introduction is given to Watson-Crick and Hoogsteen based DNA binding and the derived DNA structures. A number of other nucleic acid stabilizing molecules are described. The stabilizing effect of TINA molecules on different DNA structures is discussed and considered in relation to other nucleic acid stabilizing molecules and in relation to future use of TINA containing oligonucleotides in clinical diagnostics and therapy. In conclusion, design of TINA modified oligonucleotides for antiparallel duplex helixes and parallel triplex helixes follows simple purpose dependent rules. TINA molecules are well suited for improving multiplex PCR assays and can be used as part of novel technologies. Future research should test whether combinations of TINA molecules and other nucleic acid stabilizing molecules can increase analytical sensitivity whilst maintaining nucleobase mismatch discrimination in triplex helix based diagnostic assays.

Clinical utility of soluble interleukin-2 receptor in hemophagocytic syndromes: a systematic scoping review.

PubMed

Lin, Molly; Park, Sujin; Hayden, Anna; Giustini, Dean; Trinkaus, Martina; Pudek, Morris; Mattman, Andre; Schneider, Marion; Chen, Luke Y C

2017-08-01

The serum-soluble interleukin-2 receptor (sIL-2r) level is considered an important diagnostic test and disease marker in hemophagocytic syndromes/hemophagocytic lymphohistiocytosis (HPS/HLH). However, this cytokine receptor is rarely measured in clinical practice and has been excluded from recent diagnostic/classification criteria such as the HScore and macrophage activation syndrome (MAS) 16. We performed a systematic scoping review of 64 articles (1975-2016) examining the clinical utility of sIL-2r in HPS/HLH. Twenty-two articles describe sIL-2r as a sensitive diagnostic marker for HLH, but only three distinct datasets actually address sensitivity. The original HLH-2004 Guidelines reported sensitivity of 93% and specificity of 100% for sIL-2r ≥ 2400, based on a pediatric dataset (n = 152) which is published for the first time in this review. Two pediatric studies reported sensitivity of 89% for sIL-2r ≥ 2400 in diagnosis of MAS complicating juvenile idiopathic arthritis (JIA) (n = 27) and 88% for secondary HLH in acute liver failure (n = 9). Twenty articles described sIL-2r as a dynamic marker of disease activity that falls with response to treatment, and 15 described high initial sIL-2r levels >10,000 U/mL as a poor prognostic marker. The ability of sIL-2r to distinguish between subtypes of HPS/HLH was inconsistent. This review confirms the importance of soluble IL-2r as a diagnostic and disease marker in HPS/HLH, but also reveals the need for more primary data about its performance characteristics, particularly in adults. More emphasis should be made in including this simple, inexpensive test in clinical practice and studies of HPS/HLH.

Gold nanoparticles based colorimetric nanodiagnostics for cancer and infectious diseases

NASA Astrophysics Data System (ADS)

Valentini, Paola; Persano, Stefano; Cecere, Paola; Sabella, Stefania; Pompa, Pier Paolo

2014-03-01

Traditional in vitro diagnostics requires specialized laboratories and costly instrumentation, both for the amplification of nucleic acid targets (usually achieved by PCR) and for the assay readout, often based on fluorescence. We are developing hybrid nanomaterials-based sensors for the rapid and low-cost diagnosis of various disease biomarkers, for applications in portable platforms for diagnostics at the point-of-care. To this aim, we exploited the size and distancedependent optical properties of gold nanoparticles (AuNPs) to achieve colorimetric detection. Moreover, in order to avoid the complexity of thermal cycles associated to traditional PCR, the design of our systems includes signal amplification schemes, achieved by the use of enzymes (nucleases, helicase) or DNAzymes. Focused on instrument-free and sensitive detection, we carefully combined the intrinsic sensitivity by multivalency of functionalized AuNPs with isothermal and non-stringent enzyme-aided reaction conditions, controlled AuNPs aggregates, universal reporters and magnetic microparticles, the latter used both as a substrate and as a means for the colorimetric detection. We obtained simple and robust assays for the sensitive (pM range or better) naked-eye detection of cancer or infectious diseases (HPV, HCV) biomarkers, requiring no instrumentation except for a simple heating plate. Finally, we are also developing non-medical applications of these bio-nanosensors, such as in the development of on-field rapid tests for the detection of pollutants and other food and water contaminants.

Real-time fluorescence loop mediated isothermal amplification for the diagnosis of malaria.

PubMed

Lucchi, Naomi W; Demas, Allison; Narayanan, Jothikumar; Sumari, Deborah; Kabanywanyi, Abdunoor; Kachur, S Patrick; Barnwell, John W; Udhayakumar, Venkatachalam

2010-10-29

Molecular diagnostic methods can complement existing tools to improve the diagnosis of malaria. However, they require good laboratory infrastructure thereby restricting their use to reference laboratories and research studies. Therefore, adopting molecular tools for routine use in malaria endemic countries will require simpler molecular platforms. The recently developed loop-mediated isothermal amplification (LAMP) method is relatively simple and can be improved for better use in endemic countries. In this study, we attempted to improve this method for malaria diagnosis by using a simple and portable device capable of performing both the amplification and detection (by fluorescence) of LAMP in one platform. We refer to this as the RealAmp method. Published genus-specific primers were used to test the utility of this method. DNA derived from different species of malaria parasites was used for the initial characterization. Clinical samples of P. falciparum were used to determine the sensitivity and specificity of this system compared to microscopy and a nested PCR method. Additionally, directly boiled parasite preparations were compared with a conventional DNA isolation method. The RealAmp method was found to be simple and allowed real-time detection of DNA amplification. The time to amplification varied but was generally less than 60 minutes. All human-infecting Plasmodium species were detected. The sensitivity and specificity of RealAmp in detecting P. falciparum was 96.7% and 91.7% respectively, compared to microscopy and 98.9% and 100% respectively, compared to a standard nested PCR method. In addition, this method consistently detected P. falciparum from directly boiled blood samples. This RealAmp method has great potential as a field usable molecular tool for diagnosis of malaria. This tool can provide an alternative to conventional PCR based diagnostic methods for field use in clinical and operational programs.

Development and evaluation of a Loop Mediated Isothermal Amplification (LAMP) technique for the detection of hookworm (Necator americanus) infection in fecal samples.

PubMed

Mugambi, Robert Muriuki; Agola, Eric L; Mwangi, Ibrahim N; Kinyua, Johnson; Shiraho, Esther Andia; Mkoji, Gerald M

2015-11-06

Hookworm infection is a major concern in sub-Saharan Africa, particularly in children and pregnant women. Necator americanus and Ancylostoma duodenale are responsible for this condition. Hookworm disease is one of the Neglected tropical diseases (NTDs) that are targeted for elimination through global mass chemotherapy. To support this there is a need for reliable diagnostic tools. The conventional diagnostic test, Kato-Katz that is based on microscopic detection of parasite ova in faecal samples, is not effective due to its low sensitivity that is brought about mainly by non-random distribution of eggs in stool and day to day variation in egg output. It is tedious, cumbersome to perform and requires experience for correct diagnosis. LAMP-based tests are simple, relatively cheap, offer greater sensitivity, specificity than existing tests, have high throughput capability, and are ideal for use at the point of care. We have developed a LAMP diagnostic test for detection of hookworm infection in faecal samples. LAMP relies on auto cycling strand displacement DNA synthesis performed at isothermal temperature by Bst polymerase and a set of 4 specific primers. The primers used in the LAMP assay were based on the second Internal Transcribed Spacer (ITS-2) region and designed using Primer Explorer version 4 Software. The ITS-2 region of the ribosomal gene (rDNA) was identified as a suitable target due to its low mutation rates and substantial differences between species. DNA was extracted directly from human faecal samples, followed by LAMP amplification at isothermal temperature of 63 °C for 1 h. Amplicons were visualized using gel electrophoresis and SYBR green dye. Both specificity and sensitivity of the assay were determined. The LAMP based technique developed was able to detect N. americanus DNA in faecal samples. The assay showed 100 % specificity and no cross-reaction was observed with other helminth parasites (S. mansoni, A. lumbricoides or T. trichiura). The developed LAMP assay was 97 % sensitive and DNA at concentrations as low as 0.4 fg were amplified. The LAMP assay developed is an appropriate diagnostic method for the detection of N. americanus DNA in human stool samples because of its simplicity, low cost, sensitivity, and specificity. It holds great promise as a useful diagnostic tool for use in disease control where infection intensities have been significantly reduced.

Assessment of clinical analytical sensitivity and specificity of next-generation sequencing for detection of simple and complex mutations.

PubMed

Chin, Ephrem L H; da Silva, Cristina; Hegde, Madhuri

2013-02-19

Detecting mutations in disease genes by full gene sequence analysis is common in clinical diagnostic laboratories. Sanger dideoxy terminator sequencing allows for rapid development and implementation of sequencing assays in the clinical laboratory, but it has limited throughput, and due to cost constraints, only allows analysis of one or at most a few genes in a patient. Next-generation sequencing (NGS), on the other hand, has evolved rapidly, although to date it has mainly been used for large-scale genome sequencing projects and is beginning to be used in the clinical diagnostic testing. One advantage of NGS is that many genes can be analyzed easily at the same time, allowing for mutation detection when there are many possible causative genes for a specific phenotype. In addition, regions of a gene typically not tested for mutations, like deep intronic and promoter mutations, can also be detected. Here we use 20 previously characterized Sanger-sequenced positive controls in disease-causing genes to demonstrate the utility of NGS in a clinical setting using standard PCR based amplification to assess the analytical sensitivity and specificity of the technology for detecting all previously characterized changes (mutations and benign SNPs). The positive controls chosen for validation range from simple substitution mutations to complex deletion and insertion mutations occurring in autosomal dominant and recessive disorders. The NGS data was 100% concordant with the Sanger sequencing data identifying all 119 previously identified changes in the 20 samples. We have demonstrated that NGS technology is ready to be deployed in clinical laboratories. However, NGS and associated technologies are evolving, and clinical laboratories will need to invest significantly in staff and infrastructure to build the necessary foundation for success.

Slit-skin smear in leprosy: lest we forget it!

PubMed

Mahajan, V K

2013-01-01

Diagnosing and classifying leprosy solely on the basis of skin lesions as per WHO operational classification may lead to over or under diagnosis and inadequate treatment particularly of pauci-lesional multibacillary cases with consequent risk of resistance, relapse and progressive horizontal transmission. Announcing elimination of leprosy as public health problem in India under NLEP was probably ambitious aspiration. However, such a strategy is perhaps not justified scientifically at the moment in view of new case detection rate not showing significant decline. The fact remains that it is still highly desirable to provide sustained quality leprosy services to all individuals through general health services and good referral system. Being nearly of 100% specificity when performed expertly, slit-skin smear remains the simplest diagnostic technique available until new cutting-edge diagnostic tools become available for routine bedside use. However, the interest has been declining for learning this simple test among all the persons involved in leprosy work even in the teaching/training institutes. This is perhaps due to confusion over number and sites of smears, and its declining usefulness in WHO recommendations/guidelines. Various technical aspects of slit-skin smear testing are reviewed here keeping in view the need of leprosy workers in referral/teaching institutes.

Recent advances in diagnostic testing for gastroesophageal reflux disease.

PubMed

Naik, Rishi D; Vaezi, Michael F

2017-06-01

Gastroesophageal reflux disease (GERD) has a large economic burden with important complications that include esophagitis, Barrett's esophagus, and adenocarcinoma. Despite endoscopy, validated patient questionnaires, and traditional ambulatory pH monitoring, the diagnosis of GERD continues to be challenging. Areas covered: This review will explore the difficulties in diagnosing GERD with a focus on new developments, ranging from basic fundamental changes (histology and immunohistochemistry) to direct patient care (narrow-band imaging, impedance, and response to anti-reflux surgery). We searched PubMed using the noted keywords. We included data from full-text articles published in English. Further relevant articles were identified from the reference lists of review articles. Expert commentary: Important advances in novel parameters in intraluminal impedance monitoring such as baseline impedance monitoring has created some insight into alternative diagnostic strategies in GERD. Recent advances in endoscopic assessment of esophageal epithelial integrity via mucosal impedance measurement is questioning the paradigm of prolonged ambulatory testing for GERD. The future of reflux diagnosis may very well be without the need for currently employed technologies and could be as simple as assessing changes in epithelia integrity as a surrogate marker for GERD. However, future studies must validate such an approach.

42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...

20 CFR 404.1519m - Diagnostic tests or procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Diagnostic tests or procedures. 404.1519m... Report Content § 404.1519m Diagnostic tests or procedures. We will request the results of any diagnostic... will not order diagnostic tests or procedures that involve significant risk to you, such as myelograms...

42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...

SU-E-P-29: Testing Display Monitors for GSDF Compliance - a Practical Approach

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

Gauntt, D

2015-06-15

Purpose: To develop a simple technique for testing display monitors for compliance with the DICOM Grayscale Standard Display Function (GSDF), in accordance with the recommendations of AAPM Task Group 18. Methods: We have developed a spreadsheet that can be used to compare both the luminance response and contrast response of a display to the GSDF, using luminance measurements of the SMPTE test pattern. The contrast response compares the slope of the GSDF j-index as a function of pixel value to that of the GSDF function, and should lie within the range 0.85 to 1.15. Results: We present the results ofmore » measurements both of primary diagnostic displays and of ultrasound and acquisition workstations, all at a tertiary care hospital. The Barco displays in the radiographic reading rooms are GSDF compliant or nearly so, while those in the ultrasound reading rooms and at the acquisition workstations generally show significantly higher contrast at low luminance levels than they would if GSDF compliant, and lower contrast at high luminance levels. Conclusion: The spreadsheet that we developed allows a simple comparison of measured display contrast response to the GSDF. Although we used the SMPTE pattern, the same technique could be used with other grayscale patterns, such as TG18-QC and TG18-PQC.« less

Diagnostic performances of the fluorescent spot test for G6PD deficiency in newborns along the Thailand-Myanmar border: A cohort study.

PubMed

Thielemans, Laurence; Gornsawun, Gornpan; Hanboonkunupakarn, Borimas; Paw, Moo Kho; Porn, Pen; Moo, Paw Khu; Van Overmeire, Bart; Proux, Stephane; Nosten, François; McGready, Rose; Carrara, Verena I; Bancone, Germana

2018-01-01

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an inherited enzymatic disorder associated with severe neonatal hyperbilirubinemia and acute haemolysis after exposure to certain drugs or infections. The disorder can be diagnosed phenotypically with a fluorescent spot test (FST), which is a simple test that requires training and basic laboratory equipment. This study aimed to assess the diagnostic performances of the FST used on umbilical cord blood by locally-trained staff and to compare test results of the neonates at birth with the results after one month of age. Methods : We conducted a cohort study on newborns at the Shoklo Malaria Research Unit, along the Thai-Myanmar border between January 2015 and May 2016. The FST was performed at birth on the umbilical cord blood by locally-trained staff and quality controlled by specialised technicians at the central laboratory. The FST was repeated after one month of age. Genotyping for common local G6PD mutations was carried out for all discrepant results. Results: FST was performed on 1521 umbilical cord blood samples. Quality control and genotyping revealed 10 misdiagnoses. After quality control, 10.7% of the males (84/786) and 1.2% of the females (9/735) were phenotypically G6PD deficient at birth. The FST repeated at one month of age or later diagnosed 8 additional G6PD deficient infants who were phenotypically normal at birth. Conclusions : This study shows the short-comings of the G6PD FST in neonatal routine screening and highlights the importance of training and quality control. A more conservative interpretation of the FST in male newborns could increase the diagnostic performances. Quantitative point-of-care tests might show higher sensitivity and specificity for diagnosis of G6PD deficiency on umbilical cord blood and should be investigated.

Diagnostic performances of the fluorescent spot test for G6PD deficiency in newborns along the Thailand-Myanmar border: A cohort study

PubMed Central

Thielemans, Laurence; Gornsawun, Gornpan; Hanboonkunupakarn, Borimas; Paw, Moo Kho; Porn, Pen; Moo, Paw Khu; Van Overmeire, Bart; Proux, Stephane; Nosten, François; McGready, Rose; Carrara, Verena I.; Bancone, Germana

2018-01-01

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an inherited enzymatic disorder associated with severe neonatal hyperbilirubinemia and acute haemolysis after exposure to certain drugs or infections. The disorder can be diagnosed phenotypically with a fluorescent spot test (FST), which is a simple test that requires training and basic laboratory equipment. This study aimed to assess the diagnostic performances of the FST used on umbilical cord blood by locally-trained staff and to compare test results of the neonates at birth with the results after one month of age. Methods: We conducted a cohort study on newborns at the Shoklo Malaria Research Unit, along the Thai-Myanmar border between January 2015 and May 2016. The FST was performed at birth on the umbilical cord blood by locally-trained staff and quality controlled by specialised technicians at the central laboratory. The FST was repeated after one month of age. Genotyping for common local G6PD mutations was carried out for all discrepant results. Results: FST was performed on 1521 umbilical cord blood samples. Quality control and genotyping revealed 10 misdiagnoses. After quality control, 10.7% of the males (84/786) and 1.2% of the females (9/735) were phenotypically G6PD deficient at birth. The FST repeated at one month of age or later diagnosed 8 additional G6PD deficient infants who were phenotypically normal at birth. Conclusions: This study shows the short-comings of the G6PD FST in neonatal routine screening and highlights the importance of training and quality control. A more conservative interpretation of the FST in male newborns could increase the diagnostic performances. Quantitative point-of-care tests might show higher sensitivity and specificity for diagnosis of G6PD deficiency on umbilical cord blood and should be investigated. PMID:29552643

Evaluation of malaria rapid diagnostic test (RDT) use by community health workers: a longitudinal study in western Kenya.

PubMed

Boyce, Matthew R; Menya, Diana; Turner, Elizabeth L; Laktabai, Jeremiah; Prudhomme-O'Meara, Wendy

2018-05-18

Malaria rapid diagnostic tests (RDTs) are a simple, point-of-care technology that can improve the diagnosis and subsequent treatment of malaria. They are an increasingly common diagnostic tool, but concerns remain about their use by community health workers (CHWs). These concerns regard the long-term trends relating to infection prevention measures, the interpretation of test results and adherence to treatment protocols. This study assessed whether CHWs maintained their competency at conducting RDTs over a 12-month timeframe, and if this competency varied with specific CHW characteristics. From June to September, 2015, CHWs (n = 271) were trained to conduct RDTs using a 3-day validated curriculum and a baseline assessment was completed. Between June and August, 2016, CHWs (n = 105) were randomly selected and recruited for follow-up assessments using a 20-step checklist that classified steps as relating to safety, accuracy, and treatment; 103 CHWs participated in follow-up assessments. Poisson regressions were used to test for associations between error count data at follow-up and Poisson regression models fit using generalized estimating equations were used to compare data across time-points. At both baseline and follow-up observations, at least 80% of CHWs correctly completed 17 of the 20 steps. CHWs being 50 years of age or older was associated with increased total errors and safety errors at baseline and follow-up. At follow-up, prior experience conducting RDTs was associated with fewer errors. Performance, as it related to the correct completion of all checklist steps and safety steps, did not decline over the 12 months and performance of accuracy steps improved (mean error ratio: 0.51; 95% CI 0.40-0.63). Visual interpretation of RDT results yielded a CHW sensitivity of 92.0% and a specificity of 97.3% when compared to interpretation by the research team. None of the characteristics investigated was found to be significantly associated with RDT interpretation. With training, most CHWs performing RDTs maintain diagnostic testing competency over at least 12 months. CHWs generally perform RDTs safely and accurately interpret results. Younger age and prior experiences with RDTs were associated with better testing performance. Future research should investigate the mode by which CHW characteristics impact RDT procedures.

Use of Fine Needle Aspirate from Peripheral Nerves of Pure-neural Leprosy for Cytology and Polymerase Chain Reaction to Confirm the Diagnosis: A Follow-up Study of 4 Years.

PubMed

De, Abhishek; Hasanoor Reja, Abu Hena; Aggarwal, Ishad; Sen, Sumit; Sil, Amrita; Bhattacharya, Basudev; Sharma, Nidhi; Ansari, Asad; Sarda, Aarti; Chatterjee, Gobinda; Das, Sudip

2017-01-01

Pure neural leprosy (PNL) still remains a diagnostic challenge because of the absence of sine qua non skin lesions of leprosy and a confirmatory diagnostic method. The authors had earlier described a simple yet objective technique of combining fine needle aspiration cytology (FNAC) coupled with a multiplex polymerase chain reaction (PCR) in a pilot study, wherein the technique showed promise of a reliable diagnostic tool. In the pursuit of further evidence, the authors carried out a 4-year study with PNL cases to find the efficacy and reliability of the said method in a larger sample size. This study was conducted to find the efficacy, reliability, and reproducibility of FNAC coupled with multiplex PCR and Ziehl-Neelsen (ZN) staining in identifying the cases of PNL. All cases that were suspected to be suffering from PNL, following evaluation by two independent observers were included in the study and were subjected to FNAC from the affected nerve, and the aspirates were evaluated for cytology, ZN staining, and multiplex PCR for Mycobacterium leprae genome. In addition, serum anti-PGL1 levels were also performed in all the study subjects. Fifteen non-PNL cases were also included in the control arm. A total of 47 cases were included in the test arm and subjected to FNAC. Conventional ZN staining could demonstrate acid-fast bacilli (AFB) in only 15 out of 47 cases (31.91%) while M. leprae DNA could be elicited in 37 (78.72%) cases by the multiplex PCR. Only 13 (27.65%) out of 47 cases showed anti-PGLI-1 antibody positivity. On cytological examination of the nerve aspirates, only 11 (23.40%) cases showed epithelioid cells whereas nonspecific inflammation was seen in 26 (75.60%) cases. The results of this study conducted over a larger sample size corroborate with the findings of our pilot study. In a resource poor set up, FNAC in combination with ZN staining and multiplex PCR is a rapid, simple, and easily performed test, which can give a reproducible and objective diagnosis in cases of PNL.

Clinical significance of autoantibodies in autoimmune hepatitis.

PubMed

Liberal, Rodrigo; Mieli-Vergani, Giorgina; Vergani, Diego

2013-10-01

The accurate diagnosis and classification of autoimmune hepatitis (AIH) rely upon the detection of characteristic autoantibodies. Positivity for anti-nuclear (ANA) and/or anti-smooth muscle (SMA) autoantibodies defines AIH type 1 (AIH-1), whereas anti-liver kidney microsomal type 1 (anti-LKM1) and/or anti-liver cytosol type 1 (anti-LC1) define AIH type 2 (AIH-2). ANA and SMA, and less commonly anti-LKM1, have also been detected in de-novo autoimmune hepatitis developing after liver transplantation, a condition that may affect patients transplanted for non-autoimmune liver disease. The diagnostic autoantibodies associated with AIH-1 are also detected in the paediatric AIH/sclerosing cholangitis overlap syndrome, referred to as autoimmune sclerosing cholangitis (ASC). ASC, like adult primary sclerosing cholangitis, is often associated with atypical perinuclear anti-neutrophil cytoplasmic autoantibodies (p-ANCA), although p-ANCA are also detected in other autoimmune liver diseases. These associations highlight the necessity for simple and prompt diagnostic autoantibody testing, and the requirement for the accurate interpretation of the results of the tests in the clinical context. Fine-mapping of antigenic autoantibody targets has facilitated the development of rapid molecular assays that have the potential to revolutionise the field if properly standardised and when used in combination with classical immunofluorescence. Despite their diagnostic significance, the pathogenic role of the various autoantibodies and the mechanisms by which they can potentially inflict damage onto the liver cell remain a topic for further research. Copyright © 2013 Elsevier Ltd. All rights reserved.

Diagnostic performance of instantaneous wave-free ratio for the evaluation of coronary stenosis severity confirmed by fractional flow reserve: A PRISMA-compliant meta-analysis of randomized studies.

PubMed

Man, Wanrong; Hu, Jianqiang; Zhao, Zhijing; Zhang, Mingming; Wang, Tingting; Lin, Jie; Duan, Yu; Wang, Ling; Wang, Haichang; Sun, Dongdong; Li, Yan

2016-09-01

The instantaneous wave-free ratio (iFR) is a new vasodilator-free index of coronary stenosis severity. The aim of this meta-analysis is to assess the diagnostic performance of iFR for the evaluation of coronary stenosis severity with fractional flow reserve as standard reference. We searched PubMed, EMBASE, CENTRAL, ProQuest, Web of Science, and International Clinical Trials Registry Platform (ICTRP) for publications concerning the diagnostic value of iFR. We used a random-effects covariate to synthesize the available data of sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), and diagnostic odds ratio (DOR). Overall test performance was summarized by the summary receiver operating characteristic curve (sROC) and the area under the curve (AUC). Eight studies with 1611 subjects were included in the meta-analysis. The pooled sensitivity, specificity, LR+, LR-, and DOR for iFR were respectively 73.3% (70.1-76.2%), 86.4% (84.3-88.3%), 5.71 (4.43-7.37), 0.29 (0.22-0.38), and 20.54 (16.11-26.20). The area under the summary receiver operating characteristic curves for iFR was 0.8786. No publication bias was identified. The available evidence suggests that iFR may be a new, simple, and promising technology for coronary stenosis physiological assessment.

Two-layer Lab-on-a-chip (LOC) with passive capillary valves for mHealth medical diagnostics.

PubMed

Balsam, Joshua; Bruck, Hugh Alan; Rasooly, Avraham

2015-01-01

There is a new potential to address needs for medical diagnostics in Point-of-Care (PoC) applications using mHealth (Mobile computing, medical sensors, and communications technologies for health care), a mHealth based lab test will require a LOC to perform clinical analysis. In this work, we describe the design of a simple Lab-on-a-chip (LOC) platform for mHealth medical diagnostics. The LOC utilizes a passive capillary valve with no moving parts for fluid control using channels with very low aspect ratios cross sections (i.e., channel width ≫ height) achieved through transitions in the channel geometry via that arrest capillary flow. Using a CO2 laser in raster engraving mode, we have designed and fabricated an eight-channel LOC for fluorescence signal detection fabricated by engraving and combining just two polymer layers. Each of the LOC channels is capable of mixing two reagents (e.g., enzyme and substrate) for various assays. For mHealth detection, we used a mobile CCD detector equipped with LED multispectral illumination in the red, green, blue, and white range. This technology enables the development of low-cost LOC platforms for mHealth whose fabrication is compatible with standard industrial plastic fabrication processes to enable mass production of mHealth diagnostic devices, which may broaden the use of LOCs in PoC applications, especially in global health settings.

Dyspnoea, thoracic pain and fever in a young caucasian female: A case report.

PubMed

Fois, Alessandro Giuseppe; Trisolini, Rocco; Ginesu, Giorgio Carlo; Zinellu, Elisabetta; Negri, Silvia; Cancellieri, Alessandra; Garau, Alessandra; Pirina, Pietro

2018-05-31

The diagnostic approach to patients with mediastinal pathology is not always simple and an improper diagnostic work-up can lead to significant diagnosis delay. We report on the case of a young woman who was admitted to the Emergency Department complaining of thoracic pain, dyspnoea, fever and productive cough. The physical examination showed a painful swelling over the sternum's upper left margin, which had become evident 4 months earlier. A Computer Tomography showed the presence of a retrosternal oval lesion (5.5 x 4 cm) infiltrating the thoracic wall and showed the presence of discretely enlarged mediastinal lymph nodes in several mediastinal stations. The Multidisciplinary Team decided to perform an ultrasound-guided biopsy of the retrosternal mass that showed an inflammatory pattern, whereas microbiology tests proved negative. The lack of improvement with medical therapy (non steroideal anti-inflammatories and antibiotics) and the clinical suspicion of malignancy led us to perform a surgical biopsy of the mass that finally proved to be diagnostic for Hodgkin's lymphoma. Mediastinal masses with an aggressive behavior, should always be considered to be potentially malignant. Surgical biopsy, sometimes, can be the only way to correctly diagnose the pathological process, especially in the case of Hodgkin's lymphoma in which few diagnostic cells (Reed-Sternberg cells) are generally embedded in an abundant inflammatory background tissue. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

A multicentre observational study for early diagnosis of Gaucher disease in patients with Splenomegaly and/or Thrombocytopenia.

