[Companion diagnostics "POTELIGEO TEST IHC/FCM" used with "POTELIGEO" (mogamulizumab) for adult T-cell leukemia-lymphoma (ATL) treatment].

PubMed

Goami, Takeshi

2014-05-01

Personalized medicine offers the best treatment for individual patients, it is important for an IVD manufacturer to develop companion diagnostics in parallel with the development of new drugs through close cooperation with drug companies, and supply diagnostics companies with new drugs for physicians and patients. We received approval for a premarket approval application (PMA) for two in vitro diagnostic ("IVD") reagents, POTELIGEO TEST IHC and POTELIGEO TEST FCM ("POTELIGEO TEST"), in March 2012, and subsequently launched POTELIGEO TEST in May 2012. POTELIGEO TEST is a companion diagnostic used with POTELIGEO for which Kyowa Hakko Kirin has a new drug application (NDA) that was approved in March 2012, and is designed to help physicians identify appropriate subpopulations of adult T-cell leukemia-lymphoma(ATL) patients who are most likely to respond to POTELIGEO 20 mg (mogamulizumab) Injection ("POTELIGEO").

Development and Use of Diagnostic Tests to Evaluate Students' Misconceptions in Science.

ERIC Educational Resources Information Center

Treagust, David F.

1988-01-01

Describes 10 steps for developing a diagnostic test of students' misconceptions and the use of two tests in chemistry (covalent bonding and structure) and in biology (photosynthesis and respiration in plants). Discusses the results and some implications for teaching science. (YP)

The Development and Validation of a Three-Tier Diagnostic Test Measuring Pre-Service Elementary Education and Secondary Science Teachers' Understanding of the Water Cycle

ERIC Educational Resources Information Center

Schaffer, Dannah Lynn

2013-01-01

The main goal of this research study was to develop and validate a three-tier diagnostic test to determine pre-service teachers' (PSTs) conceptual knowledge of the water cycle. For a three-tier diagnostic test, the first tier assesses content knowledge; in the second tier, a reason is selected for the content answer; and the third tier allows…

Development and Validation of Diagnostic Economics Test for Secondary Schools

ERIC Educational Resources Information Center

Eleje, Lydia I.; Esomonu, Nkechi P. M.; Agu, Ngozi N.; Okoye, Romy O.; Obasi, Emma; Onah, Frederick E.

2016-01-01

A diagnostic test in economics to aid the teachers determine student's specific weak content areas was developed and validated. Five research questions guided the study. Preliminary validation was done by two experienced teachers in the content area of secondary economics and two experts in test construction. The pilot testing was conducted for…

Development and validation of an immunoperoxidase antigen detection test for improved diagnosis of rabies in Indonesia.

PubMed

Rahmadane, Ibnu; Certoma, Andrea F; Peck, Grantley R; Fitria, Yul; Payne, Jean; Colling, Axel; Shiell, Brian J; Beddome, Gary; Wilson, Susanne; Yu, Meng; Morrissy, Chris; Michalski, Wojtek P; Bingham, John; Gardner, Ian A; Allen, John D

2017-11-01

Rabies continues to pose a significant threat to human and animal health in regions of Indonesia. Indonesia has an extensive network of veterinary diagnostic laboratories and the 8 National laboratories are equipped to undertake diagnostic testing for rabies using the commercially-procured direct fluorescent antibody test (FAT), which is considered the reference (gold standard) test. However, many of the Indonesian Provincial diagnostic laboratories do not have a fluorescence microscope required to undertake the FAT. Instead, certain Provincial laboratories continue to screen samples using a chemical stain-based test (Seller's stain test, SST). This test has low diagnostic sensitivity, with negative SST-tested samples being forwarded to the nearest National laboratory resulting in significant delays for completion of testing and considerable additional costs. This study sought to develop a cost-effective and diagnostically-accurate immunoperoxidase antigen detection (RIAD) test for rabies that can be readily and quickly performed by the resource-constrained Provincial laboratories. This would reduce the burden on the National laboratories and allow more rapid diagnoses and implementation of post-exposure prophylaxis. The RIAD test was evaluated using brain smears fixed with acetone or formalin and its performance was validated by comparison with established rabies diagnostic tests used in Indonesia, including the SST and FAT. A proficiency testing panel was distributed between Provincial laboratories to assess the reproducibility of the test. The performance of the RIAD test was improved by using acetone fixation of brain smears rather than formalin fixation such that it was of equivalent accuracy to that of the World Organisation for Animal Health (OIE)-recommended FAT, with both tests returning median diagnostic sensitivity and specificity values of 0.989 and 0.993, respectively. The RIAD test and FAT had higher diagnostic sensitivity than the SST (median = 0.562). Proficiency testing using a panel of 6 coded samples distributed to 16 laboratories showed that the RIAD test had good reproducibility with an overall agreement of 97%. This study describes the successful development, characterisation and use of a novel RIAD test and its fitness for purpose as a screening test for use in provincial Indonesian veterinary laboratories.

Diagnostic Testing Package DX v 2.0 Technical Specification. Methodology Project.

ERIC Educational Resources Information Center

McArthur, David

This paper contains the technical specifications, schematic diagrams, and program printout for a computer software package for the development and administration of diagnostic tests. The second version of the Diagnostic Testing Package DX consists of a PASCAL-based set of modules located in two main programs: (1) EDITTEST creates, modifies, and…

Identification student’s misconception of heat and temperature using three-tier diagnostic test

NASA Astrophysics Data System (ADS)

Suliyanah; Putri, H. N. P. A.; Rohmawati, L.

2018-03-01

The objective of this research is to develop a Three-Tier Diagnostic Test (TTDT) to identify the student's misconception of heat and temperature. Stages of development include: analysis, planning, design, development, evaluation and revise. The results of this study show that (1) the quality of the three-tier type diagnostic test instrument developed has been expressed well with the following details: (a) Internal validity of 88.19% belonging to the valid category. (b) External validity of empirical construct validity test using Pearson Product Moment obtained 0.43 is classified and result of empirical construct validity test obtained false positives 6.1% and false negatives 5.9% then the instrument was valid. (c) Test reliability by using Cronbach’s Alpha of 0.98 which means acceptable. (d) The 80% difficulty level test is quite difficult. (2) Student misconceptions on the temperature of heat and displacement materials based on the II test the highest (84%), the lowest (21%), and the non-misconceptions (7%). (3) The highest cause of misconception among students is associative thinking (22%) and the lowest is caused by incomplete or incomplete reasoning (11%). Three-Tier Diagnostic Test (TTDT) could identify the student's misconception of heat and temperature.

Assessing Clinical Reasoning (ASCLIRE): Instrument Development and Validation

ERIC Educational Resources Information Center

Kunina-Habenicht, Olga; Hautz, Wolf E.; Knigge, Michel; Spies, Claudia; Ahlers, Olaf

2015-01-01

Clinical reasoning is an essential competency in medical education. This study aimed at developing and validating a test to assess diagnostic accuracy, collected information, and diagnostic decision time in clinical reasoning. A norm-referenced computer-based test for the assessment of clinical reasoning (ASCLIRE) was developed, integrating the…

Psychoacoustic Assessment of Speech Communication Systems. The Diagnostic Discrimination Test.

ERIC Educational Resources Information Center

Grether, Craig Blaine

The present report traces the rationale, development and experimental evaluation of the Diagnostic Discrimination Test (DDT). The DDT is a three-choice test of consonant discriminability of the perceptual/acoustic dimensions of consonant phonemes within specific vowel contexts. The DDT was created and developed in an attempt to provide a…

Portable Health Algorithms Test System

NASA Technical Reports Server (NTRS)

Melcher, Kevin J.; Wong, Edmond; Fulton, Christopher E.; Sowers, Thomas S.; Maul, William A.

2010-01-01

A document discusses the Portable Health Algorithms Test (PHALT) System, which has been designed as a means for evolving the maturity and credibility of algorithms developed to assess the health of aerospace systems. Comprising an integrated hardware-software environment, the PHALT system allows systems health management algorithms to be developed in a graphical programming environment, to be tested and refined using system simulation or test data playback, and to be evaluated in a real-time hardware-in-the-loop mode with a live test article. The integrated hardware and software development environment provides a seamless transition from algorithm development to real-time implementation. The portability of the hardware makes it quick and easy to transport between test facilities. This hard ware/software architecture is flexible enough to support a variety of diagnostic applications and test hardware, and the GUI-based rapid prototyping capability is sufficient to support development execution, and testing of custom diagnostic algorithms. The PHALT operating system supports execution of diagnostic algorithms under real-time constraints. PHALT can perform real-time capture and playback of test rig data with the ability to augment/ modify the data stream (e.g. inject simulated faults). It performs algorithm testing using a variety of data input sources, including real-time data acquisition, test data playback, and system simulations, and also provides system feedback to evaluate closed-loop diagnostic response and mitigation control.

Market assessment of tuberculosis diagnostics in Brazil in 2012.

PubMed

2014-01-01

Improved diagnostics for the diagnosis of tuberculosis (TB) are urgently needed. However, test developers and investors require market size data to support new product development. This study assessed the served available market for TB diagnostics in Brazil in 2012 and the market segmentation in the public and private sectors. Data were collected on test volumes done in the public and private sectors for the diagnosis of latent and active TB, drug susceptibility testing and treatment follow-up. Tests included were tuberculin skin tests, interferon-gamma releases assays, smear microscopy, solid and liquid cultures, nucleic acid amplification tests and phenotypic drug susceptibility tests. The data were collected by means of an electronic survey via the Brazilian State laboratories and from sales information provided by manufacturers. Test costs for the public sector were calculated using a components approach, while costs for the private sector were based on prices paid by patients. The overall market value (expenditure) for the entire country was calculated using the public sector test costs. During 2012, an estimated total of 2.4 million TB diagnostic tests were done in Brazil, resulting in an estimated overall market value of USD 17.2 million. The public sector accounted for 91% of the test volumes and 88% of the market value. Smear microscopy was the most commonly test (n = 1.3 million; 55% of total) at an estimated value of USD 3.7 million. Culture overall (n = 302,761) represented 13% of test volumes and 40% (USD 6.9 million) of the market value. On average, USD 208 was spent on TB diagnostics for every notified TB patient in Brazil, in 2012. The TB diagnostics market value in Brazil in 2012 was over USD 17 million. These study results will help test developers to understand the current and potential market for replacement or add-on diagnostic technologies.

Market Assessment of Tuberculosis Diagnostics in Brazil in 2012

PubMed Central

2014-01-01

Background Improved diagnostics for the diagnosis of tuberculosis (TB) are urgently needed. However, test developers and investors require market size data to support new product development. This study assessed the served available market for TB diagnostics in Brazil in 2012 and the market segmentation in the public and private sectors. Methods Data were collected on test volumes done in the public and private sectors for the diagnosis of latent and active TB, drug susceptibility testing and treatment follow-up. Tests included were tuberculin skin tests, interferon-gamma releases assays, smear microscopy, solid and liquid cultures, nucleic acid amplification tests and phenotypic drug susceptibility tests. The data were collected by means of an electronic survey via the Brazilian State laboratories and from sales information provided by manufacturers. Test costs for the public sector were calculated using a components approach, while costs for the private sector were based on prices paid by patients. The overall market value (expenditure) for the entire country was calculated using the public sector test costs. Results During 2012, an estimated total of 2.4 million TB diagnostic tests were done in Brazil, resulting in an estimated overall market value of USD 17.2 million. The public sector accounted for 91% of the test volumes and 88% of the market value. Smear microscopy was the most commonly test (n = 1.3 million; 55% of total) at an estimated value of USD 3.7 million. Culture overall (n = 302,761) represented 13% of test volumes and 40% (USD 6.9 million) of the market value. On average, USD 208 was spent on TB diagnostics for every notified TB patient in Brazil, in 2012. Conclusion The TB diagnostics market value in Brazil in 2012 was over USD 17 million. These study results will help test developers to understand the current and potential market for replacement or add-on diagnostic technologies. PMID:25099237

Diagnostic Profiles: A Standard Setting Method for Use with a Cognitive Diagnostic Model

ERIC Educational Resources Information Center

Skaggs, Gary; Hein, Serge F.; Wilkins, Jesse L. M.

2016-01-01

This article introduces the Diagnostic Profiles (DP) standard setting method for setting a performance standard on a test developed from a cognitive diagnostic model (CDM), the outcome of which is a profile of mastered and not-mastered skills or attributes rather than a single test score. In the DP method, the key judgment task for panelists is a…

Defining Characteristics of Diagnostic Classification Models and the Problem of Retrofitting in Cognitive Diagnostic Assessment

ERIC Educational Resources Information Center

Gierl, Mark J.; Cui, Ying

2008-01-01

One promising application of diagnostic classification models (DCM) is in the area of cognitive diagnostic assessment in education. However, the successful application of DCM in educational testing will likely come with a price--and this price may be in the form of new test development procedures and practices required to yield data that satisfy…

Assessing clinical reasoning (ASCLIRE): Instrument development and validation.

PubMed

Kunina-Habenicht, Olga; Hautz, Wolf E; Knigge, Michel; Spies, Claudia; Ahlers, Olaf

2015-12-01

Clinical reasoning is an essential competency in medical education. This study aimed at developing and validating a test to assess diagnostic accuracy, collected information, and diagnostic decision time in clinical reasoning. A norm-referenced computer-based test for the assessment of clinical reasoning (ASCLIRE) was developed, integrating the entire clinical decision process. In a cross-sectional study participants were asked to choose as many diagnostic measures as they deemed necessary to diagnose the underlying disease of six different cases with acute or sub-acute dyspnea and provide a diagnosis. 283 students and 20 content experts participated. In addition to diagnostic accuracy, respective decision time and number of used relevant diagnostic measures were documented as distinct performance indicators. The empirical structure of the test was investigated using a structural equation modeling approach. Experts showed higher accuracy rates and lower decision times than students. In a cross-sectional comparison, the diagnostic accuracy of students improved with the year of study. Wrong diagnoses provided by our sample were comparable to wrong diagnoses in practice. We found an excellent fit for a model with three latent factors-diagnostic accuracy, decision time, and choice of relevant diagnostic information-with diagnostic accuracy showing no significant correlation with decision time. ASCLIRE considers decision time as an important performance indicator beneath diagnostic accuracy and provides evidence that clinical reasoning is a complex ability comprising diagnostic accuracy, decision time, and choice of relevant diagnostic information as three partly correlated but still distinct aspects.

Development and Validation of a Diagnostic Grammar Test for Japanese Learners of English

ERIC Educational Resources Information Center

Koizumi, Rie; Sakai, Hideki; Ido, Takahiro; Ota, Hiroshi; Hayama, Megumi; Sato, Masatoshi; Nemoto, Akiko

2011-01-01

This article reports on the development and validation of the English Diagnostic Test of Grammar (EDiT Grammar) for Japanese learners of English. From among the many aspects of grammar, this test focuses on the knowledge of basic English noun phrases (NPs), especially their internal structures, because previous research has indicated the…

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.

Development of a dedicated isotope mass spectrometer for the noninvasive diagnostics of humans infected with Helicobacter Pylori

NASA Astrophysics Data System (ADS)

Blashenkov, N. M.; Sheshenya, E. S.; Solov'ev, S. M.; Gall', L. N.; Sachenko, V. M.; Zarutskii, I. V.; Gall', N. R.

2013-06-01

A dedicated isotope mass spectrometer for the noninvasive diagnostics of humans infected with Helicobacter Pylori using the isotope respiratory test is developed. A low-aberration mass analyzer is calculated, an input system that makes it possible to eliminate the memory effects is developed, and a small-size ion detector is constructed. The mass spectrometer is created, and the tests are performed. The measurement accuracy of the 13C/12C and 16O/18O isotope ratios are 1.7 and 2.2‰, respectively. Preliminary medical tests show that the spectrometer can be employed for the desired diagnostics.

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.

Hemorrhagic Fever with Renal Syndrome (Korean Hemorrhagic Fever)

DTIC Science & Technology

1990-06-29

particles were used for a rapid serologic diagnostic test for HFRS. ’te-re were 430 cases of HFRS in Korea in 1989 and large outbreaks of scrub typhus...almost same as in 1988. A simple and rapid serologic diagnostic test for hantavirus infection was developed by high density particle agglutination...infection and HFRS b) serologic relation cif hantaviruses isolated from the different parts of the world c) development of a simple serologic diagnostic

Formative Assessment in Teacher Education: The Development of a Diagnostic Language Test for Trainee Teachers of German

ERIC Educational Resources Information Center

Richards, Brian J.

2008-01-01

This article describes the development and validation of a diagnostic test of German and its integration in a programme of formative assessment during a one-year initial teacher-training course. The test focuses on linguistic aspects that cause difficulty for trainee teachers of German as a foreign language and assesses implicit and explicit…

Diagnostics for invasive Salmonella infections: current challenges and future directions

PubMed Central

Andrews, Jason R.; Ryan, Edward T.

2015-01-01

Invasive Salmonellosis caused by Salmonella enterica serotype Typhi or Paratyphi A, B, C, or invasive non-typhoidal Salmonella serotypes, is an immensely important disease cluster for which reliable, rapid diagnostic tests are not available. Blood culture remains the gold standard but is insensitive, slow, and resource-intensive. Existing molecular diagnostics have poor sensitivity due to the low organism burden in bodily fluids. Commercially available serologic tests for typhoidal Salmonella have had limited sensitivity and specificity. In high burden, resource-limited settings, reliance on clinical diagnosis or inaccurate tests often results in frequent, unnecessary treatment, which contributes selective pressure for the emergence of antimicrobial resistance. This practice also results in inadequate therapy for other etiologies of acute febrile illnesses, including leptospirosis and rickettsial infections. A number of novel serologic, molecular, transcriptomic and metabolomic approaches to diagnostics are under development. Target product profiles that outline specific needs may focus development and investment, and establish benchmarks for accuracy, cost, speed, and portability of new diagnostics. Of note, a critical barrier to diagnostic assay rollout will be the low cost and low perceived harm of empiric therapy on behalf of providers and patients, which leaves few perceived incentives to utilize diagnostics. Approaches that align incentives with societal goals of limiting inappropriate antimicrobial use, such as subsidizing diagnostics, may be essential for stimulating development and uptake of such assays in resource-limited settings. New diagnostics for invasive Salmonellosis should be developed and deployed alongside diagnostics for alternative etiologies of acute febrile illnesses to improve targeted use of antibiotics. PMID:25937611

Diagnostics for invasive Salmonella infections: Current challenges and future directions.

PubMed

Andrews, Jason R; Ryan, Edward T

2015-06-19

Invasive Salmonellosis caused by Salmonella enterica serotype Typhi or Paratyphi A, B, C, or invasive non-typhoidal Salmonella serotypes, is an immensely important disease cluster for which reliable, rapid diagnostic tests are not available. Blood culture remains the gold standard but is insensitive, slow, and resource-intensive. Existing molecular diagnostics have poor sensitivity due to the low organism burden in bodily fluids. Commercially available serologic tests for typhoidal Salmonella have had limited sensitivity and specificity. In high burden, resource-limited settings, reliance on clinical diagnosis or inaccurate tests often results in frequent, unnecessary treatment, which contributes selective pressure for the emergence of antimicrobial resistance. This practice also results in inadequate therapy for other etiologies of acute febrile illnesses, including leptospirosis and rickettsial infections. A number of novel serologic, molecular, transcriptomic and metabolomic approaches to diagnostics are under development. Target product profiles that outline specific needs may focus development and investment, and establish benchmarks for accuracy, cost, speed, and portability of new diagnostics. Of note, a critical barrier to diagnostic assay rollout will be the low cost and low perceived harm of empiric therapy on behalf of providers and patients, which leaves few perceived incentives to utilize diagnostics. Approaches that align incentives with societal goals of limiting inappropriate antimicrobial use, such as subsidizing diagnostics, may be essential for stimulating development and uptake of such assays in resource-limited settings. New diagnostics for invasive Salmonellosis should be developed and deployed alongside diagnostics for alternative etiologies of acute febrile illnesses to improve targeted use of antibiotics. Copyright © 2015. Published by Elsevier Ltd.

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 development of a quality appraisal tool for studies of diagnostic reliability (QAREL).

PubMed

Lucas, Nicholas P; Macaskill, Petra; Irwig, Les; Bogduk, Nikolai

2010-08-01

In systematic reviews of the reliability of diagnostic tests, no quality assessment tool has been used consistently. The aim of this study was to develop a specific quality appraisal tool for studies of diagnostic reliability. Key principles for the quality of studies of diagnostic reliability were identified with reference to epidemiologic principles, existing quality appraisal checklists, and the Standards for Reporting of Diagnostic Accuracy (STARD) and Quality Assessment of Diagnostic Accuracy Studies (QUADAS) resources. Specific items that encompassed each of the principles were developed. Experts in diagnostic research provided feedback on the items that were to form the appraisal tool. This process was iterative and continued until consensus among experts was reached. The Quality Appraisal of Reliability Studies (QAREL) checklist includes 11 items that explore seven principles. Items cover the spectrum of subjects, spectrum of examiners, examiner blinding, order effects of examination, suitability of the time interval among repeated measurements, appropriate test application and interpretation, and appropriate statistical analysis. QAREL has been developed as a specific quality appraisal tool for studies of diagnostic reliability. The reliability of this tool in different contexts needs to be evaluated. Copyright (c) 2010 Elsevier Inc. All rights reserved.

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.

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.

[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.

The ITER bolometer diagnostic: Status and plansa)

NASA Astrophysics Data System (ADS)

Meister, H.; Giannone, L.; Horton, L. D.; Raupp, G.; Zeidner, W.; Grunda, G.; Kalvin, S.; Fischer, U.; Serikov, A.; Stickel, S.; Reichle, R.

2008-10-01

A consortium consisting of four EURATOM Associations has been set up to develop the project plan for the full development of the ITER bolometer diagnostic and to continue urgent R&D activities. An overview of the current status is given, including detector development, line-of-sight optimization, performance analysis as well as the design of the diagnostic components and their integration in ITER. This is complemented by the presentation of plans for future activities required to successfully implement the bolometer diagnostic, ranging from the detector development over diagnostic design and prototype testing to RH tools for calibration.

Assessing Old and New Diagnostic Tests for Gastroesophageal Reflux Disease.

PubMed

Vaezi, Michael F; Sifrim, Daniel

2018-01-01

A detailed critique of objective measurements of gastroesophageal reflux disease (GERD) would improve management of patients suspecting of having reflux, leading to rational selection of treatment and better outcomes. Many diagnostic tests for GERD have been developed over the past decades. We analyze their development, positive- and negative-predictive values, and ability to predict response to treatment. These features are important for development of medical, surgical, and endoscopic therapies for GERD. We discuss the value of available diagnostic tests and review their role in management of patients with persistent reflux symptoms despite adequate medical or surgical treatment. This is becoming a significant health economic problem, due to the widespread use of proton pump inhibitors. GERD is believed to cause nonesophageal symptoms, such as those provoked by ear, nose, throat, or respiratory disorders. We analyze the value of GERD diagnostic tests in evaluation of these troublesome, nonesophageal symptoms. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Toxoplasma gondii: history and diagnostic test development.

PubMed

Wyrosdick, Heidi M; Schaefer, John J

2015-12-01

Toxoplasma gondii is a protozoa that causes toxoplasmosis in people and other animals. It is considered one of the most common parasitic infections in the world due to its impressive range of hosts, widespread environmental contamination and the diverse means by which animals can be infected. Despite its ubiquity and numerous ongoing research efforts into both its basic biology and clinical management, many aspects of diagnosis and management of this disease are poorly understood. The range of diagnostic options that is available for veterinary diagnostic investigators are notably more limited than those available to medical diagnosticians, making accurate interpretation of each test result critical. The current review joins other reviews on the parasite with a particular emphasis on the history and continued development of diagnostic tests that are useful for veterinary diagnostic investigations. An understanding of the strengths and shortcomings of current diagnostic techniques will assist veterinary and public health officials in formulating effective treatment and control strategies in diverse animal populations.

Development and Preparation of Lead-Containing Paint Films and Diagnostic Test Materials

EPA Science Inventory

Lead in paint continues to be a threat to children’s health in cities across the United States, which means there is an ongoing need for testing and analysis of paint. This ongoing analytical effort and especially development of new methods continue to drive the need for diagnost...

Decision analysis to complete diagnostic research by closing the gap between test characteristics and cost-effectiveness.

PubMed

Schaafsma, Joanna D; van der Graaf, Yolanda; Rinkel, Gabriel J E; Buskens, Erik

2009-12-01

The lack of a standard methodology in diagnostic research impedes adequate evaluation before implementation of constantly developing diagnostic techniques. We discuss the methodology of diagnostic research and underscore the relevance of decision analysis in the process of evaluation of diagnostic tests. Overview and conceptual discussion. Diagnostic research requires a stepwise approach comprising assessment of test characteristics followed by evaluation of added value, clinical outcome, and cost-effectiveness. These multiple goals are generally incompatible with a randomized design. Decision-analytic models provide an important alternative through integration of the best available evidence. Thus, critical assessment of clinical value and efficient use of resources can be achieved. Decision-analytic models should be considered part of the standard methodology in diagnostic research. They can serve as a valid alternative to diagnostic randomized clinical trials (RCTs).

Development, Evaluation, and Integration of a Quantitative Reverse-Transcription Polymerase Chain Reaction Diagnostic Test for Ebola Virus on a Molecular Diagnostics Platform

PubMed Central

Cnops, Lieselotte; Van den Eede, Peter; Pettitt, James; Heyndrickx, Leo; De Smet, Birgit; Coppens, Sandra; Andries, Ilse; Pattery, Theresa; Van Hove, Luc; Meersseman, Geert; Van Den Herrewegen, Sari; Vergauwe, Nicolas; Thijs, Rein; Jahrling, Peter B.; Nauwelaers, David; Ariën, Kevin K.

2016-01-01

Background. The 2013–2016 Ebola epidemic in West Africa resulted in accelerated development of rapid diagnostic tests for emergency outbreak preparedness. We describe the development and evaluation of the Idylla™ prototype Ebola virus test, a fully automated sample-to-result molecular diagnostic test for rapid detection of Zaire ebolavirus (EBOV) and Sudan ebolavirus (SUDV). Methods. The Idylla™ prototype Ebola virus test can simultaneously detect EBOV and SUDV in 200 µL of whole blood. The sample is directly added to a disposable cartridge containing all reagents for sample preparation, RNA extraction, and amplification by reverse-transcription polymerase chain reaction analysis. The performance was evaluated with a variety of sample types, including synthetic constructs and whole blood samples from healthy volunteers spiked with viral RNA, inactivated virus, and infectious virus. Results. The 95% limits of detection for EBOV and SUDV were 465 plaque-forming units (PFU)/mL (1010 copies/mL) and 324 PFU/mL (8204 copies/mL), respectively. In silico and in vitro analyses demonstrated 100% correct reactivity for EBOV and SUDV and no cross-reactivity with relevant pathogens. The diagnostic sensitivity was 97.4% (for EBOV) and 91.7% (for SUDV), the specificity was 100%, and the diagnostic accuracy was 95.9%. Conclusions. The Idylla™ prototype Ebola virus test is a fast, safe, easy-to-use, and near-patient test that meets the performance criteria to detect EBOV in patients with suspected Ebola. PMID:27247341

Systematic Benchmarking of Diagnostic Technologies for an Electrical Power System

NASA Technical Reports Server (NTRS)

Kurtoglu, Tolga; Jensen, David; Poll, Scott

2009-01-01

Automated health management is a critical functionality for complex aerospace systems. A wide variety of diagnostic algorithms have been developed to address this technical challenge. Unfortunately, the lack of support to perform large-scale V&V (verification and validation) of diagnostic technologies continues to create barriers to effective development and deployment of such algorithms for aerospace vehicles. In this paper, we describe a formal framework developed for benchmarking of diagnostic technologies. The diagnosed system is the Advanced Diagnostics and Prognostics Testbed (ADAPT), a real-world electrical power system (EPS), developed and maintained at the NASA Ames Research Center. The benchmarking approach provides a systematic, empirical basis to the testing of diagnostic software and is used to provide performance assessment for different diagnostic algorithms.

Rapid diagnostic tests for malaria

PubMed Central

Daily, Jennifer; Hotte, Nora; Dolkart, Caitlin; Cunningham, Jane; Yadav, Prashant

2015-01-01

Abstract Maintaining quality, competitiveness and innovation in global health technology is a constant challenge for manufacturers, while affordability, access and equity are challenges for governments and international agencies. In this paper we discuss these issues with reference to rapid diagnostic tests for malaria. Strategies to control and eliminate malaria depend on early and accurate diagnosis. Rapid diagnostic tests for malaria require little training and equipment and can be performed by non-specialists in remote settings. Use of these tests has expanded significantly over the last few years, following recommendations to test all suspected malaria cases before treatment and the implementation of an evaluation programme to assess the performance of the malaria rapid diagnostic tests. Despite these gains, challenges exist that, if not addressed, could jeopardize the progress made to date. We discuss recent developments in rapid diagnostic tests for malaria, highlight some of the challenges and provide suggestions to address them. PMID:26668438

Rocket Engine Plume Diagnostics at Stennis Space Center

NASA Technical Reports Server (NTRS)

Tejwani, Gopal D.; Langford, Lester A.; VanDyke, David B.; McVay, Gregory P.; Thurman, Charles C.

2003-01-01

The Stennis Space Center has been at the forefront of development and application of exhaust plume spectroscopy to rocket engine health monitoring since 1989. Various spectroscopic techniques, such as emission, absorption, FTIR, LIF, and CARS, have been considered for application at the engine test stands. By far the most successful technology h a been exhaust plume emission spectroscopy. In particular, its application to the Space Shuttle Main Engine (SSME) ground test health monitoring has been invaluable in various engine testing and development activities at SSC since 1989. On several occasions, plume diagnostic methods have successfully detected a problem with one or more components of an engine long before any other sensor indicated a problem. More often, they provide corroboration for a failure mode, if any occurred during an engine test. This paper gives a brief overview of our instrumentation and computational systems for rocket engine plume diagnostics at SSC. Some examples of successful application of exhaust plume spectroscopy (emission as well as absorption) to the SSME testing are presented. Our on-going plume diagnostics technology development projects and future requirements are discussed.

Recent advances in tuberculosis diagnostics in resource-limited settings.

PubMed

Seki, Mitsuko; Kim, Chang-Ki; Hayakawa, Satoshi; Mitarai, Satoshi

2018-04-19

Smear-negative and drug-resistant cases of tuberculosis (TB) disease necessitate the development of new diagnostic methods, especially in resource-limited settings. To improve the current TB situations, sensitive and specific TB point-of-care tests (POCTs) should be developed. This review addresses the current status of TB, novel diagnostic methodologies for TB, and the impact of those new diagnostics on TB control in such situations. Moreover, the perspective of TB management based on laboratory examinations is described. Smear microscopy with sputum samples is the only laboratory examination available in many resource-limited settings and is still used globally. Several nucleic acid amplification tests (NATs) have been developed. The World Health Organization (WHO) endorsed novel diagnostics based on NATs and updated their definition of a bacteriologically confirmed case requiring the biological specimen to be positive by smear microscopy, culture, or the WHO-recommended rapid diagnostic protocols. The use of new diagnostics increased the number of bacteriologically confirmed TB cases. Novel diagnostics are now available, but their sensitivity is still lower than that of conventional liquid culture method. To address the increasing incidence of TB, more resources including novel diagnostics as POCTs with higher sensitivity must be allocated to healthcare systems.

Point of care investigations in pediatric care to improve health care in rural areas.

PubMed

Walia, Kamini

2013-07-01

The good quality laboratory services in developing countries are often limited to major urban centers. As a result, many commercially available high-quality diagnostic tests for infectious diseases are neither accessible nor affordable to patients in the rural areas. Health facilities in rural areas are compromised and this limits the usability and performance of the best medical diagnostic technologies in rural areas as they are designed for air-conditioned laboratories, refrigerated storage of chemicals, a constant supply of calibrators and reagents, stable electrical power, highly trained personnel and rapid transportation of samples. The advent of new technologies have allowed miniaturization and integration of complex functions, which has made it possible for sophisticated diagnostic tools to move out of the developed-world laboratory in the form of a "point of care"(POC) tests. Many diagnostic tests are being developed using these platforms. However, the challenge is to develop diagnostics which are inexpensive, rugged and well suited to the medical and social contexts of the developing world and do not compromise on accuracy and reliability. The already available POC tests which are reliable and affordable, like for HIV infection, malaria, syphilis, and some neglected tropical diseases, and POC tests being developed for other diseases if correctly used and effectively regulated after rigorous evaluation, have the potential to make a difference in clinical management and improve surveillance. In order to use these tests effectively they would need to be supported by technically competent manpower, availability of good-quality reagents, and healthcare providers who value and are able to interpret laboratory results to guide treatment; and a system for timely communication between the laboratory and the healthcare provider. Strengthening the laboratories at the rural level can enable utilization of these diagnostics for improving the diagnosis and management of infectious diseases among children which require prompt treatment and thus, considerably reduce morbidity and mortality among the pediatric age group.

Accuracy of AccessBio Immunoglobulin M and Total Antibody Rapid Immunochromatographic Assays for the Diagnosis of Acute Scrub Typhus Infection

DTIC Science & Technology

2010-02-01

archived samples, we assessed the diagnostic capacity of a rapid immunochromatographic test (ICT) for the detection of Orientia tsutsugamushi IgM and...illness in the Asia-Pacific region. As very few health facilities have accessible accurate diagnostic tests , the diagnosis of scrub fever must be based...develop- ment of rapid , diagnostic tests by the use of immunochromato- graphic test (ICf) technologies has provided a mechanism for point-of-care

The development of a post-test diagnostic system for rocket engines

NASA Technical Reports Server (NTRS)

Zakrajsek, June F.

1991-01-01

An effort was undertaken by NASA to develop an automated post-test, post-flight diagnostic system for rocket engines. The automated system is designed to be generic and to automate the rocket engine data review process. A modular, distributed architecture with a generic software core was chosen to meet the design requirements. The diagnostic system is initially being applied to the Space Shuttle Main Engine data review process. The system modules currently under development are the session/message manager, and portions of the applications section, the component analysis section, and the intelligent knowledge server. An overview is presented of a rocket engine data review process, the design requirements and guidelines, the architecture and modules, and the projected benefits of the automated diagnostic system.

European Respiratory Society guidelines for the diagnosis of primary ciliary dyskinesia.

PubMed

Lucas, Jane S; Barbato, Angelo; Collins, Samuel A; Goutaki, Myrofora; Behan, Laura; Caudri, Daan; Dell, Sharon; Eber, Ernst; Escudier, Estelle; Hirst, Robert A; Hogg, Claire; Jorissen, Mark; Latzin, Philipp; Legendre, Marie; Leigh, Margaret W; Midulla, Fabio; Nielsen, Kim G; Omran, Heymut; Papon, Jean-Francois; Pohunek, Petr; Redfern, Beatrice; Rigau, David; Rindlisbacher, Bernhard; Santamaria, Francesca; Shoemark, Amelia; Snijders, Deborah; Tonia, Thomy; Titieni, Andrea; Walker, Woolf T; Werner, Claudius; Bush, Andrew; Kuehni, Claudia E

2017-01-01

The diagnosis of primary ciliary dyskinesia is often confirmed with standard, albeit complex and expensive, tests. In many cases, however, the diagnosis remains difficult despite the array of sophisticated diagnostic tests. There is no "gold standard" reference test. Hence, a Task Force supported by the European Respiratory Society has developed this guideline to provide evidence-based recommendations on diagnostic testing, especially in light of new developments in such tests, and the need for robust diagnoses of patients who might enter randomised controlled trials of treatments. The guideline is based on pre-defined questions relevant for clinical care, a systematic review of the literature, and assessment of the evidence using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach. It focuses on clinical presentation, nasal nitric oxide, analysis of ciliary beat frequency and pattern by high-speed video-microscopy analysis, transmission electron microscopy, genotyping and immunofluorescence. It then used a modified Delphi survey to develop an algorithm for the use of diagnostic tests to definitively confirm and exclude the diagnosis of primary ciliary dyskinesia; and to provide advice when the diagnosis was not conclusive. Finally, this guideline proposes a set of quality criteria for future research on the validity of diagnostic methods for primary ciliary dyskinesia. Copyright ©ERS 2017.

A diagnostic approach to hemochromatosis

PubMed Central

Tavill, Anthony S; Adams, Paul C

2006-01-01

In the present clinical review, a diagnostic approach to hemochromatosis is discussed from the perspective of two clinicians with extensive experience in this area. The introduction of genetic testing and large-scale population screening studies have broadened our understanding of the clinical expression of disease and the utility of biochemical iron tests for the detection of disease and for the assessment of disease severity. Liver biopsy has become more of a prognostic test than a diagnostic test. The authors offer a stepwise, diagnostic algorithm based on current evidence-based data, that they regard as most cost-effective. An early diagnosis can lead to phlebotomy therapy to prevent the development of cirrhosis. PMID:16955151

Plasma diagnostic development and UHV testing for the ALPHA collaboration at Marquette University

NASA Astrophysics Data System (ADS)

Tharp, T. D.; Alpha Collaboration

2017-10-01

At Marquette, we are developing the next generation of nonneutral plasma diagnostics for the ALPHA experiment at CERN. ALPHA is building a new vertical experiment to test the gravitational interaction of antihydrogen with Earth. This expansion requires significant changes to the design of our plasma diagnostic suites: the next generation of tools must be able to measure plasmas from two directions, and must be capable of operating in a horizontal position. The diagnostic suite includes measurements of plasma density, shape, and temperature. The hardware used includes a MicroChannel Plate (MCP), a Faraday Cup, and an electron gun. In addition, we are building a vacuum chamber to test the viability of 3-d printed components for UHV compatibility, with target pressures of 10-10 mbar.

A Needs-Based Approach to the Development of a Diagnostic College English Speaking Test

ERIC Educational Resources Information Center

Zhao, Zhongbao

2014-01-01

This paper investigated the current situation of oral English teaching, learning, and assessment at the tertiary level in China through needs analysis and explored the implications for the development of a diagnostic speaking test. Through random sampling, the researcher administered both a student questionnaire and a teacher questionnaire to over…

Integrating Clinical Services for HIV, Tuberculosis, and Cryptococcal Disease in the Developing World: A Step Forward with 2 Novel Diagnostic Tests

PubMed Central

Vijayan, Tara; Klausner, Jeffrey D.

2014-01-01

The success of antiretroviral therapy (ART) programs in the developing world is limited by the lack of adequate diagnostic tests to screen for life-threatening opportunistic infections such as tuberculosis (TB) and cryptococcal disease. Furthermore, there is an increasing need for implementation research in measuring the effectiveness of currently available rapid diagnostic tests. The recently developed lateral flow assays for both cryptococcal disease and TB have the potential to improve care and greatly reduce the time to initiation of ART among individuals who need it the most. However, we caution that the data on feasibility and effectiveness of these assays are limited and such research agendas must be prioritized. PMID:24065780

Autoimmune diagnostics: the technology, the strategy and the clinical governance.

PubMed

Bizzaro, Nicola; Tozzoli, Renato; Villalta, Danilo

2015-02-01

In recent years, there has been a profound change in autoimmune diagnostics. From long, tiring and inaccurate manual methods, the art of diagnostics has turned to modern, rapid and automated technology. New antibody tests have been developed, and almost all autoimmune diseases now have some specific diagnostic markers. The current need to make the most of available economic and human resources has led to the production of diagnostic algorithms and guidelines designated for optimal strategic use of the tests and to increase the diagnostic appropriateness. An important role in this scenario was assumed by the laboratory autoimmunologist, whose task is not only to govern the analytical phase, but also to help clinicians in correctly choosing the most suitable test for each clinical situation and provide consultancy support. In this review, we summarize recent advances in technology, describe the diagnostic strategies and highlight the current role of the laboratory autoimmunologist in the clinical governance of autoimmune diagnostics.

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.

It's time to change perspective! New diagnostic tools for lateral elbow pain.

PubMed

Arrigoni, P; Cucchi, D; Menon, A; Randelli, P

2017-12-01

The presence of intra-articular findings that may complement the extra-articular pathology in lateral epicondilytis has been suggested, and a role for minor instability of the elbow as part of the causative process of this disease has been postulated. This study was designed to describe two new clinical tests, aimed at detecting intra-articular pathology in patients affected by recalcitrant lateral epicondylitis and investigate their diagnostic performance. Ten patients suffering of atraumatic lateral elbow pain unresponsive to conservative treatment were considered in this study. Two clinical tests were developed and administrated prior to arthroscopy: Supination and Antero-Lateral pain Test (SALT); Posterior Elbow Pain by Palpation-Extension of the Radiocapitellar joint (PEPPER). Sensitivity, specificity, predictive values and accuracy of SALT and PEPPER as diagnostic tests for seven intra-articular findings were calculated. In 90% of the patients, at least one test was positive. All patients with signs of lateral ligamentous patholaxity or intra-articular abnormal findings had a positive response to at least one of the two tests. SALT proved to have a high sensitivity but a low specificity and is accurate in detecting the presence of intra-articular abnormal findings, especially synovitis. PEPPER test was sensible, specific and accurate in the detection of radial head chondropathy. Two new diagnostic tests (SALT and PEPPER) were specifically designed to evoke pain from intra-articular structures. These tests could be a valid support in the diagnostic algorithm of recalcitrant lateral elbow pain. Positive findings may be indicative of a minor instability of the lateral elbow condition. Diagnostic study, development of diagnostic criteria on basis of consecutive patients, level II.

A manifesto for cardiovascular imaging: addressing the human factor†

PubMed Central

Fraser, Alan G

2017-01-01

Abstract Our use of modern cardiovascular imaging tools has not kept pace with their technological development. Diagnostic errors are common but seldom investigated systematically. Rather than more impressive pictures, our main goal should be more precise tests of function which we select because their appropriate use has therapeutic implications which in turn have a beneficial impact on morbidity or mortality. We should practise analytical thinking, use checklists to avoid diagnostic pitfalls, and apply strategies that will reduce biases and avoid overdiagnosis. We should develop normative databases, so that we can apply diagnostic algorithms that take account of variations with age and risk factors and that allow us to calculate pre-test probability and report the post-test probability of disease. We should report the imprecision of a test, or its confidence limits, so that reference change values can be considered in daily clinical practice. We should develop decision support tools to improve the quality and interpretation of diagnostic imaging, so that we choose the single best test irrespective of modality. New imaging tools should be evaluated rigorously, so that their diagnostic performance is established before they are widely disseminated; this should be a shared responsibility of manufacturers with clinicians, leading to cost-effective implementation. Trials should evaluate diagnostic strategies against independent reference criteria. We should exploit advances in machine learning to analyse digital data sets and identify those features that best predict prognosis or responses to treatment. Addressing these human factors will reap benefit for patients, while technological advances continue unpredictably. PMID:29029029

Development, Evaluation, and Integration of a Quantitative Reverse-Transcription Polymerase Chain Reaction Diagnostic Test for Ebola Virus on a Molecular Diagnostics Platform.

PubMed

Cnops, Lieselotte; Van den Eede, Peter; Pettitt, James; Heyndrickx, Leo; De Smet, Birgit; Coppens, Sandra; Andries, Ilse; Pattery, Theresa; Van Hove, Luc; Meersseman, Geert; Van Den Herrewegen, Sari; Vergauwe, Nicolas; Thijs, Rein; Jahrling, Peter B; Nauwelaers, David; Ariën, Kevin K

2016-10-15

 The 2013-2016 Ebola epidemic in West Africa resulted in accelerated development of rapid diagnostic tests for emergency outbreak preparedness. We describe the development and evaluation of the Idylla™ prototype Ebola virus test, a fully automated sample-to-result molecular diagnostic test for rapid detection of Zaire ebolavirus (EBOV) and Sudan ebolavirus (SUDV).  The Idylla™ prototype Ebola virus test can simultaneously detect EBOV and SUDV in 200 µL of whole blood. The sample is directly added to a disposable cartridge containing all reagents for sample preparation, RNA extraction, and amplification by reverse-transcription polymerase chain reaction analysis. The performance was evaluated with a variety of sample types, including synthetic constructs and whole blood samples from healthy volunteers spiked with viral RNA, inactivated virus, and infectious virus.  The 95% limits of detection for EBOV and SUDV were 465 plaque-forming units (PFU)/mL (1010 copies/mL) and 324 PFU/mL (8204 copies/mL), respectively. In silico and in vitro analyses demonstrated 100% correct reactivity for EBOV and SUDV and no cross-reactivity with relevant pathogens. The diagnostic sensitivity was 97.4% (for EBOV) and 91.7% (for SUDV), the specificity was 100%, and the diagnostic accuracy was 95.9%.  The Idylla™ prototype Ebola virus test is a fast, safe, easy-to-use, and near-patient test that meets the performance criteria to detect EBOV in patients with suspected Ebola. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Medical microbiology: laboratory diagnosis of invasive pneumococcal disease.

PubMed

Werno, Anja M; Murdoch, David R

2008-03-15

The laboratory diagnosis of invasive pneumococcal disease (IPD) continues to rely on culture-based methods that have been used for many decades. The most significant recent developments have occurred with antigen detection assays, whereas the role of nucleic acid amplification tests has yet to be fully clarified. Despite developments in laboratory diagnostics, a microbiological diagnosis is still not made in most cases of IPD, particularly for pneumococcal pneumonia. The limitations of existing diagnostic tests impact the ability to obtain accurate IPD burden data and to assess the effectiveness of control measures, such as vaccination, in addition to the ability to diagnose IPD in individual patients. There is an urgent need for improved diagnostic tests for pneumococcal disease--especially tests that are suitable for use in underresourced countries.

Rapid tests for diagnosis of leptospirosis: current tools and emerging technologies.

PubMed

Picardeau, Mathieu; Bertherat, Eric; Jancloes, Michel; Skouloudis, Andreas N; Durski, Kara; Hartskeerl, Rudy A

2014-01-01

Leptospirosis is an emerging zoonosis with a worldwide distribution but is more commonly found in impoverished populations in developing countries and tropical regions with frequent flooding. The rapid detection of leptospirosis is a critical step to effectively manage the disease and to control outbreaks in both human and animal populations. Therefore, there is a need for accurate and rapid diagnostic tests and appropriate surveillance and alert systems to identify outbreaks. This review describes current in-house methods and commercialized tests for the rapid diagnosis of acute leptospirosis. It focuses on diagnostic tests that can be performed with minimal training and limited equipment in less-developed and newly industrialized countries, particularly in resource-limited settings and with results in minutes to less than 4 hours. We also describe recent technological advances in the field of diagnostic tests that could allow for the development of innovative rapid tests in the near future. © 2013 Elsevier Inc. All rights reserved.

Are there financial savings associated with supplementing current diagnostic practice for preeclampsia with a novel test? Learnings from a modeling analysis from a German payer perspective.

PubMed

Hadker, Nandini; Garg, Suchita; Costanzo, Cory; van der Helm, Wim; Creeden, James

2013-05-01

To quantify the financial impact of adding a novel serum test to the current diagnostic toolkit for preeclampsia (PE) detection in Germany. A decision-analytic model was created to quantify the economic impact of adding a recently developed novel diagnostic test for PE (Roche Diagnostics, Rotkreuz, Switzerland) to current diagnostic practice in Germany. The model simulated a cohort of 1000 pregnant patients receiving obstetric care and quantified the budget impact of adding the novel test to current German PE detection and management practices. The model estimates that the costs associated with managing a typical pregnancy in Germany are €941 when the novel test is used versus €1579 with standard practice. This represents savings of €637 per pregnant woman, even when the test is used as a supplementary diagnostic tool. The savings are attributed to the novel test's ability to better classify patients relative to current practice, specifically, its ability to reduce false negatives by 67% and false positives by 71%. The novel PE test has the potential to provide substantial cost savings to German healthcare payers, even when used as an addition to standard practice. Better classification of patients at risk for developing PE and declassification of those that are not compared to current practice leads to economic savings for the healthcare system. Furthermore, by reducing the rates of false-positive and false-negative classification relative to current standard of care, the test helps better target healthcare spending and lowers overall costs associated with PE care.

Better Tests, Better Care: Improved Diagnostics for Infectious Diseases

PubMed Central

Caliendo, Angela M.; Gilbert, David N.; Ginocchio, Christine C.; Hanson, Kimberly E.; May, Larissa; Quinn, Thomas C.; Tenover, Fred C.; Alland, David; Blaschke, Anne J.; Bonomo, Robert A.; Carroll, Karen C.; Ferraro, Mary Jane; Hirschhorn, Lisa R.; Joseph, W. Patrick; Karchmer, Tobi; MacIntyre, Ann T.; Reller, L. Barth; Jackson, Audrey F.

2013-01-01

In this IDSA policy paper, we review the current diagnostic landscape, including unmet needs and emerging technologies, and assess the challenges to the development and clinical integration of improved tests. To fulfill the promise of emerging diagnostics, IDSA presents recommendations that address a host of identified barriers. Achieving these goals will require the engagement and coordination of a number of stakeholders, including Congress, funding and regulatory bodies, public health agencies, the diagnostics industry, healthcare systems, professional societies, and individual clinicians. PMID:24200831

Selling biotechnology in the dental medicine marketplace: the OmniGene Diagnostics DNA probe tests for periodontal pathogens.

PubMed

Van Arsdell, S W; DiFronzo, F; Backman, K C; Mahler, P H

1996-09-01

OmniGene Diagnostics, Inc. has applied the principles of genetic engineering to develop species-specific DNA probe tests for eight periodontal pathogens (Porphyromonas gingivalis, Prevotella intermedia, Actinobacillus actinomycetem-comitans, Fusobacterium nucleatum, Eikenella corrodens, Campylobacter rectus, Bacteroides forsythus, and Treponema denticola). The test requires minimal effort on the part of the clinician: subgingival plaque samples are collected from the patient and sent through the mail for analysis by OmniGene Diagnostics' fully licensed clinical reference laboratory. Results are transmitted to the practitioner by phone, fax, or mail. The use of diagnostic tests for periodontal pathogens is a relatively new concept in dentistry and acceptance of the OmniGene Diagnostics tests by the dental marketplace has been slower than anticipated. OmniGene Diagnostics' challenge for the future is to persuade the dental community that monitoring periodontal pathogen levels, as well as other clinical indicators of disease, is essential to providing optimal care to the periodontitis patient.

Testing Expert-Based versus Student-Based Cognitive Models for a Grade 3 Diagnostic Mathematics Assessment

ERIC Educational Resources Information Center

Roduta Roberts, Mary; Alves, Cecilia B.; Chu, Man-Wai; Thompson, Margaret; Bahry, Louise M.; Gotzmann, Andrea

2014-01-01

The purpose of this study was to evaluate the adequacy of three cognitive models, one developed by content experts and two generated from student verbal reports for explaining examinee performance on a grade 3 diagnostic mathematics test. For this study, the items were developed to directly measure the attributes in the cognitive model. The…

Development of an antigen-based rapid diagnostic test for the identification of blowfly (Calliphoridae) species of forensic significance.

PubMed

McDonagh, Laura; Thornton, Chris; Wallman, James F; Stevens, Jamie R

2009-06-01

In this study we examine the limitations of currently used sequence-based approaches to blowfly (Calliphoridae) identification and evaluate the utility of an immunological approach to discriminate between blowfly species of forensic importance. By investigating antigenic similarity and dissimilarity between the first instar larval stages of four forensically important blowfly species, we have been able to identify immunoreactive proteins of potential use in the development of species-specific immuno-diagnostic tests. Here we outline our protein-based approach to species determination, and describe how it may be adapted to develop rapid diagnostic assays for the 'on-site' identification of blowfly species.

Estimation of diagnostic test accuracy without full verification: a review of latent class methods

PubMed Central

Collins, John; Huynh, Minh

2014-01-01

The performance of a diagnostic test is best evaluated against a reference test that is without error. For many diseases, this is not possible, and an imperfect reference test must be used. However, diagnostic accuracy estimates may be biased if inaccurately verified status is used as the truth. Statistical models have been developed to handle this situation by treating disease as a latent variable. In this paper, we conduct a systematized review of statistical methods using latent class models for estimating test accuracy and disease prevalence in the absence of complete verification. PMID:24910172

Development of a framework for international certification by OIE of diagnostic tests validated as fit for purpose.

PubMed

Wright, P; Edwards, S; Diallo, A; Jacobson, R

2006-01-01

Historically, the OIE has focused on test methods applicable to trade and the international movement of animals and animal products. With its expanding role as the World Organisation for Animal Health, the OIE has recognised the need to evaluate test methods relative to specific diagnostic applications other than trade. In collaboration with its international partners, the OIE solicited input from experts through consultants' meetings on the development of guidelines for validation and certification of diagnostic assays for infectious animal diseases. Recommendations from the first meeting were formally adopted and have subsequently been acted upon by the OIE. A validation template has been developed that specifically requires a test to be fit or suited for its intended purpose (e.g. as a screening or a confirmatory test). This is a key criterion for validation. The template incorporates four distinct stages of validation, each of which has bearing on the evaluation of fitness for purpose. The OIE has just recently created a registry for diagnostic tests that fulfil these validation requirements. Assay developers are invited to submit validation dossiers to the OIE for evaluation by a panel of experts. Recognising that validation is an incremental process, tests methods achieving at least the first stages of validation may be provisionally accepted. To provide additional confidence in assay performance, the OIE, through its network of Reference Laboratories, has embarked on the development of evaluation panels. These panels would contain specially selected test samples that would assist in verifying fitness for purpose.

Development of a framework for international certification by the OIE of diagnostic tests validated as fit for purpose.

PubMed

Wright, P; Edwards, S; Diallo, A; Jacobson, R

2007-01-01

Historically, the OIE has focussed on test methods applicable to trade and the international movement of animals and animal products. With its expanding role as the World Organisation for Animal Health, the OIE has recognised the need to evaluate test methods relative to specific diagnostic applications other than trade. In collaboration with its international partners, the OIE solicited input from experts through consultants meetings on the development of guidelines for validation and certification of diagnostic assays for infectious animal diseases. Recommendations from the first meeting were formally adopted and have subsequently been acted upon by the OIE. A validation template has been developed that specifically requires a test to be fit or suited for its intended purpose (e.g. as a screening or a confirmatory test). This is a key criterion for validation. The template incorporates four distinct stages of validation, each of which has bearing on the evaluation of fitness for purpose. The OIE has just recently created a registry for diagnostic tests that fulfil these validation requirements. Assay developers are invited to submit validation dossiers to the OIE for evaluation by a panel of experts. Recognising that validation is an incremental process, tests methods achieving at least the first stages of validation may be provisionally accepted. To provide additional confidence in assay performance, the OIE, through its network of Reference Laboratories, has embarked on the development of evaluation panels. These panels would contain specially selected test samples that would assist in verifying fitness for purpose.

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.

Background review for diagnostic test development for Zika virus infection.

PubMed

Charrel, Rémi N; Leparc-Goffart, Isabelle; Pas, Suzan; de Lamballerie, Xavier; Koopmans, Marion; Reusken, Chantal

2016-08-01

To review the state of knowledge about diagnostic testing for Zika virus infection and identify areas of research needed to address the current gaps in knowledge. We made a non-systematic review of the published literature about Zika virus and supplemented this with information from commercial diagnostic test kits and personal communications with researchers in European preparedness networks. The review covered current knowledge about the geographical spread, pathogen characteristics, life cycle and infection kinetics of the virus. The available molecular and serological tests and biosafety issues are described and discussed in the context of the current outbreak strain. We identified the following areas of research to address current knowledge gaps: (i) an urgent assessment of the laboratory capacity and capability of countries to detect Zika virus; (ii) rapid and extensive field validation of the available molecular and serological tests in areas with and without Zika virus transmission, with a focus on pregnant women; (iii) monitoring the genomic diversity of circulating Zika virus strains; (iv) prospective studies into the virus infection kinetics, focusing on diagnostic sampling (specimen types, combinations and timings); and (v) developing external quality assessments for molecular and serological testing, including differential diagnosis for similar viruses and symptom clusters. The availability of reagents for diagnostic development (virus strains and antigens, quantified viral ribonucleic acid) needs to be facilitated. An international laboratory response is needed, including preparation of protocols for prospective studies to address the most pressing information needs.

Background review for diagnostic test development for Zika virus infection

PubMed Central

Charrel, Rémi N; Leparc-Goffart, Isabelle; Pas, Suzan; de Lamballerie, Xavier; Koopmans, Marion; Reusken, Chantal

2016-01-01

Abstract Objective To review the state of knowledge about diagnostic testing for Zika virus infection and identify areas of research needed to address the current gaps in knowledge. Methods We made a non-systematic review of the published literature about Zika virus and supplemented this with information from commercial diagnostic test kits and personal communications with researchers in European preparedness networks. The review covered current knowledge about the geographical spread, pathogen characteristics, life cycle and infection kinetics of the virus. The available molecular and serological tests and biosafety issues are described and discussed in the context of the current outbreak strain. Findings We identified the following areas of research to address current knowledge gaps: (i) an urgent assessment of the laboratory capacity and capability of countries to detect Zika virus; (ii) rapid and extensive field validation of the available molecular and serological tests in areas with and without Zika virus transmission, with a focus on pregnant women; (iii) monitoring the genomic diversity of circulating Zika virus strains; (iv) prospective studies into the virus infection kinetics, focusing on diagnostic sampling (specimen types, combinations and timings); and (v) developing external quality assessments for molecular and serological testing, including differential diagnosis for similar viruses and symptom clusters. The availability of reagents for diagnostic development (virus strains and antigens, quantified viral ribonucleic acid) needs to be facilitated. Conclusion An international laboratory response is needed, including preparation of protocols for prospective studies to address the most pressing information needs. PMID:27516635

Perspectives on Introduction and Implementation of New Point-of-Care Diagnostic Tests

PubMed Central

Palamountain, Kara M.; Baker, Jeff; Cowan, Elliot P.; Essajee, Shaffiq; Mazzola, Laura T.; Metzler, Mutsumi; Schito, Marco; Stevens, Wendy S.; Young, Gloria J.