PubMed

Motta, Irene; Filocamo, Mirella; Poggiali, Erika; Stroppiano, Marina; Dragani, Alfredo; Consonni, Dario; Barcellini, Wilma; Gaidano, Gianluca; Facchini, Luca; Specchia, Giorgina; Cappellini, Maria Domenica

2016-04-01

Gaucher disease (GD) is the most common lysosomal disorder resulting from deficient activity of the β-glucosidase enzyme that causes accumulation of glucosylceramide in the macrophage-monocyte system. Notably, because of non-specific symptoms and a lack of awareness, patients with GD experience long diagnostic delays. The aim of this study was to apply a diagnostic algorithm to identify GD type 1 among adults subjects referred to Italian haematology outpatient units because of splenomegaly and/or thrombocytopenia and, eventually, to estimate the prevalence of GD in this selected population. One hundred and ninety-six subjects (61 females, 135 males; mean age 47.8 ± 18.2 years) have been enrolled in the study and tested for β-glucosidase enzyme activity on dried blood spot (DBS). Seven of 196 patients have been diagnosed with GD, (5 females and 2 males) with mean age 31.8 ± 8.2 years, with a prevalence of 3.6% (with a prevalence of 3.6% (I95% CI 1.4-7.2; 1/28 patients) in this population. These results show that the use of an appropriate diagnostic algorithm and a simple diagnostic method, such as DBS, are important tools to facilitate the diagnosis of a rare disease even for not disease-expert physicians. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Monotone Properties of a General Diagnostic Model. Research Report. ETS RR-07-25

ERIC Educational Resources Information Center

Xu, Xueli

2007-01-01

Monotonicity properties of a general diagnostic model (GDM) are considered in this paper. Simple data summaries are identified to inform about the ordered categories of latent traits. The findings are very much in accordance with the statements made about the GPCM (Hemker, Sijtsma, Molenaar, & Junker, 1996, 1997). On the one hand, by fitting a…

30 CFR 250.525 - What do I submit if my casing diagnostic test requires action?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What do I submit if my casing diagnostic test... if my casing diagnostic test requires action? Within 14 days after you perform a casing diagnostic... Corrective Action Plan within 30 days of the diagnostic test. (b) a casing pressure request, Regional...

Chronic abdominal wall pain--a diagnostic challenge for the surgeon.

PubMed

Lindsetmo, Rolv-Ole; Stulberg, Jonah

2009-07-01

Chronic abdominal wall pain (CAWP) occurs in about 30% of all patients presenting with chronic abdominal pain. The authors review the literature identified in a PubMed search regarding the abdominal wall as the origin of chronic abdominal pain. CAWP is frequently misinterpreted as visceral or functional abdominal pain. Misdiagnosis often leads to a variety of investigational procedures and even abdominal operations with negative results. With a simple clinical test (Carnett's test), >90% of patients with CAWP can be recognized, without risk for missing intra-abdominal pathology. The condition can be confirmed when the injection of local anesthetics in the trigger point(s) relieves the pain. A fasciotomy in the anterior abdominal rectus muscle sheath through the nerve foramina of the affected branch of one of the anterior intercostal nerves heals the pain.

An influenza A virus agglutination test using antibody-like polymers.

PubMed

Sukjee, Wannisa; Thitithanyanont, Arunee; Wiboon-Ut, Suwimon; Lieberzeit, Peter A; Paul Gleeson, M; Navakul, Krongkaew; Sangma, Chak

2017-10-01

Antibodies are commonly used in diagnostic routines to identify pathogens. The testing protocols are relatively simple, requiring a certain amount of a specific antibody to detect its corresponding pathogen. Antibody functionality can be mimicked by synthesizing molecularly imprinted polymers (MIPs), i.e. polymers that can selectively recognize a given template structure. Thus, MIPs are sometimes termed 'plastic antibody (PA)'. In this study, we have synthesized new granular MIPs using influenza A virus templates by precipitation polymerization. The selective binding of influenza A to the MIP particles was assessed and subsequently contrasted with other viruses. The affinities of influenza A virus towards the MIP was estimated based on an agglutination test by measuring the amount of influenza subtypes absorbed onto the MIPs. The MIPs produced using the H1N1 template showed specific reactivity to H1N1 while those produced using H5N1 and H3N2 templates showed cross-reactivity.

Highly sensitive sandwich immunoassay and immunochromatographic test for the detection of Clostridial epsilon toxin in complex matrices.

PubMed

Féraudet-Tarisse, Cécile; Mazuet, Christelle; Pauillac, Serge; Krüger, Maren; Lacroux, Caroline; Popoff, Michel R; Dorner, Brigitte G; Andréoletti, Olivier; Plaisance, Marc; Volland, Hervé; Simon, Stéphanie

2017-01-01

Epsilon toxin is one of the four major toxins of Clostridium perfringens. It is the third most potent clostridial toxin after botulinum and tetanus toxins and is thus considered as a potential biological weapon classified as category B by the Centers for Disease Control and Prevention (CDC). In the case of a bioterrorist attack, there will be a need for a rapid, sensitive and specific detection method to monitor food and water contamination by this toxin, and for a simple human diagnostic test. We have produced and characterized five monoclonal antibodies against common epitopes of epsilon toxin and prototoxin. Three of them neutralize the cytotoxic effects of epsilon toxin in vitro. With these antibodies, we have developed highly sensitive tests, overnight and 4-h sandwich enzyme immunoassays and an immunochromatographic test performed in 20 min, reaching detection limits of at least 5 pg/mL (0.15 pM), 30 pg/mL (0.9 pM) and 100 pg/mL (3.5 pM) in buffer, respectively. These tests were also evaluated for detection of epsilon toxin in different matrices: milk and tap water for biological threat detection, serum, stool and intestinal content for human or veterinary diagnostic purposes. Detection limits in these complex matrices were at least 5-fold better than those described in the literature (around 1 to 5 ng/mL), reaching 10 to 300 pg/mL using the enzyme immunoassay and 100 to 2000 pg/mL using the immunochromatographic test.

Highly sensitive sandwich immunoassay and immunochromatographic test for the detection of Clostridial epsilon toxin in complex matrices

PubMed Central

Mazuet, Christelle; Pauillac, Serge; Krüger, Maren; Lacroux, Caroline; Popoff, Michel R.; Dorner, Brigitte G.; Andréoletti, Olivier; Plaisance, Marc; Volland, Hervé; Simon, Stéphanie

2017-01-01

Epsilon toxin is one of the four major toxins of Clostridium perfringens. It is the third most potent clostridial toxin after botulinum and tetanus toxins and is thus considered as a potential biological weapon classified as category B by the Centers for Disease Control and Prevention (CDC). In the case of a bioterrorist attack, there will be a need for a rapid, sensitive and specific detection method to monitor food and water contamination by this toxin, and for a simple human diagnostic test. We have produced and characterized five monoclonal antibodies against common epitopes of epsilon toxin and prototoxin. Three of them neutralize the cytotoxic effects of epsilon toxin in vitro. With these antibodies, we have developed highly sensitive tests, overnight and 4-h sandwich enzyme immunoassays and an immunochromatographic test performed in 20 min, reaching detection limits of at least 5 pg/mL (0.15 pM), 30 pg/mL (0.9 pM) and 100 pg/mL (3.5 pM) in buffer, respectively. These tests were also evaluated for detection of epsilon toxin in different matrices: milk and tap water for biological threat detection, serum, stool and intestinal content for human or veterinary diagnostic purposes. Detection limits in these complex matrices were at least 5-fold better than those described in the literature (around 1 to 5 ng/mL), reaching 10 to 300 pg/mL using the enzyme immunoassay and 100 to 2000 pg/mL using the immunochromatographic test. PMID:28700661

What Sensing Tells Us: Towards a Formal Theory of Testing for Dynamical Systems

NASA Technical Reports Server (NTRS)

McIlraith, Sheila; Scherl, Richard

2005-01-01

Just as actions can have indirect effects on the state of the world, so too can sensing actions have indirect effects on an agent's state of knowledge. In this paper, we investigate "what sensing actions tell us", i.e., what an agent comes to know indirectly from the outcome of a sensing action, given knowledge of its actions and state constraints that hold in the world. To this end, we propose a formalization of the notion of testing within a dialect of the situation calculus that includes knowledge and sensing actions. Realizing this formalization requires addressing the ramification problem for sensing actions. We formalize simple tests as sensing actions. Complex tests are expressed in the logic programming language Golog. We examine what it means to perform a test, and how the outcome of a test affects an agent's state of knowledge. Finally, we propose automated reasoning techniques for test generation and complex-test verification, under certain restrictions. The work presented in this paper is relevant to a number of application domains including diagnostic problem solving, natural language understanding, plan recognition, and active vision.

Rapid and quantitative detection of zoonotic influenza A virus infection utilizing coumarin-derived dendrimer-based fluorescent immunochromatographic strip test (FICT).

PubMed

Yeo, Seon-Ju; Huong, Dinh Thi; Hong, Nguyen Ngoc; Li, Chun-Ying; Choi, Kyunghan; Yu, Kyoungsik; Choi, Du-Young; Chong, Chom-Kyu; Choi, Hak Soo; Mallik, Shyam Kumar; Kim, Hak Sung; Sung, Haan Woo; Park, Hyun

2014-01-01

Great efforts have been made to develop robust signal-generating fluorescence materials which will help in improving the rapid diagnostic test (RDT) in terms of sensitivity and quantification. In this study, we developed coumarin-derived dendrimer-based fluorescent immunochromatographic strip test (FICT) assay with enhanced sensitivity as a quantitative diagnostic tool in typical RDT environments. The accuracy of the proposed FICT was compared with that of dot blot immunoassay techniques and conventional RDTs. Through conjugation of coumarin-derived dendrimers with latex beads, fluorescent emission covering broad output spectral ranges was obtained which provided a distinct advantage of easy discrimination of the fluorescent emission of the latex beads with a simple insertion of a long-pass optical filter away from the excitation wavelength. The newly developed FICT assay was able to detect 100 ng/10 μL of influenza A nucleoprotein (NP) antigen within 5 minutes, which corresponded to 2.5-fold higher sensitivity than that of the dot blot immunoassay or conventional RDTs. Moreover, the FICT assay was confirmed to detect at least four avian influenza A subtypes (H5N3, H7N1, H7N7, and H9N2). On applying the FICT to the clinical swab samples infected with respiratory viruses, our FICT assay was confirmed to differentiate influenza H1N1 infection from other respiratory viral diseases. These data demonstrate that the proposed FICT assay is able to detect zoonotic influenza A viruses with a high sensitivity, and it enables the quantitation of the infection intensity by providing the numerical diagnostic values; thus demonstrating enhanced detectability of influenza A viruses.

Development of a Competitive Enzyme-Linked Immunosorbent Assay for Detection of Antibodies against the 3B Protein of Foot-and-Mouth Disease Virus

PubMed Central

Yang, Ming; Parida, Satya; Salo, Tim; Hole, Kate; Velazquez-Salinas, Lauro

2015-01-01

Foot-and-mouth disease (FMD) is one of the most highly contagious and economically devastating diseases, and it severely constrains the international trade of animals. Vaccination against FMD is a key element in the control of FMD. However, vaccination of susceptible animals raises critical issues, such as the differentiation of infected animals from vaccinated animals. The current study developed a reliable and rapid test to detect antibodies against the conserved, nonstructural proteins (NSPs) of the FMD virus (FMDV) to distinguish infected animals from vaccinated animals. A monoclonal antibody (MAb) against the FMDV NSP 3B was produced. A competitive enzyme-linked immunosorbent assay (cELISA) for FMDV/NSP antibody detection was developed using a recombinant 3ABC protein as the antigen and the 3B-specific MAb. Sera collected from naive, FMDV experimentally infected, vaccinated carrier, and noncarrier animals were tested using the 3B cELISA. The diagnostic specificity was 99.4% for naive animals (cattle, pigs, and sheep) and 99.7% for vaccinated noncarrier animals. The diagnostic sensitivity was 100% for experimentally inoculated animals and 64% for vaccinated carrier animals. The performance of this 3B cELISA was compared to that of four commercial ELISA kits using a panel of serum samples established by the World Reference Laboratory for FMD at The Pirbright Institute, Pirbright, United Kingdom. The diagnostic sensitivity of the 3B cELISA for the panel of FMDV/NSP-positive bovine serum samples was 94%, which was comparable to or better than that of the commercially available NSP antibody detection kits. This 3B cELISA is a simple, reliable test to detect antibodies against FMDV nonstructural proteins. PMID:25651918

Cost-effectiveness of a novel blood-pool contrast agent in the setting of chest pain evaluation in an emergency department.

PubMed

Espinosa, Gabriela; Annapragada, Ananth

2013-10-01

We evaluated three diagnostic strategies with the objective of comparing the current standard of care for individuals presenting acute chest pain and no history of coronary artery disease (CAD) with a novel diagnostic strategy using an emerging technology (blood-pool contrast agent [BPCA]) to identify the potential benefits and cost reductions. A decision analytic model of diagnostic strategies and outcomes using a BPCA and a conventional agent for CT angiography (CTA) in patients with acute chest pain was built. The model was used to evaluate three diagnostic strategies: CTA using a BPCA followed by invasive coronary angiography (ICA), CTA using a conventional agent followed by ICA, and ICA alone. The use of the two CTA-based triage tests before ICA in a population with a CAD prevalence of less than 47% was predicted to be more cost-effective than ICA alone. Using the base-case values and a cost premium for BPCA over the conventional CT agent (cost of BPCA ≈ 5× that of a conventional agent) showed that CTA with a BPCA before ICA resulted in the most cost-effective strategy; the other strategies were ruled out by simple dominance. The model strongly depends on the rates of complications from the diagnostic tests included in the model. In a population with an elevated risk of contrast-induced nephropathy (CIN), a significant premium cost per BPCA dose still resulted in the alternative whereby CTA using BPCA was more cost-effective than CTA using a conventional agent. A similar effect was observed for potential complications resulting from the BPCA injection. Conversely, in the presence of a similar complication rate from BPCA, the diagnostic strategy of CTA using a conventional agent would be the optimal alternative. BPCAs could have a significant impact in the diagnosis of acute chest pain, in particular for populations with high incidences of CIN. In addition, a BPCA strategy could garner further savings if currently excluded phenomena including renal disease and incidental findings were included in the decision model.

Fetal Intelligent Navigation Echocardiography (FINE): a novel method for rapid, simple, and automatic examination of the fetal heart.

PubMed

Yeo, Lami; Romero, Roberto

2013-09-01

To describe a novel method (Fetal Intelligent Navigation Echocardiography (FINE)) for visualization of standard fetal echocardiography views from volume datasets obtained with spatiotemporal image correlation (STIC) and application of 'intelligent navigation' technology. We developed a method to: 1) demonstrate nine cardiac diagnostic planes; and 2) spontaneously navigate the anatomy surrounding each of the nine cardiac diagnostic planes (Virtual Intelligent Sonographer Assistance (VIS-Assistance®)). The method consists of marking seven anatomical structures of the fetal heart. The following echocardiography views are then automatically generated: 1) four chamber; 2) five chamber; 3) left ventricular outflow tract; 4) short-axis view of great vessels/right ventricular outflow tract; 5) three vessels and trachea; 6) abdomen/stomach; 7) ductal arch; 8) aortic arch; and 9) superior and inferior vena cava. The FINE method was tested in a separate set of 50 STIC volumes of normal hearts (18.6-37.2 weeks of gestation), and visualization rates for fetal echocardiography views using diagnostic planes and/or VIS-Assistance® were calculated. To examine the feasibility of identifying abnormal cardiac anatomy, we tested the method in four cases with proven congenital heart defects (coarctation of aorta, tetralogy of Fallot, transposition of great vessels and pulmonary atresia with intact ventricular septum). In normal cases, the FINE method was able to generate nine fetal echocardiography views using: 1) diagnostic planes in 78-100% of cases; 2) VIS-Assistance® in 98-100% of cases; and 3) a combination of diagnostic planes and/or VIS-Assistance® in 98-100% of cases. In all four abnormal cases, the FINE method demonstrated evidence of abnormal fetal cardiac anatomy. The FINE method can be used to visualize nine standard fetal echocardiography views in normal hearts by applying 'intelligent navigation' technology to STIC volume datasets. This method can simplify examination of the fetal heart and reduce operator dependency. The observation of abnormal echocardiography views in the diagnostic planes and/or VIS-Assistance® should raise the index of suspicion for congenital heart disease. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

Magnetic Levitation Coupled with Portable Imaging and Analysis for Disease Diagnostics.

PubMed

Knowlton, Stephanie M; Yenilmez, Bekir; Amin, Reza; Tasoglu, Savas

2017-02-19

Currently, many clinical diagnostic procedures are complex, costly, inefficient, and inaccessible to a large population in the world. The requirements for specialized equipment and trained personnel require that many diagnostic tests be performed at remote, centralized clinical laboratories. Magnetic levitation is a simple yet powerful technique and can be applied to levitate cells, which are suspended in a paramagnetic solution and placed in a magnetic field, at a position determined by equilibrium between a magnetic force and a buoyancy force. Here, we present a versatile platform technology designed for point-of-care diagnostics which uses magnetic levitation coupled to microscopic imaging and automated analysis to determine the density distribution of a patient's cells as a useful diagnostic indicator. We present two platforms operating on this principle: (i) a smartphone-compatible version of the technology, where the built-in smartphone camera is used to image cells in the magnetic field and a smartphone application processes the images and to measures the density distribution of the cells and (ii) a self-contained version where a camera board is used to capture images and an embedded processing unit with attached thin-film-transistor (TFT) screen measures and displays the results. Demonstrated applications include: (i) measuring the altered distribution of a cell population with a disease phenotype compared to a healthy phenotype, which is applied to sickle cell disease diagnosis, and (ii) separation of different cell types based on their characteristic densities, which is applied to separate white blood cells from red blood cells for white blood cell cytometry. These applications, as well as future extensions of the essential density-based measurements enabled by this portable, user-friendly platform technology, will significantly enhance disease diagnostic capabilities at the point of care.

Paper-based assay for red blood cell antigen typing by the indirect antiglobulin test.

PubMed

Yeow, Natasha; McLiesh, Heather; Guan, Liyun; Shen, Wei; Garnier, Gil

2016-07-01

A rapid and simple paper-based elution assay for red blood cell antigen typing by the indirect antiglobulin test (IAT) was established. This allows to type blood using IgG antibodies for the important blood groups in which IgM antibodies do not exist. Red blood cells incubated with IgG anti-D were washed with saline and spotted onto the paper assay pre-treated with anti-IgG. The blood spot was eluted with an elution buffer solution in a chromatography tank. Positive samples were identified by the agglutinated and fixed red blood cells on the original spotting area, while red blood cells from negative samples completely eluted away from the spot of origin. Optimum concentrations for both anti-IgG and anti-D were identified to eliminate the washing step after the incubation phase. Based on the no-washing procedure, the critical variables were investigated to establish the optimal conditions for the paper-based assay. Two hundred ten donor blood samples were tested in optimal conditions for the paper test with anti-D and anti-Kell. Positive and negative samples were clearly distinguished. This assay opens up new applications of the IAT on paper including antibody detection and blood donor-recipient crossmatching and extends its uses into non-blood typing applications with IgG antibody-based diagnostics. Graphical abstract A rapid and simple paper-based assay for red blood cell antigen typing by the indirect antiglobulin test.

40 CFR 85.2222 - On-board diagnostic test procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 19 2013-07-01 2013-07-01 false On-board diagnostic test procedures... Warranty Short Tests § 85.2222 On-board diagnostic test procedures. The test sequence for the inspection of on-board diagnostic systems on 1996 and newer light-duty vehicles and light-duty trucks shall consist...

40 CFR 85.2222 - On-board diagnostic test procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 19 2012-07-01 2012-07-01 false On-board diagnostic test procedures... Warranty Short Tests § 85.2222 On-board diagnostic test procedures. The test sequence for the inspection of on-board diagnostic systems on 1996 and newer light-duty vehicles and light-duty trucks shall consist...

40 CFR 85.2231 - On-board diagnostic test equipment requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 19 2012-07-01 2012-07-01 false On-board diagnostic test equipment... Warranty Short Tests § 85.2231 On-board diagnostic test equipment requirements. (a) The test system interface to the vehicle shall include a plug that conforms to SAE J1962 “Diagnostic Connector.” The...

40 CFR 85.2222 - On-board diagnostic test procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 18 2011-07-01 2011-07-01 false On-board diagnostic test procedures... Warranty Short Tests § 85.2222 On-board diagnostic test procedures. The test sequence for the inspection of on-board diagnostic systems on 1996 and newer light-duty vehicles and light-duty trucks shall consist...

40 CFR 85.2231 - On-board diagnostic test equipment requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 18 2011-07-01 2011-07-01 false On-board diagnostic test equipment... Warranty Short Tests § 85.2231 On-board diagnostic test equipment requirements. (a) The test system interface to the vehicle shall include a plug that conforms to SAE J1962 “Diagnostic Connector.” The...

40 CFR 85.2231 - On-board diagnostic test equipment requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 19 2013-07-01 2013-07-01 false On-board diagnostic test equipment... Warranty Short Tests § 85.2231 On-board diagnostic test equipment requirements. (a) The test system interface to the vehicle shall include a plug that conforms to SAE J1962 “Diagnostic Connector.” The...

Diagnostic Methods for Bile Acid Malabsorption in Clinical Practice

PubMed Central

Vijayvargiya, Priya; Camilleri, Michael; Shin, Andrea; Saenger, Amy

2013-01-01

Altered bile acid (BA) concentrations in the colon may cause diarrhea or constipation. BA malabsorption (BAM) accounts for >25% of patients with irritable bowel syndrome (IBS) with diarrhea and chronic diarrhea in Western countries. As BAM is increasingly recognized, proper diagnostic methods are desired in clinical practice to help direct the most effective treatment course for the chronic bowel dysfunction. This review appraises the methodology, advantages and disadvantages of 4 tools that directly measure BAM: 14C-glycocholate breath and stool test, 75Selenium HomotauroCholic Acid Test (SeHCAT), 7 α-hydroxy-4-cholesten-3-one (C4) and fecal BAs. 14C-glycocholate is a laborious test no longer widely utilized. 75SeHCAT is validated, but not available in the United States. Serum C4 is a simple, accurate method that is applicable to a majority of patients, but requires further clinical validation. Fecal measurements to quantify total and individual fecal BAs are technically cumbersome and not widely available. Regrettably, none of these tests are routinely available in the U.S., and a therapeutic trial with a BA binder is used as a surrogate for diagnosis of BAM. Recent data suggest there is an advantage to studying fecal excretion of the individual BAs and their role in BAM; this may constitute a significant advantage of the fecal BA method over the other tests. Fecal BA test could become a routine addition to fecal fat measurement in patients with unexplained diarrhea. In summary, availability determines the choice of test among C4, SeHCAT and fecal BA; more widespread availability of such tests would enhance clinical management of these patients. PMID:23644387

Quantitation of 5-Methyltetrahydrofolate in Cerebrospinal Fluid Using Liquid Chromatography-Electrospray Tandem Mass Spectrometry.

PubMed

Arning, Erland; Bottiglieri, Teodoro

2016-01-01

We describe a simple stable isotope dilution method for accurate and precise measurement of cerebrospinal fluid (CSF) 5-methyltetrahydrofolate (5-MTHF) as a clinical diagnostic test. 5-MTHF is the main biologically active form of folic acid and is involved in regulation of homocysteine and DNA synthesis. Measurement of 5-MTHF in CSF provides diagnostic information regarding diseases affecting folate metabolism within the central nervous system, in particular inborn errors of folate metabolism. Determination of 5-MTHF in CSF (50 μL) was performed utilizing high performance liquid chromatography coupled with electrospray positive ionization tandem mass spectrometry (HPLC-ESI-MS/MS). 5-MTHF in CSF is determined by a 1:2 dilution with internal standard (5-MTHF-(13)C5) and injected directly onto the HPLC-ESI-MS/MS system. Each assay is quantified using a five-point standard curve (25-400 nM) and has an analytical measurement range of 3-1000 nM.

Characterization and Separation of Cancer Cells with a Wicking Fiber Device.

PubMed

Tabbaa, Suzanne M; Sharp, Julia L; Burg, Karen J L

2017-12-01

Current cancer diagnostic methods lack the ability to quickly, simply, efficiently, and inexpensively screen cancer cells from a mixed population of cancer and normal cells. Methods based on biomarkers are unreliable due to complexity of cancer cells, plasticity of markers, and lack of common tumorigenic markers. Diagnostics are time intensive, require multiple tests, and provide limited information. In this study, we developed a novel wicking fiber device that separates cancer and normal cell types. To the best of our knowledge, no previous work has used vertical wicking of cells through fibers to identify and isolate cancer cells. The device separated mouse mammary tumor cells from a cellular mixture containing normal mouse mammary cells. Further investigation showed the device separated and isolated human cancer cells from a heterogeneous mixture of normal and cancerous human cells. We report a simple, inexpensive, and rapid technique that has potential to identify and isolate cancer cells from large volumes of liquid samples that can be translated to on-site clinic diagnosis.

Telltale signs of patient-centered diagnosis.

PubMed

Millenson, Michael L

2014-01-01

A best-selling book from the mid-1980s was entitled, All I Really Need to Know I Learned in Kindergarten. Some doctors may similarly feel that well-worn epigrams from Hippocrates, Osler and others have told them all they really need to know about patient-centered care. The problem is that aphorisms and action are not one and the same. The workup for patient-centered diagnosis takes work, and there are telltale signs along the way. Effective patient engagement requires training and practice. It means incorporating patient-generated data into the diagnostic process. And it means being sensitive to new economic constraints on patients. Ensuring that diagnostic processes and decisions meet the test of patient-centeredness poses a challenge. The new criteria do not replace the professional obligation of beneficence; rather they add an additional obligation of power sharing. While that is neither simple nor easy, it promises better care for patients, a more satisfying clinical encounter and a better health care system for all.

Mechanical system diagnostics using vibration testing techniques

NASA Technical Reports Server (NTRS)

Mcleod, Catherine D.; Raju, P. K.; Crocker, M. J.

1990-01-01

The 'Cepstrum' technique of vibration-path identification allows the recovery of the transfer function of a system with little knowledge as to its excitation force, by means of a mathematical manipulation of the system output in conjunction with subtraction of part of the output and suitable signal processing. An experimental program has been conducted to evaluate the usefulness of this technique in the cases of simple, cantilever-beam and free-free plate structures as well as in that of a complex mechanical system. On the basis of the transfer functions thus recovered, it was possible to evaluate the shifts in the resonance frequencies of a structure due to the presence of defects.

Development of a robotic evaluation system for the ability of proprioceptive sensation in slow hand motion.

PubMed

Tanaka, Yoshiyuki; Mizoe, Genki; Kawaguchi, Tomohiro

2015-01-01

This paper proposes a simple diagnostic methodology for checking the ability of proprioceptive/kinesthetic sensation by using a robotic device. The perception ability of virtual frictional forces is examined in operations of the robotic device by the hand at a uniform slow velocity along the virtual straight/circular path. Experimental results by healthy subjects demonstrate that percentage of correct answers for the designed perceptual tests changes in the motion direction as well as the arm configuration and the HFM (human force manipulability) measure. It can be supposed that the proposed methodology can be applied into the early detection of neuromuscular/neurological disorders.

Towards more accurate HIV testing in sub-Saharan Africa: a multi-site evaluation of HIV RDTs and risk factors for false positives

PubMed Central

Kosack, Cara S; Page, Anne-Laure; Beelaert, Greet; Benson, Tumwesigye; Savane, Aboubacar; Ng’ang’a, Anne; Andre, Bita; Zahinda, Jean-Paul BN; Shanks, Leslie; Fransen, Katrien

2017-01-01

Abstract Introduction: Although individual HIV rapid diagnostic tests (RDTs) show good performance in evaluations conducted by WHO, reports from several African countries highlight potentially significant performance issues. Despite widespread use of RDTs for HIV diagnosis in resource-constrained settings, there has been no systematic, head-to-head evaluation of their accuracy with specimens from diverse settings across sub-Saharan Africa. We conducted a standardized, centralized evaluation of eight HIV RDTs and two simple confirmatory assays at a WHO collaborating centre for evaluation of HIV diagnostics using specimens from six sites in five sub-Saharan African countries. Methods: Specimens were transported to the Institute of Tropical Medicine (ITM), Antwerp, Belgium for testing. The tests were evaluated by comparing their results to a state-of-the-art reference algorithm to estimate sensitivity, specificity and predictive values. Results: 2785 samples collected from August 2011 to January 2015 were tested at ITM. All RDTs showed very high sensitivity, from 98.8% for First Response HIV Card Test 1–2.0 to 100% for Determine HIV 1/2, Genie Fast, SD Bioline HIV 1/2 3.0 and INSTI HIV-1/HIV-2 Antibody Test kit. Specificity ranged from 90.4% for First Response to 99.7% for HIV 1/2 STAT-PAK with wide variation based on the geographical origin of specimens. Multivariate analysis showed several factors were associated with false-positive results, including gender, provider-initiated testing and the geographical origin of specimens. For simple confirmatory assays, the total sensitivity and specificity was 100% and 98.8% for ImmunoComb II HIV 12 CombFirm (ImmunoComb) and 99.7% and 98.4% for Geenius HIV 1/2 with indeterminate rates of 8.9% and 9.4%. Conclusions: In this first systematic head-to-head evaluation of the most widely used RDTs, individual RDTs performed more poorly than in the WHO evaluations: only one test met the recommended thresholds for RDTs of ≥99% sensitivity and ≥98% specificity. By performing all tests in a centralized setting, we show that these differences in performance cannot be attributed to study procedure, end-user variation, storage conditions, or other methodological factors. These results highlight the existence of geographical and population differences in individual HIV RDT performance and underscore the challenges of designing locally validated algorithms that meet the latest WHO-recommended thresholds. PMID:28364560

[Principle of LAMP method--a simple and rapid gene amplification method].