2012-01-01

In recent years, there has been significant investment from both the private and public sectors in the development of diagnostic technologies to meet the need for human immunodeficiency virus (HIV) and tuberculosis testing in low-resource settings. Future investments should ensure that the most appropriate technologies are adopted in settings where they will have a sustainable impact. Achieving these aims requires the involvement of many stakeholders, as their needs, operational constraints, and priorities are often distinct. Here, we discuss these considerations from different perspectives representing those of various stakeholders involved in the development, introduction, and implementation of diagnostic tests. We also discuss some opportunities to address these considerations. PMID:22402038

Surface enhanced Raman spectroscopy (SERS) for in vitro diagnostic testing at the point of care

NASA Astrophysics Data System (ADS)

Marks, Haley; Schechinger, Monika; Garza, Javier; Locke, Andrea; Coté, Gerard

2017-06-01

Point-of-care (POC) device development is a growing field that aims to develop low-cost, rapid, sensitive in-vitro diagnostic testing platforms that are portable, self-contained, and can be used anywhere - from modern clinics to remote and low resource areas. In this review, surface enhanced Raman spectroscopy (SERS) is discussed as a solution to facilitating the translation of bioanalytical sensing to the POC. The potential for SERS to meet the widely accepted "ASSURED" (Affordable, Sensitive, Specific, User-friendly, Rapid, Equipment-free, and Deliverable) criterion provided by the World Health Organization is discussed based on recent advances in SERS in vitro assay development. As SERS provides attractive characteristics for multiplexed sensing at low concentration limits with a high degree of specificity, it holds great promise for enhancing current efforts in rapid diagnostic testing. In outlining the progression of SERS techniques over the past years combined with recent developments in smart nanomaterials, high-throughput microfluidics, and low-cost paper diagnostics, an extensive number of new possibilities show potential for translating SERS biosensors to the POC.

Development and clinical evaluation of a rapid diagnostic kit for feline leukemia virus infection.

PubMed

Kim, Won-Shik; Chong, Chom-Kyu; Kim, Hak-Yong; Lee, Gyu-Cheol; Jeong, Wooseog; An, Dong-Jun; Jeoung, Hye-Young; Lee, Jae-In; Lee, Young-Ki

2014-01-01

Feline leukemia virus (FeLV) causes a range of neoplastic and degenerative diseases in cats. To obtain a more sensitive and convenient diagnosis of the disease, we prepared monoclonal antibodies specific for the FeLV p27 to develop a rapid diagnostic test with enhanced sensitivity and specificity. Among these antibodies, we identified two clones (hybridomas 8F8B5 and 8G7D1) that specifically bound to FeLV and were very suitable for a diagnostic kit. The affinity constants for 8F8B5 and 8G7D1 were 0.35 × 10⁸ and 0.86 × 10⁸, respectively. To investigate the diagnostic abilities of the rapid kit using these antibodies, we performed several clinical studies. Assessment of analytical sensitivity revealed that the detection threshold of the rapid diagnostic test was 2 ng/mL for recombinant p27 and 12.5 × 10⁴ IU/mL for FeLV. When evaluating 252 cat sera samples, the kit was found to have a kappa value of 0.88 compared to polymerase chain reaction (PCR), indicating a significant correlation between data from the rapid diagnostic test and PCR. Sensitivity and specificity of the kit were 95.2% (20/21) and 98.5% (257/261), respectively. Our results demonstrated that the rapid diagnostic test would be a suitable diagnostic tool for the rapid detection of FeLV infection in cats.

Diagnostic hearing testing of infants aged 0-36 months in 3 South African provinces - Comparison of audiology records to HPCSA guidelines.

PubMed

Moodley, Selvarani; Störbeck, Claudine

2016-12-01

Within the Early Hearing Detection and Intervention (EHDI) pathway, which includes the processes of screening, diagnosis and intervention for paediatric hearing loss, paediatric diagnostic audiology involves a battery of specific tests and procedures. International studies have highlighted a golden standard for diagnosis of paediatric hearing loss as based on the Joint Committee of Infant Hearing (2007) diagnostic guidelines, closely resembling the HPCSA diagnostic guidelines. There are limited South African studies on the processes and protocols followed in diagnostic paediatric audiology. This study aims to provide a comparison for how the tests used for diagnosis of paediatric hearing loss in South Africa (within both the public and private healthcare sectors) compare to the HPCSA recommended diagnostic guidelines. A retrospective record review of paediatric clients with hearing loss (recruited through nonprobability convenience sampling) was conducted. This study is part of a longitudinal study of 711 deaf or hard of hearing children referred to the HI HOPES early intervention programme from September 2006 to December 2011. Diagnostic data from audiology reports of 117 children between 0 and 36 months were coded and analysed. Large variation was found in the tests included in the diagnostic audiology reports. For 22 children (19%) a comprehensive test battery was used. Health Professions Council of South Africa (HPCSA) recommended guidelines for diagnostic testing were not followed in any of the records analysed. Components of the HPCSA recommended test battery most frequently omitted was bone conduction testing. For both electrophysiology and behavioural testing, there was limited frequency specificity information. This exclusion of information is evidence of deficiencies in data recording and management, as well as having an effect on accuracy of classification of degree and type of hearing loss. There are gaps in age-appropriate assessment protocols, which will have an effect on accurate differential diagnosis of paediatric hearing loss. Reasons for not including all testing components of the HPCSA recommended guidelines, as well as the possibility of developing guidelines more relevant to a developing world context, should be explored. There might be a need for. The impact of South African specific factors that have an effect on provision of accurate paediatric diagnostic audiology services should be determined. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

New and developing diagnostic technologies for urinary tract infections

PubMed Central

Davenport, Michael; Mach, Kathleen E.; Dairiki Shortliffe, Linda M.; Banaei, Niaz; Wang, Tza-Huei; Liao, Joseph C.

2017-01-01

Timely and accurate identification and determination of the antimicrobial susceptibility of uropathogens is central to the management of UTIs. Urine dipsticks are fast and amenable to point-of-care testing, but do not have adequate diagnostic accuracy or provide microbiological diagnosis. Urine culture with antimicrobial susceptibility testing takes 2 3 days and requires a clinical laboratory. The common use of empirical antibiotics has contributed to the rise of multidrug-resistant organisms, reducing treatment options and increasing costs. In addition to improved antimicrobial stewardship and the development of new antimicrobials, novel diagnostics are needed for timely microbial identification and determination of antimicrobial susceptibilities. New diagnostic platforms, including nucleic acid tests and mass spectrometry, have been approved for clinical use and have improved the speed and accuracy of pathogen identification from primary cultures. Optimization for direct urine testing would reduce the time to diagnosis, yet these technologies do not provide comprehensive information on antimicrobial susceptibility. Emerging technologies including biosensors, microfluidics, and other integrated platforms could improve UTI diagnosis via direct pathogen detection from urine samples, rapid antimicrobial susceptibility testing, and point-of-care testing. Successful development and implementation of these technologies has the potential to usher in an era of precision medicine to improve patient care and public health. PMID:28248946

A computational framework for converting textual clinical diagnostic criteria into the quality data model.

PubMed

Hong, Na; Li, Dingcheng; Yu, Yue; Xiu, Qiongying; Liu, Hongfang; Jiang, Guoqian

2016-10-01

Constructing standard and computable clinical diagnostic criteria is an important but challenging research field in the clinical informatics community. The Quality Data Model (QDM) is emerging as a promising information model for standardizing clinical diagnostic criteria. To develop and evaluate automated methods for converting textual clinical diagnostic criteria in a structured format using QDM. We used a clinical Natural Language Processing (NLP) tool known as cTAKES to detect sentences and annotate events in diagnostic criteria. We developed a rule-based approach for assigning the QDM datatype(s) to an individual criterion, whereas we invoked a machine learning algorithm based on the Conditional Random Fields (CRFs) for annotating attributes belonging to each particular QDM datatype. We manually developed an annotated corpus as the gold standard and used standard measures (precision, recall and f-measure) for the performance evaluation. We harvested 267 individual criteria with the datatypes of Symptom and Laboratory Test from 63 textual diagnostic criteria. We manually annotated attributes and values in 142 individual Laboratory Test criteria. The average performance of our rule-based approach was 0.84 of precision, 0.86 of recall, and 0.85 of f-measure; the performance of CRFs-based classification was 0.95 of precision, 0.88 of recall and 0.91 of f-measure. We also implemented a web-based tool that automatically translates textual Laboratory Test criteria into the QDM XML template format. The results indicated that our approaches leveraging cTAKES and CRFs are effective in facilitating diagnostic criteria annotation and classification. Our NLP-based computational framework is a feasible and useful solution in developing diagnostic criteria representation and computerization. Copyright © 2016 Elsevier Inc. All rights reserved.

Improvement of Railroad Roller Bearing Test Procedures & Development of Roller Bearing Diagnostic Techniques. Volume 2.

DOT National Transportation Integrated Search

1982-04-01

A comprehensive review of existing basic diagnostic techniques applicable to the railcar roller bearing defect and failure problem was made. Of the potentially feasible diagnostic techniques identified, high frequency vibration was selected for exper...

External quality assurance for HIV point-of-care testing in Africa: A collaborative country-partner approach to strengthen diagnostic services

PubMed Central

2016-01-01

It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing. PMID:28879132

Psychometric properties of the motor diagnostics in the German football talent identification and development programme.

PubMed

HÖner, Oliver; Votteler, Andreas; Schmid, Markus; Schultz, Florian; Roth, Klaus

2015-01-01

The utilisation of motor performance tests for talent identification in youth sports is discussed intensively in talent research. This article examines the reliability, differential stability and validity of the motor diagnostics conducted nationwide by the German football talent identification and development programme and provides reference values for a standardised interpretation of the diagnostics results. Highly selected players (the top 4% of their age groups, U12-U15) took part in the diagnostics at 17 measurement points between spring 2004 and spring 2012 (N = 68,158). The heterogeneous test battery measured speed abilities and football-specific technical skills (sprint, agility, dribbling, ball control, shooting, juggling). For all measurement points, the overall score and the speed tests showed high internal consistency, high test-retest reliability and satisfying differential stability. The diagnostics demonstrated satisfying factorial-related validity with plausible and stable loadings on the two empirical factors "speed" and "technical skills". The score, and the technical skills dribbling and juggling, differentiated the most among players of different performance levels and thus showed the highest criterion-related validity. Satisfactory psychometric properties for the diagnostics are an important prerequisite for a scientifically sound rating of players' actual motor performance and for the future examination of the prognostic validity for success in adulthood.

Developing a new diagnostic algorithm for human papilloma virus associated oropharyngeal carcinoma: an investigation of HPV DNA assays.

PubMed

Cohen, Natasha; Gupta, Michael; Doerwald-Munoz, Lilian; Jang, Dan; Young, James Edward Massey; Archibald, Stuart; Jackson, Bernard; Lee, Jenny; Chernesky, Max

2017-02-13

Human papilloma virus (HPV) has been implicated in the development of a large proportion of oropharyngeal squamous cell carcinoma (OPSCC). Current techniques used to diagnose HPV etiology require histopathologic analysis. We aim to investigate the diagnostic accuracy of a new application non-histopathologic diagnostic tests to help assist diagnosis of HPV-related oropharyngeal tumors. Patients with OPSCC with nodal metastasis were consecutively recruited from a multidisciplinary cancer clinic. Appropriate samples were collected and analyzed. The various tests examined included COBAS® 4800, Cervista® HR and Genotyping. These tests were compared to p16 staining, which was used as the diagnostic standard. StataIC 14.2 was used to perform analysis, including sensitivity, specificity and receiver operator characteristic [ROC] curves. The COBAS® FNA (area under ROC 0.863) and saliva (area under ROC 0.847) samples performed well in diagnosing HPV positive and negative tumors. Samples tested with Cervista® did not corroborate p16 status reliably. We were able to increase the diagnostic yield of the COBAS® FNA samples by applying the results of the saliva test to negative FNA samples which correctly identified 11 additional p16 positive tumors (area under ROC 0.915). Surrogate testing for HPV using alternate methods is feasible and closely predicts the results of standard diagnostic methods. In the future, these could minimize invasive procedures for diagnosing HPV-related oropharyngeal cancer, but also help to diagnose and treat patients with unknown primaries.

A Comparison of the Mathematical Performance of Mature Students and Traditional Students over a 10-Year Period

ERIC Educational Resources Information Center

Faulkner, Fiona; Fitzmaurice, Olivia; Hannigan, Ailish

2016-01-01

Every student who enrols in a degree programme involving service mathematics in the University of Limerick in Ireland is given a mathematics diagnostic test. The diagnostic test was developed due to mathematics lecturers' anxiety regarding students' mathematical competency levels. Students receive the 40 question paper-based test in their first…

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

James, Veronica J.; ANU)

An early diagnosis of malignancies correlates directly with a better prognosis. Yet for many malignancies there are no readily available, noninvasive, cost-effective diagnostic tests with patients often presenting too late for effective treatment. This article describes for the first time the use of fiber diffraction patterns of skin or fingernails, using X-ray sources, as a biometric diagnostic method for detecting neoplastic disorders including but not limited to melanoma, breast, colon and prostate cancers. With suitable further development, an early low-cost, totally noninvasive yet reliable diagnostic test could be conducted on a regular basis in local radiology facilities, as a confirmatorymore » test for other diagnostic procedures or as a mass screening test using suitable small angle X-ray beam-lines at synchrotrons.« less

Develop Advanced Nonlinear Signal Analysis Topographical Mapping System

NASA Technical Reports Server (NTRS)

Jong, Jen-Yi

1997-01-01

During the development of the SSME, a hierarchy of advanced signal analysis techniques for mechanical signature analysis has been developed by NASA and AI Signal Research Inc. (ASRI) to improve the safety and reliability for Space Shuttle operations. These techniques can process and identify intelligent information hidden in a measured signal which is often unidentifiable using conventional signal analysis methods. Currently, due to the highly interactive processing requirements and the volume of dynamic data involved, detailed diagnostic analysis is being performed manually which requires immense man-hours with extensive human interface. To overcome this manual process, NASA implemented this program to develop an Advanced nonlinear signal Analysis Topographical Mapping System (ATMS) to provide automatic/unsupervised engine diagnostic capabilities. The ATMS will utilize a rule-based Clips expert system to supervise a hierarchy of diagnostic signature analysis techniques in the Advanced Signal Analysis Library (ASAL). ASAL will perform automatic signal processing, archiving, and anomaly detection/identification tasks in order to provide an intelligent and fully automated engine diagnostic capability. The ATMS has been successfully developed under this contract. In summary, the program objectives to design, develop, test and conduct performance evaluation for an automated engine diagnostic system have been successfully achieved. Software implementation of the entire ATMS system on MSFC's OISPS computer has been completed. The significance of the ATMS developed under this program is attributed to the fully automated coherence analysis capability for anomaly detection and identification which can greatly enhance the power and reliability of engine diagnostic evaluation. The results have demonstrated that ATMS can significantly save time and man-hours in performing engine test/flight data analysis and performance evaluation of large volumes of dynamic test data.

Information engineering for molecular diagnostics.

PubMed Central

Sorace, J. M.; Ritondo, M.; Canfield, K.

1994-01-01

Clinical laboratories are beginning to apply the recent advances in molecular biology to the testing of patient samples. The emerging field of Molecular Diagnostics will require a new Molecular Diagnostics Laboratory Information System which handles the data types, samples and test methods found in this field. The system must be very flexible in regards to supporting ad-hoc queries. The requirements which are shaping the developments in this field are reviewed and a data model developed. Several queries which demonstrate the data models ability to support the information needs of this area have been developed and run. These results demonstrate the ability of the purposed data model to meet the current and projected needs of this rapidly expanding field. PMID:7949937

DIAGNOSTIC TOOL DEVELOPMENT AND APPLICATION THROUGH REGIONAL CASE STUDIES

EPA Science Inventory

Case studies are a useful vehicle for developing and testing conceptual models, classification systems, diagnostic tools and models, and stressor-response relationships. Furthermore, case studies focused on specific places or issues of interest to the Agency provide an excellent ...

The impact of patents on the development of genome-based clinical diagnostics: an analysis of case studies

PubMed Central

Pierce, Brandon L.; Carlson, Christopher S.; Kuszler, Patricia C.; Stanford, Janet L.; Austin, Melissa A.

2010-01-01

Purpose Fragmented ownership of diagnostic gene patents has the potential to create an ‘anticommons’ in the area of genomic diagnostics, making it difficult and expensive to assemble the patent rights necessary to develop a panel of genetic tests. The objectives of this study were to identify U.S. patents that protect existing panels of genetic tests, describe how (or if) test providers acquired rights to these patents, and determine if fragmented patent ownership has inhibited the commercialization of these panels. Methods As case studies, we selected four clinical applications of genetic testing (cystic fibrosis, maturity-onset diabetes of the young, long QT syndrome, and hereditary breast cancer) that utilize tests protected by ≥3 U.S. patents. We summarized publically available information on relevant patents, test providers, licenses, and litigation. Results For each case study, all tests of major genes/mutations were patented, and at least one party held the collective rights to conduct all relevant tests, often as a result of licensing agreements. Conclusions We did not find evidence that fragmentation of patent rights has inhibited commercialization of genetic testing services. However, as knowledge of genetic susceptibility increases, it will be important to consider the potential consequences of fragmented ownership of diagnostic gene patents. PMID:19367193

Nucleic acid-based diagnostics for infectious diseases in public health affairs.

PubMed

Yu, Albert Cheung-Hoi; Vatcher, Greg; Yue, Xin; Dong, Yan; Li, Mao Hua; Tam, Patrick H K; Tsang, Parker Y L; Wong, April K Y; Hui, Michael H K; Yang, Bin; Tang, Hao; Lau, Lok-Ting

2012-06-01

Infectious diseases, mostly caused by bacteria and viruses but also a result of fungal and parasitic infection, have been one of the most important public health concerns throughout human history. The first step in combating these pathogens is to get a timely and accurate diagnosis at an affordable cost. Many kinds of diagnostics have been developed, such as pathogen culture, biochemical tests and serological tests, to help detect and fight against the causative agents of diseases. However, these diagnostic tests are generally unsatisfactory because they are not particularly sensitive and specific and are unable to deliver speedy results. Nucleic acid-based diagnostics, detecting pathogens through the identification of their genomic sequences, have shown promise to overcome the above limitations and become more widely adopted in clinical tests. Here we review some of the most popular nucleic acid-based diagnostics and focus on their adaptability and applicability to routine clinical usage. We also compare and contrast the characteristics of different types of nucleic acid-based diagnostics.

Hydrocarbon-Fueled Rocket Engine Plume Diagnostics: Analytical Developments and Experimental Results

NASA Technical Reports Server (NTRS)

Tejwani, Gopal D.; McVay, Gregory P.; Langford, Lester A.; St. Cyr, William W.

2006-01-01

A viewgraph presentation describing experimental results and analytical developments about plume diagnostics for hydrocarbon-fueled rocket engines is shown. The topics include: 1) SSC Plume Diagnostics Background; 2) Engine Health Monitoring Approach; 3) Rocket Plume Spectroscopy Simulation Code; 4) Spectral Simulation for 10 Atomic Species and for 11 Diatomic Molecular Electronic Bands; 5) "Best" Lines for Plume Diagnostics for Hydrocarbon-Fueled Rocket Engines; 6) Experimental Set Up for the Methane Thruster Test Program and Experimental Results; and 7) Summary and Recommendations.

Understanding the medical and nonmedical value of diagnostic testing.

PubMed

Lee, David W; Neumann, Peter J; Rizzo, John A

2010-01-01

To develop a framework for defining the potential value of diagnostic testing, and discuss its implications for the health-care delivery system. We reviewed the conceptual and empirical literature related to the valuing of diagnostic tests, and used this information to create a framework for characterizing their value. We then made inferences about the impact of this framework on health insurance coverage, health technology assessment, physician-patient relationships, and public health policy. Three dimensions can effectively classify the potential value created by diagnostic tests: 1) medical value (impact on treatment decisions); 2) planning value (affect on patients' ability to make better life decisions); and 3) psychic value (how test information affects patients' sense of self). This comprehensive framework for valuing diagnostics suggests that existing health technology assessments may systematically under- or overvalue diagnostics, leading to potentially incorrect conclusions about cost-effectiveness. Further, failure to account for all value dimensions may lead to distorted payments under a value-based health-care system. The potential value created by medical diagnostics incorporates medical value as well as value associated with well-being and planning. Consideration of all three dimensions has important implications for technology assessment and value-based payment.

Diagnostic challenges of childhood asthma.

PubMed

Bakirtas, Arzu

2017-01-01

Diagnosis of asthma in childhood is challenging. Both underdiagnosis and overdiagnosis of asthma are important issues. The present review gives information about challenging factors for an accurate diagnosis of childhood asthma. Although underdiagnosis of asthma in childhood has always been the most important diagnostic problem, overdiagnosis of asthma has also been increasingly recognized. This is probably due to diagnosis of asthma based on symptoms and signs alone. Demonstration of variable airflow obstruction by lung function tests is the most common asthma diagnostic tests used in practice and is therefore strongly recommended in children who can cooperate. Recently, an asthma guideline combining the clinical and economic evidences with sensitivity and specificity of diagnostic procedures was developed to improve accuracy of diagnosis and to avoid overdiagnosis. This guideline provided an algorithmic clinical and cost-effective approach and included fractional exhaled nitric oxide measurement as one of the diagnostic tests in addition to lung function. Diagnosis of asthma in children should be made by combining relevant history with at least two confirmatory diagnostic tests whenever possible. Diagnosis based on short-period treatment trials should be limited to young children who are unable to cooperate with these tests.

Development and Application of a Novel Rasch-Based Methodology for Evaluating Multi-Tiered Assessment Instruments: Validation and Utilization of an Undergraduate Diagnostic Test of the Water Cycle

ERIC Educational Resources Information Center

Romine, William L.; Schaffer, Dane L.; Barrow, Lloyd

2015-01-01

We describe the development and validation of a three-tiered diagnostic test of the water cycle (DTWC) and use it to evaluate the impact of prior learning experiences on undergraduates' misconceptions. While most approaches to instrument validation take a positivist perspective using singular criteria such as reliability and fit with a measurement…

Diagnostic triage and the role of natriuretic peptide testing and echocardiography for suspected heart failure: an appropriateness ratings evaluation by UK GPs

PubMed Central

Campbell, Stephen M; Fuat, Ahmet; Summerton, Nick; Lancaster, Neil; Hobbs, FD Richard

2011-01-01

Background Some UK GPs are acquiring access to natriuretic peptide (NP) testing or echocardiography as diagnostic tests for heart failure. This study developed appropriateness ratings for the diagnostic application of these tests in routine general practice. Aim To develop appropriateness ratings for the diagnostic application of NP testing or echocardiography for heart failure in general practice. Design and setting An appropriateness ratings evaluation in UK general practice. Method Four presenting symptoms (cough, bilateral ankle swelling, dyspnoea, fatigue), three levels of risk of cardiovascular disease (low, intermediate, high), and dichotomous categorisations of cardiovascular/chest examination and electrocardiogram result, were used to create 540 appropriateness scenarios for patients in whom NP testing or echocardiography might be considered. These were rated by a 10-person expert panel, consisting of GPs and GPs with specialist interests in cardiology, in a two-round RAND Appropriateness Method. Results Onward referral for NP testing or echocardiography was rated as an appropriate next step in 217 (40.2%) of the 540 scenarios; in 194 (35.9%) it was rated inappropriate. The ratings also show where NP testing or echocardiography were ranked as equivalent next steps and when one test was seen as the more appropriate than the other. Conclusion NP testing should be the routine test for suspected heart failure where referral for diagnostic testing is considered appropriate. An abnormal electrocardiogram status makes referral to echocardiography an accompanying, or more appropriate, next step alongside NP testing, especially in the presence of dyspnoea. Abnormal NP testing should subsequently be followed up with referral for echocardiography. PMID:21722451

Molecular and Nonmolecular Diagnostic Methods for Invasive Fungal Infections

PubMed Central

Arvanitis, Marios; Anagnostou, Theodora; Fuchs, Beth Burgwyn; Caliendo, Angela M.

2014-01-01

SUMMARY Invasive fungal infections constitute a serious threat to an ever-growing population of immunocompromised individuals and other individuals at risk. Traditional diagnostic methods, such as histopathology and culture, which are still considered the gold standards, have low sensitivity, which underscores the need for the development of new means of detecting fungal infectious agents. Indeed, novel serologic and molecular techniques have been developed and are currently under clinical evaluation. Tests like the galactomannan antigen test for aspergillosis and the β-glucan test for invasive Candida spp. and molds, as well as other antigen and antibody tests, for Cryptococcus spp., Pneumocystis spp., and dimorphic fungi, have already been established as important diagnostic approaches and are implemented in routine clinical practice. On the other hand, PCR and other molecular approaches, such as matrix-assisted laser desorption ionization (MALDI) and fluorescence in situ hybridization (FISH), have proved promising in clinical trials but still need to undergo standardization before their clinical use can become widespread. The purpose of this review is to highlight the different diagnostic approaches that are currently utilized or under development for invasive fungal infections and to identify their performance characteristics and the challenges associated with their use. PMID:24982319

Laboratory development and testing of spacecraft diagnostics

NASA Astrophysics Data System (ADS)

Amatucci, William; Tejero, Erik; Blackwell, Dave; Walker, Dave; Gatling, George; Enloe, Lon; Gillman, Eric

2017-10-01

The Naval Research Laboratory's Space Chamber experiment is a large-scale laboratory device dedicated to the creation of large-volume plasmas with parameters scaled to realistic space plasmas. Such devices make valuable contributions to the investigation of space plasma phenomena under controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. However, in addition to investigations such as plasma wave and instability studies, such devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this talk, we will describe how the laboratory simulation of space plasmas made this development path possible. Work sponsored by the US Naval Research Laboratory Base Program.

Development of immune-diagnostic reagents to diagnose bovine tuberculosis in cattle.

PubMed

Vordermeier, H Martin; Jones, Gareth J; Buddle, Bryce M; Hewinson, R Glyn

2016-11-15

Bovine tuberculosis remains a major economic and animal welfare concern worldwide. As part of control strategies, cattle vaccination is being considered. This approach, used alongside conventional control policies, also requires the development of vaccine compatible diagnostic assays to distinguish infected from vaccinated animals (DIVA). In this review we discuss recent advances in DIVA development based on the detection of host cellular immune responses by blood testing or skin testing approaches. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

Development of a diagnostic test set to assess agreement in breast pathology: practical application of the Guidelines for Reporting Reliability and Agreement Studies (GRRAS).

PubMed

Oster, Natalia V; Carney, Patricia A; Allison, Kimberly H; Weaver, Donald L; Reisch, Lisa M; Longton, Gary; Onega, Tracy; Pepe, Margaret; Geller, Berta M; Nelson, Heidi D; Ross, Tyler R; Tosteson, Aanna N A; Elmore, Joann G

2013-02-05

Diagnostic test sets are a valuable research tool that contributes importantly to the validity and reliability of studies that assess agreement in breast pathology. In order to fully understand the strengths and weaknesses of any agreement and reliability study, however, the methods should be fully reported. In this paper we provide a step-by-step description of the methods used to create four complex test sets for a study of diagnostic agreement among pathologists interpreting breast biopsy specimens. We use the newly developed Guidelines for Reporting Reliability and Agreement Studies (GRRAS) as a basis to report these methods. Breast tissue biopsies were selected from the National Cancer Institute-funded Breast Cancer Surveillance Consortium sites. We used a random sampling stratified according to woman's age (40-49 vs. ≥50), parenchymal breast density (low vs. high) and interpretation of the original pathologist. A 3-member panel of expert breast pathologists first independently interpreted each case using five primary diagnostic categories (non-proliferative changes, proliferative changes without atypia, atypical ductal hyperplasia, ductal carcinoma in situ, and invasive carcinoma). When the experts did not unanimously agree on a case diagnosis a modified Delphi method was used to determine the reference standard consensus diagnosis. The final test cases were stratified and randomly assigned into one of four unique test sets. We found GRRAS recommendations to be very useful in reporting diagnostic test set development and recommend inclusion of two additional criteria: 1) characterizing the study population and 2) describing the methods for reference diagnosis, when applicable.

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics.

PubMed

Simon, Richard

2008-06-01

Developments in genomics and biotechnology provide unprecedented opportunities for the development of effective therapeutics and companion diagnostics for matching the right drug to the right patient. Effective co-development involves many new challenges with increased opportunity for success as well as delay and failure. Clinical trial designs and adaptive analysis plans for the prospective design of pivotal trials of new therapeutics and companion diagnostics are reviewed. Effective co-development requires careful prospective planning of the design and analysis strategy for pivotal clinical trials. Randomized clinical trials continue to be important for evaluating the effectiveness of new treatments, but the target populations for analysis should be prospectively specified based on the companion diagnostic. Post hoc analyses of traditionally designed randomized clinical trials are often deeply problematic. Clear separation is generally required of the data used for developing the diagnostic test, including their threshold of positivity, from the data used for evaluating treatment effectiveness in subsets determined by the test. Adaptive analysis can be used to provide flexibility to the analysis but the use of such methods requires careful planning and prospective definition in order to assure that the pivotal trial adequately limits the chance of erroneous conclusions.

Cost Implications of Value-Based Pricing for Companion Diagnostic Tests in Precision Medicine.

PubMed

Zaric, Gregory S

2016-07-01

Many interpretations of personalized medicine, also referred to as precision medicine, include discussions of companion diagnostic tests that allow drugs to be targeted to those individuals who are most likely to benefit or that allow treatment to be designed in a way such that individuals who are unlikely to benefit do not receive treatment. Many authors have commented on the clinical and competitive implications of companion diagnostics, but there has been relatively little formal analysis of the cost implications of companion diagnostics, although cost reduction is often cited as a significant benefit of precision medicine. We investigate the potential impact on costs of precision medicine implemented through the use of companion diagnostics. We develop a framework in which the costs of companion diagnostic tests are determined by considerations of profit maximization and cost effectiveness. We analyze four scenarios that are defined by the incremental cost-effectiveness ratio of the new drug in the absence of a companion diagnostic test. We find that, in most scenarios, precision medicine strategies based on companion diagnostics should be expected to lead to increases in costs in the short term and that costs would fall only in a limited number of situations.

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.

[Companion diagnostics in the era of personalized medicine--chairmen's introductory remarks].

PubMed

Fukutsuka, Katsuhiro; Takubo, Takayuki

2014-04-01

Personalized medicine is a medical model that proposes the customization of treatment for individual patients. In this model, diagnostic tests are essential for selecting safer and more efficacious treatments. The term "companion diagnostics" has been used to describe these tests, whereby molecular assays that measure the levels of proteins or specific gene mutations are used to provide a specific therapy for an individual by stratifying the disease status, selecting the proper medication, and tailoring dosages. Examples of companion diagnostics in the field of cancer medicine for molecular targeted therapy include tests for the ALK-fusion gene in non-small cell lung cancer and expression of CCR4 in adult T-cell leukemia. For breast cancer, the expression of HER2 protein is evaluated by immunohistochemistry (IHC), and gene amplification of HER2 is tested by fluorescence in situ hybridization (FISH); both tests consist of pre-analysis, analysis, and post-analysis processes that require quality control to ensure the reliability of the results. This symposium includes: 1) future aspects of companion diagnostics addressing many of the problems that must be overcome, 2) companion diagnostics using FISH focusing on HER2 amplification and ALK alteration, 3) newly developed diagnostic tests using tumor specimens and cell-free DNA in serum, and 4) CCR4 expression detected by IHC and flow cytometry.

Evaluating College Students' Conceptual Knowledge of Modern Physics: Test of Understanding on Concepts of Modern Physics (TUCO-MP)

ERIC Educational Resources Information Center

Akarsu, Bayram

2011-01-01

In present paper, we propose a new diagnostic test to measure students' conceptual knowledge of principles of modern physics topics. Over few decades since born of physics education research (PER), many diagnostic instruments that measure students' conceptual understanding of various topics in physics, the earliest tests developed in PER are Force…

Built-In-Test Equipment Requirements Workshop. Workshop Presentation

DTIC Science & Technology

1981-08-01

quantitatively evaluated in test. (2) It is necessary to develop the statistical methods that should be used for predicting and confirming of diagnostic...of different performance levels of BIT peacetime and wartime applications, and the corresponding manpower and other support requirements should be...reports. The scope of the workshop involves the areas of require- ments for built-in-test and diagnostics, and the methods of testing to ensure that the

A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics

PubMed Central

Luo, Dee; Smith, James A.; Meadows, Nick A.; Schuh, A.; Manescu, Katie E.; Bure, Kim; Davies, Benjamin; Horne, Rob; Kope, Mike; DiGiusto, David L.; Brindley, David A.

2016-01-01

Rapid innovation in (epi)genetics and biomarker sciences is driving a new drug development and product development pathway, with the personalized medicine era dominated by biologic therapeutics and companion diagnostics. Companion diagnostics (CDx) are tests and assays that detect biomarkers and specific mutations to elucidate disease pathways, stratify patient populations, and target drug therapies. CDx can substantially influence the development and regulatory approval for certain high-risk biologics. However, despite the increasingly important role of companion diagnostics in the realization of personalized medicine, in the USA, there are only 23 Food and Drug Administration (FDA) approved companion diagnostics on the market for 11 unique indications. Personalized medicines have great potential, yet their use is currently constrained. A major factor for this may lie in the increased complexity of the companion diagnostic and corresponding therapeutic development and adoption pathways. Understanding the market dynamics of companion diagnostic/therapeutic (CDx/Rx) pairs is important to further development and adoption of personalized medicine. Therefore, data collected on a variety of factors may highlight incentives or disincentives driving the development of companion diagnostics. Statistical analysis for 36 hypotheses resulted in two significant relationships and 34 non-significant relationships. The sensitivity of the companion diagnostic was the only factor that significantly correlated with the price of the companion diagnostic. This result indicates that while there is regulatory pressure for the diagnostic and pharmaceutical industry to collaborate and co-develop companion diagnostics for the approval of personalized therapeutics, there seems to be a lack of parallel economic collaboration to incentivize development of companion diagnostics. PMID:26858745

A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics.

PubMed

Luo, Dee; Smith, James A; Meadows, Nick A; Schuh, A; Manescu, Katie E; Bure, Kim; Davies, Benjamin; Horne, Rob; Kope, Mike; DiGiusto, David L; Brindley, David A

2015-01-01

Rapid innovation in (epi)genetics and biomarker sciences is driving a new drug development and product development pathway, with the personalized medicine era dominated by biologic therapeutics and companion diagnostics. Companion diagnostics (CDx) are tests and assays that detect biomarkers and specific mutations to elucidate disease pathways, stratify patient populations, and target drug therapies. CDx can substantially influence the development and regulatory approval for certain high-risk biologics. However, despite the increasingly important role of companion diagnostics in the realization of personalized medicine, in the USA, there are only 23 Food and Drug Administration (FDA) approved companion diagnostics on the market for 11 unique indications. Personalized medicines have great potential, yet their use is currently constrained. A major factor for this may lie in the increased complexity of the companion diagnostic and corresponding therapeutic development and adoption pathways. Understanding the market dynamics of companion diagnostic/therapeutic (CDx/Rx) pairs is important to further development and adoption of personalized medicine. Therefore, data collected on a variety of factors may highlight incentives or disincentives driving the development of companion diagnostics. Statistical analysis for 36 hypotheses resulted in two significant relationships and 34 non-significant relationships. The sensitivity of the companion diagnostic was the only factor that significantly correlated with the price of the companion diagnostic. This result indicates that while there is regulatory pressure for the diagnostic and pharmaceutical industry to collaborate and co-develop companion diagnostics for the approval of personalized therapeutics, there seems to be a lack of parallel economic collaboration to incentivize development of companion diagnostics.

Validity of Combining History Elements and Physical Examination Tests to Diagnose Patellofemoral Pain.

PubMed

Décary, Simon; Frémont, Pierre; Pelletier, Bruno; Fallaha, Michel; Belzile, Sylvain; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Feldman, Debbie; Sylvestre, Marie-Pierre; Vendittoli, Pascal-André; Desmeules, François

2018-04-01

To assess the validity of diagnostic clusters combining history elements and physical examination tests to diagnose or exclude patellofemoral pain (PFP). Prospective diagnostic study. Orthopedic outpatient clinics, family medicine clinics, and community-dwelling. Consecutive patients (N=279) consulting one of the participating orthopedic surgeons (n=3) or sport medicine physicians (n=2) for any knee complaint. Not applicable. History elements and physical examination tests were obtained by a trained physiotherapist blinded to the reference standard: a composite diagnosis including both physical examination tests and imaging results interpretation performed by an expert physician. Penalized logistic regression (least absolute shrinkage and selection operator) was used to identify history elements and physical examination tests associated with the diagnosis of PFP, and recursive partitioning was used to develop diagnostic clusters. Diagnostic accuracy measures including sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios with associated 95% confidence intervals (CIs) were calculated. Two hundred seventy-nine participants were evaluated, and 75 had a diagnosis of PFP (26.9%). Different combinations of history elements and physical examination tests including the age of participants, knee pain location, difficulty descending stairs, patellar facet palpation, and passive knee extension range of motion were associated with a diagnosis of PFP and used in clusters to accurately discriminate between individuals with PFP and individuals without PFP. Two diagnostic clusters developed to confirm the presence of PFP yielded a positive likelihood ratio of 8.7 (95% CI, 5.2-14.6) and 3 clusters to exclude PFP yielded a negative likelihood ratio of .12 (95% CI, .06-.27). Diagnostic clusters combining common history elements and physical examination tests that can accurately diagnose or exclude PFP compared to various knee disorders were developed. External validation is required before clinical use. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Defining the next generation of Plasmodium vivax diagnostic tests for control and elimination: Target product profiles

PubMed Central

Ade, Maria Paz; Baird, J. Kevin; Cheng, Qin; Cunningham, Jane; Dhorda, Mehul; Drakeley, Chris; Felger, Ingrid; Gamboa, Dionicia; Harbers, Matthias; Herrera, Socrates; Lucchi, Naomi; Mayor, Alfredo; Mueller, Ivo; Sattabongkot, Jetsumon; Ratsimbason, Arsène; Richards, Jack; Tanner, Marcel; González, Iveth J.

2017-01-01

The global prevalence of malaria has decreased over the past fifteen years, but similar gains have not been realized against Plasmodium vivax because this species is less responsive to conventional malaria control interventions aimed principally at P. falciparum. Approximately half of all malaria cases outside of Africa are caused by P. vivax. This species places dormant forms in human liver that cause repeated clinical attacks without involving another mosquito bite. The diagnosis of acute patent P. vivax malaria relies primarily on light microscopy. Specific rapid diagnostic tests exist but typically perform relatively poorly compared to those for P. falciparum. Better diagnostic tests are needed for P. vivax. To guide their development, FIND, in collaboration with P. vivax experts, identified the specific diagnostic needs associated with this species and defined a series of three distinct target product profiles, each aimed at a particular diagnostic application: (i) point-of-care of acutely ill patients for clinical care purposes; (ii) point-of-care asymptomatic and otherwise sub-patent residents for public health purposes, e.g., mass screen and treat campaigns; and (iii) ultra-sensitive not point-of-care diagnosis for epidemiological research/surveillance purposes. This report presents and discusses the rationale for these P. vivax-specific diagnostic target product profiles. These contribute to the rational development of fit-for-purpose diagnostic tests suitable for the clinical management, control and elimination of P. vivax malaria. PMID:28369085

Development of a molecular diagnostic test for Retinitis Pigmentosa in the Japanese population.

PubMed

Maeda, Akiko; Yoshida, Akiko; Kawai, Kanako; Arai, Yuki; Akiba, Ryutaro; Inaba, Akira; Takagi, Seiji; Fujiki, Ryoji; Hirami, Yasuhiko; Kurimoto, Yasuo; Ohara, Osamu; Takahashi, Masayo

2018-05-21

Retinitis Pigmentosa (RP) is the most common form of inherited retinal dystrophy caused by different genetic variants. More than 60 causative genes have been identified to date. The establishment of cost-effective molecular diagnostic tests with high sensitivity and specificity can be beneficial for patients and clinicians. Here, we developed a clinical diagnostic test for RP in the Japanese population. Evaluation of diagnostic technology, Prospective, Clinical and experimental study. A panel of 39 genes reported to cause RP in Japanese patients was established. Next generation sequence (NGS) technology was applied for the analyses of 94 probands with RP and RP-related diseases. After interpretation of detected genetic variants, molecular diagnosis based on a study of the genetic variants and a clinical phenotype was made by a multidisciplinary team including clinicians, researchers and genetic counselors. NGS analyses found 14,343 variants from 94 probands. Among them, 189 variants in 83 probands (88.3% of all cases) were selected as pathogenic variants and 64 probands (68.1%) have variants which can cause diseases. After the deliberation of these 64 cases, molecular diagnosis was made in 43 probands (45.7%). The final molecular diagnostic rate with the current system combining supplemental Sanger sequencing was 47.9% (45 of 94 cases). The RP panel provides the significant advantage of detecting genetic variants with a high molecular diagnostic rate. This type of race-specific high-throughput genotyping allows us to conduct a cost-effective and clinically useful genetic diagnostic test.

Investigation of Gear and Bearing Fatigue Damage Using Debris Particle Distributions

NASA Technical Reports Server (NTRS)

Dempsey, Paula J.; Lewicki, David G.; Decker, Harry J.

2004-01-01

A diagnostic tool was developed for detecting fatigue damage to spur gears, spiral bevel gears, and rolling element bearings. This diagnostic tool was developed and evaluated experimentally by collecting oil debris data from fatigue tests performed in the NASA Glenn Spur Gear Fatigue Rig, Spiral Bevel Gear Test Facility, and the 500hp Helicopter Transmission Test Stand. During each test, data from an online, in-line, inductance type oil debris sensor was monitored and recorded for the occurrence of pitting damage. Results indicate oil debris alone cannot discriminate between bearing and gear fatigue damage.

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

A fault injection experiment using the AIRLAB Diagnostic Emulation Facility

NASA Technical Reports Server (NTRS)

Baker, Robert; Mangum, Scott; Scheper, Charlotte

1988-01-01

The preparation for, conduct of, and results of a simulation based fault injection experiment conducted using the AIRLAB Diagnostic Emulation facilities is described. An objective of this experiment was to determine the effectiveness of the diagnostic self-test sequences used to uncover latent faults in a logic network providing the key fault tolerance features for a flight control computer. Another objective was to develop methods, tools, and techniques for conducting the experiment. More than 1600 faults were injected into a logic gate level model of the Data Communicator/Interstage (C/I). For each fault injected, diagnostic self-test sequences consisting of over 300 test vectors were supplied to the C/I model as inputs. For each test vector within a test sequence, the outputs from the C/I model were compared to the outputs of a fault free C/I. If the outputs differed, the fault was considered detectable for the given test vector. These results were then analyzed to determine the effectiveness of some test sequences. The results established coverage of selt-test diagnostics, identified areas in the C/I logic where the tests did not locate faults, and suggest fault latency reduction opportunities.

A Model-Based Expert System for Space Power Distribution Diagnostics

NASA Technical Reports Server (NTRS)

Quinn, Todd M.; Schlegelmilch, Richard F.

1994-01-01

When engineers diagnose system failures, they often use models to confirm system operation. This concept has produced a class of advanced expert systems that perform model-based diagnosis. A model-based diagnostic expert system for the Space Station Freedom electrical power distribution test bed is currently being developed at the NASA Lewis Research Center. The objective of this expert system is to autonomously detect and isolate electrical fault conditions. Marple, a software package developed at TRW, provides a model-based environment utilizing constraint suspension. Originally, constraint suspension techniques were developed for digital systems. However, Marple provides the mechanisms for applying this approach to analog systems such as the test bed, as well. The expert system was developed using Marple and Lucid Common Lisp running on a Sun Sparc-2 workstation. The Marple modeling environment has proved to be a useful tool for investigating the various aspects of model-based diagnostics. This report describes work completed to date and lessons learned while employing model-based diagnostics using constraint suspension within an analog system.

An ontology-driven, diagnostic modeling system.

PubMed

Haug, Peter J; Ferraro, Jeffrey P; Holmen, John; Wu, Xinzi; Mynam, Kumar; Ebert, Matthew; Dean, Nathan; Jones, Jason

2013-06-01

To present a system that uses knowledge stored in a medical ontology to automate the development of diagnostic decision support systems. To illustrate its function through an example focused on the development of a tool for diagnosing pneumonia. We developed a system that automates the creation of diagnostic decision-support applications. It relies on a medical ontology to direct the acquisition of clinic data from a clinical data warehouse and uses an automated analytic system to apply a sequence of machine learning algorithms that create applications for diagnostic screening. We refer to this system as the ontology-driven diagnostic modeling system (ODMS). We tested this system using samples of patient data collected in Salt Lake City emergency rooms and stored in Intermountain Healthcare's enterprise data warehouse. The system was used in the preliminary development steps of a tool to identify patients with pneumonia in the emergency department. This tool was compared with a manually created diagnostic tool derived from a curated dataset. The manually created tool is currently in clinical use. The automatically created tool had an area under the receiver operating characteristic curve of 0.920 (95% CI 0.916 to 0.924), compared with 0.944 (95% CI 0.942 to 0.947) for the manually created tool. Initial testing of the ODMS demonstrates promising accuracy for the highly automated results and illustrates the route to model improvement. The use of medical knowledge, embedded in ontologies, to direct the initial development of diagnostic computing systems appears feasible.

Development of life prediction capabilities for liquid propellant rocket engines. Post-fire diagnostic system for the SSME system architecture study

NASA Technical Reports Server (NTRS)

Gage, Mark; Dehoff, Ronald

1991-01-01

This system architecture task (1) analyzed the current process used to make an assessment of engine and component health after each test or flight firing of an SSME, (2) developed an approach and a specific set of objectives and requirements for automated diagnostics during post fire health assessment, and (3) listed and described the software applications required to implement this system. The diagnostic system described is a distributed system with a database management system to store diagnostic information and test data, a CAE package for visual data analysis and preparation of plots of hot-fire data, a set of procedural applications for routine anomaly detection, and an expert system for the advanced anomaly detection and evaluation.

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.

Clinically expedient reporting of rapid diagnostic test information.

PubMed

Doern, G V

1986-03-01

With the development of rapid diagnostic tests in the clinical microbiology laboratory has come an awareness of the importance of rapid results reporting. Clearly, the potential clinical impact of rapid diagnostic tests is dependent on expeditious reporting. Traditional manual reporting systems are encumbered by the necessity of transcription of test information onto hard copy reports and then the subsequent distribution of such reports into the hands of the user. Laboratory computers when linked directly to CRTs located in nursing stations, ambulatory clinics, or physician's offices, both inside and outside of the hospital, permit essentially instantaneous transfer of test results from the laboratory to the clinician. Computer-assisted results reporting, while representing a significant advance over manual reporting systems is not, however, without problems. Concerns include validation of test information, authorization of users with access to test information, mechanical integrity, and cost. These issues notwithstanding, computerized results reporting will undoubtedly play a central role in optimizing the clinical impact of rapid diagnostic tests.

The Log-Linear Cognitive Diagnostic Model (LCDM) as a Special Case of The General Diagnostic Model (GDM). Research Report. ETS RR-14-40

ERIC Educational Resources Information Center

von Davier, Matthias

2014-01-01

Diagnostic models combine multiple binary latent variables in an attempt to produce a latent structure that provides more information about test takers' performance than do unidimensional latent variable models. Recent developments in diagnostic modeling emphasize the possibility that multiple skills may interact in a conjunctive way within the…

Discussion of the quality control and performance testing of ultrasound diagnostic equipment

NASA Astrophysics Data System (ADS)

Jiang, Junjie

2018-03-01

In recent years, with the rapid development of ultrasonography, the application and popularization of new technology used in ultrasound equipment, the level of providing diagnostic information for doctors enhances unceasingly, which has become the indispensable diagnostic tool for medical institutions. The performance of equipment is directly related to the doctor’s diagnosis and the patient’s health, therefore, it is very important to choose a good method for quality control and performance testing.

HIV testing updates and challenges: when regulatory caution and public health imperatives collide.

PubMed

Branson, Bernard M

2015-03-01

Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV. Access to these developments, however, is often delayed by the regulatory apparatus for approval and oversight of HIV testing in the USA. This article summarizes recent developments in HIV diagnostic testing technology, outlines their implications for clinical management and public health, describes current systems of regulatory oversight for HIV testing in the USA, and proposes alternatives that could expedite access to improved tests as they become available.

Overcoming regulatory and economic challenges facing pharmacogenomics.

PubMed

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

Diagnosing schistosomiasis: where are we?

PubMed

Gomes, Luciana Inácia; Enk, Martin Johannes; Rabello, Ana

2014-01-01

In light of the World Health Organization's initiative to extend schistosomiasis morbidity and mortality control programs by including a disease elimination strategy in low endemic settings, this paper reviews diagnostic tools described during the last decades and provide an overview of ongoing efforts in making an efficient diagnostic tool available worldwide. A literature search on PubMed using the search criteria schistosomiasis and diagnosis within the period from 1978 to 2013 was carried out. Articles with abstract in English and that used laboratory techniques specifically developed for the detection of schistosomiasis in humans were included. Publications were categorized according to the methodology applied (parasitological, immunological, or molecular) and stage of development (in house development, limited field, or large scale field testing). The initial research generated 4,535 publications, of which only 643 met the inclusion criteria. The vast majority (537) of the publications focused on immunological techniques; 81 focused on parasitological diagnosis, and 25 focused on molecular diagnostic methods. Regarding the stage of development, 307 papers referred to in-house development, 202 referred to limited field tests, and 134 referred to large scale field testing. The data obtained show that promising new diagnostic tools, especially for Schistosoma antigen and deoxyribonucleic acid (DNA) detection, which are characterized by high sensitivity and specificity, are being developed. In combination with international funding initiatives these tools may result in a significant step forward in successful disease elimination and surveillance, which is to make efficient tests accessible and its large use self-sustainable for control programs in endemic countries.

Diagnosis of aphasia in stroke populations: A systematic review of language tests

PubMed Central

2018-01-01

Background and purpose Accurate aphasia diagnosis is important in stroke care. A wide range of language tests are available and include informal assessments, tests developed by healthcare institutions and commercially published tests available for purchase in pre-packaged kits. The psychometrics of these tests are often reported online or within the purchased test manuals, not the peer-reviewed literature, therefore the diagnostic capabilities of these measures have not been systematically evaluated. This review aimed to identify both commercial and non-commercial language tests and tests used in stroke care and to examine the diagnostic capabilities of all identified measures in diagnosing aphasia in stroke populations. Methods Language tests were identified through a systematic search of 161 publisher databases, professional and resource websites and language tests reported to be used in stroke care. Two independent reviewers evaluated test manuals or associated resources for cohort or cross-sectional studies reporting the tests’ diagnostic capabilities (sensitivity, specificity, likelihood ratios or diagnostic odds ratios) in differentiating aphasic and non-aphasic stroke populations. Results Fifty-six tests met the study eligibility criteria. Six “non-specialist” brief screening tests reported sensitivity and specificity information, however none of these measures reported to meet the specific diagnostic needs of speech pathologists. The 50 remaining measures either did not report validity data (n = 7); did not compare patient test performance with a comparison group (n = 17); included non-stroke participants within their samples (n = 23) or did not compare stroke patient performance against a language reference standard (n = 3). Diagnostic sensitivity analysis was completed for six speech pathology measures (WAB, PICA, CADL-2, ASHA-FACS, Adult FAVRES and EFA-4), however all studies compared aphasic performance with that of non-stroke healthy controls and were consequently excluded from the review. Conclusions No speech pathology test was found which reported diagnostic data for identifying aphasia in stroke populations. A diagnostically validated post-stroke aphasia test is needed. PMID:29566043

Aerospike Engine Post-Test Diagnostic System Delivered to Rocketdyne

NASA Technical Reports Server (NTRS)

Meyer, Claudia M.

2000-01-01

The NASA Glenn Research Center at Lewis Field, in cooperation with Rocketdyne, has designed, developed, and implemented an automated Post-Test Diagnostic System (PTDS) for the X-33 linear aerospike engine. The PTDS was developed to reduce analysis time and to increase the accuracy and repeatability of rocket engine ground test fire and flight data analysis. This diagnostic system provides a fast, consistent, first-pass data analysis, thereby aiding engineers who are responsible for detecting and diagnosing engine anomalies from sensor data. It uses analytical methods modeled after the analysis strategies used by engineers. Glenn delivered the first version of PTDS in September of 1998 to support testing of the engine s power pack assembly. The system was used to analyze all 17 power pack tests and assisted Rocketdyne engineers in troubleshooting both data acquisition and test article anomalies. The engine version of PTDS, which was delivered in June of 1999, will support all single-engine, dual-engine, and flight firings of the aerospike engine.

Investigation of Tapered Roller Bearing Damage Detection Using Oil Debris Analysis

NASA Technical Reports Server (NTRS)

Dempsey, Paula J.; Krieder, Gary; Fichter, Thomas

2006-01-01

A diagnostic tool was developed for detecting fatigue damage to tapered roller bearings. Tapered roller bearings are used in helicopter transmissions and have potential for use in high bypass advanced gas turbine aircraft engines. This diagnostic tool was developed and evaluated experimentally by collecting oil debris data from failure progression tests performed by The Timken Company in their Tapered Roller Bearing Health Monitoring Test Rig. Failure progression tests were performed under simulated engine load conditions. Tests were performed on one healthy bearing and three predamaged bearings. During each test, data from an on-line, in-line, inductance type oil debris sensor was monitored and recorded for the occurrence of debris generated during failure of the bearing. The bearing was removed periodically for inspection throughout the failure progression tests. Results indicate the accumulated oil debris mass is a good predictor of damage on tapered roller bearings. The use of a fuzzy logic model to enable an easily interpreted diagnostic metric was proposed and demonstrated.

[Development of a diagnostic test system for early non-invasive detection of prostate cancer based on PCA3 mRNA levels in urine sediment using quantitative reverse tanscription polymerase chain reaction (qRT-PCR)].

PubMed

Pavlov, K A; Shkoporov, A N; Khokhlova, E V; Korchagina, A A; Sidorenkov, A V; Grigor'ev, M É; Pushkar', D Iu; Chekhonin, V P

2013-01-01

The wide introduction of prostatic specific antigen (PSA) determination into clinical practice has resulted in a larger number of prostate biopsies, while the lower age threshold for PSA has led to a larger number of unnecessary prostate biopsies. Hence, there is a need for new biomarkers that can detect prostate cancer. PCA3 is a noncoding messenger ribonucleic acid (mRNA) that is expressed exclusively in prostate cells. The aim of the study has been to develop a diagnostic test system for early non-invasive detection of prostate cancer based on PCA3 mRNA levels in urine sediment using quantitative reverse transcription polymerase chain reaction (qRT-PCR). As part of the study, a laboratory diagnostic test system prototype has been designed, an application methodology has been developed and specificity and sensitivity data of the method has been assessed. The diagnostic system has demonstrated its ability to detect significantly elevated levels of PCA 3/KLK 3 in samples from prostate cancer (PCa) patients compared with those from healthy men. The findings have shown relatively high diagnostic sensitivity, specificity and negative-predictive values for an early non-invasive screening of prostate cancer

Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test

PubMed Central

Lawn, Stephen D; Mwaba, Peter; Bates, Matthew; Piatek, Amy; Alexander, Heather; Marais, Ben J; Cuevas, Luis E; McHugh, Timothy D; Zijenah, Lynn; Kapata, Nathan; Abubakar, Ibrahim; McNerney, Ruth; Hoelscher, Michael; Memish, Ziad A; Migliori, Giovanni Battista; Kim, Peter; Maeurer, Markus; Schito, Marco; Zumla, Alimuddin

2015-01-01

Rapid progress has been made in the development of new diagnostic assays for tuberculosis in recent years. New technologies have been developed and assessed, and are now being implemented. The Xpert MTB/RIF assay, which enables simultaneous detection of Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance, was endorsed by WHO in December, 2010. This assay was specifically recommended for use as the initial diagnostic test for suspected drug-resistant or HIV-associated pulmonary tuberculosis. By June, 2012, two-thirds of countries with a high tuberculosis burden and half of countries with a high multidrug-resistant tuberculosis burden had incorporated the assay into their national tuberculosis programme guidelines. Although the development of the Xpert MTB/RIF assay is undoubtedly a landmark event, clinical and programmatic effects and cost-effectiveness remain to be defined. We review the rapidly growing body of scientific literature and discuss the advantages and challenges of using the Xpert MTB/RIF assay in areas where tuberculosis is endemic. We also review other prospects within the developmental pipeline. A rapid, accurate point-of-care diagnostic test that is affordable and can be readily implemented is urgently needed. Investment in the tuberculosis diagnostics pipeline should remain a major priority for funders and researchers. PMID:23531388

Validity Arguments for Diagnostic Assessment Using Automated Writing Evaluation

ERIC Educational Resources Information Center

Chapelle, Carol A.; Cotos, Elena; Lee, Jooyoung

2015-01-01

Two examples demonstrate an argument-based approach to validation of diagnostic assessment using automated writing evaluation (AWE). "Criterion"®, was developed by Educational Testing Service to analyze students' papers grammatically, providing sentence-level error feedback. An interpretive argument was developed for its use as part of…

Dual-Objective Item Selection Criteria in Cognitive Diagnostic Computerized Adaptive Testing

ERIC Educational Resources Information Center

Kang, Hyeon-Ah; Zhang, Susu; Chang, Hua-Hua

2017-01-01

The development of cognitive diagnostic-computerized adaptive testing (CD-CAT) has provided a new perspective for gaining information about examinees' mastery on a set of cognitive attributes. This study proposes a new item selection method within the framework of dual-objective CD-CAT that simultaneously addresses examinees' attribute mastery…

INNOVATIVE TECHNOLOGY VERIFICATION REPORT "FIELD MEASUREMENT TECHNOLOGIES FOR TOTAL PETROLEUM HYDROCARBONS IN SOIL" STRATEGIC DIAGNOSTICS INC. ENSYS PETRO TEST SYSTEM

EPA Science Inventory

The EnSys Petro Test System developed by Strategic Diagnostics Inc. (SDI), was demonstrated under the U.S. Environmental Protection Agency Superfund Innovative Technology Evaluation Program in June 2000 at the Navy Base Ventura County site in Port Hueneme, California. The...