PubMed

Ushikubo, Hiroshi

2004-06-01

So far nucleic acid test (NAT) has been employed in various fields, including infectious disease diagnoses. However, due to its complicated procedures and relatively high cost, it has not been widely utilized in many actual diagnostic applications. We have therefore developed a simple and rapid gene amplification technology, Loop-mediated Isothermal Amplification (LAMP) method, which has shown prominent results of surpassing the performance of the conventional gene amplification methods. LAMP method acquires three main features: (1) all reaction can be carried out under isothermal conditions; (2) the amplification efficiency is extremely high and tremendous amount of amplification products can be obtained; and (3) the reaction is highly specific. Furthermore, developed from the standard LAMP method, a rapid LAMP method, by adding in the loop primers, can reduce the amplification time from the previous 1 hour to less than 30 minutes. Enormous amount of white precipitate of magnesium pyrophosphate is produced as a by-product of the amplification, therefore, direct visual detection is possible without using any reaction indicators and detection equipments. We believe LAMP technology, with the integration of these features, can rightly apply to clinical genetic testing, food and environmental analysis, as well as NAT in different fields.

A simple, one-tube assay for the simultaneous detection and diagnosis of ten Australian poultry Eimeria.

PubMed

Godwin, Rosamond M; Morgan, Jess A T

2014-02-01

Coccidiosis is a costly worldwide enteric disease of chickens caused by parasites of the genus Eimeria. At present, there are seven described species that occur globally and a further three undescribed, operational taxonomic units (OTUs X, Y, and Z) that are known to infect chickens from Australia. Species of Eimeria have both overlapping morphology and pathology and frequently occur as mixed-species infections. This makes definitive diagnosis with currently available tests difficult and, to date, there is no test for the detection of the three OTUs. This paper describes the development of a PCR-based assay that is capable of detecting all ten species of Eimeria, including OTUs X, Y, and Z in field samples. The assay is based on a single set of generic primers that amplifies a single diagnostic fragment from the mitochondrial genome of each species. This one-tube assay is simple, low-cost, and has the capacity to be high throughput. It will therefore be of great benefit to the poultry industry for Eimeria detection and control, and the confirmation of identity and purity of vaccine strains. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The Quantitative Science of Evaluating Imaging Evidence.

PubMed

Genders, Tessa S S; Ferket, Bart S; Hunink, M G Myriam

2017-03-01

Cardiovascular diagnostic imaging tests are increasingly used in everyday clinical practice, but are often imperfect, just like any other diagnostic test. The performance of a cardiovascular diagnostic imaging test is usually expressed in terms of sensitivity and specificity compared with the reference standard (gold standard) for diagnosing the disease. However, evidence-based application of a diagnostic test also requires knowledge about the pre-test probability of disease, the benefit of making a correct diagnosis, the harm caused by false-positive imaging test results, and potential adverse effects of performing the test itself. To assist in clinical decision making regarding appropriate use of cardiovascular diagnostic imaging tests, we reviewed quantitative concepts related to diagnostic performance (e.g., sensitivity, specificity, predictive values, likelihood ratios), as well as possible biases and solutions in diagnostic performance studies, Bayesian principles, and the threshold approach to decision making. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Evaluating Diagnostic Point-of-Care Tests in Resource-Limited Settings

PubMed Central

Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V

2014-01-01

Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389

[Diagnostic test scale SI5: Assessment of sacroiliac joint dysfunction].

PubMed

Acevedo González, Juan C; Quintero Oliveros, Silvia

2015-01-01

Sacroiliac joint dysfunction is a known cause of low back pain. We think that a diagnostic score scale (SI5) may be performed to assess diagnostic utility of clinical signs of sacroiliac joint dysfunction. The primary aim of the present study was to conduct the pilot study of our new diagnostic score scale, the SI5, for sacroiliac joint syndrome. We reviewed the literature on clinical characteristics, diagnostic tests and imaging most commonly used in diagnosing sacroiliac joint dysfunction. Our group evaluated the diagnostic utility of these aspects and we used those considered most representative to develop the SI5 diagnostic scale. The SI5 scale was applied to 22 patients with low back pain; afterwards, the standard test for diagnosing this pathology (selective blockage of the SI joint) was also performed on these patients. The sensitivity and specificity for each sign were also assessed and the diagnostic scale called SI5 was then proposed, based on these data. The most sensitive clinical tests for diagnosing SI joint dysfunction were 2 patient-reported clinical characteristics, the Laguerre Test, sacroiliac rocking test and Yeomans test (greater than 80% sensitivity). The tests with greatest diagnostic specificity (>80%) were the Lewitt test, Piedallu test and Gillet test. The proposed SI5 test score scale showed sensitivity of 73% and specificity of 71%. Sacroiliac joint syndrome has been shown to produce low back pain frequently; however, the diagnostic value of examination tests for sacroiliac joint pain has been questioned by other authors. The pilot study on the SI5 diagnostic score scale showed good sensitivity and specificity. However, the process of statistical validation of the SI5 needs to be continued. Copyright © 2014 Sociedad Española de Neurocirugía. Published by Elsevier España. All rights reserved.

How to Use the DX SYSTEM of Diagnostic Testing. Methodology Project.

ERIC Educational Resources Information Center

McArthur, David; Cabello, Beverly

The DX SYSTEM of Diagnostic Testing is an easy-to-use computerized system for developing and administering diagnostic tests. A diagnostic test measures a student's mastery of a specific domain (skill or content area). It examines the necessary subskills hierarchically from the most to the least complex. The DX SYSTEM features tailored testing with…

Chromatic-aberration diagnostic based on a spectrally resolved lateral-shearing interferometer

DOE PAGES

Bahk, Seung -Whan; Dorrer, Christopher; Roides, Rick G.; ...

2016-03-18

Here, a simple diagnostic characterizing one-dimensional chromatic aberrations in a broadband beam is introduced. A Ronchi grating placed in front of a spectrometer entrance slit provides spectrally coupled spatial phase information. The radial-group delay of a refractive system and the pulse-front delay of a wedged glass plate have been characterized accurately in a demonstration experiment.

Measures of accuracy and performance of diagnostic tests.

PubMed

Drobatz, Kenneth J

2009-05-01

Diagnostic tests are integral to the practice of veterinary cardiology, any other specialty, and general veterinary medicine. Developing and understanding diagnostic tests is one of the cornerstones of clinical research. This manuscript describes the diagnostic test properties including sensitivity, specificity, predictive value, likelihood ratio, receiver operating characteristic curve. Review of practical book chapters and standard statistics manuscripts. Diagnostics such as sensitivity, specificity, predictive value, likelihood ratio, and receiver operating characteristic curve are described and illustrated. Basic understanding of how diagnostic tests are developed and interpreted is essential in reviewing clinical scientific papers and understanding evidence based medicine.

Designing HIV Testing Algorithms Based on 2015 WHO Guidelines Using Data from Six Sites in Sub-Saharan Africa

PubMed Central

Kosack, Cara S.; Shanks, Leslie; Beelaert, Greet; Benson, Tumwesigye; Savane, Aboubacar; Ng'ang'a, Anne; Bita, André; Zahinda, Jean-Paul B. N.; Fransen, Katrien

2017-01-01

ABSTRACT Our objective was to evaluate the performance of HIV testing algorithms based on WHO recommendations, using data from specimens collected at six HIV testing and counseling sites in sub-Saharan Africa (Conakry, Guinea; Kitgum and Arua, Uganda; Homa Bay, Kenya; Douala, Cameroon; Baraka, Democratic Republic of Congo). A total of 2,780 samples, including 1,306 HIV-positive samples, were included in the analysis. HIV testing algorithms were designed using Determine as a first test. Second and third rapid diagnostic tests (RDTs) were selected based on site-specific performance, adhering where possible to the WHO-recommended minimum requirements of ≥99% sensitivity and specificity. The threshold for specificity was reduced to 98% or 96% if necessary. We also simulated algorithms consisting of one RDT followed by a simple confirmatory assay. The positive predictive values (PPV) of the simulated algorithms ranged from 75.8% to 100% using strategies recommended for high-prevalence settings, 98.7% to 100% using strategies recommended for low-prevalence settings, and 98.1% to 100% using a rapid test followed by a simple confirmatory assay. Although we were able to design algorithms that met the recommended PPV of ≥99% in five of six sites using the applicable high-prevalence strategy, options were often very limited due to suboptimal performance of individual RDTs and to shared falsely reactive results. These results underscore the impact of the sequence of HIV tests and of shared false-reactivity data on algorithm performance. Where it is not possible to identify tests that meet WHO-recommended specifications, the low-prevalence strategy may be more suitable. PMID:28747371

42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Code of Federal Regulations, 2014 CFR

2014-10-01

.... Nonphysician practitioners (that is, clinical nurse specialists, clinical psychologists, clinical social... that do not involve the use of contrast media; and (iii) Diagnostic mammograms if the approved portable...

What Do Diagnostic Reading Tests Really Diagnose?

ERIC Educational Resources Information Center

Winkley, Carol K.

A study was made of nine reading tests, including both group and individually-administered measures, which are claimed to be chiefly diagnostic. Instruments analyzed were the following: Silent Reading Diagnostic Tests (Bond, Balow, and Hoyt), Botel Reading Inventory, Durrell Analysis of Reading Difficulty, Gates-McKillop Reading Diagnostic Tests,…

9 CFR 93.404 - Import permits for ruminants and for ruminant test specimens for diagnostic purposes; and...

Code of Federal Regulations, 2012 CFR

2012-01-01

... ruminant test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities... for ruminants and for ruminant test specimens for diagnostic purposes; and reservation fees for space...) For ruminants and ruminant test specimens for diagnostic screening purposes intended for importation...

9 CFR 93.404 - Import permits for ruminants and for ruminant test specimens for diagnostic purposes; and...

Code of Federal Regulations, 2013 CFR

2013-01-01

... ruminant test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities... for ruminants and for ruminant test specimens for diagnostic purposes; and reservation fees for space...) For ruminants and ruminant test specimens for diagnostic screening purposes intended for importation...

9 CFR 93.404 - Import permits for ruminants and for ruminant test specimens for diagnostic purposes; and...

Code of Federal Regulations, 2014 CFR

2014-01-01

... ruminant test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities... for ruminants and for ruminant test specimens for diagnostic purposes; and reservation fees for space...) For ruminants and ruminant test specimens for diagnostic screening purposes intended for importation...

9 CFR 93.404 - Import permits for ruminants and for ruminant test specimens for diagnostic purposes; and...

Code of Federal Regulations, 2010 CFR

2010-01-01

... ruminant test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities... for ruminants and for ruminant test specimens for diagnostic purposes; and reservation fees for space...) For ruminants and ruminant test specimens for diagnostic screening purposes intended for importation...

9 CFR 93.404 - Import permits for ruminants and for ruminant test specimens for diagnostic purposes; and...

Code of Federal Regulations, 2011 CFR

2011-01-01

... ruminant test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities... for ruminants and for ruminant test specimens for diagnostic purposes; and reservation fees for space...) For ruminants and ruminant test specimens for diagnostic screening purposes intended for importation...

Uptake of prenatal diagnostic testing and the effectiveness of prenatal screening for Down syndrome.

PubMed

Jaques, Alice M; Collins, Veronica R; Muggli, Evelyne E; Amor, David J; Francis, Ivan; Sheffield, Leslie J; Halliday, Jane L

2010-06-01

To map prenatal screening and diagnostic testing pathways in Victorian pregnant women during 2003 to 2004; measure the impact of prenatal diagnostic testing uptake on the effectiveness of prenatal screening for Down syndrome; and assess factors influencing uptake of diagnostic testing following screening. State-wide data collections of prenatal screening and diagnostic tests were linked to all Victorian births and pregnancy terminations for birth defects. Overall, 52% of women had a prenatal test (65 692/126 305); screening (44.9%), diagnostic testing (3.9%), or both (3.2%). Uptake of diagnostic testing was 71.4% (2390/3349) after an increased risk screen result, and 2.5% (1381/54 286) after a low risk result. Variation in uptake of diagnostic testing reduced the effectiveness of the screening program by 11.2%: from 87.4% (sensitivity - 125/143) to 76.2% (prenatal diagnoses of Down syndrome - 109/143). In both the increased and low risk groups, uptake was influenced by absolute numerical risk, as well as by the change in numerical risk from a priori risk. This comprehensive follow-up demonstrates clearly that numerical risk is being used to aid in decision making about confirmatory diagnostic testing. Collectively, these fundamental individual decisions will impact on the overall effectiveness of screening programmes for Down syndrome.

[Myasthenia gravis in infancy. A report of 12 cases].

PubMed

Garófalo-Gómez, N; Sardiñas-Hernández, N L; Vargas-Díaz, J; Rojas-Massipe, E; Novoa-López, L

Myasthenia gravis (MG) shows specific clinical features in children. It is essential to know this and also the use of diagnostic techniques used in infancy and childhood for correct diagnosis. To analyze the clinical behaviour of this disorder and the use of complementary tests in the diagnosis of paediatric patients. We studied a group of 12 children diagnosed as having MG, who were admitted to the Instituto de Neurolog a y Neurocirug a de Ciudad de La Habana (Cuba) between March 1997 and June 2001. Data were obtained from the clinical histories regarding the clinical picture, anticholinesterase test, repetitive stimulation test (RST), simple fibre test (SFT), computerized axial tomography (CAT) of the mediastinum and the treatment given in each case. Juvenile myasthenia gravis (JMG) presented in 91% of the patients studied. The average age of onset of JMG was 7.45 years, with no difference in presentation in the two sexes. The extrinsic muscles of the eye were most affected and the form with generalized clinical involvement predominated at the time of admission. The RST was positive in four of the nine patients in whom it was done (44%) and the SFT was positive in the six cases in which it was done. No changes were found in the mediastinum on CAT scanning. Mestinon and prednisone were the most commonly used drugs. In our group JMG was the most frequent form seen. Neurophysiological studies were very useful diagnostic tools.

The role of latex agglutination test for the etiological diagnosis of pleural effusion in children and adolescents.

PubMed

Camargos, Paulo; Fonseca, Ana Cristina; Amantéa, Sérgio; Oliveira, Elizabeth; Benfica, Maria das Graças; Chamone, Chequer

2017-05-01

The etiological diagnosis of pleural effusion is a difficult task because the diagnostic tools can only establish a definitive etiological diagnosis in at most 76% of cases. To verify the diagnostic accuracy of the latex agglutination test (LAT) for the etiological diagnosis of pleural effusions caused by Streptococcus pneumoniae and Haemophilus influenzae type b. After thoracocentesis, paired fresh samples of pleural fluid from 418 children and adolescents were included in this investigation. They were tested blindly and simultaneously through counterimmunoelectrophoresis (CIE) and LAT for both bacteria. Sensitivity, specificity, predictive values and likelihood ratios (LR) were calculated taking CIE as a reference standard. The sensitivity and specificity of LAT was 100% (95% confidence interval, 94.4%-100%) and 83.3% (95% confidence interval, 79.0%-87.0%), respectively, whereas the positive (calculated from Bayes' theorem) and negative predictive values were, respectively, lower than 1% and 100% (95% confidence interval, 98.8%-100%). Positive and negative LR were 6.0 (95% confidence interval, 4.7-7.6) and zero, respectively. Our results suggest that LAT is a useful tool for the etiological diagnosis of pleural effusion. It is a reliable, rapid, simple to perform and shows an excellent yield in our studied population, helping to prescribe appropriate antibiotics for this clinical condition. © 2015 John Wiley & Sons Ltd.

Preliminary assessment of the diagnostic performances of a new rapid diagnostic test for the serodiagnosis of human cystic echinococcosis.

PubMed

Vola, Ambra; Tamarozzi, Francesca; Noordin, Rahmah; Yunus, Muhammad Hafiznur; Khanbabaie, Sam; De Silvestri, Annalisa; Brunetti, Enrico; Mariconti, Mara

2018-04-14

Rapid diagnostic tests for cystic echinococcosis (CE) are convenient to support ultrasound diagnosis in uncertain cases, especially in resource-limited settings. We found comparable diagnostic performances of the experimental Hyd Rapid Test and the commercial VIRapid HYDATIDOSIS Test, used in our diagnostic laboratory, using samples from well-characterized hepatic CE cases. Copyright © 2018 Elsevier Inc. All rights reserved.

Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: The PRISMA-DTA Statement.

PubMed

McInnes, Matthew D F; Moher, David; Thombs, Brett D; McGrath, Trevor A; Bossuyt, Patrick M; Clifford, Tammy; Cohen, Jérémie F; Deeks, Jonathan J; Gatsonis, Constantine; Hooft, Lotty; Hunt, Harriet A; Hyde, Christopher J; Korevaar, Daniël A; Leeflang, Mariska M G; Macaskill, Petra; Reitsma, Johannes B; Rodin, Rachel; Rutjes, Anne W S; Salameh, Jean-Paul; Stevens, Adrienne; Takwoingi, Yemisi; Tonelli, Marcello; Weeks, Laura; Whiting, Penny; Willis, Brian H

2018-01-23

Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy. To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews. Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group. The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted. The 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews. The PRISMA diagnostic test accuracy guideline can facilitate the transparent reporting of reviews, and may assist in the evaluation of validity and applicability, enhance replicability of reviews, and make the results from systematic reviews of diagnostic test accuracy studies more useful.

Diagnostic Accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex Scores in Predicting the Presence of Esophageal Varices in Liver Cirrhosis: A Systematic Review and Meta-Analysis.

PubMed

Deng, Han; Qi, Xingshun; Guo, Xiaozhong

2015-10-01

Aspartate aminotransferase-to-platelet ratio (APRI), aspartate aminotransferase-to-alanine aminotransferase ratio (AAR), FIB-4, FI, King, Lok, Forns, and FibroIndex scores may be simple and convenient noninvasive diagnostic tests, because they are based on the regular laboratory tests and demographic data. This study aimed to systematically evaluate their diagnostic accuracy for the prediction of varices in liver cirrhosis.All relevant papers were searched via PubMed, EMBASE, CNKI, and Wanfang databases. The area under the summary receiver operating characteristic curve (AUSROC), sensitivity, specificity, positive and negative likelihood ratio (PLR and NLR), and diagnostic odds ratio (DOR) were calculated.Overall, 12, 4, 5, 0, 0, 4, 3, and 1 paper was identified to explore the diagnostic accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex scores, respectively. The AUSROCs of APRI, AAR, FIB-4, Lok, and Forns scores for the prediction of varices were 0.6774, 0.7275, 0.7755, 0.7885, and 0.7517, respectively; and those for the prediction of large varices were 0.7278, 0.7448, 0.7095, 0.7264, and 0.6530, respectively. The diagnostic threshold effects of FIB-4 and Forns scores for the prediction of varices were statistically significant. The sensitivities/specificities/PLRs/NLRs/DORs of APRI, AAR, and Lok scores for the prediction of varices were 0.60/0.67/1.77/0.58/3.13, 0.64/0.63/1.97/0.54/4.18, and 0.74/0.68/2.34/0.40/5.76, respectively. The sensitivities/specificities/PLRs/NLRs/DORs of APRI, AAR, FIB-4, Lok, and Forns scores for the prediction of large varices were 0.65/0.66/2.15/0.47/4.97, 0.68/0.58/2.07/0.54/3.93, 0.62/0.64/2.02/0.56/3.57, 0.78/0.63/2.09/0.37/5.55, and 0.65/0.61/1.62/0.59/2.75, respectively.APRI, AAR, FIB-4, Lok, and Forns scores had low to moderate diagnostic accuracy in predicting the presence of varices in liver cirrhosis.

Identifying Students' Mathematical Skills from a Multiple-Choice Diagnostic Test Using an Iterative Technique to Minimise False Positives

ERIC Educational Resources Information Center

Manning, S.; Dix, A.

2008-01-01

There is anecdotal evidence that a significant number of students studying computing related courses at degree level have difficulty with sub-GCE mathematics. Testing of students' skills is often performed using diagnostic tests and a number of computer-based diagnostic tests exist, which work, essentially, by testing one specific diagnostic skill…

Agreement Analysis: What He Said, She Said Versus You Said.

PubMed

Vetter, Thomas R; Schober, Patrick

2018-06-01

Correlation and agreement are 2 concepts that are widely applied in the medical literature and clinical practice to assess for the presence and strength of an association. However, because correlation and agreement are conceptually distinct, they require the use of different statistics. Agreement is a concept that is closely related to but fundamentally different from and often confused with correlation. The idea of agreement refers to the notion of reproducibility of clinical evaluations or biomedical measurements. The intraclass correlation coefficient is a commonly applied measure of agreement for continuous data. The intraclass correlation coefficient can be validly applied specifically to assess intrarater reliability and interrater reliability. As its name implies, the Lin concordance correlation coefficient is another measure of agreement or concordance. In undertaking a comparison of a new measurement technique with an established one, it is necessary to determine whether they agree sufficiently for the new to replace the old. Bland and Altman demonstrated that using a correlation coefficient is not appropriate for assessing the interchangeability of 2 such measurement methods. They in turn described an alternative approach, the since widely applied graphical Bland-Altman Plot, which is based on a simple estimation of the mean and standard deviation of differences between measurements by the 2 methods. In reading a medical journal article that includes the interpretation of diagnostic tests and application of diagnostic criteria, attention is conventionally focused on aspects like sensitivity, specificity, predictive values, and likelihood ratios. However, if the clinicians who interpret the test cannot agree on its interpretation and resulting typically dichotomous or binary diagnosis, the test results will be of little practical use. Such agreement between observers (interobserver agreement) about a dichotomous or binary variable is often reported as the kappa statistic. Assessing the interrater agreement between observers, in the case of ordinal variables and data, also has important biomedical applicability. Typically, this situation calls for use of the Cohen weighted kappa. Questionnaires, psychometric scales, and diagnostic tests are widespread and increasingly used by not only researchers but also clinicians in their daily practice. It is essential that these questionnaires, scales, and diagnostic tests have a high degree of agreement between observers. It is therefore vital that biomedical researchers and clinicians apply the appropriate statistical measures of agreement to assess the reproducibility and quality of these measurement instruments and decision-making processes.

Knee osteoarthritis, degenerative meniscal lesion and osteonecrosis of the knee: Can a simple gait test direct us to a better clinical diagnosis.

PubMed

Debi, R; Elbaz, A; Mor, A; Kahn, G; Peskin, B; Beer, Y; Agar, G; Morag, G; Segal, G

2017-06-01

The purpose of the current study was to compare the gait patterns in patients with three differing knee pathologies - knee osteoarthritis (OA), degenerative meniscal lesion (DML) and spontaneous osteonecrosis of the knee (SONK) and a group of healthy controls. A simple gait test will detect differences between different knee pathologies. Forty-seven patients with bilateral knee OA, 47 patients with DML, 28 patients with SONK and 27 healthy controls were included in this analysis. Patients underwent a spatiotemporal gait assessment and were asked to complete the Western Ontario and McMaster University (WOMAC) Index and the Short-Form (SF)-36 Health Survey. ANOVA tests, followed by Bonferroni multiple comparison tests and the Chi 2 tests were performed for continuous and categorical variables, respectively. Significant differences were found for all gait measures and clinical questionnaires between healthy controls and all knee conditions. Patients with SONK differed from patients with bilateral knee OA and DML in all gait measures and clinical questionnaires, except for WOMAC subscales. There were no significant differences between patients with bilateral knee OA and patients with DML. Symmetry was also examined and revealed asymmetry in some gait parameters in patients with SONK and DML. Based on the differences in gait parameters that were found in the current study, adding an objective functional spatiotemporal gait test may assist in the diagnostic process of knee pathologies. Case Control study Level III. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Urinary biomarkers for the non-invasive diagnosis of endometriosis.

PubMed

Liu, Emily; Nisenblat, Vicki; Farquhar, Cindy; Fraser, Ian; Bossuyt, Patrick M M; Johnson, Neil; Hull, M Louise

2015-12-23

About 10% of reproductive-aged women suffer from endometriosis which is a costly chronic disease that causes pelvic pain and subfertility. Laparoscopy is the 'gold standard' diagnostic test for endometriosis, but it is expensive and carries surgical risks. Currently, there are no simple non-invasive or minimally-invasive tests available in clinical practice that accurately diagnoses endometriosis. 1. To provide summary estimates of the diagnostic accuracy of urinary biomarkers for the diagnosis of pelvic endometriosis compared to surgical diagnosis as a reference standard.2. To assess the diagnostic utility of biomarkers that could differentiate ovarian endometrioma from other ovarian masses.Urinary biomarkers were evaluated as replacement tests for surgical diagnosis and as triage tests to inform decisions to undertake surgery for endometriosis. The searches were not restricted to particular study design, language or publication dates. We searched the following databases to 20 April - 31 July 2015: CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP and ClinicalTrials.gov (trial register). MEDION, DARE, and PubMed were also searched to identify reviews and guidelines as reference sources of potentially relevant studies. Recently published papers not yet indexed in the major databases were also sought. The search strategy incorporated words in the title, abstract, text words across the record and the medical subject headings (MeSH) and was modified for each database. Published peer-reviewed, randomised controlled or cross-sectional studies of any size were considered, which included prospectively collected samples from any population of reproductive-aged women suspected of having one or more of the following target conditions: ovarian, peritoneal or deep infiltrating endometriosis (DIE). We included studies comparing the diagnostic test accuracy of one or more urinary biomarkers with surgical visualisation of endometriotic lesions. Two authors independently collected and performed a quality assessment of the data from each study. For each diagnostic test, the data were classified as positive or negative for the surgical detection of endometriosis and sensitivity and specificity estimates were calculated. If two or more tests were evaluated in the same cohort, each was considered as a separate data set. The bivariate model was used to obtain pooled estimates of sensitivity and specificity whenever sufficient data sets were available. The predetermined criteria for a clinically useful urine test to replace diagnostic surgery was one with a sensitivity of 94% and a specificity of 79% to detect endometriosis. The criteria for triage tests were set at sensitivity of equal or greater than 95% and specificity of equal or greater than 50%, which in case of negative result rules out the diagnosis (SnOUT test) or sensitivity of equal or greater than 50% with specificity of equal or greater than 95%, which in case of positive result rules the diagnosis in (SpIN test). We included eight studies involving 646 participants, most of which were of poor methodological quality. The urinary biomarkers were evaluated either in a specific phase of menstrual cycle or irrespective of the cycle phase. Five studies evaluated the diagnostic performance of four urinary biomarkers for endometriosis, including three biomarkers distinguishing women with and without endometriosis (enolase 1 (NNE); vitamin D binding protein (VDBP); and urinary peptide profiling); and one biomarker (cytokeratin 19 (CK 19)) showing no significant difference between the two groups. All of these biomarkers were assessed in small individual studies and could not be statistically evaluated in a meaningful way. None of the biomarkers met the criteria for a replacement test or a triage test. Three studies evaluated three biomarkers that did not differentiate women with endometriosis from disease-free controls. There was insufficient evidence to recommend any urinary biomarker for use as a replacement or triage test in clinical practice for the diagnosis of endometriosis. Several urinary biomarkers may have diagnostic potential, but require further evaluation before being introduced into routine clinical practice. Laparoscopy remains the gold standard for the diagnosis of endometriosis, and diagnosis of endometriosis using urinary biomarkers should only be undertaken in a research setting.

42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...

42 CFR 414.506 - Procedures for public consultation for payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2011 CFR

2011-10-01

... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...

Understanding the properties of diagnostic tests - Part 2: Likelihood ratios.

PubMed

Ranganathan, Priya; Aggarwal, Rakesh

2018-01-01

Diagnostic tests are used to identify subjects with and without disease. In a previous article in this series, we examined some attributes of diagnostic tests - sensitivity, specificity, and predictive values. In this second article, we look at likelihood ratios, which are useful for the interpretation of diagnostic test results in everyday clinical practice.

Do patients' disruptive behaviours influence the accuracy of a doctor's diagnosis? A randomised experiment.

PubMed

Schmidt, H G; Van Gog, Tamara; Schuit, Stephanie Ce; Van den Berge, Kees; Van Daele, Paul L; Bueving, Herman; Van der Zee, Tim; Van den Broek, Walter W; Van Saase, Jan L; Mamede, Sílvia

2017-01-01

Literature suggests that patients who display disruptive behaviours in the consulting room fuel negative emotions in doctors. These emotions, in turn, are said to cause diagnostic errors. Evidence substantiating this claim is however lacking. The purpose of the present experiment was to study the effect of such difficult patients' behaviours on doctors' diagnostic performance. We created six vignettes in which patients were depicted as difficult (displaying distressing behaviours) or neutral. Three clinical cases were deemed to be diagnostically simple and three deemed diagnostically complex. Sixty-three family practice residents were asked to evaluate the vignettes and make the patient's diagnosis quickly and then through deliberate reflection. In addition, amount of time needed to arrive at a diagnosis was measured. Finally, the participants rated the patient's likability. Mean diagnostic accuracy scores (range 0-1) were significantly lower for difficult than for neutral patients (0.54 vs 0.64; p=0.017). Overall diagnostic accuracy was higher for simple than for complex cases. Deliberate reflection upon the case improved initial diagnostic, regardless of case complexity and of patient behaviours (0.60 vs 0.68, p=0.002). Amount of time needed to diagnose the case was similar regardless of the patient's behaviour. Finally, average likability ratings were lower for difficult than for neutral-patient cases. Disruptive behaviours displayed by patients seem to induce doctors to make diagnostic errors. Interestingly, the confrontation with difficult patients does however not cause the doctor to spend less time on such case. Time can therefore not be considered an intermediary between the way the patient is perceived, his or her likability and diagnostic performance. 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/.

Epidemiology and diagnostic and therapeutic management of febrile seizures in the Italian pediatric emergency departments: A prospective observational study.

PubMed

Vitaliti, Giovanna; Castagno, Emanuele; Ricceri, Fulvio; Urbino, Antonio; Di Pianella, Alberto Verrotti; Lubrano, Riccardo; Caramaschi, Elisa; Prota, Maurizio; Pulvirenti, Rita Maria; Ajovalasit, Patrizia; Signorile, Giuseppe; Navone, Carla; La Bianca, Maria Rosaria; Villani, Alberto; Corsello, Giovanni; Falsaperla, Raffaele

2017-01-01

Febrile seizures (FS) involve 2-5% of the paediatric population, among which Complex FS (CFS) account for one third of accesses for FS in Emergency Departments (EDs). The aim of our study was to define the epidemiology, the clinical, diagnostic and therapeutic approach to FS and CFSs in the Italian EDs. A multicenter prospective observational study was performed between April 2014 and March 2015. Patients between 1 and 60 months of age, randomly accessing to ED for ongoing FS or reported FS at home were included. Demographic features and diagnostic-therapeutic follow-up were recorded. FS were categorized in simple (<10min), prolonged (10-30min) and status epilepticus (>30min). The study population consisted of 268 children. Most of the children experienced simple FS (71.65%). Among the 68 (25.37%) patients with complex FS, 11 were 6-12 month-old, accounting for 45.83% of all the infants with FS in the younger age group. No therapy has been administered at home in 76.12% patients; 23.51% of them received endorectal diazepam and only 1 patient received buccal midazolam. At arrival at ED, no therapy was necessary for 70.52% patients; 50.63% received endorectal diazepam and 17.72% an i.v. bolus of midazolam. Blood tests and acid-base balanced were performed respectively in 82.09% of cases. An electroencephalogram at ED was performed in 21.64% of patients. Neuroimagings were done in 3.73% of cases. A neurologic consultation was asked for 36 patients (13.43%). this is the first study assessing epidemiologic characteristics of FS in the Italian pediatric population, evidencing a higher prevalence of CFSs in children younger than 12 months of age and opening a new research scenario on the blood brain barrier vulnerability. On a national level, our study showed the need for a diagnostic standardized work-up to improve the cost/benefit ratio on CFS management. Copyright © 2016 Elsevier B.V. All rights reserved.

Investigation of the Applicability of a Rapid Diagnosis Test in the Diagnosis of Cystic Echinococcosis.

PubMed

Ertuğ, Sema; Çalışkan, Serçin Özlem; Malatyalı, Erdoğan; Ertabaklar, Hatice

2018-05-21

Echinococcus granulosus, the etiological agent of cystic echinococcosis (CE) in humans and livestock, is a widely distributed zoonotic pathogen tapeworm. The infection is transmitted to humans by the ingestion of E. granulosus eggs released in the feces of definitive hosts such as dogs. The larval stage of the parasite develops a slowly enlarging cyst in the visceral organs, particularly in the liver and/or lung. The aim of the present study was to evaluate the diagnostic value of an immunochromatographic test (ICT) for CE. A total of 50 sera from surgically and/or pathologically confirmed patients with CE were included in the study as the study group; the control group comprised patients who tested negative for enzyme-linked immunosorbent assay (ELISA). Sera were selected from the collection at Adnan Menderes University, Faculty of Medicine, Parasitology Laboratory, by simple random sampling. The collection included sera obtained between 2010 and 2014; antibody titers of each serum sample were determined using in-house ELISA, before storage at -20°C. The presence of E. granulosus antibody in the sera was determined using a commercially available ICT (VIRAPID® HYDATIDOSIS) kit method. In the study group (E. granulosus-confirmed cases), two (4%) of the 50 sera were negative and 48 (96%) were positive with ICT. In the control group (ELISA-negative), all were negative with ICT. The rapid diagnostic test has been evaluated as a practical, easy-to-use method for detecting CE, and it can be used as a screening test in routine diagnosis and research.

Serological diagnosis of brucellosis.

PubMed

Nielsen, K; Yu, W L

2010-01-01

To present a review and to describe the most widely used laboratory tests for serology diagnosis of brucellosis along with their pros and cons. Review the recent literature on brucellosis serology diagnostic tests. The choice of the testing strategy depends on the prevailing brucellosis epidemiological situation and the goal of testing. The 'gold standard' for the diagnosis of brucellosis is isolation and identification of the causative bacterium, a member of Brucella sp. Isolation of Brucella sp. requires high security laboratory facilities (biological containment level 3), highly skilled personnel, an extended turnaround time for results and it is considered a hazardous procedure. Hence brucellosis is generally diagnosed by detection of an elevated level of antibody in serum or other body fluid. This is a presumptive diagnosis as other microorganisms and perhaps environmental factors can also cause increased antibody levels. A large number of serological tests for brucellosis have been devised over the 100+ years since its initial isolation, starting with a simple agglutination test and progressing to sophisticated primary binding assays available today. However, no test devised to date is 100% accurate so generally serological diagnosis consists of testing sera by several tests, usually a screening test of high sensitivity, followed by a confirmatory test of high specificity.

Diagnostic performance of T lymphocyte subpopulations in assessment of liver fibrosis stages in hepatitis C virus patients: simple noninvasive score.

PubMed

Toson, El-Shatat A; Shiha, Gamal E; El-Mezayen, Hatem A; El-Sharkawy, Aml M

2016-08-01

Evaluation of liver fibrosis in patients infected with hepatitis C virus is highly useful for the diagnosis of the disease as well as therapeutic decision. Our aim was to develop and validate a simple noninvasive score for liver fibrosis staging in chronic hepatitis C (CHC) patients and compare its performance against three published simple noninvasive indexes. CHC patients were divided into two groups: an estimated group (n=70) and a validated group (n=52). Liver fibrosis was tested in biopsies using the Metavair score system. CD4 and CD8 count/percentage were assayed by fluorescence-activated cell sorting analysis. The multivariate discriminant analysis selects a function on the basis of absolute values of five biochemical markers: immune fibrosis index (IFI); score=3.07+3.06×CD4/CD8+0.02×α-fetoprotein (U/l)-0.07×alanine aminotransferase ratio-0.005×platelet count (10/l)-1.4×albumin (g/dl). The IFI score produced areas under curve of 0.949, 0.947, and 0.806 for differentiation of all patient categories [significant fibrosis (F2-F4), advanced fibrosis (F3-F4), and cirrhosis (F4)]. The IFI score, a novel noninvasive test, can be used easily for the prediction of liver fibrosis stage in CHC patients. Our score was more efficient than aspartate aminotransferase to platelet ratio index, fibrosis index, and fibroQ and more suitable for use in Egyptian hepatitis C virus patients.

A Versatile PDMS/Paper Hybrid Microfluidic Platform for Sensitive Infectious Disease Diagnosis

PubMed Central

2015-01-01

Bacterial meningitis is a serious health concern worldwide. Given that meningitis can be fatal and many meningitis cases occurred in high-poverty areas, a simple, low-cost, highly sensitive method is in great need for immediate and early diagnosis of meningitis. Herein, we report a versatile and cost-effective polydimethylsiloxane (PDMS)/paper hybrid microfluidic device integrated with loop-mediated isothermal amplification (LAMP) for the rapid, sensitive, and instrument-free detection of the main meningitis-causing bacteria, Neisseria meningitidis (N. meningitidis). The introduction of paper into the microfluidic device for LAMP reactions enables stable test results over a much longer period of time than a paper-free microfluidic system. This hybrid system also offers versatile functions, by providing not only on-site qualitative diagnostic analysis (i.e., a yes or no answer), but also confirmatory testing and quantitative analysis in laboratory settings. The limit of detection of N. meningitidis is about 3 copies per LAMP zone within 45 min, close to single-bacterium detection sensitivity. In addition, we have achieved simple pathogenic microorganism detection without a laborious sample preparation process and without the use of centrifuges. This low-cost hybrid microfluidic system provides a simple and highly sensitive approach for fast instrument-free diagnosis of N. meningitidis in resource-limited settings. This versatile PDMS/paper microfluidic platform has great potential for the point of care (POC) diagnosis of a wide range of infectious diseases, especially for developing nations. PMID:25019330

Comparing diagnostic tests on benefit-risk.

PubMed

Pennello, Gene; Pantoja-Galicia, Norberto; Evans, Scott

2016-01-01

Comparing diagnostic tests on accuracy alone can be inconclusive. For example, a test may have better sensitivity than another test yet worse specificity. Comparing tests on benefit risk may be more conclusive because clinical consequences of diagnostic error are considered. For benefit-risk evaluation, we propose diagnostic yield, the expected distribution of subjects with true positive, false positive, true negative, and false negative test results in a hypothetical population. We construct a table of diagnostic yield that includes the number of false positive subjects experiencing adverse consequences from unnecessary work-up. We then develop a decision theory for evaluating tests. The theory provides additional interpretation to quantities in the diagnostic yield table. It also indicates that the expected utility of a test relative to a perfect test is a weighted accuracy measure, the average of sensitivity and specificity weighted for prevalence and relative importance of false positive and false negative testing errors, also interpretable as the cost-benefit ratio of treating non-diseased and diseased subjects. We propose plots of diagnostic yield, weighted accuracy, and relative net benefit of tests as functions of prevalence or cost-benefit ratio. Concepts are illustrated with hypothetical screening tests for colorectal cancer with test positive subjects being referred to colonoscopy.

Modeling sound transmission and reflection in the pulmonary system and chest with application to diagnosis of a collapsed lung

NASA Astrophysics Data System (ADS)

Royston, Thomas J.; Zhang, Xiangling; Mansy, Hussein A.; Sandler, Richard H.

2002-05-01

Experimental studies have shown that a pneumothorax (collapsed lung) substantially alters the propagation of sound introduced at the mouth of an intubated subject and measured at the chest surface. Thus, it is hypothesized that an inexpensive diagnostic procedure could be developed for detection of a pneumothorax based on a simple acoustic test. In the present study, theoretical models of sound transmission through the pulmonary system and chest region are reviewed in the context of their ability to predict acoustic changes caused by a pneumothorax, as well as other pathologic conditions. Such models could aid in parametric design studies to develop acoustic means of diagnosing pneumothorax and other lung pathologies. Extensions of previously developed simple models of the authors are presented that are in more quantitative agreement with experimental results and that simulate both transmission from the bronchial airways to the chest wall, as well as reflection in the bronchial airways. [Research supported by NIH NCRR Grant No. 14250 and NIH NHLBI Grant No. 61108.

A low cost, safe, disposable, rapid and self-sustainable paper-based platform for diagnostic testing: lab-on-paper.

PubMed

Costa, M N; Veigas, B; Jacob, J M; Santos, D S; Gomes, J; Baptista, P V; Martins, R; Inácio, J; Fortunato, E

2014-03-07

There is a strong interest in the use of biopolymers in the electronic and biomedical industries, mainly towards low-cost applications. The possibility of developing entirely new kinds of products based on cellulose is of current interest, in order to enhance and to add new functionalities to conventional paper-based products. We present our results towards the development of paper-based microfluidics for molecular diagnostic testing. Paper properties were evaluated and compared to nitrocellulose, the most commonly used material in lateral flow and other rapid tests. Focusing on the use of paper as a substrate for microfluidic applications, through an eco-friendly wax-printing technology, we present three main and distinct colorimetric approaches: (i) enzymatic reactions (glucose detection); (ii) immunoassays (antibodies anti-Leishmania detection); (iii) nucleic acid sequence identification (Mycobacterium tuberculosis complex detection). Colorimetric glucose quantification was achieved through enzymatic reactions performed within specific zones of the paper-based device. The colouration achieved increased with growing glucose concentration and was highly homogeneous, covering all the surface of the paper reaction zones in a 3D sensor format. These devices showed a major advantage when compared to the 2D lateral flow glucose sensors, where some carryover of the coloured products usually occurs. The detection of anti-Leishmania antibodies in canine sera was conceptually achieved using a paper-based 96-well enzyme-linked immunosorbent assay format. However, optimization is still needed for this test, regarding the efficiency of the immobilization of antigens on the cellulose fibres. The detection of Mycobacterium tuberculosis nucleic acids integrated with a non-cross-linking gold nanoprobe detection scheme was also achieved in a wax-printed 384-well paper-based microplate, by the hybridization with a species-specific probe. The obtained results with the above-mentioned proof-of-concept sensors are thus promising towards the future development of simple and cost-effective paper-based diagnostic devices.

A low cost, safe, disposable, rapid and self-sustainable paper-based platform for diagnostic testing: lab-on-paper

NASA Astrophysics Data System (ADS)

Costa, M. N.; Veigas, B.; Jacob, J. M.; Santos, D. S.; Gomes, J.; Baptista, P. V.; Martins, R.; Inácio, J.; Fortunato, E.

2014-03-01

There is a strong interest in the use of biopolymers in the electronic and biomedical industries, mainly towards low-cost applications. The possibility of developing entirely new kinds of products based on cellulose is of current interest, in order to enhance and to add new functionalities to conventional paper-based products. We present our results towards the development of paper-based microfluidics for molecular diagnostic testing. Paper properties were evaluated and compared to nitrocellulose, the most commonly used material in lateral flow and other rapid tests. Focusing on the use of paper as a substrate for microfluidic applications, through an eco-friendly wax-printing technology, we present three main and distinct colorimetric approaches: (i) enzymatic reactions (glucose detection); (ii) immunoassays (antibodies anti-Leishmania detection); (iii) nucleic acid sequence identification (Mycobacterium tuberculosis complex detection). Colorimetric glucose quantification was achieved through enzymatic reactions performed within specific zones of the paper-based device. The colouration achieved increased with growing glucose concentration and was highly homogeneous, covering all the surface of the paper reaction zones in a 3D sensor format. These devices showed a major advantage when compared to the 2D lateral flow glucose sensors, where some carryover of the coloured products usually occurs. The detection of anti-Leishmania antibodies in canine sera was conceptually achieved using a paper-based 96-well enzyme-linked immunosorbent assay format. However, optimization is still needed for this test, regarding the efficiency of the immobilization of antigens on the cellulose fibres. The detection of Mycobacterium tuberculosis nucleic acids integrated with a non-cross-linking gold nanoprobe detection scheme was also achieved in a wax-printed 384-well paper-based microplate, by the hybridization with a species-specific probe. The obtained results with the above-mentioned proof-of-concept sensors are thus promising towards the future development of simple and cost-effective paper-based diagnostic devices.

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.

The 2016 Academic Emergency Medicine Consensus Conference, "Shared Decision Making in the Emergency Department: Development of a Policy-relevant Patient-centered Research Agenda" Diagnostic Testing Breakout Session Report.

PubMed

Barrett, Tyler W; Rising, Kristin L; Bellolio, M Fernanda; Hall, M Kennedy; Brody, Aaron; Dodd, Kenneth W; Grieser, Mira; Levy, Phillip D; Raja, Ali S; Self, Wesley H; Weingarten, Gail; Hess, Erik P; Hollander, Judd E

2016-12-01

Diagnostic testing is an integral component of patient evaluation in the emergency department (ED). Emergency clinicians frequently use diagnostic testing to more confidently exclude "worst-case" diagnoses rather than to determine the most likely etiology for a presenting complaint. Increased utilization of diagnostic testing has not been associated with reductions in disease-related mortality but has led to increased overall healthcare costs and other unintended consequences (e.g., incidental findings requiring further workup, unnecessary exposure to ionizing radiation or potentially nephrotoxic contrast). Shared decision making (SDM) presents an opportunity for clinicians to discuss the benefits and harms associated with diagnostic testing with patients to more closely tailor testing to patient risk. This article introduces the challenges and opportunities associated with incorporating SDM into emergency care by summarizing the conclusions of the diagnostic testing group at the 2016 Academic Emergency Medicine Consensus Conference on SDM. Three primary domains emerged: 1) characteristics of a condition or test appropriate for SDM, 2) critical elements of and potential barriers to SDM discussions on diagnostic testing, and 3) financial aspects of SDM applied to diagnostic testing. The most critical research questions to improve engagement of patients in their acute care diagnostic decisions were determined by consensus. © 2016 by the Society for Academic Emergency Medicine.

20 CFR 416.919m - Diagnostic tests or procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Diagnostic tests or procedures. 416.919m... for Report Content § 416.919m Diagnostic tests or procedures. We will request the results of any diagnostic tests or procedures that have been performed as part of a workup by your treating source or other...

Guanidinoacetate methyltransferase (GAMT) deficiency: a rare but treatable epilepsy.

PubMed

Stern, William M; Winston, Joel S; Murphy, Elaine; Cross, J Helen; Sander, Josemir W

2017-06-01

Epilepsy commonly presents in childhood as part of a syndrome, and some such children may reach adult services without an underlying syndromic diagnosis. For adult neurologists taking over their care, it is often unclear how hard to search for an underlying diagnosis. The diagnostic yield may be small and such a diagnosis may not change management. Young adults with learning difficulties are also challenging to investigate, as they may not tolerate standard epilepsy tests.We present such a case in which simple tests identified a unifying diagnosis. With the new diagnosis came a new treatment that had a significant impact on seizures and quality of life. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Diagnostics and Active Control of Aircraft Interior Noise

NASA Technical Reports Server (NTRS)

Fuller, C. R.

1998-01-01

This project deals with developing advanced methods for investigating and controlling interior noise in aircraft. The work concentrates on developing and applying the techniques of Near Field Acoustic Holography (NAH) and Principal Component Analysis (PCA) to the aircraft interior noise dynamic problem. This involves investigating the current state of the art, developing new techniques and then applying them to the particular problem being studied. The knowledge gained under the first part of the project was then used to develop and apply new, advanced noise control techniques for reducing interior noise. A new fully active control approach based on the PCA was developed and implemented on a test cylinder. Finally an active-passive approach based on tunable vibration absorbers was to be developed and analytically applied to a range of test structures from simple plates to aircraft fuselages.

Versatile electrophoresis-based self-test platform.

PubMed

Guijt, Rosanne M

2015-03-01

Lab on a Chip technology offers the possibility to extract chemical information from a complex sample in a simple, automated way without the need for a laboratory setting. In the health care sector, this chemical information could be used as a diagnostic tool for example to inform dosing. In this issue, the research underpinning a family of electrophoresis-based point-of-care devices for self-testing of ionic analytes in various sample matrices is described [Electrophoresis 2015, 36, 712-721.]. Hardware, software, and methodological chances made to improve the overall analytical performance in terms of accuracy, precision, detection limit, and reliability are discussed. In addition to the main focus of lithium monitoring, new applications including the use of the platform for veterinary purposes, sodium, and for creatinine measurements are included. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Adaptive Noise Suppression of Pediatric Lung Auscultations With Real Applications to Noisy Clinical Settings in Developing Countries

PubMed Central

Emmanouilidou, Dimitra; McCollum, Eric D.; Park, Daniel E.

2015-01-01

Goal Chest auscultation constitutes a portable low-cost tool widely used for respiratory disease detection. Though it offers a powerful means of pulmonary examination, it remains riddled with a number of issues that limit its diagnostic capability. Particularly, patient agitation (especially in children), background chatter, and other environmental noises often contaminate the auscultation, hence affecting the clarity of the lung sound itself. This paper proposes an automated multiband denoising scheme for improving the quality of auscultation signals against heavy background contaminations. Methods The algorithm works on a simple two-microphone setup, dynamically adapts to the background noise and suppresses contaminations while successfully preserving the lung sound content. The proposed scheme is refined to offset maximal noise suppression against maintaining the integrity of the lung signal, particularly its unknown adventitious components that provide the most informative diagnostic value during lung pathology. Results The algorithm is applied to digital recordings obtained in the field in a busy clinic in West Africa and evaluated using objective signal fidelity measures and perceptual listening tests performed by a panel of licensed physicians. A strong preference of the enhanced sounds is revealed. Significance The strengths and benefits of the proposed method lie in the simple automated setup and its adaptive nature, both fundamental conditions for everyday clinical applicability. It can be simply extended to a real-time implementation, and integrated with lung sound acquisition protocols. PMID:25879837

First overpower tests of metallic IFR [Integral Fast Reactor] fuel in TREAT [Transient Reactor Test Facility]: Data and analysis from tests M5, M6, and M7

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

Bauer, T. H.; Robinson, W. R.; Holland, J. W.

1989-12-01

Results and analyses of margin to cladding failure and pre-failure axial expansion of metallic fuel are reported for TREAT in-pile transient overpower tests M5--M7. These are the first such tests on reference binary and ternary alloy fuel of the Integral Fast Reactor (IFR) concept with burnup ranging from 1 to 10 at. %. In all cases, test fuel was subjected to an exponential power rise on an 8 s period until either incipient or actual cladding failure was achieved. Objectives, designs and methods are described with emphasis on developments unique to metal fuel safety testing. The resulting database for claddingmore » failure threshold and prefailure fuel expansion is presented. The nature of the observed cladding failure and resultant fuel dispersals is described. Simple models of cladding failures and pre-failure axial expansions are described and compared with experimental results. Reported results include: temperature, flow, and pressure data from test instrumentation; fuel motion diagnostic data principally from the fast neutron hodoscope; and test remains described from both destructive and non-destructive post-test examination. 24 refs., 144 figs., 17 tabs.« less

Development of diagnostic test instruments to reveal level student conception in kinematic and dynamics

NASA Astrophysics Data System (ADS)

Handhika, J.; Cari, C.; Suparmi, A.; Sunarno, W.; Purwandari, P.

2018-03-01

The purpose of this research was to develop a diagnostic test instrument to reveal students' conceptions in kinematics and dynamics. The diagnostic test was developed based on the content indicator the concept of (1) displacement and distance, (2) instantaneous and average velocity, (3) zero and constant acceleration, (4) gravitational acceleration (5) Newton's first Law, (6) and Newton's third Law. The diagnostic test development model includes: Diagnostic test requirement analysis, formulating test-making objectives, developing tests, checking the validity of the content and the performance of reliability, and application of tests. The Content Validation Index (CVI) results in the category are highly relevant, with a value of 0.85. Three questions get negative Content Validation Ratio CVR) (-0.6), after revised distractors and clarify visual presentation; the CVR become 1 (highly relevant). This test was applied, obtained 16 valid test items, with Cronbach Alpha value of 0.80. It can conclude that diagnostic test can be used to reveal the level of students conception in kinematics and dynamics.

Protocol for HER2 FISH Using a Non-cross-linking, Formalin-free Tissue Fixative to Combine Advantages of Cryo-preservation and Formalin Fixation

PubMed Central

Loibner, Martina; Oberauner-Wappis, Lisa; Viertler, Christian; Groelz, Daniel; Zatloukal, Kurt

2017-01-01

Morphologic assessment of formalin-fixed, paraffin-embedded (FFPE) tissue samples has been the gold standard for cancer diagnostics for decades due to its excellent preservation of morphology. Personalized medicine increasingly provides individually adapted and targeted therapies for characterized individual diseases enabled by combined morphological and molecular analytical technologies and diagnostics. Performance of morphologic and molecular assays from the same FFPE specimen is challenging because of the negative impact of formalin due to chemical modification and cross-linking of nucleic acids and proteins. A non-cross-linking, formalin-free tissue fixative has been recently developed to fulfil both requirements, i.e., to preserve morphology like FFPE and biomolecules like cryo-preservation. Since FISH is often required in combination with histopathology and molecular diagnostics, we tested the applicability of FISH protocols on tissues treated with this new fixative. We found that formalin post-fixation of histological sections of non-cross-linking, formalin-free and paraffin-embedded (NCFPE) breast cancer tissue generated equivalent results to those with FFPE tissue in human epidermal growth factor receptor 2 (HER2) FISH analysis. This protocol describes how a FISH assay originally developed and validated for FFPE tissue can be used for NCFPE tissues by a simple post-fixation step of histological sections. PMID:29364207

Novel calibration tools and validation concepts for microarray-based platforms used in molecular diagnostics and food safety control.

PubMed

Brunner, C; Hoffmann, K; Thiele, T; Schedler, U; Jehle, H; Resch-Genger, U

2015-04-01

Commercial platforms consisting of ready-to-use microarrays printed with target-specific DNA probes, a microarray scanner, and software for data analysis are available for different applications in medical diagnostics and food analysis, detecting, e.g., viral and bacteriological DNA sequences. The transfer of these tools from basic research to routine analysis, their broad acceptance in regulated areas, and their use in medical practice requires suitable calibration tools for regular control of instrument performance in addition to internal assay controls. Here, we present the development of a novel assay-adapted calibration slide for a commercialized DNA-based assay platform, consisting of precisely arranged fluorescent areas of various intensities obtained by incorporating different concentrations of a "green" dye and a "red" dye in a polymer matrix. These dyes present "Cy3" and "Cy5" analogues with improved photostability, chosen based upon their spectroscopic properties closely matching those of common labels for the green and red channel of microarray scanners. This simple tool allows to efficiently and regularly assess and control the performance of the microarray scanner provided with the biochip platform and to compare different scanners. It will be eventually used as fluorescence intensity scale for referencing of assays results and to enhance the overall comparability of diagnostic tests.

Bacteriophage-fused peptides for serodiagnosis of human strongyloidiasis.

PubMed

Feliciano, Nágilla Daliane; Ribeiro, Vanessa da Silva; Santos, Fabiana de Almeida Araújo; Fujimura, Patricia Tiemi; Gonzaga, Henrique Tomaz; Goulart, Luiz Ricardo; Costa-Cruz, Julia Maria

2014-01-01

Strongyloidiasis, a human intestinal infection caused by the nematode Strongyloides stercoralis, is frequently underdiagnosed and although its high prevalence is still a neglected parasitic disease because conventional diagnostic tests based on parasitological examination (presence of Strongyloides larvae in stool) are not sufficiently sensitive due to the low parasitic load and to the irregular larval output. There is an urgent need to improve diagnostic assays, especially for immunocompromised patients with high parasitic load as consequence of self-infection cycle, which can disseminate throughout the body, resulting in a potentially fatal hyperinfection syndrome often accompanied by sepsis or meningitis. We have performed Phage Display technology to select peptides that mimic S. stercoralis antigens, capable of detecting a humoral response in patients with strongyloidiasis. The peptides reactivity was investigated by Phage-ELISA through different panels of serum samples. We have successfully selected five peptides with significant immunoreactivity to circulating IgG from patients' sera with strongyloidiasis. The phage displayed peptides C9 and C10 presented the highest diagnostic potential (AUC>0.87) with excellent sensitivity (>85%) and good specificity (>77.5%), suggesting that some S. stercoralis antigens trigger systemic immune response. These novel antigens are interesting serum biomarkers for routine strongyloidiasis screenings due to the easy production and simple assay using Phage-ELISA. Such markers may also present a promising application for therapeutic monitoring.

Late-night salivary cortisol measurement in the diagnosis of Cushing's syndrome.

PubMed

Carroll, Ty; Raff, Hershel; Findling, James W

2008-06-01

Making a definite diagnosis of Cushing's syndrome is a challenging problem. Unsuspected Cushing's syndrome occurs in 2-3% of patients with poorly controlled diabetes, 0.5-1% with hypertension, 6-9% with incidental adrenal masses, and 11% with unexplained osteoporosis and vertebral fractures. The increasing recognition of this syndrome highlights the need for a simple, sensitive, and specific diagnostic test. Patients with Cushing's syndrome consistently do not reach a normal nadir of cortisol secretion at night. The measurement of late-night salivary cortisol levels might, therefore, provide a new diagnostic approach for this disorder. Salivary cortisol concentrations reflect those of active free cortisol in plasma and saliva samples can easily be obtained in a nonstressful environment (e.g. at home). Late-night salivary cortisol measurement yields excellent overall diagnostic accuracy for Cushing's syndrome, with a sensitivity of 92-100% and a specificity of 93-100%. Several factors can, however, make interpretation of results difficult; these factors include disturbed sleep-wake cycles, contamination of samples (particularly by topical corticosteroids), and illnesses known to cause physiologic activation of the pituitary-adrenal axis. In this Review, we discuss the methods and value of measuring salivary cortisol for the diagnosis of Cushing's syndrome, and put forward some recommendations to maximize accuracy of results.

Validation of the ANSR Listeria method for detection of Listeria spp. in environmental samples.

PubMed

Wendorf, Michael; Feldpausch, Emily; Pinkava, Lisa; Luplow, Karen; Hosking, Edan; Norton, Paul; Biswas, Preetha; Mozola, Mark; Rice, Jennifer

2013-01-01

ANSR Listeria is a new diagnostic assay for detection of Listeria spp. in sponge or swab samples taken from a variety of environmental surfaces. The method is an isothermal nucleic acid amplification assay based on the nicking enzyme amplification reaction technology. Following single-step sample enrichment for 16-24 h, the assay is completed in 40 min, requiring only simple instrumentation. In inclusivity testing, 48 of 51 Listeria strains tested positive, with only the three strains of L. grayi producing negative results. Further investigation showed that L. grayi is reactive in the ANSR assay, but its ability to grow under the selective enrichment conditions used in the method is variable. In exclusivity testing, 32 species of non-Listeria, Gram-positive bacteria all produced negative ANSR assay results. Performance of the ANSR method was compared to that of the U.S. Department of Agriculture-Food Safety and Inspection Service reference culture procedure for detection of Listeria spp. in sponge or swab samples taken from inoculated stainless steel, plastic, ceramic tile, sealed concrete, and rubber surfaces. Data were analyzed using Chi-square and probability of detection models. Only one surface, stainless steel, showed a significant difference in performance between the methods, with the ANSR method producing more positive results. Results of internal trials were supported by findings from independent laboratory testing. The ANSR Listeria method can be used as an accurate, rapid, and simple alternative to standard culture methods for detection of Listeria spp. in environmental samples.