Network meta-analysis of diagnostic test accuracy studies identifies and ranks the optimal diagnostic tests and thresholds for health care policy and decision-making.

PubMed

Owen, Rhiannon K; Cooper, Nicola J; Quinn, Terence J; Lees, Rosalind; Sutton, Alex J

2018-07-01

Network meta-analyses (NMA) have extensively been used to compare the effectiveness of multiple interventions for health care policy and decision-making. However, methods for evaluating the performance of multiple diagnostic tests are less established. In a decision-making context, we are often interested in comparing and ranking the performance of multiple diagnostic tests, at varying levels of test thresholds, in one simultaneous analysis. Motivated by an example of cognitive impairment diagnosis following stroke, we synthesized data from 13 studies assessing the efficiency of two diagnostic tests: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), at two test thresholds: MMSE <25/30 and <27/30, and MoCA <22/30 and <26/30. Using Markov chain Monte Carlo (MCMC) methods, we fitted a bivariate network meta-analysis model incorporating constraints on increasing test threshold, and accounting for the correlations between multiple test accuracy measures from the same study. We developed and successfully fitted a model comparing multiple tests/threshold combinations while imposing threshold constraints. Using this model, we found that MoCA at threshold <26/30 appeared to have the best true positive rate, whereas MMSE at threshold <25/30 appeared to have the best true negative rate. The combined analysis of multiple tests at multiple thresholds allowed for more rigorous comparisons between competing diagnostics tests for decision making. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Panel-based Genetic Diagnostic Testing for Inherited Eye Diseases is Highly Accurate and Reproducible and More Sensitive for Variant Detection Than Exome Sequencing

PubMed Central

Bujakowska, Kinga M.; Sousa, Maria E.; Fonseca-Kelly, Zoë D.; Taub, Daniel G.; Janessian, Maria; Wang, Dan Yi; Au, Elizabeth D.; Sims, Katherine B.; Sweetser, David A.; Fulton, Anne B.; Liu, Qin; Wiggs, Janey L.; Gai, Xiaowu; Pierce, Eric A.

2015-01-01

Purpose Next-generation sequencing (NGS) based methods are being adopted broadly for genetic diagnostic testing, but the performance characteristics of these techniques have not been fully defined with regard to test accuracy and reproducibility. Methods We developed a targeted enrichment and NGS approach for genetic diagnostic testing of patients with inherited eye disorders, including inherited retinal degenerations, optic atrophy and glaucoma. In preparation for providing this Genetic Eye Disease (GEDi) test on a CLIA-certified basis, we performed experiments to measure the sensitivity, specificity, reproducibility as well as the clinical sensitivity of the test. Results The GEDi test is highly reproducible and accurate, with sensitivity and specificity for single nucleotide variant detection of 97.9% and 100%, respectively. The sensitivity for variant detection was notably better than the 88.3% achieved by whole exome sequencing (WES) using the same metrics, due to better coverage of targeted genes in the GEDi test compared to commercially available exome capture sets. Prospective testing of 192 patients with IRDs indicated that the clinical sensitivity of the GEDi test is high, with a diagnostic rate of 51%. Conclusion The data suggest that based on quantified performance metrics, selective targeted enrichment is preferable to WES for genetic diagnostic testing. PMID:25412400

How recent advances in molecular tests could impact the diagnosis of pneumonia.

PubMed

Murdoch, David R

2016-01-01

Molecular diagnostic tests have been the single major development in pneumonia diagnostics over recent years. Nucleic acid detection tests (NATs) have greatly improved the ability to detect respiratory viruses and bacterial pathogens that do not normally colonize the respiratory tract. In contrast, NATs do not yet have an established role for diagnosing pneumonia caused by bacteria that commonly colonize the nasopharynx due to difficulties discriminating between pathogens and coincidental carriage strains. New approaches are needed to distinguish infection from colonization, such as through use of quantitative methods and identification of discriminating cut-off levels. The recent realization that the lung microbiome exists has provided new insights into the pathogenesis of pneumonia involving the interaction between multiple microorganisms. New developments in molecular diagnostics must account for this new paradigm.

Point-of-care diagnostics: extending the laboratory network to reach the last mile.

PubMed

Drain, Paul K; Rousseau, Christine

2017-03-01

More point-of-care (POC) diagnostic tests are becoming available for HIV diagnosis and treatment in resource-limited settings. These novel technologies have the potential to foster decentralized HIV care and treatment for the benefit of clinical laboratories, HIV clinics, and HIV-infected patients. There continue to be many business, technological, and operational challenges that limit product development and regulatory approval, which limits products available for the required operational and cost-effectiveness studies and delays policy adoption and implementation. Although the rapid HIV diagnostic test has been widely successful, the pathways for POC CD4 cell count and HIV viral load assay analyzers have been more challenging. We describe significant hurdles for product development, approval, and implementation, which include the business case, technical development, clinical impact, and integrating laboratory and clinical networks. The objective of this review is to highlight the obstacles for developing and implementing appropriate strategies for POC HIV testing assays to improve the clinical services for HIV-infected patients in resource-limited settings.

Consensus guidelines for the use of empiric and diagnostic-driven antifungal treatment strategies in haematological malignancy, 2014.

PubMed

Morrissey, C O; Gilroy, N M; Macesic, N; Walker, P; Ananda-Rajah, M; May, M; Heath, C H; Grigg, A; Bardy, P G; Kwan, J; Kirsa, S W; Slavin, M; Gottlieb, T; Chen, S

2014-12-01

Invasive fungal disease (IFD) causes significant morbidity and mortality in patients undergoing allogeneic haemopoietic stem cell transplantation or chemotherapy for haematological malignancy. Much of these adverse outcomes are due to the limited ability of traditional diagnostic tests (i.e. culture and histology) to make an early and accurate diagnosis. As persistent or recurrent fevers of unknown origin (PFUO) in neutropenic patients despite broad-spectrum antibiotics have been associated with the development of IFD, most centres have traditionally administered empiric antifungal therapy (EAFT) to patients with PFUO. However, use of an EAFT strategy has not been shown to have an overall survival benefit and is associated with excessive antifungal therapy use. As a result, the focus has shifted to developing more sensitive and specific diagnostic tests for early and more targeted antifungal treatment. These tests, including the galactomannan enzyme-linked immunosorbent assay and Aspergillus polymerase chain reaction (PCR), have enabled the development of diagnostic-driven antifungal treatment (DDAT) strategies, which have been shown to be safe and feasible, reducing antifungal usage. In addition, the development of effective antifungal prophylactic strategies has changed the landscape in terms of the incidence and types of IFD that clinicians have encountered. In this review, we examine the current role of EAFT and provide up-to-date data on the newer diagnostic tests and algorithms available for use in EAFT and DDAT strategies, within the context of patient risk and type of antifungal prophylaxis used. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

Potential Cost-effectiveness of Early Identification of Hospital-acquired Infection in Critically Ill Patients.

PubMed

Tsalik, Ephraim L; Li, Yanhong; Hudson, Lori L; Chu, Vivian H; Himmel, Tiffany; Limkakeng, Alex T; Katz, Jason N; Glickman, Seth W; McClain, Micah T; Welty-Wolf, Karen E; Fowler, Vance G; Ginsburg, Geoffrey S; Woods, Christopher W; Reed, Shelby D

2016-03-01

Limitations in methods for the rapid diagnosis of hospital-acquired infections often delay initiation of effective antimicrobial therapy. New diagnostic approaches offer potential clinical and cost-related improvements in the management of these infections. We developed a decision modeling framework to assess the potential cost-effectiveness of a rapid biomarker assay to identify hospital-acquired infection in high-risk patients earlier than standard diagnostic testing. The framework includes parameters representing rates of infection, rates of delayed appropriate therapy, and impact of delayed therapy on mortality, along with assumptions about diagnostic test characteristics and their impact on delayed therapy and length of stay. Parameter estimates were based on contemporary, published studies and supplemented with data from a four-site, observational, clinical study. Extensive sensitivity analyses were performed. The base-case analysis assumed 17.6% of ventilated patients and 11.2% of nonventilated patients develop hospital-acquired infection and that 28.7% of patients with hospital-acquired infection experience delays in appropriate antibiotic therapy with standard care. We assumed this percentage decreased by 50% (to 14.4%) among patients with true-positive results and increased by 50% (to 43.1%) among patients with false-negative results using a hypothetical biomarker assay. Cost of testing was set at $110/d. In the base-case analysis, among ventilated patients, daily diagnostic testing starting on admission reduced inpatient mortality from 12.3 to 11.9% and increased mean costs by $1,640 per patient, resulting in an incremental cost-effectiveness ratio of $21,389 per life-year saved. Among nonventilated patients, inpatient mortality decreased from 7.3 to 7.1% and costs increased by $1,381 with diagnostic testing. The resulting incremental cost-effectiveness ratio was $42,325 per life-year saved. Threshold analyses revealed the probabilities of developing hospital-acquired infection in ventilated and nonventilated patients could be as low as 8.4 and 9.8%, respectively, to maintain incremental cost-effectiveness ratios less than $50,000 per life-year saved. Development and use of serial diagnostic testing that reduces the proportion of patients with delays in appropriate antibiotic therapy for hospital-acquired infections could reduce inpatient mortality. The model presented here offers a cost-effectiveness framework for future test development.

Genetic testing: new challenges in the healthcare of women. Interview by Hannah Branch.

PubMed

Hofmann, Wera; Branch, Hannah

2013-11-01

Dr Wera Hofmann is an expert in biochemistry and has over 12 years of human genetic diagnostics experience. Until 2006, she supervised a diagnostic unit for BRCA gene testing at the Interdisciplinary Center for Hereditary Breast Cancer (Max Delbrück Center, Berlin, Germany). She has also been the Managing Director of the Professional Association of German Human Geneticists, BVDH, which is a trade association. In 2008, Hofmann became a Medical Director at LifeCodexx (Konstanz, Germany), where she has worked on the development of a noninvasive prenatal diagnostic test that detects chromosomal aneuploidies in fetuses.

Microfluidic paper-based analytical devices for potential use in quantitative and direct detection of disease biomarkers in clinical analysis.

PubMed

Lim, Wei Yin; Goh, Boon Tong; Khor, Sook Mei

2017-08-15

Clinicians, working in the health-care diagnostic systems of developing countries, currently face the challenges of rising costs, increased number of patient visits, and limited resources. A significant trend is using low-cost substrates to develop microfluidic devices for diagnostic purposes. Various fabrication techniques, materials, and detection methods have been explored to develop these devices. Microfluidic paper-based analytical devices (μPADs) have gained attention for sensing multiplex analytes, confirming diagnostic test results, rapid sample analysis, and reducing the volume of samples and analytical reagents. μPADs, which can provide accurate and reliable direct measurement without sample pretreatment, can reduce patient medical burden and yield rapid test results, aiding physicians in choosing appropriate treatment. The objectives of this review are to provide an overview of the strategies used for developing paper-based sensors with enhanced analytical performances and to discuss the current challenges, limitations, advantages, disadvantages, and future prospects of paper-based microfluidic platforms in clinical diagnostics. μPADs, with validated and justified analytical performances, can potentially improve the quality of life by providing inexpensive, rapid, portable, biodegradable, and reliable diagnostics. Copyright © 2017 Elsevier B.V. All rights reserved.

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

PubMed

Parkinson, David R; McCormack, Robert T; Keating, Susan M; Gutman, Steven I; Hamilton, Stanley R; Mansfield, Elizabeth A; Piper, Margaret A; Deverka, Patricia; Frueh, Felix W; Jessup, J Milburn; McShane, Lisa M; Tunis, Sean R; Sigman, Caroline C; Kelloff, Gary J

2014-03-15

This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond analytical and clinical validation, successful demonstration of clinical utility involves developing sufficient evidence to demonstrate that a diagnostic test results in an improvement in patient outcomes. This discussion is complementary to theoretical frameworks described in previously published guidance and literature reports by the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, Institute of Medicine, and Center for Medical Technology Policy, among others. These reports are comprehensive and specifically clarify appropriate clinical use, adoption, and payer reimbursement for assay manufacturers, as well as Clinical Laboratory Improvement Amendments-certified laboratories, including those that develop assays (laboratory developed tests). Practical criteria and steps for establishing clinical utility are crucial to subsequent decisions for reimbursement without which high-performing molecular diagnostics will have limited availability to patients with cancer and fail to translate scientific advances into high-quality and cost-effective cancer care. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

Methodology and preliminary results of a systematic literature review of ante-mortem and post-mortem diagnostic tests for bovine tuberculosis.

PubMed

Downs, Sara H; Parry, Jessica E; Upton, Paul A; Broughan, Jennifer M; Goodchild, Anthony V; Nuñez-Garcia, Javier; Greiner, Matthias; Abernethy, Darrell A; Cameron, Angus R; Cook, Alasdair J; de la Rua-Domenech, Ricardo; Gunn, Jane; Pritchard, Elizabeth; Rhodes, Shelley; Rolfe, Simon; Sharp, Michael; Vordermeier, H Martin; Watson, Eamon; Welsh, Michael; Whelan, Adam O; Woolliams, John A; More, Simon J; Clifton-Hadley, Richard S

2018-05-01

A systematic review was conducted to identify studies with data for statistical meta-analyses of sensitivity (Se) and specificity (Sp) of ante-mortem and post-mortem diagnostic tests for bovine tuberculosis (bTB) in cattle. Members of a working group (WG) developed and tested search criteria and developed a standardised two-stage review process, to identify primary studies with numerator and denominator data for test performance and an agreed range of covariate data. No limits were applied to year, language, region or type of test in initial searches of electronic databases. In stage 1, titles and available abstracts were reviewed. References that complied with stage 1 selection criteria were reviewed in entirety and agreed data were extracted from references that complied with stage 2 selection criteria. At stage 1, 9782 references were reviewed and 261 (2.6%) passed through to stage 2 where 215 English language references were each randomly allocated to two of 18 WG reviewers and 46 references in other languages were allocated to native speakers. Agreement regarding eligibility between reviewers of the same reference at stage 2 was moderate (Kappa statistic = 0.51) and a resolution procedure was conducted. Only 119 references (published 1934-2009) were identified with eligible performance estimates for one or more of 14 different diagnostic test types; despite a comprehensive search strategy and the global impact of bTB. Searches of electronic databases for diagnostic test performance data were found to be nonspecific with regard to identifying references with diagnostic test Se or Sp data. Guidelines for the content of abstracts to research papers reporting diagnostic test performance are presented. The results of meta-analyses of the sensitivity and specificity of the tests, and of an evaluation of the methodological quality of the source references, are presented in accompanying papers (Nuñez-Garcia et al., 2017; Downs et al., 2017). Copyright © 2017. Published by Elsevier B.V.

Progress in the molecular diagnosis of Lyme disease.

PubMed

Ružić-Sabljić, Eva; Cerar, Tjaša

2017-01-01

Current laboratory testing of Lyme borreliosis mostly relies on serological methods with known limitations. Diagnostic modalities enabling direct detection of pathogen at the onset of the clinical signs could overcome some of the limitations. Molecular methods detecting borrelial DNA seem to be the ideal solution, although there are some aspects that need to be considered. Areas covered: This review represent summary and discussion of the published data obtained from literature searches from PubMed and The National Library of Medicine (USA) together with our own experience on molecular diagnosis of Lyme disease. Expert commentary: Molecular methods are promising and currently serve as supporting diagnostic testing in Lyme borreliosis. Since the field of molecular diagnostics is under rapid development, molecular testing could become an important diagnostic modality.

Accelerating the Development and Validation of New Value-Based Diagnostics by Leveraging Biobanks.

PubMed

Schneider, Daniel; Riegman, Peter H J; Cronin, Maureen; Negrouk, Anastassia; Moch, Holger; Balling, Rudi; Penault-Llorca, Frederiques; Zatloukal, Kurt; Horgan, Denis

The challenges faced in developing value-based diagnostics has resulted in few of these tests reaching the clinic, leaving many treatment modalities without matching diagnostics to select patients for particular therapies. Many patients receive therapies from which they are unlikely to benefit, resulting in worse outcomes and wasted health care resources. The paucity of value-based diagnostics is a result of the scientific challenges in developing predictive markers, specifically: (1) complex biology, (2) a limited research infrastructure supporting diagnostic development, and (3) the lack of incentives for diagnostic developers to invest the necessary resources. Better access to biospecimens can address some of these challenges. Methodologies developed to evaluate biomarkers from biospecimens archived from patients enrolled in randomized clinical trials offer the greatest opportunity to develop and validate high-value molecular diagnostics. An alternative opportunity is to access high-quality biospecimens collected from large public and private longitudinal observational cohorts such as the UK Biobank, the US Million Veteran Program, the UK 100,000 Genomes Project, or the French E3N cohort. Value-based diagnostics can be developed to work in a range of samples including blood, serum, plasma, urine, and tumour tissue, and better access to these high-quality biospecimens with clinical data can facilitate biomarker research. © 2016 S. Karger AG, Basel.

Bulgarian experience in the establishment of reference dose levels and implementation of a quality control system in diagnostic radiology.

PubMed

Vassileva, J; Dimov, A; Slavchev, A; Karadjov, A

2005-01-01

Results from a Bulgarian patient dose survey in diagnostic radiology are presented. Reference levels for entrance surface dose (ESD) were 0.9 mGy for chest radiography (PA), 30 mGy for lumbar spine (Lat), 10 mGy for pelvis, 5 mGy for skull (AP), 3 mGy for skull (Lat) and 13 mGy for mammography. Quality control (QC) programmes were proposed for various areas of diagnostic radiology. Film processing QC warranted special attention. Proposed QC programmes included parameters to be tested, level of expertise needed and two action levels: remedial and suspension. Programmes were tested under clinical conditions to assess initial results and draw conclusions for further QC system development. On the basis of international experience, measurement protocols were developed for all parameters tested. QC equipment was provided as part of the PHARE project. A future problem for QC programme implementation may be the small number of medical physics experts in diagnostic radiology.

Development and validation of a highly sensitive urine-based test to identify patients with colonic adenomatous polyps.

PubMed

Wang, Haili; Tso, Victor; Wong, Clarence; Sadowski, Dan; Fedorak, Richard N

2014-03-20

Adenomatous polyps are precursors of colorectal cancer; their detection and removal is the goal of colon cancer screening programs. However, fecal-based methods identify patients with adenomatous polyps with low levels of sensitivity. The aim or this study was to develop a highly accurate, prototypic, proof-of-concept, spot urine-based diagnostic test using metabolomic technology to distinguish persons with adenomatous polyps from those without polyps. Prospective urine and stool samples were collected from 876 participants undergoing colonoscopy examination in a colon cancer screening program, from April 2008 to October 2009 at the University of Alberta. Colonoscopy reference standard identified 633 participants with no colonic polyps and 243 with colonic adenomatous polyps. One-dimensional nuclear magnetic resonance spectra of urine metabolites were analyzed to define a diagnostic metabolomic profile for colonic adenomas. A urine metabolomic diagnostic test for colonic adenomatous polyps was established using 67% of the samples (un-blinded training set) and validated using the other 33% of the samples (blinded testing set). The urine metabolomic diagnostic test's specificity and sensitivity were compared with those of fecal-based tests. Using a two-component, orthogonal, partial least-squares model of the metabolomic profile, the un-blinded training set identified patients with colonic adenomatous polyps with 88.9% sensitivity and 50.2% specificity. Validation using the blinded testing set confirmed sensitivity and specificity values of 82.7% and 51.2%, respectively. Sensitivities of fecal-based tests to identify colonic adenomas ranged from 2.5 to 11.9%. We describe a proof-of-concept spot urine-based metabolomic diagnostic test that identifies patients with colonic adenomatous polyps with a greater level of sensitivity (83%) than fecal-based tests.

[Potentialities of the vegetative resonance test for diagnostics of hyperplastic processes in vocal folds].

PubMed

Ukhankova, N I; Sotskaia, T Iu

2010-01-01

The objective of the present study was to evaluate potentialities of the vegetative resonance test (VRT) for the elucidation of metabolic aspects of the inflammatory process in different forms of chronic vocal fold hyperplasty. The proposed diagnostic criteria characterize the inflammatory process in the larynx, specific features of metabolism in patients presenting with catarrhal and oedematopolypous laryngitis, characteristic changes in oedematofibrous and fibrous polyps. The use of VRT allowed diagnostic criteria for precarcinogenic conditions in the larynx to be developed.

Small business development for molecular diagnostics.

PubMed

Anagostou, Anthanasia; Liotta, Lance A

2012-01-01

Molecular profiling, which is the application of molecular diagnostics technology to tissue and blood -specimens, is an integral element in the new era of molecular medicine and individualized therapy. Molecular diagnostics is a fertile ground for small business development because it can generate products that meet immediate demands in the health-care sector: (a) Detection of disease risk, or early-stage disease, with a higher specificity and sensitivity compared to previous testing methods, and (b) "Companion diagnostics" for stratifying patients to receive a treatment choice optimized to their individual disease. This chapter reviews the promise and challenges of business development in this field. Guidelines are provided for the creation of a business model and the generation of a marketing plan around a candidate molecular diagnostic product. Steps to commercialization are outlined using existing molecular diagnostics companies as learning examples.

[Diagnostic kits in parasitology: which controls?].

PubMed

Rossi, P

2004-06-01

The development of new diagnostic tools particularly for some parasitic "neglected diseases", is slowed or even hindered by limited resources assigned for basic and applied research in public institution and private sector. Even if the time-line and costs needed for developing a new In Vitro Diagnostic (IVD) test are generally lower compared to vaccines or new drugs, industry is poorly engaged in investing resources due to the perception of limited markets. To accelerate the development of diagnostics for the world's most deadly diseases, the World Health Organization's (WHO) Special Programme for Research and Training in Tropical Diseases (TDR), the United Nations Development Programme, the World Bank and the Gates Foundation, last year launched a new initiative, FIND (Foundation for Innovative New Diagnostics, www.finddiagnostics.org). The aim is to "apply the latest biotechnology innovations to develop and validate affordable diagnostic tests for diseases of the developing world". Ideally, a new diagnostic test should be accurately evaluated prior to use in medical practice. The first step would be a pre-clinical evaluation, an analytic study to determine its laboratory performance. A crucial point in this phase is the calibration of reagents (antigens, antibodies, DNA probes, etc.) against a standard reference preparation. WHO, through the WHO International Laboratories for Biological Standards, "provides International Biological Reference Preparations which serve as reference sources of defined biological activity expressed in an internationally agreed unit" (www.who.int/biologicals/IBRP/index.htm). Standardization allows "comparison of biological measurements worldwide" and ensures the reliability of diagnostic procedures. These preparations are generally intended for use in the characterization of the activity of secondary reference preparations (regional, national or in-house working standards). Unfortunately, international reference standards for parasitic diseases are not available at present, except for Toxoplasma antibodies. The first international standard reagent for Anti-Toxoplasma Serum was established in 1968 and at present, an international standard reference serum, Anti-toxoplasma serum, human TOXM is available at the National Institute for Biological Standards and Control (NIBSC) in UK. Several collaborative, multicenter studies were carried out to assess the performance of different methods and commercial tests for the diagnosis of toxoplasmosis, by providing to participating laboratories a panel of well-defined sera to be tested. A four-phase process following well-accepted methodological standards for the development of diagnostics, analogous to those internationally accepted for drugs and vaccines was recently proposed. The pre-clinical evaluation, the analytic study to assess sensitivity, specificity, predictive values in laboratory (phase I), should be followed by a proof of principle study to distinguish diseased from healthy persons in easily accessible populations (phase II). The evaluation of test performance in populations of intended use (phase III), and finally the delineation of cost-effectiveness and societal impact of new tests in comparison with existing tools (phase IV) should complete the validation procedure. In this context, national regulatory agencies play a major role in pre-market approval and post-market surveillance of IVDs. The European Community in 1998 approved a directive (Directive 98/79/EC) which rules the marketing of IVD medical devices, in order to harmonise the performance levels and standards in European countries. But, among IVDs for parasitic diseases, only those to detect congenital toxoplasmosis are submitted to defined procedures to provide the verification of products before their placing on the market and the surveillance after their marketing by a notified body, which perform appropriate examinations, tests and inspections to production facilities to verify if the device meets the requirements of the directive. In U.S.A., the Food and Drug Administration (FDA), through the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), provides a comprehensive and regulatory activity for IVDs through pre-market evaluation and post-market surveillance. In developing countries, the scarcity of resources limits the procedures through which the national control authority can assure safety, quality and efficacy of products marketed, both imported and locally manufactured.

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

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.

Bayesian multivariate hierarchical transformation models for ROC analysis.

PubMed

O'Malley, A James; Zou, Kelly H

2006-02-15

A Bayesian multivariate hierarchical transformation model (BMHTM) is developed for receiver operating characteristic (ROC) curve analysis based on clustered continuous diagnostic outcome data with covariates. Two special features of this model are that it incorporates non-linear monotone transformations of the outcomes and that multiple correlated outcomes may be analysed. The mean, variance, and transformation components are all modelled parametrically, enabling a wide range of inferences. The general framework is illustrated by focusing on two problems: (1) analysis of the diagnostic accuracy of a covariate-dependent univariate test outcome requiring a Box-Cox transformation within each cluster to map the test outcomes to a common family of distributions; (2) development of an optimal composite diagnostic test using multivariate clustered outcome data. In the second problem, the composite test is estimated using discriminant function analysis and compared to the test derived from logistic regression analysis where the gold standard is a binary outcome. The proposed methodology is illustrated on prostate cancer biopsy data from a multi-centre clinical trial.

Bayesian multivariate hierarchical transformation models for ROC analysis

PubMed Central

O'Malley, A. James; Zou, Kelly H.

2006-01-01

SUMMARY A Bayesian multivariate hierarchical transformation model (BMHTM) is developed for receiver operating characteristic (ROC) curve analysis based on clustered continuous diagnostic outcome data with covariates. Two special features of this model are that it incorporates non-linear monotone transformations of the outcomes and that multiple correlated outcomes may be analysed. The mean, variance, and transformation components are all modelled parametrically, enabling a wide range of inferences. The general framework is illustrated by focusing on two problems: (1) analysis of the diagnostic accuracy of a covariate-dependent univariate test outcome requiring a Box–Cox transformation within each cluster to map the test outcomes to a common family of distributions; (2) development of an optimal composite diagnostic test using multivariate clustered outcome data. In the second problem, the composite test is estimated using discriminant function analysis and compared to the test derived from logistic regression analysis where the gold standard is a binary outcome. The proposed methodology is illustrated on prostate cancer biopsy data from a multi-centre clinical trial. PMID:16217836

An Iconic Comparison of Photographs and the Live Television Screen in Visual Diagnostic Ability.

ERIC Educational Resources Information Center

Hofer, Jarrel

This study focused on five major activities: (1) developing an achievement test to measure visual diagnostic ability of television service technicians, (2) assessing the independence of the dimension of visual diagnostic ability, (3) comparing the iconic equivalence of photographs with motion cues and live screen presentations of defective…

Assessing Disease Class-Specific Diagnostic Ability: A Practical Adaptive Test Approach.

ERIC Educational Resources Information Center

Papa, Frank J.; Schumacker, Randall E.

Measures of the robustness of disease class-specific diagnostic concepts could play a central role in training programs designed to assure the development of diagnostic competence. In the pilot study, the authors used disease/sign-symptom conditional probability estimates, Monte Carlo procedures, and artificial intelligence (AI) tools to create…

Assessing the Success of a Discipline-Based Communication Skills Development and Enhancement Program in a Graduate Accounting Course

ERIC Educational Resources Information Center

Barratt, Catherine; Hanlon, Dean; Rankin, Michaela

2011-01-01

In this paper we present results of the impact diagnostic testing and associated context-specific workshops have on students' written communication skills in a graduate-level accounting course. We find that students who undertook diagnostic testing performed better in their first semester accounting subject. This improvement is positively…

Web-Based Two-Tier Diagnostic Test and Remedial Learning Experiment

ERIC Educational Resources Information Center

Lai, Ah-Fur; Chen, Deng-Jyi

2010-01-01

Offering a series of diagnosis and individual remedial learning activities for a general class by means of web and multimedia technology can overcome the dilemma of conventional diagnosis and remedial instruction. The study proposes a three-layer conceptual framework and adopts a two-tier diagnostic test theory to develop a web-based two-tier…

Power calculation for comparing diagnostic accuracies in a multi-reader, multi-test design.

PubMed

Kim, Eunhee; Zhang, Zheng; Wang, Youdan; Zeng, Donglin

2014-12-01

Receiver operating characteristic (ROC) analysis is widely used to evaluate the performance of diagnostic tests with continuous or ordinal responses. A popular study design for assessing the accuracy of diagnostic tests involves multiple readers interpreting multiple diagnostic test results, called the multi-reader, multi-test design. Although several different approaches to analyzing data from this design exist, few methods have discussed the sample size and power issues. In this article, we develop a power formula to compare the correlated areas under the ROC curves (AUC) in a multi-reader, multi-test design. We present a nonparametric approach to estimate and compare the correlated AUCs by extending DeLong et al.'s (1988, Biometrics 44, 837-845) approach. A power formula is derived based on the asymptotic distribution of the nonparametric AUCs. Simulation studies are conducted to demonstrate the performance of the proposed power formula and an example is provided to illustrate the proposed procedure. © 2014, The International Biometric Society.

The cobas® 6800/8800 System: a new era of automation in molecular diagnostics.

PubMed

Cobb, Bryan; Simon, Christian O; Stramer, Susan L; Body, Barbara; Mitchell, P Shawn; Reisch, Natasa; Stevens, Wendy; Carmona, Sergio; Katz, Louis; Will, Stephen; Liesenfeld, Oliver

2017-02-01

Molecular diagnostics is a key component of laboratory medicine. Here, the authors review key triggers of ever-increasing automation in nucleic acid amplification testing (NAAT) with a focus on specific automated Polymerase Chain Reaction (PCR) testing and platforms such as the recently launched cobas® 6800 and cobas® 8800 Systems. The benefits of such automation for different stakeholders including patients, clinicians, laboratory personnel, hospital administrators, payers, and manufacturers are described. Areas Covered: The authors describe how molecular diagnostics has achieved total laboratory automation over time, rivaling clinical chemistry to significantly improve testing efficiency. Finally, the authors discuss how advances in automation decrease the development time for new tests enabling clinicians to more readily provide test results. Expert Commentary: The advancements described enable complete diagnostic solutions whereby specific test results can be combined with relevant patient data sets to allow healthcare providers to deliver comprehensive clinical recommendations in multiple fields ranging from infectious disease to outbreak management and blood safety solutions.

The role of standards in the development and implementation of clinical laboratory tests: a domestic and global perspective.

PubMed

Michaud, Ginette Y

2005-01-01

In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.

Development of Methods to Predict the Effects of Test Media in Ground-Based Propulsion Testing

NASA Technical Reports Server (NTRS)

Drummond, J. Philip; Danehy, Paul M.; Gaffney, Richard L., Jr.; Parker, Peter A.; Tedder, Sarah A.; Chelliah, Harsha K.; Cutler, Andrew D.; Bivolaru, Daniel; Givi, Peyman; Hassan, Hassan A.

2009-01-01

This report discusses work that began in mid-2004 sponsored by the Office of the Secretary of Defense (OSD) Test & Evaluation/Science & Technology (T&E/S&T) Program. The work was undertaken to improve the state of the art of CFD capabilities for predicting the effects of the test media on the flameholding characteristics in scramjet engines. The program had several components including the development of advanced algorithms and models for simulating engine flowpaths as well as a fundamental experimental and diagnostic development effort to support the formulation and validation of the mathematical models. This report provides details of the completed work, involving the development of phenomenological models for Reynolds averaged Navier-Stokes codes, large-eddy simulation techniques and reduced-kinetics models. Experiments that provided data for the modeling efforts are also described, along with with the associated nonintrusive diagnostics used to collect the data.

Development of monitoring and diagnostic methods for robots used in remediation of waste sites. 1997 annual progress report

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

Tecza, J.

1998-06-01

'Safe and efficient clean up of hazardous and radioactive waste sites throughout the DOE complex will require extensive use of robots. This research effort focuses on developing Monitoring and Diagnostic (M and D) methods for robots that will provide early detection, isolation, and tracking of impending faults before they result in serious failure. The utility and effectiveness of applying M and D methods to hydraulic robots has never been proven. The present research program is utilizing seeded faults in a laboratory test rig that is representative of an existing hydraulically-powered remediation robot. This report summarizes activity conducted in the firstmore » 9 months of the project. The research team has analyzed the Rosie Mobile Worksystem as a representative hydraulic robot, developed a test rig for implanted fault testing, developed a test plan and agenda, and established methods for acquiring and analyzing the test data.'« less

Multiplex PCR Tests for Detection of Pathogens Associated with Gastroenteritis

PubMed Central

Zhang, Hongwei; Morrison, Scott; Tang, Yi-Wei

2016-01-01

Synopsis A wide range of enteric pathogens can cause infectious gastroenteritis. Conventional diagnostic algorithms including culture, biochemical identification, immunoassay and microscopic examination are time consuming and often lack sensitivity and specificity. Advances in molecular technology have as allowed its use as clinical diagnostic tools. Multiplex PCR based testing has made its way to gastroenterology diagnostic arena in recent years. In this article we present a review of recent laboratory developed multiplex PCR tests and current commercial multiplex gastrointestinal pathogen tests. We will focus on two FDA cleared commercial syndromic multiplex tests: Luminex xTAG GPP and Biofire FimArray GI test. These multiplex tests can detect and identify multiple enteric pathogens in one test and provide results within hours. Multiplex PCR tests have shown superior sensitivity to conventional methods for detection of most pathogens. The high negative predictive value of these multiplex tests has led to the suggestion that they be used as screening tools especially in outbreaks. Although the clinical utility and benefit of multiplex PCR test are to be further investigated, implementing these multiplex PCR tests in gastroenterology diagnostic algorithm has the potential to improve diagnosis of infectious gastroenteritis. PMID:26004652

Optimal triage test characteristics to improve the cost-effectiveness of the Xpert MTB/RIF assay for TB diagnosis: a decision analysis.

PubMed

van't Hoog, Anna H; Cobelens, Frank; Vassall, Anna; van Kampen, Sanne; Dorman, Susan E; Alland, David; Ellner, Jerrold

2013-01-01

High costs are a limitation to scaling up the Xpert MTB/RIF assay (Xpert) for the diagnosis of tuberculosis in resource-constrained settings. A triaging strategy in which a sensitive but not necessarily highly specific rapid test is used to select patients for Xpert may result in a more affordable diagnostic algorithm. To inform the selection and development of particular diagnostics as a triage test we explored combinations of sensitivity, specificity and cost at which a hypothetical triage test will improve affordability of the Xpert assay. In a decision analytical model parameterized for Uganda, India and South Africa, we compared a diagnostic algorithm in which a cohort of patients with presumptive TB received Xpert to a triage algorithm whereby only those with a positive triage test were tested by Xpert. A triage test with sensitivity equal to Xpert, 75% specificity, and costs of US$5 per patient tested reduced total diagnostic costs by 42% in the Uganda setting, and by 34% and 39% respectively in the India and South Africa settings. When exploring triage algorithms with lower sensitivity, the use of an example triage test with 95% sensitivity relative to Xpert, 75% specificity and test costs $5 resulted in similar cost reduction, and was cost-effective by the WHO willingness-to-pay threshold compared to Xpert for all in Uganda, but not in India and South Africa. The gain in affordability of the examined triage algorithms increased with decreasing prevalence of tuberculosis among the cohort. A triage test strategy could potentially improve the affordability of Xpert for TB diagnosis, particularly in low-income countries and with enhanced case-finding. Tests and markers with lower accuracy than desired of a diagnostic test may fall within the ranges of sensitivity, specificity and cost required for triage tests and be developed as such.

Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group.

PubMed

Garfield, Susan; Polisena, Julie; S Spinner, Daryl; Postulka, Anne; Y Lu, Christine; Tiwana, Simrandeep K; Faulkner, Eric; Poulios, Nick; Zah, Vladimir; Longacre, Michael

2016-01-01

Health technology assessments (HTAs) are increasingly used to inform coverage, access, and utilization of medical technologies including molecular diagnostics (MDx). Although MDx are used to screen patients and inform disease management and treatment decisions, there is no uniform approach to their evaluation by HTA organizations. The International Society for Pharmacoeconomics and Outcomes Research Devices and Diagnostics Special Interest Group reviewed diagnostic-specific HTA programs and identified elements representing common and best practices. MDx-specific HTA programs in Europe, Australia, and North America were characterized by methodology, evaluation framework, and impact. Published MDx HTAs were reviewed, and five representative case studies of test evaluations were developed: United Kingdom (National Institute for Health and Care Excellence's Diagnostics Assessment Programme, epidermal growth factor receptor tyrosine kinase mutation), United States (Palmetto's Molecular Diagnostic Services Program, OncotypeDx prostate cancer test), Germany (Institute for Quality and Efficiency in Healthcare, human papillomavirus testing), Australia (Medical Services Advisory Committee, anaplastic lymphoma kinase testing for non-small cell lung cancer), and Canada (Canadian Agency for Drugs and Technologies in Health, Rapid Response: Non-invasive Prenatal Testing). Overall, the few HTA programs that have MDx-specific methods do not provide clear parameters of acceptability related to clinical and analytic performance, clinical utility, and economic impact. The case studies highlight similarities and differences in evaluation approaches across HTAs in the performance metrics used (analytic and clinical validity, clinical utility), evidence requirements, and how value is measured. Not all HTAs are directly linked to reimbursement outcomes. To improve MDx HTAs, organizations should provide greater transparency, better communication and collaboration between industry and HTA stakeholders, clearer links between HTA and funding decisions, explicit recognition of and rationale for differential approaches to laboratory-developed versus regulatory-approved test, and clear evidence requirements. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Optimal Combinations of Diagnostic Tests Based on AUC.

PubMed

Huang, Xin; Qin, Gengsheng; Fang, Yixin

2011-06-01

When several diagnostic tests are available, one can combine them to achieve better diagnostic accuracy. This article considers the optimal linear combination that maximizes the area under the receiver operating characteristic curve (AUC); the estimates of the combination's coefficients can be obtained via a nonparametric procedure. However, for estimating the AUC associated with the estimated coefficients, the apparent estimation by re-substitution is too optimistic. To adjust for the upward bias, several methods are proposed. Among them the cross-validation approach is especially advocated, and an approximated cross-validation is developed to reduce the computational cost. Furthermore, these proposed methods can be applied for variable selection to select important diagnostic tests. The proposed methods are examined through simulation studies and applications to three real examples. © 2010, The International Biometric Society.

A Self-Diagnostic System for the M6 Accelerometer

NASA Technical Reports Server (NTRS)

Flanagan, Patrick M.; Lekki, John

2001-01-01

The design of a Self-Diagnostic (SD) accelerometer system for the Space Shuttle Main Engine is presented. This retrofit system connects diagnostic electronic hardware and software to the current M6 accelerometer system. This paper discusses the general operation of the M6 accelerometer SD system and procedures for developing and evaluating the SD system. Signal processing techniques using M6 accelerometer diagnostic data are explained. Test results include diagnostic data responding to changing ambient temperature, mounting torque and base mounting impedance.

A comprehensive custom panel design for routine hereditary cancer testing: preserving control, improving diagnostics and revealing a complex variation landscape.

PubMed

Castellanos, Elisabeth; Gel, Bernat; Rosas, Inma; Tornero, Eva; Santín, Sheila; Pluvinet, Raquel; Velasco, Juan; Sumoy, Lauro; Del Valle, Jesús; Perucho, Manuel; Blanco, Ignacio; Navarro, Matilde; Brunet, Joan; Pineda, Marta; Feliubadaló, Lidia; Capellá, Gabi; Lázaro, Conxi; Serra, Eduard

2017-01-04

We wanted to implement an NGS strategy to globally analyze hereditary cancer with diagnostic quality while retaining the same degree of understanding and control we had in pre-NGS strategies. To do this, we developed the I2HCP panel, a custom bait library covering 122 hereditary cancer genes. We improved bait design, tested different NGS platforms and created a clinically driven custom data analysis pipeline. The I2HCP panel was developed using a training set of hereditary colorectal cancer, hereditary breast and ovarian cancer and neurofibromatosis patients and reached an accuracy, analytical sensitivity and specificity greater than 99%, which was maintained in a validation set. I2HCP changed our diagnostic approach, involving clinicians and a genetic diagnostics team from panel design to reporting. The new strategy improved diagnostic sensitivity, solved uncertain clinical diagnoses and identified mutations in new genes. We assessed the genetic variation in the complete set of hereditary cancer genes, revealing a complex variation landscape that coexists with the disease-causing mutation. We developed, validated and implemented a custom NGS-based strategy for hereditary cancer diagnostics that improved our previous workflows. Additionally, the existence of a rich genetic variation in hereditary cancer genes favors the use of this panel to investigate their role in cancer risk.

Convergent and diagnostic validity of STAVUX, a word and pseudoword spelling test for adults.

PubMed

Östberg, Per; Backlund, Charlotte; Lindström, Emma

2016-10-01

Few comprehensive spelling tests are available in Swedish, and none have been validated in adults with reading and writing disorders. The recently developed STAVUX test includes word and pseudoword spelling subtests with high internal consistency and adult norms stratified by education. This study evaluated the convergent and diagnostic validity of STAVUX in adults with dyslexia. Forty-six adults, 23 with dyslexia and 23 controls, took STAVUX together with a standard word-decoding test and a self-rated measure of spelling skills. STAVUX subtest scores showed moderate to strong correlations with word-decoding scores and predicted self-rated spelling skills. Word and pseudoword subtest scores both predicted dyslexia status. Receiver-operating characteristic (ROC) analysis showed excellent diagnostic discriminability. Sensitivity was 91% and specificity 96%. In conclusion, the results of this study support the convergent and diagnostic validity of STAVUX.

A portable hardware-in-the-loop (HIL) device for automotive diagnostic control systems.

PubMed

Palladino, A; Fiengo, G; Lanzo, D

2012-01-01

In-vehicle driving tests for evaluating the performance and diagnostic functionalities of engine control systems are often time consuming, expensive, and not reproducible. Using a hardware-in-the-loop (HIL) simulation approach, new control strategies and diagnostic functions on a controller area network (CAN) line can be easily tested in real time, in order to reduce the effort and the cost of the testing phase. Nowadays, spark ignition engines are controlled by an electronic control unit (ECU) with a large number of embedded sensors and actuators. In order to meet the rising demand of lower emissions and fuel consumption, an increasing number of control functions are added into such a unit. This work aims at presenting a portable electronic environment system, suited for HIL simulations, in order to test the engine control software and the diagnostic functionality on a CAN line, respectively, through non-regression and diagnostic tests. The performances of the proposed electronic device, called a micro hardware-in-the-loop system, are presented through the testing of the engine management system software of a 1.6 l Fiat gasoline engine with variable valve actuation for the ECU development version. Copyright © 2011 ISA. Published by Elsevier Ltd. All rights reserved.

Propulsion Diagnostic Method Evaluation Strategy (ProDiMES) User's Guide

NASA Technical Reports Server (NTRS)

Simon, Donald L.

2010-01-01

This report is a User's Guide for the Propulsion Diagnostic Method Evaluation Strategy (ProDiMES). ProDiMES is a standard benchmarking problem and a set of evaluation metrics to enable the comparison of candidate aircraft engine gas path diagnostic methods. This Matlab (The Mathworks, Inc.) based software tool enables users to independently develop and evaluate diagnostic methods. Additionally, a set of blind test case data is also distributed as part of the software. This will enable the side-by-side comparison of diagnostic approaches developed by multiple users. The Users Guide describes the various components of ProDiMES, and provides instructions for the installation and operation of the tool.

Winthrop-University Hospital Infectious Disease Division's swine influenza (H1N1) pneumonia diagnostic weighted point score system for hospitalized adults with influenza-like illnesses (ILIs) and negative rapid influenza diagnostic tests (RIDTs).

PubMed

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

2009-01-01

In spring 2009, a novel strain of influenza A originating in Veracruz, Mexico, quickly spread to the United States and throughout the world. This influenza A virus was the product of gene reassortment of 4 different genetic elements: human influenza, swine influenza, avian influenza, and Eurasian swine influenza. In the United States, New York was the epicenter of the swine influenza (H1N1) pandemic. Hospital emergency departments (EDs) were inundated with patients with influenza-like illnesses (ILIs) requesting screening for H1N1. Our ED screening, as well as many others, used a rapid screening test for influenza A (QuickVue A/B) because H1N1 was a variant of influenza A. The definitive laboratory test i.e., RT-PCR for H1N1 was developed by the Centers for Disease Control (Atlanta, GA) and subsequently distributed to health departments. Because of the extraordinary volume of test requests, health authorities restricted reverse transcription polymerase chain reaction (RT-PCR) testing. Hence most EDs, including our own, were dependent on rapid influenza diagnostic tests (RIDTs) for swine influenza. A positive rapid influenza A test was usually predictive of RT-PCR H1N1 positivity, but the rapid influenza A screening test (QuickVue A/B) was associated with 30% false negatives. The inability to rely on RIDTs for H1N1 diagnosis resulted in underdiagnosing H1N1. Confronted with adults admitted with ILIs, negative RIDTs, and restricted RT-PCR testing, there was a critical need to develop clinical criteria to diagnose probable swine influenza H1N1 pneumonia. During the pandemic, the Infectious Disease Division at Winthrop-University Hospital developed clinical criteria for adult admitted patients with ILIs and negative RIDTs. Similar to the one developed for the clinical diagnosis of legionnaire's disease. The Winthrop-University Hospital Infectious Disease Division's diagnostic weighted point score system for swine influenza H1N1 pneumonia is based on key clinical and laboratory features. During the "herald" wave of the swine influenza H1N1 pandemic, the diagnostic weighted point score system accurately identified probable swine influenza H1N1 pneumonia and accurately differentiated swine influenza H1N1 pneumonia from ILIs and other viral and bacterial community-acquired pneumonias. In hospitalized adults with ILIs and negative RIDTs, the diagnostic weighted diagnostic point score system, may be used to make a presumptive clinical diagnosis of swine influenza H1N1 pneumonia.

Recommended reporting standards for test accuracy studies of infectious diseases of finfish, amphibians, molluscs and crustaceans: the STRADAS-aquatic checklist

USGS Publications Warehouse

Gardner, Ian A; Whittington, Richard J; Caraguel, Charles G B; Hick, Paul; Moody, Nicholas J G; Corbeil, Serge; Garver, Kyle A.; Warg, Janet V.; Arzul, Isabelle; Purcell, Maureen; St. J. Crane, Mark; Waltzek, Thomas B.; Olesen, Niels J; Lagno, Alicia Gallardo

2016-01-01

Complete and transparent reporting of key elements of diagnostic accuracy studies for infectious diseases in cultured and wild aquatic animals benefits end-users of these tests, enabling the rational design of surveillance programs, the assessment of test results from clinical cases and comparisons of diagnostic test performance. Based on deficiencies in the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines identified in a prior finfish study (Gardner et al. 2014), we adapted the Standards for Reporting of Animal Diagnostic Accuracy Studies—paratuberculosis (STRADAS-paraTB) checklist of 25 reporting items to increase their relevance to finfish, amphibians, molluscs, and crustaceans and provided examples and explanations for each item. The checklist, known as STRADAS-aquatic, was developed and refined by an expert group of 14 transdisciplinary scientists with experience in test evaluation studies using field and experimental samples, in operation of reference laboratories for aquatic animal pathogens, and in development of international aquatic animal health policy. The main changes to the STRADAS-paraTB checklist were to nomenclature related to the species, the addition of guidelines for experimental challenge studies, and the designation of some items as relevant only to experimental studies and ante-mortem tests. We believe that adoption of these guidelines will improve reporting of primary studies of test accuracy for aquatic animal diseases and facilitate assessment of their fitness-for-purpose. Given the importance of diagnostic tests to underpin the Sanitary and Phytosanitary agreement of the World Trade Organization, the principles outlined in this paper should be applied to other World Organisation for Animal Health (OIE)-relevant species.

Recommended reporting standards for test accuracy studies of infectious diseases of finfish, amphibians, molluscs and crustaceans: the STRADAS-aquatic checklist.

PubMed

Gardner, Ian A; Whittington, Richard J; Caraguel, Charles G B; Hick, Paul; Moody, Nicholas J G; Corbeil, Serge; Garver, Kyle A; Warg, Janet V; Arzul, Isabelle; Purcell, Maureen K; Crane, Mark St J; Waltzek, Thomas B; Olesen, Niels J; Gallardo Lagno, Alicia

2016-02-25

Complete and transparent reporting of key elements of diagnostic accuracy studies for infectious diseases in cultured and wild aquatic animals benefits end-users of these tests, enabling the rational design of surveillance programs, the assessment of test results from clinical cases and comparisons of diagnostic test performance. Based on deficiencies in the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines identified in a prior finfish study (Gardner et al. 2014), we adapted the Standards for Reporting of Animal Diagnostic Accuracy Studies-paratuberculosis (STRADAS-paraTB) checklist of 25 reporting items to increase their relevance to finfish, amphibians, molluscs, and crustaceans and provided examples and explanations for each item. The checklist, known as STRADAS-aquatic, was developed and refined by an expert group of 14 transdisciplinary scientists with experience in test evaluation studies using field and experimental samples, in operation of reference laboratories for aquatic animal pathogens, and in development of international aquatic animal health policy. The main changes to the STRADAS-paraTB checklist were to nomenclature related to the species, the addition of guidelines for experimental challenge studies, and the designation of some items as relevant only to experimental studies and ante-mortem tests. We believe that adoption of these guidelines will improve reporting of primary studies of test accuracy for aquatic animal diseases and facilitate assessment of their fitness-for-purpose. Given the importance of diagnostic tests to underpin the Sanitary and Phytosanitary agreement of the World Trade Organization, the principles outlined in this paper should be applied to other World Organisation for Animal Health (OIE)-relevant species.

Molecular malaria diagnostics: A systematic review and meta-analysis.

PubMed

Roth, Johanna M; Korevaar, Daniël A; Leeflang, Mariska M G; Mens, Pètra F

2016-01-01

Accurate diagnosis of malaria is essential for identification and subsequent treatment of the disease. Currently, microscopy and rapid diagnostic tests are the most commonly used diagnostics, next to treatment based on clinical signs only. These tests are easy to deploy, but have a relatively high detection limit. With declining prevalence in many areas, there is an increasing need for more sensitive diagnostics. Molecular tools may be a suitable alternative, although costs and technical requirements currently hamper their implementation in resource limited settings. A range of (near) point-of-care diagnostics is therefore under development, including simplifications in sample preparation, amplification and/or read-out of the test. Accuracy data, in combination with technical characteristics, are essential in determining which molecular test, if any, would be the most promising to be deployed. This review presents a comprehensive overview of the currently available molecular malaria diagnostics, ranging from well-known tests to platforms in early stages of evaluation, and systematically evaluates their published accuracy. No important difference in accuracy was found between the most commonly used PCR-based assays (conventional, nested and real-time PCR), with most of them having high sensitivity and specificity, implying that there are no reasons other than practical ones to choose one technique over the other. Loop-mediated isothermal amplification and other (novel) diagnostics appear to be highly accurate as well, with some offering potential to be used in resource-limited settings.

DARTTS Diagnostic Assessments of Reading with Trial Teaching Strategies: Administrator's Summary. Report No. 9-49040.

ERIC Educational Resources Information Center

Riverside Publishing Co., Chicago. IL.

The Diagnostic Assessments of Reading with Trial Teaching Strategies (DARTTS) is a program of diagnostic tests with sample lessons in aspects of literacy. Developed by Florence G. Roswell and Jeanne S. Chall, the DARTTS program is published in a multilevel format for beginning through advanced (high school) readers. Teachers administer and score…

How patients navigate the diagnostic ecosystem in a fragmented health system: a qualitative study from India

PubMed Central

Yellapa, Vijayashree; Devadasan, Narayanan; Krumeich, Anja; Pant Pai, Nitika; Vadnais, Caroline; Pai, Madhukar; Engel, Nora

2017-01-01

ABSTRACT Background: Depending on a country’s diagnostic infrastructure, patients and providers play different roles in ensuring that correct and timely diagnosis is made. However, little is known about the work done by patients in accessing diagnostic services and completing the ‘test and treat’ loop. Objective: To address this knowledge gap, we traced the diagnostic journeys of patients with tuberculosis, diabetes, hypertension and typhoid, and examined the work they had to do to arrive at a diagnosis. Methods: This paper draws on a qualitative study, which included 78 semi-structured interviews and 13 focus group discussions with patients, public and private healthcare providers, community health workers, test manufacturers, laboratory technicians, program managers and policymakers. Data were collected between January and June 2013 in rural and urban Karnataka, South India, as part of a larger project on barriers to point-of-care testing. We reconstructed patient diagnostic processes retrospectively and analyzed emerging themes and patterns. Results: The journey to access diagnostic services requires a high level of involvement and immense work from patients and/or their caretakers. This process entails overcoming cost and distance, negotiating social relations, continuously making sense of their illness and diagnosis, producing and transporting samples, dealing with the social consequences of diagnosis, and returning results to the treating provider. The quality and content of interactions with providers were crucial for completion of test and treat loops. If the tasks became overwhelming, patients opted out, delayed being tested, switched providers and/or reverted to self-testing or self-treatment practices. Conclusion: Our study demonstrated how difficult it can be for patients to complete diagnostic journeys and how the health system works as far as diagnostics are concerned. If new point-of-care tests are to be implemented successfully, policymakers, program officers and test developers need to find ways to ease patient navigation through diagnostic services. PMID:28762894

Diagnostic reliability of MMPI-2 computer-based test interpretations.

PubMed

Pant, Hina; McCabe, Brian J; Deskovitz, Mark A; Weed, Nathan C; Williams, John E

2014-09-01

Reflecting the common use of the MMPI-2 to provide diagnostic considerations, computer-based test interpretations (CBTIs) also typically offer diagnostic suggestions. However, these diagnostic suggestions can sometimes be shown to vary widely across different CBTI programs even for identical MMPI-2 profiles. The present study evaluated the diagnostic reliability of 6 commercially available CBTIs using a 20-item Q-sort task developed for this study. Four raters each sorted diagnostic classifications based on these 6 CBTI reports for 20 MMPI-2 profiles. Two questions were addressed. First, do users of CBTIs understand the diagnostic information contained within the reports similarly? Overall, diagnostic sorts of the CBTIs showed moderate inter-interpreter diagnostic reliability (mean r = .56), with sorts for the 1/2/3 profile showing the highest inter-interpreter diagnostic reliability (mean r = .67). Second, do different CBTIs programs vary with respect to diagnostic suggestions? It was found that diagnostic sorts of the CBTIs had a mean inter-CBTI diagnostic reliability of r = .56, indicating moderate but not strong agreement across CBTIs in terms of diagnostic suggestions. The strongest inter-CBTI diagnostic agreement was found for sorts of the 1/2/3 profile CBTIs (mean r = .71). Limitations and future directions are discussed. PsycINFO Database Record (c) 2014 APA, all rights reserved.

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

Adherence to Standards for Reporting Diagnostic Accuracy in Emergency Medicine Research.

PubMed

Gallo, Lucas; Hua, Nadia; Mercuri, Mathew; Silveira, Angela; Worster, Andrew

2017-08-01

Diagnostic tests are used frequently in the emergency department (ED) to guide clinical decision making and, hence, influence clinical outcomes. The Standards for Reporting of Diagnostic Accuracy (STARD) criteria were developed to ensure that diagnostic test studies are performed and reported to best inform clinical decision making in the ED. The objective was to determine the extent to which diagnostic studies published in emergency medicine journals adhered to STARD 2003 criteria. Diagnostic studies published in eight MEDLINE-listed, peer-reviewed, emergency medicine journals over a 5-year period were reviewed for compliance to STARD criteria. A total of 12,649 articles were screened and 114 studies were included in our study. Twenty percent of these were randomly selected for assessment using STARD 2003 criteria. Adherence to STARD 2003 reporting standards for each criteria ranged from 8.7% adherence (criteria-reporting adverse events from performing index test or reference standard) to 100% (multiple criteria). Just over half of STARD criteria are reported in more than 80% studies. As poorly reported studies may negatively impact their clinical usefulness, it is essential that studies of diagnostic test accuracy be performed and reported adequately. Future studies should assess whether studies have improved compliance with the STARD 2015 criteria amendment. © 2017 by the Society for Academic Emergency Medicine.

A Research Agenda for Malaria Eradication: Diagnoses and Diagnostics

PubMed Central

2011-01-01

Many of malaria's signs and symptoms are indistinguishable from those of other febrile diseases. Detection of the presence of Plasmodium parasites is essential, therefore, to guide case management. Improved diagnostic tools are required to enable targeted treatment of infected individuals. In addition, field-ready diagnostic tools for mass screening and surveillance that can detect asymptomatic infections of very low parasite densities are needed to monitor transmission reduction and ensure elimination. Antibody-based tests for infection and novel methods based on biomarkers need further development and validation, as do methods for the detection and treatment of Plasmodium vivax. Current rapid diagnostic tests targeting P. vivax are generally less effective than those targeting Plasmodium falciparum. Moreover, because current drugs for radical cure may cause serious side effects in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, more information is needed on the distribution of G6PD-deficiency variants as well as tests to identify at-risk individuals. Finally, in an environment of very low or absent malaria transmission, sustaining interest in elimination and maintaining resources will become increasingly important. Thus, research is required into the context in which malaria diagnostic tests are used, into diagnostics for other febrile diseases, and into the integration of these tests into health systems. PMID:21311583

Proband-only medical exome sequencing as a cost-effective first-tier genetic diagnostic test for patients without prior molecular tests and clinical diagnosis in a developing country: the China experience.

PubMed

Hu, Xuyun; Li, Niu; Xu, Yufei; Li, Guoqiang; Yu, Tingting; Yao, Ru-En; Fu, Lijun; Wang, Jiwen; Yin, Lei; Yin, Yong; Wang, Ying; Jin, Xingming; Wang, Xiumin; Wang, Jian; Shen, Yiping

2017-11-02

PurposeTo evaluate the performance of proband-only medical exome sequencing (POMES) as a cost-effective first-tier diagnostic test for pediatric patients with unselected conditions.MethodsA total of 1,323 patients were tested by POMES, which targeted 2,742 known disease-causing genes. Clinical relevant variants were Sanger-confirmed in probands and parents. We assessed the diagnostic validity and clinical utility of POMES by means of a survey questionnaire.ResultsPOMES, ordered by 136 physicians, identified 512 pathogenic or likely pathogenic variants associated with over 200 conditions. The overall diagnostic rate was 28.8%, ranging from 10% in neonatal intensive care unit patients to over 35% in pediatric intensive care unit patients. The test results had an impact on the management of the 45.1% of patients for whom there were positive findings. The average turnaround time was 57 days; the cost was $360/case.ConclusionWe adopted a relatively efficient and cost-effective approach in China for the molecular diagnosis of pediatric patients with suspected genetic conditions. While training for clinical geneticists and other specialists is lagging behind in China POMES is serving as a diagnostic equalizer for patients who do not normally receive extensive clinical evaluation and clinical diagnosis prior to testing. This Chinese experience should be applicable to other developing countries that are lacking clinical, financial, and personnel resources.GENETICS in MEDICINE advance online publication, 2 November 2017; doi:10.1038/gim.2017.195.

Get the Diagnosis: an evidence-based medicine collaborative Wiki for diagnostic test accuracy.

PubMed

Hammer, Mark M; Kohlberg, Gavriel D

2017-04-01

Despite widespread calls for its use, there are challenges to the implementation of evidence-based medicine (EBM) in clinical practice. In response to the challenges of finding timely, pertinent information on diagnostic test accuracy, we developed an online, crowd-sourced Wiki on diagnostic test accuracy called Get the Diagnosis (GTD, http://www.getthediagnosis.org). Since its launch in November 2008 till October 2015, GTD has accumulated information on 300 diagnoses, with 1617 total diagnostic entries. There are a total of 1097 unique diagnostic tests with a mean of 5.4 tests (range 0-38) per diagnosis. 73% of entries (1182 of 1617) have an associated sensitivity and specificity and 89% of entries (1432 of 1617) have associated peer-reviewed literature citations. Altogether, GTD contains 474 unique literature citations. For a sample of three diagnoses, the search precision (percentage of relevant results in the first 30 entries) in GTD was 100% as compared with a range of 13.3%-63.3% for PubMed and between 6.7% and 76.7% for Google Scholar. GTD offers a fast, precise and efficient way to look up diagnostic test accuracy. On three selected examples, GTD had a greater precision rate compared with PubMed and Google Scholar in identifying diagnostic test information. GTD is a free resource that complements other currently available resources. 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/.

Using molecular diagnostic testing to personalize the treatment of patients with gastrointestinal stromal tumors.

PubMed

Bannon, Amber E; Klug, Lillian R; Corless, Christopher L; Heinrich, Michael C

2017-05-01

The diagnosis and treatment of gastrointestinal stromal tumor (GIST) has emerged as a paradigm for modern cancer treatment ('precision medicine'), as it highlights the importance of matching molecular defects with specific therapies. Over the past two decades, the molecular classification and diagnostic work up of GIST has been radically transformed, accompanied by the development of molecular therapies for specific subgroups of GIST. This review summarizes the developments in the field of molecular diagnosis of GIST, particularly as they relate to optimizing medical therapy. Areas covered: Based on an extensive literature search of the molecular and clinical aspects of GIST, the authors review the most important developments in this field with an emphasis on the differential diagnosis of GIST including mutation testing, therapeutic implications of each molecular subtype, and emerging technologies relevant to the field. Expert commentary: The use of molecular diagnostics to classify GIST has been shown to be successful in optimizing patient treatment, but these methods remain under-utilized. In order to facilitate efficient and comprehensive molecular testing, the authors have developed a decision tree to aid clinicians.

Development of a highly sensitive immunochromatographic detection kit for H5 influenza virus hemagglutinin using silver amplification.

PubMed

Wada, Atsuhiko; Sakoda, Yoshihiro; Oyamada, Takayoshi; Kida, Hiroshi

2011-12-01

H5N1, a highly pathogenic avian influenza virus (HPAIV), has become a serious epizootic threat to the poultry population in Asia. In addition, significant numbers of human cases of HPAIV infection have been reported to date. To prevent the spread of HPAIV among humans and to allow for timely medical intervention, a rapid and high sensitive method is needed to detect and subtype the causative HPAIVs. In the present study, a silver amplification technique used in photographic development was combined with immunochromatography technologies and a highly sensitive and rapid diagnostic test to detect the hemagglutinin of H5 influenza viruses was developed. The sensitivity of the test kit was increased 500 times by silver amplification. The sensitivity of the method was more than 10 times higher than those of conventional rapid influenza diagnostic tests, which detect viral nucleoproteins. The diagnostic system developed in the present study can therefore provide rapid and highly sensitive results and will be useful for diagnosis of H5 HPAIV infection in humans and animals. Copyright © 2011 Elsevier B.V. All rights reserved.

A review of current and future molecular diagnostic tests for use in the microbiology laboratory.

PubMed

Jannes, Geert; De Vos, Daniel

2006-01-01

Nucleic acid-based diagnostics gradually are replacing or complementing culture-based, biochemical, and immunological assays in routine microbiology laboratories. Similar to conventional tests, the first-generation deoxyribonucleic acid assays determined only a single analyte. Recent improvements in detection technologies have paved the way for the development of multiparameter assays using macroarrays or micro-arrays, while the introduction of closed-tube real-time polymerase chain reaction systems has resulted in the development of rapid microbial diagnostics with a reduced contamination risk. The use of these new molecular technologies is not restricted to detection and identification of microbial pathogens but also can be used for genotyping, allowing one to determine antibiotic resistance or to perform microbial fingerprinting.

Nonparametric predictive inference for combining diagnostic tests with parametric copula

NASA Astrophysics Data System (ADS)

Muhammad, Noryanti; Coolen, F. P. A.; Coolen-Maturi, T.

2017-09-01

Measuring the accuracy of diagnostic tests is crucial in many application areas including medicine and health care. The Receiver Operating Characteristic (ROC) curve is a popular statistical tool for describing the performance of diagnostic tests. The area under the ROC curve (AUC) is often used as a measure of the overall performance of the diagnostic test. In this paper, we interest in developing strategies for combining test results in order to increase the diagnostic accuracy. We introduce nonparametric predictive inference (NPI) for combining two diagnostic test results with considering dependence structure using parametric copula. NPI is a frequentist statistical framework for inference on a future observation based on past data observations. NPI uses lower and upper probabilities to quantify uncertainty and is based on only a few modelling assumptions. While copula is a well-known statistical concept for modelling dependence of random variables. A copula is a joint distribution function whose marginals are all uniformly distributed and it can be used to model the dependence separately from the marginal distributions. In this research, we estimate the copula density using a parametric method which is maximum likelihood estimator (MLE). We investigate the performance of this proposed method via data sets from the literature and discuss results to show how our method performs for different family of copulas. Finally, we briefly outline related challenges and opportunities for future research.

Addressing Barriers to the Development and Adoption of Rapid Diagnostic Tests in Global Health.

PubMed

Miller, Eric; Sikes, Hadley D

Immunochromatographic rapid diagnostic tests (RDTs) have demonstrated significant potential for use as point-of-care diagnostic tests in resource-limited settings. Most notably, RDTs for malaria have reached an unparalleled level of technological maturity and market penetration, and are now considered an important complement to standard microscopic methods of malaria diagnosis. However, the technical development of RDTs for other infectious diseases, and their uptake within the global health community as a core diagnostic modality, has been hindered by a number of extant challenges. These range from technical and biological issues, such as the need for better affinity agents and biomarkers of disease, to social, infrastructural, regulatory and economic barriers, which have all served to slow their adoption and diminish their impact. In order for the immunochromatographic RDT format to be successfully adapted to other disease targets, to see widespread distribution, and to improve clinical outcomes for patients on a global scale, these challenges must be identified and addressed, and the global health community must be engaged in championing the broader use of RDTs.

Addressing Barriers to the Development and Adoption of Rapid Diagnostic Tests in Global Health

PubMed Central

Miller, Eric; Sikes, Hadley D.

2015-01-01

Immunochromatographic rapid diagnostic tests (RDTs) have demonstrated significant potential for use as point-of-care diagnostic tests in resource-limited settings. Most notably, RDTs for malaria have reached an unparalleled level of technological maturity and market penetration, and are now considered an important complement to standard microscopic methods of malaria diagnosis. However, the technical development of RDTs for other infectious diseases, and their uptake within the global health community as a core diagnostic modality, has been hindered by a number of extant challenges. These range from technical and biological issues, such as the need for better affinity agents and biomarkers of disease, to social, infrastructural, regulatory and economic barriers, which have all served to slow their adoption and diminish their impact. In order for the immunochromatographic RDT format to be successfully adapted to other disease targets, to see widespread distribution, and to improve clinical outcomes for patients on a global scale, these challenges must be identified and addressed, and the global health community must be engaged in championing the broader use of RDTs. PMID:26594252

A data-driven algorithm integrating clinical and laboratory features for the diagnosis and prognosis of necrotizing enterocolitis.

PubMed

Ji, Jun; Ling, Xuefeng B; Zhao, Yingzhen; Hu, Zhongkai; Zheng, Xiaolin; Xu, Zhening; Wen, Qiaojun; Kastenberg, Zachary J; Li, Ping; Abdullah, Fizan; Brandt, Mary L; Ehrenkranz, Richard A; Harris, Mary Catherine; Lee, Timothy C; Simpson, B Joyce; Bowers, Corinna; Moss, R Lawrence; Sylvester, Karl G

2014-01-01

Necrotizing enterocolitis (NEC) is a major source of neonatal morbidity and mortality. Since there is no specific diagnostic test or risk of progression model available for NEC, the diagnosis and outcome prediction of NEC is made on clinical grounds. The objective in this study was to develop and validate new NEC scoring systems for automated staging and prognostic forecasting. A six-center consortium of university based pediatric teaching hospitals prospectively collected data on infants under suspicion of having NEC over a 7-year period. A database comprised of 520 infants was utilized to develop the NEC diagnostic and prognostic models by dividing the entire dataset into training and testing cohorts of demographically matched subjects. Developed on the training cohort and validated on the blind testing cohort, our multivariate analyses led to NEC scoring metrics integrating clinical data. Machine learning using clinical and laboratory results at the time of clinical presentation led to two nec models: (1) an automated diagnostic classification scheme; (2) a dynamic prognostic method for risk-stratifying patients into low, intermediate and high NEC scores to determine the risk for disease progression. We submit that dynamic risk stratification of infants with NEC will assist clinicians in determining the need for additional diagnostic testing and guide potential therapies in a dynamic manner. http://translationalmedicine.stanford.edu/cgi-bin/NEC/index.pl and smartphone application upon request.

Development and Evaluation of the Diagnostic Power for a Computer-Based Two-Tier Assessment

ERIC Educational Resources Information Center

Lin, Jing-Wen

2016-01-01

This study adopted a quasi-experimental design with follow-up interview to develop a computer-based two-tier assessment (CBA) regarding the science topic of electric circuits and to evaluate the diagnostic power of the assessment. Three assessment formats (i.e., paper-and-pencil, static computer-based, and dynamic computer-based tests) using…

Applying a Qualitative Modeling Shell to Process Diagnosis: The Caster System. ONR Technical Report #16.

ERIC Educational Resources Information Center

Thompson, Timothy F.; Clancey, William J.

This report describes the application of a shell expert system from the medical diagnostic system, Neomycin, to Caster, a diagnostic system for malfunctions in industrial sandcasting. This system was developed to test the hypothesis that starting with a well-developed classification procedure and a relational language for stating the…

Do Students Know What They Know and What They Don't Know? Using a Four-Tier Diagnostic Test to Assess the Nature of Students' Alternative Conceptions

ERIC Educational Resources Information Center

Caleon, Imelda S.; Subramaniam, R.

2010-01-01

This study reports on the development and application of a four-tier multiple-choice (4TMC) diagnostic instrument, which has not been reported in the literature. It is an enhanced version of the two-tier multiple-choice (2TMC) test. As in 2TMC tests, its answer and reason tiers measure students' content knowledge and explanatory knowledge,…

Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.

PubMed

Tazawa, Yoshiaki

2016-01-01

On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.

Comparison of four diagnostic tests for the identification of serum antibodies in small ruminants infected with Mycoplasma agalactiae.

PubMed

Kittelberger, R; O'Keefe, J S; Meynell, R; Sewell, M; Rosati, S; Lambert, M; Dufour, P; Pépin, M

2006-02-01

To determine the diagnostic capability of a newly developed Western blot (WB) assay for the detection of serum antibodies against Mycoplasma agalactiae compared with conventional serological tests, and to identify the best test for routine diagnostic use. The serological test methods used were: two commercial indirect enzyme-linked immunosorbent assays (ELISA), viz ELISA-1, using a bacterial antigen preparation, and ELISA-2, using a recombinant protein (lipoprotein p48) antigen; the complement fixation test (CFT); and a newly developed WB assay, the latter both using a bacterial antigen preparation. Thirty sera from goats infected with M. agalactiae and 97 sera from non-infected sheep were tested using all four methods. Staining patterns in the WB were quite variable. An immuno-dominant band of 41 kDa was detected in 63% of sera from infected animals. The same band also appeared, although mostly very weakly, in 10% of sera from non-infected animals. When suspicious or very weak reactors were omitted, the diagnostic sensitivity (DSE) and diagnostic specificity (DSP), respectively, for the four assays were: WB=56.7%, 97.9%; ELISA-1=76.7%, 99.0%; ELISA-2=56.7%, 100%; and CFT=40.0%, 94.8%. ELISA-1 performed best in this comparison. While the WB can be used, it did not have a technical advantage over the ELISA. The CFT should be discouraged as the primary screening method for contagious agalactia and should be replaced by ELISA-1. Results from this study confirm that serological test methods for contagious agalactia are useful for the detection of infected flocks but will not detect every individual infected animal.

Potential point of care tests (POCTs) for maternal health in Peru, perspectives of pregnant women and their partners

PubMed Central

2014-01-01

Background Globally, no qualitative studies have explored the perspectives of women and their partners about the integration of technology – and specifically diagnostic testing technologies – into antenatal care. The study objective was to describe the demand side for pregnancy-related diagnostic tests from the perspective of Peruvian consumers, including female and male community members, by engaging participants about their awareness of and care-seeking for pregnancy-related diagnostic tests and their preferred characteristics and testing conditions for pregnancy-related point-of-care diagnostic tests (POCTs). Methods Sixty-seven mothers and fathers of children under one from the peri-urban coast and the peri-urban and rural highlands and jungle of Peru participated in ten focus groups. Results Participants think that pregnancy-related diagnostic tests are important and they and their fellow community members are committed to ensuring that pregnant women receive the tests they need. Participants expressed clear demands for pregnancy-related POCTs, including important characteristics for the tests themselves (certification, rapid, reliable results) and for test implementation (well-trained, personable good communicators as test administrators at well-equipped, convenient testing sites). Participants emphasized the importance of short waiting times and explained that many people have some ability to pay for POCTs, particularly if they are innovative, rapid or multiplex. Conclusions Engaging future POCT users as consumers who are able to make key decisions about the development and implementation of pregnancy-related POCTs is valuable and informative. PMID:24433514

University students' perspectives on diagnostic testing in mathematics

NASA Astrophysics Data System (ADS)

fhloinn, Eabhnat Ní; Macan Bhaird, Ciarán; Nolan, Brien

2014-01-01

Many universities issue mathematical diagnostic tests to incoming first-year students, covering a range of the basic concepts with which they should be comfortable from secondary school. As far as many lecturers are concerned, the purpose of this test is to determine the students' mathematical knowledge on entry. It should also provide an early indication of which students are likely to need additional help, and hopefully encourage such students to avail of extra support mechanisms at an early stage. However, it is not clear that students recognize these intentions and there is a fear that students who score poorly in the test will have their confidence further damaged in relation to mathematics and will be reluctant to seek help. To this end, a questionnaire was developed to explore students' perspectives on diagnostic testing. Analysis of responses received to the questionnaire provided an interesting insight into students' perspectives including the optimum time to conduct such a test, their views on the aims of diagnostic testing, whether they feel that testing is a good idea, and their attitudes to the support systems put in place to help those who scored poorly in the test.

An electronic thesaurus of Evidence Based Laboratory Medicine hematological and biochemical diagnostic tests.

PubMed

Dorizzi, R M; Maconi, M; Giavarina, D; Loza, G; Aman, M; Moreira, J; Bisoffi, Z; Gennuso, C

2009-10-01

The adoption of Evidence Based Laboratory Medicine (EBLM) has been hampered until today by the lack of effective tools. The SIMeL EBLM e-Thesaurus (on-line Repertoire of the diagnostic effectiveness of the laboratory, radiology and cardiology test) provides a useful support to clinical laboratory professionals and to clinicians for the interpretation of the diagnostic tests. The e-Thesaurus is an application developed using Microsoft Active Server Pages technology and carried out with Web Server Microsoft Internet Information Server and is available at the SIMeL website using a browser running JavaScript scripts (Internet Explorer is recommended). It contains a database (in Italian, English and Spanish) of the sensitivity and specificity (including the 95% confidence interval), the positive and negative likelihood ratios, the Diagnostic Odds Ratio and the Number Needed to Diagnose of more than 2000 diagnostic (most laboratory but also cardiology and radiology) tests. The e-Thesaurus improves the previous SIMeL paper and CD Thesaurus; its main features are a three languages search and a continuous and an easy updating capability.

An Investigation of the Teacher Competencies Needed to Utilize Diagnostic Test Data in Prescribing Occupational Learning Experiences in Teaching EMRS. Final Report. Part II. Appendices.

ERIC Educational Resources Information Center

Nelson, Orville; And Others

These appendixes are to the final report of an action research Project conducted to determine the teacher competencies needed in order to develop valid and effective occupational learning experiences for educable mentally retarded (EMR) students based on available diagnostic test data and information. Included are (1) participant vitas and…

Quantitative detection of PfHRP2 in saliva of malaria patients in the Philippines

PubMed Central

2012-01-01

Background Malaria is a global health priority with a heavy burden of fatality and morbidity. Improvements in field diagnostics are needed to support the agenda for malaria elimination. Saliva has shown significant potential for use in non-invasive diagnostics, but the development of off-the-shelf saliva diagnostic kits requires best practices for sample preparation and quantitative insight on the availability of biomarkers and the dynamics of immunoassay in saliva. This pilot study measured the levels of the PfHRP2 in patient saliva to inform the development of salivary diagnostic tests for malaria. Methods Matched samples of blood and saliva were collected between January and May, 2011 from eight patients at Palawan Baptist Hospital in Roxas, Palawan, Philippines. Parasite density was determined from thick-film blood smears. Concentrations of PfHRP2 in saliva of malaria-positive patients were measured using a custom chemiluminescent ELISA in microtitre plates. Sixteen negative-control patients were enrolled at UCLA. A substantive difference between this protocol and previous related studies was that saliva samples were stabilized with protease inhibitors. Results Of the eight patients with microscopically confirmed P. falciparum malaria, seven tested positive for PfHRP2 in the blood using rapid diagnostic test kits, and all tested positive for PfHRP2 in saliva. All negative-control samples tested negative for salivary PfHRP2. On a binary-decision basis, the ELISA agreed with microscopy with 100 % sensitivity and 100 % specificity. Salivary levels of PfHRP2 ranged from 17 to 1,167 pg/mL in the malaria-positive group. Conclusion Saliva is a promising diagnostic fluid for malaria when protein degradation and matrix effects are mitigated. Systematic quantitation of other malaria biomarkers in saliva would identify those with the best clinical relevance and suitability for off-the-shelf diagnostic kits. PMID:22631858

Bivariate random-effects meta-analysis models for diagnostic test accuracy studies using arcsine-based transformations.

PubMed

Negeri, Zelalem F; Shaikh, Mateen; Beyene, Joseph

2018-05-11

Diagnostic or screening tests are widely used in medical fields to classify patients according to their disease status. Several statistical models for meta-analysis of diagnostic test accuracy studies have been developed to synthesize test sensitivity and specificity of a diagnostic test of interest. Because of the correlation between test sensitivity and specificity, modeling the two measures using a bivariate model is recommended. In this paper, we extend the current standard bivariate linear mixed model (LMM) by proposing two variance-stabilizing transformations: the arcsine square root and the Freeman-Tukey double arcsine transformation. We compared the performance of the proposed methods with the standard method through simulations using several performance measures. The simulation results showed that our proposed methods performed better than the standard LMM in terms of bias, root mean square error, and coverage probability in most of the scenarios, even when data were generated assuming the standard LMM. We also illustrated the methods using two real data sets. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Tuberculosis Diagnostics in 2015: Landscape, Priorities, Needs, and Prospects

PubMed Central

Pai, Madhukar; Schito, Marco

2015-01-01

In 2015, tuberculosis remains a major global health problem, and drug-resistant tuberculosis is a growing threat. Although tuberculosis diagnosis in many countries is still reliant on older tools, new diagnostics are changing the landscape. Stimulated, in part, by the success and roll out of Xpert MTB/RIF, there is now considerable interest in new technologies. The landscape looks promising, with a robust pipeline of new tools, particularly molecular diagnostics, and well over 50 companies actively engaged in product development. However, new diagnostics are yet to reach scale, and there needs to be greater convergence between diagnostics development and development of shorter-duration tuberculosis drug regimens. Another concern is the relative absence of non–sputum-based diagnostics in the pipeline for children and of biomarker tests for triage, cure, and progression of latent Mycobacterium tuberculosis infection. Several initiatives, described in this supplement, have been launched to further stimulate product development and policy, including assessment of needs and priorities, development of target product profiles, compilation of data on resistance-associated mutations, and assessment of market size and potential for new diagnostics. Advocacy is needed to increase funding for tuberculosis research and development, and governments in high-burden countries must invest more in tuberculosis control to meet post-2015 targets for care, control, and prevention. PMID:25765103

Diagnostic Evasion of Highly-Resistant Microorganisms: A Critical Factor in Nosocomial Outbreaks.

PubMed

Zhou, Xuewei; Friedrich, Alexander W; Bathoorn, Erik

2017-01-01

Highly resistant microorganisms (HRMOs) may evade screening strategies used in routine diagnostics. Bacteria that have evolved to evade diagnostic tests may have a selective advantage in the nosocomial environment. Evasion of resistance detection can result from the following mechanisms: low-level expression of resistance genes not resulting in detectable resistance, slow growing variants, mimicry of wild-type-resistance, and resistance mechanisms that are only detected if induced by antibiotic pressure. We reviewed reports on hospital outbreaks in the Netherlands over the past 5 years. Remarkably, many outbreaks including major nation-wide outbreaks were caused by microorganisms able to evade resistance detection by diagnostic screening tests. We describe various examples of diagnostic evasion by several HRMOs and discuss this in a broad and international perspective. The epidemiology of hospital-associated bacteria may strongly be affected by diagnostic screening strategies. This may result in an increasing reservoir of resistance genes in hospital populations that is unnoticed. The resistance elements may horizontally transfer to hosts with systems for high-level expression, resulting in a clinically significant resistance problem. We advise to communicate the identification of HRMOs that evade diagnostics within national and regional networks. Such signaling networks may prevent inter-hospital outbreaks, and allow collaborative development of adapted diagnostic tests.

Development of a low cost test rig for standalone WECS subject to electrical faults.

PubMed

Himani; Dahiya, Ratna

2016-11-01

In this paper, a contribution to the development of low-cost wind turbine (WT) test rig for stator fault diagnosis of wind turbine generator is proposed. The test rig is developed using a 2.5kW, 1750 RPM DC motor coupled to a 1.5kW, 1500 RPM self-excited induction generator interfaced with a WT mathematical model in LabVIEW. The performance of the test rig is benchmarked with already proven wind turbine test rigs. In order to detect the stator faults using non-stationary signals in self-excited induction generator, an online fault diagnostic technique of DWT-based multi-resolution analysis is proposed. It has been experimentally proven that for varying wind conditions wavelet decomposition allows good differentiation between faulty and healthy conditions leading to an effective diagnostic procedure for wind turbine condition monitoring. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

Predicting the Effects of Test Media in Ground-Based Propulsion Testing

NASA Technical Reports Server (NTRS)

Drummond, J. Philip; Danehy, Paul M.; Bivolaru, Daniel; Gaffney, Richard L.; Parker, Peter A.; Chelliah, Harsha K.; Cutler, Andrew D.; Givi, Peyman; Hassan, Hassan, A.

2006-01-01

This paper discusses the progress of work which began in mid-2004 sponsored by the Office of the Secretary of Defense (OSD) Test & Evaluation/Science & Technology (T&E/S&T) Program. The purpose of the work is to improve the state of the art of CFD capabilities for predicting the effects of the test media on the flameholding characteristics in scramjet engines. The program has several components including the development of advance algorithms and models for simulating engine flowpaths as well as a fundamental experimental and diagnostic development effort to support the formulation and validation of the mathematical models. The paper will provide details of current work involving the development of phenomenological models for Reynolds averaged Navier-Stokes codes, large-eddy simulation techniques and reduced-kinetics models. Experiments that will provide data for the modeling efforts will also be described, along with with the associated nonintrusive diagnostics used to collect the data.

Economic evaluation of test-and-treat and empirical treatment strategies in the eradication of Helicobacter pylori infection; A Markov model in an Iranian adult population.

PubMed

Mazdaki, Alireza; Ghiasvand, Hesam; Sarabi Asiabar, Ali; Naghdi, Seyran; Aryankhesal, Aidin

2016-01-01

Helicobacter pylori may cause many gastrointestinal problems in developing countries such as Iran. We aimed to analyze the cost- effectiveness and cost- utility of the test-and-treat and empirical treatment strategies in managing Helicobacter pylori infection. This was a Markov based economic evaluation. Effectiveness was defined as the symptoms free numbers and QALYs in 100,000 hypothetical adults. The sensitivity analysis was based on Monte Carlo approach. In the test- and- treat strategy, if the serology is the first diagnostic test vs. histology, the cost per symptoms free number would be 291,736.1 Rials while the cost per QALYs would be 339,226.1 Rials. The cost per symptoms free number and cost per QALYs when the 13 C-UBT was used as the first diagnostic test vs. serology was 1,283,200 and 1,492,103 Rials, respectively. In the empirical strategy, if histology is used as the first diagnostic test vs. 13 CUBT, the cost per symptoms free numbers and cost per QALYs would be 793,234 and 955,698 Rials, respectively. If serology were used as the first diagnostic test vs. histology, the cost per symptoms free and QALYs would be 793,234 and 368941 Rials, respectively. There was no significant and considerable dominancy between the alternatives and the diagnostic tests.

Some imminent but overlooked preanalytical and analytical challenges currently facing biomarkers and companion diagnostics.

PubMed

Halim, Abdel-Baset

2015-06-01

An incredibly high failure rate in the pharmaceutical industry has positioned personalized medicine with its prerequisite drug-diagnostic codevelopment, commonly known as companion diagnostics (CDx), in the frontline as an potential rescuer. This hopefulness is potentiated by the recent major advances and competitiveness in molecular diagnostics, making laboratory tests widely accessible at affordable prices. If executed correctly, biomarkers and CDx can potentially help the drug industry by enhancing the probability of success and possibly accelerating time to market; help the diagnostics industry develop tests utilizing precious, clinically annotated human samples; and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most efficacious and least toxic therapies. However, this spectacular road is not yet paved, and it faces an enormous number of challenges. This paper will list these challenges and highlight some critical problems with representative examples of imminent but still overlooked preanalytical and analytical variables that can defeat the whole purpose of biomarkers and CDx and mislead drug developers and clinicians. The paper will provide some suggestions for mitigation. © 2015 New York Academy of Sciences.

Towards intelligent diagnostic system employing integration of mathematical and engineering model

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

Isa, Nor Ashidi Mat

The development of medical diagnostic system has been one of the main research fields during years. The goal of the medical diagnostic system is to place a nosological system that could ease the diagnostic evaluation normally performed by scientists and doctors. Efficient diagnostic evaluation is essentials and requires broad knowledge in order to improve conventional diagnostic system. Several approaches on developing the medical diagnostic system have been designed and tested since the earliest 60s. Attempts on improving their performance have been made which utilizes the fields of artificial intelligence, statistical analyses, mathematical model and engineering theories. With the availability ofmore » the microcomputer and software development as well as the promising aforementioned fields, medical diagnostic prototypes could be developed. In general, the medical diagnostic system consists of several stages, namely the 1) data acquisition, 2) feature extraction, 3) feature selection, and 4) classifications stages. Data acquisition stage plays an important role in converting the inputs measured from the real world physical conditions to the digital numeric values that can be manipulated by the computer system. One of the common medical inputs could be medical microscopic images, radiographic images, magnetic resonance image (MRI) as well as medical signals such as electrocardiogram (ECG) and electroencephalogram (EEG). Normally, the scientist or doctors have to deal with myriad of data and redundant to be processed. In order to reduce the complexity of the diagnosis process, only the significant features of the raw data such as peak value of the ECG signal or size of lesion in the mammogram images will be extracted and considered in the subsequent stages. Mathematical models and statistical analyses will be performed to select the most significant features to be classified. The statistical analyses such as principal component analysis and discriminant analysis as well as mathematical model of clustering technique have been widely used in developing the medical diagnostic systems. The selected features will be classified using mathematical models that embedded engineering theory such as artificial intelligence, support vector machine, neural network and fuzzy-neuro system. These classifiers will provide the diagnostic results without human intervention. Among many publishable researches, several prototypes have been developed namely NeuralPap, Neural Mammo, and Cervix Kit. The former system (NeuralPap) is an automatic intelligent diagnostic system for classifying and distinguishing between the normal and cervical cancerous cells. Meanwhile, the Cervix Kit is a portable Field-programmable gate array (FPGA)-based cervical diagnostic kit that could automatically diagnose the cancerous cell based on the images obtained during sampling test. Besides the cervical diagnostic system, the Neural Mammo system is developed to specifically aid the diagnosis of breast cancer using a fine needle aspiration image.« less

Towards intelligent diagnostic system employing integration of mathematical and engineering model

NASA Astrophysics Data System (ADS)

Isa, Nor Ashidi Mat

2015-05-01

The development of medical diagnostic system has been one of the main research fields during years. The goal of the medical diagnostic system is to place a nosological system that could ease the diagnostic evaluation normally performed by scientists and doctors. Efficient diagnostic evaluation is essentials and requires broad knowledge in order to improve conventional diagnostic system. Several approaches on developing the medical diagnostic system have been designed and tested since the earliest 60s. Attempts on improving their performance have been made which utilizes the fields of artificial intelligence, statistical analyses, mathematical model and engineering theories. With the availability of the microcomputer and software development as well as the promising aforementioned fields, medical diagnostic prototypes could be developed. In general, the medical diagnostic system consists of several stages, namely the 1) data acquisition, 2) feature extraction, 3) feature selection, and 4) classifications stages. Data acquisition stage plays an important role in converting the inputs measured from the real world physical conditions to the digital numeric values that can be manipulated by the computer system. One of the common medical inputs could be medical microscopic images, radiographic images, magnetic resonance image (MRI) as well as medical signals such as electrocardiogram (ECG) and electroencephalogram (EEG). Normally, the scientist or doctors have to deal with myriad of data and redundant to be processed. In order to reduce the complexity of the diagnosis process, only the significant features of the raw data such as peak value of the ECG signal or size of lesion in the mammogram images will be extracted and considered in the subsequent stages. Mathematical models and statistical analyses will be performed to select the most significant features to be classified. The statistical analyses such as principal component analysis and discriminant analysis as well as mathematical model of clustering technique have been widely used in developing the medical diagnostic systems. The selected features will be classified using mathematical models that embedded engineering theory such as artificial intelligence, support vector machine, neural network and fuzzy-neuro system. These classifiers will provide the diagnostic results without human intervention. Among many publishable researches, several prototypes have been developed namely NeuralPap, Neural Mammo, and Cervix Kit. The former system (NeuralPap) is an automatic intelligent diagnostic system for classifying and distinguishing between the normal and cervical cancerous cells. Meanwhile, the Cervix Kit is a portable Field-programmable gate array (FPGA)-based cervical diagnostic kit that could automatically diagnose the cancerous cell based on the images obtained during sampling test. Besides the cervical diagnostic system, the Neural Mammo system is developed to specifically aid the diagnosis of breast cancer using a fine needle aspiration image.

Enhancing the Usability of an Optical Reader System to Support Point-of-Care Rapid Diagnostic Testing: An Iterative Design Approach.

PubMed

Hohenstein, Jess; O'Dell, Dakota; Murnane, Elizabeth L; Lu, Zhengda; Erickson, David; Gay, Geri

2017-11-21

In today's health care environment, increasing costs and inadequate medical resources have created a worldwide need for more affordable diagnostic tools that are also portable, fast, and easy to use. To address this issue, numerous research and commercial efforts have focused on developing rapid diagnostic technologies; however, the efficacy of existing systems has been hindered by usability problems or high production costs, making them infeasible for deployment in at-home, point-of-care (POC), or resource-limited settings. The aim of this study was to create a low-cost optical reader system that integrates with any smart device and accepts any type of rapid diagnostic test strip to provide fast and accurate data collection, sample analysis, and diagnostic result reporting. An iterative design methodology was employed by a multidisciplinary research team to engineer three versions of a portable diagnostic testing device that were evaluated for usability and overall user receptivity. Repeated design critiques and usability studies identified a number of system requirements and considerations (eg, software compatibility, biomatter contamination, and physical footprint) that we worked to incrementally incorporate into successive system variants. Our final design phase culminated in the development of Tidbit, a reader that is compatible with any Wi-Fi-enabled device and test strip format. The Tidbit includes various features that support intuitive operation, including a straightforward test strip insertion point, external indicator lights, concealed electronic components, and an asymmetric shape, which inherently signals correct device orientation. Usability testing of the Tidbit indicates high usability for potential user communities. This study presents the design process, specification, and user reception of the Tidbit, an inexpensive, easy-to-use, portable optical reader for fast, accurate quantification of rapid diagnostic test results. Usability testing suggests that the reader is usable among and can benefit a wide group of potential users, including in POC contexts. Generally, the methodology of this study demonstrates the importance of testing these types of systems with potential users and exemplifies how iterative design processes can be employed by multidisciplinary research teams to produce compelling technological solutions. ©Jess Hohenstein, Dakota O'Dell, Elizabeth L Murnane, Zhengda Lu, David Erickson, Geri Gay. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 21.11.2017.

External Quality Assessment beyond the analytical phase: an Australian perspective.

PubMed

Badrick, Tony; Gay, Stephanie; McCaughey, Euan J; Georgiou, Andrew

2017-02-15

External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion.

External Quality Assessment beyond the analytical phase: an Australian perspective

PubMed Central

Gay, Stephanie; McCaughey, Euan J.; Georgiou, Andrew

2017-01-01

External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion. PMID:28392728

Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL.

PubMed

Deans, Zandra C; Costa, Jose Luis; Cree, Ian; Dequeker, Els; Edsjö, Anders; Henderson, Shirley; Hummel, Michael; Ligtenberg, Marjolijn Jl; Loddo, Marco; Machado, Jose Carlos; Marchetti, Antonio; Marquis, Katherine; Mason, Joanne; Normanno, Nicola; Rouleau, Etienne; Schuuring, Ed; Snelson, Keeda-Marie; Thunnissen, Erik; Tops, Bastiaan; Williams, Gareth; van Krieken, Han; Hall, Jacqueline A

2017-01-01

The clinical demand for mutation detection within multiple genes from a single tumour sample requires molecular diagnostic laboratories to develop rapid, high-throughput, highly sensitive, accurate and parallel testing within tight budget constraints. To meet this demand, many laboratories employ next-generation sequencing (NGS) based on small amplicons. Building on existing publications and general guidance for the clinical use of NGS and learnings from germline testing, the following guidelines establish consensus standards for somatic diagnostic testing, specifically for identifying and reporting mutations in solid tumours. These guidelines cover the testing strategy, implementation of testing within clinical service, sample requirements, data analysis and reporting of results. In conjunction with appropriate staff training and international standards for laboratory testing, these consensus standards for the use of NGS in molecular pathology of solid tumours will assist laboratories in implementing NGS in clinical services.

Statistical analysis of Turbine Engine Diagnostic (TED) field test data

NASA Astrophysics Data System (ADS)

Taylor, Malcolm S.; Monyak, John T.

1994-11-01

During the summer of 1993, a field test of turbine engine diagnostic (TED) software, developed jointly by U.S. Army Research Laboratory and the U.S. Army Ordnance Center and School, was conducted at Fort Stuart, GA. The data were collected in conformance with a cross-over design, some of whose considerations are detailed. The initial analysis of the field test data was exploratory, followed by a more formal investigation. Technical aspects of the data analysis insights that were elicited are reported.

Development of a Three-Tier Test to Assess Misconceptions about Simple Electric Circuits

ERIC Educational Resources Information Center

Pesman, Haki; Eryilmaz, Ali

2010-01-01

The authors aimed to propose a valid and reliable diagnostic instrument by developing a three-tier test on simple electric circuits. Based on findings from the interviews, open-ended questions, and the related literature, the test was developed and administered to 124 high school students. In addition to some qualitative techniques for…

78 FR 28866 - Cooperative Research and Development Agreement (CRADA) Opportunity With the Department of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

...-Mouth Disease 3ABC ELISA Diagnostic Kit AGENCY: Science and Technology Directorate, Plum Island Animal... Center (PIADC), is seeking industry collaborators to aid DHS S&T in developing an ELISA diagnostic test... and Mouth Disease virus (FMDV) non-structural proteins (NSP): 3A, 3B, or 3C. This new FMDV 3ABC ELISA...

Biologics industry challenges for developing diagnostic tests for the National Veterinary Stockpile.

PubMed

Hardham, J M; Lamichhane, C M

2013-01-01

Veterinary diagnostic products generated ~$3 billion US dollars in global sales in 2010. This industry is poised to undergo tremendous changes in the next decade as technological advances move diagnostic products from the traditional laboratory-based and handheld immunologic assays towards highly technical, point of care devices with increased sensitivity, specificity, and complexity. Despite these opportunities for advancing diagnostic products, the industry continues to face numerous challenges in developing diagnostic products for emerging and foreign animal diseases. Because of the need to deliver a return on the investment, research and development dollars continue to be focused on infectious diseases that have a negative impact on current domestic herd health, production systems, or companion animal health. Overcoming the administrative, legal, fiscal, and technological barriers to provide veterinary diagnostic products for the National Veterinary Stockpile will reduce the threat of natural or intentional spread of foreign diseases and increase the security of the food supply in the US.

Changes in laboratory test results and diagnostic imaging presentation before the detection of occupational cholangiocarcinoma.

PubMed

Kubo, Shoji; Takemura, Shigekazu; Sakata, Chikaharu; Urata, Yorihisa; Nishioka, Takayoshi; Nozawa, Akinori; Kinoshita, Masahiko; Hamano, Genya; Nakanuma, Yasuni; Endo, Ginji

2014-01-01

A cholangiocarcinoma outbreak among workers of an offset color proof-printing department in a printing company was recently reported. It is important to understand the clinical course leading to occupational cholangiocarcinoma development for investigation of the carcinogenesis process and for surveillance and early detection. We evaluated the changes in laboratory test results and diagnostic imaging presentation before the detection of cholangiocarcinoma. We investigated the changes in laboratory test results and diagnostic imaging presentation before the detection of cholangiocarcinoma in 2 patients because the data were available. Results The clinical courses observed in the 2 participating patients showed persistent elevation of serum γ-glutamyl transpeptidase levels with or without elevated serum levels of alanine aminotransferase and/or aspartate aminotransferase before cholangiocarcinoma detection. Dilatation of the bile ducts without tumor-induced stenosis was observed several years before cholangiocarcinoma detection and progressed gradually in both patients. The serum concentration of carbohydrate 19-9 also increased prior to cholangiocarcinoma detection in both patients. Eventually, observation of stenosis of the bile duct and a space-occupying lesion strongly suggested cholangiocarcinoma. Pathological examination of the resected specimens showed chronic bile duct injury and neoplastic lesions, such as "biliary intraepithelial neoplasia" and "intraductal papillary neoplasm of the bile duct" in various sites of the bile ducts, particularly in the dilated bile ducts. The changes in laboratory test results and diagnostic imaging might be related to the development of cholangiocarcinoma. It is important to monitor diagnostic imaging presentation and laboratory test results in workers with extended exposure to organic solvents.

Gaseous electron multiplier-based soft x-ray plasma diagnostics development: Preliminary tests at ASDEX Upgrade.

PubMed

Chernyshova, M; Malinowski, K; Czarski, T; Wojeński, A; Vezinet, D; Poźniak, K T; Kasprowicz, G; Mazon, D; Jardin, A; Herrmann, A; Kowalska-Strzęciwilk, E; Krawczyk, R; Kolasiński, P; Zabołotny, W; Zienkiewicz, P

2016-11-01

A Gaseous Electron Multiplier (GEM)-based detector is being developed for soft X-ray diagnostics on tokamaks. Its main goal is to facilitate transport studies of impurities like tungsten. Such studies are very relevant to ITER, where the excessive accumulation of impurities in the plasma core should be avoided. This contribution provides details of the preliminary tests at ASDEX Upgrade (AUG) with a focus on the most important aspects for detector operation in harsh radiation environment. It was shown that both spatially and spectrally resolved data could be collected, in a reasonable agreement with other AUG diagnostics. Contributions to the GEM signal include also hard X-rays, gammas, and neutrons. First simulations of the effect of high-energy photons have helped understanding these contributions.

Gaseous electron multiplier-based soft x-ray plasma diagnostics development: Preliminary tests at ASDEX Upgrade

NASA Astrophysics Data System (ADS)

Chernyshova, M.; Malinowski, K.; Czarski, T.; Wojeński, A.; Vezinet, D.; Poźniak, K. T.; Kasprowicz, G.; Mazon, D.; Jardin, A.; Herrmann, A.; Kowalska-Strzeciwilk, E.; Krawczyk, R.; Kolasiński, P.; Zabołotny, W.; Zienkiewicz, P.

2016-11-01

A Gaseous Electron Multiplier (GEM)-based detector is being developed for soft X-ray diagnostics on tokamaks. Its main goal is to facilitate transport studies of impurities like tungsten. Such studies are very relevant to ITER, where the excessive accumulation of impurities in the plasma core should be avoided. This contribution provides details of the preliminary tests at ASDEX Upgrade (AUG) with a focus on the most important aspects for detector operation in harsh radiation environment. It was shown that both spatially and spectrally resolved data could be collected, in a reasonable agreement with other AUG diagnostics. Contributions to the GEM signal include also hard X-rays, gammas, and neutrons. First simulations of the effect of high-energy photons have helped understanding these contributions.

Benchmarking Diagnostic Algorithms on an Electrical Power System Testbed

NASA Technical Reports Server (NTRS)

Kurtoglu, Tolga; Narasimhan, Sriram; Poll, Scott; Garcia, David; Wright, Stephanie

2009-01-01

Diagnostic algorithms (DAs) are key to enabling automated health management. These algorithms are designed to detect and isolate anomalies of either a component or the whole system based on observations received from sensors. In recent years a wide range of algorithms, both model-based and data-driven, have been developed to increase autonomy and improve system reliability and affordability. However, the lack of support to perform systematic benchmarking of these algorithms continues to create barriers for effective development and deployment of diagnostic technologies. In this paper, we present our efforts to benchmark a set of DAs on a common platform using a framework that was developed to evaluate and compare various performance metrics for diagnostic technologies. The diagnosed system is an electrical power system, namely the Advanced Diagnostics and Prognostics Testbed (ADAPT) developed and located at the NASA Ames Research Center. The paper presents the fundamentals of the benchmarking framework, the ADAPT system, description of faults and data sets, the metrics used for evaluation, and an in-depth analysis of benchmarking results obtained from testing ten diagnostic algorithms on the ADAPT electrical power system testbed.

The development and validation of a three-tier diagnostic test measuring pre-service elementary education and secondary science teachers' understanding of the water cycle

NASA Astrophysics Data System (ADS)

Schaffer, Dannah Lynn

The main goal of this research study was to develop and validate a three-tier diagnostic test to determine pre-service teachers' (PSTs) conceptual knowledge of the water cycle. For a three-tier diagnostic test, the first tier assesses content knowledge; in the second tier, a reason is selected for the content answer; and the third tier allows test-takers to select how confident they are in their answers for the first two tiers. The second goal of this study was to diagnose any alternative conceptions PSTs might have about the water cycle. The Water Cycle Diagnostic Test (WCDT) was developed using the theoretical framework by Treagust (1986, 1988, and 1995), and in similar studies that developed diagnostic tests (e.g., Calean & Subramaniam, 2010a; Odom & Barrow, 2007; Pesman & Eryilmaz, 2010). The final instrument consisted of 15 items along with a demographic survey that examined PSTs' weather-related experiences that may or may not have affected the PSTs' understanding of the water cycle. The WCDT was administered to 77 PSTs enrolled in science methods courses during the fall of 2012. Among the 77 participants, 37 of the PSTs were enrolled in elementary education (EPST) and 40 in secondary science (SPST). Using exploratory factor analysis, five categories were factored out for the WCDT: Phase Change of Water; Condensation and Storage; Clouds; Global Climate Change; and Movement through the Water Cycle. Analysis of the PSTs' responses demonstrated acceptable reliability (alpha = 0.62) for the instrument, and acceptable difficulty indices and discrimination indices for 12 of the items. Analysis indicated that the majority of the PSTs had a limited understanding of the water cycle. Of the PSTs sampled, SPSTs were significantly more confident in their answers' on the WCDT than the EPSTs. Completion of an undergraduate atmospheric science and/or meteorology course, as well as a higher interest in listening and/or viewing weather-related programs, resulted in PSTs having greater understanding and confidence in their answers on the WCDT. The analysis of the PSTs' responses revealed 49 potential alternative conceptions and areas where PSTs' lack of knowledge was revealed from the WCDT.

Application of whole genome re-sequencing data in the development of diagnostic DNA markers tightly linked to a disease-resistance locus for marker-assisted selection in lupin (Lupinus angustifolius).

PubMed

Yang, Huaan; Jian, Jianbo; Li, Xuan; Renshaw, Daniel; Clements, Jonathan; Sweetingham, Mark W; Tan, Cong; Li, Chengdao

2015-09-02

Molecular marker-assisted breeding provides an efficient tool to develop improved crop varieties. A major challenge for the broad application of markers in marker-assisted selection is that the marker phenotypes must match plant phenotypes in a wide range of breeding germplasm. In this study, we used the legume crop species Lupinus angustifolius (lupin) to demonstrate the utility of whole genome sequencing and re-sequencing on the development of diagnostic markers for molecular plant breeding. Nine lupin cultivars released in Australia from 1973 to 2007 were subjected to whole genome re-sequencing. The re-sequencing data together with the reference genome sequence data were used in marker development, which revealed 180,596 to 795,735 SNP markers from pairwise comparisons among the cultivars. A total of 207,887 markers were anchored on the lupin genetic linkage map. Marker mining obtained an average of 387 SNP markers and 87 InDel markers for each of the 24 genome sequence assembly scaffolds bearing markers linked to 11 genes of agronomic interest. Using the R gene PhtjR conferring resistance to phomopsis stem blight disease as a test case, we discovered 17 candidate diagnostic markers by genotyping and selecting markers on a genetic linkage map. A further 243 candidate diagnostic markers were discovered by marker mining on a scaffold bearing non-diagnostic markers linked to the PhtjR gene. Nine out from the ten tested candidate diagnostic markers were confirmed as truly diagnostic on a broad range of commercial cultivars. Markers developed using these strategies meet the requirements for broad application in molecular plant breeding. We demonstrated that low-cost genome sequencing and re-sequencing data were sufficient and very effective in the development of diagnostic markers for marker-assisted selection. The strategies used in this study may be applied to any trait or plant species. Whole genome sequencing and re-sequencing provides a powerful tool to overcome current limitations in molecular plant breeding, which will enable plant breeders to precisely pyramid favourable genes to develop super crop varieties to meet future food demands.

Evidence-Based Point-of-Care Diagnostics: Current Status and Emerging Technologies

NASA Astrophysics Data System (ADS)

Chan, Cangel Pui Yee; Mak, Wing Cheung; Cheung, Kwan Yee; Sin, King Keung; Yu, Cheuk Man; Rainer, Timothy H.; Renneberg, Reinhard

2013-06-01

Point-of-care (POC) diagnostics brings tests nearer to the site of patient care. The turnaround time is short, and minimal manual interference enables quick clinical management decisions. Growth in POC diagnostics is being continuously fueled by the global burden of cardiovascular and infectious diseases. Early diagnosis and rapid initiation of treatment are crucial in the management of such patients. This review provides the rationale for the use of POC tests in acute coronary syndrome, heart failure, human immunodeficiency virus, and tuberculosis. We also consider emerging technologies that are based on advanced nanomaterials and microfluidics, improved assay sensitivity, miniaturization in device design, reduced costs, and high-throughput multiplex detection, all of which may shape the future development of POC diagnostics.

Tapered Roller Bearing Damage Detection Using Decision Fusion Analysis

NASA Technical Reports Server (NTRS)

Dempsey, Paula J.; Kreider, Gary; Fichter, Thomas

2006-01-01

A diagnostic tool was developed for detecting fatigue damage of tapered roller bearings. Tapered roller bearings are used in helicopter transmissions and have potential for use in high bypass advanced gas turbine aircraft engines. A diagnostic tool was developed and evaluated experimentally by collecting oil debris data from failure progression tests conducted using health monitoring hardware. Failure progression tests were performed with tapered roller bearings under simulated engine load conditions. Tests were performed on one healthy bearing and three pre-damaged bearings. During each test, data from an on-line, in-line, inductance type oil debris sensor and three accelerometers were monitored and recorded for the occurrence of bearing failure. The bearing was removed and inspected periodically for damage progression throughout testing. Using data fusion techniques, two different monitoring technologies, oil debris analysis and vibration, were integrated into a health monitoring system for detecting bearing surface fatigue pitting damage. The data fusion diagnostic tool was evaluated during bearing failure progression tests under simulated engine load conditions. This integrated system showed improved detection of fatigue damage and health assessment of the tapered roller bearings as compared to using individual health monitoring technologies.

Is there a role for antibody testing in the diagnosis of invasive candidiasis?

PubMed

Quindós, Guillermo; Moragues, María Dolores; Pontón, José

2004-03-01

During the last decades, the use of antibody tests for the diagnosis of invasive mycoses has declined as a consequence of the general belief that they are insensitive and non-specific. However, there is a clear evidence that antibodies can be detected in highly immunodeficient patients (such as bone marrow transplant recipients), and that those antibodies are useful for the diagnosis. Antibody tests are currently in use as diagnostic tools for some primary mycoses, such as the endemic mycoses, aspergilloma, allergic bronchopulmonary aspergilosis and sporothrichosis. For invasive candidiasis, diagnostic methods must differentiate Candida colonization of mucous membranes or superficial infection from tissue invasion by this microorganism. Substantial progress has been made in diagnosis of invasive candidiasis with the development of a variety of methods for the detection of antibodies and antigens. However, no single test has found widespread clinical use and there is a consensus that diagnosis based on a single specimen lacks sensitivity. It is necessary to test sequential samples taken while the patient is at greatest risk for developing invasive candidiasis to optimize the diagnosis. Results obtained from a panel of diagnostic tests in association with clinical aspects will likely be the most useful strategy for early diagnosis and therapy.

Advances in diagnosis and treatment of latent tuberculosis infection.

PubMed

Chapman, Helena J; Lauzardo, Michael

2014-01-01

In the United States, latent tuberculosis infection (LTBI) affects between 10 and 15 million people, of whom 10% may develop active tuberculosis disease. People at increased risk for tuberculosis reactivation include recent immigrants from countries with a high incidence of tuberculosis, children younger than age 5, people who have been infected with Mycobacterium tuberculosis within the past 2 years, or people with immunosuppression for a variety of reasons. Appropriate diagnosis and treatment of LTBI are critical for controlling and eventually eliminating tuberculosis as a public health problem. Although the tuberculin skin test is the traditional diagnostic measure for LTBI, reduced specificity has promoted the development and utilization of the interferon-γ release assays as an in vitro blood test with specific antigens to M. tuberculosis (QuantiFERON-TB Gold In-Tube test and the T.SPOT-TB test are commercially available). Despite the rise of the new diagnostic tests, however, there is still no gold standard for diagnosing LTBI, and epidemiologic risks and comorbidities need to be taken into account before initiating therapy. Current diagnostic tests combined with recommended treatment regimens are valuable tools that, when used correctly, promise to hurry the elimination of tuberculosis. © Copyright 2014 by the American Board of Family Medicine.

Towards Modernizing the Characterization of Shock and Detonation Physics Performance via Novel Diagnostics and Tests

NASA Astrophysics Data System (ADS)

Salyer, Terry

2017-06-01

For the bulk of detonation performance experiments, a fairly basic set of diagnostic techniques has evolved as the standard for acquiring the necessary measurements. Gold standard techniques such as pin switches and streak cameras still produce the high-quality data required, yet much room remains for improvement with regard to ease of use, cost of fielding, breadth of data, and diagnostic versatility. Over the past several years, an alternate set of diagnostics has been under development to replace many of these traditional techniques. Pulse Correlation Reflectometry (PCR) is a capable substitute for pin switches with the advantage of obtaining orders of magnitude more data at a small fraction of the cost and fielding time. Spectrally Encoded Imaging (SEI) can replace most applications of streak camera with the advantage of imaging surfaces through a single optical fiber that are otherwise optically inaccessible. Such diagnostics advance the measurement state of the art, but even further improvements may come through revamping the standardized tests themselves such as the copper cylinder expansion test. At the core of this modernization, the aforementioned diagnostics play a significant role in revamping and improving the standard test suite for the present era. This research was performed under the auspices of the United States Department of Energy.

Antimicrobial susceptibility testing by Australian veterinary diagnostic laboratories.

PubMed

Hardefeldt, L Y; Marenda, M; Crabb, H; Stevenson, M A; Gilkerson, J R; Billman-Jacobe, H; Browning, G F

2018-04-01

The national strategy for tackling antimicrobial resistance highlights the need for antimicrobial stewardship in veterinary practice and for surveillance of antimicrobial susceptibility in veterinary pathogens. Diagnostic laboratories have an important role in facilitating both of these processes, but it is unclear whether data from veterinary diagnostic laboratories are similar enough to allow for compilation and if there is consistent promotion of appropriate antimicrobial use embedded in the approaches of different laboratories to susceptibility testing. A cross-sectional study of antimicrobial susceptibility testing and reporting procedures by Australian veterinary diagnostic laboratories was conducted in 2017 using an online questionnaire. All 18 veterinary diagnostic laboratories in Australia completed the questionnaire. Kirby-Bauer disc diffusion was the method predominantly used for antimicrobial susceptibility testing and was used to evaluate 86% of all isolates, although two different protocols were used across the 18 laboratories (CLSI 15/18, CDS 3/18). Minimum inhibitory concentrations were never reported by 61% of laboratories. Common isolates were consistently reported on across all species, except for gram-negative isolates in pigs, for which there was some variation in the approach to reporting. There was considerable diversity in the panels of antimicrobials used for susceptibility testing on common isolates and no consistency was apparent between laboratories for any bacterial species. We recommend that nationally agreed and consistent antimicrobial panels for routine susceptibility testing should be developed and a uniform set of guidelines should be adopted by veterinary diagnostic laboratories in Australia. © 2018 Australian Veterinary Association.

Diagnosis of Helicobacter pylori infection: Current options and developments

PubMed Central

Wang, Yao-Kuang; Kuo, Fu-Chen; Liu, Chung-Jung; Wu, Meng-Chieh; Shih, Hsiang-Yao; Wang, Sophie SW; Wu, Jeng-Yih; Kuo, Chao-Hung; Huang, Yao-Kang; Wu, Deng-Chyang

2015-01-01

Accurate diagnosis of Helicobacter pylori (H. pylori) infection is a crucial part in the effective management of many gastroduodenal diseases. Several invasive and non-invasive diagnostic tests are available for the detection of H. pylori and each test has its usefulness and limitations in different clinical situations. Although none can be considered as a single gold standard in clinical practice, several techniques have been developed to give the more reliable results. Invasive tests are performed via endoscopic biopsy specimens and these tests include histology, culture, rapid urease test as well as molecular methods. Developments of endoscopic equipment also contribute to the real-time diagnosis of H. pylori during endoscopy. Urea breathing test and stool antigen test are most widely used non-invasive tests, whereas serology is useful in screening and epidemiological studies. Molecular methods have been used in variable specimens other than gastric mucosa. More than detection of H. pylori infection, several tests are introduced into the evaluation of virulence factors and antibiotic sensitivity of H. pylori, as well as screening precancerous lesions and gastric cancer. The aim of this article is to review the current options and novel developments of diagnostic tests and their applications in different clinical conditions or for specific purposes. PMID:26523098

Leveling the Playing Field: Bringing Development of Biomarkers and Molecular Diagnostics up to the Standards for Drug Development

PubMed Central

Poste, George; Carbone, David P.; Parkinson, David R.; Verweij, Jaap; Hewitt, Stephen; Jessup, J. Milburn

2012-01-01

Molecular diagnostics are increasingly important in clinical research to stratify or identify molecularly profiled patient cohorts for targeted therapies, to modify the dose of a therapeutic, or to assess early response to therapy or monitor patients. Molecular diagnostics can also be used to identify pharmocogenetic risk of adverse drug reactions. The articles of this CCR Focus section on Molecular Diagnosis describe the development and use of markers for medical decision-making in the cancer patient. They define the sources of preanalytic variability to minimize as well as the regulatory and financial challenges in diagnostic development and integration into clinical practice. They also outline an NCI program to assist diagnostic development. Molecular diagnostic clinical tests require rigor in their development and clinical validation with sufficient sensitivity, specificity and validity that is comparable to that used for development of therapeutics. These diagnostics must be offered at a realistic cost that reflects both their clinical value and the costs associated with their development. When genome sequencing technologies move into the clinic, they must be integrated with and traceable to current technology because they may identify more efficient and accurate approaches to drug development. In addition, regulators may define progressive drug approval for companion diagnostics that requires further evidence regarding efficacy and safety before full approval. A way to accomplish this is to emphasize Phase IV post-marketing hypothesis driven clinical trials with biological characterization that permits accurate definition of the association of low prevalence gene alterations with toxicity or response in large cohorts. PMID:22422403

Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development.