Toxoplasmosis serology: an efficient hemagglutination procedure to detect IgG and IgM antibodies.

PubMed

Camargo, M E; Moura, M E; Leser, P G

1989-01-01

In search of an efficient but simple, low cost procedure for the serodiagnosis of Toxoplasmosis, especially suited for routine laboratories facing technical and budget limitations as in less developed countries, the diagnostic capability of Hematoxo, an hemagglutination test for toxoplasmosis, was evaluated in relation to a battery of tests including IgG- and IgM-immunofluorescence tests, hemagglutination and an IgM-capture enzymatic assay. Detecting a little as 5 I.U. of IgG antitoxoplasma antibodies, Hematoxo showed a straight agreement as to reactivity and non-reactivity for the 443 non-reactive and the 387 reactive serum samples, included in this study. In 23 cases presenting a serological pattern of acute toxoplasmosis and showing IgM antibodies, Hematoxo could detect IgM antibodies in 18, indicated by negativation or a significant decrease in titers as a result of treating samples with 2-mercapto-ethanol. However, a neat increase in sensitivity for IgM specific antibodies could be achieved by previously removing IgG from the sample, as demonstrated in a series of acute toxoplasmosis sera. A simple procedure was developed for this purpose, by reconstituting a lyophilized suspension of Protein A--rich Staphylococcus with the lowest serum dilution to be tested. Of low cost and easy to perform, Hematoxo affords not only a practical qualitative procedure for screening reactors and non-reactors, as in prenatal services, but also quantitative assays that permit to titrate antibodies as well as to identify IgM antibodies.

Simple Ultraviolet Short-Pulse Intensity Diagnostic Method Using Atmosphere

NASA Astrophysics Data System (ADS)

Aota, Tatsuya; Takahashi, Eiichi; Losev, Leonid L.; Tabuchi, Takeyuki; Kato, Susumu; Matsumoto, Yuji; Okuda, Isao; Owadano, Yoshiro

2005-05-01

An ultraviolet (UV) short-pulse intensity diagnostic method using atmosphere as a nonlinear medium was developed. This diagnostic method is based on evaluating the ion charge of the two-photon ionization of atmospheric oxygen upon irradiation with a UV (238-299 nm) short-pulse laser. The observed ion signal increased proportionally to the input intensity to the power of ˜2.2, during the two-photon ionization of atmospheric oxygen. An autocorrelator was constructed and used to successfully measure a UV laser pulse of ˜400 fs duration. Since this diagnostic system is used in the open-air under windowless conditions, it can be set along the beam path and used as a UV intensity monitor.

Liquid biopsy in pancreatic cancer: the beginning of a new era

PubMed Central

Yadav, Dipesh Kumar; Bai, Xueli; Yadav, Rajesh Kumar; Singh, Alina; Li, Guogang; Ma, Tao; Chen, Wei; Liang, Tingbo

2018-01-01

With dismal survival rate pancreatic cancer remains one of the most aggressive and devastating malignancy. Predominantly, due to the absence of a dependable methodology for early identification and limited therapeutic options for advanced disease. However, it takes over 17 years to develop pancreatic cancer from initiation of mutation to metastatic cancer; therefore, if diagnosed early; it may increase overall survival dramatically, thus, providing a window of opportunity for early detection. Recently, genomic expression analysis defined 4 subtypes of pancreatic cancer based on mutated genes. Hence, we need simple and standard, minimally invasive test that can monitor those altered genes or their associated pathways in time for the success of precision medicine, and liquid biopsy seems to be one answer to all these questions. Again, liquid biopsy has an ability to pair with genomic tests. Additionally, liquid biopsy based development of circulating tumor cells derived xenografts, 3D organoids system, real-time monitoring of genetic mutations by circulating tumor DNA and exosome as the targeted drug delivery vehicle holds lots of potential for the treatment and cure of pancreatic cancer. At present, diagnosis of pancreatic cancer is frantically done on the premise of CA19-9 and radiological features only, which doesn't give a picture of genetic mutations and epigenetic alteration involved. In this manner, the current diagnostic paradigm for pancreatic cancer diagnosis experiences low diagnostic accuracy. This review article discusses the current state of liquid biopsy in pancreatic cancer as diagnostic and therapeutic tools and future perspectives of research in the light of circulating tumor cells, circulating tumor DNA and exosomes.

Motor abilities and anthropometrics in youth cross-country skiing.

PubMed

Stöggl, R; Müller, E; Stöggl, T

2015-02-01

The purposes were to validate whether general motor abilities and anthropometrics are determinants of youth cross-country (XC) skiing performance; evaluate gender-specific differences; and to establish noninvasive diagnostics. Fifty-one youth XC skiers (34 boys; 13.8 ± 0.6 years and 17 girls; 13.4 ± 0.9 years) performed motor skill and laboratory tests, and anthropometric data were collected and correlated with XC skiing performance. Anthropometrics and maturity status were related to boys but not to girls XC skiing performance. Push-ups and 20-m sprint were correlated to XC skiing performance in both boys and girls. XC skiing performance of boys was predominantly influenced by upper body and trunk strength capacities (medicine ball throw, push-ups, and pull-ups) and jumping power (standing long and triple jump), whereas XC skiing of girls was mainly influenced by aerobic capacities (3000-m run). Laboratory measures did not reveal greater correlations to XC skiing performance compared with simple test concepts of speed, strength, and endurance. Maturity was a major confounding variable in boys but not girls. Use of noninvasive simple test concepts for determination of upper body strength, speed, and endurance represent practicable support for ski clubs, schools, or skiing federations in the guidance and evaluation of young talent, being aware of the effect of maturity especially in boys. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

30 CFR 250.523 - How long do I keep records of casing pressure and diagnostic tests?

Code of Federal Regulations, 2011 CFR

2011-07-01

... and diagnostic tests? 250.523 Section 250.523 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT... long do I keep records of casing pressure and diagnostic tests? Records of casing pressure and diagnostic tests must be kept at the field office nearest the well for a minimum of 2 years. The last casing...

Novel approach based on one-tube nested PCR and a lateral flow strip for highly sensitive diagnosis of tuberculous meningitis.

PubMed

Sun, Yajuan; Chen, Jiajun; Li, Jia; Xu, Yawei; Jin, Hui; Xu, Na; Yin, Rui; Hu, Guohua

2017-01-01

Rapid and sensitive detection of Mycobacterium tuberculosis (M. Tb) in cerebrospinal fluid is crucial in the diagnosis of tuberculous meningitis (TBM), but conventional diagnostic technologies have limited sensitivity and specificity or are time-consuming. In this work, a novel, highly sensitive molecular diagnostic method, one-tube nested PCR-lateral flow strip test (OTNPCR-LFST), was developed for detecting M. tuberculosis. This one-tube nested PCR maintains the sensitivity of conventional two-step nested PCR and reduces both the chance of cross-contamination and the time required for analysis. The PCR product was detected by a lateral flow strip assay, which provided a basis for migration of the test to a point-of-care (POC) microfluidic format. The developed assay had an improved sensitivity compared with traditional PCR, and the limit of detection was up to 1 fg DNA isolated from M. tuberculosis. The assay was also specific for M. tuberculosis, and no cross-reactions were found in other non-target bacteria. The application of this technique to clinical samples was successfully evaluated, and OTNPCR-LFST showed 89% overall sensitivity and 100% specificity for TBM patients. This one-tube nested PCR-lateral flow strip assay is useful for detecting M. tuberculosis in TBM due to its rapidity, high sensitivity and simple manipulation.

Syphilis.

PubMed

Peeling, Rosanna W; Mabey, David; Kamb, Mary L; Chen, Xiang-Sheng; Radolf, Justin D; Benzaken, Adele S

2017-10-12

Treponema pallidum subspecies pallidum (T. pallidum) causes syphilis via sexual exposure or via vertical transmission during pregnancy. T. pallidum is renowned for its invasiveness and immune-evasiveness; its clinical manifestations result from local inflammatory responses to replicating spirochaetes and often imitate those of other diseases. The spirochaete has a long latent period during which individuals have no signs or symptoms but can remain infectious. Despite the availability of simple diagnostic tests and the effectiveness of treatment with a single dose of long-acting penicillin, syphilis is re-emerging as a global public health problem, particularly among men who have sex with men (MSM) in high-income and middle-income countries. Syphilis also causes several hundred thousand stillbirths and neonatal deaths every year in developing nations. Although several low-income countries have achieved WHO targets for the elimination of congenital syphilis, an alarming increase in the prevalence of syphilis in HIV-infected MSM serves as a strong reminder of the tenacity of T. pallidum as a pathogen. Strong advocacy and community involvement are needed to ensure that syphilis is given a high priority on the global health agenda. More investment is needed in research on the interaction between HIV and syphilis in MSM as well as into improved diagnostics, a better test of cure, intensified public health measures and, ultimately, a vaccine.

Goodness-of-fit tests and model diagnostics for negative binomial regression of RNA sequencing data.

PubMed

Mi, Gu; Di, Yanming; Schafer, Daniel W

2015-01-01

This work is about assessing model adequacy for negative binomial (NB) regression, particularly (1) assessing the adequacy of the NB assumption, and (2) assessing the appropriateness of models for NB dispersion parameters. Tools for the first are appropriate for NB regression generally; those for the second are primarily intended for RNA sequencing (RNA-Seq) data analysis. The typically small number of biological samples and large number of genes in RNA-Seq analysis motivate us to address the trade-offs between robustness and statistical power using NB regression models. One widely-used power-saving strategy, for example, is to assume some commonalities of NB dispersion parameters across genes via simple models relating them to mean expression rates, and many such models have been proposed. As RNA-Seq analysis is becoming ever more popular, it is appropriate to make more thorough investigations into power and robustness of the resulting methods, and into practical tools for model assessment. In this article, we propose simulation-based statistical tests and diagnostic graphics to address model adequacy. We provide simulated and real data examples to illustrate that our proposed methods are effective for detecting the misspecification of the NB mean-variance relationship as well as judging the adequacy of fit of several NB dispersion models.

Plant-Derived Chimeric Virus Particles for the Diagnosis of Primary Sjögren Syndrome.

PubMed

Tinazzi, Elisa; Merlin, Matilde; Bason, Caterina; Beri, Ruggero; Zampieri, Roberta; Lico, Chiara; Bartoloni, Elena; Puccetti, Antonio; Lunardi, Claudio; Pezzotti, Mario; Avesani, Linda

2015-01-01

Plants are ideal for the production of protein-based nanomaterials because they synthesize and assemble complex multimeric proteins that cannot be expressed efficiently using other platforms. Plant viruses can be thought of as self-replicating proteinaceous nanomaterials generally stable and easily produced in high titers. We used Potato virus X (PVX), chimeric virus particles, and Cowpea mosaic virus, empty virus-like particles to display a linear peptide (lipo) derived from human lipocalin, which is immunodominant in Sjögren's syndrome (SjS) and is thus recognized by autoantibodies in SjS patient serum. These virus-derived nanoparticles were thus used to develop a diagnostic assay for SjS based on a direct enzyme linked immunosorbent assay format. We found that PVX-lipo formulations were more sensitive than the chemically synthesized immunodominant peptide and equally specific when used to distinguish between healthy individuals and SjS patients. Our novel assay therefore allows the diagnosis of SjS using a simple, low-invasive serum test, contrasting with the invasive labial biopsy required for current tests. Our results demonstrate that nanomaterials based on plant viruses can be used as diagnostic reagents for SjS, and could also be developed for the diagnosis of other diseases.

Rapid, Affordable and Portable Medium-Throughput Molecular Device for Zika Virus

PubMed Central

Chan, Kamfai; Weaver, Scott C.; Wong, Pui-Yan; Lie, Sherly; Wang, Eryu; Guerbois, Mathilde; Vayugundla, Siva Praneeth; Wong, Season

2016-01-01

Zika virus (ZIKV) has gained global attention as an etiologic agent of fetal microcephaly and Guillain-Barré syndrome. Existing immuno-based rapid tests often fail to distinguish between Zika and related flaviviruses that are common in affected regions of Central and South Americas and the Caribbean. The US CDC and qualified state health department laboratories can perform the reverse transcription polymerase chain reaction (RT-PCR) ZIKV test using highly sophisticated instruments with long turnaround times. The preliminary results of a portable and low-cost molecular diagnostics system for ZIKV infection are reported here. In less than 15 minutes, this low-cost platform can automatically perform high quality RNA extraction from up to 12 ZIKV-spiked urine samples simultaneously. It can also perform reverse transcription recombinase polymerase amplification reaction (RT-RPA) in ≤15 minutes. The fluorescent signal produced from probe-based RT-RPA or RT-PCR assays can be monitored using LEDs and a smartphone camera. In addition, the RT-RPA and RT-PCR assays do not cross-react with dengue and chikungunya viral RNA. This low-cost system lacks complicated, sensitive and high cost components, making it suitable for resource-limited settings. It has the potential to offer simple sample-to-answer molecular diagnostics and can inform healthcare workers of patients’ diagnosis promptly. PMID:27934884

Exercise induced von Willebrand Factor release -- new model for routine endothelial testing.

PubMed

Balen, Sanja; Ruzić, Alen; Mirat, Jure; Persić, Viktor

2007-01-01

Endothelial dysfunction (ED) is actively involved in the mechanism of occurrence, development and progression of all the degrees of atherosclerosis. The established impact of ED on the progress and outcome of cardiovascular diseases, together with convincing indications of a possible successful therapeutic modification, necessitate the changeover of ED assessment from experimental to a routine practice. As there is no appropriate method for a clinical practice, scientists anticipate significant research efforts in the further development. Among numerous methods already available, von Willebrand Factor (vWF) stands out significantly. In accordance with the accepted leading diagnostic role of vWF baseline levels in the group of peripheral endothelial markers, and earlier scientific observations on the absence of its expected reactivation during physical exercise, we hypothesised this promising theory. We believe that a constant stronger release of vWF in endothelial cell injury leads to the exhaustion of its stores in Weibel-Palade bodies with the consequent absence of the expected rise of concentration during the exercise. Therefore, we hypothesised that ED could be exhaustible vWF endothelopathy and the exercise induced release of vWF a new, simple, safe and reliable test for the detection of ED and monitoring of the expected therapeutic effect. In order to have a final clinical usability of the proposed diagnostic model, it is necessary to test its reliability in different pathological and risk states, and establish susceptibility in therapeutic procedures. The correlation with invasive functional angiographic tests and the flow mediated dilatation test of peripheral arteries also needs to be validated. We expect the proposed test of vWF inducibility to find its place in clinical practice, i.e. in prevention, prediction and therapy of cardiovascular diseases.

KRAS mutation testing in borderline ovarian tumors and low-grade ovarian carcinomas with a rapid, fully integrated molecular diagnostic system.

PubMed

Sadlecki, Pawel; Antosik, Paulina; Grzanka, Dariusz; Grabiec, Marek; Walentowicz-Sadlecka, Malgorzata

2017-10-01

Epithelial ovarian neoplasms are a heterogeneous group of tumors, including various malignancies with distinct clinicopathologic and molecular features. Mutations in BRAF and KRAS genes are the most frequent genetic aberrations found in low-grade serous ovarian carcinomas and serous and mucinous borderline tumors. Implementation of targeted therapeutic strategies requires access to highly specific and highly sensitive diagnostic tests for rapid determination of mutation status. One candidate for such test is fully integrated, real-time polymerase chain reaction-based Idylla™ system for quick and simple detection of KRAS mutations in formaldehyde fixed-paraffin embedded tumor samples. The primary aim of this study was to verify whether fully integrated real-time polymerase chain reaction-based Idylla system may be useful in determination of KRAS mutation status in patients with borderline ovarian tumors and low-grade ovarian carcinomas. The study included tissue specimens from 37 patients with histopathologically verified ovarian masses, operated on at the Department of Obstetrics and Gynecology, Nicolaus Copernicus University Collegium Medicum in Bydgoszcz (Poland) between January 2009 and June 2012. Based on histopathological examination of surgical specimens, 30 lesions were classified as low-grade ovarian carcinomas and 7 as borderline ovarian tumors. Seven patients examined with Idylla KRAS Mutation Test tested positive for KRAS mutation. No statistically significant association was found between the incidence of KRAS mutations and histopathological type of ovarian tumors. Mean survival of the study subjects was 48.51 months (range 3-60 months). Presence of KRAS mutation did not exert a significant effect on the duration of survival in our series. Our findings suggest that Idylla KRAS Mutation Test may be a useful tool for rapid detection of KRAS mutations in ovarian tumor tissue.

76 FR 49491 - Medicare Program; Section 3113: The Treatment of Certain Complex Diagnostic Laboratory Tests...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

...] Medicare Program; Section 3113: The Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration... code under the Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration. The deadline for... interested parties of an opportunity to participate in the Treatment of Certain Complex Diagnostic Laboratory...

Accuracy of simple biochemical tests in identifying liver fibrosis in patients co-infected with human immunodeficiency virus and hepatitis C virus.

PubMed

Tural, Cristina; Tor, Jordi; Sanvisens, Arantza; Pérez-Alvarez, Núria; Martínez, Elisenda; Ojanguren, Isabel; García-Samaniego, Javier; Rockstroh, Juergen; Barluenga, Eva; Muga, Robert; Planas, Ramon; Sirera, Guillem; Rey-Joly, Celestino; Clotet, Bonaventura

2009-03-01

We assessed the ability of 3 simple biochemical tests to stage liver fibrosis in patients co-infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). We analyzed liver biopsy samples from 324 consecutive HIV/HCV-positive patients (72% men; mean age, 38 y; mean CD4+ T-cell counts, 548 cells/mm(3)). Scheuer fibrosis scores were as follows: 30% had F0, 22% had F1, 19% had F2, 23% had F3, and 6% had F4. Logistic regression analyses were used to predict the probability of significant (>or=F2) or advanced (>or=F3) fibrosis, based on numeric scores from the APRI, FORNS, or FIB-4 tests (alone and in combination). Area under the receiver operating characteristic curves were analyzed to assess diagnostic performance. Area under the receiver operating characteristic curves analyses indicated that the 3 tests had similar abilities to identify F2 and F3; the ability of APRI, FORNS, and FIB-4 were as follows: F2 or greater: 0.72, 0.67, and 0.72, respectively; F3 or greater: 0.75, 0.73, and 0.78, respectively. The accuracy of each test in predicting which samples were F3 or greater was significantly higher than for F2 or greater (APRI, FORNS, and FIB-4: >or=F3: 75%, 76%, and 76%, respectively; >or=F2: 66%, 62%, and 68%, respectively). By using the lowest cut-off values for all 3 tests, F3 or greater was ruled out with sensitivity and negative predictive values of 79% to 94% and 87% to 91%, respectively, and 47% to 70% accuracy. Advanced liver fibrosis (>or=F3) was identified using the highest cut-off value, with specificity and positive predictive values of 90% to 96% and 63% to 73%, respectively, and 75% to 77% accuracy. Simple biochemical tests accurately predicted liver fibrosis in more than half the HIV/HCV co-infected patients. The absence and presence of liver fibrosis are predicted fairly using the lowest and highest cut-off levels, respectively.

New diagnostic index for sarcopenia in patients with cardiovascular diseases

PubMed Central

Kai, Hisashi; Shibata, Rei; Niiyama, Hiroshi; Nishiyama, Yasuhiro; Murohara, Toyoaki; Yoshida, Noriko; Katoh, Atsushi; Ikeda, Hisao

2017-01-01

Background Sarcopenia is an aging and disease-related syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, with the risk of frailty and poor quality of life. Sarcopenia is diagnosed by a decrease in skeletal muscle index (SMI) and reduction of either handgrip strength or gait speed. However, measurement of SMI is difficult for general physicians because it requires special equipment for bioelectrical impedance assay or dual-energy X-ray absorptiometry. The purpose of this study was, therefore, to explore a novel, simple diagnostic method of sarcopenia evaluation in patients with cardiovascular diseases (CVD). Methods We retrospectively investigated 132 inpatients with CVD (age: 72±12 years, age range: 27–93 years, males: 61%) Binomial logistic regression and correlation analyses were used to assess the associations of sarcopenia with simple physical data and biomarkers, including muscle-related inflammation makers and nutritional markers. Results Sarcopenia was present in 29.5% of the study population. Serum concentrations of adiponectin and sialic acid were significantly higher in sarcopenic than non-sarcopenic CVD patients. Stepwise multivariate binomial logistic regression analysis revealed that adiponectin, sialic acid, sex, age, and body mass index were independent factors for sarcopenia detection. Sarcopenia index, obtained from the diagnostic regression formula for sarcopenia detection including the five independent factors, indicated a high accuracy in ROC curve analysis (sensitivity 94.9%, specificity 69.9%) and the cutoff value for sarcopenia detection was -1.6134. Sarcopenia index had a significant correlation with the conventional diagnostic parameters of sarcopenia. Conclusions Our new sarcopenia index using simple parameters would be useful for diagnosing sarcopenia in CVD patients. PMID:28542531

Development of Multi-perspective Diagnostics and Analysis Algorithms with Applications to Subsonic and Supersonic Combustors

NASA Astrophysics Data System (ADS)

Wickersham, Andrew Joseph

There are two critical research needs for the study of hydrocarbon combustion in high speed flows: 1) combustion diagnostics with adequate temporal and spatial resolution, and 2) mathematical techniques that can extract key information from large datasets. The goal of this work is to address these needs, respectively, by the use of high speed and multi-perspective chemiluminescence and advanced mathematical algorithms. To obtain the measurements, this work explored the application of high speed chemiluminescence diagnostics and the use of fiber-based endoscopes (FBEs) for non-intrusive and multi-perspective chemiluminescence imaging up to 20 kHz. Non-intrusive and full-field imaging measurements provide a wealth of information for model validation and design optimization of propulsion systems. However, it is challenging to obtain such measurements due to various implementation difficulties such as optical access, thermal management, and equipment cost. This work therefore explores the application of FBEs for non-intrusive imaging to supersonic propulsion systems. The FBEs used in this work are demonstrated to overcome many of the aforementioned difficulties and provided datasets from multiple angular positions up to 20 kHz in a supersonic combustor. The combustor operated on ethylene fuel at Mach 2 with an inlet stagnation temperature and pressure of approximately 640 degrees Fahrenheit and 70 psia, respectively. The imaging measurements were obtained from eight perspectives simultaneously, providing full-field datasets under such flow conditions for the first time, allowing the possibility of inferring multi-dimensional measurements. Due to the high speed and multi-perspective nature, such new diagnostic capability generates a large volume of data and calls for analysis algorithms that can process the data and extract key physics effectively. To extract the key combustion dynamics from the measurements, three mathematical methods were investigated in this work: Fourier analysis, proper orthogonal decomposition (POD), and wavelet analysis (WA). These algorithms were first demonstrated and tested on imaging measurements obtained from one perspective in a sub-sonic combustor (up to Mach 0.2). The results show that these algorithms are effective in extracting the key physics from large datasets, including the characteristic frequencies of flow-flame interactions especially during transient processes such as lean blow off and ignition. After these relatively simple tests and demonstrations, these algorithms were applied to process the measurements obtained from multi-perspective in the supersonic combustor. compared to past analyses (which have been limited to data obtained from one perspective only), the availability of data at multiple perspective provide further insights into the flame and flow structures in high speed flows. In summary, this work shows that high speed chemiluminescence is a simple yet powerful combustion diagnostic. Especially when combined with FBEs and the analyses algorithms described in this work, such diagnostics provide full-field imaging at high repetition rate in challenging flows. Based on such measurements, a wealth of information can be obtained from proper analysis algorithms, including characteristic frequency, dominating flame modes, and even multi-dimensional flame and flow structures.

Autoantibody Approach for Serum-Based Detection of Head and Neck Cancer — EDRN Public Portal

Cancer.gov

Our long term goal is to improve survival of patients with head and neck squamous cell carcinoma (HNSCC) through early detection using simple noninvasive serum assays in an ELISA-like platform. The objective of this proposal is to improve and confirm the validity of a diagnostic serum assay based on a panel of cancer-specific biomarkers for early cancer detection in patients with HNSCC. Our central hypothesis is that the detection of antibody responses to HNSCC-specific antigens, using a panel of biomarkers, can provide sufficient sensitivity and specificity suitable for clinical testing in the primary setting to screen and diagnose HNSCC in high risk populations to improve early detection.

Simulations and design of microfabricated interdigitated electrodes for use in a gold nanoparticle enhanced biosensor.

PubMed

Hermansen, Peter; MacKay, Scott; Wishart, David; Jie Chen

2016-08-01

Microfabricated interdigitated electrode chips have been designed for use in a unique gold-nanoparticle based biosensor system. The use of these electrodes will allow for simple, accurate, inexpensive, and portable biosensing, with potential applications in diagnostics, medical research, and environmental testing. To determine the optimal design for these electrodes, finite element analysis simulations were carried out using COMSOL Multiphysics software. The results of these simulations determined some of the optimal design parameters for microfabricating interdigitated electrodes as well as predicting the effects of different electrode materials. Finally, based on the results of these simulations two different kinds of interdigitated electrode chips were made using photolithography.

Transition Matrices: A Tool to Assess Student Learning and Improve Instruction

NASA Astrophysics Data System (ADS)

Morris, Gary A.; Walter, Paul; Skees, Spencer; Schwartz, Samantha

2017-03-01

This paper introduces a new spreadsheet tool for adoption by high school or college-level physics teachers who use common assessments in a pre-instruction/post-instruction mode to diagnose student learning and teaching effectiveness. The spreadsheet creates a simple matrix that identifies the percentage of students who select each possible pre-/post-test answer combination on each question of the diagnostic exam. Leveraging analysis of the quality of the incorrect answer choices, one can order the answer choices from worst to best (i.e., correct), resulting in "transition matrices" that can provide deeper insight into student learning and the success or failure of the pedagogical approach than traditional analyses that employ dichotomous scoring.

Oral exfoliative cytology as a rapid diagnostic tool for paracoccidioidomycosis.

PubMed

Talhari, Carolina; de Souza, João Vicente Braga; Parreira, Vilmar José; Reinel, Dieter; Talhari, Sinésio

2008-03-01

Paracoccidioidomycosis is a common deep mycosis in South America. It is caused by the dimorphic fungus Paracoccidioides brasiliensis. We report a case of a 47-year-old Brazilian man with oral lesions due to paracoccidioidomycosis, which was diagnosed by exfoliative cytology without any special staining. We highlight this diagnostic tool as a simple, low-cost, painless, non-invasive and fast method for the diagnosis of paracoccidioidomycosis.

Pyrosequencing-based validation of a simple cell-suspension polymerase chain reaction assay for Campylobacter... of high-processivity polymerase with novel internal amplification controls for rapid and specific detection.

USDA-ARS?s Scientific Manuscript database

Although Campylobacter is an important food-borne human pathogen, there remains a lack of molecular diagnostic assays that are simple to use, cost-effective, and provide rapid results in research, clinical, or regulatory laboratories. Of the numerous Campylobacter assays that do exist, to our knowl...

A novel diagnostic method for malaria using loop-mediated isothermal amplification (LAMP) and MinION™ nanopore sequencer.

PubMed

Imai, Kazuo; Tarumoto, Norihito; Misawa, Kazuhisa; Runtuwene, Lucky Ronald; Sakai, Jun; Hayashida, Kyoko; Eshita, Yuki; Maeda, Ryuichiro; Tuda, Josef; Murakami, Takashi; Maesaki, Shigefumi; Suzuki, Yutaka; Yamagishi, Junya; Maeda, Takuya

2017-09-13

A simple and accurate molecular diagnostic method for malaria is urgently needed due to the limitations of conventional microscopic examination. In this study, we demonstrate a new diagnostic procedure for human malaria using loop mediated isothermal amplification (LAMP) and the MinION™ nanopore sequencer. We generated specific LAMP primers targeting the 18S-rRNA gene of all five human Plasmodium species including two P. ovale subspecies (P. falciparum, P. vivax, P. ovale wallikeri, P. ovale curtisi, P. knowlesi and P. malariae) and examined human blood samples collected from 63 malaria patients in Indonesia. Additionally, we performed amplicon sequencing of our LAMP products using MinION™ nanopore sequencer to identify each Plasmodium species. Our LAMP method allowed amplification of all targeted 18S-rRNA genes of the reference plasmids with detection limits of 10-100 copies per reaction. Among the 63 clinical samples, 54 and 55 samples were positive by nested PCR and our LAMP method, respectively. Identification of the Plasmodium species by LAMP amplicon sequencing analysis using the MinION™ was consistent with the reference plasmid sequences and the results of nested PCR. Our diagnostic method combined with LAMP and MinION™ could become a simple and accurate tool for the identification of human Plasmodium species, even in resource-limited situations.