PubMed

Poste, George; Carbone, David P; Parkinson, David R; Verweij, Jaap; Hewitt, Stephen M; Jessup, J Milburn

2012-03-15

Molecular diagnostics are becoming increasingly important in clinical research to stratify or identify molecularly profiled patient cohorts for targeted therapies, to modify the dose of a therapeutic, and to assess early response to therapy or monitor patients. Molecular diagnostics can also be used to identify the pharmacogenetic risk of adverse drug reactions. The articles in this CCR Focus section on molecular diagnosis describe the development and use of markers to guide medical decisions regarding cancer patients. They define sources of preanalytic variability that need to be minimized, as well as the regulatory and financial challenges involved in developing diagnostics and integrating them into clinical practice. They also outline a National Cancer Institute program to assist diagnostic development. Molecular diagnostic clinical tests require rigor in their development and clinical validation, with sensitivity, specificity, and validity comparable to those required for the development of therapeutics. These diagnostics must be offered at a realistic cost that reflects both their clinical value and the costs associated with their development. When genome-sequencing technologies move into the clinic, they must be integrated with and traceable to current technology because they may identify more efficient and accurate approaches to drug development. In addition, regulators may define progressive drug approval for companion diagnostics that requires further evidence regarding efficacy and safety before full approval can be achieved. One way to accomplish this is to emphasize phase IV postmarketing, hypothesis-driven clinical trials with biological characterization that would permit an accurate definition of the association of low-prevalence gene alterations with toxicity or response in large cohorts.

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...

Tissue microarrays and quantitative tissue-based image analysis as a tool for oncology biomarker and diagnostic development.

PubMed

Dolled-Filhart, Marisa P; Gustavson, Mark D

2012-11-01

Translational oncology has been improved by using tissue microarrays (TMAs), which facilitate biomarker analysis of large cohorts on a single slide. This has allowed for rapid analysis and validation of potential biomarkers for prognostic and predictive value, as well as for evaluation of biomarker prevalence. Coupled with quantitative analysis of immunohistochemical (IHC) staining, objective and standardized biomarker data from tumor samples can further advance companion diagnostic approaches for the identification of drug-responsive or resistant patient subpopulations. This review covers the advantages, disadvantages and applications of TMAs for biomarker research. Research literature and reviews of TMAs and quantitative image analysis methodology have been surveyed for this review (with an AQUA® analysis focus). Applications such as multi-marker diagnostic development and pathway-based biomarker subpopulation analyses are described. Tissue microarrays are a useful tool for biomarker analyses including prevalence surveys, disease progression assessment and addressing potential prognostic or predictive value. By combining quantitative image analysis with TMAs, analyses will be more objective and reproducible, allowing for more robust IHC-based diagnostic test development. Quantitative multi-biomarker IHC diagnostic tests that can predict drug response will allow for greater success of clinical trials for targeted therapies and provide more personalized clinical decision making.

DEVELOPMENT OF DIAGNOSTIC ANALYTICAL AND MECHANICAL ABILITY TESTS THROUGH FACET DESIGN AND ANALYSIS.

ERIC Educational Resources Information Center

GUTTMAN, LOUIS,; SCHLESINGER, I.M.

METHODOLOGY BASED ON FACET THEORY (MODIFIED SET THEORY) WAS USED IN TEST CONSTRUCTION AND ANALYSIS TO PROVIDE AN EFFICIENT TOOL OF EVALUATION FOR VOCATIONAL GUIDANCE AND VOCATIONAL SCHOOL USE. THE TYPE OF TEST DEVELOPMENT UNDERTAKEN WAS LIMITED TO THE USE OF NONVERBAL PICTORIAL ITEMS. ITEMS FOR TESTING ABILITY TO IDENTIFY ELEMENTS BELONGING TO AN…

Renal angina: concept and development of pretest probability assessment in acute kidney injury.

PubMed

Chawla, Lakhmir S; Goldstein, Stuart L; Kellum, John A; Ronco, Claudio

2015-02-27

The context of a diagnostic test is a critical component for the interpretation of its result. This context defines the pretest probability of the diagnosis and forms the basis for the interpretation and value of adding the diagnostic test. In the field of acute kidney injury, a multitude of early diagnostic biomarkers have been developed, but utilization in the appropriate context is less well understood and has not been codified until recently. In order to better operationalize the context and pretest probability assessment for acute kidney injury diagnosis, the renal angina concept was proposed in 2010 for use in both children and adults. Renal angina has been assessed in approximately 1,000 subjects. However, renal angina as a concept is still unfamiliar to most clinicians and the rationale for introducing the term is not obvious. We therefore review the concept and development of renal angina, and the currently available data validating it. We discuss the various arguments for and against this construct. Future research testing the performance of renal angina with acute kidney injury biomarkers is warranted.

Current Guidelines, Common Clinical Pitfalls, and Future Directions for Laboratory Diagnosis of Lyme Disease, United States.

PubMed

Moore, Andrew; Nelson, Christina; Molins, Claudia; Mead, Paul; Schriefer, Martin

2016-07-01

In the United States, Lyme disease is caused by Borrelia burgdorferi and transmitted to humans by blacklegged ticks. Patients with an erythema migrans lesion and epidemiologic risk can receive a diagnosis without laboratory testing. For all other patients, laboratory testing is necessary to confirm the diagnosis, but proper interpretation depends on symptoms and timing of illness. The recommended laboratory test in the United States is 2-tiered serologic analysis consisting of an enzyme-linked immunoassay or immunofluorescence assay, followed by reflexive immunoblotting. Sensitivity of 2-tiered testing is low (30%-40%) during early infection while the antibody response is developing (window period). For disseminated Lyme disease, sensitivity is 70%-100%. Specificity is high (>95%) during all stages of disease. Use of other diagnostic tests for Lyme disease is limited. We review the rationale behind current US testing guidelines, appropriate use and interpretation of tests, and recent developments in Lyme disease diagnostics.

Evaluation of a 5-Marker Blood Test for Colorectal Cancer Early Detection in a Colorectal Cancer Screening Setting.

PubMed

Werner, Simone; Krause, Friedemann; Rolny, Vinzent; Strobl, Matthias; Morgenstern, David; Datz, Christian; Chen, Hongda; Brenner, Hermann

2016-04-01

In initial studies that included colorectal cancer patients undergoing diagnostic colonoscopy, we had identified a serum marker combination able to detect colorectal cancer with similar diagnostic performance as fecal immunochemical test (FIT). In this study, we aimed to validate the results in participants of a large colorectal cancer screening study conducted in the average-risk, asymptomatic screening population. We tested serum samples from 1,200 controls, 420 advanced adenoma patients, 4 carcinoma in situ patients, and 36 colorectal cancer patients with a 5-marker blood test [carcinoembryonic antigen (CEA)+anti-p53+osteopontin+seprase+ferritin]. The diagnostic performance of individual markers and marker combinations was assessed and compared with stool test results. AUCs for the detection of colorectal cancer and advanced adenomas with the 5-marker blood test were 0.78 [95% confidence interval (CI), 0.68-0.87] and 0.56 (95% CI, 0.53-0.59), respectively, which now is comparable with guaiac-based fecal occult blood test (gFOBT) but inferior to FIT. With cutoffs yielding specificities of 80%, 90%, and 95%, the sensitivities for the detection of colorectal cancer were 64%, 50%, and 42%, and early-stage cancers were detected as well as late-stage cancers. For osteopontin, seprase, and ferritin, the diagnostic performance in the screening setting was reduced compared with previous studies in diagnostic settings while CEA and anti-p53 showed similar diagnostic performance in both settings. Performance of the 5-marker blood test under screening conditions is inferior to FIT even though it is still comparable with the performance of gFOBT. CEA and anti-p53 could contribute to the development of a multiple marker blood-based test for early detection of colorectal cancer. ©2015 American Association for Cancer Research.

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.

The diagnostic plot analysis of artesian aquifers with case studies in Table Mountain Group of South Africa

NASA Astrophysics Data System (ADS)

Sun, Xiaobin; Xu, Yongxin; Lin, Lixiang

2015-05-01

Parameter estimates of artesian aquifers where piezometric head is above ground level are largely made through free-flowing and recovery tests. The straight-line method proposed by Jacob-Lohman is often used for interpretation of flow rate measured at flowing artesian boreholes. However, the approach fails to interpret the free-flowing test data from two artesian boreholes in the fractured-rock aquifer in Table Mountain Group (TMG) of South Africa. The diagnostic plot method using the reciprocal rate derivative is adapted to evaluate the artesian aquifer properties. The variation of the derivative helps not only identify flow regimes and discern the boundary conditions, but also facilitates conceptualization of the aquifer system and selection of an appropriate model for data interpretation later on. Test data from two free-flowing tests conducted in different sites in TMG are analysed using the diagnostic plot method. Based on the results, conceptual models and appropriate approaches are developed to evaluate the aquifer properties. The advantages and limitations of using the diagnostic plot method on free-flowing test data are discussed.

Towards non- and minimally instrumented, microfluidics-based diagnostic devices†

PubMed Central

Weigl, Bernhard; Domingo, Gonzalo; LaBarre, Paul; Gerlach, Jay

2009-01-01

In many health care settings, it is uneconomical, impractical, or unaffordable to maintain and access a fully equipped diagnostics laboratory. Examples include home health care, developing-country health care, and emergency situations in which first responders are dealing with pandemics or biowarfare agent release. In those settings, fully disposable diagnostic devices that require no instrument support, reagent, or significant training are well suited. Although the only such technology to have found widespread adoption so far is the immunochromatographic rapid assay strip test, microfluidics holds promise to expand the range of assay technologies that can be performed in formats similar to that of a strip test. In this paper, we review progress toward development of disposable, low-cost, easy-to-use microfluidics-based diagnostics that require no instrument at all. We also present examples of microfluidic functional elements—including mixers, separators, and detectors—as well as complete microfluidic devices that function entirely without any moving parts and external power sources. PMID:19023463

Cancer diagnostics: The journey from histomorphology to molecular profiling.

PubMed

Ahmed, Atif A; Abedalthagafi, Malak

2016-09-06

Although histomorphology has made significant advances into the understanding of cancer etiology, classification and pathogenesis, it is sometimes complicated by morphologic ambiguities, and other shortcomings that necessitate the development of ancillary tests to complement its diagnostic value. A new approach to cancer patient management consists of targeting specific molecules or gene mutations in the cancer genome by inhibitory therapy. Molecular diagnostic tests and genomic profiling methods are increasingly being developed to identify tumor targeted molecular profile that is the basis of targeted therapy. Novel targeted therapy has revolutionized the treatment of gastrointestinal stromal tumor, renal cell carcinoma and other cancers that were previously difficult to treat with standard chemotherapy. In this review, we discuss the role of histomorphology in cancer diagnosis and management and the rising role of molecular profiling in targeted therapy. Molecular profiling in certain diagnostic and therapeutic difficulties may provide a practical and useful complement to histomorphology and opens new avenues for targeted therapy and alternative methods of cancer patient management.

Integrating Oil Debris and Vibration Gear Damage Detection Technologies Using Fuzzy Logic

NASA Technical Reports Server (NTRS)

Dempsey, Paula J.; Afjeh, Abdollah A.

2002-01-01

A diagnostic tool for detecting damage to spur gears was developed. Two different measurement technologies, wear debris analysis and vibration, were integrated into a health monitoring system for detecting surface fatigue pitting damage on gears. This integrated system showed improved detection and decision-making capabilities as compared to using individual measurement technologies. This diagnostic tool was developed and evaluated experimentally by collecting vibration and oil debris data from fatigue tests performed in the NASA Glenn Spur Gear Fatigue Test Rig. Experimental data were collected during experiments performed in this test rig with and without pitting. Results show combining the two measurement technologies improves the detection of pitting damage on spur gears.

Storming the Molecular Diagnostic IP Fortress

PubMed Central

TERRY, MARK

2006-01-01

How genes are patented, and how companies control those patents through licensing, raises issues of patient access to medical tests, monopolistic business practices, ethics, lab-test quality, and the future of genetic test development. PMID:23424336

A Meta-Analysis of Typhoid Diagnostic Accuracy Studies: A Recommendation to Adopt a Standardized Composite Reference

PubMed Central

Storey, Helen L.; Huang, Ying; Crudder, Chris; Golden, Allison; de los Santos, Tala; Hawkins, Kenneth

2015-01-01

Novel typhoid diagnostics currently under development have the potential to improve clinical care, surveillance, and the disease burden estimates that support vaccine introduction. Blood culture is most often used as the reference method to evaluate the accuracy of new typhoid tests; however, it is recognized to be an imperfect gold standard. If no single gold standard test exists, use of a composite reference standard (CRS) can improve estimation of diagnostic accuracy. Numerous studies have used a CRS to evaluate new typhoid diagnostics; however, there is no consensus on an appropriate CRS. In order to evaluate existing tests for use as a reference test or inclusion in a CRS, we performed a systematic review of the typhoid literature to include all index/reference test combinations observed. We described the landscape of comparisons performed, showed results of a meta-analysis on the accuracy of the more common combinations, and evaluated sources of variability based on study quality. This wide-ranging meta-analysis suggests that no single test has sufficiently good performance but some existing diagnostics may be useful as part of a CRS. Additionally, based on findings from the meta-analysis and a constructed numerical example demonstrating the use of CRS, we proposed necessary criteria and potential components of a typhoid CRS to guide future recommendations. Agreement and adoption by all investigators of a standardized CRS is requisite, and would improve comparison of new diagnostics across independent studies, leading to the identification of a better reference test and improved confidence in prevalence estimates. PMID:26566275

A clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions?

PubMed Central

van Zimmeren, Esther; Verbeure, Birgit; Matthijs, Gert; Van Overwalle, Geertrui

2006-01-01

In genetic diagnostics, the emergence of a so-called "patent thicket" is imminent. Such an overlapping set of patent rights may have restrictive effects on further research and development of diagnostic tests, and the provision of clinical diagnostic services. Currently, two models that may facilitate access to and use of patented genetic inventions are attracting much debate in various national and international fora: patent pools and clearing houses. In this article, we explore the concept of clearing houses. Several types of clearing houses are identified. First, we describe and discuss two types that would provide access to information on the patented inventions: the information clearing house and the technology exchange clearing house. Second, three types of clearing houses are analysed that not only offer access to information but also provide an instrument to facilitate the use of the patented inventions: the open access clearing house, the standardized licences clearing house and the royalty collection clearing house. A royalty collection clearing house for genetic diagnostic testing would be the most comprehensive as it would serve several functions: identifying patents and patent claims essential to diagnostic testing, matching licensees with licensors, developing and supplying standardized licences, collecting royalties, monitoring whether users respect licensing conditions, and providing dispute resolution services such as mediation and arbitration. In this way, it might function as an effective model for users to facilitate access to and use of the patented inventions. However, it remains to be seen whether patent holders with a strong patent portfolio will be convinced by the advantages of the royalty collection clearing house and be willing to participate. PMID:16710543

Aircraft Engine Gas Path Diagnostic Methods: Public Benchmarking Results

NASA Technical Reports Server (NTRS)

Simon, Donald L.; Borguet, Sebastien; Leonard, Olivier; Zhang, Xiaodong (Frank)

2013-01-01

Recent technology reviews have identified the need for objective assessments of aircraft engine health management (EHM) technologies. To help address this issue, a gas path diagnostic benchmark problem has been created and made publicly available. This software tool, referred to as the Propulsion Diagnostic Method Evaluation Strategy (ProDiMES), has been constructed based on feedback provided by the aircraft EHM community. It provides a standard benchmark problem enabling users to develop, evaluate and compare diagnostic methods. This paper will present an overview of ProDiMES along with a description of four gas path diagnostic methods developed and applied to the problem. These methods, which include analytical and empirical diagnostic techniques, will be described and associated blind-test-case metric results will be presented and compared. Lessons learned along with recommendations for improving the public benchmarking processes will also be presented and discussed.

(13)C breath tests in personalized medicine: fiction or reality?

PubMed

Modak, Anil S

2009-11-01

The concept of personalized medicine is gathering momentum as various biomarkers are being discovered and developed to lead to genotype and phenotype diagnostic tests, which will enable physicians to individualize therapy. Noninvasive, rapid (13)C breath tests have the potential to serve as clinically significant diagnostic tools, especially for evaluating the enzyme activity of polymorphic enzymes. This would enable physicians to rapidly identify responders/nonresponders to various drugs primarily metabolized by these enzymes prior to initiation of therapy. With the information on enzyme activity, the physician can prescribe the right drug, at the right dose, at the right time, to the right individual, for the right clinical outcome. However, the promise of the era of personalized medicine, including the novel (13)C breath tests, will have to overcome several regulatory, business and financial hurdles for diagnostic tests to become part of routine mainstream clinical practice over the next decade.

Conversion-Integration of MSFC Nonlinear Signal Diagnostic Analysis Algorithms for Realtime Execution of MSFC's MPP Prototype System

NASA Technical Reports Server (NTRS)

Jong, Jen-Yi

1996-01-01

NASA's advanced propulsion system Small Scale Magnetic Disturbances/Advanced Technology Development (SSME/ATD) has been undergoing extensive flight certification and developmental testing, which involves large numbers of health monitoring measurements. To enhance engine safety and reliability, detailed analysis and evaluation of the measurement signals are mandatory to assess its dynamic characteristics and operational condition. Efficient and reliable signal detection techniques will reduce the risk of catastrophic system failures and expedite the evaluation of both flight and ground test data, and thereby reduce launch turn-around time. During the development of SSME, ASRI participated in the research and development of several advanced non- linear signal diagnostic methods for health monitoring and failure prediction in turbomachinery components. However, due to the intensive computational requirement associated with such advanced analysis tasks, current SSME dynamic data analysis and diagnostic evaluation is performed off-line following flight or ground test with a typical diagnostic turnaround time of one to two days. The objective of MSFC's MPP Prototype System is to eliminate such 'diagnostic lag time' by achieving signal processing and analysis in real-time. Such an on-line diagnostic system can provide sufficient lead time to initiate corrective action and also to enable efficient scheduling of inspection, maintenance and repair activities. The major objective of this project was to convert and implement a number of advanced nonlinear diagnostic DSP algorithms in a format consistent with that required for integration into the Vanderbilt Multigraph Architecture (MGA) Model Based Programming environment. This effort will allow the real-time execution of these algorithms using the MSFC MPP Prototype System. ASRI has completed the software conversion and integration of a sequence of nonlinear signal analysis techniques specified in the SOW for real-time execution on MSFC's MPP Prototype. This report documents and summarizes the results of the contract tasks; provides the complete computer source code; including all FORTRAN/C Utilities; and all other utilities/supporting software libraries that are required for operation.

Safety of falciparum malaria diagnostic strategy based on rapid diagnostic tests in returning travellers and migrants: a retrospective study

PubMed Central

2012-01-01

Background Rapid diagnostic tests for malaria (RDTs) allow accurate diagnosis and prompt treatment. Validation of their usefulness in travellers with fever was needed. The safety of a strategy to diagnose falciparum malaria based on RDT followed by immediate or delayed microscopy reading at first attendance was evaluated in one referral hospital in Switzerland. Methods A retrospective study was conducted in the outpatient clinic and emergency ward of University Hospital, covering a period of eight years (1999–2007). The study was conducted in the outpatient clinic and emergency ward of University Hospital. All adults suspected of malaria with a diagnostic test performed were included. RDT and microscopy as immediate tests were performed during working hours, and RDT as immediate test and delayed microscopy reading out of laboratory working hours. The main outcome measure was occurrence of specific complications in RDT negative and RDT positive adults. Results 2,139 patients were recruited. 1987 had both initial RDT and blood smear (BS) result negative. Among those, 2/1987 (0.1%) developed uncomplicated malaria with both RDT and BS positive on day 1 and day 6 respectively. Among the 152 patients initially malaria positive, 137 had both RDT and BS positive, four only BS positive and five only RDT positive (PCR confirmed) (six had only one test performed). None of the four initially RDT negative/BS positive and none of the five initially BS negative/RDT positive developed severe malaria while 6/137 of both RDT and BS positive did so. The use of RDT allowed a reduction of a median of 2.1 hours to get a first malaria test result. Conclusions A malaria diagnostic strategy based on RDTs and a delayed BS is safe in non-immune populations, and shortens the time to first malaria test result. PMID:23158019

Portable devices and mobile instruments for infectious diseases point-of-care testing.

PubMed

Bissonnette, Luc; Bergeron, Michel G

2017-05-01

Rapidity, simplicity, and portability are highly desirable characteristics of tests and devices designed for performing diagnostics at the point of care (POC), either near patients managed in healthcare facilities or to offer bioanalytical alternatives in external settings. By reducing the turnaround time of the diagnostic cycle, POC diagnostics can reduce the dissemination, morbidity, and mortality of infectious diseases and provide tools to control the global threat of antimicrobial resistance. Areas covered: A literature search of PubMed and Google Scholar, and extensive mining of specialized publications, Internet resources, and manufacturers' websites have been used to organize and write this overview of the challenges and requirements associated with the development of portable sample-to-answer diagnostics, and showcase relevant examples of handheld devices, portable instruments, and less mobile systems which may or could be operated at POC. Expert commentary: Rapid (<1 h) diagnostics can contribute to control infectious diseases and antimicrobial resistant pathogens. Portable devices or instruments enabling sample-to-answer bioanalysis can provide rapid, robust, and reproducible testing at the POC or close from it. Beyond testing, to realize some promises of personalized/precision medicine, it will be critical to connect instruments to healthcare data management systems, to efficiently link decentralized testing results to the electronic medical record of patients.

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.

Social anxiety disorder diagnostic criteria perform equally across age, comorbid diagnosis, and performance/interaction subtypes.

PubMed

Crome, Erica; Baillie, Andrew

2015-01-01

The prevalence of social anxiety disorder (SAD) is frequently higher in younger age groups and people with other anxiety or mood disorders; however, it is unclear whether these groups have a higher risk for developing SAD or are simply more likely to endorse diagnostic criteria than other people with similar levels of social anxiety. Explicitly testing the assumption all people respond to structured diagnostic interviews in comparable ways (measurement invariance) is essential in ensuring systematic response biases do not create spurious group differences. This research aims to systematically test whether age, comorbidity status, or types of social fears affect responses to a structured diagnostic interview. Responses from 1755 participants in a large-scale survey of mental health in Australia screening into the social phobia/SAD section of the Composite International Diagnostic Interview were used. Three series of multigroup confirmatory factor analyses for categorical data systematically tested for increasingly strict levels of measurement invariance. Overall, patterns of responding to diagnostic criteria were comparable across the groups, supporting assumptions of measurement invariance. Establishment of invariance supports the interpretation of differences between age, comorbidity status, and types of social situations feared as genuine differences in experience as opposed to measurement biases.

A Research Agenda for Helminth Diseases of Humans: Diagnostics for Control and Elimination Programmes

PubMed Central

McCarthy, James S.; Lustigman, Sara; Yang, Guo-Jing; Barakat, Rashida M.; García, Héctor H.; Sripa, Banchob; Willingham, Arve Lee; Prichard, Roger K.; Basáñez, María-Gloria

2012-01-01

Diagnostic tools appropriate for undertaking interventions to control helminth infections are key to their success. Many diagnostic tests for helminth infection have unsatisfactory performance characteristics and are not well suited for use in the parasite control programmes that are being increasingly implemented. Although the application of modern laboratory research techniques to improve diagnostics for helminth infection has resulted in some technical advances, uptake has not been uniform. Frequently, pilot or proof of concept studies of promising diagnostic technologies have not been followed by much needed product development, and in many settings diagnosis continues to rely on insensitive and unsatisfactory parasitological or serodiagnostic techniques. In contrast, PCR-based xenomonitoring of arthropod vectors, and use of parasite recombinant proteins as reagents for serodiagnostic tests, have resulted in critical advances in the control of specific helminth parasites. The Disease Reference Group on Helminths Infections (DRG4), established in 2009 by the Special Programme for Research and Training in Tropical Diseases (TDR) was given the mandate to review helminthiases research and identify research priorities and gaps. In this review, the diagnostic technologies relevant to control of helminth infections, either available or in development, are reviewed. Critical gaps are identified and opportunities to improve needed technologies are discussed. PMID:22545166

Photovoltaic array space power plus diagnostics experiment

NASA Technical Reports Server (NTRS)

Burger, D. R.

1990-01-01

The objective is to summarize the five years of hardware development and fabrication represented by the Photovoltaic Array Space Power Plus Diagnostics (PASP Plus) Instrument. The original PASP Experiment requirements and background is presented along with the modifications which were requested to transform the PASP Experiment into the PASP Plus Instrument. The PASP Plus hardware and software is described. Test results for components and subsystems are given as well as final system tests. Also included are appendices which describe the major subsystems and present supporting documentation such as block diagrams, schematics, circuit board artwork, drawings, test procedures and test reports.

Photovoltaic test and demonstration project. [residential energy program

NASA Technical Reports Server (NTRS)

Forestieri, A. F.; Brandhorst, H. W., Jr.; Deyo, J. N.

1976-01-01

The considered project consists of three subprojects related to applications, device performance and diagnostics, and endurance testing. The objectives of the applications subproject include the determination of the operating characteristics for a variety of photovoltaic conversion systems. A system test facility is being constructed in this connection and a prototype residence experiment is to be conducted. Market demand for solar cells is to be stimulated by demonstrating suitability of solar cells for specific near-term applications. Activities conducted in connection with device performance studies and diagnostics are also discussed along with developments in the area of endurance testing.

Impact and cost-effectiveness of current and future tuberculosis diagnostics: the contribution of modelling

PubMed Central

Houben, R.; Cohen, T.; Pai, M.; Cobelens, F.; Vassall, A.; Menzies, N. A.; Gomez, G. B.; Langley, I.; Squire, S. B.; White, R.

2014-01-01

SUMMARY The landscape of diagnostic testing for tuberculosis (TB) is changing rapidly, and stakeholders need urgent guidance on how to develop, deploy and optimize TB diagnostics in a way that maximizes impact and makes best use of available resources. When decisions must be made with only incomplete or preliminary data available, modelling is a useful tool for providing such guidance. Following a meeting of modelers and other key stakeholders organized by the TB Modelling and Analysis Consortium, we propose a conceptual framework for positioning models of TB diagnostics. We use that framework to describe modelling priorities in four key areas: Xpert® MTB/RIF scale-up, target product profiles for novel assays, drug susceptibility testing to support new drug regimens, and the improvement of future TB diagnostic models. If we are to maximize the impact and cost-effectiveness of TB diagnostics, these modelling priorities should figure prominently as targets for future research. PMID:25189546

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.

Dust measurements in tokamaks (invited).

PubMed

Rudakov, D L; Yu, J H; Boedo, J A; Hollmann, E M; Krasheninnikov, S I; Moyer, R A; Muller, S H; Pigarov, A Yu; Rosenberg, M; Smirnov, R D; West, W P; Boivin, R L; Bray, B D; Brooks, N H; Hyatt, A W; Wong, C P C; Roquemore, A L; Skinner, C H; Solomon, W M; Ratynskaia, S; Fenstermacher, M E; Groth, M; Lasnier, C J; McLean, A G; Stangeby, P C

2008-10-01

Dust production and accumulation present potential safety and operational issues for the ITER. Dust diagnostics can be divided into two groups: diagnostics of dust on surfaces and diagnostics of dust in plasma. Diagnostics from both groups are employed in contemporary tokamaks; new diagnostics suitable for ITER are also being developed and tested. Dust accumulation in ITER is likely to occur in hidden areas, e.g., between tiles and under divertor baffles. A novel electrostatic dust detector for monitoring dust in these regions has been developed and tested at PPPL. In the DIII-D tokamak dust diagnostics include Mie scattering from Nd:YAG lasers, visible imaging, and spectroscopy. Laser scattering is able to resolve particles between 0.16 and 1.6 microm in diameter; using these data the total dust content in the edge plasmas and trends in the dust production rates within this size range have been established. Individual dust particles are observed by visible imaging using fast framing cameras, detecting dust particles of a few microns in diameter and larger. Dust velocities and trajectories can be determined in two-dimension with a single camera or three-dimension using multiple cameras, but determination of particle size is challenging. In order to calibrate diagnostics and benchmark dust dynamics modeling, precharacterized carbon dust has been injected into the lower divertor of DIII-D. Injected dust is seen by cameras, and spectroscopic diagnostics observe an increase in carbon line (CI, CII, C(2) dimer) and thermal continuum emissions from the injected dust. The latter observation can be used in the design of novel dust survey diagnostics.

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

Rudakov, D. L.; Yu, J. H.; Boedo, J. A.

Dust production and accumulation present potential safety and operational issues for the ITER. Dust diagnostics can be divided into two groups: diagnostics of dust on surfaces and diagnostics of dust in plasma. Diagnostics from both groups are employed in contemporary tokamaks; new diagnostics suitable for ITER are also being developed and tested. Dust accumulation in ITER is likely to occur in hidden areas, e.g., between tiles and under divertor baffles. A novel electrostatic dust detector for monitoring dust in these regions has been developed and tested at PPPL. In the DIII-D tokamak dust diagnostics include Mie scattering from Nd:YAG lasers,more » visible imaging, and spectroscopy. Laser scattering is able to resolve particles between 0.16 and 1.6 {mu}m in diameter; using these data the total dust content in the edge plasmas and trends in the dust production rates within this size range have been established. Individual dust particles are observed by visible imaging using fast framing cameras, detecting dust particles of a few microns in diameter and larger. Dust velocities and trajectories can be determined in two-dimension with a single camera or three-dimension using multiple cameras, but determination of particle size is challenging. In order to calibrate diagnostics and benchmark dust dynamics modeling, precharacterized carbon dust has been injected into the lower divertor of DIII-D. Injected dust is seen by cameras, and spectroscopic diagnostics observe an increase in carbon line (CI, CII, C{sub 2} dimer) and thermal continuum emissions from the injected dust. The latter observation can be used in the design of novel dust survey diagnostics.« less

Perspectives on Advances in Tuberculosis Diagnostics, Drugs, and Vaccines

PubMed Central

Schito, Marco; Migliori, Giovanni Battista; Fletcher, Helen A.; McNerney, Ruth; Centis, Rosella; D'Ambrosio, Lia; Bates, Matthew; Kibiki, Gibson; Kapata, Nathan; Corrah, Tumena; Bomanji, Jamshed; Vilaplana, Cris; Johnson, Daniel; Mwaba, Peter; Maeurer, Markus; Zumla, Alimuddin

2015-01-01

Despite concerted efforts over the past 2 decades at developing new diagnostics, drugs, and vaccines with expanding pipelines, tuberculosis remains a global emergency. Several novel diagnostic technologies show promise of better point-of-care rapid tests for tuberculosis including nucleic acid–based amplification tests, imaging, and breath analysis of volatile organic compounds. Advances in new and repurposed drugs for use in multidrug-resistant (MDR) or extensively drug-resistant (XDR) tuberculosis have focused on development of several new drug regimens and their evaluation in clinical trials and now influence World Health Organization guidelines. Since the failure of the MVA85A vaccine 2 years ago, there have been no new tuberculosis vaccine candidates entering clinical testing. The current status quo of the lengthy treatment duration and poor treatment outcomes associated with MDR/XDR tuberculosis and with comorbidity of tuberculosis with human immunodeficiency virus and noncommunicable diseases is unacceptable. New innovations and political and funder commitment for early rapid diagnosis, shortening duration of therapy, improving treatment outcomes, and prevention are urgently required. PMID:26409271

Test Review: Prueba de Lectura y Lenguaje Escrito.

ERIC Educational Resources Information Center

Crawford, Alan N.

1984-01-01

Describes the Prueba de Lectura y Lenguaje Escrito (PPLE--roughly translatable as the "Test of Early Language Development") that may meet the need for standardized and diagnostic tests of reading and written composition in Spanish. (HOD)

Paper-based sample-to-answer molecular diagnostic platform for point-of-care diagnostics.

PubMed

Choi, Jane Ru; Tang, Ruihua; Wang, ShuQi; Wan Abas, Wan Abu Bakar; Pingguan-Murphy, Belinda; Xu, Feng

2015-12-15

Nucleic acid testing (NAT), as a molecular diagnostic technique, including nucleic acid extraction, amplification and detection, plays a fundamental role in medical diagnosis for timely medical treatment. However, current NAT technologies require relatively high-end instrumentation, skilled personnel, and are time-consuming. These drawbacks mean conventional NAT becomes impractical in many resource-limited disease-endemic settings, leading to an urgent need to develop a fast and portable NAT diagnostic tool. Paper-based devices are typically robust, cost-effective and user-friendly, holding a great potential for NAT at the point of care. In view of the escalating demand for the low cost diagnostic devices, we highlight the beneficial use of paper as a platform for NAT, the current state of its development, and the existing challenges preventing its widespread use. We suggest a strategy involving integrating all three steps of NAT into one single paper-based sample-to-answer diagnostic device for rapid medical diagnostics in the near future. Copyright © 2015 Elsevier B.V. All rights reserved.

Model Diagnostics for the Department of Energy's Accelerated Climate Modeling for Energy (ACME) Project

NASA Astrophysics Data System (ADS)

Smith, B.

2015-12-01

In 2014, eight Department of Energy (DOE) national laboratories, four academic institutions, one company, and the National Centre for Atmospheric Research combined forces in a project called Accelerated Climate Modeling for Energy (ACME) with the goal to speed Earth system model development for climate and energy. Over the planned 10-year span, the project will conduct simulations and modeling on DOE's most powerful high-performance computing systems at Oak Ridge, Argonne, and Lawrence Berkeley Leadership Compute Facilities. A key component of the ACME project is the development of an interactive test bed for the advanced Earth system model. Its execution infrastructure will accelerate model development and testing cycles. The ACME Workflow Group is leading the efforts to automate labor-intensive tasks, provide intelligent support for complex tasks and reduce duplication of effort through collaboration support. As part of this new workflow environment, we have created a diagnostic, metric, and intercomparison Python framework, called UVCMetrics, to aid in the testing-to-production execution of the ACME model. The framework exploits similarities among different diagnostics to compactly support diagnosis of new models. It presently focuses on atmosphere and land but is designed to support ocean and sea ice model components as well. This framework is built on top of the existing open-source software framework known as the Ultrascale Visualization Climate Data Analysis Tools (UV-CDAT). Because of its flexible framework design, scientists and modelers now can generate thousands of possible diagnostic outputs. These diagnostics can compare model runs, compare model vs. observation, or simply verify a model is physically realistic. Additional diagnostics are easily integrated into the framework, and our users have already added several. Diagnostics can be generated, viewed, and manipulated from the UV-CDAT graphical user interface, Python command line scripts and programs, and web browsers. The framework is designed to be scalable to large datasets, yet easy to use and familiar to scientists using previous tools. Integration in the ACME overall user interface facilitates data publication, further analysis, and quick feedback to model developers and scientists making component or coupled model runs.

The STARD statement for reporting diagnostic accuracy studies: application to the history and physical examination.

PubMed

Simel, David L; Rennie, Drummond; Bossuyt, Patrick M M

2008-06-01

The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Nonsystematic review of the STARD statement. Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient's history and physical examination.

Constructing and Implementing a Four Tier Test about Static Electricity to Diagnose Pre-service Elementary School Teacher’ Misconceptions

NASA Astrophysics Data System (ADS)

Hermita, N.; Suhandi, A.; Syaodih, E.; Samsudin, A.; Isjoni; Johan, H.; Rosa, F.; Setyaningsih, R.; Sapriadil; Safitri, D.

2017-09-01

We have already constructed and implemented the diagnostic test formed in the four tier test to diagnose pre-service elementary teachers’ misconceptions about static electricity. The method which is utilized in this study is 3D-1I (Define, Design, Develop and Implementation) conducted to the pre-service elementary school teachers. The number of respondents involved in the study is 78 students of PGSD FKIP Universitas Riau. The data was collected by administering diagnostic test items in the form of four tier test. The result indicates that there are several misconceptions related to static electricity concept, these include: 1) Electrostatic objects cannot attract neutral objects, 2) A neutral object is an object that does not contain an electrical charge, and 3) the magnitude of the tensile force between two charged objects depends on the size of the charge. Moreover, the research’s results establish that the diagnostic test is able to analyse number of misconceptions and classify level of understanding pre-service elementary school teachers that is scientific knowledge, misconception, lack knowledge, and error. In conclusion, the diagnostic test item in the form of four tier test has already been constructed and implemented to diagnose students’ conceptions on static electricity.

Gaseous electron multiplier-based soft x-ray plasma diagnostics development: Preliminary tests at ASDEX Upgrade

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

Chernyshova, M., E-mail: maryna.chernyshova@ipplm.pl; Malinowski, K.; Czarski, T.

2016-11-15

A Gaseous Electron Multiplier (GEM)-based detector is being developed for soft X-ray diagnostics on tokamaks. Its main goal is to facilitate transport studies of impurities like tungsten. Such studies are very relevant to ITER, where the excessive accumulation of impurities in the plasma core should be avoided. This contribution provides details of the preliminary tests at ASDEX Upgrade (AUG) with a focus on the most important aspects for detector operation in harsh radiation environment. It was shown that both spatially and spectrally resolved data could be collected, in a reasonable agreement with other AUG diagnostics. Contributions to the GEM signalmore » include also hard X-rays, gammas, and neutrons. First simulations of the effect of high-energy photons have helped understanding these contributions.« less

The hypersensitivity pneumonitis diagnostic index: use of non-invasive testing to diagnose hypersensitivity pneumonitis in metalworkers.

PubMed

Dangman, Kenneth H; Cole, Solon R; Hodgson, Michael J; Kuhn, Charles; Metersky, Mark L; Schenck, Paula; Storey, Eileen

2002-08-01

Since 1993, several outbreaks of hypersensitivity pneumonitis (HP) have been reported in metalworkers. We report the largest outbreak of HP in metalworkers yet known. It occurred in a Connecticut factory that produces precision parts for the aerospace industry. The workers typically presented with systemic and respiratory problems ("sick fatigue," myalgias, cough, dyspnea, wheezing, and chest tightness). They had variable findings on clinical tests, which complicated diagnosis. An HP diagnostic index was developed to help reduce the uncertainties in case identification. Data from 16 biopsy-confirmed cases and 14 non-HP patients were compared, and the HP diagnostic index was derived using variables that best discriminated between the two groups. The index is based on (a) work-related symptoms, (b) dry crackles on auscultation, (c) restrictive spirometry, (d) decreased diffusion capacity and/or increased A-a oxygen gradient, (e) elevated erythrocyte sedimentation rate, (f) abnormal radiographic images, and (g) abnormal gallium scans. We then applied the HP diagnostic index and, for comparison, the "Kenosha epidemiological case criteria" (developed during a recent HP outbreak in an automobile factory) to our data set. The HP diagnostic index and the Kenosha criteria confirmed HP in overlapping sets of 36 and 34 patients, respectively, that were both in good agreement with the clinical diagnoses. The HP diagnostic index relies less heavily on symptoms, subjective evaluations, and invasive tests than the Kenosha criteria, but both identified similar subsets of the 61 patients as having HP. The HP diagnostic index could provide a useful tool in future HP outbreaks, which are increasingly being recognized in metalworking facilities. Copyright 2002 Wiley-Liss, Inc.

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...

Decision making about healthcare-related tests and diagnostic test strategies. Paper 4: International guidelines show variability in their approaches.

PubMed

Mustafa, Reem A; Wiercioch, Wojtek; Arevalo-Rodriguez, Ingrid; Cheung, Adrienne; Prediger, Barbara; Ivanova, Liudmila; Ventresca, Matthew; Brozek, Jan; Santesso, Nancy; Bossuyt, Patrick; Garg, Amit X; Lloyd, Nancy; Lelgemann, Monika; Bühler, Diedrich; Schünemann, Holger J

2017-12-01

The objective of the study was to describe and compare current practices in developing guidelines about the use of healthcare-related tests and diagnostic strategies (HCTDS). We sampled 37 public health and clinical practice guidelines about HCTDS from various sources without language restrictions. Detailed descriptions of the systems used to assess the quality of evidence and develop recommendations were challenging to find within guidelines. We observed much variability among and within organizations with respect to how they develop recommendations about HCTDS. Twenty-four percent of the guidelines did not consider health benefits and harms but based decisions solely on test accuracy. We did not identify guidelines that described the main potential care pathways involving tests for a healthcare problem. In addition, we did not identify guidelines that systematically assessed, described, and referenced the evidence that linked test accuracy and patient-important outcomes. There is considerable variability among the processes used and factors considered in developing recommendations about the use of tests. This variability may be the cause for the disagreement we observed in recommendations about testing for the same condition. Copyright © 2017 Elsevier Inc. All rights reserved.

bcROCsurface: an R package for correcting verification bias in estimation of the ROC surface and its volume for continuous diagnostic tests.

PubMed

To Duc, Khanh

2017-11-18

Receiver operating characteristic (ROC) surface analysis is usually employed to assess the accuracy of a medical diagnostic test when there are three ordered disease status (e.g. non-diseased, intermediate, diseased). In practice, verification bias can occur due to missingness of the true disease status and can lead to a distorted conclusion on diagnostic accuracy. In such situations, bias-corrected inference tools are required. This paper introduce an R package, named bcROCsurface, which provides utility functions for verification bias-corrected ROC surface analysis. The shiny web application of the correction for verification bias in estimation of the ROC surface analysis is also developed. bcROCsurface may become an important tool for the statistical evaluation of three-class diagnostic markers in presence of verification bias. The R package, readme and example data are available on CRAN. The web interface enables users less familiar with R to evaluate the accuracy of diagnostic tests, and can be found at http://khanhtoduc.shinyapps.io/bcROCsurface_shiny/ .

Diagnostic accuracy of two multiplex real-time polymerase chain reaction assays for the diagnosis of meningitis in children in a resource-limited setting.

PubMed

Khumalo, Jermaine; Nicol, Mark; Hardie, Diana; Muloiwa, Rudzani; Mteshana, Phindile; Bamford, Colleen

2017-01-01

Accurate etiological diagnosis of meningitis is important, but difficult in resource-limited settings due to prior administration of antibiotics and lack of viral diagnostics. We aimed to develop and validate 2 real-time multiplex PCR (RT-PCR) assays for the detection of common causes of community-acquired bacterial and viral meningitis in South African children. We developed 2 multiplex RT- PCRs for detection of S. pneumoniae, N. meningitidis, H. influenzae, enteroviruses, mumps virus and herpes simplex virus. We tested residual CSF samples from children presenting to a local paediatric hospital over a one-year period, whose CSF showed an abnormal cell count. Results were compared with routine diagnostic tests and the final discharge diagnosis. We calculated accuracy of the bacterial RT-PCR assay compared to CSF culture and using World Health Organisation definitions of laboratory-confirmed bacterial meningitis. From 292 samples, bacterial DNA was detected in 12 (4.1%) and viral nucleic acids in 94 (32%). Compared to CSF culture, the sensitivity and specificity of the bacterial RT-PCR was 100% and 97.2% with complete agreement in organism identification. None of the cases positive by viral RT-PCR had a bacterial cause confirmed on CSF culture. Only 9/90 (10%) of patients diagnosed clinically as bacterial meningitis or partially treated bacterial meningitis tested positive with the bacterial RT-PCR. In this population the use of 2 multiplex RT-PCRs targeting 6 common pathogens gave promising results. If introduced into routine diagnostic testing, these multiplex RT-PCR assays would supplement other diagnostic tests, and have the potential to limit unnecessary antibiotic therapy and hospitalisation.

Diagnostic accuracy of two multiplex real-time polymerase chain reaction assays for the diagnosis of meningitis in children in a resource-limited setting

PubMed Central

Khumalo, Jermaine; Nicol, Mark; Hardie, Diana; Muloiwa, Rudzani; Mteshana, Phindile

2017-01-01

Introduction Accurate etiological diagnosis of meningitis is important, but difficult in resource-limited settings due to prior administration of antibiotics and lack of viral diagnostics. We aimed to develop and validate 2 real-time multiplex PCR (RT-PCR) assays for the detection of common causes of community-acquired bacterial and viral meningitis in South African children. Methods We developed 2 multiplex RT- PCRs for detection of S. pneumoniae, N. meningitidis, H. influenzae, enteroviruses, mumps virus and herpes simplex virus. We tested residual CSF samples from children presenting to a local paediatric hospital over a one-year period, whose CSF showed an abnormal cell count. Results were compared with routine diagnostic tests and the final discharge diagnosis. We calculated accuracy of the bacterial RT-PCR assay compared to CSF culture and using World Health Organisation definitions of laboratory-confirmed bacterial meningitis. Results From 292 samples, bacterial DNA was detected in 12 (4.1%) and viral nucleic acids in 94 (32%). Compared to CSF culture, the sensitivity and specificity of the bacterial RT-PCR was 100% and 97.2% with complete agreement in organism identification. None of the cases positive by viral RT-PCR had a bacterial cause confirmed on CSF culture. Only 9/90 (10%) of patients diagnosed clinically as bacterial meningitis or partially treated bacterial meningitis tested positive with the bacterial RT-PCR. Discussion In this population the use of 2 multiplex RT-PCRs targeting 6 common pathogens gave promising results. If introduced into routine diagnostic testing, these multiplex RT-PCR assays would supplement other diagnostic tests, and have the potential to limit unnecessary antibiotic therapy and hospitalisation. PMID:28346504

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 tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

PubMed Central

Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.

2006-01-01

We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233

Turning the Page: Advancing Paper-Based Microfluidics for Broad Diagnostic Application.

PubMed

Gong, Max M; Sinton, David

2017-06-28

Infectious diseases are a major global health issue. Diagnosis is a critical first step in effectively managing their spread. Paper-based microfluidic diagnostics first emerged in 2007 as a low-cost alternative to conventional laboratory testing, with the goal of improving accessibility to medical diagnostics in developing countries. In this review, we examine the advances in paper-based microfluidic diagnostics for medical diagnosis in the context of global health from 2007 to 2016. The theory of fluid transport in paper is first presented. The next section examines the strategies that have been employed to control fluid and analyte transport in paper-based assays. Tasks such as mixing, timing, and sequential fluid delivery have been achieved in paper and have enabled analytical capabilities comparable to those of conventional laboratory methods. The following section examines paper-based sample processing and analysis. The most impactful advancement here has been the translation of nucleic acid analysis to a paper-based format. Smartphone-based analysis is another exciting development with potential for wide dissemination. The last core section of the review highlights emerging health applications, such as male fertility testing and wearable diagnostics. We conclude the review with the future outlook, remaining challenges, and emerging opportunities.

Propulsion IVHM Technology Experiment

NASA Technical Reports Server (NTRS)

Chicatelli, Amy K.; Maul, William A.; Fulton, Christopher E.

2006-01-01

The Propulsion IVHM Technology Experiment (PITEX) successfully demonstrated real-time fault detection and isolation of a virtual reusable launch vehicle (RLV) main propulsion system (MPS). Specifically, the PITEX research project developed and applied a model-based diagnostic system for the MPS of the X-34 RLV, a space-launch technology demonstrator. The demonstration was simulation-based using detailed models of the propulsion subsystem to generate nominal and failure scenarios during captive carry, which is the most safety-critical portion of the X-34 flight. Since no system-level testing of the X-34 Main Propulsion System (MPS) was performed, these simulated data were used to verify and validate the software system. Advanced diagnostic and signal processing algorithms were developed and tested in real time on flight-like hardware. In an attempt to expose potential performance problems, the PITEX diagnostic system was subjected to numerous realistic effects in the simulated data including noise, sensor resolution, command/valve talkback information, and nominal build variations. In all cases, the PITEX system performed as required. The research demonstrated potential benefits of model-based diagnostics, defined performance metrics required to evaluate the diagnostic system, and studied the impact of real-world challenges encountered when monitoring propulsion subsystems.

LASER BIOLOGY AND MEDICINE: A laser-spectroscopy system for fluorescent diagnostics and photodynamic therapy of diseases of eye retina and choroid

NASA Astrophysics Data System (ADS)

Meerovich, G. A.; Shevchik, S. A.; Loshchenov, M. V.; Budzinskaya, M. V.; Ermakova, N. A.; Kharnas, S. S.

2002-11-01

A laser-spectroscopy system for the fluorescent diagnostics and photodynamic therapy of pathologic eye-fundus changes combined with the use of the Photosens compound is developed. The system is tested on experimental animals (mice and rabbits).

Dynamic Assessment in Combination with Video Interaction Guidance in Preschool Education

ERIC Educational Resources Information Center

Krejcová, Kristýna

2015-01-01

Dynamic assessment represents an alternative diagnostic approach focused on the revelation of the tested persons' learning potential. The learning potential is observed via the emphasis on the achievement process. It aims at meaningful connection with the intervention that immediately applies diagnostic findings to support the development of an…

White Paper: Movement System Diagnoses in Neurologic Physical Therapy.

PubMed

Hedman, Lois D; Quinn, Lori; Gill-Body, Kathleen; Brown, David A; Quiben, Myla; Riley, Nora; Scheets, Patricia L

2018-04-01

The APTA recently established a vision for physical therapists to transform society by optimizing movement to promote health and wellness, mitigate impairments, and prevent disability. An important element of this vision entails the integration of the movement system into the profession, and necessitates the development of movement system diagnoses by physical therapists. At this point in time, the profession as a whole has not agreed upon diagnostic classifications or guidelines to assist in developing movement system diagnoses that will consistently capture an individual's movement problems. We propose that, going forward, diagnostic classifications of movement system problems need to be developed, tested, and validated. The Academy of Neurologic Physical Therapy's Movement System Task Force was convened to address these issues with respect to management of movement system problems in patients with neurologic conditions. The purpose of this article is to report on the work and recommendations of the Task Force. The Task Force identified 4 essential elements necessary to develop and implement movement system diagnoses for patients with primarily neurologic involvement from existing movement system classifications. The Task Force considered the potential impact of using movement system diagnoses on clinical practice, education and, research. Recommendations were developed and provided recommendations for potential next steps to broaden this discussion and foster the development of movement system diagnostic classifications. The Task Force proposes that diagnostic classifications of movement system problems need to be developed, tested, and validated with the long-range goal to reach consensus on and adoption of a movement system diagnostic framework for clients with neurologic injury or disease states.Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A198).

Collection and Characterization of Samples for Establishment of a Serum Repository for Lyme Disease Diagnostic Test Development and Evaluation

PubMed Central

Molins, Claudia R.; Sexton, Christopher; Young, John W.; Ashton, Laura V.; Pappert, Ryan; Beard, Charles B.

2014-01-01

Serological assays and a two-tiered test algorithm are recommended for laboratory confirmation of Lyme disease. In the United States, the sensitivity of two-tiered testing using commercially available serology-based assays is dependent on the stage of infection and ranges from 30% in the early localized disease stage to near 100% in late-stage disease. Other variables, including subjectivity in reading Western blots, compliance with two-tiered recommendations, use of different first- and second-tier test combinations, and use of different test samples, all contribute to variation in two-tiered test performance. The availability and use of sample sets from well-characterized Lyme disease patients and controls are needed to better assess the performance of existing tests and for development of improved assays. To address this need, the Centers for Disease Control and Prevention and the National Institutes of Health prospectively collected sera from patients at all stages of Lyme disease, as well as healthy donors and patients with look-alike diseases. Patients and healthy controls were recruited using strict inclusion and exclusion criteria. Samples from all included patients were retrospectively characterized by two-tiered testing. The results from two-tiered testing corroborated the need for novel and improved diagnostics, particularly for laboratory diagnosis of earlier stages of infection. Furthermore, the two-tiered results provide a baseline with samples from well-characterized patients that can be used in comparing the sensitivity and specificity of novel diagnostics. Panels of sera and accompanying clinical and laboratory testing results are now available to Lyme disease serological test users and researchers developing novel tests. PMID:25122862

Addressing the Real-World Challenges in the Development of Propulsion IVHM Technology Experiment (PITEX)

NASA Technical Reports Server (NTRS)

Maul, William A.; Chicatelli, Amy; Fulton, Christopher E.; Balaban, Edward; Sweet, Adam; Hayden, Sandra Claire; Bajwa, Anupa

2005-01-01

The Propulsion IVHM Technology Experiment (PITEX) has been an on-going research effort conducted over several years. PITEX has developed and applied a model-based diagnostic system for the main propulsion system of the X-34 reusable launch vehicle, a space-launch technology demonstrator. The application was simulation-based using detailed models of the propulsion subsystem to generate nominal and failure scenarios during captive carry, which is the most safety-critical portion of the X-34 flight. Since no system-level testing of the X-34 Main Propulsion System (MPS) was performed, these simulated data were used to verify and validate the software system. Advanced diagnostic and signal processing algorithms were developed and tested in real-time on flight-like hardware. In an attempt to expose potential performance problems, these PITEX algorithms were subject to numerous real-world effects in the simulated data including noise, sensor resolution, command/valve talkback information, and nominal build variations. The current research has demonstrated the potential benefits of model-based diagnostics, defined the performance metrics required to evaluate the diagnostic system, and studied the impact of real-world challenges encountered when monitoring propulsion subsystems.

Development of a standardized battery of performance tests for the assessment of noise stress effects

NASA Technical Reports Server (NTRS)

Theologus, G. C.; Wheaton, G. R.; Mirabella, A.; Brahlek, R. E.

1973-01-01

A set of 36 relatively independent categories of human performance were identified. These categories encompass human performance in the cognitive, perceptual, and psychomotor areas, and include diagnostic measures and sensitive performance metrics. Then a prototype standardized test battery was constructed, and research was conducted to obtain information on the sensitivity of the tests to stress, the sensitivity of selected categories of performance degradation, the time course of stress effects on each of the selected tests, and the learning curves associated with each test. A research project utilizing a three factor partially repeated analysis of covariance design was conducted in which 60 male subjects were exposed to variations in noise level and quality during performance testing. Effects of randomly intermittent noise on performance of the reaction time tests were observed, but most of the other performance tests showed consistent stability. The results of 14 analyses of covariance of the data taken from the performance of the 60 subjects on the prototype standardized test battery provided information which will enable the final development and test of a standardized test battery and the associated development of differential sensitivity metrics and diagnostic classificatory system.

Proteomic Identification of Immunodiagnostic Antigens for Trypanosoma vivax Infections in Cattle and Generation of a Proof-of-Concept Lateral Flow Test Diagnostic Device.

PubMed

Fleming, Jennifer R; Sastry, Lalitha; Wall, Steven J; Sullivan, Lauren; Ferguson, Michael A J

2016-09-01

Trypanosoma vivax is one of the causative agents of Animal African Trypanosomosis in cattle, which is endemic in sub-Saharan Africa and transmitted primarily by the bite of the tsetse fly vector. The parasite can also be mechanically transmitted, and this has allowed its spread to South America. Diagnostics are limited for this parasite and in farm settings diagnosis is mainly symptom-based. We set out to identify, using a proteomic approach, candidate diagnostic antigens to develop into an easy to use pen-side lateral flow test device. Two related members the invariant surface glycoprotein family, TvY486_0045500 and TvY486_0019690, were selected. Segments of these antigens, lacking N-terminal signal peptides and C-terminal transmembrane domains, were expressed in E. coli. Both were developed into ELISA tests and one of them, TvY486_0045500, was developed into a lateral flow test prototype. The tests were all evaluated blind with 113 randomised serum samples, taken from 37 calves before and after infection with T. vivax or T. congolense. The TvY486_0045500 and TvY486_0019690 ELISA tests gave identical sensitivity and specificity values for T. vivax infection of 94.5% (95% CI, 86.5% to 98.5%) and 88.0% (95% CI, 75.7% to 95.5%), respectively, and the TvY486_0045500 lateral flow test prototype a sensitivity and specificity of 92.0% (95% CI, 83.4% to 97.0%) and 89.8% (95% CI, 77.8% to 96.6%), respectively. These data suggest that recombinant TvY486_0045500 shows promise for the development of a pen-side lateral flow test for the diagnosis of T. vivax animal African trypanosomosis.

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.

Optical systems for point-of-care diagnostic instrumentation: analysis of imaging performance and cost.

PubMed

Pierce, Mark C; Weigum, Shannon E; Jaslove, Jacob M; Richards-Kortum, Rebecca; Tkaczyk, Tomasz S

2014-01-01

One of the key elements in point-of-care (POC) diagnostic test instrumentation is the optical system required for signal detection and/or imaging. Many tests which use fluorescence, absorbance, or colorimetric optical signals are under development for management of infectious diseases in resource limited settings, where the overall size and cost of the device is of critical importance. At present, high-performance lenses are expensive to fabricate and difficult to obtain commercially, presenting barriers for developers of in vitro POC tests or microscopic image-based diagnostics. We recently described a compact "hybrid" objective lens incorporating both glass and plastic optical elements, with a numerical aperture of 1.0 and field-of-view of 250 μm. This design concept may potentially enable mass-production of high-performance, low-cost optical systems which can be easily incorporated in the readout path of existing and emerging POC diagnostic assays. In this paper, we evaluate the biological imaging performance of these lens systems in three broad POC diagnostic application areas; (1) bright field microscopy of histopathology slides, (2) cytologic examination of blood smears, and (3) immunofluorescence imaging. We also break down the fabrication costs and draw comparisons with other miniature optical systems. The hybrid lenses provided images with quality comparable to conventional microscopy, enabling examination of neoplastic pathology and infectious parasites including malaria and cryptosporidium. We describe how these components can be produced at below $10 per unit in full-scale production quantities, making these systems well suited for use within POC diagnostic instrumentation.

The way to universal and correct medical presentation of diagnostic informations for complex spectrophotometry noninvasive medical diagnostic systems

NASA Astrophysics Data System (ADS)

Rogatkin, Dmitrii A.; Tchernyi, Vladimir V.

2003-07-01

The optical noninvasive diagnostic systems are now widely applied and investigated in different areas of medicine. One of the such techniques is the noninvasive spectrophotometry, the complex diagnostic technique consisting on elastic scattering spectroscopy, absorption spectroscopy, fluorescent diagnostics, photoplethismography, etc. Today a lot of real optical diagnostic systems indicate the technical parameters and physical data only as a result of the diagnostic procedure. But, it is clear that for the medical staff the more convenient medical information is needed. This presentation lights the general way for development a diagnostic system"s software, which can produce the full processing of the diagnostic data from a physical to a medical level. It is shown, that this process is a multilevel (3-level) procedure and the main diagnostic result for noninvasive spectrophotometry methods, the biochemical and morphological composition of the tested tissues, arises in it on a second level of calculations.

Repeated significance tests of linear combinations of sensitivity and specificity of a diagnostic biomarker

PubMed Central

Wu, Mixia; Shu, Yu; Li, Zhaohai; Liu, Aiyi

2016-01-01

A sequential design is proposed to test whether the accuracy of a binary diagnostic biomarker meets the minimal level of acceptance. The accuracy of a binary diagnostic biomarker is a linear combination of the marker’s sensitivity and specificity. The objective of the sequential method is to minimize the maximum expected sample size under the null hypothesis that the marker’s accuracy is below the minimal level of acceptance. The exact results of two-stage designs based on Youden’s index and efficiency indicate that the maximum expected sample sizes are smaller than the sample sizes of the fixed designs. Exact methods are also developed for estimation, confidence interval and p-value concerning the proposed accuracy index upon termination of the sequential testing. PMID:26947768

Comparison of visual and automated Deki Reader interpretation of malaria rapid diagnostic tests in rural Tanzanian military health facilities.

PubMed

Kalinga, Akili K; Mwanziva, Charles; Chiduo, Sarah; Mswanya, Christopher; Ishengoma, Deus I; Francis, Filbert; Temu, Lucky; Mahikwano, Lucas; Mgata, Saidi; Amoo, George; Anova, Lalaine; Wurrapa, Eyako; Zwingerman, Nora; Ferro, Santiago; Bhat, Geeta; Fine, Ian; Vesely, Brian; Waters, Norman; Kreishman-Deitrick, Mara; Hickman, Mark; Paris, Robert; Kamau, Edwin; Ohrt, Colin; Kavishe, Reginald A

2018-05-29

Although microscopy is a standard diagnostic tool for malaria and the gold standard, it is infrequently used because of unavailability of laboratory facilities and the absence of skilled readers in poor resource settings. Malaria rapid diagnostic tests (RDT) are currently used instead of or as an adjunct to microscopy. However, at very low parasitaemia (usually < 100 asexual parasites/µl), the test line on malaria rapid diagnostic tests can be faint and consequently hard to visualize and this may potentially affect the interpretation of the test results. Fio Corporation (Canada), developed an automated RDT reader named Deki Reader™ for automatic analysis and interpretation of rapid diagnostic tests. This study aimed to compare visual assessment and automated Deki Reader evaluations to interpret malaria rapid diagnostic tests against microscopy. Unlike in the previous studies where expert laboratory technicians interpreted the test results visually and operated the device, in this study low cadre health care workers who have not attended any formal professional training in laboratory sciences were employed. Finger prick blood from 1293 outpatients with fever was tested for malaria using RDT and Giemsa-stained microscopy for thick and thin blood smears. Blood samples for RDTs were processed according to manufacturers' instructions automated in the Deki Reader. Results of malaria diagnoses were compared between visual and the automated devise reading of RDT and microscopy. The sensitivity of malaria rapid diagnostic test results interpreted by the Deki Reader was 94.1% and that of visual interpretation was 93.9%. The specificity of malaria rapid diagnostic test results was 71.8% and that of human interpretation was 72.0%. The positive predictive value of malaria RDT results by the Deki Reader and visual interpretation was 75.8 and 75.4%, respectively, while the negative predictive values were 92.8 and 92.4%, respectively. The accuracy of RDT as interpreted by DR and visually was 82.6 and 82.1%, respectively. There was no significant difference in performance of RDTs interpreted by either automated DR or visually by unskilled health workers. However, despite the similarities in performance parameters, the device has proven useful because it provides stepwise guidance on processing RDT, data transfer and reporting.

[Detection of rubella virus RNA in clinical material by real time polymerase chain reaction method].

PubMed

Domonova, É A; Shipulina, O Iu; Kuevda, D A; Larichev, V F; Safonova, A P; Burchik, M A; Butenko, A M; Shipulin, G A

2012-01-01

Development of a reagent kit for detection of rubella virus RNA in clinical material by PCR-RT. During development and determination of analytical specificity and sensitivity DNA and RNA of 33 different microorganisms including 4 rubella strains were used. Comparison of analytical sensitivity of virological and molecular-biological methods was performed by using rubella virus strains Wistar RA 27/3, M-33, "Orlov", Judith. Evaluation of diagnostic informativity of rubella virus RNAisolation in various clinical material by PCR-RT method was performed in comparison with determination of virus specific serum antibodies by enzyme immunoassay. A reagent kit for the detection of rubella virus RNA in clinical material by PCR-RT was developed. Analytical specificity was 100%, analytical sensitivity - 400 virus RNA copies per ml. Analytical sensitivity of the developed technique exceeds analytical sensitivity of the Vero E6 cell culture infection method in studies of rubella virus strains Wistar RA 27/3 and "Orlov" by 11g and 31g, and for M-33 and Judith strains is analogous. Diagnostic specificity is 100%. Diagnostic specificity for testing samples obtained within 5 days of rash onset: for peripheral blood sera - 20.9%, saliva - 92.5%, nasopharyngeal swabs - 70.1%, saliva and nasopharyngeal swabs - 97%. Positive and negative predictive values of the results were shown depending on the type of clinical material tested. Application of reagent kit will allow to increase rubella diagnostics effectiveness at the early stages of infectious process development, timely and qualitatively perform differential diagnostics of exanthema diseases, support tactics of anti-epidemic regime.

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.

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.

Advanced Techniques in Pulmonary Function Test Analysis Interpretation and Diagnosis

PubMed Central

Gildea, T.J.; Bell, C. William

1980-01-01

The Pulmonary Functions Analysis and Diagnostic System is an advanced clinical processing system developed for use at the Pulmonary Division, Department of Medicine at the University of Nebraska Medical Center. The system generates comparative results and diagnostic impressions for a variety of routine and specialized pulmonary functions test data. Routine evaluation deals with static lung volumes, breathing mechanics, diffusing capacity, and blood gases while specialized tests include lung compliance studies, small airways dysfunction studies and dead space to tidal volume ratios. Output includes tabular results of normal vs. observed values, clinical impressions and commentary and, where indicated, a diagnostic impression. A number of pulmonary physiological and state variables are entered or sampled (A to D) with periodic status reports generated for the test supervisor. Among the various physiological variables sampled are respiratory frequency, minute ventilation, oxygen consumption, carbon dioxide production, and arterial oxygen saturation.

The changing face of hemostasis testing in modern laboratories: consolidation, automation, and beyond.

PubMed

Lippi, Giuseppe; Plebani, Mario; Favaloro, Emmanuel J

2015-04-01

The reality of laboratory diagnostics as a whole, and hemostasis testing in particular, is evolving under new paradigms of efficiency. The driving forces of health care and laboratory diagnostics in the third millennium are mainly represented by macro- and microeconomics. In a world with limited resources, shattered by an unprecedented economic crisis, laboratory diagnostics is undergoing a substantial reorganization, with emergence of new models under the imperative of terms, such as bedside testing, consolidation, and networking. The paradigms under which these changes are being developed include a variety of environment, preanalytical, technological, professional, and health-care aspects. The maintenance of continued quality is indeed the major challenge to be faced in the foreseeable future. In fact, some challenges prepotently emerge during a consolidation process, which basically involve delayed testing, centrifugation, transportation, and stability of the specimens, as well as the potential mismatch of sample matrix. This article is aimed to provide an overview of the current economic scenario of laboratory diagnostics and discuss the changing face of hemostasis testing in modern laboratories, providing a synthetic overview about potential drawbacks of actualized solutions. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

New developments in epidemiology, diagnosis, and treatment of fascioliasis.

PubMed

Cabada, Miguel M; White, A Clinton

2012-10-01

This review focuses on the recent developments in the epidemiology, burden of disease, diagnostic tests, and treatment of fascioliasis. Recent epidemiologic data suggest that either the endemic areas are expanding or disease is being recognized in areas where it was not previously observed. In addition, recent data highlight the effects of fascioliasis on childhood anemia and nutrition. Diagnosis remains problematic, but newer diagnostic tests including antibody, antigen, and DNA detection tests may facilitate earlier diagnosis. Recent studies suggest that point-of-care testing may soon be possible. Treatment with triclabendazole is effective, but resistance is emerging in livestock and may pose a threat for patients. Fascioliasis continues to emerge as an important neglected disease, with new studies highlighting the under-recognized burden of disease. Further studies are needed on burden of disease, improved diagnosis, and alternative to triclabendazole treatment.

An enhancement to the NA4 gear vibration diagnostic parameter

NASA Technical Reports Server (NTRS)

Decker, Harry J.; Handschuh, Robert F.; Zakrajsek, James J.

1994-01-01

A new vibration diagnostic parameter for health monitoring of gears, NA4*, is proposed and tested. A recently developed gear vibration diagnostic parameter NA4 outperformed other fault detection methods at indicating the start and initial progression of damage. However, in some cases, as the damage progressed, the sensitivity of the NA4 and FM4 parameters tended to decrease and no longer indicated damage. A new parameter, NA4* was developed by enhancing NA4 to improve the trending of the parameter. This allows for the indication of damage both at initiation and also as the damage progresses. The NA4* parameter was verified and compared to the NA4 and FM4 parameters using experimental data from single mesh spur and spiral bevel gear fatigue rigs. The primary failure mode for the test cases was naturally occurring tooth surface pitting. The NA4* parameter is shown to be a more robust indicator of damage.

Preanalytics in lung cancer.

PubMed

Warth, Arne; Muley, Thomas; Meister, Michael; Weichert, Wilko

2015-01-01

Preanalytic sampling techniques and preparation of tissue specimens strongly influence analytical results in lung tissue diagnostics both on the morphological but also on the molecular level. However, in contrast to analytics where tremendous achievements in the last decade have led to a whole new portfolio of test methods, developments in preanalytics have been minimal. This is specifically unfortunate in lung cancer, where usually only small amounts of tissue are at hand and optimization in all processing steps is mandatory in order to increase the diagnostic yield. In the following, we provide a comprehensive overview on some aspects of preanalytics in lung cancer from the method of sampling over tissue processing to its impact on analytical test results. We specifically discuss the role of preanalytics in novel technologies like next-generation sequencing and in the state-of the-art cytology preparations. In addition, we point out specific problems in preanalytics which hamper further developments in the field of lung tissue diagnostics.

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...

Validation of Ten Noninvasive Diagnostic Models for Prediction of Liver Fibrosis in Patients with Chronic Hepatitis B

PubMed Central

Cheng, Jieyao; Hou, Jinlin; Ding, Huiguo; Chen, Guofeng; Xie, Qing; Wang, Yuming; Zeng, Minde; Ou, Xiaojuan; Ma, Hong; Jia, Jidong

2015-01-01

Background and Aims Noninvasive models have been developed for fibrosis assessment in patients with chronic hepatitis B. However, the sensitivity, specificity and diagnostic accuracy in evaluating liver fibrosis of these methods have not been validated and compared in the same group of patients. The aim of this study was to verify the diagnostic performance and reproducibility of ten reported noninvasive models in a large cohort of Asian CHB patients. Methods The diagnostic performance of ten noninvasive models (HALF index, FibroScan, S index, Zeng model, Youyi model, Hui model, APAG, APRI, FIB-4 and FibroTest) was assessed against the liver histology by ROC curve analysis in CHB patients. The reproducibility of the ten models were evaluated by recalculating the diagnostic values at the given cut-off values defined by the original studies. Results Six models (HALF index, FibroScan, Zeng model, Youyi model, S index and FibroTest) had AUROCs higher than 0.70 in predicting any fibrosis stage and 2 of them had best diagnostic performance with AUROCs to predict F≥2, F≥3 and F4 being 0.83, 0.89 and 0.89 for HALF index, 0.82, 0.87 and 0.87 for FibroScan, respectively. Four models (HALF index, FibroScan, Zeng model and Youyi model) showed good diagnostic values at given cut-offs. Conclusions HALF index, FibroScan, Zeng model, Youyi model, S index and FibroTest show a good diagnostic performance and all of them, except S index and FibroTest, have good reproducibility for evaluating liver fibrosis in CHB patients. Registration Number ChiCTR-DCS-07000039. PMID:26709706

Engineering Paper-Based Sensors for Zika Virus

DOE PAGES

Meagher, Robert J.; Negrete, Oscar A.; Van Rompay, Koen K.

2016-05-30

The emergence of Zika virus in Latin America has created an urgent need for new, simple yet sensitive diagnostic tests. We highlight recent work using paper-based sensors coupled with CRISPR/Cas9 to detect Zika RNA, as a new approach to rapid development and deployment of field-ready diagnostics for emerging infectious diseases.

Engineering Paper-Based Sensors for Zika Virus

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

Meagher, Robert J.; Negrete, Oscar A.; Van Rompay, Koen K.

The emergence of Zika virus in Latin America has created an urgent need for new, simple yet sensitive diagnostic tests. We highlight recent work using paper-based sensors coupled with CRISPR/Cas9 to detect Zika RNA, as a new approach to rapid development and deployment of field-ready diagnostics for emerging infectious diseases.

Electrochemistry-based Approaches to Low Cost, High Sensitivity, Automated, Multiplexed Protein Immunoassays for Cancer Diagnostics

PubMed Central

Dixit, Chandra K.; Kadimisetty, Karteek; Otieno, Brunah A.; Tang, Chi; Malla, Spundana; Krause, Colleen E.; Rusling, James F.

2015-01-01

Early detection and reliable diagnostics are keys to effectively design cancer therapies with better prognoses. Simultaneous detection of panels of biomarker proteins holds great promise as a general tool for reliable cancer diagnostics. A major challenge in designing such a panel is to decide upon a coherent group of biomarkers which have higher specificity for a given type of cancer. The second big challenge is to develop test devices to measure these biomarkers quantitatively with high sensitivity and specificity, such that there are no interferences from the complex serum or tissue matrices. Lastly, integrating all these tests into a technology that doesn’t require exclusive training to operate, and can be used at point-of-care (POC) is another potential bottleneck in futuristic cancer diagnostics. In this article, we review electrochemistry-based tools and technologies developed and/or used in our laboratories to construct low-cost microfluidic protein arrays for highly sensitive detection of the panel of cancer-specific biomarkers with high specificity and at the same time have the potential to be translated into a POC. PMID:26525998

Electrochemistry-based approaches to low cost, high sensitivity, automated, multiplexed protein immunoassays for cancer diagnostics.

PubMed

Dixit, Chandra K; Kadimisetty, Karteek; Otieno, Brunah A; Tang, Chi; Malla, Spundana; Krause, Colleen E; Rusling, James F

2016-01-21

Early detection and reliable diagnostics are keys to effectively design cancer therapies with better prognoses. The simultaneous detection of panels of biomarker proteins holds great promise as a general tool for reliable cancer diagnostics. A major challenge in designing such a panel is to decide upon a coherent group of biomarkers which have higher specificity for a given type of cancer. The second big challenge is to develop test devices to measure these biomarkers quantitatively with high sensitivity and specificity, such that there are no interferences from the complex serum or tissue matrices. Lastly, integrating all these tests into a technology that does not require exclusive training to operate, and can be used at point-of-care (POC) is another potential bottleneck in futuristic cancer diagnostics. In this article, we review electrochemistry-based tools and technologies developed and/or used in our laboratories to construct low-cost microfluidic protein arrays for the highly sensitive detection of a panel of cancer-specific biomarkers with high specificity which at the same time has the potential to be translated into POC applications.

Technological Innovations for High-Throughput Approaches to In Vitro Allergy Diagnosis.

PubMed

Chapman, Martin D; Wuenschmann, Sabina; King, Eva; Pomés, Anna

2015-07-01

Allergy diagnostics is being transformed by the advent of in vitro IgE testing using purified allergen molecules, combined with multiplex technology and biosensors, to deliver discriminating, sensitive, and high-throughput molecular diagnostics at the point of care. Essential elements of IgE molecular diagnostics are purified natural or recombinant allergens with defined purity and IgE reactivity, planar or bead-based multiplex systems to enable IgE to multiple allergens to be measured simultaneously, and, most recently, nanotechnology-based biosensors that facilitate rapid reaction rates and delivery of test results via mobile devices. Molecular diagnostics relies on measurement of IgE to purified allergens, the "active ingredients" of allergenic extracts. Typically, this involves measuring IgE to multiple allergens which is facilitated by multiplex technology and biosensors. The technology differentiates between clinically significant cross-reactive allergens (which could not be deduced by conventional IgE assays using allergenic extracts) and provides better diagnostic outcomes. Purified allergens are manufactured under good laboratory practice and validated using protein chemistry, mass spectrometry, and IgE antibody binding. Recently, multiple allergens (from dog) were expressed as a single molecule with high diagnostic efficacy. Challenges faced by molecular allergy diagnostic companies include generation of large panels of purified allergens with known diagnostic efficacy, access to flexible and robust array or sensor technology, and, importantly, access to well-defined serum panels form allergic patients for product development and validation. Innovations in IgE molecular diagnostics are rapidly being brought to market and will strengthen allergy testing at the point of care.

The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination

PubMed Central

Rennie, Drummond; Bossuyt, Patrick M. M.

2008-01-01

Summary Objective The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Setting Nonsystematic review of the STARD statement. Interventions Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. Measurements and Main Results The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. Conclusions The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient’s history and physical examination. PMID:18347878

Current Guidelines, Common Clinical Pitfalls, and Future Directions for Laboratory Diagnosis of Lyme Disease, United States

PubMed Central

Moore, Andrew; Nelson, Christina; Molins, Claudia; Mead, Paul

2016-01-01

In the United States, Lyme disease is caused by Borrelia burgdorferi and transmitted to humans by blacklegged ticks. Patients with an erythema migrans lesion and epidemiologic risk can receive a diagnosis without laboratory testing. For all other patients, laboratory testing is necessary to confirm the diagnosis, but proper interpretation depends on symptoms and timing of illness. The recommended laboratory test in the United States is 2-tiered serologic analysis consisting of an enzyme-linked immunoassay or immunofluorescence assay, followed by reflexive immunoblotting. Sensitivity of 2-tiered testing is low (30%–40%) during early infection while the antibody response is developing (window period). For disseminated Lyme disease, sensitivity is 70%–100%. Specificity is high (>95%) during all stages of disease. Use of other diagnostic tests for Lyme disease is limited. We review the rationale behind current US testing guidelines, appropriate use and interpretation of tests, and recent developments in Lyme disease diagnostics. PMID:27314832

A systematic review of diagnostic criteria for psoriasis in adults and children: evidence from studies with a primary aim to develop or validate diagnostic criteria.

PubMed

Burden-Teh, E; Phillips, R C; Thomas, K S; Ratib, S; Grindlay, D; Murphy, R

2017-11-06

The diagnosis of psoriasis in adults and children is made clinically, for both patient management and the selection of participants in research. Diagnostic criteria provide a structure for clinical assessment, which in turn helps standardize patient recruitment into clinical trials and case definitions in observational studies. The aim of this systematic review was to identify and critically appraise the published studies to date that had a primary research aim to develop or validate diagnostic criteria for psoriasis. A search of Ovid MEDLINE and Ovid Embase was conducted in October 2016. The primary objective was to record the sensitivity and specificity of diagnostic criteria for psoriasis. Secondary objectives included diagnostic recommendations, applicability to children and study characteristics. Diagnostic accuracy studies were critically appraised for risk of bias using the QUADAS-2 tool. Twenty-three studies met the inclusion criteria. None detailed clinical examination-based diagnostic criteria. The included criteria varied from genetic and molecular diagnostic models to skin imaging, histopathology, and questionnaire-based, computer-aided and traditional Chinese medicine criteria. High sensitivity and specificity (> 90%) were reported in many studies. However, the study authors often did not specify how the criteria would be used clinically or in research. This review identified studies with varying risk of bias, and due to each study developing separate criteria meta-analysis was not possible. Clinical examination-based diagnostic criteria are currently lacking for psoriasis. Future research could follow an international collaborative approach and employ study designs allowing high-quality diagnostic accuracy testing. Existing and newly developed criteria require validation. © 2017 British Association of Dermatologists.

Improving the Efficiency and Quality of the Value Assessment Process for Companion Diagnostic Tests: The Companion test Assessment Tool (CAT).

PubMed

Canestaro, William J; Pritchard, Daryl E; Garrison, Louis P; Dubois, Robert; Veenstra, David L

2015-08-01

Companion diagnostic tests (CDTs) have emerged as a vital technology in the effective use of an increasing number of targeted drug therapies. Although CDTs can offer a multitude of potential benefits, assessing their value within a health technology appraisal process can be challenging because of a complex array of factors that influence clinical and economic outcomes. To develop a user-friendly tool to assist managed care and other health care decision makers in screening companion tests and determining whether an intensive technology review is necessary and, if so, where the review should be focused to improve efficiency. First, we conducted a systematic literature review of CDT cost-effectiveness studies to identify value drivers. Second, we conducted key informant interviews with a diverse group of stakeholders to elicit feedback and solicit any additional value drivers and identify desirable attributes for an evidence review tool. A draft tool was developed based on this information that captured value drivers, usability features, and had a particular focus on practical use by nonexperts. Finally, the tool was pilot tested with test developers and managed care evidence evaluators to assess face-validity and usability. The tool was also evaluated using several diverse examples of existing companion diagnostics and refined accordingly. We identified 65 cost-effectiveness studies of companion diagnostic technologies. The following factors were most commonly identified as value drivers from our literature review: clinical validity of testing; efficacy, safety, and cost of baseline and alternative treatments; cost and mortality of health states; and biomarker prevalence and testing cost. Stakeholders identified the following additional factors that they believed influenced the overall value of a companion test: regulatory status, actionability, utility, and market penetration. These factors were used to maximize the efficiency of the evidence review process. Stakeholders also stated that a tool should be easy to use and time efficient. Cognitive interviews with stakeholders led to minor changes in the draft tool to improve usability and relevance. The final tool consisted of 4 sections: (1) eligibility for review (2 questions), (2) prioritization of review (3 questions), (3) clinical review (3 questions), and (4) economic review (5 questions). Although the evaluation of CDTs can be challenging because of limited evidence and the added complexity of incorporating a diagnostic test into drug treatment decisions, using a pragmatic tool to identify tests that do not need extensive evaluation may improve the efficiency and effectiveness of CDT value assessments.

Global-to-local policy transfer in the introduction of new molecular tuberculosis diagnostics in South Africa.

PubMed

Colvin, C J; Leon, N; Wills, C; van Niekerk, M; Bissell, K; Naidoo, P

2015-11-01

Lack of innovation in diagnostics has contributed to tuberculosis (TB) remaining a global health challenge. It is critical to understand how new diagnostic technologies are translated into policies and how these are implemented. To examine policy transfer for two rapid molecular diagnostic tests, GenoType(®) MDRTBplus and Xpert(®) MTB/RIF, to understand policy development, uptake and implementation in South Africa. A policy transfer analysis framework integrating the key dimensions of policy transfer into one coherent model was used. Two phases of key informant interviews were undertaken with a wide range of stakeholders. Both tests were developed through innovative partnerships and responded to urgent public health needs. GenoType was introduced through a process that was more inclusive than that for Xpert. National policy and planning processes were opaque for both tests. Their implementation, maintenance and expansion suffered from poor communication and coordination, insufficient attention to resource implications, technical challenges and a lack of broader health systems thinking. Our analysis identified the risks and benefits of partnerships for technological innovation, the complex intersections between global and national actors and the impact of health systems on policy transfer, and the risks of rescue- and technology-focused thinking in addressing public health challenges.

Diagnostic Health Monitoring System Development for Army Vehicle Reliability

DTIC Science & Technology

2011-07-01

19-24 3.4 Receiver Operator Characteristics for fault detection ……………………….. 24-28 3.5 Extended diagnostic speed bump modal data analysis...extended diagnostic speed bump was akin to the use of modal impact testing for exciting broadband frequency ranges in mechanical systems for use in...for a front axle wheel crossing measured using long cleat for ( ) first 30, ( ) second 11, ( ) third 11, ( ) fourth 11, and ( ) fifth 11 data series

Current challenges in diagnostic imaging of venous thromboembolism.

PubMed

Huisman, Menno V; Klok, Frederikus A

2015-01-01

Because the clinical diagnosis of deep-vein thrombosis and pulmonary embolism is nonspecific, integrated diagnostic approaches for patients with suspected venous thromboembolism have been developed over the years, involving both non-invasive bedside tools (clinical decision rules and D-dimer blood tests) for patients with low pretest probability and diagnostic techniques (compression ultrasound for deep-vein thrombosis and computed tomography pulmonary angiography for pulmonary embolism) for those with a high pretest probability. This combination has led to standardized diagnostic algorithms with proven safety for excluding venous thrombotic disease. At the same time, it has become apparent that, as a result of the natural history of venous thrombosis, there are special patient populations in which the current standard diagnostic algorithms are not sufficient. In this review, we present 3 evidence-based patient cases to underline recent developments in the imaging diagnosis of venous thromboembolism. © 2015 by The American Society of Hematology. All rights reserved.

Mining balance disorders' data for the development of diagnostic decision support systems.

PubMed

Exarchos, T P; Rigas, G; Bibas, A; Kikidis, D; Nikitas, C; Wuyts, F L; Ihtijarevic, B; Maes, L; Cenciarini, M; Maurer, C; Macdonald, N; Bamiou, D-E; Luxon, L; Prasinos, M; Spanoudakis, G; Koutsouris, D D; Fotiadis, D I

2016-10-01

In this work we present the methodology for the development of the EMBalance diagnostic Decision Support System (DSS) for balance disorders. Medical data from patients with balance disorders have been analysed using data mining techniques for the development of the diagnostic DSS. The proposed methodology uses various data, ranging from demographic characteristics to clinical examination, auditory and vestibular tests, in order to provide an accurate diagnosis. The system aims to provide decision support for general practitioners (GPs) and experts in the diagnosis of balance disorders as well as to provide recommendations for the appropriate information and data to be requested at each step of the diagnostic process. Detailed results are provided for the diagnosis of 12 balance disorders, both for GPs and experts. Overall, the reported accuracy ranges from 59.3 to 89.8% for GPs and from 74.3 to 92.1% for experts. Copyright © 2016 Elsevier Ltd. All rights reserved.

Point-of-care diagnostics: an advancing sector with nontechnical issues.

PubMed

Huckle, David

2008-11-01

The particular reasons for the relative lack in development of point-of-care (PoC) diagnostics in a business context were discussed in our sister journal, Expert Review of Medical Devices, over 2 years ago. At that time, it could be seen that the concept of PoC testing was being revisited for at least the fifth time in the last 20 years. There had been important advances in technology but, with changes in global healthcare structures and funding, the overall in vitro diagnostics sector has had sluggish growth. Only molecular diagnostics and PoC testing are growing strongly. PoC testing is now a quarter of the total global in vitro diagnostics market, but largely due to use in diabetes monitoring. An increased focus on areas other than glucose self-testing has created a disturbance in the market. An implementation issue from this disturbance is that of control between central laboratories and the proposed sites for PoC testing. Evidence is presented to show that the first step is likely to be increased use in clinics and outpatient facilities closely linked with the laboratory. The aim will be to control the quality of the test, maintenance of equipment and provide support for the clinician in interpretation. The major problem for effective PoC implementation will be the significant changes to patient pathways that are required. The changes will benefit the patient and clinical outcomes but will require healthcare professionals to change their work patterns. This will be an uphill task!

Diagnostics of Polymer Composite Materials and Analysis of Their Production Technology by Using the Method of Acoustic Emission

NASA Astrophysics Data System (ADS)

Bashkov, O. V.; Protsenko, A. E.; Bryanskii, A. A.; Romashko, R. V.

2017-09-01

The strength properties of glass-fiber-reinforced plastics produced by vacuum and vacuum autoclave molding techniques are studied. Based on acoustic emission data, a method of diagnostic and prediction of the bearing capacity of polymer composite materials by using data from three-point bending tests is developed. The method is based on evaluating changes in the exponent of a power function relating the total acoustic emission to the test stress.

Structured syncope care pathways based on lean six sigma methodology optimises resource use with shorter time to diagnosis and increased diagnostic yield.

PubMed

Martens, Leon; Goode, Grahame; Wold, Johan F H; Beck, Lionel; Martin, Georgina; Perings, Christian; Stolt, Pelle; Baggerman, Lucas

2014-01-01

To conduct a pilot study on the potential to optimise care pathways in syncope/Transient Loss of Consciousness management by using Lean Six Sigma methodology while maintaining compliance with ESC and/or NICE guidelines. Five hospitals in four European countries took part. The Lean Six Sigma methodology consisted of 3 phases: 1) Assessment phase, in which baseline performance was mapped in each centre, processes were evaluated and a new operational model was developed with an improvement plan that included best practices and change management; 2) Improvement phase, in which optimisation pathways and standardised best practice tools and forms were developed and implemented. Staff were trained on new processes and change-management support provided; 3) Sustaining phase, which included support, refinement of tools and metrics. The impact of the implementation of new pathways was evaluated on number of tests performed, diagnostic yield, time to diagnosis and compliance with guidelines. One hospital with focus on geriatric populations was analysed separately from the other four. With the new pathways, there was a 59% reduction in the average time to diagnosis (p = 0.048) and a 75% increase in diagnostic yield (p = 0.007). There was a marked reduction in repetitions of diagnostic tests and improved prioritisation of indicated tests. Applying a structured Lean Six Sigma based methodology to pathways for syncope management has the potential to improve time to diagnosis and diagnostic yield.

Structured Syncope Care Pathways Based on Lean Six Sigma Methodology Optimises Resource Use with Shorter Time to Diagnosis and Increased Diagnostic Yield

PubMed Central

Martens, Leon; Goode, Grahame; Wold, Johan F. H.; Beck, Lionel; Martin, Georgina; Perings, Christian; Stolt, Pelle; Baggerman, Lucas

2014-01-01

Aims To conduct a pilot study on the potential to optimise care pathways in syncope/Transient Loss of Consciousness management by using Lean Six Sigma methodology while maintaining compliance with ESC and/or NICE guidelines. Methods Five hospitals in four European countries took part. The Lean Six Sigma methodology consisted of 3 phases: 1) Assessment phase, in which baseline performance was mapped in each centre, processes were evaluated and a new operational model was developed with an improvement plan that included best practices and change management; 2) Improvement phase, in which optimisation pathways and standardised best practice tools and forms were developed and implemented. Staff were trained on new processes and change-management support provided; 3) Sustaining phase, which included support, refinement of tools and metrics. The impact of the implementation of new pathways was evaluated on number of tests performed, diagnostic yield, time to diagnosis and compliance with guidelines. One hospital with focus on geriatric populations was analysed separately from the other four. Results With the new pathways, there was a 59% reduction in the average time to diagnosis (p = 0.048) and a 75% increase in diagnostic yield (p = 0.007). There was a marked reduction in repetitions of diagnostic tests and improved prioritisation of indicated tests. Conclusions Applying a structured Lean Six Sigma based methodology to pathways for syncope management has the potential to improve time to diagnosis and diagnostic yield. PMID:24927475

Determination of the optimal cutoff value for a serological assay: an example using the Johne's Absorbed EIA.

PubMed Central

Ridge, S E; Vizard, A L

1993-01-01

Traditionally, in order to improve diagnostic accuracy, existing tests have been replaced with newly developed diagnostic tests with superior sensitivity and specificity. However, it is possible to improve existing tests by altering the cutoff value chosen to distinguish infected individuals from uninfected individuals. This paper uses data obtained from an investigation of the operating characteristics of the Johne's Absorbed EIA to demonstrate a method of determining a preferred cutoff value from several potentially useful cutoff settings. A method of determining the financial gain from using the preferred rather than the current cutoff value and a decision analysis method to assist in determining the optimal cutoff value when critical population parameters are not known with certainty are demonstrated. The results of this study indicate that the currently recommended cutoff value for the Johne's Absorbed EIA is only close to optimal when the disease prevalence is very low and false-positive test results are deemed to be very costly. In other situations, there were considerable financial advantages to using cutoff values calculated to maximize the benefit of testing. It is probable that the current cutoff values for other diagnostic tests may not be the most appropriate for every testing situation. This paper offers methods for identifying the cutoff value that maximizes the benefit of medical and veterinary diagnostic tests. PMID:8501227

Development of a Three-Tier Test as a Valid Diagnostic Tool for Identification of Misconceptions Related to Carbohydrates

ERIC Educational Resources Information Center

Milenkovic, Dusica D.; Hrin, Tamara N.; Segedinac, Mirjana D.; Horvat, Sasa

2016-01-01

This study describes the development and application of a three-tier test as a valid and reliable tool in diagnosing students' misconceptions regarding some basic concepts about carbohydrates. The test was administrated to students of the Pharmacy Department at the University of Bijeljina (Serb Republic). The results denoted construct and content…

Multidimensional Approach to the Development of a Mandarin Chinese-Oriented Sound Test

ERIC Educational Resources Information Center

Hung, Yu-Chen; Lin, Chun-Yi; Tsai, Li-Chiun; Lee, Ya-Jung

2016-01-01

Purpose: Because the Ling six-sound test is based on American English phonemes, it can yield unreliable results when administered to non-English speakers. In this study, we aimed to improve specifically the diagnostic palette for Mandarin Chinese users by developing an adapted version of the Ling six-sound test. Method: To determine the set of…

Clinical diagnosis of partial or complete anterior cruciate ligament tears using patients' history elements and physical examination tests.

PubMed

Décary, Simon; Fallaha, Michel; Belzile, Sylvain; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Feldman, Debbie; Sylvestre, Marie-Pierre; Vendittoli, Pascal-André; Desmeules, François

2018-01-01

To assess the diagnostic validity of clusters combining history elements and physical examination tests to diagnose partial or complete anterior cruciate ligament (ACL) tears. Prospective diagnostic study. Orthopaedic clinics (n = 2), family medicine clinics (n = 2) and community-dwelling. Consecutive patients with a knee complaint (n = 279) and consulting one of the participating orthopaedic surgeons (n = 3) or sport medicine physicians (n = 2). Not applicable. History elements and physical examination tests performed independently were compared to the reference standard: an expert physicians' composite diagnosis including history elements, physical tests and confirmatory magnetic resonance imaging. Penalized logistic regression (LASSO) was used to identify history elements and physical examination tests associated with the diagnosis of ACL tear and recursive partitioning was used to develop diagnostic clusters. Diagnostic accuracy measures including sensitivity (Se), specificity (Sp), predictive values and positive and negative likelihood ratios (LR+/-) with associated 95% confidence intervals (CI) were calculated. Forty-three individuals received a diagnosis of partial or complete ACL tear (15.4% of total cohort). The Lachman test alone was able to diagnose partial or complete ACL tears (LR+: 38.4; 95%CI: 16.0-92.5). Combining a history of trauma during a pivot with a "popping" sensation also reached a high diagnostic validity for partial or complete tears (LR+: 9.8; 95%CI: 5.6-17.3). Combining a history of trauma during a pivot, immediate effusion after trauma and a positive Lachman test was able to identify individuals with a complete ACL tear (LR+: 17.5; 95%CI: 9.8-31.5). Finally, combining a negative history of pivot or a negative popping sensation during trauma with a negative Lachman or pivot shift test was able to exclude both partial or complete ACL tears (LR-: 0.08; 95%CI: 0.03-0.24). Diagnostic clusters combining history elements and physical examination tests can support the differential diagnosis of ACL tears compared to various knee disorders.

Nested-PCR and a new ELISA-based NovaLisa test kit for malaria diagnosis in an endemic area of Thailand.

PubMed

Thongdee, Pimwan; Chaijaroenkul, Wanna; Kuesap, Jiraporn; Na-Bangchang, Kesara

2014-08-01

Microscopy is considered as the gold standard for malaria diagnosis although its wide application is limited by the requirement of highly experienced microscopists. PCR and serological tests provide efficient diagnostic performance and have been applied for malaria diagnosis and research. The aim of this study was to investigate the diagnostic performance of nested PCR and a recently developed an ELISA-based new rapid diagnosis test (RDT), NovaLisa test kit, for diagnosis of malaria infection, using microscopic method as the gold standard. The performance of nested-PCR as a malaria diagnostic tool is excellent with respect to its high accuracy, sensitivity, specificity, and ability to discriminate Plasmodium species. The sensitivity and specificity of nested-PCR compared with the microscopic method for detection of Plasmodium falciparum, Plasmodium vivax, and P. falciparum/P. vivax mixed infection were 71.4 vs 100%, 100 vs 98.7%, and 100 vs 95.0%, respectively. The sensitivity and specificity of the ELISA-based NovaLisa test kit compared with the microscopic method for detection of Plasmodium genus were 89.0 vs 91.6%, respectively. NovaLisa test kit provided comparable diagnostic performance. Its relatively low cost, simplicity, and rapidity enables large scale field application.

Lyssaviruses: special emphasis on rabies virus and other members of the lyssavirus genus.

PubMed

Harkess, Graeme; Fooks, Anthony R

2011-01-01

Rabies is routinely diagnosed based on the clinical description and history of exposure in a rabies-endemic country. A negative diagnostic test for rabies virus or a related lyssavirus does not exclude the clinical diagnosis. Diagnostic tests are never optimal and are entirely dependent on the nature and quality of the sample supplied. Often, only a sample from a single time point is investigated reducing the overall sensitivity of any diagnosis. With the advent of molecular biology, tests have been developed that are rapid, robust, and sensitive in support of the rapid detection and strain identification of rabies virus from clinical specimens. These molecular tests complement conventional tests in rabies diagnosis, particularly for human cases, for which an early laboratory diagnosis is critical and may decrease the number of unnecessary contacts with the patient, reduce the requirement for invasive and costly interventions, and enable the appropriate medical treatment regimen to be administered for the patient. The barrier to success is in transferring the technology for the latest techniques in rabies diagnosis to rabies-endemic countries. These barriers are not insurmountable and in liaison with international organisations, especially OIE, FAO, and WHO, these diagnostic tests will be validated for rabies diagnosis and surveillance, and implemented in modern and well-equipped diagnostic laboratories throughout the world.

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...

[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.

What Health Problems Can Develop during Pregnancy?

MedlinePlus

... glucose challenge screening test around 24 to 28 weeks of pregnancy, followed by a diagnostic test called ... of protein in the urine after the 20th week of pregnancy), and cesarean birth . Treatment includes controlling ...

Technical Highlight: NREL Improves Building Energy Simulation Programs Through Diagnostic Testing

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

Polly, B.

2012-01-09

This technical highlight describes NREL research to develop Building Energy Simulation Test for Existing Homes (BESTEST-EX) to increase the quality and accuracy of energy analysis tools for the building retrofit market.

Development of a miRNA-based diagnostic assay for pancreatic ductal adenocarcinoma.

PubMed

Szafranska-Schwarzbach, Anna E; Adai, Alex T; Lee, Linda S; Conwell, Darwin L; Andruss, Bernard F

2011-04-01

Diagnosis of pancreatic cancer remains a clinical challenge. Both chronic pancreatitis and pancreatic cancer may present with similar symptoms and similar imaging features, often leading to incorrect interpretation. Thus, the use of an objective molecular test that can discriminate between chronic pancreatitis and pancreatic cancer will be a valuable asset in obtaining a definitive diagnosis of pancreatic cancer. Following Clinical Laboratory Improvement Amendments and College of American Pathologists guidelines, Asuragen Clinical Services Laboratory has developed and validated a laboratory-developed test, miRInform(®) Pancreas, to aid in the identification of pancreatic ductal adenocarcinoma. This molecular diagnostic tool uses reverse-transcription quantitative PCR to measure the expression difference between two miRNAs, miR-196a and miR-217, in fixed tissue specimens. This article describes the test validation process as well as determination of performance parameters of miRInform Pancreas.

Testing. Occasional Papers 21.

ERIC Educational Resources Information Center

Culhane, P. T., Ed.; White, J., Ed.

Five papers on testing in English as a second language are included in this volume. "A Preliminary Diagnostic Test for Adult Immigrants" by Johan I. Arthur presents the first stage in a project to develop a test for limited English speaking adults in the Colchester, Essex area. "An Initial Testing Battery on a Course for Air Traffic…

Educating Consumers in Self-Testing: The Development of an Online Decision Aid

ERIC Educational Resources Information Center

Ickenroth, Martine H. P.; Grispen, Janaica E. J.; Ronda, Gaby; Dinant, Geert-Jan; de Vries, Nanne K.; van der Weijden, Trudy

2015-01-01

Context and objective: Diagnostic self-tests have become available worldwide. The most frequently performed self-tests in the Netherlands are tests to detect high cholesterol and diabetes. Since these tests can be performed without professional guidance, potential consumers need to receive independent information on the pros and cons of…

Spinal meningioma, aortic aneurysms and the missing link of observation: the anchoring heuristic approach.

PubMed

Floros, Nikolaos; Papadakis, Marios; Schelzig, Hubert; Oberhuber, Alexander

2018-03-10

Over the last three decades, the development of systematic and protocol-based algorithms, and advances in available diagnostic tests have become the indispensable parts of practising medicine. Naturally, despite the implementation of meticulous protocols involving diagnostic tests or even trials of empirical therapies, the cause of one's symptoms may still not be obvious. We herein report a case of chronic back pain, which took about 5 years to get accurately diagnosed. The case challenges the diagnostic assumptions and sets ground of discussion for the diagnostic reasoning pitfalls and heuristic biases that mislead the caring physicians and cost years of low quality of life to our patient. This case serves as an example of how anchoring heuristics can interfere in the diagnostic process of a complex and rare entity when combined with a concurrent potentially life-threatening condition. © BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Computer Vision Malaria Diagnostic Systems-Progress and Prospects.

PubMed

Pollak, Joseph Joel; Houri-Yafin, Arnon; Salpeter, Seth J

2017-01-01

Accurate malaria diagnosis is critical to prevent malaria fatalities, curb overuse of antimalarial drugs, and promote appropriate management of other causes of fever. While several diagnostic tests exist, the need for a rapid and highly accurate malaria assay remains. Microscopy and rapid diagnostic tests are the main diagnostic modalities available, yet they can demonstrate poor performance and accuracy. Automated microscopy platforms have the potential to significantly improve and standardize malaria diagnosis. Based on image recognition and machine learning algorithms, these systems maintain the benefits of light microscopy and provide improvements such as quicker scanning time, greater scanning area, and increased consistency brought by automation. While these applications have been in development for over a decade, recently several commercial platforms have emerged. In this review, we discuss the most advanced computer vision malaria diagnostic technologies and investigate several of their features which are central to field use. Additionally, we discuss the technological and policy barriers to implementing these technologies in low-resource settings world-wide.

Demise of Polymerase Chain Reaction/Electrospray Ionization-Mass Spectrometry as an Infectious Diseases Diagnostic Tool.

PubMed

Özenci, Volkan; Patel, Robin; Ullberg, Måns; Strålin, Kristoffer

2018-01-18

Although there are several US Food and Drug Administration (FDA)-approved/cleared molecular microbiology diagnostics for direct analysis of patient samples, all are single target or panel-based tests. There is no FDA-approved/cleared diagnostic for broad microbial detection. Polymerase chain reaction (PCR)/electrospray ionization-mass spectrometry (PCR/ESI-MS), commercialized as the IRIDICA system (Abbott) and formerly PLEX-ID, had been under development for over a decade and had become CE-marked and commercially available in Europe in 2014. Capable of detecting a large number of microorganisms, it was under review at the FDA when, in April 2017, Abbott discontinued it. This turn of events represents not only the loss of a potential diagnostic tool for infectious diseases but may be a harbinger of similar situations with other emerging and expensive microbial diagnostics, especially genomic tests. © The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Moderate reagent mixing on an orbital shaker reduces the incubation time of enzyme-linked immunosorbent assay.

PubMed

Kumar, Saroj; Ahirwar, Rajesh; Rehman, Ishita; Nahar, Pradip

2017-07-01

Rapid diagnostic tests can be developed using ELISA for detection of diseases in emergency conditions. Conventional ELISA takes 1-2 days, making it unsuitable for rapid diagnostics. Here, we report the effect of reagents mixing via shaking or vortexing on the assay timing of ELISA. A 48-min protocol of ELISA involving 12-min incubations with reagent mixing at 750 rpm for every step was optimized. Contrary to this, time-optimized control ELISA performed without mixing produced similar results in 8 h, leaving a time gain of 7 h using the developed protocol. Collectively, the findings suggest the development of ELISA-based rapid diagnostics. Copyright © 2017 Elsevier Inc. All rights reserved.

Costs of novel tuberculosis diagnostics--will countries be able to afford it?

PubMed

Pantoja, Andrea; Kik, Sandra V; Denkinger, Claudia M

2015-04-01

Four priority target product profiles for the development of diagnostic tests for tuberculosis were identified: 1) Rapid sputum-based (RSP), 2) non-sputum Biomarker-based (BMT), 3) triage test followed by confirmatory test (TT), and 4) drug-susceptibility testing (DST). We assessed the cost of the new tests in suitable strategies and of the conventional diagnosis of tuberculosis as per World Health Organization guidelines, in 36 high tuberculosis and MDR burden countries. Costs were then compared to the available funding for tuberculosis at country level. Costs of diagnosing tuberculosis using RSP ranged US$93-187 million/year; if RSP unit cost is of US$2-4 it would be lower/similar cost than conventional strategy with sputum smear microscopy (US$ 119 million/year). Using BMT (with unit cost of US$2-4) would cost US$70-121 million/year and be lower/comparable cost than conventional diagnostics. Using TT with TPP characteristics (unit cost of US$1-2) followed by Xpert would reduce diagnostic costs up to US$36 million/year. Costs of using different novel DST strategies for the diagnosis of drug resistance would be higher compared with conventional diagnosis. Introducing a TT or a biomarker test with optimal characteristics would be affordable from a cost and affordability perspective at the current available funding for tuberculosis. Additional domestic or donor funding would be needed in most countries to achieve affordability for other new diagnostic tests. © 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 Neisseria gonorrhoeae Using Molecular Beacon

PubMed Central

Patel, Achchhe Lal; Sonkar, Subash Chandra; Kumari, Indu; Saluja, Daman

2015-01-01

Neisseria gonorrhoeae is an important sexually transmitted diseases (STD) causing pathogen worldwide. Due to absence of an affordable diagnostic assay, routine screening of gonococcal infection becomes impossible in developing countries where infection rates are maximum. Treatment is given on the basis of symptoms alone which leads to spread of infection. Thus, development of a rapid, sensitive, specific, and PCR based visual diagnostic assay suitable for developing countries, required for better disease management, is aimed at in present study. Endocervical swabs were collected from patients visiting gynecology department of various hospitals in Delhi. In-house PCR based assay was developed and modified to visual assay using molecular beacon for end-point detection. It was evaluated against Roche AMPLICOR NG kit and rmp gene. Specificity of beacon was confirmed by competition experiments. Diagnostic test was 98.21% specific and 99.59% sensitive whereas negative and positive predicted value were 99.40% and 98.78%, respectively. We also observed that twice the concentration (2X) of premix was stable at 4°C for 4 months and dry swab samples gave concordant results with that of wet swabs. These features make the test best suitable for routine diagnosis of genital infections in developing countries. PMID:25802857

Interactive visualisation for interpreting diagnostic test accuracy study results.

PubMed

Fanshawe, Thomas R; Power, Michael; Graziadio, Sara; Ordóñez-Mena, José M; Simpson, John; Allen, Joy

2018-02-01

Information about the performance of diagnostic tests is typically presented in the form of measures of test accuracy such as sensitivity and specificity. These measures may be difficult to translate directly into decisions about patient treatment, for which information presented in the form of probabilities of disease after a positive or a negative test result may be more useful. These probabilities depend on the prevalence of the disease, which is likely to vary between populations. This article aims to clarify the relationship between pre-test (prevalence) and post-test probabilities of disease, and presents two free, online interactive tools to illustrate this relationship. These tools allow probabilities of disease to be compared with decision thresholds above and below which different treatment decisions may be indicated. They are intended to help those involved in communicating information about diagnostic test performance and are likely to be of benefit when teaching these concepts. A substantive example is presented using C reactive protein as a diagnostic marker for bacterial infection in the older adult population. The tools may also be useful for manufacturers of clinical tests in planning product development, for authors of test evaluation studies to improve reporting and for users of test evaluations to facilitate interpretation and application of the results. © 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.

New diagnostics for latent and active tuberculosis: state of the art and future prospects.

PubMed

Pai, Madhukar; O'Brien, Richard

2008-10-01

Tuberculosis (TB) continues to be the world's most important infectious cause of morbidity and mortality among adults. Nearly 9 million people develop TB disease each year, and an estimated 1.6 million die from the disease. Despite this enormous global burden, case detection rates are low, posing serious hurdles for TB control. Conventional TB diagnosis continues to rely on antiquated tests such as sputum smear microscopy, culture, tuberculin skin test, and chest radiography. These tests have several limitations and perform poorly in populations affected by the HIV epidemic. Conventional tests for detection of drug resistance are time consuming, tedious, and inaccessible in most settings. In this review, we describe recent advances in the diagnosis of latent and active TB, and detection of drug resistance. Although the perfect test will not be ready for large-scale roll-out and integration into routine TB care services for some time, substantial progress has been made in expanding the TB diagnostic product pipeline. With the resurgence of interest in the development of new tools for TB control, and the recent influx of funding and political support, it is likely that the next few years will see the introduction of new diagnostic tools into routine TB control programs.

Diagnosis and therapy with CRISPR advanced CRISPR based tools for point of care diagnostics and early therapies.

PubMed

Uppada, Vanita; Gokara, Mahesh; Rasineni, Girish Kumar

2018-05-20

Molecular diagnostics is of critical importance to public health worldwide. It facilitates not only detection and characterization of diseases, but also monitors drug responses, assists in the identification of genetic modifiers and disease susceptibility. Based upon DNA variation, a wide range of molecular-based tests are available to assess/diagnose diseases. The CRISPR-Cas9 system has recently emerged as a versatile tool for biological and medical research. In this system, a single guide RNA (sgRNA) directs the endonuclease Cas9 to a targeted DNA sequence for site-specific manipulation. As designing CRISPR-guided nucleases can be done easily and relatively fast, the CRISPR/Cas9 system has evolved as widely used DNA editing tool. This technique led to a large number of gene editing studies in variety of organisms. CRISPR/Cas9-mediated diagnosis and therapy has picked up pace due to specificity and accuracy of CRISPR. The aim is not only to identify specific pathogens, especially virus but also to repair disease-causing alleles by changing the DNA sequence at the exact location on the chromosome. At present, PCR-based molecular diagnostic testing predominates; however, alternative technologies aimed at reducing genome complexity without PCR are anticipated to gain momentum in the coming years. Furthermore, development of integrated chip devices should allow point-of-care testing and facilitate genetic readouts from single cells and molecules. Together with molecular based therapy CRISPR based diagnostic testing will be a revolution in modern health care settings. In this review, we emphasize on current developing diagnostic techniques based upon CRISPR Cas approach along with short insights on its therapeutic usage. Copyright © 2018 Elsevier B.V. All rights reserved.

Multiple dopant injection system for small rocket engines

NASA Technical Reports Server (NTRS)

Sakala, G. G.; Raines, N. G.

1992-01-01

The Diagnostics Test Facility (DTF) at NASA's Stennis Space Center (SSC) was designed and built to provide a standard rocket engine exhaust plume for use in the research and development of engine health monitoring instrumentation. A 1000 lb thrust class liquid oxygen (LOX)-gaseous hydrogen (GH2) fueled rocket engine is used as the subscale plume source to simulate the SSME during experimentation and instrument development. The ability of the DTF to provide efficient, and low cost test operations makes it uniquely suited for plume diagnostic experimentation. The most unique feature of the DTF is the Multiple Dopant Injection System (MDIS) that is used to seed the exhaust plume with the desired element or metal alloy. The dopant injection takes place at the fuel injector, yielding a very uniform and homogeneous distribution of the seeding material in the exhaust plume. The MDIS allows during a single test firing of the DTF, the seeding of the exhaust plume with up to three different dopants and also provides distilled water base lines between the dopants. A number of plume diagnostic-related experiments have already utilized the unique capabilities of the DTF.

Clinical pathologist in Korea--training program and its roles in laboratories.

PubMed

Cho, Han-Ik; Lee, Kap No; Park, Jong-Woo; Park, Hyosoon; Kwak, Yun Sik

2002-01-01

A rapid development of practice of laboratory medicine in Korea owes its success to the clinical pathologists (CP), who have played a role of a pathfinder for laboratories. The Korean CP postgraduate education (residency) program is unique in that it is exclusively for laboratory medicine. The training program for clinical pathologists includes diagnostic hematology, diagnostic immunology, clinical microbiology, clinical chemistry, blood bank, diagnostic genetics, informatics and laboratory management. The program has produced a strong group of about 600 laboratory physicians, officially clinical pathologists since 1963. Most of Korean clinical pathologists work as laboratory directors, directors of university hospital laboratories or teaching faculty members in medical schools. The roles of clinical pathologists are laboratory management, interpretation of laboratory test results, clinical consulting services to clinicians and patients, ordering secondary tests after reviews of requested test results and utilization management. The clinical pathologists have developed clinical laboratories to be a main contributor for improved medical practice. During the last 40 years under the turbulent healthcare system, clinical pathologists have significantly contributed to safeguard the laboratory interests. The education program and the role of clinical pathologists are described.

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...

Fully 3D printed integrated reactor array for point-of-care molecular diagnostics.

PubMed

Kadimisetty, Karteek; Song, Jinzhao; Doto, Aoife M; Hwang, Young; Peng, Jing; Mauk, Michael G; Bushman, Frederic D; Gross, Robert; Jarvis, Joseph N; Liu, Changchun

2018-06-30

Molecular diagnostics that involve nucleic acid amplification tests (NAATs) are crucial for prevention and treatment of infectious diseases. In this study, we developed a simple, inexpensive, disposable, fully 3D printed microfluidic reactor array that is capable of carrying out extraction, concentration and isothermal amplification of nucleic acids in variety of body fluids. The method allows rapid molecular diagnostic tests for infectious diseases at point of care. A simple leak-proof polymerization strategy was developed to integrate flow-through nucleic acid isolation membranes into microfluidic devices, yielding a multifunctional diagnostic platform. Static coating technology was adopted to improve the biocompatibility of our 3D printed device. We demonstrated the suitability of our device for both end-point colorimetric qualitative detection and real-time fluorescence quantitative detection. We applied our diagnostic device to detection of Plasmodium falciparum in plasma samples and Neisseria meningitides in cerebrospinal fluid (CSF) samples by loop-mediated, isothermal amplification (LAMP) within 50 min. The detection limits were 100 fg for P. falciparum and 50 colony-forming unit (CFU) for N. meningitidis per reaction, which are comparable to that of benchtop instruments. This rapid and inexpensive 3D printed device has great potential for point-of-care molecular diagnosis of infectious disease in resource-limited settings. Copyright © 2018 Elsevier B.V. All rights reserved.

The current status and future potential of personalized diagnostics: Streamlining a customized process.

PubMed

Richmond, Terri D

2008-01-01

Recent genetic discoveries and related developments in genomic techniques have led to the commercialization of novel diagnostic platforms for studying disease or gauging therapeutic outcomes in individual patients. This newly emerging field is called "personalized medicine," and uses the patient's genetic composition to tailor strategies for patient-specific disease detection, treatment, or prevention. Personalized diagnostic tests are used to detect patient-to-patient variations in gene or protein expression levels, which act as indicators for drug treatments or disease prognosis. In turn, medical professionals can better answer questions such as: "Who should be treated with which drug?" and "How should the treatment be administered?" The regulations governing personalized medicine can be complicated because they encompass in vitro diagnostic systems and laboratory tests as well as methods of disease treatment and patient care. Industry, academia, medicine, and the Food and Drug Administration (FDA) are all involved in the cultivation of the field: substantial collaborations between drug developers and regulatory authorities are required to consider and shape emerging regulations as personalized drug strategies mature. Some of the regulatory issues identified by industry and the FDA about personalized medicine and personalized diagnostics will be addressed. In addition, relevant collaborations, advances, and current and draft regulatory guidances will be discussed with respect to the future of personalized medicine.

Quantitative polymerase chain reaction (PCR) for detection of aquatic animal pathogens in a diagnostic laboratory setting

USGS Publications Warehouse

Purcell, Maureen K.; Getchell, Rodman G.; McClure, Carol A.; Weber, S.E.; Garver, Kyle A.

2011-01-01

Real-time, or quantitative, polymerase chain reaction (qPCR) is quickly supplanting other molecular methods for detecting the nucleic acids of human and other animal pathogens owing to the speed and robustness of the technology. As the aquatic animal health community moves toward implementing national diagnostic testing schemes, it will need to evaluate how qPCR technology should be employed. This review outlines the basic principles of qPCR technology, considerations for assay development, standards and controls, assay performance, diagnostic validation, implementation in the diagnostic laboratory, and quality assurance and control measures. These factors are fundamental for ensuring the validity of qPCR assay results obtained in the diagnostic laboratory setting.