Reporting Diagnostic Scores in Educational Testing: Temptations, Pitfalls, and Some Solutions

ERIC Educational Resources Information Center

Sinharay, Sandip; Puhan, Gautam; Haberman, Shelby J.

2010-01-01

Diagnostic scores are of increasing interest in educational testing due to their potential remedial and instructional benefit. Naturally, the number of educational tests that report diagnostic scores is on the rise, as are the number of research publications on such scores. This article provides a critical evaluation of diagnostic score reporting…

Development and evaluation of an in-house single step loop-mediated isothermal amplification (SS-LAMP) assay for the detection of Mycobacterium tuberculosis complex in sputum samples from Moroccan patients.

PubMed

Bentaleb, El Mehdi; Abid, Mohammed; El Messaoudi, My Driss; Lakssir, Brahim; Ressami, El Mostafa; Amzazi, Saaïd; Sefrioui, Hassan; Ait Benhassou, Hassan

2016-09-27

Tuberculosis (TB) is a major global health problem and remains the leading cause of morbidity and mortality in developing countries. Routinely used TB diagnostic methods, in most endemic areas, are time-consuming, often less-sensitive, expensive and inaccessible to most patients. Therefore, there is an urgent need for the development of early, easy to use and effective diagnosis tools of TB, which can be effectively integrated into resource limited settings, to anticipate the early treatment and limit further spread of the disease. Over the last decade, Loop-mediated isothermal amplification (LAMP) assays have become a powerful tool for rapid diagnosis of infectious diseases because of the simplicity of device requirements. Indeed, LAMP is a simple, quick and cost effective Isothermal Nucleic Acid Amplification diagnostic test (INAAT) that has the potential to be used in TB endemic settings of resource-poor countries. In the present study, we have developed a simple and rapid TB molecular diagnostic test using a Single-Step Loop-mediated isothermal DNA amplification (SS-LAMP) method for the detection of Mycobacterium tuberculosis complex (MTBC) strains, with a simplified sample preparation procedure, eliminating DNA extraction prior to LAMP amplification, DNA initial denaturation and enzymatic inactivation steps during the amplification process. To perform our in-house SS-LAMP assay, a set of six specific primers was specifically designed to recognize eight distinct regions on the MTBC species-specific repetitive insertion sequence 6110 (IS6110). The amplification of the targeted DNA was carried out under isothermal conditions at 65 °C within 1 h. Our protocol was firstly optimized using 60 of confirmed MTBC isolates and a recombinant pGEMeasy-IS6110 vector for sensitivity testing. Thereafter, the assay was evaluated on liquefied sputum specimens collected from 157 Moroccan patients suspected of having TB. Our SS-LAMP developed assay was able to detect MTBC DNA directly from liquefied sputum samples without any prior DNA extraction, denaturation nor the final enzymatic inactivation step. When compared to routinely used Löwenstein Jensen (LJ) Culture method, our SS-LAMP assay is rapid and showed specificity and sensitivity of 99.14 % and 82.93 % respectively which are within the international standards. In addition, the limit of detection of our assay was found to be as little as 10 copies of bacterial DNA. To our knowledge, this is the first study using a single step LAMP (SS-LAMP) procedure as a rapid, easy to perform and cost effective testing for TB early detection. This innovative assay could be suitable for low-income countries with restricted health equipment facilities.

Social Cognition Deficits: The Key to Discriminate Behavioral Variant Frontotemporal Dementia from Alzheimer's Disease Regardless of Amnesia?

PubMed

Bertoux, Maxime; de Souza, Leonardo Cruz; O'Callaghan, Claire; Greve, Andrea; Sarazin, Marie; Dubois, Bruno; Hornberger, Michael

2016-01-01

Relative sparing of episodic memory is a diagnostic criterion of behavioral variant frontotemporal dementia (bvFTD). However, increasing evidence suggests that bvFTD patients can show episodic memory deficits at a similar level as Alzheimer's disease (AD). Social cognition tasks have been proposed to distinguish bvFTD, but no study to date has explored the utility of such tasks for the diagnosis of amnestic bvFTD. Here, we contrasted social cognition performance of amnestic and non-amnestic bvFTD from AD, with a subgroup having confirmed in vivo pathology markers. Ninety-six participants (38 bvFTD and 28 AD patients as well as 30 controls) performed the short Social-cognition and Emotional Assessment (mini-SEA). BvFTD patients were divided into amnestic versus non-amnestic presentation using the validated Free and Cued Selective Reminding Test (FCSRT) assessing episodic memory. As expected, the accuracy of the FCSRT to distinguish the overall bvFTD group from AD was low (69.7% ) with ∼50% of bvFTD patients being amnestic. By contrast, the diagnostic accuracy of the mini-SEA was high (87.9% ). When bvFTD patients were split on the level of amnesia, mini-SEA diagnostic accuracy remained high (85.1% ) for amnestic bvFTD versus AD and increased to very high (93.9% ) for non-amnestic bvFTD versus AD. Social cognition deficits can distinguish bvFTD and AD regardless of amnesia to a high degree and provide a simple way to distinguish both diseases at presentation. These findings have clear implications for the diagnostic criteria of bvFTD. They suggest that the emphasis should be on social cognition deficits with episodic memory deficits not being a helpful diagnostic criterion in bvFTD.

Methylation-sensitive high-resolution melting-curve analysis of the SNRPN gene as a diagnostic screen for Prader-Willi and Angelman syndromes.

PubMed

White, Helen E; Hall, Victoria J; Cross, Nicholas C P

2007-11-01

Angelman syndrome (AS) and Prader-Willi syndrome (PWS) are 2 distinct neurodevelopmental disorders caused primarily by deficiency of specific parental contributions at an imprinted domain within the chromosomal region 15q11.2-13. Lack of paternal contribution results in PWS either by paternal deletion (approximately 70%) or maternal uniparental disomy (UPD) (approximately 25%). Most cases of AS result from the lack of a maternal contribution from this same region, by maternal deletion (70%) or paternal UPD (approximately 5%). Analysis of allelic methylation differences at the small nuclear ribonucleoprotein polypeptide N (SNRPN) locus differentiates the maternally and paternally inherited chromosome 15 and can be used as a diagnostic test for AS and PWS. Methylation-sensitive high-resolution melting-curve analysis (MS-HRM) using the DNA binding dye EvaGreen was used to analyze methylation differences at the SNRPN locus in anonymized DNA samples from individuals with PWS (n = 39) or AS (n = 31) and from healthy control individuals (n = 95). Results from the MS-HRM assay were compared to those obtained by use of a methylation-specific PCR (MSP) protocol that is used commonly in diagnostic practice. With the MS-HRM assay 97.6% of samples were unambiguously assigned to the 3 diagnostic categories (AS, PWS, normal) by use of automated calling with an 80% confidence percentage threshold, and the failure rate was 0.6%. One PWS sample showed a discordant result for the MS-HRM assay compared to MSP data. MS-HRM is a simple, rapid, and robust method for screening methylation differences at the SNRPN locus and could be used as a diagnostic screen for PWS and AS.

Myasthenia Gravis: Tests and Diagnostic Methods

MedlinePlus

... Focus on MG Newsletter MG Quarterly Test & Diagnostic methods In addition to a complete medical and neurological ... How can I help? About MGFA Test & Diagnostic methods Treatment for MG FAQ's Upcoming Events 2018 MG ...

Symmetrical treatment of "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition", for major depressive disorders.

PubMed

Sawamura, Jitsuki; Morishita, Shigeru; Ishigooka, Jun

2016-01-01

We previously presented a group theoretical model that describes psychiatric patient states or clinical data in a graded vector-like format based on modulo groups. Meanwhile, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5, the current version), is frequently used for diagnosis in daily psychiatric treatments and biological research. The diagnostic criteria of DSM-5 contain simple binominal items relating to the presence or absence of specific symptoms. In spite of its simple form, the practical structure of the DSM-5 system is not sufficiently systemized for data to be treated in a more rationally sophisticated way. To view the disease states in terms of symmetry in the manner of abstract algebra is considered important for the future systematization of clinical medicine. We provide a simple idea for the practical treatment of the psychiatric diagnosis/score of DSM-5 using depressive symptoms in line with our previously proposed method. An expression is given employing modulo-2 and -7 arithmetic (in particular, additive group theory) for Criterion A of a 'major depressive episode' that must be met for the diagnosis of 'major depressive disorder' in DSM-5. For this purpose, the novel concept of an imaginary value 0 that can be recognized as an explicit 0 or implicit 0 was introduced to compose the model. The zeros allow the incorporation or deletion of an item between any other symptoms if they are ordered appropriately. Optionally, a vector-like expression can be used to rate/select only specific items when modifying the criterion/scale. Simple examples are illustrated concretely. Further development of the proposed method for the criteria/scale of a disease is expected to raise the level of formalism of clinical medicine to that of other fields of natural science.

Implementation of Rapid Molecular Infectious Disease Diagnostics: the Role of Diagnostic and Antimicrobial Stewardship.

PubMed

Messacar, Kevin; Parker, Sarah K; Todd, James K; Dominguez, Samuel R

2017-03-01

New rapid molecular diagnostic technologies for infectious diseases enable expedited accurate microbiological diagnoses. However, diagnostic stewardship and antimicrobial stewardship are necessary to ensure that these technologies conserve, rather than consume, additional health care resources and optimally affect patient care. Diagnostic stewardship is needed to implement appropriate tests for the clinical setting and to direct testing toward appropriate patients. Antimicrobial stewardship is needed to ensure prompt appropriate clinical action to translate faster diagnostic test results in the laboratory into improved outcomes at the bedside. This minireview outlines the roles of diagnostic stewardship and antimicrobial stewardship in the implementation of rapid molecular infectious disease diagnostics. Copyright © 2017 American Society for Microbiology.

Development of a quantitative rapid diagnostic test for multibacillary leprosy using smart phone technology.

PubMed

Paula Vaz Cardoso, Ludimila; Dias, Ronaldo Ferreira; Freitas, Aline Araújo; Hungria, Emerith Mayra; Oliveira, Regiane Morillas; Collovati, Marco; Reed, Steven G; Duthie, Malcolm S; Martins Araújo Stefani, Mariane

2013-10-23

Despite efforts to eliminate leprosy as public health problem, delayed diagnosis and disabilities still occur in many countries. Leprosy diagnosis remains based on clinical manifestations and the number of clinicians with expertise in leprosy diagnosis is in decline. We have developed a new immunochromatographic test with the goal of producing a simple and rapid system that can be used, with a minimal amount of training, to provide an objective and consistent diagnosis of multibacillary leprosy. The test immobilizes two antigens that have been recognized as excellent candidates for serologic diagnosis (the PGL-I mimetic, ND-O, and LID-1), on a nitrocellulose membrane. This allows the detection of specific IgM and IgG antibodies within 20 minutes of the addition of patient sera. Furthermore, we coupled the NDO-LID® rapid tests with a new cell phone-based test reader platform (Smart Reader®) to provide objective interpretation that was both quantifiable and consistent. Direct comparison of serologic responses indicated that the rapid test detected a greater proportion of leprosy patients than a lab-based PGL-I ELISA. While positive responses were detected by PGL-I ELISA in 83.3% of multibacillary patients and 15.4% of paucibacillary patients, these numbers were increased to 87% and 21.2%, respectively, when a combination of the NDO-LID® test and Smart Reader® was used. Among multibacillary leprosy the sensitivity of NDO-LID® test assessed by Smart Reader® was 87% (95% CI, 79.2-92.7%) and the specificity was 96.1% (95% CI, 91.7- 98.6%). The positive predictive value and the negative predictive value of NDO-LID® tests were 94% (95% CI, 87.4-97.8%) and 91.4% (95% CI, 85.9-95.2%), respectively. The widespread provision of rapid diagnostic tests to facilitate the diagnosis or prognosis of multibacillary leprosy could impact on leprosy control programs by aiding early detection, directing appropriate treatment and potentially interrupting Mycobacterium leprae transmission.

Feasibility of home management using ACT for childhood malaria episodes in an urban setting

PubMed Central

Nsagha, Dickson S; Elat, Jean-Bosco N; Ndong, Proper AB; Tata, Peter N; Tayong, Maureen-Nill N; Pokem, Francois F; Wankah, Christian C

2012-01-01

Background Over 90% of malaria cases occur in Sub-Saharan Africa, where a child under the age of 5 years dies from this illness every 30 seconds. The majority of families in Sub- Saharan Africa treat malaria at home, but therapy is often incomplete, hence the World Health Organization has adopted the strategy of home management of malaria to solve the problem. The purpose of this study was to determine community perception and the treatment response to episodes of childhood malaria in an urban setting prior to implementation of home management using artemisinin-based combination therapy (ACT). Methods This qualitative exploratory study on the home management of malaria in urban children under 5 years of age used 15 focus group discussions and 20 in-depth interviews in various categories of caregivers of children under 5 years. One hundred and eighteen people participated in the focus group discussions and 20 in the in-depth interviews. The study explored beliefs and knowledge about malaria, mothers’ perception of home management of the disease, health-seeking behavior, prepackaged treatment of malaria using ACT and a rapid diagnostic test, preferred channels for home management of uncomplicated malaria, communication, the role of the community in home management of malaria, and the motivation of drug distributors in the community. Results The mothers’ perception of malaria was the outcome of events other than mosquito bites. Home treatment is very common and is guided by the way mothers perceive signs and symptoms of malaria. Frequent change of malarial drugs by the national health policy and financial difficulties were the main problems mothers faced in treating febrile children. Rapid diagnostic testing and prepackaged ACT for simple malaria in children under 5 years would be accepted if it was offered at an affordable price. Tribalism and religious beliefs might hinder the delivery of home management of malaria. The availability of rapid diagnostic testing and ACT all year round is one of the challenges of home management of malaria. Although radio and television featured among the current sources of information within the community, meetings, churches, schools, and other public gatherings were the best venues for social mobilization, while community health workers and community leaders were the best sensitization agents for positive behavior change to adhere to home management of malaria. Monetary incentives should be offered to community drug distributors. This should be deducted from the combined price of ACT and rapid diagnostic testing. Conclusion For successful implementation of home management of malaria, there should be proper education, social mobilization of the population, and continuous monitoring and evaluation of field activities to ensure adequate stocks of ACT and rapid diagnostic testing within the framework of the intervention. PMID:22328833

Systematic Review of the Performance of Noninvasive Tests in Diagnosing Bladder Outlet Obstruction in Men with Lower Urinary Tract Symptoms.

PubMed

Malde, Sachin; Nambiar, Arjun K; Umbach, Roland; Lam, Thomas B; Bach, Thorsten; Bachmann, Alexander; Drake, Marcus J; Gacci, Mauro; Gratzke, Christian; Madersbacher, Stephan; Mamoulakis, Charalampos; Tikkinen, Kari A O; Gravas, Stavros

2017-03-01

Several noninvasive tests have been developed for diagnosing bladder outlet obstruction (BOO) in men to avoid the burden and morbidity associated with invasive urodynamics. The diagnostic accuracy of these tests, however, remains uncertain. To systematically review available evidence regarding the diagnostic accuracy of noninvasive tests in diagnosing BOO in men with lower urinary tract symptoms (LUTS) using a pressure-flow study as the reference standard. The EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Central, Google Scholar, and WHO International Clinical Trials Registry Platform Search Portal databases were searched up to May 18, 2016. All studies reporting diagnostic accuracy for noninvasive tests for BOO or detrusor underactivity in men with LUTS compared to pressure-flow studies were included. Two reviewers independently screened all articles, searched the reference lists of retrieved articles, and performed the data extraction. The quality of evidence and risk of bias were assessed using the QUADAS-2 tool. The search yielded 2774 potentially relevant reports. After screening titles and abstracts, 53 reports were retrieved for full-text screening, of which 42 (recruiting a total of 4444 patients) were eligible. Overall, the results were predominantly based on findings from nonrandomised experimental studies and, within the limits of such study designs, the quality of evidence was typically moderate across the literature. Differences in noninvasive test threshold values and variations in the urodynamic definition of BOO between studies limited the comparability of the data. Detrusor wall thickness (median sensitivity 82%, specificity 92%), near-infrared spectroscopy (median sensitivity 85%, specificity 87%), and the penile cuff test (median sensitivity 88%, specificity 75%) were all found to have high sensitivity and specificity in diagnosing BOO. Uroflowmetry with a maximum flow rate of <10ml/s was reported to have lower median sensitivity and specificity of 68% and 70%, respectively. Intravesical prostatic protrusion of >10mm was reported to have similar diagnostic accuracy, with median sensitivity of 68% and specificity of 75%. According to the literature, a number of noninvasive tests have high sensitivity and specificity in diagnosing BOO in men. However, although the majority of studies have a low overall risk of bias, the available evidence is limited by heterogeneity. While several tests have shown promising results regarding noninvasive assessment of BOO, invasive urodynamics remain the gold standard. Urodynamics is an accurate but potentially uncomfortable test for patients in diagnosing bladder problems such as obstruction. We performed a thorough and comprehensive review of the literature to determine if there were less uncomfortable but equally effective alternatives to urodynamics for diagnosing bladder problems. We found that some simple tests appear to be promising, although they are not as accurate. Further research is needed before these tests are routinely used in place of urodynamics. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Advances in addressing technical challenges of point-of-care diagnostics in resource-limited settings

PubMed Central

Wang, ShuQi; Lifson, Mark A.; Inci, Fatih; Liang, Li-Guo; Sheng, Ye-Feng; Demirci, Utkan

2016-01-01

The striking prevalence of HIV, TB and malaria, as well as outbreaks of emerging infectious diseases, such as influenza A (H7N9), Ebola and MERS, poses great challenges for patient care in resource-limited settings (RLS). However, advanced diagnostic technologies cannot be implemented in RLS largely due to economic constraints. Simple and inexpensive point-of-care (POC) diagnostics, which rely less on environmental context and operator training, have thus been extensively studied to achieve early diagnosis and treatment monitoring in non-laboratory settings. Despite great input from material science, biomedical engineering and nanotechnology for developing POC diagnostics, significant technical challenges are yet to be overcome. Summarized here are the technical challenges associated with POC diagnostics from a RLS perspective and the latest advances in addressing these challenges are reviewed. PMID:26777725

Diagnostic Approach for Differentiating Infected from Vaccinated Poultry on the Basis of Antibodies to NS1, the Nonstructural Protein of Influenza A Virus

PubMed Central

Tumpey, Terrence M.; Alvarez, Rene; Swayne, David E.; Suarez, David L.

2005-01-01

Vaccination programs for the control of avian influenza (AI) in poultry have limitations due to the problem of differentiating between vaccinated and virus-infected birds. We have used NS1, the conserved nonstructural protein of influenza A virus, as a differential diagnostic marker for influenza virus infection. Experimentally infected poultry were evaluated for the ability to induce antibodies reactive to NS1 recombinant protein produced in Escherichia coli or to chemically synthesized NS1 peptides. Immune sera were obtained from chickens and turkeys inoculated with live AI virus, inactivated purified vaccines, or inactivated commercial vaccines. Seroconversion to positivity for antibodies to the NS1 protein was achieved in birds experimentally infected with multiple subtypes of influenza A virus, as determined by enzyme-linked immunosorbent assay (ELISA) and Western blot analysis. In contrast, animals inoculated with inactivated gradient-purified vaccines had no seroconversion to positivity for antibodies to the NS1 protein, and animals vaccinated with commercial vaccines had low, but detectable, levels of NS1 antibodies. The use of a second ELISA with diluted sera identified a diagnostic test that results in seropositivity for antibodies to the NS1 protein only in infected birds. For the field application phase of this study, serum samples were collected from vaccinated and infected poultry, diluted, and screened for anti-NS1 antibodies. Field sera from poultry that received commercial AI vaccines were found to possess antibodies against AI virus, as measured by the standard agar gel precipitin (AGP) test, but they were negative by the NS1 ELISA. Conversely, diluted field sera from AI-infected poultry were positive for both AGP and NS1 antibodies. These results demonstrate the potential benefit of a simple, specific ELISA for anti-NS1 antibodies that may have diagnostic value for the poultry industries. PMID:15695663

APRI test and hyaluronic acid as non-invasive diagnostic tools for post HCV liver fibrosis: Systematic review and meta-analysis.

PubMed

El Serafy, Magdy Amin; Kassem, Abdel Meguid; Omar, Heba; Mahfouz, Mohammad Shaaban; El Said El Raziky, Maissa

2017-06-01

Hepatitis C virus (HCV) accounts for a sizable proportion of chronic liver disease cases and represents the most common indication for liver transplantation. Precise diagnosis of hepatic fibrosis stage is considered a funnel-neck in proper management and follow-up of HCV-infected patients. Given the possible complications of liver biopsy, a non-invasive method for assessing hepatic fibrosis is needed. This study aimed to evaluate the diagnostic accuracy of APRI and hyaluronic acid as non-invasive diagnostic assessment tools for post HCV liver fibrosis. Systematic literature searching identified studies performed on Egyptian territory to evaluate APRI and hyaluronic acid as non-invasive tests of fibrosis and using liver biopsy as the reference standard. Meta-analysis was performed for areas with an adequate number of publications. Validation of meta- analysis on APRI was done on a subset of 150 treatment-naïve post-hepatitis C patients. Both APRI and hyaluronic acid have superior predictive power for hepatic cirrhosis (F4) than for significant fibrosis (F2-F3). The pooled estimate for sensitivities and specificities of APRI and hyaluronic acid to diagnose F4 were (84% and 82%) and (83% and 89%) respectively. In the subgroup of treatment naïve post-hepatitis C patients, APRI had higher diagnostic performance to diagnose liver cirrhosis with 93.8% sensitivity and 72.4% specificity (AUC; 0.908, 95%CI; 0.851-0.965, p-value; <0.001) compared to its accuracy to diagnose significant hepatic fibrosis with 65.1% sensitivity and 77.8% (AUC; 0.685, 95% CI; 0.59-0.78, p-value; 0.001). APRI score and hyaluronic acid levels are simple and reliable non-invasive markers to detect advanced fibrosis among post-hepatitis C patients. Copyright © 2017 Pan-Arab Association of Gastroenterology. Published by Elsevier B.V. All rights reserved.

The Rapid-Heat LAMPellet Method: A Potential Diagnostic Method for Human Urogenital Schistosomiasis

PubMed Central

Carranza-Rodríguez, Cristina; Pérez-Arellano, José Luis; Vicente, Belén; López-Abán, Julio; Muro, Antonio

2015-01-01

Background Urogenital schistosomiasis due to Schistosoma haematobium is a serious underestimated public health problem affecting 112 million people - particularly in sub-Saharan Africa. Microscopic examination of urine samples to detect parasite eggs still remains as definitive diagnosis. This work was focussed on developing a novel loop-mediated isothermal amplification (LAMP) assay for detection of S. haematobium DNA in human urine samples as a high-throughput, simple, accurate and affordable diagnostic tool to use in diagnosis of urogenital schistosomiasis. Methodology/Principal Findings A LAMP assay targeting a species specific sequence of S. haematobium ribosomal intergenic spacer was designed. The effectiveness of our LAMP was assessed in a number of patients´ urine samples with microscopy confirmed S. haematobium infection. For potentially large-scale application in field conditions, different DNA extraction methods, including a commercial kit, a modified NaOH extraction method and a rapid heating method were tested using small volumes of urine fractions (whole urine, supernatants and pellets). The heating of pellets from clinical samples was the most efficient method to obtain good-quality DNA detectable by LAMP. The detection limit of our LAMP was 1 fg/µL of S. haematobium DNA in urine samples. When testing all patients´ urine samples included in our study, diagnostic parameters for sensitivity and specificity were calculated for LAMP assay, 100% sensitivity (95% CI: 81.32%-100%) and 86.67% specificity (95% CI: 75.40%-94.05%), and also for microscopy detection of eggs in urine samples, 69.23% sensitivity (95% CI: 48.21% -85.63%) and 100% specificity (95% CI: 93.08%-100%). Conclusions/Significance We have developed and evaluated, for the first time, a LAMP assay for detection of S. haematobium DNA in heated pellets from patients´ urine samples using no complicated requirement procedure for DNA extraction. The procedure has been named the Rapid-Heat LAMPellet method and has the potential to be developed further as a field diagnostic tool for use in urogenital schistosomiasis-endemic areas. PMID:26230990

Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force.

PubMed

Cox, Linda; Williams, Brock; Sicherer, Scott; Oppenheimer, John; Sher, Larry; Hamilton, Robert; Golden, David

2008-12-01

The intended purpose of this monograph is to provide a general overview of allergy diagnostics for health care professionals who care for patients with allergic disease. For a more comprehensive review of allergy diagnostic testing, readers can refer to the Allergy Diagnostic Practice Parameters. A key message is that a positive allergy test result (skin or blood) indicates only the presence of allergen specific IgE (called sensitization). It does not necessarily mean clinical allergy (ie, allergic symptoms with exposure). It is important for this reason that the allergy evaluation be based on the patient's history and directed by a health care professional with sufficient understanding of allergy diagnostic testing to use the information obtained from his/her evaluation of the patient to determine (1) what allergy diagnostic tests to order, (2) how to interpret the allergy diagnostic test results, and (3) how to use the information obtained from the allergy evaluation to develop an appropriate therapeutic treatment plan.

A novel tool for user-friendly estimation of natural, diagnostic and professional radiation risk: Radio-Risk software.

PubMed

Carpeggiani, Clara; Paterni, Marco; Caramella, Davide; Vano, Eliseo; Semelka, Richard C; Picano, Eugenio

2012-11-01

Awareness of radiological risk is low among doctors and patients. An educational/decision tool that considers each patient' s cumulative lifetime radiation exposure would facilitate provider-patient communication. The purpose of this work was to develop user-friendly software for simple estimation and communication of radiological risk to patients and doctors as a part of the SUIT-Heart (Stop Useless Imaging Testing in Heart disease) Project of the Tuscany Region. We developed a novel software program (PC-platform, Windows OS fully downloadable at http://suit-heart.ifc.cnr.it) considering reference dose estimates from American Heart Association Radiological Imaging 2009 guidelines and UK Royal College of Radiology 2007 guidelines. Cancer age and gender-weighted risk were derived from Biological Effects of Ionising Radiation VII Committee, 2006. With simple input functions (demographics, age, gender) the user selects from a predetermined menu variables relating to natural (e.g., airplane flights and geo-tracked background exposure), professional (e.g., cath lab workers) and medical (e.g., CT, cardiac scintigraphy, coronary stenting) sources. The program provides a simple numeric (cumulative effective dose in milliSievert, mSv, and equivalent number of chest X-rays) and graphic (cumulative temporal trends of exposure, cancer cases out of 100 exposed persons) display. A simple software program allows straightforward estimation of cumulative dose (in multiples of chest X-rays) and risk (in extra % lifetime cancer risk), with simple numbers quantifying lifetime extra cancer risk. Pictorial display of radiation risk may be valuable for increasing radiological awareness in cardiologists. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

42 CFR 414.509 - Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.

Code of Federal Regulations, 2010 CFR

2010-10-01

... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory...

A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus.

PubMed

Golden, Allison; Stevens, Eric J; Yokobe, Lindsay; Faulx, Dunia; Kalnoky, Michael; Peck, Roger; Valdez, Melissa; Steel, Cathy; Karabou, Potochoziou; Banla, Méba; Soboslay, Peter T; Adade, Kangi; Tekle, Afework H; Cama, Vitaliano A; Fischer, Peter U; Nutman, Thomas B; Unnasch, Thomas R; de los Santos, Tala; Domingo, Gonzalo J

2016-01-01

Serological assays for human IgG4 to the Onchocerca volvulus antigen Ov16 have been used to confirm elimination of onchocerciasis in much of the Americas and parts of Africa. A standardized source of positive control antibody (human anti-Ov16 IgG4) will ensure the quality of surveillance data using these tests. A recombinant human IgG4 antibody to Ov16 was identified by screening against a synthetic human Fab phage display library and converted into human IgG4. This antibody was developed into different positive control formulations for enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT) platforms. Variation in ELISA results and utility as a positive control of the antibody were assessed from multiple laboratories. Temperature and humidity conditions were collected across seven surveillance activities from 2011-2014 to inform stability requirements for RDTs and positive controls. The feasibility of the dried positive control for RDT was evaluated during onchocerciasis surveillance activity in Togo, in 2014. When the anti-Ov16 IgG4 antibody was used as a standard dilution in horseradish peroxidase (HRP) and alkaline phosphatase (AP) ELISAs, the detection limits were approximately 1ng/mL by HRP ELISA and 10ng/mL by AP ELISA. Positive control dilutions and spiked dried blood spots (DBS) produced similar ELISA results. Used as a simple plate normalization control, the positive control antibody may improve ELISA data comparison in the context of inter-laboratory variation. The aggregate temperature and humidity monitor data informed temperature parameters under which the dried positive control was tested and are applicable inputs for testing of diagnostics tools intended for sub-Saharan Africa. As a packaged positive control for Ov16 RDTs, stability of the antibody was demonstrated for over six months at relevant temperatures in the laboratory and for over 15 weeks under field conditions. The recombinant human anti-Ov16 IgG4 antibody-based positive control will benefit inter-laboratory validation of ELISA assays and serve as quality control (QC) reagents for Ov16 RDTs at different points of the supply chain from manufacturer to field use.