Microfluidic technology for molecular diagnostics.

PubMed

Robinson, Tom; Dittrich, Petra S

2013-01-01

Molecular diagnostics have helped to improve the lives of millions of patients worldwide by allowing clinicians to diagnose patients earlier as well as providing better ongoing therapies. Point-of-care (POC) testing can bring these laboratory-based techniques to the patient in a home setting or to remote settings in the developing world. However, despite substantial progress in the field, there still remain many challenges. Progress in molecular diagnostics has benefitted greatly from microfluidic technology. This chapter aims to summarise the more recent advances in microfluidic-based molecular diagnostics. Sections include an introduction to microfluidic technology, the challenges of molecular diagnostics, how microfluidic advances are working to solve these issues, some alternative design approaches, and detection within these systems.

Natural rubber latex skin testing reagents: safety and diagnostic accuracy of nonammoniated latex, ammoniated latex, and latex rubber glove extracts.

PubMed

Hamilton, R G; Adkinson, N F

1996-11-01

Nonammoniated latex, ammoniated latex, and rubber glove extracts are the only sources of natural rubber (Hevea brasiliensis) latex that have potential for use as skin testing reagents in the diagnosis of latex allergy. Their diagnostic sensitivity and specificity as skin test reagents are unknown. We conducted a phase 1/2 clinical study to examine the safety and diagnostic accuracy (sensitivity and specificity) of nonammoniated latex, ammoniated latex, and rubber glove extracts as skin test extracts to identify the most efficacious source material for future skin test reagent development. Twenty-four adults not allergic to latex, 19 adults with hand dermatitis or pruritus, and 59 adults with a latex allergy were identified by clinical history. All provided blood and then received puncture skin tests and intradermal skin tests with nonammoniated latex, ammoniated latex, and rubber glove extracts from Malaysian H. brasiliensis latex by use of sequential titration. A glove provocation test and IgE anti-latex RAST were used to clarify positive history-negative skin test response and negative history-positive skin test response mismatches. All three extracts were biologically safe and sterile. After normalization to 1 mg/ml of total protein, all three extracts produced equivalent diagnostic sensitivity and specificity in puncture skin tests and intradermal skin tests at various extract concentrations. Optimal diagnostic accuracy was safely achieved at 100 micrograms/ml for intradermal skin tests (e.g., nonammoniated latex: puncture skin test sensitivity 96%, specificity 100%; intradermal skin test sensitivity 93%, specificity 96%). The presence of IgE antibody in skin was highly correlated with IgE anti-latex in serum (nonammoniated latex: r = 0.98, p < 0.001; ammoniated latex: r = 0.94, p < 0.001; rubber glove extract: r = 0.96, p < 0.001). All five available subjects with a positive history, negative skin test response, and absence of IgE antibody in serum had a negative glove provocation test response, indicating no clinical evidence of latex allergy. No systemic or large local allergic reactions were observed with puncture skin tests or intradermal skin tests. Equivalent diagnostic sensitivity and specificity were observed with the nonammoniated latex, ammoniated latex, and rubber glove extract skin test reagents after normalization for total protein; nonammoniated latex may be considered the reagent of choice on the basis of practical quality control and reproducibility considerations.

The current and future state of companion diagnostics

PubMed Central

Agarwal, Amit; Ressler, Dan; Snyder, Glenn

2015-01-01

Companion diagnostics are an indispensable part of personalized medicine and will likely continue to rapidly increase in number and application to disease areas. The first companion diagnostics were launched in the 1980s and in the face of significant initial skepticism from drug developers as to whether segmenting a drug’s market through a diagnostic was advisable. The commercial success of drugs such as Herceptin® (trastuzumab) and Gleevec® (imatinib), which both require testing with companion diagnostics before they can be prescribed, has moved the entire companion diagnostic field forward. From an initial start of a handful of oncology drugs with corresponding diagnostics, the field has expanded to include multiple therapeutic areas, and the number of combinations has grown by 12-fold. Based on drugs in clinical trials, the rapid growth will likely continue for the foreseeable future. This expansion of companion diagnostics will also have a global component as markets in Europe will evolve in a similar but not identical pattern as the US. One of the greatest challenges to future growth in companion diagnostics is aligning the incentives of all stakeholders. A major driver of growth will continue to be the economic incentives for drug developers to pair their products with diagnostics. However, diagnostic companies are caught between the conflicting demands of two major stakeholders, pharmaceutical companies on one hand and payers/providers on the other. Regulators are also becoming more demanding in aligning development time lines between drugs and diagnostics. In order to survive and prosper, diagnostic companies will need to think more broadly about companion diagnostics than the historical match between a specific drug and a single diagnostic. They will also have to continue the process of consolidation and global expansion that the industry has already begun. Despite these potential obstacles, companion diagnostics have become one of the hottest areas of deal making in the diagnostic space in recent years, and the future trends continue to look bright. PMID:25897259

Estimating the Burden of Pneumococcal Pneumonia among Adults: A Systematic Review and Meta-Analysis of Diagnostic Techniques

PubMed Central

Said, Maria A.; Johnson, Hope L.; Nonyane, Bareng A. S.; Deloria-Knoll, Maria; O′Brien, Katherine L.

2013-01-01

Background Pneumococcal pneumonia causes significant morbidity and mortality among adults. Given limitations of diagnostic tests for non-bacteremic pneumococcal pneumonia, most studies report the incidence of bacteremic or invasive pneumococcal disease (IPD), and thus, grossly underestimate the pneumococcal pneumonia burden. We aimed to develop a conceptual and quantitative strategy to estimate the non-bacteremic disease burden among adults with community-acquired pneumonia (CAP) using systematic study methods and the availability of a urine antigen assay. Methods and Findings We performed a systematic literature review of studies providing information on the relative yield of various diagnostic assays (BinaxNOW® S. pneumoniae urine antigen test (UAT) with blood and/or sputum culture) in diagnosing pneumococcal pneumonia. We estimated the proportion of pneumococcal pneumonia that is bacteremic, the proportion of CAP attributable to pneumococcus, and the additional contribution of the Binax UAT beyond conventional diagnostic techniques, using random effects meta-analytic methods and bootstrapping. We included 35 studies in the analysis, predominantly from developed countries. The estimated proportion of pneumococcal pneumonia that is bacteremic was 24.8% (95% CI: 21.3%, 28.9%). The estimated proportion of CAP attributable to pneumococcus was 27.3% (95% CI: 23.9%, 31.1%). The Binax UAT diagnosed an additional 11.4% (95% CI: 9.6, 13.6%) of CAP beyond conventional techniques. We were limited by the fact that not all patients underwent all diagnostic tests and by the sensitivity and specificity of the diagnostic tests themselves. We address these resulting biases and provide a range of plausible values in order to estimate the burden of pneumococcal pneumonia among adults. Conclusions Estimating the adult burden of pneumococcal disease from bacteremic pneumococcal pneumonia data alone significantly underestimates the true burden of disease in adults. For every case of bacteremic pneumococcal pneumonia, we estimate that there are at least 3 additional cases of non-bacteremic pneumococcal pneumonia. PMID:23565216

A 'difficult' insect allergy patient: reliable history of a sting, but all testing negative.

PubMed

Tracy, James M; Olsen, Jonathan A; Carlson, John

2015-08-01

Few conditions are as treatable as allergy to stinging insects, with venom immunotherapy (VIT) providing up to 98% protection to subsequent stings. The challenge with VIT is not in the treatment, but in the diagnosis. To offer VIT, one must determine a history of a systemic reaction to a stinging insect in conjunction with the presence venom-specific IgE. Current diagnostic methods, although sensitive and specific, are imperfect, and some newer testing options are not widely available. A conundrum occasionally faced is the patient with a reliable and compelling history of a systemic allergic reaction yet negative venom-specific testing. This diagnostic dilemma presents an opportunity to consider possible causes for this diagnostic challenge. Our evolving understanding of the role of occult mast cell disease may begin to help us understand this situation and develop appropriate management strategies. Venom-specific skin testing has long been the cornerstone of the evaluation of venom sensitivity and is often combined with in-vitro assays to add clarity, but even these occasionally may fall short. Exploring novel venom diagnostic testing methods may help to fill in some of the diagnostic gaps. Do currently available venom vaccines contain all the key venom species? Are there enough differences between insect species that we may simply be missing the relevant allergens? What is the significance of the antigenicity of carbohydrate moieties in venoms? What is the role of recombinant venom extracts? VIT is the definitive treatment for insect allergic individuals. To utilize VIT, identification of the relevant Hymenoptera is necessary. Unfortunately, this cannot always be accomplished. This deficiency can have several causes: a potential comorbid condition such as occult mast cell disease, limitations of currently available diagnostic resources, or testing vaccines with an insufficient coverage of relevant venom allergens. Exploring these potential causes may help to provide important insight into this important diagnostic conundrum. The use of a case report may help clarify this challenge.

Space Laboratory on a Table Top: A Next Generative ECLSS design and diagnostic tool

NASA Technical Reports Server (NTRS)

Ramachandran, N.

2005-01-01

This paper describes the development plan for a comprehensive research and diagnostic tool for aspects of advanced life support systems in space-based laboratories. Specifically it aims to build a high fidelity tabletop model that can be used for the purpose of risk mitigation, failure mode analysis, contamination tracking, and testing reliability. We envision a comprehensive approach involving experimental work coupled with numerical simulation to develop this diagnostic tool. It envisions a 10% scale transparent model of a space platform such as the International Space Station that operates with water or a specific matched index of refraction liquid as the working fluid. This allows the scaling of a 10 ft x 10 ft x 10 ft room with air flow to 1 ft x 1 ft x 1 ft tabletop model with water/liquid flow. Dynamic similitude for this length scale dictates model velocities to be 67% of full-scale and thereby the time scale of the model to represent 15% of the full- scale system; meaning identical processes in the model are completed in 15% of the full- scale-time. The use of an index matching fluid (fluid that matches the refractive index of cast acrylic, the model material) allows making the entire model (with complex internal geometry) transparent and hence conducive to non-intrusive optical diagnostics. So using such a system one can test environment control parameters such as core flows (axial flows), cross flows (from registers and diffusers), potential problem areas such as flow short circuits, inadequate oxygen content, build up of other gases beyond desirable levels, test mixing processes within the system at local nodes or compartments and assess the overall system performance. The system allows quantitative measurements of contaminants introduced in the system and allows testing and optimizing the tracking process and removal of contaminants. The envisaged system will be modular and hence flexible for quick configuration change and subsequent testing. The data and inferences from the tests will allow for improvements in the development and design of next generation life support systems and configurations. Preliminary experimental and modeling work in this area will be presented. This involves testing of a single inlet-exit model with detailed 3-D flow visualization and quantitative diagnostics and computational modeling of the system.

A Three-Tier Diagnostic Test to Assess Pre-Service Teachers' Misconceptions about Global Warming, Greenhouse Effect, Ozone Layer Depletion, and Acid Rain

NASA Astrophysics Data System (ADS)

Ozge Arslan, Harika; Cigdemoglu, Ceyhan; Moseley, Christine

2012-07-01

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 procedure as described by Treagust constitutes the framework for this study. To differentiate a lack of knowledge from a misconception, a certainty response index is added as a third tier to each item. Based on propositional knowledge statements, related literature, and the identified misconceptions gathered initially from 157 pre-service teachers, the AREPDiT was constructed and administered to 256 pre-service teachers. The Cronbach alpha reliability coefficient of the pre-service teachers' scores was estimated to be 0.74. Content and face validations were established by senior experts. A moderate positive correlation between the participants' both-tiers scores and their certainty scores indicated evidence for construct validity. Therefore, the AREPDiT is a reliable and valid instrument not only to identify pre-service teachers' misconceptions about GW, GE, OLD, and AR but also to differentiate these misconceptions from lack of knowledge. The results also reveal that a majority of the respondents demonstrated limited understandings about atmosphere-related environmental problems and held six common misconceptions. Future studies could test the AREPDiT as a tool for assessing the misconceptions held by pre-service teachers from different programs as well as in-service teachers and high school students.

Development of principles of two-cascaded laser speckle-microscopy with implication to high-precision express diagnostics of chlamydial infection

NASA Astrophysics Data System (ADS)

Ulianova, Onega; Moiseeva, Yulia; Filonova, Nadezhda; Subbotina, Irina; Zaitsev, Sergey; Saltykov, Yury; Polyanina, Tatiana; Lyapina, Anna; Ulyanov, Sergey; Larionova, Olga; Utz, Sergey; Feodorova, Valentina

2018-04-01

Principles of two-cascaded laser speckle-microscopy prospect for application to express diagnostics of chlamydial infection are developed. Prototype of two-cascaded speckle-microscope is designed and tested. Specific case of illumination of bacterial cells by dynamic speckles is considered. Express method of detection of epithelial cells, containing defects, which are caused by Chlamydia trachomatis bacteria, is suggested. Results of improved recognition of C. trachomatis bacteria are discussed.

Development and improvement of the operating diagnostics systems of NPO CKTI works for turbine of thermal and nuclear power plants

NASA Astrophysics Data System (ADS)

Kovalev, I. A.; Rakovskii, V. G.; Isakov, N. Yu.; Sandovskii, A. V.

2016-03-01

The work results on the development and improvement of the techniques, algorithms, and software-hardware of continuous operating diagnostics systems of rotating units and parts of turbine equipment state are presented. In particular, to ensure the full remote service of monitored turbine equipment using web technologies, the web version of the software of the automated systems of vibration-based diagnostics (ASVD VIDAS) was developed. The experience in the automated analysis of data obtained by ASVD VIDAS form the basis of the new algorithm of early detection of such dangerous defects as rotor deflection, crack in the rotor, and strong misalignment of supports. The program-technical complex of monitoring and measuring the deflection of medium pressure rotor (PTC) realizing this algorithm will alert the electric power plant staff during a deflection and indicate its value. This will give the opportunity to take timely measures to prevent the further extension of the defect. Repeatedly, recorded cases of full or partial destruction of shrouded shelves of rotor blades of the last stages of low-pressure cylinders of steam turbines defined the need to develop a version of the automated system of blade diagnostics (ASBD SKALA) for shrouded stages. The processing, analysis, presentation, and backup of data characterizing the mechanical state of blade device are carried out with a newly developed controller of the diagnostics system. As a result of the implementation of the works, the diagnosed parameters determining the operation security of rotating elements of equipment was expanded and the new tasks on monitoring the state of units and parts of turbines were solved. All algorithmic solutions and hardware-software implementations mentioned in the article were tested on the test benches and applied at some power plants.

Development of an intelligent diagnostic system for reusable rocket engine control

NASA Technical Reports Server (NTRS)

Anex, R. P.; Russell, J. R.; Guo, T.-H.

1991-01-01

A description of an intelligent diagnostic system for the Space Shuttle Main Engines (SSME) is presented. This system is suitable for incorporation in an intelligent controller which implements accommodating closed-loop control to extend engine life and maximize available performance. The diagnostic system architecture is a modular, hierarchical, blackboard system which is particularly well suited for real-time implementation of a system which must be repeatedly updated and extended. The diagnostic problem is formulated as a hierarchical classification problem in which the failure hypotheses are represented in terms of predefined data patterns. The diagnostic expert system incorporates techniques for priority-based diagnostics, the combination of analytical and heuristic knowledge for diagnosis, integration of different AI systems, and the implementation of hierarchical distributed systems. A prototype reusable rocket engine diagnostic system (ReREDS) has been implemented. The prototype user interface and diagnostic performance using SSME test data are described.

Rocket engine diagnostics using qualitative modeling techniques

NASA Technical Reports Server (NTRS)

Binder, Michael; Maul, William; Meyer, Claudia; Sovie, Amy

1992-01-01

Researchers at NASA Lewis Research Center are presently developing qualitative modeling techniques for automated rocket engine diagnostics. A qualitative model of a turbopump interpropellant seal system has been created. The qualitative model describes the effects of seal failures on the system steady-state behavior. This model is able to diagnose the failure of particular seals in the system based on anomalous temperature and pressure values. The anomalous values input to the qualitative model are generated using numerical simulations. Diagnostic test cases include both single and multiple seal failures.

Rocket engine diagnostics using qualitative modeling techniques

NASA Technical Reports Server (NTRS)

Binder, Michael; Maul, William; Meyer, Claudia; Sovie, Amy

1992-01-01

Researchers at NASA Lewis Research Center are presently developing qualitative modeling techniques for automated rocket engine diagnostics. A qualitative model of a turbopump interpropellant seal system was created. The qualitative model describes the effects of seal failures on the system steady state behavior. This model is able to diagnose the failure of particular seals in the system based on anomalous temperature and pressure values. The anomalous values input to the qualitative model are generated using numerical simulations. Diagnostic test cases include both single and multiple seal failures.

The evolving potential of companion diagnostics.

PubMed

Khoury, Joseph D

2016-01-01

The scope of companion diagnostics in cancer has undergone significant shifts in the past few years, with increased development of targeted therapies and novel testing platforms. This has provided new opportunities to effect unprecedented paradigm shifts in the application of personalized medicine principles for patients with cancer. These shifts involve assay platforms, analytes, regulations, and therapeutic approaches. As opportunities involving each of these facets of companion diagnostics expand, close collaborations between key stakeholders should be enhanced to ensure optimal performance characteristics and patient outcomes.

Nanotechnology-Based Surface Plasmon Resonance Affinity Biosensors for In Vitro Diagnostics

PubMed Central

Antiochia, Riccarda; Bollella, Paolo; Favero, Gabriele

2016-01-01

In the last decades, in vitro diagnostic devices (IVDDs) became a very important tool in medicine for an early and correct diagnosis, a proper screening of targeted population, and also assessing the efficiency of a specific therapy. In this review, the most recent developments regarding different configurations of surface plasmon resonance affinity biosensors modified by using several nanostructured materials for in vitro diagnostics are critically discussed. Both assembly and performances of the IVDDs tested in biological samples are reported and compared. PMID:27594884

Development of Three-Tier Heat, Temperature and Internal Energy Diagnostic Test

ERIC Educational Resources Information Center

Gurcay, Deniz; Gulbas, Etna

2015-01-01

Background: Misconceptions are major obstacles to learning physics, and the concepts of heat and temperature are some of the common misconceptions that are encountered in daily life. Therefore, it is important to develop valid and reliable tools to determine students' misconceptions about basic thermodynamics concepts. Three-tier tests are…

Initiating a Developmental Motor Skills Program for Identified Primary Students.

ERIC Educational Resources Information Center

Harville, Valerie Terrill

A physical education specialist at an elementary school in one of the fastest growing sections of the country developed and implemented a developmental motor skills program for primary school students. The program focused on: (1) developing a method of referring students for testing; (2) providing a specialized motor diagnostic test; (3) improving…

[Development of an Atypical Response Scale.

ERIC Educational Resources Information Center

Mendelsohn, Mark; Linden, James

The development of an objective diagnostic scale to measure atypical behavior is discussed. The Atypical Response Scale (ARS) is a structured projective test consisting of 17 items, each weighted 1, 2, or 3, that were tested for convergence and reliability. ARS may be individually or group administered in 10-15 minutes; hand scoring requires 90…

The Evolutionary Development of Echocardiography

PubMed Central

Maleki, Majid; Esmaeilzadeh, Maryam

2012-01-01

Echocardiography is a non-invasive diagnostic technique which provides information on cardiac morphology, function, and hemodynamics. It is the most frequently used cardiovascular diagnostic test only after electrocardiography. In less than five decades, the evolution in this technique has made it the basic part of cardiovascular medicine. Herein, the evolution of various forms of echocardiography is briefly described. PMID:23390327

Thai Grade 11 Students' Alternative Conceptions for Acid-Base Chemistry

ERIC Educational Resources Information Center

Artdej, Romklao; Ratanaroutai, Thasaneeya; Coll, Richard Kevin; Thongpanchang, Tienthong

2010-01-01

This study involved the development of a two-tier diagnostic instrument to assess Thai high school students' understanding of acid-base chemistry. The acid-base diagnostic test (ABDT) comprising 18 items was administered to 55 Grade 11 students in a science and mathematics programme during the second semester of the 2008 academic year. Analysis of…

Nonlinear Penalized Estimation of True Q-Matrix in Cognitive Diagnostic Models

ERIC Educational Resources Information Center

Xiang, Rui

2013-01-01

A key issue of cognitive diagnostic models (CDMs) is the correct identification of Q-matrix which indicates the relationship between attributes and test items. Previous CDMs typically assumed a known Q-matrix provided by domain experts such as those who developed the questions. However, misspecifications of Q-matrix had been discovered in the past…

Toward theragnostics.

PubMed

Pene, Frédéric; Courtine, Emilie; Cariou, Alain; Mira, Jean-Paul

2009-01-01

Theragnostics is a treatment strategy that combines therapeutics with diagnostics. It associates both a diagnostic test that identifies patients most likely to be helped or harmed by a new medication, and targeted drug therapy based on the test results. Bioinformatics, genomics, proteomics, and functional genomics are molecular biology tools essential for the progress of molecular theragnostics. These tools generate the genetic and protein information required for the development of diagnostic assays. Theragnostics includes a wide range of subjects, including personalized medicine, pharmacogenomics, and molecular imaging to develop efficient new targeted therapies with adequate benefit/risk to patients and a better molecular understanding of how to optimize drug selection. Furthermore, theragnostics aims to monitor the response to the treatment, to increase drug efficacy and safety. In addition, theragnostics could eliminate the unnecessary treatment of patients for whom therapy is not appropriate, resulting in significant drug cost savings for the healthcare system. However, the introduction of theragnostic tests into routine health care requires both a demonstration of cost-effectiveness and the availability of appropriate accessible testing systems. This review reports validation studies in oncology and infectious diseases that have demonstrated the benefits of such approach in well-defined subpopulations of patients, moving the field from the drug development process toward clinical practice and routine application. Theragnostics may change the usual business model of pharmaceutical companies from the classic blockbuster model toward targeted therapies.

Development of a reliable simulation-based test for diagnostic abdominal ultrasound with a pass/fail standard usable for mastery learning.

PubMed

Østergaard, Mia L; Nielsen, Kristina R; Albrecht-Beste, Elisabeth; Konge, Lars; Nielsen, Michael B

2018-01-01

This study aimed to develop a test with validity evidence for abdominal diagnostic ultrasound with a pass/fail-standard to facilitate mastery learning. The simulator had 150 real-life patient abdominal scans of which 15 cases with 44 findings were selected, representing level 1 from The European Federation of Societies for Ultrasound in Medicine and Biology. Four groups of experience levels were constructed: Novices (medical students), trainees (first-year radiology residents), intermediates (third- to fourth-year radiology residents) and advanced (physicians with ultrasound fellowship). Participants were tested in a standardized setup and scored by two blinded reviewers prior to an item analysis. The item analysis excluded 14 diagnoses. Both internal consistency (Cronbach's alpha 0.96) and inter-rater reliability (0.99) were good and there were statistically significant differences (p < 0.001) between all four groups, except the intermediate and advanced groups (p = 1.0). There was a statistically significant correlation between experience and test scores (Pearson's r = 0.82, p < 0.001). The pass/fail-standard failed all novices (no false positives) and passed all advanced (no false negatives). All intermediate participants and six out of 14 trainees passed. We developed a test for diagnostic abdominal ultrasound with solid validity evidence and a pass/fail-standard without any false-positive or false-negative scores. • Ultrasound training can benefit from competency-based education based on reliable tests. • This simulation-based test can differentiate between competency levels of ultrasound examiners. • This test is suitable for competency-based education, e.g. mastery learning. • We provide a pass/fail standard without false-negative or false-positive scores.

Current ante-mortem techniques for diagnosis of bovine tuberculosis.

PubMed

Bezos, Javier; Casal, Carmen; Romero, Beatriz; Schroeder, Bjoern; Hardegger, Roland; Raeber, Alex J; López, Lissette; Rueda, Paloma; Domínguez, Lucas

2014-10-01

Bovine tuberculosis (TB), mainly caused by Mycobacterium bovis, is a zoonotic disease with implications for Public Health and having an economic impact due to decreased production and limitations to the trade. Bovine TB is subjected to official eradication campaigns mainly based on a test and slaughter policy using diagnostic assays based on the cell-mediated immune response as the intradermal tuberculin test and the gamma-interferon (IFN-γ) assay. Moreover, several diagnostic assays based on the detection of specific antibodies (Abs) have been developed in the last few years with the aim of complementing the current diagnostic techniques in the near future. This review provides an overview of the current ante-mortem diagnostic tools for diagnosis of bovine TB regarding historical background, methodologies and sensitivity (Se) and specificity (Sp) obtained in previous studies under different epidemiological situations. Copyright © 2014 Elsevier Ltd. All rights reserved.

Monocyte Activation in Immunopathology: Cellular Test for Development of Diagnostics and Therapy.

PubMed

Ivanova, Ekaterina A; Orekhov, Alexander N

2016-01-01

Several highly prevalent human diseases are associated with immunopathology. Alterations in the immune system are found in such life-threatening disorders as cancer and atherosclerosis. Monocyte activation followed by macrophage polarization is an important step in normal immune response to pathogens and other relevant stimuli. Depending on the nature of the activation signal, macrophages can acquire pro- or anti-inflammatory phenotypes that are characterized by the expression of distinct patterns of secreted cytokines and surface antigens. This process is disturbed in immunopathologies resulting in abnormal monocyte activation and/or bias of macrophage polarization towards one or the other phenotype. Such alterations could be used as important diagnostic markers and also as possible targets for the development of immunomodulating therapy. Recently developed cellular tests are designed to analyze the phenotype and activity of living cells circulating in patient's bloodstream. Monocyte/macrophage activation test is a successful example of cellular test relevant for atherosclerosis and oncopathology. This test demonstrated changes in macrophage activation in subclinical atherosclerosis and breast cancer and could also be used for screening a panel of natural agents with immunomodulatory activity. Further development of cellular tests will allow broadening the scope of their clinical implication. Such tests may become useful tools for drug research and therapy optimization.

Rapid tests for sexually transmitted infections (STIs): the way forward

PubMed Central

Peeling, R W; Holmes, K K; Mabey, D

2006-01-01

In the developing world, laboratory services for sexually transmitted infections (STIs) are either not available, or where limited services are available, patients may not be able to pay for or physically access those services. Despite the existence of national policy for antenatal screening to prevent congenital syphilis and substantial evidence that antenatal screening is cost‐effective, implementation of syphilis screening programmes remains unacceptably low because of lack of screening tools that can be used in primary health care settings. The World Health Organization Sexually Transmitted Diseases Diagnostics Initiative (SDI) has developed the ASSURED criteria as a benchmark to decide if tests address disease control needs: Affordable, Sensitive, Specific, User‐friendly, Rapid and robust, Equipment‐free and Deliverable to end‐users. Rapid syphilis tests that can be used with whole blood approach the ASSURED criteria and can now be deployed in areas where no previous screening has been possible. Although rapid tests for chlamydia and gonorrhoea lack sensitivity, more tests are in development. The way forward for STI diagnostics requires a continuing quest for ASSURED tests, the development of a road map for test introduction, sustainable programmes for quality assurance, and the creation of a robust infrastructure linked to HIV prevention that ensures sustainability of STI control efforts that includes viral STIs. PMID:17151023

Rapid tests for sexually transmitted infections (STIs): the way forward.

PubMed

Peeling, R W; Holmes, K K; Mabey, D; Ronald, A

2006-12-01

In the developing world, laboratory services for sexually transmitted infections (STIs) are either not available, or where limited services are available, patients may not be able to pay for or physically access those services. Despite the existence of national policy for antenatal screening to prevent congenital syphilis and substantial evidence that antenatal screening is cost-effective, implementation of syphilis screening programmes remains unacceptably low because of lack of screening tools that can be used in primary health care settings. The World Health Organization Sexually Transmitted Diseases Diagnostics Initiative (SDI) has developed the ASSURED criteria as a benchmark to decide if tests address disease control needs: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users. Rapid syphilis tests that can be used with whole blood approach the ASSURED criteria and can now be deployed in areas where no previous screening has been possible. Although rapid tests for chlamydia and gonorrhoea lack sensitivity, more tests are in development. The way forward for STI diagnostics requires a continuing quest for ASSURED tests, the development of a road map for test introduction, sustainable programmes for quality assurance, and the creation of a robust infrastructure linked to HIV prevention that ensures sustainability of STI control efforts that includes viral STIs.

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...

[Current status and clinical application prospect of Akabane's test].

PubMed

Wang, Wenjie; Du, Yanjun

2016-06-12

The Akabane's test is one of the meridian diagnostic methods. Compared with the current meridian diagnostic methods, it has the advantages of convenience and efficiency, but it also has several disadvantages such as the accuracy is difficult to control, the outcome interpretation is limited, etc. In this paper, the influence factors of Akabane's test were analyzed one by one, especially proposed personal opinion on outcome interpretation, which could ascertain the location and nature of disease, leading to disease syndrome. With accurate syndrome, the treatment plan could be established. The application prospect of Akabane's test was initially explored, and it was proposed that wearable automation equipment could be one of the development directions.

Creating and field-testing diagnostic criteria for partner and child maltreatment.

PubMed

Heyman, Richard E; Smith Slep, Amy M

2006-09-01

An integrated set of diagnostic criteria for partner abuse and child abuse and neglect were developed and tested in 4 studies conducted with a branch of America's largest family maltreatment protection agency (i.e., the U.S. military's Family Advocacy Program). Maltreatment criteria then in force were found to have adequate levels of content validity, but experts' and users' feedback indicated ambiguities and poorly specified criteria that undermined reliable application. Criteria incorporating elements of the best existing civilian and military operationalizations were developed and evaluated in two field trials. The final definitions were found to support very high levels of agreement (92%) between base adjudicating committees and master reviewers. Copyright (c) 2006 APA, all rights reserved.

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.

INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD): development and validation.

PubMed

Juneja, Monica; Mishra, Devendra; Russell, Paul S S; Gulati, Sheffali; Deshmukh, Vaishali; Tudu, Poma; Sagar, Rajesh; Silberberg, Donald; Bhutani, Vinod K; Pinto, Jennifer M; Durkin, Maureen; Pandey, Ravindra M; Nair, M K C; Arora, Narendra K

2014-05-01

To develop and validate INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD). Diagnostic test evaluation by cross sectional design. Four tertiary pediatric neurology centers in Delhi and Thiruvanthapuram, India. Children aged 2-9 years were enrolled in the study. INDT-ASD and Childhood Autism Rating Scale (CARS) were administered in a randomly decided sequence by trained psychologist, followed by an expert evaluation by DSM-IV TR diagnostic criteria (gold standard). Psychometric parameters of diagnostic accuracy, validity (construct, criterion and convergent) and internal consistency. 154 children (110 boys, mean age 64.2 mo) were enrolled. The overall diagnostic accuracy (AUC=0.97, 95% CI 0.93, 0.99; P<0.001) and validity (sensitivity 98%, specificity 95%, positive predictive value 91%, negative predictive value 99%) of INDT-ASD for Autism spectrum disorder were high, taking expert diagnosis using DSM-IV-TR as gold standard. The concordance rate between the INDT-ASD and expert diagnosis for 'ASD group' was 82.52% [Cohen's k=0.89; 95% CI (0.82, 0.97); P=0.001]. The internal consistency of INDT-ASD was 0.96. The convergent validity with CARS (r = 0.73, P= 0.001) and divergent validity with Binet-Kamat Test of intelligence (r = -0.37; P=0.004) were significantly high. INDT-ASD has a 4-factor structure explaining 85.3% of the variance. INDT-ASD has high diagnostic accuracy, adequate content validity, good internal consistency high criterion validity and high to moderate convergent validity and 4-factor construct validity for diagnosis of Autistm spectrum disorder.

Celiac Disease: Diagnostic Standards and Dilemmas

PubMed Central

Kaswala, Dharmesh H.; Veeraraghavan, Gopal; Kelly, Ciaran P.; Leffler, Daniel A.

2015-01-01

Celiac Disease (CD) affects at least 1% of the population and evidence suggests that prevalence is increasing. The diagnosis of CD depends on providers being alert to both typical and atypical presentations and those situations in which patients are at high risk for the disease. Because of variable presentation, physicians need to have a low threshold for celiac testing. Robust knowledge of the pathogenesis of this autoimmune disease has served as a catalyst for the development of novel diagnostic tools. Highly sensitive and specific serological assays including Endomysial Antibody (EMA), tissue transglutaminase (tTG), and Deamidated Gliadin Peptide (DGP) have greatly simplified testing for CD and serve as the foundation for celiac diagnosis. In addition, genetic testing for HLA DQ2 and DQ8 has become more widely available and there has been refinement of the gluten challenge for use in diagnostic algorithms. While diagnosis is usually straightforward, in special conditions including IgA deficiency, very young children, discrepant histology and serology, and adoption of a gluten free diet prior to testing, CD can be difficult to diagnose. In this review, we provide an overview of the history and current state of celiac disease diagnosis and provide guidance for evaluation of CD in difficult diagnostic circumstances. PMID:28943611

Performance of the High-Energy Single-Event Effects Test Facility (SEETF) at Michigan State University's National Superconducting Cyclotron Laboratory (NSCL)

NASA Technical Reports Server (NTRS)

Ladbury, R.; Reed, R. A.; Marshall, P. W.; LaBel, K. A.; Anantaraman, R.; Fox, R.; Sanderson, D. P.; Stolz, A.; Yurkon, J.; Zeller, A. F.;

Use of objective testing in the diagnosis of work-related asthma by physician specialty.

PubMed

Curwick, Christy C; Bonauto, David K; Adams, Darrin A

2006-10-01

Although early and accurate diagnosis of work-related asthma is critical to avoid unnecessary medical, legal, social, and economic consequences, little is currently known about the diagnostic practices of physicians treating workers with work-related asthma. To characterize the use of objective diagnostic testing for work-related asthma by physician specialty. A cross-sectional, descriptive, comparative evaluation was conducted of 301 workers' compensation claimants with work-related asthma. A few claimants (36.9%) were treated by specialists in work-related asthma (allergists, pulmonologists, or occupational medicine physicians) either initially or through the course of their claim. Workers with occupational asthma were more likely to have seen a specialist than those with work-aggravated asthma (47.9% vs 23.0%; P < .001). Less than half of the claimants with work-related asthma (43.2%) had received an objective evaluation of pulmonary function, through either pulmonary function testing or testing for reversible airflow limitation, for the evaluation of their work-related asthma. Claimants treated by specialists were significantly more likely to have received diagnostic testing during evaluation of their disease than those treated solely by generalists (82.9% vs 20.0%; P < .001). The results of this study point to the lack of appropriate diagnostic care received by workers with work-related asthma. Physicians who may have questions about diagnostic procedures should consider referral to a specialist. The development of referral networks for work-related asthma may be warranted and should be explored.

Assessment of cortical auditory evoked potentials in children with specific language impairment.

PubMed

Włodarczyk, Elżbieta; Szkiełkowska, Agata; Pilka, Adam; Skarżyński, Henryk

2018-02-28

The proper course of speech development heavily influences the cognitive and personal development of children. It is a condition for achieving preschool and school successes - it facilitates socializing and expressing feelings and needs. Impairment of language and its development in children represents a major diagnostic and therapeutic challenge for physicians and therapists. Early diagnosis of coexisting deficits and starting the therapy influence the therapeutic success. One of the basic diagnostic tests for children suffering from specific language impairment (SLI) is audiometry, thus far referred to as a hearing test. Auditory processing is just as important as a proper hearing threshold. Therefore, diagnosis of central auditory disorder may be a valuable supplementation of diagnosis of language impairment. Early diagnosis and implementation of appropriate treatment may contribute to an effective language therapy.

Intelligent Engine Systems: Bearing System

NASA Technical Reports Server (NTRS)

Singh, Arnant P.

2008-01-01

The overall requirements necessary for sensing bearing distress and the related criteria to select a particular rotating sensor were established during the phase I. The current phase II efforts performed studies to evaluate the Robustness and Durability Enhancement of the rotating sensors, and to design, and develop the Built-in Telemetry System concepts for an aircraft engine differential sump. A generic test vehicle that can test the proposed bearing diagnostic system was designed, developed, and built. The Timken Company, who also assisted with testing the GE concept of using rotating sensors for the differential bearing diagnostics during previous phase, was selected as a subcontractor to assist General Electric (GE) for the design, and procurement of the test vehicle. A purchase order was prepared to define the different sub-tasks, and deliverables for this task. The University of Akron was selected to provide the necessary support for installing, and integrating the test vehicle with their newly designed test facility capable of simulating the operating environment for the planned testing. The planned testing with good and damaged bearings will be on hold pending further continuation of this effort during next phase.

A New Spin on an Old Technology: Piezoelectric Ejecta Diagnostics for Shock Environments

NASA Astrophysics Data System (ADS)

Vogan, W. S.; Anderson, W. W.; Grover, M.; King, N. S. P.; Lamoreaux, S. K.; Morley, K. B.; Rigg, P. A.; Stevens, G. D.; Turley, W. D.; Buttler, W. T.

2006-07-01

In our investigation of ejecta, or metal particulate emitted from a surface subjected to shock-loaded conditions, we have developed a shock experiment suitable for testing new ideas in piezoelectric mass and impact detectors. High-explosive (HE) shock loading of tin targets subjected to various machined and compressed finishes results in significant trends in ejecta characteristics of interest such as areal density and velocity. Our enhanced piezoelectric diagnostic, "piezo-pins" modified for shock mitigation, have proven levels of robustness and reliability suitable for effective operation in these ejecta milieux. These field tests address questions about ejecta production from surfaces of interest; experimental results are discussed and compared with those from complementary diagnostics such as x-ray and optical attenuation visualization techniques.

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

Comprehensive Social Skills Taxonomy: Development and Application.

PubMed

Kauffman, Nancy A; Kinnealey, Moya

2015-01-01

We developed a comprehensive social skills taxonomy based on archived children's social skill goal sheets, and we applied the taxonomy to 6,897 goals of children in 6 diagnostic categories to explore patterns related to diagnosis. We used a grounded theory approach to code and analyze social skill goals and develop the taxonomy. Multivariate analysis of variance and Tukey post hoc honestly significant difference test were used to analyze differences in social skill needs among diagnostic groups. We developed a taxonomy of 7 social skill constructs or categories, descriptions, and behavioral indicators. The 7 social skill categories were reflected across 6 diagnostic groups, and differences in social skill needs among groups were identified. This comprehensive taxonomy of social skills can be useful in developing research-based individual, group, or institutional programming to improve social skills. Copyright © 2015 by the American Occupational Therapy Association, Inc.

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.

The impact of commercial rapid respiratory virus diagnostic tests on patient outcomes and health system utilization.

PubMed

Ko, Fiona; Drews, Steven J

2017-10-01

Acute respiratory tract infections due to influenza A/B and respiratory syncytial virus (RSV) are major causes of morbidity and mortality globally. Rapid tests for detection of these pathogens include antigen detection point of care tests (POC) and newer easy to use molecular tests. From experience, these assays improve both laboratory workflow and assay interpretation issues. However, the question of the benefits of using rapid test technology compared to routine laboratory testing for respiratory viral pathogens is still often asked. Areas covered: Specifically, this review aims to; 1) identify clinical/patient indicators that can be measured prior to and following the implementation of rapid diagnostic test for influenza and RSV, 2) provide multiple perspectives on the extent of impact of a rapid diagnostic test, including direct and indirect outcomes, and 3) identify the technological advancements in the development of rapid testing, demonstrating a timeline that transitions from antigen-based assays to molecular assays. Expert commentary: Key benefits to the use of either antigen-based or molecular rapid tests for patient care, patient flow within institutions, as well as laboratory utilization are identified. Due to improved test characteristics, the authors feel that rapid molecular tests have greater benefits than antigen-based detection methods.

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

Compare diagnostic tests using transformation-invariant smoothed ROC curves⋆

PubMed Central

Tang, Liansheng; Du, Pang; Wu, Chengqing

2012-01-01

Receiver operating characteristic (ROC) curve, plotting true positive rates against false positive rates as threshold varies, is an important tool for evaluating biomarkers in diagnostic medicine studies. By definition, ROC curve is monotone increasing from 0 to 1 and is invariant to any monotone transformation of test results. And it is often a curve with certain level of smoothness when test results from the diseased and non-diseased subjects follow continuous distributions. Most existing ROC curve estimation methods do not guarantee all of these properties. One of the exceptions is Du and Tang (2009) which applies certain monotone spline regression procedure to empirical ROC estimates. However, their method does not consider the inherent correlations between empirical ROC estimates. This makes the derivation of the asymptotic properties very difficult. In this paper we propose a penalized weighted least square estimation method, which incorporates the covariance between empirical ROC estimates as a weight matrix. The resulting estimator satisfies all the aforementioned properties, and we show that it is also consistent. Then a resampling approach is used to extend our method for comparisons of two or more diagnostic tests. Our simulations show a significantly improved performance over the existing method, especially for steep ROC curves. We then apply the proposed method to a cancer diagnostic study that compares several newly developed diagnostic biomarkers to a traditional one. PMID:22639484

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

PubMed

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

Cost-effective Diagnostic Checklists for Meningitis in Resource Limited Settings

PubMed Central

Durski, Kara N.; Kuntz, Karen M.; Yasukawa, Kosuke; Virnig, Beth A.; Meya, David B.; Boulware, David R.

2013-01-01

Background Checklists can standardize patient care, reduce errors, and improve health outcomes. For meningitis in resource-limited settings, with high patient loads and limited financial resources, CNS diagnostic algorithms may be useful to guide diagnosis and treatment. However, the cost-effectiveness of such algorithms is unknown. Methods We used decision analysis methodology to evaluate the costs, diagnostic yield, and cost-effectiveness of diagnostic strategies for adults with suspected meningitis in resource limited settings with moderate/high HIV prevalence. We considered three strategies: 1) comprehensive “shotgun” approach of utilizing all routine tests; 2) “stepwise” strategy with tests performed in a specific order with additional TB diagnostics; 3) “minimalist” strategy of sequential ordering of high-yield tests only. Each strategy resulted in one of four meningitis diagnoses: bacterial (4%), cryptococcal (59%), TB (8%), or other (aseptic) meningitis (29%). In model development, we utilized prevalence data from two Ugandan sites and published data on test performance. We validated the strategies with data from Malawi, South Africa, and Zimbabwe. Results The current comprehensive testing strategy resulted in 93.3% correct meningitis diagnoses costing $32.00/patient. A stepwise strategy had 93.8% correct diagnoses costing an average of $9.72/patient, and a minimalist strategy had 91.1% correct diagnoses costing an average of $6.17/patient. The incremental cost effectiveness ratio was $133 per additional correct diagnosis for the stepwise over minimalist strategy. Conclusions Through strategically choosing the order and type of testing coupled with disease prevalence rates, algorithms can deliver more care more efficiently. The algorithms presented herein are generalizable to East Africa and Southern Africa. PMID:23466647

Toward a Framework for Benefit-Risk Assessment in Diagnostic Imaging: Identifying Scenario-specific Criteria.

PubMed

Agapova, Maria; Bresnahan, Brian W; Linnau, Ken F; Garrison, Louis P; Higashi, Mitchell; Kessler, Larry; Devine, Beth

2017-05-01

Diagnostic imaging has many effects and there is no common definition of value in diagnostic radiology. As benefit-risk trade-offs are rarely made explicit, it is not clear which framework is used in clinical guideline development. We describe initial steps toward the creation of a benefit-risk framework for diagnostic radiology. We performed a literature search and an online survey of physicians to identify and collect benefit-risk criteria (BRC) relevant to diagnostic imaging tests. We operationalized a process for selection of BRC with the use of four clinical use case scenarios that vary by diagnostic alternatives and clinical indication. Respondent BRC selections were compared across clinical scenarios and between radiologists and nonradiologists. Thirty-six BRC were identified and organized into three domains: (1) those that account for differences attributable only to the test or device (n = 17); (2) those that account for clinical management and provider experiences (n = 12); and (3) those that capture patient experience (n = 7). Forty-eight survey participants selected 22 criteria from the initial list in the survey (9-11 per case). Engaging ordering physicians increased the number of criteria selected in each of the four clinical scenarios presented. We developed a process for standardizing selection of BRC in guideline development. These results suggest that a process relying on elements of comparative effectiveness and the use of standardized BRC may ensure consistent examination of differences among alternatives by way of making explicit implicit trade-offs that otherwise enter the decision-making space and detract from consistency and transparency. These findings also highlight the need for multidisciplinary teams that include input from ordering physicians. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

In-situ material-motion diagnostics and fuel radiography in experimental reactors

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

DeVolpi, A.

1982-01-01

Material-motion monitoring has become a routine part of in-pile transient reactor-safety experiments. Diagnostic systems, such as the fast-neutron hodoscope, were developed for the purpose of providing direct time-resolved data on pre-failure fuel motion, cladding-breach time and location, and post-failure fuel relocation. Hodoscopes for this purpose have been installed at TREAT and CABRI; other types of imaging systems that have been tested are a coded-aperture at ACRR and a pinhole at TREAT. Diagnostic systems that use penetrating radiation emitted from the test section can non-invasively monitor fuel without damage to the measuring instrument during the radiographic images of test sections installedmore » in the reator. Studies have been made of applications of hodoscopes to other experimental reactors, including PBF, FARET, STF, ETR, EBR-II, SAREF-STF, and DMT.« less

Automated knowledge generation

NASA Technical Reports Server (NTRS)

Myler, Harley R.; Gonzalez, Avelino J.

1988-01-01

The general objectives of the NASA/UCF Automated Knowledge Generation Project were the development of an intelligent software system that could access CAD design data bases, interpret them, and generate a diagnostic knowledge base in the form of a system model. The initial area of concentration is in the diagnosis of the process control system using the Knowledge-based Autonomous Test Engineer (KATE) diagnostic system. A secondary objective was the study of general problems of automated knowledge generation. A prototype was developed, based on object-oriented language (Flavors).

Intelligent Engine Systems

NASA Technical Reports Server (NTRS)

Xie, Ming

2008-01-01

A high bypass jet engine fan case represents one of the largest, heaviest single components in an engine. In addition to supporting the inlet and providing the fan flowpath, the most critical function is the containment of a failed fan blade. In this development program, a lightweight, low-cost composite containment case with diagnostic capabilities was developed, fabricated, and tested. The fan case design, containment methods, and diagnostic concepts evaluated in the initial Propulsion 21 program were improved and scaled up to a full case design.

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.

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...

Minimum target prices for production of direct-acting antivirals and associated diagnostics to combat hepatitis C virus

PubMed Central

van de Ven, Nikolien; Fortunak, Joe; Simmons, Bryony; Ford, Nathan; Cooke, Graham S; Khoo, Saye; Hill, Andrew

2015-01-01

Combinations of direct-acting antivirals (DAAs) can cure hepatitis C virus (HCV) in the majority of treatment-naïve patients. Mass treatment programs to cure HCV in developing countries are only feasible if the costs of treatment and laboratory diagnostics are very low. This analysis aimed to estimate minimum costs of DAA treatment and associated diagnostic monitoring. Clinical trials of HCV DAAs were reviewed to identify combinations with consistently high rates of sustained virological response across hepatitis C genotypes. For each DAA, molecular structures, doses, treatment duration, and components of retrosynthesis were used to estimate costs of large-scale, generic production. Manufacturing costs per gram of DAA were based upon treating at least 5 million patients per year and a 40% margin for formulation. Costs of diagnostic support were estimated based on published minimum prices of genotyping, HCV antigen tests plus full blood count/clinical chemistry tests. Predicted minimum costs for 12-week courses of combination DAAs with the most consistent efficacy results were: US$122 per person for sofosbuvir+daclatasvir; US$152 for sofosbuvir+ribavirin; US$192 for sofosbuvir+ledipasvir; and US$115 for MK-8742+MK-5172. Diagnostic testing costs were estimated at US$90 for genotyping US$34 for two HCV antigen tests and US$22 for two full blood count/clinical chemistry tests. Conclusions: Minimum costs of treatment and diagnostics to cure hepatitis C virus infection were estimated at US$171-360 per person without genotyping or US$261-450 per person with genotyping. These cost estimates assume that existing large-scale treatment programs can be established. (Hepatology 2015;61:1174–1182) PMID:25482139

Minimum target prices for production of direct-acting antivirals and associated diagnostics to combat hepatitis C virus.

PubMed

van de Ven, Nikolien; Fortunak, Joe; Simmons, Bryony; Ford, Nathan; Cooke, Graham S; Khoo, Saye; Hill, Andrew

2015-04-01

Combinations of direct-acting antivirals (DAAs) can cure hepatitis C virus (HCV) in the majority of treatment-naïve patients. Mass treatment programs to cure HCV in developing countries are only feasible if the costs of treatment and laboratory diagnostics are very low. This analysis aimed to estimate minimum costs of DAA treatment and associated diagnostic monitoring. Clinical trials of HCV DAAs were reviewed to identify combinations with consistently high rates of sustained virological response across hepatitis C genotypes. For each DAA, molecular structures, doses, treatment duration, and components of retrosynthesis were used to estimate costs of large-scale, generic production. Manufacturing costs per gram of DAA were based upon treating at least 5 million patients per year and a 40% margin for formulation. Costs of diagnostic support were estimated based on published minimum prices of genotyping, HCV antigen tests plus full blood count/clinical chemistry tests. Predicted minimum costs for 12-week courses of combination DAAs with the most consistent efficacy results were: US$122 per person for sofosbuvir+daclatasvir; US$152 for sofosbuvir+ribavirin; US$192 for sofosbuvir+ledipasvir; and US$115 for MK-8742+MK-5172. Diagnostic testing costs were estimated at US$90 for genotyping US$34 for two HCV antigen tests and US$22 for two full blood count/clinical chemistry tests. Minimum costs of treatment and diagnostics to cure hepatitis C virus infection were estimated at US$171-360 per person without genotyping or US$261-450 per person with genotyping. These cost estimates assume that existing large-scale treatment programs can be established. © 2014 The Authors. Hepatology published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases.

What is an ROC curve?

PubMed

Hoo, Zhe Hui; Candlish, Jane; Teare, Dawn

2017-06-01

The paper by Body et al is concerned with the evaluation of decision aids, which can be used to identify potential acute coronary syndromes (ACS) in the ED. The authors previously developed the Manchester Acute Coronary Syndromes model (MACS) decision aid, which uses several clinical variables and two biomarkers to 'rule in' and 'rule out' ACS. However, one of the two biomarkers (heart-type fatty acid bindingprotein, H-FABP) is not widely used so a revised decision aid has been developed (Troponin-only Manchester Acute Coronary Syndromes, T-MACS), which include a single biomarker hs-cTnT. In this issue, the authors show how they derive a revised decision aid and describe its performance in a number of independent diagnostic cohort studies. Decision aids (as well as other types of 'diagnostic tests') are often evaluated in terms of diagnostic testing parameters such as the area under the receiver operating characteristic (ROC) curve, sensitivity and specificity. In this article, we explain how the ROC analysis is conducted and why it is an essential step towards developing a test with the desirable levels of sensitivity and specificity. © 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.

Meta-analysis of diagnostic test data: a bivariate Bayesian modeling approach.

PubMed

Verde, Pablo E

2010-12-30

In the last decades, the amount of published results on clinical diagnostic tests has expanded very rapidly. The counterpart to this development has been the formal evaluation and synthesis of diagnostic results. However, published results present substantial heterogeneity and they can be regarded as so far removed from the classical domain of meta-analysis, that they can provide a rather severe test of classical statistical methods. Recently, bivariate random effects meta-analytic methods, which model the pairs of sensitivities and specificities, have been presented from the classical point of view. In this work a bivariate Bayesian modeling approach is presented. This approach substantially extends the scope of classical bivariate methods by allowing the structural distribution of the random effects to depend on multiple sources of variability. Meta-analysis is summarized by the predictive posterior distributions for sensitivity and specificity. This new approach allows, also, to perform substantial model checking, model diagnostic and model selection. Statistical computations are implemented in the public domain statistical software (WinBUGS and R) and illustrated with real data examples. Copyright © 2010 John Wiley & Sons, Ltd.

Flight Test of Propulsion Monitoring and Diagnostic System

NASA Technical Reports Server (NTRS)

Gabel, Steve; Elgersma, Mike

2002-01-01

The objective of this program was to perform flight tests of the propulsion monitoring and diagnostic system (PMDS) technology concept developed by Honeywell under the NASA Advanced General Aviation Transport Experiment (AGATE) program. The PMDS concept is intended to independently monitor the performance of the engine, providing continuous status to the pilot along with warnings if necessary as well as making the data available to ground maintenance personnel via a special interface. These flight tests were intended to demonstrate the ability of the PMDS concept to detect a class of selected sensor hardware failures, and the ability to successfully model the engine for the purpose of engine diagnosis.

The diagnostic value of troponin in critically ill.

PubMed

Voga, Gorazd

2010-01-01

Troponin T and I are sensitive and specific markers of myocardial necrosis. They are used for the routine diagnosis of acute coronary syndrome. In critically ill patients they are basic diagnostic tool for diagnosis of myocardial necrosis due to myocardial ischemia. Moreover, the increase of troponin I and T is related with adverse outcome in many subgroups of critically ill patients. The new, high sensitivity tests which have been developed recently allow earlier and more accurate diagnosis of acute coronary syndrome. The use of the new tests has not been studied in critically ill patients, but they will probably replace the old tests and will be used on the routine basis.

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.

Quality of information accompanying on-line marketing of home diagnostic tests.

PubMed

Datta, Adrija K; Selman, Tara J; Kwok, Tony; Tang, Teresa; Khan, Khalid S

2008-01-01

To assess the quality of information provided to consumers by websites marketing medical home diagnostic tests. A cross-sectional analysis of a database developed from searching targeted websites. Data sources were websites written in English which marketed medical home diagnostic tests. A meta-search engine was used to identify the first 20 citations for each type of home diagnostic medical test. Relevant websites limited to those written in English were reviewed independently and in triplicate, with disputes resolved by two further reviewers. Information on the quality of these sites was extracted using a pre-piloted performer. 168 websites were suitable for inclusion in the review. The quality of these sites showed marked variation. Only 24 of 168 (14.2%) complied with at least three-quarters of the quality items and just over half (95 of 168, 56.5%) reported official approval or certification of the test. Information on accuracy of the test marketed was reported by 87 of 168 (51.7%) websites, with 15 of 168 (8.9%) providing a scientific reference. Instructions for use of the product were found in 97 of 168 (57.9%). However, the course of action to be taken after obtaining the test result was stated in only 63 of 168 (37.5%) for a positive result and 43 of 168 (25.5%) for a negative result. The quality of information posted on commercial websites marketing home tests online is unsatisfactory and potentially misleading for consumers.

Diagnosis of stinging insect allergy: utility of cellular in-vitro tests.

PubMed

Scherer, Kathrin; Bircher, Andreas J; Heijnen, Ingmar Afm

2009-08-01

Diagnosis of stinging insect allergy is based on a detailed history, venom skin tests, and detection of venom-specific IgE. As an additional diagnostic tool, basophil responsiveness to venom allergens has been shown to be helpful in selected patients. This review summarizes the current diagnostic procedures for stinging insect allergy and discusses the latest developments in cellular in-vitro tests. Cellular assays have been evaluated in patients with Hymenoptera venom allergy. The diagnostic performance of the cellular mediator release test is similar to that of the flow cytometric basophil activation test (BAT), but the BAT has been the most intensively studied. BAT offers the possibility to assess basophil reactivity to allergens in their natural environment and to simultaneously analyze surface marker expression and intracellular signaling. It has been demonstrated that BAT represents a valuable additional diagnostic tool in selected patients when used in combination with other well established tests. A major limitation is the current lack of unified, standardized protocols. Flow cytometry offers huge possibilities to enhance knowledge of basophil functions. The BAT may be used as an additional test to confirm the diagnosis of stinging insect allergy in selected patients, provided that it is performed by an experienced laboratory using a validated assay. Test results have to be interpreted by clinicians familiar with the methodological aspects. The utility of the BAT to confirm allergy diagnosis and to predict the risk of subsequent systemic reactions may be improved by combined analysis of multiple surface markers and intracellular signaling pathways.

Quality of information accompanying on-line marketing of home diagnostic tests

PubMed Central

Datta, Adrija K; Selman, Tara J; Kwok, Tony; Tang, Teresa; Khan, Khalid S

2008-01-01

Objective To assess the quality of information provided to consumers by websites marketing medical home diagnostic tests. Design A cross-sectional analysis of a database developed from searching targeted websites. Setting Data sources were websites written in English which marketed medical home diagnostic tests. Main outcome measures A meta-search engine was used to identify the first 20 citations for each type of home diagnostic medical test. Relevant websites limited to those written in English were reviewed independently and in triplicate, with disputes resolved by two further reviewers. Information on the quality of these sites was extracted using a pre-piloted performer. Results 168 websites were suitable for inclusion in the review. The quality of these sites showed marked variation. Only 24 of 168 (14.2%) complied with at least three-quarters of the quality items and just over half (95 of 168, 56.5%) reported official approval or certification of the test. Information on accuracy of the test marketed was reported by 87 of 168 (51.7%) websites, with 15 of 168 (8.9%) providing a scientific reference. Instructions for use of the product were found in 97 of 168 (57.9%). However, the course of action to be taken after obtaining the test result was stated in only 63 of 168 (37.5%) for a positive result and 43 of 168 (25.5%) for a negative result. Conclusions The quality of information posted on commercial websites marketing home tests online is unsatisfactory and potentially misleading for consumers. PMID:18263912

Amplion, Inc.