[Simple and useful evaluation of motor difficulty in childhood (9-12 years old children ) by interview score on motor skills and soft neurological signs--aim for the diagnosis of developmental coordination disorder].

PubMed

Kashiwagi, Mitsuru; Suzuki, Shuhei

2009-09-01

Many children with developmental disorders are known to have motor impairment such as clumsiness and poor physical ability;however, the objective evaluation of such difficulties is not easy in routine clinical practice. In this study, we aimed to establish a simple method for evaluating motor difficulty of childhood. This method employs a scored interview and examination for detecting soft neurological signs (SNSs). After a preliminary survey with 22 normal children, we set the items and the cutoffs for the interview and SNSs. The interview consisted of questions pertaining to 12 items related to a child's motor skills in his/her past and current life, such as skipping, jumping a rope, ball sports, origami, and using chopsticks. The SNS evaluation included 5 tests, namely, standing on one leg with eyes closed, diadochokinesia, associated movements during diadochokinesia, finger opposition test, and laterally fixed gaze. We applied this method to 43 children, including 25 cases of developmental disorders. Children showing significantly high scores in both the interview and SNS were assigned to the "with motor difficulty" group, while those with low scores in both the tests were assigned to the "without motor difficulty" group. The remaining children were assigned to the "with suspicious motor difficulty" group. More than 90% of the children in the "with motor difficulty" group had high impairment scores in Movement Assessment Battery for Children (M-ABC), a standardized motor test, whereas 82% of the children in the "without motor difficulty" group revealed no motor impairment. Thus, we conclude that our simple method and criteria would be useful for the evaluation of motor difficulty of childhood. Further, we have discussed the diagnostic process for developmental coordination disorder using our evaluation method.

Multi-energy x-ray imaging and sensing for diagnostic and control of the burning plasma.

PubMed

Stutman, D; Tritz, K; Finkenthal, M

2012-10-01

New diagnostic and sensor designs are needed for future burning plasma (BP) fusion experiments, having good space and time resolution and capable of prolonged operation in the harsh BP environment. We evaluate the potential of multi-energy x-ray imaging with filtered detector arrays for BP diagnostic and control. Experimental studies show that this simple and robust technique enables measuring with good accuracy, speed, and spatial resolution the T(e) profile, impurity content, and MHD activity in a tokamak. Applied to the BP this diagnostic could also serve for non-magnetic sensing of the plasma position, centroid, ELM, and RWM instability. BP compatible x-ray sensors are proposed using "optical array" or "bi-cell" detectors.

Audible handheld Doppler ultrasound determines reliable and inexpensive exclusion of significant peripheral arterial disease.

PubMed

Alavi, Afsaneh; Sibbald, R Gary; Nabavizadeh, Reza; Valaei, Farnaz; Coutts, Pat; Mayer, Dieter

2015-12-01

To determine the accuracy of audible arterial foot signals with an audible handheld Doppler ultrasound for identification of significant peripheral arterial disease as a simple, quick, and readily available bedside screening tool. Two hundred consecutive patients referred to an interprofessional wound care clinic underwent audible handheld Doppler ultrasound of both legs. As a control and comparator, a formal bilateral lower leg vascular study including the calculation of Ankle Brachial Pressure Index and toe pressure (TP) was performed at the vascular lab. Diagnostic reliability of audible handheld Doppler ultrasound was calculated versus Ankle Brachial Pressure Index as the gold standard test. A sensitivity of 42.8%, a specificity of 97.5%, negative predictive value of 94.10%, positive predictive value of 65.22%, positive likelihood ratio of 17.52, and negative likelihood ratio of 0.59. The univariable logistic regression model had an area under the curve of 0.78. There was a statistically significant difference at the 5% level between univariable and multivariable area under the curves of the dorsalis pedis and posterior tibial models (p < 0.001). Audible handheld Doppler ultrasound proved to be a reliable, simple, rapid, and inexpensive bedside exclusion test of peripheral arterial disease in diabetic and nondiabetic patients. © The Author(s) 2015.

A Probabilistic Model for Cushing's Syndrome Screening in At-Risk Populations: A Prospective Multicenter Study.

PubMed

León-Justel, Antonio; Madrazo-Atutxa, Ainara; Alvarez-Rios, Ana I; Infantes-Fontán, Rocio; Garcia-Arnés, Juan A; Lillo-Muñoz, Juan A; Aulinas, Anna; Urgell-Rull, Eulàlia; Boronat, Mauro; Sánchez-de-Abajo, Ana; Fajardo-Montañana, Carmen; Ortuño-Alonso, Mario; Salinas-Vert, Isabel; Granada, Maria L; Cano, David A; Leal-Cerro, Alfonso

2016-10-01

Cushing's syndrome (CS) is challenging to diagnose. Increased prevalence of CS in specific patient populations has been reported, but routine screening for CS remains questionable. To decrease the diagnostic delay and improve disease outcomes, simple new screening methods for CS in at-risk populations are needed. To develop and validate a simple scoring system to predict CS based on clinical signs and an easy-to-use biochemical test. Observational, prospective, multicenter. Referral hospital. A cohort of 353 patients attending endocrinology units for outpatient visits. All patients were evaluated with late-night salivary cortisol (LNSC) and a low-dose dexamethasone suppression test for CS. Diagnosis or exclusion of CS. Twenty-six cases of CS were diagnosed in the cohort. A risk scoring system was developed by logistic regression analysis, and cutoff values were derived from a receiver operating characteristic curve. This risk score included clinical signs and symptoms (muscular atrophy, osteoporosis, and dorsocervical fat pad) and LNSC levels. The estimated area under the receiver operating characteristic curve was 0.93, with a sensitivity of 96.2% and specificity of 82.9%. We developed a risk score to predict CS in an at-risk population. This score may help to identify at-risk patients in non-endocrinological settings such as primary care, but external validation is warranted.

[Evaluation of exercise capacity in pulmonary arterial hypertension].

PubMed

Demir, Rengin; Küçükoğlu, Mehmet Serdar

2010-12-01

Pulmonary arterial hypertension (PAH) is a life-threatening disease characterized by increased pulmonary vascular resistance that leads to right ventricular failure. The most common clinical features of PAH are dyspnea and exercise intolerance. Measurement of exercise capacity is of considerable importance for the assessment of disease severity as well as routine monitoring of disease. Maximal, symptom-limited, cardiopulmonary exercise test (CPET) is the gold standard for the evaluation of exercise capacity, whereby functions of several systems involved in exercise can be assessed, including cardiovascular, respiratory, and metabolic systems. However, in order to derive the most useful diagnostic information on physiologic limitations to exercise, CPET requires maximal effort of the patient, which can be difficult and risky for some severely ill patients. Moreover, it requires specific exercise equipment and measurement systems, and experienced and trained personnel. Thus, routine clinical use of CPET to assess exercise capacity in patients with PAH may not always be feasible. A practical and simple alternative to CPET to determine exercise capacity is the 6-minute walk test (6MWT). It is simple to perform, safe, and reproducible. In contrast to CPET, the 6MWT reflects a submaximal level of exertion that is more consistent with the effort required for daily physical activities. This review focuses on the role of CPET and 6MWT in patients with PAH.

Use of Fine Needle Aspirate from Peripheral Nerves of Pure-neural Leprosy for Cytology and Polymerase Chain Reaction to Confirm the Diagnosis: A Follow-up Study of 4 Years

PubMed Central

De, Abhishek; Hasanoor Reja, Abu Hena; Aggarwal, Ishad; Sen, Sumit; Sil, Amrita; Bhattacharya, Basudev; Sharma, Nidhi; Ansari, Asad; Sarda, Aarti; Chatterjee, Gobinda; Das, Sudip

2017-01-01

Background: Pure neural leprosy (PNL) still remains a diagnostic challenge because of the absence of sine qua non skin lesions of leprosy and a confirmatory diagnostic method. The authors had earlier described a simple yet objective technique of combining fine needle aspiration cytology (FNAC) coupled with a multiplex polymerase chain reaction (PCR) in a pilot study, wherein the technique showed promise of a reliable diagnostic tool. In the pursuit of further evidence, the authors carried out a 4-year study with PNL cases to find the efficacy and reliability of the said method in a larger sample size. Aim: This study was conducted to find the efficacy, reliability, and reproducibility of FNAC coupled with multiplex PCR and Ziehl-Neelsen (ZN) staining in identifying the cases of PNL. Materials and Methods: All cases that were suspected to be suffering from PNL, following evaluation by two independent observers were included in the study and were subjected to FNAC from the affected nerve, and the aspirates were evaluated for cytology, ZN staining, and multiplex PCR for Mycobacterium leprae genome. In addition, serum anti-PGL1 levels were also performed in all the study subjects. Fifteen non-PNL cases were also included in the control arm. Results: A total of 47 cases were included in the test arm and subjected to FNAC. Conventional ZN staining could demonstrate acid-fast bacilli (AFB) in only 15 out of 47 cases (31.91%) while M. leprae DNA could be elicited in 37 (78.72%) cases by the multiplex PCR. Only 13 (27.65%) out of 47 cases showed anti-PGLI-1 antibody positivity. On cytological examination of the nerve aspirates, only 11 (23.40%) cases showed epithelioid cells whereas nonspecific inflammation was seen in 26 (75.60%) cases. Conclusion: The results of this study conducted over a larger sample size corroborate with the findings of our pilot study. In a resource poor set up, FNAC in combination with ZN staining and multiplex PCR is a rapid, simple, and easily performed test, which can give a reproducible and objective diagnosis in cases of PNL. PMID:29263539

[Accuracy of three methods for the rapid diagnosis of oral candidiasis].

PubMed

Lyu, X; Zhao, C; Yan, Z M; Hua, H

2016-10-09

Objective: To explore a simple, rapid and efficient method for the diagnosis of oral candidiasis in clinical practice. Methods: Totally 124 consecutive patients with suspected oral candidiasis were enrolled from Department of Oral Medicine, Peking University School and Hospital of Stomatology, Beijing, China. Exfoliated cells of oral mucosa and saliva or concentrated oral rinse) obtained from all participants were tested by three rapid smear methods(10% KOH smear, gram-stained smear, Congo red stained smear). The diagnostic efficacy(sensitivity, specificity, Youden's index, likelihood ratio, consistency, predictive value and area under curve(AUC) of each of the above mentioned three methods was assessed by comparing the results with the gold standard(combination of clinical diagnosis, laboratory diagnosis and expert opinion). Results: Gram-stained smear of saliva(or concentrated oral rinse) demonstrated highest sensitivity(82.3%). Test of 10%KOH smear of exfoliated cells showed highest specificity(93.5%). Congo red stained smear of saliva(or concentrated oral rinse) displayed highest diagnostic efficacy(79.0% sensitivity, 80.6% specificity, 0.60 Youden's index, 4.08 positive likelihood ratio, 0.26 negative likelihood ratio, 80% consistency, 80.3% positive predictive value, 79.4% negative predictive value and 0.80 AUC). Conclusions: Test of Congo red stained smear of saliva(or concentrated oral rinse) could be used as a point-of-care tool for the rapid diagnosis of oral candidiasis in clinical practice. Trial registration: Chinese Clinical Trial Registry, ChiCTR-DDD-16008118.

A Novel Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-14-2-0195 TITLE: A Novel Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis PRINCIPAL INVESTIGATOR...Field-Deployable Point-of-Care Diagnostic Test for Cutaneous Leishmaniasis 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S...Month % completion Aim 1: To use simulated field conditions to optimize and produce the established RPA lateral flow diagnostic test for POC

Special Educator's Complete Guide to 109 Diagnostic Tests: How To Select & Interpret Tests, Use Results in IEPs, and Remediate Specific Difficulties.

ERIC Educational Resources Information Center

Pierangelo, Roger; Giuliani, George

This manual is a guide to the special education diagnostic process and covers the various stages of evaluation, interpretation, diagnosis, prescription, and remediation. Test information includes: explanations of the most commonly used diagnostic tests, coverage of the areas measured by each test, interpretation of test patterns for commonly used…

Development of a Simple Tool for Identifying Alcohol Use Disorder in Female Korean Drinkers from Previous Questionnaires.

PubMed

Seo, Yu Ri; Kim, Jong Sung; Kim, Sung Soo; Yoon, Seok Joon; Suh, Won Yoon; Youn, Kwangmi

2016-01-01

This study aimed to develop a simple tool for identifying alcohol use disorders in female Korean drinkers from previous questionnaires. This research was conducted on 400 women who consumed at least one alcoholic drink during the past month and visited the health promotion center at Chungnam National University Hospital between June 2013 to May 2014. Drinking habits and alcohol use disorders were assessed by structured interviews using the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition diagnostic criteria. The subjects were also asked to answer the Alcohol Use Disorders Identification Test (AUDIT), AUDIT-Consumption, CAGE (Cut down, Annoyed, Guilty, Eye-opener), TWEAK (Tolerance, Worried, Eye-opener, Amnesia, Kut down), TACE (Tolerance, Annoyed, Cut down, Eye-opener), and NET (Normal drinker, Eye-opener, Tolerance) questionnaires. The area under receiver operating characteristic (AUROC) of each question of the questionnaires on alcohol use disorders was assessed. After combining two questions with the largest AUROC, it was compared to other previous questionnaires. Among the 400 subjects, 58 (14.5%) were identified as having an alcohol use disorder. Two questions with the largest AUROC were question no. 7 in AUDIT, "How often during the last year have you had a feeling of guilt or remorse after drinking?" and question no. 5 in AUDIT, "How often during the past year have you failed to do what was normally expected from you because of drinking?" with an AUROC (95% confidence interval [CI]) of 0.886 (0.850-0.915) and 0.862 (0.824-0.894), respectively. The AUROC (95% CI) of the combination of the two questions was 0.958 (0.934-0.976) with no significant difference as compared to the existing AUDIT with the largest AUROC. The above results suggest that the simple tool consisting of questions no. 5 and no. 7 in AUDIT is useful in identifying alcohol use disorders in Korean female drinkers.

Demonstration of the use of ADAPT to derive predictive maintenance algorithms for the KSC central heat plant

NASA Technical Reports Server (NTRS)

Hunter, H. E.

1972-01-01

The Avco Data Analysis and Prediction Techniques (ADAPT) were employed to determine laws capable of detecting failures in a heat plant up to three days in advance of the occurrence of the failure. The projected performance of algorithms yielded a detection probability of 90% with false alarm rates of the order of 1 per year for a sample rate of 1 per day with each detection, followed by 3 hourly samplings. This performance was verified on 173 independent test cases. The program also demonstrated diagnostic algorithms and the ability to predict the time of failure to approximately plus or minus 8 hours up to three days in advance of the failure. The ADAPT programs produce simple algorithms which have a unique possibility of a relatively low cost updating procedure. The algorithms were implemented on general purpose computers at Kennedy Space Flight Center and tested against current data.

A Rotatable Quality Control Phantom for Evaluating the Performance of Flat Panel Detectors in Imaging Moving Objects.

PubMed

Haga, Yoshihiro; Chida, Koichi; Inaba, Yohei; Kaga, Yuji; Meguro, Taiichiro; Zuguchi, Masayuki

2016-02-01

As the use of diagnostic X-ray equipment with flat panel detectors (FPDs) has increased, so has the importance of proper management of FPD systems. To ensure quality control (QC) of FPD system, an easy method for evaluating FPD imaging performance for both stationary and moving objects is required. Until now, simple rotatable QC phantoms have not been available for the easy evaluation of the performance (spatial resolution and dynamic range) of FPD in imaging moving objects. We developed a QC phantom for this purpose. It consists of three thicknesses of copper and a rotatable test pattern of piano wires of various diameters. Initial tests confirmed its stable performance. Our moving phantom is very useful for QC of FPD images of moving objects because it enables visual evaluation of image performance (spatial resolution and dynamic range) easily.

Advances in paper-based sample pretreatment for point-of-care testing.

PubMed

Tang, Rui Hua; Yang, Hui; Choi, Jane Ru; Gong, Yan; Feng, Shang Sheng; Pingguan-Murphy, Belinda; Huang, Qing Sheng; Shi, Jun Ling; Mei, Qi Bing; Xu, Feng

2017-06-01

In recent years, paper-based point-of-care testing (POCT) has been widely used in medical diagnostics, food safety and environmental monitoring. However, a high-cost, time-consuming and equipment-dependent sample pretreatment technique is generally required for raw sample processing, which are impractical for low-resource and disease-endemic areas. Therefore, there is an escalating demand for a cost-effective, simple and portable pretreatment technique, to be coupled with the commonly used paper-based assay (e.g. lateral flow assay) in POCT. In this review, we focus on the importance of using paper as a platform for sample pretreatment. We firstly discuss the beneficial use of paper for sample pretreatment, including sample collection and storage, separation, extraction, and concentration. We highlight the working principle and fabrication of each sample pretreatment device, the existing challenges and the future perspectives for developing paper-based sample pretreatment technique.

Interaction between a steady detonation wave in nitromethane and geometrical complex confinement defects.

NASA Astrophysics Data System (ADS)

Crouzet, Blandine; Carion, Noel; Manczur, Philippe

2007-06-01

It is well known that detonation propagation is altered if the explosive is encased in an inert confining material. But in practice, explosives are rarely used without confinement and particular attention must be paid to the problem of explosive/confinement interactions. In this work, we have carried out two copper cylinder expansion tests on nitromethane. They differ from the classical cylinder test in that the liner includes evenly-spaced protruding circular defects. The aim is to study how a detonation front propagating in the liquid explosive interacts with the confining material defects. The subsequent motion of the metal, accelerated by the expanding detonation products, is measured using a range of diagnostic techniques: electrical probes, rapid framing camera, glass block associated with streak camera and velocity laser interferometers. The different experimental records have been examined in the light of a simple 2D theoretical shock polar analysis and 2D numerical simulations.

Multi-Center Evaluation of the Fully Automated PCR-Based Idylla™ KRAS Mutation Assay for Rapid KRAS Mutation Status Determination on Formalin-Fixed Paraffin-Embedded Tissue of Human Colorectal Cancer

PubMed Central

Solassol, Jérôme; Vendrell, Julie; Märkl, Bruno; Haas, Christian; Bellosillo, Beatriz; Montagut, Clara; Smith, Matthew; O’Sullivan, Brendan; D’Haene, Nicky; Le Mercier, Marie; Grauslund, Morten; Melchior, Linea Cecilie; Burt, Emma; Cotter, Finbarr; Stieber, Daniel; Schmitt, Fernando de Lander; Motta, Valentina; Lauricella, Calogero; Colling, Richard; Soilleux, Elizabeth; Fassan, Matteo; Mescoli, Claudia; Collin, Christine; Pagès, Jean-Christophe; Sillekens, Peter

2016-01-01

Since the advent of monoclonal antibodies against epidermal growth factor receptor (EGFR) in colorectal cancer therapy, the determination of RAS mutational status is needed for therapeutic decision-making. Most prevalent in colorectal cancer are KRAS exon 2 mutations (40% prevalence); lower prevalence is observed for KRAS exon 3 and 4 mutations (6%) and NRAS exon 2, 3, and 4 mutations (5%). The Idylla™ KRAS Mutation Test on the molecular diagnostics Idylla™ platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) in vitro diagnostic sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the KRAS oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla™ KRAS Mutation Assay, for Research Use Only, was assessed on archived formalin-fixed paraffin-embedded (FFPE) tissue sections by comparing its results with the results previously obtained by routine reference approaches for KRAS genotyping. In case of discordance, samples were assessed further by additional methods. Among the 374 colorectal cancer FFPE samples tested, the overall concordance between the Idylla™ KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla™ KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla™ KRAS Mutation Test can be applied as routine tool in any clinical setting, without needing molecular infrastructure or expertise, to guide the personalized treatment of colorectal cancer patients. PMID:27685259

NutriPhone: vitamin B12 testing on your smartphone (Conference Presentation)

NASA Astrophysics Data System (ADS)

Lee, Seoho; O'Dell, Dakota; Hohenstein, Jessica; Colt, Susannah; Mehta, Saurabh; Erickson, David

2016-03-01

Vitamin B12 deficiency is the leading cause of cognitive decline in the elderly and is associated with increased risks of several acute and chronic conditions including anemia. The deficiency is prevalent among the world population, most of whom are unaware of their condition due to the lack of a simple diagnostics system. Recent advancements in the smartphone-enabled mobile health can help address this problem by making the deficiency tests more accessible. Previously, our group has demonstrated the NutriPhone, a smartphone platform for the accurate quantification of vitamin D levels. The NutriPhone technology comprises of a disposable test strip that performs a colorimetric reaction upon collecting a sample, a reusable accessory that interfaces with the smartphone camera, and a smartphone app that stores the algorithm for analyzing the test-strip reaction. In this work, we show that the NutriPhone can be expanded to measure vitamin B12 concentrations by developing a lateral flow assay for B12 that is compatible with our NutriPhone system. Our novel vitamin B12 assay incorporates blood sample processing and key reagent storage on-chip, which advances it into a sample-in-answer-out format that is suitable for point-of-care diagnostic applications. In order to enable the detection of pM levels of vitamin B12 levels, silver amplification of the initial signal is used within the total assay time of less than 15 minutes. We demonstrate the effectiveness of our NutriPhone system by deploying it in a resource-limited clinical setting in India where it is used to test tens of participants for vitamin B12 deficiency.

A study of a self diagnostic platform for the detection of A2 biomarker for Leishmania donovani

NASA Astrophysics Data System (ADS)

Roche, Philip J. R.; Cheung, Maurice C.; Najih, Mohamed; McCall, Laura-Isobel; Fakih, Ibrahim; Chodavarapu, Vamsy P.; Ward, Brian; Ndao, Momar; Kirk, Andrew G.

2012-03-01

Visceral leishmaniasis (L.donovani) is a protozoan infection that attacks mononuclear phagocytes and causes the liver and spleen damage that can cause death. The investigation presented is a proof of concept development applying a plasmonic diagnostic platform with simple microfluidic sample delivery and optical readout. An immune-assay method is applied to the quantification of A2 protein, a highly immunogenic biomarker for the pathogen. Quantification of A2 was performed in the ng/ml range, analysis by ELISA suggested that a limit of 0.1ng/ml of A2 is approximate to 1 pathogen per ml and the sensing system shows the potential to deliver a similar level of quantification. Significant reduction in assay complexity as further enzyme linked enhancement is not required when applying a plasmonic methodology to an immunoassay. The basic instrumentation required for a portable device and potential dual optical readout where both plasmonic and photoluminescent response are assessed and investigated including consideration of the application of the device to testing where non-literate communication of results is considered and issues of performance are addressed.

Combining simple patient-oriented tests with state-of-the-art molecular diagnostics for early diagnosis of cancer.

PubMed

Fitzgerald, Rebecca C

2015-06-01

Early diagnosis is an important strategy to improve outcomes from cancer. Oesophageal adenocarcinoma is an example of a cancer that presents late, with very poor outcomes, and for which the presence of the precursor lesion Barrett's oesophagus provides the opportunity to intervene at an early stage. In this review, I describe the challenges in the field and the work that we have done to devise a conceptually novel approach to early diagnosis, using a cell collection device (Cytosponge), coupled with molecular assays. This is a personal perspective in which I also describe the career pathway that led me into academic gastroenterology, and the rewards and challenges of translational research in molecular diagnostics. There are fantastic opportunities for clinicians wishing to pursue academic medicine, because it is a time when massive strides are being made in a whole number of areas; for example: imaging, sequencing technology and targeted therapies. Clinicians who can straddle the laboratory and the clinic are essential, to maximise the progress that can be made for the benefit of patients.

[Iron deficiency anaemia: clinical presentation, biological diagnosis and management].

PubMed

Espanel, C; Kafando, E; Hérault, B; Petit, A; Herault, O; Binet, C

2007-05-01

The iron deficiency is the first cause of anaemia. In healthy young adult, anemia is well tolerated because of its progressive installation. The most common symptoms of anemia are pallor, fatigue and dyspnea. In biological exams, anemia is classically associated with microcytosis and hypochromia. The origins of microcytic anemia are iron deficiency, inflammatory aetiologies, thalassemia and sideroblastic anaemia. The iron-deficiency diagnosis includes two explorations: biological and clinical. The biological exploration is based on interpretation of serum biologics tests as blood iron, ferritin, transferrin with saturation, total iron-binding capacity and its soluble receptors. This interpretation is simple if it is not associated with clinical disorders influencing the internal iron cycle. The clinical exploration must always be followed by a careful assessment of the underlying cause as blood loss. The most common causes in women of reproductive age are gynaecologic. In men and menopausal women, the gastrointestinal tract bleeding is source of anemia. Therapeutic management of anemia is oral iron therapy. Etiological diagnostic of microcytosis is essential before iron therapy. If not, the treatment could be inefficient or it could mask or delay the etiological diagnostic.

Blast-Loading Assessment of Multi-Energy Flash Computed Tomography (MEFCT) Diagnostic

DTIC Science & Technology

2016-08-01

Perrella JA, Sturgill JM. Design of a simple blast pressure gauge based on a heterodyne velocimetry measuring technique. Aberdeen Proving Ground (MD...position unless so designated by other authorized documents. Citation of manufacturer’s or trade names does not constitute an official endorsement or...of the radiation dose throughout the angular span of the 150-, 300-, and 450-kV flash X-ray sources used in the MEFCT diagnostic: left image shows

How to: evaluate a diagnostic test.

PubMed

Leeflang, Mariska M G; Allerberger, Franz

2018-06-12

The development of an in vitro diagnostic test from a good idea to a clinically relevant tool takes several steps, with more stringent requirements at every step. This article aims to summarize the necessary questions to be asked about a test and to illustrate study designs answering these questions. We also aim to relate the Regulation (EU) 2017/746 to the needs of evidence-based diagnostic testing, where applicable. We used literature on evidence-based diagnostics, a text book on clinical trials in the development and marketing of medical devices and the English version of Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices. The combination of different test uses and different stages of development determine the required test characteristics and suitability of study designs. In an earlier stage of test development it may be crucial to know whether a test can differentiate diseased persons from healthy controls, while this tells us little about how a test will perform in practice. Later stages focus on the diagnostic accuracy of a test in a clinically relevant situation. However, a test that perfectly distinguishes between patients with and without a certain condition may still have little effect on patient outcomes. Therefore, randomized controlled trials of testing may be needed, as well as post-marketing monitoring. Both researchers and users of tests need to be aware of the limitations of diagnostic test accuracy and realize that accuracy is only indirectly linked to people's health status. Copyright © 2018. Published by Elsevier Ltd.

A green and facile approach for synthesizing imine to develop optical biosensor for wide range detection of bilirubin in human biofluids.

PubMed

Ellairaja, Sundaram; Shenbagavalli, Kathiravan; Ponmariappan, Sarkaraisamy; Vasantha, Vairathevar Sivasamy

2017-05-15

Bilirubin, a key biomarker for the jaundice and its clinical diagnosis needs a better analytical tool. A novel and simple fluorescent platform based on (2,2'-((1E,1'E)-((6-bromopyridine-2,3-diyl) bis(azanylylidene)) bis(methanylylidene diphenol) (BAMD) was designed. BAMD showed a remarkable fluorescent intensity with a very good quantum yield of 0.85 and lifetime of 870ps. Hence, it was applied for the determination of bilirubin using both colorimetric and fluorimetric techniques in physiological and basic pH. Under optimized experimental conditions, the probe detects bilirubin selectively in the presence of other interfering biomolecules and metal ions. The linear range of detection is 1pM-500µM at pH=7.4 and LOD is 2.8 and 3.3 pM at pH=7.4 and 9.0, respectively, which were reported so far. The probe detects the bilirubin through FRET mechanism. The practical application of the probe was successfully tested in the human blood and urine samples. Based on all above advantages, this simple idea can be applied to design a simple clinical diagnostic tool for jaundice. Copyright © 2016. Published by Elsevier B.V.

Text Based Analogy in Overcoming Student Misconception on Simple Electricity Circuit Material

NASA Astrophysics Data System (ADS)

Hesti, R.; Maknun, J.; Feranie, S.

2017-09-01

Some researcher have found that the use of analogy in learning and teaching physics was effective enough in giving comprehension in a complicated physics concept such as electrical circuits. Meanwhile, misconception become main cause that makes students failed when learning physics. To provide teaching physics effectively, the misconception should be resolved. Using Text Based Analogy is one of the way to identifying misconceptions and it is enough to assist teachers in conveying scientific truths in order to overcome misconceptions. The purpose of the study to investigate the use of text based analogy in overcoming students misconception on simple electrical circuit material. The samples of this research were 28 of junior high school students taken purposively from one high school in South Jakarta. The method use in this research is pre-experimental and design in one shot case study. Students who are the participants of sample have been identified misconception on the electrical circuit material by using the Diagnostic Test of Simple Electricity Circuit. The results of this study found that TBA can replace the misconceptions of the concept possessed by students with scientific truths conveyed in the text in a way that is easily understood so that TBA is strongly recommended to use in other physics materials.

Analysis of the ectoenzymes ADA, ALP, ENPP1, and ENPP3, in the contents of ovarian endometriomas as candidate biomarkers of endometriosis.

PubMed

Trapero, Carla; Jover, Lluis; Fernández-Montolí, Maria Eulàlia; García-Tejedor, Amparo; Vidal, August; Gómez de Aranda, Inmaculada; Ponce, Jordi; Matias-Guiu, Xavier; Martín-Satué, Mireia

2018-02-01

The diagnosis of endometriosis, a prevalent chronic disease with a strong inflammatory component, is usually delayed due to the lack of noninvasive diagnostic tests. Purinergic signaling, a key cell pathway, is altered in many inflammatory disorders. The aim of the present work was to evaluate the levels of adenosine deaminase (ADA), alkaline phosphatase (ALP), ecto-nucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1), and ENPP3, elements of purinergic signaling, as biomarker candidates for endometriosis. A case-control comparative study was conducted to determine ADA, ALP, ENPP1 and ENPP3 levels in echo-guided aspirated fluids of endometriomas (case group) and simple ovarian cysts (control group) using the ELISA technique. Adenosine deaminase, ALP, ENPP1, and ENPP3 were present and quantifiable in the contents of endometriomas and simple cysts. There were significant differences in ADA and ENPP1 levels in endometriomas in comparison with simple cysts (2787 U/L and 103.9 ng/mL more in endometriomas, for ADA and ENPP1, respectively). Comparisons of ALP and ENPP3 levels between the two groups did not reveal significant differences. The ectoenzymes ADA and ENPP1 are biomarker candidates for endometriosis. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

ACER Physics Unit Tests: Unit Tests, Diagnostic Aids, [and] Teachers Handbook.

ERIC Educational Resources Information Center

Australian Council for Educational Research, Hawthorn.

The Physics Unit Tests are designed to assist in the diagnostic evaluation of students' progress in the study of physics during the last two years of secondary schooling. They consist of a collection of 21 separate tests, each related to a different topic, and 21 diagnostic aids corresponding to the tests. The topics covered are: physical…

Direct detection and characterization of foot-and-mouth disease virus in East Africa using a field-ready real-time PCR platform.

PubMed

Howson, E L A; Armson, B; Lyons, N A; Chepkwony, E; Kasanga, C J; Kandusi, S; Ndusilo, N; Yamazaki, W; Gizaw, D; Cleaveland, S; Lembo, T; Rauh, R; Nelson, W M; Wood, B A; Mioulet, V; King, D P; Fowler, V L

2018-02-01

Effective control and monitoring of foot-and-mouth disease (FMD) relies upon rapid and accurate disease confirmation. Currently, clinical samples are usually tested in reference laboratories using standardized assays recommended by The World Organisation for Animal Health (OIE). However, the requirements for prompt and serotype-specific diagnosis during FMD outbreaks, and the need to establish robust laboratory testing capacity in FMD-endemic countries have motivated the development of simple diagnostic platforms to support local decision-making. Using a portable thermocycler, the T-COR™ 8, this study describes the laboratory and field evaluation of a commercially available, lyophilized pan-serotype-specific real-time RT-PCR (rRT-PCR) assay and a newly available FMD virus (FMDV) typing assay (East Africa-specific for serotypes: O, A, Southern African Territories [SAT] 1 and 2). Analytical sensitivity, diagnostic sensitivity and specificity of the pan-serotype-specific lyophilized assay were comparable to that of an OIE-recommended laboratory-based rRT-PCR (determined using a panel of 57 FMDV-positive samples and six non-FMDV vesicular disease samples for differential diagnosis). The FMDV-typing assay was able to correctly identify the serotype of 33/36 FMDV-positive samples (no cross-reactivity between serotypes was evident). Furthermore, the assays were able to accurately detect and type FMDV RNA in multiple sample types, including epithelial tissue suspensions, serum, oesophageal-pharyngeal (OP) fluid and oral swabs, both with and without the use of nucleic acid extraction. When deployed in laboratory and field settings in Tanzania, Kenya and Ethiopia, both assays reliably detected and serotyped FMDV RNA in samples (n = 144) collected from pre-clinical, clinical and clinically recovered cattle. These data support the use of field-ready rRT-PCR platforms in endemic settings for simple, highly sensitive and rapid detection and/or characterization of FMDV. © 2017 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.

Detection of Respiratory Viruses in Sputum from Adults by Use of Automated Multiplex PCR

PubMed Central

Walsh, Edward E.; Formica, Maria A.; Falsey, Ann R.

2014-01-01

Respiratory tract infections (RTI) frequently cause hospital admissions among adults. Diagnostic viral reverse transcriptase PCR (RT-PCR) of nose and throat swabs (NTS) is useful for patient care by informing antiviral use and appropriate isolation. However, automated RT-PCR systems are not amenable to utilizing sputum due to its viscosity. We evaluated a simple method of processing sputum samples in a fully automated respiratory viral panel RT-PCR assay (FilmArray). Archived sputum and NTS samples collected in 2008-2012 from hospitalized adults with RTI were evaluated. A subset of sputum samples positive for 10 common viruses by a uniplex RT-PCR was selected. A sterile cotton-tip swab was dunked in sputum, swirled in 700 μL of sterile water (dunk and swirl method) and tested by the FilmArray assay. Quantitative RT-PCR was performed on “dunked” sputum and NTS samples for influenza A (Flu A), respiratory syncytial virus (RSV), coronavirus OC43 (OC43), and human metapneumovirus (HMPV). Viruses were identified in 31% of 965 illnesses using a uniplex RT-PCR. The sputum sample was the only sample positive for 105 subjects, including 35% (22/64) of influenza cases and significantly increased the diagnostic yield of NTS alone (302/965 [31%] versus 197/965 [20%]; P = 0.0001). Of 108 sputum samples evaluated by the FilmArray assay using the dunk and swirl method, 99 (92%) were positive. Quantitative RT-PCR revealed higher mean viral loads in dunked sputum samples compared to NTS samples for Flu A, RSV, and HMPV (P = 0.0001, P = 0.006, and P = 0.011, respectively). The dunk and swirl method is a simple and practical method for reliably processing sputum samples in a fully automated PCR system. The higher viral loads in sputa may increase detection over NTS testing alone. PMID:25056335

Meta-analysis for the comparison of two diagnostic tests to a common gold standard: A generalized linear mixed model approach.

PubMed

Hoyer, Annika; Kuss, Oliver

2018-05-01

Meta-analysis of diagnostic studies is still a rapidly developing area of biostatistical research. Especially, there is an increasing interest in methods to compare different diagnostic tests to a common gold standard. Restricting to the case of two diagnostic tests, in these meta-analyses the parameters of interest are the differences of sensitivities and specificities (with their corresponding confidence intervals) between the two diagnostic tests while accounting for the various associations across single studies and between the two tests. We propose statistical models with a quadrivariate response (where sensitivity of test 1, specificity of test 1, sensitivity of test 2, and specificity of test 2 are the four responses) as a sensible approach to this task. Using a quadrivariate generalized linear mixed model naturally generalizes the common standard bivariate model of meta-analysis for a single diagnostic test. If information on several thresholds of the tests is available, the quadrivariate model can be further generalized to yield a comparison of full receiver operating characteristic (ROC) curves. We illustrate our model by an example where two screening methods for the diagnosis of type 2 diabetes are compared.

Efficient fault diagnosis of helicopter gearboxes

NASA Technical Reports Server (NTRS)

Chin, H.; Danai, K.; Lewicki, D. G.

1993-01-01

Application of a diagnostic system to a helicopter gearbox is presented. The diagnostic system is a nonparametric pattern classifier that uses a multi-valued influence matrix (MVIM) as its diagnostic model and benefits from a fast learning algorithm that enables it to estimate its diagnostic model from a small number of measurement-fault data. To test this diagnostic system, vibration measurements were collected from a helicopter gearbox test stand during accelerated fatigue tests and at various fault instances. The diagnostic results indicate that the MVIM system can accurately detect and diagnose various gearbox faults so long as they are included in training.

The impact of new trends in POCTs for companion diagnostics, non-invasive testing and molecular diagnostics.

PubMed

Huckle, David

2015-06-01

Point-of-care diagnostics have been slowly developing over several decades and have taken on a new importance in current healthcare delivery for both diagnostics and development of new drugs. Molecular diagnostics have become a key driver of technology change and opened up new areas in companion diagnostics for use alongside pharmaceuticals and in new clinical approaches such as non-invasive testing. Future areas involving smartphone and other information technology advances, together with new developments in molecular biology, microfluidics and surface chemistry are adding to advances in the market. The focus for point-of-care tests with molecular diagnostic technologies is focused on advancing effective applications.

42 CFR 419.2 - Basis of payment.

Code of Federal Regulations, 2012 CFR

2012-10-01

... prospective payment system establishes a national payment rate, standardized for geographic wage differences...) Capital-related costs; (9) Implantable items used in connection with diagnostic X-ray tests, diagnostic laboratory tests, and other diagnostic tests; (10) Durable medical equipment that is implantable; (11...

Laboratory Information Systems in Molecular Diagnostics: Why Molecular Diagnostics Data are Different.

PubMed

Lee, Roy E; Henricks, Walter H; Sirintrapun, Sahussapont J

2016-03-01

Molecular diagnostic testing presents new challenges to information management that are yet to be sufficiently addressed by currently available information systems for the molecular laboratory. These challenges relate to unique aspects of molecular genetic testing: molecular test ordering, informed consent issues, diverse specimen types that encompass the full breadth of specimens handled by traditional anatomic and clinical pathology information systems, data structures and data elements specific to molecular testing, varied testing workflows and protocols, diverse instrument outputs, unique needs and requirements of molecular test reporting, and nuances related to the dissemination of molecular pathology test reports. By satisfactorily addressing these needs in molecular test data management, a laboratory information system designed for the unique needs of molecular diagnostics presents a compelling reason to migrate away from the current paper and spreadsheet information management that many molecular laboratories currently use. This paper reviews the issues and challenges of information management in the molecular diagnostics laboratory.

9 CFR 93.406 - Diagnostic tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Diagnostic tests. 93.406 Section 93... CONVEYANCE AND SHIPPING CONTAINERS Ruminants § 93.406 Diagnostic tests. (a) Tuberculosis and brucellosis tests of cattle. Except as provided in paragraph (d) of this section and in §§ 93.418, 93.427(d), and 93...

9 CFR 93.406 - Diagnostic tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Diagnostic tests. 93.406 Section 93... CONVEYANCE AND SHIPPING CONTAINERS Ruminants § 93.406 Diagnostic tests. (a) Tuberculosis and brucellosis tests of cattle. Except as provided in paragraph (d) of this section and in §§ 93.418, 93.427(d), and 93...

A Three-Tier Diagnostic Test to Assess Pre-Service Teachers' Misconceptions about Global Warming, Greenhouse Effect, Ozone Layer Depletion, and Acid Rain

ERIC Educational Resources Information Center

Arslan, Harika Ozge; Cigdemoglu, Ceyhan; Moseley, Christine

2012-01-01

This study describes the development and validation of a three-tier multiple-choice diagnostic test, the atmosphere-related environmental problems diagnostic test (AREPDiT), to reveal common misconceptions of global warming (GW), greenhouse effect (GE), ozone layer depletion (OLD), and acid rain (AR). The development of a two-tier diagnostic test…

Artificial Neural Network Based Fault Diagnostics of Rolling Element Bearings Using Time-Domain Features

NASA Astrophysics Data System (ADS)

Samanta, B.; Al-Balushi, K. R.

2003-03-01

A procedure is presented for fault diagnosis of rolling element bearings through artificial neural network (ANN). The characteristic features of time-domain vibration signals of the rotating machinery with normal and defective bearings have been used as inputs to the ANN consisting of input, hidden and output layers. The features are obtained from direct processing of the signal segments using very simple preprocessing. The input layer consists of five nodes, one each for root mean square, variance, skewness, kurtosis and normalised sixth central moment of the time-domain vibration signals. The inputs are normalised in the range of 0.0 and 1.0 except for the skewness which is normalised between -1.0 and 1.0. The output layer consists of two binary nodes indicating the status of the machine—normal or defective bearings. Two hidden layers with different number of neurons have been used. The ANN is trained using backpropagation algorithm with a subset of the experimental data for known machine conditions. The ANN is tested using the remaining set of data. The effects of some preprocessing techniques like high-pass, band-pass filtration, envelope detection (demodulation) and wavelet transform of the vibration signals, prior to feature extraction, are also studied. The results show the effectiveness of the ANN in diagnosis of the machine condition. The proposed procedure requires only a few features extracted from the measured vibration data either directly or with simple preprocessing. The reduced number of inputs leads to faster training requiring far less iterations making the procedure suitable for on-line condition monitoring and diagnostics of machines.

Development of a species-specific coproantigen ELISA for human Taenia solium taeniasis.

PubMed

Guezala, Maria-Claudia; Rodriguez, Silvia; Zamora, Humberto; Garcia, Hector H; Gonzalez, Armando E; Tembo, Alice; Allan, James C; Craig, Philip S

2009-09-01

Taenia solium causes human neurocysticercosis and is endemic in underdeveloped countries where backyard pig keeping is common. Microscopic fecal diagnostic methods for human T. solium taeniasis are not very sensitive, and Taenia saginata and Taenia solium eggs are indistinguishable under the light microscope. Coproantigen (CoAg) ELISA methods are very sensitive, but currently only genus (Taenia) specific. This paper describes the development of a highly species-specific coproantigen ELISA test to detect T. solium intestinal taeniasis. Sensitivity was maintained using a capture antibody of rabbit IgG against T. solium adult whole worm somatic extract, whereas species specificity was achieved by utilization of an enzyme-conjugated rabbit IgG against T. solium adult excretory-secretory (ES) antigen. A known panel of positive and negative human fecal samples was tested with this hybrid sandwich ELISA. The ELISA test gave 100% specificity and 96.4% sensitivity for T. solium tapeworm carriers (N = 28), with a J index of 0.96. This simple ELISA incorporating anti-adult somatic and anti-adult ES antibodies provides the first potentially species-specific coproantigen test for human T. solium taeniasis.

Streptococcus group B typing: comparison of counter-immunoelectrophoresis with the precipitin method.

PubMed

Kubín, V; Jelínková, J; Franêk, J

1977-07-01

The method of counter-immunoelectrophoresis (CIE) was tested for its applicability to group B streptococcus typing. The results obtained were compared with the typing by the ring precipitin test. Identical antigens and identical hyperimmune typing serum batches had been used in both methods. A large majority of 75 freshly isolated strains were typed identically by both methods. Five strains with a weak antigenic outfit were untypable by the ring precipitin test but were typed by CIE owing to a higher sensitivity of CIE method. Two strains were typable by the precipitin test but not by CIE; an explanation for this phenomenon is lacking. The CIE method in group B typing is specific, rapid, highly sensitive and relatively simple. It requires strict maintenance of standard conditions. The method is economical with respect to manipulation and material, requires small amounts of diagnostic antisera. Potent antisera may be used diluted. Moreover, sera for CIE typing need not be absorbed to remove group B antibodies. CIE method is practicable for group B streptococcus typing, especially in laboratories carrying out routine large scale type identification.

Development of a Rapid Point-of-Use DNA Test for the Screening of Genuity® Roundup Ready 2 Yield® Soybean in Seed Samples.

PubMed

Chandu, Dilip; Paul, Sudakshina; Parker, Mathew; Dudin, Yelena; King-Sitzes, Jennifer; Perez, Tim; Mittanck, Don W; Shah, Manali; Glenn, Kevin C; Piepenburg, Olaf

2016-01-01

Testing for the presence of genetically modified material in seed samples is of critical importance for all stakeholders in the agricultural industry, including growers, seed manufacturers, and regulatory bodies. While rapid antibody-based testing for the transgenic protein has fulfilled this need in the past, the introduction of new variants of a given transgene demands new diagnostic regimen that allows distinguishing different traits at the nucleic acid level. Although such molecular tests can be performed by PCR in the laboratory, their requirement for expensive equipment and sophisticated operation have prevented its uptake in point-of-use applications. A recently developed isothermal DNA amplification technique, recombinase polymerase amplification (RPA), combines simple sample preparation and amplification work-flow procedures with the use of minimal detection equipment in real time. Here, we report the development of a highly sensitive and specific RPA-based detection system for Genuity Roundup Ready 2 Yield (RR2Y) material in soybean (Glycine max) seed samples and present the results of studies applying the method in both laboratory and field-type settings.

Diagnostic accuracy of intracellular mycobacterium tuberculosis detection for tuberculous meningitis.

PubMed

Feng, Guo-dong; Shi, Ming; Ma, Lei; Chen, Ping; Wang, Bing-ju; Zhang, Min; Chang, Xiao-lin; Su, Xiu-chu; Yang, Yi-ning; Fan, Xin-hong; Dai, Wen; Liu, Ting-ting; He, Ying; Bian, Ting; Duan, Li-xin; Li, Jin-ge; Hao, Xiao-ke; Liu, Jia-yun; Xue, Xin; Song, Yun-zhang; Wu, Hai-qin; Niu, Guo-qiang; Zhang, Li; Han, Cui-juan; Lin, Hong; Lin, Zhi-hui; Liu, Jian-jun; Jian, Qian; Zhang, Jin-she; Tian, Ye; Zhou, Bai-yu; Wang, Jing; Xue, Chang-hu; Han, Xiao-fang; Wang, Jian-feng; Wang, Shou-lian; Thwaites, Guy E; Zhao, Gang

2014-02-15

Early diagnosis and treatment of tuberculous meningitis saves lives, but current laboratory diagnostic tests lack sensitivity. We investigated whether the detection of intracellular bacteria by a modified Ziehl-Neelsen stain and early secretory antigen target (ESAT)-6 in cerebrospinal fluid leukocytes improves tuberculous meningitis diagnosis. Cerebrospinal fluid specimens from patients with suspected tuberculous meningitis were stained by conventional Ziehl-Neelsen stain, a modified Ziehl-Neelsen stain involving cytospin slides with Triton processing, and an ESAT-6 immunocytochemical stain. Acid-fast bacteria and ESAT-6-expressing leukocytes were detected by microscopy. All tests were performed prospectively in a central laboratory by experienced technicians masked to the patients' final diagnosis. Two hundred and eighty patients with suspected tuberculous meningitis were enrolled. Thirty-seven had Mycobacterium tuberculosis cultured from cerebrospinal fluid; 40 had a microbiologically confirmed alternative diagnosis; the rest had probable or possible tuberculous meningitis according to published criteria. Against a clinical diagnostic gold standard the sensitivity of conventional Ziehl-Neelsen stain was 3.3% (95% confidence interval, 1.6-6.7%), compared with 82.9% (95% confidence interval, 77.4-87.3%) for modified Ziehl-Neelsen stain and 75.1% (95% confidence interval, 68.8-80.6%) for ESAT-6 immunostain. Intracellular bacteria were seen in 87.8% of the slides positive by the modified Ziehl-Neelsen stain. The specificity of modified Ziehl-Neelsen and ESAT-6 stain was 85.0% (95% confidence interval, 69.4-93.8%) and 90.0% (95% confidence interval, 75.4-96.7%), respectively. Enhanced bacterial detection by simple modification of the Ziehl-Neelsen stain and an ESAT-6 intracellular stain improve the laboratory diagnosis of tuberculous meningitis.

Optimised Spectral Kurtosis for bearing diagnostics under electromagnetic interference

NASA Astrophysics Data System (ADS)

Smith, Wade A.; Fan, Zhiqi; Peng, Zhongxiao; Li, Huaizhong; Randall, Robert B.

2016-06-01

The selection of the optimal demodulation frequency band is a significant step in bearing fault diagnosis because it determines whether the fault information can be extracted from the demodulated signal via envelope analysis. Two well-known methods for selecting the demodulation band are the Fast Kurtogram, based on the kurtosis of the filtered time signal, and the Protrugram, which uses the kurtosis of the envelope (amplitude) spectrum. Although these two methods have been successfully applied in many cases, the authors have observed that they may fail in specific environments, such as in the presence of electromagnetic interference (EMI) or other impulsive masking signals. In this paper, a simple spectral kurtosis-based approach is proposed for selecting the best demodulation band to extract bearing fault-related impulsive content from vibration signals contaminated with strong EMI. The method is applied to vibration signals obtained from a planetary gearbox test rig with planet bearings seeded with inner and outer race faults. Results from the Fast Kurtogram and Protrugram methods are also included for comparison. The proposed approach is found to exhibit superior diagnostic performance in the presence of intense EMI. Another contribution of the paper is to introduce and explain the issue of EMI to the condition monitoring community. The paper outlines the characteristics of EMI arising from widely-used variable frequency drives, and these characteristics are used to simulate an EMI-contaminated vibration signal to further test the performance of the proposed approach. Although EMI has been acknowledged as a serious problem in many industrial cases, there have been very few studies showing its adverse effects on machine diagnostics. It is important for analysts to be able to identify EMI in measured vibration signals, lest it interfere with the analysis undertaken.

Diagnostic utility of the acoustic reflex in predicting hearing in paediatric populations.

PubMed

Pérez-Villa, Yolanda E; Mena-Ramírez, María E; Aguirre, Laura E Chamlati; Mora-Magaña, Ignacio; Gutiérrez-Farfán, Ileana S

2014-01-01

The sensitivity of prediction of acoustic reflex, in determining the level of hearing loss, is especially useful in paediatric populations. It is based on the difference between the pure tone stapedius reflex threshold and contralateral white noise. The white noise threshold was 60 dB and that of pure tone was 80 dB. Our objective was to determine the diagnostic sensitivity of the prediction of the acoustic reflex. We studied children aged <10 years, from October 2011 to May 2012, by measuring the acoustic reflex with white noise and pure tone. We used contrast tests, with X2 and student t-test. Concordance was measured with Kappa. Results were considered significant at P≤.05. Our protocol was approved by Institutional Ethics Committee. Informed consent was obtained from the parents in all cases. Prediction of normal hearing was 0.84 for the right ear and 0.78 in left ear, while for hearing loss of an unspecified grade, it was 0.98 for the right ear and 0.96 in the left ear. Kappa value was 0.7 to 0.6 for the right ear and left ear. The acoustic reflex is of little diagnostic utility in predicting the degree of hearing loss, but it predicts more than 80% of normal hearing. The clinical utility of the reflex is indisputable, as it is an objective method, simple and rapid to use, that can be performed from birth and whose results are independent of the cooperation and willingness of the subject. It is proposed as an obligatory part of hearing screening. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

Diagnostic value of a pattern of exhaled breath condensate biomarkers in asthmatic children.

PubMed

Maloča Vuljanko, I; Turkalj, M; Nogalo, B; Bulat Lokas, S; Plavec, D

Diagnosing asthma in children is a challenge and using a single biomarker from exhaled breath condensate (EBC) showed the lack of improvement in it. The aim of this study was to assess the diagnostic potential of a pattern of simple chemical biomarkers from EBC in diagnosing asthma in children in a real-life setting, its association with lung function and gastroesophageal reflux disease (GERD). In 75 consecutive children aged 5-7 years with asthma-like symptoms the following tests were performed: skin prick tests, spirometry, impulse oscillometry (IOS), exhaled NO (F E NO), 24-hour oesophageal pH monitoring and EBC collection with subsequent analysis of pH, carbon dioxide tension, oxygen tension, and concentrations of magnesium, calcium, iron and urates. No significant differences were found for individual EBC biomarkers between asthmatics and non-asthmatics (p>0.05 for all). A pattern of six EBC biomarkers showed a statistically significant (p=0.046) predictive model for asthma (AUC=0.698, PPV=84.2%, NPV=38.9%). None to moderate association (R 2 up to 0.43) between EBC biomarkers and lung function measures and F E NO was found, with IOS parameters showing the best association with EBC biomarkers. A significantly higher EBC Fe was found in children with asthma and GERD compared to asthmatics without GERD (p=0.049). An approach that involves a pattern of EBC biomarkers had a better diagnostic accuracy for asthma in children in real-life settings compared to a single one. Poor to moderate association of EBC biomarkers with lung function suggests a complementary value of EBC analysis for asthma diagnosis in children. Copyright © 2016 SEICAP. Published by Elsevier España, S.L.U. All rights reserved.

Ebola Check: Delivering molecular diagnostics at the point of need.

PubMed

Moschos, Sterghios A

2015-01-01

The 2013-5 global outbreak of Ebolavirus disease brought to sharp focus the need for diagnostic capacity to be equitably available on a global scale: from the most under-developed areas of resource-limited countries in West Africa to high volume international travel hubs in Europe and the USA. Quick detection of the causal agent of disease is pivotal to containment, contact tracing and clinical action to protect healthcare workers, communities and patients. Nucleic acid testing (NAT) by real time reverse transcription quantitative polymerase chain reaction (RT-PCR) has emerged as the preferred method for reliable patient status confirmation. Presently, this is served through advanced clinical molecular laboratory testing in a <8hr manual process that requires 3.5ml venous blood samples. To meet the demand in West Africa, this has necessitated large-scale mobile laboratory and volunteer biomedical scientist deployment: a solution that has proven eventually adequate, albeit temporary against future re-emergence of this and other haemorrhagic fever disease agents prevalent in the region. The EbolaCheck consortium was formed in August 2014 to address the need for delivering NAT at the point of care. We have developed a novel platform technology that can QUantitatively, RAPidly IDentify (QuRapID) known RNA or DNA targets in viruses, bacteria, or eukaryotic cells directly in crude biofluids, including whole blood, in under 40min using a 5 microliter sample. The portable, battery-operated system lacks microfluidics, pumps or other sensitive/high cost parts making it suitable for the environmental and economic challenges of resource-limited countries. The simple, safe, 5-step sample-to-answer process requires minimal training and informs frontline healthcare workers of diagnostic status, whilst reporting remotely epidemiologically relevant results. Data on biosafety level 2 surrogate Ebolavirus templates presented in encapsulated or enveloped viruses indicate performance comparable to clinical laboratory testing and utility beyond filoviruses. Emerging performance data on live Ebolavirus, non-human primate disease model and patient samples, as well as future development plans will be discussed.

Diagnostic methods for insect sting allergy.

PubMed

Hamilton, Robert G

2004-08-01

This review overviews advances from mid-2002 to the present in the validation and performance methods used in the diagnosis of Hymenoptera venom-induced immediate-type hypersensitivity. The general diagnostic algorithm for insect sting allergy is initially discussed with an examination of the AAAAI's 2003 revised practice parameter guidelines. Changes as a result of a greater recognition of skin test negative systemic reactors include repeat analysis of all testing and acceptance of serology as a complementary diagnostic test to the skin test. Original data examining concordance of venom-specific IgE results produced by the second-generation Pharmacia CAP System with the Johns Hopkins University radioallergosorbent test are presented. Diagnostic performance of honeybee venom-specific IgE assays used in clinical laboratories in North America is discussed using data from the Diagnostic Allergy Proficiency Survey conducted by the College of American Pathologists. Validity of venom-specific IgE antibody in postmortem blood specimens is demonstrated. The utility of alternative in-vivo (provocation) and in-vitro (basophil-based) diagnostic testing methods is critiqued. This overview supports the following conclusions. Improved practice parameter guidelines include serology and skin test as complementary in supporting a positive clinical history during the diagnostic process. Data are provided which support the analytical performance of commercially available venom-specific IgE antibody serology-based assays. Intentional sting challenge in-vivo provocation, in-vitro basophil flow cytometry (CD63, CD203c) based assays, and in-vitro basophil histamine and sulfidoleukotriene release assays have their utility in the study of difficult diagnostic cases, but their use will remain as supplementary, secondary diagnostic tests.

On-Chip Imaging of Schistosoma haematobium Eggs in Urine for Diagnosis by Computer Vision

PubMed Central

Linder, Ewert; Grote, Anne; Varjo, Sami; Linder, Nina; Lebbad, Marianne; Lundin, Mikael; Diwan, Vinod; Hannuksela, Jari; Lundin, Johan

2013-01-01

Background Microscopy, being relatively easy to perform at low cost, is the universal diagnostic method for detection of most globally important parasitic infections. As quality control is hard to maintain, misdiagnosis is common, which affects both estimates of parasite burdens and patient care. Novel techniques for high-resolution imaging and image transfer over data networks may offer solutions to these problems through provision of education, quality assurance and diagnostics. Imaging can be done directly on image sensor chips, a technique possible to exploit commercially for the development of inexpensive “mini-microscopes”. Images can be transferred for analysis both visually and by computer vision both at point-of-care and at remote locations. Methods/Principal Findings Here we describe imaging of helminth eggs using mini-microscopes constructed from webcams and mobile phone cameras. The results show that an inexpensive webcam, stripped off its optics to allow direct application of the test sample on the exposed surface of the sensor, yields images of Schistosoma haematobium eggs, which can be identified visually. Using a highly specific image pattern recognition algorithm, 4 out of 5 eggs observed visually could be identified. Conclusions/Significance As proof of concept we show that an inexpensive imaging device, such as a webcam, may be easily modified into a microscope, for the detection of helminth eggs based on on-chip imaging. Furthermore, algorithms for helminth egg detection by machine vision can be generated for automated diagnostics. The results can be exploited for constructing simple imaging devices for low-cost diagnostics of urogenital schistosomiasis and other neglected tropical infectious diseases. PMID:24340107