PubMed

Taylor, Seth; Carroll, Adam; Lord, Jessi

2016-07-01

Amplion, Inc. (OR, USA) is focused on progressing the primary drivers of precision medicine. Focused on enabling the front end of the healthcare value chain, pharmaceutical developers and diagnostic test developers, Amplion zeros in on the research and market components that will make precision medicine a reality. With BiomarkerBase™, Amplion's flagship product, Amplion provides evidence-based biomarker information that support the key strategic decisions pharmaceutical and diagnostic developers need to make to be successful in the emerging world of precision medicine. A passion for saving lives and improving patient outcomes using precision medicine inspires Amplion's product BiomarkerBase™. A unique combination of hard science and data science positions Amplion to surface the relationships of biomarkers and clinical evidence that gives pharmaceutical and diagnostic companies unique insight into the technical realities and market opportunities provided by biomarkers.

Benefits and challenges of molecular diagnostics for childhood tuberculosis.

PubMed

Gutierrez, Cristina

2016-12-01

Expanding tuberculosis (TB)-diagnostic services, including access to rapid tests, is a World Health Organization (WHO) strategy to accelerate progress toward ending TB. Faster and more sensitive molecular tests capable of diagnosing TB and drug-resistant TB have the technical capacity to address limitations associated with smears and cultures by increasing accuracy and shortening turnaround times as compared with those of these conventional laboratory methods. Nucleic acid amplification assays used to detect and analyze Mycobacterium tuberculosis (MTB)-complex nucleic acids can be used directly on specimens from patients suspected of having TB. Recently, several commercial molecular tests were developed to detect MTB and determine the drug resistance (DR) based on detection of specific genetic mutations conferring resistance. The first to be endorsed by the WHO was molecular line-probe assay technology. This test uses polymerase chain reaction (PCR) and reverse-hybridization methods to rapidly identify MTB and DR-related mutations simultaneously. More recently, the WHO endorsed Xpert MTB/RIF, Cepheid Inc, CA, USA, a fully automated assay used for TB diagnosis that relies upon PCR techniques for detection of TB and rifampicin resistance-related mutations. Other promising molecular TB assays for simplifying PCR-based testing protocols and increasing their accuracy are under development and evaluation. Although we lack a practical gold standard for the diagnosis of childhood TB, its bacteriological confirmation is always recommended to be sought whenever possible prior to a diagnostic decision being made. Conventional diagnostic laboratory TB tests are less efficient for children as compared with adults, because sufficient sputum samples are more difficult to collect from infants and young children, and their disease is often paucibacillary, resulting in smear-negative disease. These inherent challenges associated with childhood TB are due to immunological- and pathophysiological-response differences relative to those observed in adults. Several recent meta-analyses showed low sensitivity estimates of PCR-based TB assays for paucibacillary forms of TB (extrapulmonary TB and smear-negative pulmonary disease), which represent the vast majority of childhood TB cases. Despite the lack of evidence regarding use of the rapid molecular assays to identify TB and detect DR in children, and due to the clinical nature of childhood TB, TB-expert groups recommend including rapid methods for TB identification and DR detection in diagnostic algorithms for children suspected of both smear-positive and -negative pulmonary or extrapulmonary TB, both with or without human immunodeficiency virus (HIV)-coinfection, when combined with standard methods (including clinical, microbiological, and radiological assessment) for diagnosing active TB and conventional DR. Since 2011, the WHO has specifically recommended use of the Xpert MTB/RIF test as an initial diagnostic tool for children with suspected HIV-associated TB or multidrug-resistant TB based on successful treatment data related to adults. Implementation of the rapid molecular assays for rapid detection of TB and DR should occur in laboratories with proven capability to run molecular tests and where quality control systems are implemented. Molecular approaches should be more largely tested in children, given their status as the group in whom the diagnostic dilemma is most pronounced. These tests should also be included in specific childhood TB diagnostic algorithms adapted to the local/national context in combination with other strategies for improving diagnostics, including more effective specimen collection. Copyright © 2016.

How clinicians should use the diagnostic laboratory in a changing medical world.

PubMed

Lundberg, G D

1999-02-01

In developed countries, clinicians are faced with a plethora of diagnostic tests to apply to patients to guide their clinical management. The quality, effectiveness, and efficiency of patient care should be foremost in the clinician's mind. Laboratory directors should make every effort to guide clinicians in appropriate laboratory test ordering, interpretation, and resulting actions. Medicine, being at its center a moral enterprise grounded in a covenant of trust, and laboratory medicine being a subset of medicine, must first care and advocate for the patient, and consider clinical outcomes as most important.

Optimizing Patient-centered Communication and Multidisciplinary Care Coordination in Emergency Diagnostic Imaging: A Research Agenda.

PubMed

Sabbatini, Amber K; Merck, Lisa H; Froemming, Adam T; Vaughan, William; Brown, Michael D; Hess, Erik P; Applegate, Kimberly E; Comfere, Nneka I

2015-12-01

Patient-centered emergency diagnostic imaging relies on efficient communication and multispecialty care coordination to ensure optimal imaging utilization. The construct of the emergency diagnostic imaging care coordination cycle with three main phases (pretest, test, and posttest) provides a useful framework to evaluate care coordination in patient-centered emergency diagnostic imaging. This article summarizes findings reached during the patient-centered outcomes session of the 2015 Academic Emergency Medicine consensus conference "Diagnostic Imaging in the Emergency Department: A Research Agenda to Optimize Utilization." The primary objective was to develop a research agenda focused on 1) defining component parts of the emergency diagnostic imaging care coordination process, 2) identifying gaps in communication that affect emergency diagnostic imaging, and 3) defining optimal methods of communication and multidisciplinary care coordination that ensure patient-centered emergency diagnostic imaging. Prioritized research questions provided the framework to define a research agenda for multidisciplinary care coordination in emergency diagnostic imaging. © 2015 by the Society for Academic Emergency Medicine.

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.

Photovoltaic test and demonstration project for the National Photovoltaic Conversion program

NASA Technical Reports Server (NTRS)

Deyo, J. N.

1975-01-01

Proposed are photovoltaic system tests and demonstrations covering a wide range of applications in order to develop low cost photovoltaic cells suitable for terrestrial applications. Program objectives are: (1) tests and model system demonstrations; (2) device performance and diagnostics; and (3) endurance of solar cell modules and arrays.

Journal: Efficient Hydrologic Tracer-Test Design for Tracer-Mass Estimation and Sample Collection Frequency, 1 Method Development

EPA Science Inventory

Hydrological tracer testing is the most reliable diagnostic technique available for the determination of basic hydraulic and geometric parameters necessary for establishing operative solute-transport processes. Tracer-test design can be difficult because of a lack of prior knowl...

New Testing Methods to Assess Technical Problem-Solving Ability.

ERIC Educational Resources Information Center

Hambleton, Ronald K.; And Others

Tests to assess problem-solving ability being provided for the Air Force are described, and some details on the development and validation of these computer-administered diagnostic achievement tests are discussed. Three measurement approaches were employed: (1) sequential problem solving; (2) context-free assessment of fundamental skills and…

Market assessment of tuberculosis diagnostics in India in 2013.

PubMed

Maheshwari, P; Chauhan, K; Kadam, R; Pujani, A; Kaur, M; Chitalia, M; Dabas, H; Perkins, M D; Boehme, C C; Denkinger, C M; Raizada, N; Ginnard, J; Jefferson, C; Pantoja, A; Rupert, S; Kik, S V; Cohen, C; Chedore, P; Satyanarayana, S; Pai, M

2016-03-01

India represents a significant potential market for new tests. We assessed India's market for tuberculosis (TB) diagnostics in 2013. Test volumes and unit costs were assessed for tuberculin tests, interferon-gamma release assays, sputum smear microscopy, serology, culture, speciation testing, nucleic-acid amplification tests (i.e., in-house polymerase chain reaction, Xpert(®) MTB/RIF, line-probe assays) and drug susceptibility testing. Data from the public sector were collected from the Revised National TB Control Programme reports. Private sector data were collected through a survey of private laboratories and practitioners. Data were also collected from manufacturers. In 2013, India's public sector performed 19.2 million tests, with a market value of US$22.9 million. The private sector performed 13.6 million tests, with a market value of US$60.4 million when prices charged to the patient were applied. The overall market was US$70.8 million when unit costs from the ingredient approach were used for the 32.8 million TB tests performed in the entire country. Smear microscopy was the most common test performed, accounting for 25% of the overall market value. India's estimated market value for TB diagnostics in 2013 was US$70.8 million. These data should be of relevance to test developers, donors and implementers.

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.

Xpert Flu for point-of-care diagnosis of human influenza in industrialized countries.

PubMed

Salez, Nicolas; Nougairede, Antoine; Ninove, Laetitia; Zandotti, Christine; de Lamballerie, Xavier; Charrel, Rémi N

2014-05-01

Respiratory infections, particularly those caused by influenza viruses, represent the third-most important cause of death in the world due to infectious diseases. Nevertheless, despite the enormous publicity attracted by epidemics due to these viruses, laboratory diagnosis, documentation and recording of respiratory diseases is still unsatisfactory. Available diagnostic tests capable of providing results rapidly are either limited and insufficiently sensitive or highly sensitive and specific but insufficiently rapid. Considerable investment and research efforts have been made towards the development of new diagnostics for influenza A and B viruses and the Xpert(®) Flu assay (Cepheid(®), CA, USA) has emerged as one of the most promising. In this article, we review current knowledge of the Xpert Flu test, discuss its potential value as a point-of-care test and outline the potential leads for future development.

True versus Apparent Malaria Infection Prevalence: The Contribution of a Bayesian Approach

PubMed Central

Claes, Filip; Van Hong, Nguyen; Torres, Kathy; Mao, Sokny; Van den Eede, Peter; Thi Thinh, Ta; Gamboa, Dioni; Sochantha, Tho; Thang, Ngo Duc; Coosemans, Marc; Büscher, Philippe; D'Alessandro, Umberto; Berkvens, Dirk; Erhart, Annette

2011-01-01

Aims To present a new approach for estimating the “true prevalence” of malaria and apply it to datasets from Peru, Vietnam, and Cambodia. Methods Bayesian models were developed for estimating both the malaria prevalence using different diagnostic tests (microscopy, PCR & ELISA), without the need of a gold standard, and the tests' characteristics. Several sources of information, i.e. data, expert opinions and other sources of knowledge can be integrated into the model. This approach resulting in an optimal and harmonized estimate of malaria infection prevalence, with no conflict between the different sources of information, was tested on data from Peru, Vietnam and Cambodia. Results Malaria sero-prevalence was relatively low in all sites, with ELISA showing the highest estimates. The sensitivity of microscopy and ELISA were statistically lower in Vietnam than in the other sites. Similarly, the specificities of microscopy, ELISA and PCR were significantly lower in Vietnam than in the other sites. In Vietnam and Peru, microscopy was closer to the “true” estimate than the other 2 tests while as expected ELISA, with its lower specificity, usually overestimated the prevalence. Conclusions Bayesian methods are useful for analyzing prevalence results when no gold standard diagnostic test is available. Though some results are expected, e.g. PCR more sensitive than microscopy, a standardized and context-independent quantification of the diagnostic tests' characteristics (sensitivity and specificity) and the underlying malaria prevalence may be useful for comparing different sites. Indeed, the use of a single diagnostic technique could strongly bias the prevalence estimation. This limitation can be circumvented by using a Bayesian framework taking into account the imperfect characteristics of the currently available diagnostic tests. As discussed in the paper, this approach may further support global malaria burden estimation initiatives. PMID:21364745

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…

The changing purpose of Prader-Willi syndrome clinical diagnostic criteria and proposed revised criteria.

PubMed

Gunay-Aygun, M; Schwartz, S; Heeger, S; O'Riordan, M A; Cassidy, S B

2001-11-01

Prader-Willi syndrome (PWS) is a complex, multisystem disorder. Its major clinical features include neonatal hypotonia, developmental delay, short stature, behavioral abnormalities, childhood-onset obesity, hypothalamic hypogonadism, and characteristic appearance. The genetic basis of PWS is also complex. It is caused by absence of expression of the paternally active genes in the PWS critical region on 15q11-q13. In approximately 70% of cases this is the result of deletion of this region from the paternal chromosome 15. In approximately 28%, it is attributable to maternal uniparental disomy (UPD; inheritance of 2 copies of a chromosome from the mother and no copies from the father, as opposed to the normal 1 copy from each parent) of chromosome 15, and in <2%, it is the result of a mutation, deletion, or other defect in the imprinting center. Clinical diagnostic criteria were established by consensus in 1993. Subsequently, definitive molecular genetic testing became available for laboratory diagnosis of PWS. However, identification of appropriate patients for testing remains a challenge for most practitioners because many features of the disorder are nonspecific and others can be subtle or evolve over time. For example, hypotonic infants who are still in the failure to thrive phase of the disorder often do not have sufficient features for recognition of PWS and often are not tested. Initial screening with these diagnostic criteria can increase the yield of molecular testing for older children and adults with nonspecific obesity and mental retardation. Therefore, the purpose of clinical diagnostic criteria has shifted from assisting in making the definitive diagnosis to raising diagnostic suspicion, thereby prompting testing. We conducted a retrospective review of patients with PWS confirmed with genetic testing to assess the validity and sensitivity of clinical diagnostic criteria published before the widespread availability of testing for all affected patients and recommend revised clinical criteria. Charts of all 90 patients with laboratory-confirmed PWS were reviewed. For each patient, the presence or absence of the major, minor, and supportive features listed in the published diagnostic criteria was recorded. The sensitivity of each criterion, mean of the total number of major and minor criteria, and mean total score for each patient were calculated. There were 68 patients with a deletion (del 15q11-q13), 21 with maternal UPD of chromosome 15, and 1 with a presumed imprinting defect. Age range at the time of the most recent evaluation was 5 months to 60 years (median: 14.5 years; del median: 14 years; range: 5 months-60 years; UPD median: 18 years; range: 5-42 years). The sensitivities of the major criteria ranged from 49% (characteristic facial features) to 98% (developmental delay). Global developmental delay and neonatal hypotonia were the 2 most consistently positive major criteria and were positive in >97% of the patients. Feeding problems in infancy, excessive weight gain after 1 year, hypogonadism, and hyperphagia were all present in 93% or more of patients. Sensitivities of the minor criteria ranged form 37% (sleep disturbance and apneas) to 93% (speech and articulation defects). Interestingly, the sensitivities of 8 of the minor criteria were higher than the sensitivity of characteristic facial features, which is a major criterion. Fifteen out of 90 patients with molecular diagnosis did not meet the clinical diagnostic criteria retrospectively. When definitive diagnostic testing is not available, as was the case for PWS when the 1993 criteria were developed, diagnostic criteria are important to avoid overdiagnosis and to ensure that diagnostic test development is performed on appropriate samples. When diagnostic testing is available, as is now the case for PWS, diagnostic criteria should serve to raise diagnostic suspicion, ensure that all appropriate people are tested, and avoid the expense of testing unnecessarily. Our results indicate that the sensitivities of most of the published criteria are acceptable. However, 16.7% of patients with molecular diagnosis did not meet the 1993 clinical diagnostic criteria retrospectively, suggesting that the published criteria may be too exclusive. A less strict scoring system may ensure that all appropriate people are tested. Accordingly, we suggest revised clinical criteria to help identify the appropriate patients for DNA testing for PWS. The suggested age groupings are based on characteristic phases of the natural history of PWS. Some of the features (eg, neonatal hypotonia, feeding problems in infancy) serve to diagnose the syndrome in the first few years of life, whereas others (eg, excessive eating) are useful during early childhood. Similarly, hypogonadism is most useful during and after adolescence. Some of the features like neonatal hypotonia and infantile feeding problems are less likely to be missed, whereas others such as characteristic facial features and hypogonadism (especially in prepubertal females) may require more careful and/or expert examination. The issue of who should have diagnostic testing is distinct from the determination of features among confirmed patients. Based on the sensitivities of the published criteria and our experience, we suggest testing all newborns/infants with otherwise unexplained hypotonia with poor suck. For children between 2 and 6 years of age, we consider hypotonia with history of poor suck associated with global developmental delay sufficient criteria to prompt testing. Between 6 and 12 years of age, we suggest testing those with hypotonia (or history of hypotonia with poor suck), global developmental delay, and excessive eating with central obesity (if uncontrolled). At the ages of 13 years and above, we recommend testing patients with cognitive impairment, excessive eating with central obesity (if uncontrolled), and hypogonadotropic hypogonadism and/or typical behavior problems (including temper tantrums and obsessive-compulsive features). Thus, we propose a lower threshold to prompt diagnostic DNA testing, leading to a higher likelihood of diagnosis of this disorder in which anticipatory guidance and intervention can significantly influence outcome.

[Validity criteria of a short test to assess speech and language competence in 4-year-olds].

PubMed

Euler, H A; Holler-Zittlau, I; Minnen, S; Sick, U; Dux, W; Zaretsky, Y; Neumann, K

2010-11-01

A psychometrically constructed short test as a prerequisite for screening was developed on the basis of a revision of the Marburger Speech Screening to assess speech/language competence among children in Hessen (Germany). A total of 257 children (age 4.0 to 4.5 years) performed the test battery for speech/language competence; 214 children repeated the test 1 year later. Test scores correlated highly with scores of two competing language screenings (SSV, HASE) and with a combined score from four diagnostic tests of individual speech/language competences (Reynell III, patholinguistic diagnostics in impaired language development, PLAKSS, AWST-R). Validity was demonstrated by three comparisons: (1) Children with German family language had higher scores than children with another language. (2) The 3-month-older children achieved higher scores than younger children. (3) The difference between the children with German family language and those with another language was higher for the 3-month-older than for the younger children. The short test assesses the speech/language competence of 4-year-olds quickly, validly, and comprehensively.

Development of a Culture Specific Critical Thinking Ability Test and Using It as a Supportive Diagnostic Test for Giftedness

ERIC Educational Resources Information Center

Köksal, Mustafa Serdar

2016-01-01

The purposes of this study were to develop a culture specific critical thinking ability test for 6, 7, and 8. grade students in Turkey and to use it as an assessment instrument for giftedness. For these purposes, item pool involving 22 items was formed by writing items focusing on the current and common events presented in (Turkish) media from…

Definition of osteoarthritis on MRI: results of a Delphi exercise.

PubMed

Hunter, D J; Arden, N; Conaghan, P G; Eckstein, F; Gold, G; Grainger, A; Guermazi, A; Harvey, W; Jones, G; Hellio Le Graverand, M P; Laredo, J D; Lo, G; Losina, E; Mosher, T J; Roemer, F; Zhang, W

2011-08-01

Despite a growing body of Magnetic Resonance Imaging (MRI) literature in osteoarthritis (OA), there is little uniformity in its diagnostic application. We envisage in the first instance the definition requiring further validation and testing in the research setting before considering implementation/feasibility testing in the clinical setting. The objective of our research was to develop an MRI definition of structural OA. We undertook a multistage process consisting of a number of different steps. The intent was to develop testable definitions of OA (knee, hip and/or hand) on MRI. This was an evidence driven approach with results of a systematic review provided to the group prior to a Delphi exercise. Each participant of the steering group was allowed to submit independently up to five propositions related to key aspects in MRI diagnosis of knee OA. The steering group then participated in a Delphi exercise to reach consensus on which propositions we would recommend for a definition of structural OA on MRI. For each round of voting, ≥60% votes led to include and ≤20% votes led to exclude a proposition. After developing the proposition one of the definitions developed was tested for its validity against radiographic OA in an extant database. For the systematic review we identified 25 studies which met all of our inclusion criteria and contained relevant diagnostic measure and performance data. At the completion of the Delphi voting exercise 11 propositions were accepted for definition of structural OA on MRI. We assessed the diagnostic performance of the tibiofemoral MRI definition against a radiographic reference standard. The diagnostic performance for individual features was: osteophyte C statistic=0.61, for cartilage loss C statistic=0.73, for bone marrow lesions C statistic=0.72 and for meniscus tear in any region C statistic=0.78. The overall composite model for these four features was a C statistic=0.59. We detected good specificity (1) but less optimal sensitivity (0.46) likely due to detection of disease earlier on MRI. We have developed MRI definition of knee OA that requires further formal testing with regards their diagnostic performance (especially in datasets of persons with early disease), before they are more widely used. Our current analysis suggests that further testing should focus on comparisons other than the radiograph, that may capture later stage disease and thus nullify the potential for detecting early disease that MRI may afford. The propositions are not to detract from, nor to discourage the use of traditional means of diagnosing OA. Copyright © 2011 Osteoarthritis Research Society International. All rights reserved.

On the importance of developing a new generation of breath tests for Helicobacter pylori detection.

PubMed

Kushch, Ievgeniia; Korenev, Nikolai; Kamarchuk, Lyudmila; Pospelov, Alexander; Kravchenko, Andrey; Bajenov, Leonid; Kabulov, Mels; Amann, Anton; Kamarchuk, Gennadii

2015-12-15

State-of-the-art methods for non-invasive detection of the Helicobacter pylori (H. pylori) infection have been considered. A reported global tendency towards a non-decreasing prevalence of H. pylori worldwide could be co-influenced by the functional limitations of urea breath tests (UBTs), currently preferred for the non-invasive recognition of H. pylori in a clinical setting. Namely, the UBTs can demonstrate false-positive or false-negative results. Within this context, limitations of conventional clinically exploited H. pylori tests have been discussed to justify the existing need for the development of a new generation of breath tests for the detection of H. pylori and the differentiation of pathogenic and non-pathogenic strains of the bacterium. This paper presents the results of a pilot clinical study aimed at evaluating the development and diagnostic potential of a new method based on the detection of the non-urease products of H. pylori vital activity in exhaled gas. The characteristics of breath of adolescents with H. pylori-positive and H. pylori-negative functional dyspepsia, together with a consideration of the cytotoxin-associated gene A (CagA) status of H. pylori-positive subjects, have been determined for the first time using innovative point-contact nanosensor devices based on salts of the organic conductor tetracyanoquinodimethane (TCNQ). The clinical and diagnostic relevance of the response curves of the point-contact sensors was assessed. It was found that the recovery time of the point-contact sensors has a diagnostic value for differentiation of the H. pylori-associated peptic ulcer disease. The diagnostically significant elongation of the recovery time was even more pronounced in patients infected with CagA-positive H. pylori strains compared to the CagA-negative patients. Taking into account the operation of the point-contact sensors in the real-time mode, the obtained results are essential prerequisites for the development of a fast and portable breath test for non-invasive detection of cytotoxic CagA strains of H. pylori infection. The relaxation time of the point-contact nanosensors could be selected as a diagnostic criterion for non-invasive determination of H. pylori-associated destructive lesions of the gastroduodenal area in adolescents, using the point-contact spectroscopic concept of breath analysis. This can subsequently be implemented into a 'test-and-treat' approach for the management of uninvestigated dyspepsia in populations with a high prevalence of H. pylori (according to the Maastricht III and IV Consensus recommendations).

Diagnostic imaging and spending review: extreme problems call for extreme measures.

PubMed

Ciarrapico, Anna Micaela; Ugenti, Rossana; Di Minco, Lidia; Santori, Elisabetta; Altobelli, Simone; Coco, Irene; D'Onofrio, Silvia; Simonetti, Giovanni

2017-04-01

The number of diagnostic imaging tests has increased dramatically over the past decade and about 5 billion diagnostic examinations are performed worldwide each year. According to Health Ministry, Italy, is in second place for the number of CT and MR tests per thousand inhabitants in 2014 with a score of 83.3 (only Germany has a higher score, 95.2) that is a long way off from the European average of 46.5. It has also the highest ratio of magnetic resonances per person with 24,6 machines per million inhabitants, followed only by Greece and Finland. The development of the New Health Information System (NSIS) in 2010 made uniformly readable the non-homogeneous clinical data from all the different Italian regions and permitted a detailed analysis of all diagnostic imaging within the public outpatient care setting in Italy in 2012. Despite that MRI examinations represented only the 10% of the total number of imaging tests performed, their cost reached 30% of the health-care expenditure for outpatient diagnostic imaging with an overwhelming contribution coming from musculoskeletal MR which accounted for the 73% of the performed MR tests. It is reasonable to assume that these phenomena are likely due to a lack of appropriateness in MR requests that is difficult to analyze due to an absence or invalid query on the prescriptions which together accounted for the 98.7% of cases. Taking into account the above-mentioned situation, this is possibly why the Ministry of Health decided to perform "linear cuts" in expenditure for some diagnostic examinations.

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.

Consolidated Laser-Induced Fluorescence Diagnostic Systems for the NASA Ames Arc Jet Facilities

NASA Technical Reports Server (NTRS)

Grinstead, Jay H.; Wilder, Michael C.; Porter, Barry J.; Brown, Jeffrey D.; Yeung, Dickson; Battazzo, Stephen J.; Brubaker, Timothy R.

2016-01-01

The spectroscopic diagnostic technique of two photon absorption laser-induced fluorescence (LIF) of atomic species for non-intrusive arc jet flow property measurement was first implemented at NASA Ames in the mid-1990s. In 2013-2014, NASA combined the agency's large-scale arc jet test capabilities at NASA Ames. Concurrent with that effort, the agency also sponsored a project to establish two comprehensive LIF diagnostic systems for the Aerodynamic Heating Facility (AHF) and Interaction Heating Facility (IHF) arc jets. The scope of the project enabled further engineering development of the existing IHF LIF system as well as the complete reconstruction of the AHF LIF system. The updated LIF systems are identical in design and capability. They represent the culmination of over 20 years of development experience in transitioning a specialized laboratory research tool into a measurement system for large-scale, high-demand test facilities. This paper will document the latest improvements of the LIF system design and demonstrations of the redeveloped AHF and IHF LIF systems.

Design of Malaria Diagnostic Criteria for the Sysmex XE-2100 Hematology Analyzer

PubMed Central

Campuzano-Zuluaga, Germán; Álvarez-Sánchez, Gonzalo; Escobar-Gallo, Gloria Elcy; Valencia-Zuluaga, Luz Marina; Ríos-Orrego, Alexandra Marcela; Pabón-Vidal, Adriana; Miranda-Arboleda, Andrés Felipe; Blair-Trujillo, Silvia; Campuzano-Maya, Germán

2010-01-01

Thick film, the standard diagnostic procedure for malaria, is not always ordered promptly. A failsafe diagnostic strategy using an XE-2100 analyzer is proposed, and for this strategy, malaria diagnostic models for the XE-2100 were developed and tested for accuracy. Two hundred eighty-one samples were distributed into Plasmodium vivax, P. falciparum, and acute febrile syndrome groups for model construction. Model validation was performed using 60% of malaria cases and a composite control group of samples from AFS and healthy participants from endemic and non-endemic regions. For P. vivax, two observer-dependent models (accuracy = 95.3–96.9%), one non–observer-dependent model using built-in variables (accuracy = 94.7%), and one non–observer-dependent model using new and built-in variables (accuracy = 96.8%) were developed. For P. falciparum, two non–observer-dependent models (accuracies = 85% and 89%) were developed. These models could be used by health personnel or be integrated as a malaria alarm for the XE-2100 to prompt early malaria microscopic diagnosis. PMID:20207864

The development, evaluation and performance of molecular diagnostics for detection of Mycobacterium tuberculosis.

PubMed

Bates, Matthew; Zumla, Alimuddin

2016-01-01

The unique pathogenesis of tuberculosis (TB) poses several barriers to the development of accurate diagnostics: a) the establishment of life-long latency by Mycobacterium tuberculosis (M.tb) after primary infection confounds the development of classical antibody or antigen based assays; b) our poor understanding of the molecular pathways that influence progression from latent to active disease; c) the intracellular nature of M.tb infection in tissues means that M.tb and/or its components, are not readily detectable in peripheral specimens; and d) the variable presence of M.tb bacilli in specimens from patients with extrapulmonary TB or children. The literature on the current portfolio of molecular diagnostics tests for TB is reviewed here and the developmental pipeline is summarized. Also reviewed are data from recently published operational research on the GeneXpert MTB/RIF assay and discussed are the lessons that can be taken forward for the design of studies to evaluate the impact of TB diagnostics.

Development of Two-Tier Diagnostic Test Pictorial-Based for Identifying High School Students Misconceptions on the Mole Concept

NASA Astrophysics Data System (ADS)

Siswaningsih, W.; Firman, H.; Zackiyah; Khoirunnisa, A.

2017-02-01

The aim of this study was to develop the two-tier pictorial-based diagnostic test for identifying student misconceptions on mole concept. The method of this study is used development and validation. The development of the test Obtained through four phases, development of any items, validation, determination key, and application test. Test was developed in the form of pictorial consisting of two tier, the first tier Consist of four possible answers and the second tier Consist of four possible reasons. Based on the results of content validity of 20 items using the CVR (Content Validity Ratio), a number of 18 items declared valid. Based on the results of the reliability test using SPSS, Obtained 17 items with Cronbach’s Alpha value of 0703, the which means that items have accepted. A total of 10 items was conducted to 35 students of senior high school students who have studied the mole concept on one of the high schools in Cimahi. Based on the results of the application test, student misconceptions were identified in each label concept in mole concept with the percentage of misconceptions on the label concept of mole (60.15%), Avogadro’s number (34.28%), relative atomic mass (62, 84%), relative molecule mass (77.08%), molar mass (68.53%), molar volume of gas (57.11%), molarity (71.32%), chemical equation (82.77%), limiting reactants (91.40%), and molecular formula (77.13%).

Validation of a screening tool for the rapid and reliable detection of CGG trinucleotide repeat expansions in FMR1.

PubMed

Basehore, Monica J; Marlowe, Natalia M; Jones, Julie R; Behlendorf, Deborah E; Laver, Thomas A; Friez, Michael J

2012-06-01

Most individuals with intellectual disability and/or autism are tested for Fragile X syndrome at some point in their lifetime. Greater than 99% of individuals with Fragile X have an expanded CGG trinucleotide repeat motif in the promoter region of the FMR1 gene, and diagnostic testing involves determining the size of the CGG repeat as well as methylation status when an expansion is present. Using a previously described triplet repeat-primed polymerase chain reaction, we have performed additional validation studies using two cohorts with previous diagnostic testing results available for comparison purposes. The first cohort (n=88) consisted of both males and females and had a high percentage of abnormal samples, while the second cohort (n=624) consisted of only females and was not enriched for expansion mutations. Data from each cohort were completely concordant with the results previously obtained during the course of diagnostic testing. This study further demonstrates the utility of using laboratory-developed triplet repeat-primed FMR1 testing in a clinical setting.

Integrating Oil Debris and Vibration Measurements for Intelligent Machine Health Monitoring. Degree awarded by Toledo Univ., May 2002

NASA Technical Reports Server (NTRS)

Dempsey, Paula J.

2003-01-01

A diagnostic tool for detecting damage to gears was developed. Two different measurement technologies, oil debris analysis and vibration were integrated into a health monitoring system for detecting surface fatigue pitting damage on gears. This integrated system showed improved detection and decision-making capabilities as compared to using individual measurement technologies. This diagnostic tool was developed and evaluated experimentally by collecting vibration and oil debris data from fatigue tests performed in the NASA Glenn Spur Gear Fatigue Rig. An oil debris sensor and the two vibration algorithms were adapted as the diagnostic tools. An inductance type oil debris sensor was selected for the oil analysis measurement technology. Gear damage data for this type of sensor was limited to data collected in the NASA Glenn test rigs. For this reason, this analysis included development of a parameter for detecting gear pitting damage using this type of sensor. The vibration data was used to calculate two previously available gear vibration diagnostic algorithms. The two vibration algorithms were selected based on their maturity and published success in detecting damage to gears. Oil debris and vibration features were then developed using fuzzy logic analysis techniques, then input into a multi sensor data fusion process. Results show combining the vibration and oil debris measurement technologies improves the detection of pitting damage on spur gears. As a result of this research, this new diagnostic tool has significantly improved detection of gear damage in the NASA Glenn Spur Gear Fatigue Rigs. This research also resulted in several other findings that will improve the development of future health monitoring systems. Oil debris analysis was found to be more reliable than vibration analysis for detecting pitting fatigue failure of gears and is capable of indicating damage progression. Also, some vibration algorithms are as sensitive to operational effects as they are to damage. Another finding was that clear threshold limits must be established for diagnostic tools. Based on additional experimental data obtained from the NASA Glenn Spiral Bevel Gear Fatigue Rig, the methodology developed in this study can be successfully implemented on other geared systems.

The Zone of Potential Development: Implications for Intelligence Testing in the Year 2000. Technical Report No. 128.

ERIC Educational Resources Information Center

Brown, Ann L.; French, Lucia A.

The practice and interpretation of intelligence testing of educable retarded and learning disabled children is examined in this report. The current and future state of intelligence testing is discussed in terms of its predictive, diagnostic, and remedial functions. The first section places a consideration of individual testing formats within a…

Development of advanced diagnostics for characterization of burning droplets in microgravity

NASA Technical Reports Server (NTRS)

Sankar, Subramanian; Buermann, Dale H.; Bachalo, William D.

1995-01-01

Diagnostic techniques currently used for microgravity research are generally not as advanced as those used in earth based gravity experiments. Diagnostic techniques for measuring the instantaneous radial temperature profile (or temperature gradients) within the burning droplet do not exist. Over the past few years, Aerometrics has been researching and developing a rainbow thermometric technique for measuring the droplet temperatures of burning droplets. This technique has recently been integrated with the phase Doppler interferometric technique to yield a diagnostic instrument that can be used to simultaneously measure the size, velocity, and temperature of burning droplets in complex spray flames. Also, the rainbow thermometric technique has been recently integrated with a point-diffraction interferometric technique for measuring the instantaneous gas phase temperature field surrounding a burning droplet. These research programs, apart from being very successful, have also helped us identify other innovative techniques for the characterization of burning droplets. For example, new techniques have been identified for measuring the instantaneous regression rate of burning droplets. Also, there is the possibility of extracting the instantaneous radial temperature distribution or the temperature gradients within a droplet during transient heating. What is important is that these diagnostic techniques have the potential for making use of inexpensive, light-weight, and rugged devices such as diode lasers and linear CCD arrays. As a result, they can be easily packaged for incorporation into microgravity drop-test and flight-test facilities. Furthermore, with the use of linear CCD arrays, data rates as high as 10-100 kHz can be easily achieved. This data rate is orders of magnitude higher than what is currently achievable. In this research and development program, a compact and rugged diagnostic system will be developed that can be used to measure instantaneous fuel droplet diameter, droplet regression rate, and the droplet internal temperature profiles or gradients at very high data rates in microgravity experiments.

A national study of breast and colorectal cancer patients' decision-making for novel personalized medicine genomic diagnostics.

PubMed

Issa, Amalia M; Tufail, Waqas; Atehortua, Nelson; McKeever, John

2013-05-01

Molecular diagnostics are increasingly being used to help guide decision-making for personalized medical treatment of breast and colorectal cancer patients. The main aim of this study was to better understand and determine breast and colorectal cancer patients' decision-making strategies and the trade-offs they make in deciding about characteristics of molecular genomic diagnostics for breast and colorectal cancer. We surveyed a nationally representative sample of 300 breast and colorectal cancer patients using a previously developed web-administered instrument. Eligibility criteria included patients aged 18 years and older with either breast or colorectal cancer. We explored several attributes and attribute levels of molecular genomic diagnostics in 20 scenarios. Our analysis revealed that both breast and colorectal cancer patients weighted the capability of molecular genomic diagnostics to determine the probability of treatment efficacy as being of greater importance than information provided to detect adverse events. The probability of either false-positive or -negative results was ranked highly as a potential barrier by both breast and colorectal patients. However, 78.6% of breast cancer patients ranked the possibility of a 'false-negative test result leading to undertreatment' higher than the 'chance of a false positive, which may lead to overtreatment' (68%). This finding contrasted with the views of colorectal cancer patients who ranked the chance of a false positive as being of greater concern than a false negative (72.8 vs 63%). Overall, cancer patients exhibited a high willingness to accept and pay for genomic diagnostic tests, especially among breast cancer patients. Cancer patients seek a test accuracy rate of 90% or higher. Breast and colorectal cancer patients' decisions about genomic diagnostics are influenced more by the probability of being cured than by avoiding potential severe adverse events. This study provides insights into the relative weight that breast and colorectal cancer patients place on various aspects of molecular genomic diagnostics, and the trade-offs they are willing to make among attributes of such tests.

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.

Development and Testing of an LED-Based Near-Infrared Sensor for Human Kidney Tumor Diagnostics

PubMed Central

Zabarylo, Urszula; Kirsanov, Dmitry; Belikova, Valeria; Ageev, Vladimir; Usenov, Iskander; Galyanin, Vladislav; Minet, Olaf; Sakharova, Tatiana; Danielyan, Georgy; Feliksberger, Elena; Artyushenko, Viacheslav

2017-01-01

Optical spectroscopy is increasingly used for cancer diagnostics. Tumor detection feasibility in human kidney samples using mid- and near-infrared (NIR) spectroscopy, fluorescence spectroscopy, and Raman spectroscopy has been reported (Artyushenko et al., Spectral fiber sensors for cancer diagnostics in vitro. In Proceedings of the European Conference on Biomedical Optics, Munich, Germany, 21–25 June 2015). In the present work, a simplification of the NIR spectroscopic analysis for cancer diagnostics was studied. The conventional high-resolution NIR spectroscopic method of kidney tumor diagnostics was replaced by a compact optical sensing device constructively represented by a set of four light-emitting diodes (LEDs) at selected wavelengths and one detecting photodiode. Two sensor prototypes were tested using 14 in vitro clinical samples of 7 different patients. Statistical data evaluation using principal component analysis (PCA) and partial least-squares discriminant analysis (PLS-DA) confirmed the general applicability of the LED-based sensing approach to kidney tumor detection. An additional validation of the results was performed by means of sample permutation. PMID:28825612

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.

Diagnostic test accuracy of nutritional tools used to identify undernutrition in patients with colorectal cancer: a systematic review.

PubMed

Håkonsen, Sasja Jul; Pedersen, Preben Ulrich; Bath-Hextall, Fiona; Kirkpatrick, Pamela

2015-05-15

Effective nutritional screening, nutritional care planning and nutritional support are essential in all settings, and there is no doubt that a health service seeking to increase safety and clinical effectiveness must take nutritional care seriously. Screening and early detection of malnutrition is crucial in identifying patients at nutritional risk. There is a high prevalence of malnutrition in hospitalized patients undergoing treatment for colorectal cancer. To synthesize the best available evidence regarding the diagnostic test accuracy of nutritional tools (sensitivity and specificity) used to identify malnutrition (specifically undernutrition) in patients with colorectal cancer (such as the Malnutrition Screening Tool and Nutritional Risk Index) compared to reference tests (such as the Subjective Global Assessment or Patient Generated Subjective Global Assessment). Patients with colorectal cancer requiring either (or all) surgery, chemotherapy and/or radiotherapy in secondary care. Focus of the review: The diagnostic test accuracy of validated assessment tools/instruments (such as the Malnutrition Screening Tool and Nutritional Risk Index) in the diagnosis of malnutrition (specifically under-nutrition) in patients with colorectal cancer, relative to reference tests (Subjective Global Assessment or Patient Generated Subjective Global Assessment). Types of studies: Diagnostic test accuracy studies regardless of study design. Studies published in English, German, Danish, Swedish and Norwegian were considered for inclusion in this review. Databases were searched from their inception to April 2014. Methodological quality was determined using the Quality Assessment of Diagnostic Accuracy Studies checklist. Data was collected using the data extraction form: the Standards for Reporting Studies of Diagnostic Accuracy checklist for the reporting of studies of diagnostic accuracy. The accuracy of diagnostic tests is presented in terms of sensitivity, specificity, positive and negative predictive values. In addition, the positive likelihood ratio (sensitivity/ [1 - specificity]) and negative likelihood ratio (1 - sensitivity)/ specificity), were also calculated and presented in this review to provide information about the likelihood that a given test result would be expected when the target condition is present compared with the likelihood that the same result would be expected when the condition is absent. Not all trials reported true positive, true negative, false positive and false negative rates, therefore these rates were calculated based on the data in the published papers. A two-by-two truth table was reconstructed for each study, and sensitivity, specificity, positive predictive value, negative predictive value positive likelihood ratio and negative likelihood ratio were calculated for each study. A summary receiver operator characteristics curve was constructed to determine the relationship between sensitivity and specificity, and the area under the summary receiver operator characteristics curve which measured the usefulness of a test was calculated. Meta-analysis was not considered appropriate, therefore data was synthesized in a narrative summary. 1. One study evaluated the Malnutrition Screening Tool against the reference standard Patient-Generated Subjective Global Assessment. The sensitivity was 56% and the specificity 84%. The positive likelihood ratio was 3.100, negative likelihood ratio was 0.59, the diagnostic odds ratio (CI 95%) was 5.20 (1.09-24.90) and the Area Under the Curve (AUC) represents only a poor to fair diagnostic test accuracy. A total of two studies evaluated the diagnostic accuracy of Malnutrition Universal Screening Tool (MUST) (index test) compared to both Subjective Global Assessment (SGA) (reference standard) and PG-SGA (reference standard) in patients with colorectal cancer. In MUST vs SGA the sensitivity of the tool was 96%, specificity was 75%, LR+ 3.826, LR- 0.058, diagnostic OR (CI 95%) 66.00 (6.61-659.24) and AUC represented excellent diagnostic accuracy. In MUST vs PG-SGA the sensitivity of the tool was 72%, specificity 48.9%, LR+ 1.382, LR- 0.579, diagnostic OR (CI 95%) 2.39 (0.87-6.58) and AUC indicated that the tool failed as a diagnostic test to identify patients with colorectal cancer at nutritional risk,. The Nutrition Risk Index (NRI) was compared to SGA representing a sensitivity of 95.2%, specificity of 62.5%, LR+ 2.521, LR- 0.087, diagnostic OR (CI 95%) 28.89 (6.93-120.40) and AUC represented good diagnostic accuracy. In regard to NRI vs PG-SGA the sensitivity of the tool was 68%, specificity 64%, LR+ 1.947, LR- 0.487, diagnostic OR (CI 95%) 4.00 (1.23-13.01) and AUC indicated poor diagnostic test accuracy. There are no single, specific tools used to screen or assess the nutritional status of colorectal cancer patients. All tools showed varied diagnostic accuracies when compared to the reference standards SGA and PG-SGA. Hence clinical judgment combined with perhaps the SGA or PG-SGA should play a major role. The PG-SGA offers several advantages over the SGA tool: 1) the patient completes the medical history component, thereby decreasing the amount of time involved; 2) it contains more nutrition impact symptoms, which are important to the patient with cancer; and 3) it has a scoring system that allows patients to be triaged for nutritional intervention. Therefore, the PG-SGA could be used as a nutrition assessment tool as it allows quick identification and prioritization of colorectal cancer patients with malnutrition in combination with other parameters. This systematic review highlights the need for the following: Further studies needs to investigate the diagnostic accuracy of already existing nutritional screening tools in the context of colorectal cancer patients. If new screenings tools are developed, they should be developed and validated in the specific clinical context within the same patient population (colorectal cancer patients). The Joanna Briggs Institute.

Advanced life support control/monitor instrumentation concepts for flight application

NASA Technical Reports Server (NTRS)

Heppner, D. B.; Dahlhausen, M. J.; Fell, R. B.

1986-01-01

Development of regenerative Environmental Control/Life Support Systems requires instrumentation characteristics which evolve with successive development phases. As the development phase moves toward flight hardware, the system availability becomes an important design aspect which requires high reliability and maintainability. This program was directed toward instrumentation designs which incorporate features compatible with anticipated flight requirements. The first task consisted of the design, fabrication and test of a Performance Diagnostic Unit. In interfacing with a subsystem's instrumentation, the Performance Diagnostic Unit is capable of determining faulty operation and components within a subsystem, perform on-line diagnostics of what maintenance is needed and accept historical status on subsystem performance as such information is retained in the memory of a subsystem's computerized controller. The second focus was development and demonstration of analog signal conditioning concepts which reduce the weight, power, volume, cost and maintenance and improve the reliability of this key assembly of advanced life support instrumentation. The approach was to develop a generic set of signal conditioning elements or cards which can be configured to fit various subsystems. Four generic sensor signal conditioning cards were identified as being required to handle more than 90 percent of the sensors encountered in life support systems. Under company funding, these were detail designed, built and successfully tested.

Clinical diagnosis of partial or complete anterior cruciate ligament tears using patients' history elements and physical examination tests

PubMed Central

Fallaha, Michel; Belzile, Sylvain; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Feldman, Debbie; Sylvestre, Marie-Pierre; Vendittoli, Pascal-André; Desmeules, François

2018-01-01

Objective To assess the diagnostic validity of clusters combining history elements and physical examination tests to diagnose partial or complete anterior cruciate ligament (ACL) tears. Design Prospective diagnostic study. Settings Orthopaedic clinics (n = 2), family medicine clinics (n = 2) and community-dwelling. Participants Consecutive patients with a knee complaint (n = 279) and consulting one of the participating orthopaedic surgeons (n = 3) or sport medicine physicians (n = 2). Interventions Not applicable. Main outcome measures History elements and physical examination tests performed independently were compared to the reference standard: an expert physicians’ composite diagnosis including history elements, physical tests and confirmatory magnetic resonance imaging. Penalized logistic regression (LASSO) was used to identify history elements and physical examination tests associated with the diagnosis of ACL tear and recursive partitioning was used to develop diagnostic clusters. Diagnostic accuracy measures including sensitivity (Se), specificity (Sp), predictive values and positive and negative likelihood ratios (LR+/-) with associated 95% confidence intervals (CI) were calculated. Results Forty-three individuals received a diagnosis of partial or complete ACL tear (15.4% of total cohort). The Lachman test alone was able to diagnose partial or complete ACL tears (LR+: 38.4; 95%CI: 16.0–92.5). Combining a history of trauma during a pivot with a “popping” sensation also reached a high diagnostic validity for partial or complete tears (LR+: 9.8; 95%CI: 5.6–17.3). Combining a history of trauma during a pivot, immediate effusion after trauma and a positive Lachman test was able to identify individuals with a complete ACL tear (LR+: 17.5; 95%CI: 9.8–31.5). Finally, combining a negative history of pivot or a negative popping sensation during trauma with a negative Lachman or pivot shift test was able to exclude both partial or complete ACL tears (LR-: 0.08; 95%CI: 0.03–0.24). Conclusion Diagnostic clusters combining history elements and physical examination tests can support the differential diagnosis of ACL tears compared to various knee disorders. PMID:29894492

Serology in Finfish for Diagnosis, Surveillance, and Research: A Systematic Review.

PubMed

Jaramillo, Diana; Peeler, Edmund J; Laurin, Emilie; Gardner, Ian A; Whittington, Richard J

2017-03-01

Historically, serological tests for finfish diseases have been underused when compared with their use in terrestrial animal health. For years the nonspecific immune response in fish was judged to make serology unreliable and inferior to the direct measurement of agent analytes. We conducted a systematic review of peer-reviewed publications that reported on the development, validation, or application of serological tests for finfish diseases. A total of 168 articles met the screening criteria; most of them were focused on salmonid pathogens (e.g., Aeromonas spp. and viral hemorrhagic septicemia virus). Before the 1980s, most publications reported the use of agglutination tests, but our review indicates that enzyme-linked immunosorbent assay (ELISA) has more recently become the dominant serological test. The main application of serological tests has been in the assessment of vaccine efficacy, with few applications for surveillance or demonstration of freedom from disease, despite the advantages of serological tests over direct detection at the population level. Nonlethal sampling, low cost, and postinfection persistence of antibodies make serological assays the test of choice in surveillance, especially of valuable broodstock. However, their adoption has been constrained by poor characterization and validation. The number of publications in our review reporting diagnostic sensitivity and specificity of serological tests in finfish was small (n = 7). Foreseeing a wider use of serological tests in the future for diagnostic end purposes, we offer recommendations for mitigating deficiencies in the development and evaluation of serological tests, including optimization, control of nonspecific reactions, informed cutoff points, diagnostic accuracy, and serological baseline studies. Achieving these goals will facilitate greater international recognition of serological testing in programs supporting aquatic animal health. Received March 21, 2016; accepted September 24, 2016.

Specialized data analysis for the Space Shuttle Main Engine and diagnostic evaluation of advanced propulsion system components

NASA Technical Reports Server (NTRS)

1993-01-01

The Marshall Space Flight Center is responsible for the development and management of advanced launch vehicle propulsion systems, including the Space Shuttle Main Engine (SSME), which is presently operational, and the Space Transportation Main Engine (STME) under development. The SSME's provide high performance within stringent constraints on size, weight, and reliability. Based on operational experience, continuous design improvement is in progress to enhance system durability and reliability. Specialized data analysis and interpretation is required in support of SSME and advanced propulsion system diagnostic evaluations. Comprehensive evaluation of the dynamic measurements obtained from test and flight operations is necessary to provide timely assessment of the vibrational characteristics indicating the operational status of turbomachinery and other critical engine components. Efficient performance of this effort is critical due to the significant impact of dynamic evaluation results on ground test and launch schedules, and requires direct familiarity with SSME and derivative systems, test data acquisition, and diagnostic software. Detailed analysis and evaluation of dynamic measurements obtained during SSME and advanced system ground test and flight operations was performed including analytical/statistical assessment of component dynamic behavior, and the development and implementation of analytical/statistical models to efficiently define nominal component dynamic characteristics, detect anomalous behavior, and assess machinery operational condition. In addition, the SSME and J-2 data will be applied to develop vibroacoustic environments for advanced propulsion system components, as required. This study will provide timely assessment of engine component operational status, identify probable causes of malfunction, and indicate feasible engineering solutions. This contract will be performed through accomplishment of negotiated task orders.

Design of practical alignment device in KSTAR Thomson diagnostic

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

Lee, J. H., E-mail: jhlee@nfri.re.kr; University of Science and Technology; Lee, S. H.

2016-11-15

The precise alignment of the laser path and collection optics in Thomson scattering measurements is essential for accurately determining electron temperature and density in tokamak experiments. For the last five years, during the development stage, the KSTAR tokamak’s Thomson diagnostic system has had alignment fibers installed in its optical collection modules, but these lacked a proper alignment detection system. In order to address these difficulties, an alignment verifying detection device between lasers and an object field of collection optics is developed. The alignment detection device utilizes two types of filters: a narrow laser band wavelength for laser, and a broadmore » wavelength filter for Thomson scattering signal. Four such alignment detection devices have been successfully developed for the KSTAR Thomson scattering system in this year, and these will be tested in KSTAR experiments in 2016. In this paper, we present the newly developed alignment detection device for KSTAR’s Thomson scattering diagnostics.« less

Design of practical alignment device in KSTAR Thomson diagnostic.

PubMed

Lee, J H; Lee, S H; Yamada, I

2016-11-01

The precise alignment of the laser path and collection optics in Thomson scattering measurements is essential for accurately determining electron temperature and density in tokamak experiments. For the last five years, during the development stage, the KSTAR tokamak's Thomson diagnostic system has had alignment fibers installed in its optical collection modules, but these lacked a proper alignment detection system. In order to address these difficulties, an alignment verifying detection device between lasers and an object field of collection optics is developed. The alignment detection device utilizes two types of filters: a narrow laser band wavelength for laser, and a broad wavelength filter for Thomson scattering signal. Four such alignment detection devices have been successfully developed for the KSTAR Thomson scattering system in this year, and these will be tested in KSTAR experiments in 2016. In this paper, we present the newly developed alignment detection device for KSTAR's Thomson scattering diagnostics.

Diagnostic validation of selected serological tests for detecting scrub typhus.

PubMed

Koraluru, Munegowda; Bairy, Indira; Varma, Muralidhar; Vidyasagar, Sudha

2015-07-01

Clinical diagnosis of scrub typhus is often difficult because the symptoms are very similar to those of other febrile illness such as dengue, leptospirosis, malaria and other viral hemorrhagic fevers. Though better diagnostic tests are available for rickettsial diseases and scrub typhus elsewhere, the Weil-Felix test is still commonly used in India, mainly because microimmunofluorescence assays (M-IFA) were not available in India till recently and relevant staff had insufficient training. The present study was performed to investigate the performance of M-IFA, IgM ELISA, and Weil-Felix test on 546 non-repeated serum samples from subjects suspected of having scrub typhus. One hundred and forty-three of these 546 samples were positive by M-IFA; these cases were also confirmed clinically to have scrub typhus based on their dramatic responses to doxycycline therapy. IgM ELISA was positive in 122 of the 143 M-IFA positive cases and the Weil-Felix test in 96. Though the Weil-Felix test is a heterophile agglutination test, it was found in this study to have good specificity but far too little sensitivity to use as a routine diagnostic test. IgM ELISA can be a good substitute for M-IFA. Incorporation of multiple prototype antigens on M-IFA slides is likely one of the reasons for its superior performance. As newer and better diagnostic assays become available for scrub typhus diagnosis in developed countries, it will be imperative to also use such tests in other endemic countries to prevent over- or under-diagnosis of scrub typhus. © 2015 The Societies and Wiley Publishing Asia Pty Ltd.

Development of computer informational system of diagnostics integrated optical materials, elements, and devices

NASA Astrophysics Data System (ADS)

Volosovitch, Anatoly E.; Konopaltseva, Lyudmila I.

1995-11-01

Well-known methods of optical diagnostics, database for their storage, as well as expert system (ES) for their development are analyzed. A computer informational system is developed, which is based on a hybrid ES built on modern DBMS. As an example, the structural and constructive circuits of the hybrid integrated-optical devices based on laser diodes, diffusion waveguides, geodetic lenses, package-free linear photodiode arrays, etc. are presented. The features of methods and test results as well as the advanced directions of works related to the hybrid integrated-optical devices in the field of metrology are discussed.

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...

Objective speech quality evaluation of real-time speech coders

NASA Astrophysics Data System (ADS)

Viswanathan, V. R.; Russell, W. H.; Huggins, A. W. F.

1984-02-01

This report describes the work performed in two areas: subjective testing of a real-time 16 kbit/s adaptive predictive coder (APC) and objective speech quality evaluation of real-time coders. The speech intelligibility of the APC coder was tested using the Diagnostic Rhyme Test (DRT), and the speech quality was tested using the Diagnostic Acceptability Measure (DAM) test, under eight operating conditions involving channel error, acoustic background noise, and tandem link with two other coders. The test results showed that the DRT and DAM scores of the APC coder equalled or exceeded the corresponding test scores fo the 32 kbit/s CVSD coder. In the area of objective speech quality evaluation, the report describes the development, testing, and validation of a procedure for automatically computing several objective speech quality measures, given only the tape-recordings of the input speech and the corresponding output speech of a real-time speech coder.

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.

Open Rotor - Analysis of Diagnostic Data

NASA Technical Reports Server (NTRS)

Envia, Edmane

2011-01-01

NASA is researching open rotor propulsion as part of its technology research and development plan for addressing the subsonic transport aircraft noise, emission and fuel burn goals. The low-speed wind tunnel test for investigating the aerodynamic and acoustic performance of a benchmark blade set at the approach and takeoff conditions has recently concluded. A high-speed wind tunnel diagnostic test campaign has begun to investigate the performance of this benchmark open rotor blade set at the cruise condition. Databases from both speed regimes will comprise a comprehensive collection of benchmark open rotor data for use in assessing/validating aerodynamic and noise prediction tools (component & system level) as well as providing insights into the physics of open rotors to help guide the development of quieter open rotors.

[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.

Continuous stacking computational approach based automated microscope slide scanner

NASA Astrophysics Data System (ADS)

Murali, Swetha; Adhikari, Jayesh Vasudeva; Jagannadh, Veerendra Kalyan; Gorthi, Sai Siva

2018-02-01

Cost-effective and automated acquisition of whole slide images is a bottleneck for wide-scale deployment of digital pathology. In this article, a computation augmented approach for the development of an automated microscope slide scanner is presented. The realization of a prototype device built using inexpensive off-the-shelf optical components and motors is detailed. The applicability of the developed prototype to clinical diagnostic testing is demonstrated by generating good quality digital images of malaria-infected blood smears. Further, the acquired slide images have been processed to identify and count the number of malaria-infected red blood cells and thereby perform quantitative parasitemia level estimation. The presented prototype would enable cost-effective deployment of slide-based cyto-diagnostic testing in endemic areas.

Sequential analysis of sperm functional aspects involved in fertilisation: a pilot study.

PubMed

Abu, D A H; Franken, D R; Hoffman, B; Henkel, R

2012-05-01

The development of diagnostic techniques in andrology as a second level of approach to the diagnosis of male factor infertility has enthused the focus of researchers on the development of a sequential diagnostic programme for these men. Semen samples of 78 men form couples undergoing in vitro fertilisation therapy were used in the study. The semen samples were used to test sperm functional aspects known to interfere with fertilisation. These tests included semen profile, DNA integrity, apoptosis, chromatin packaging, acridin orange staining, zona binding capacity, zona-induced acrosome reaction (AR). Results were correlated with fertilisation outcome. Statistical analyses of the recorded data were carried out using a logistic regression analysis model on all sperm functional tests. A negative and significant association with the fertilisation rates was recorded for DNA damage (r = -0.56; P ≤ 0.0005). A positive significant correlation was recorded between fertilisation rates and sperm with normal DNA (r = -0.57, P ≤ 0.0004), and zona-induced AR (r = 0.33, P ≤ 0.002). Diagnostic andrology can be regarded as a mandatory part of the male factor patient's work-up schedule to assist clinicians with the most suitable therapeutic modality to follow. © 2011 Blackwell Verlag GmbH.

Production of recombinant dengue non-structural 1 (NS1) proteins from clinical virus isolates.

PubMed

Yohan, Benediktus; Wardhani, Puspa; Aryati; Trimarsanto, Hidayat; Sasmono, R Tedjo

2017-01-01

Dengue is a febrile disease caused by infection of dengue virus (DENV). Early diagnosis of dengue infection is important for better management of the disease. The DENV Non-Structural Protein 1 (NS1) antigen has been routinely used for the early dengue detection. In dengue epidemic countries such as Indonesia, clinicians are increasingly relying on the NS1 detection for confirmation of dengue infection. Various NS1 diagnostic tests are commercially available, however different sensitivities and specificities were observed in various settings. This study was aimed to generate dengue NS1 recombinant protein for the development of dengue diagnostic tests. Four Indonesian DENV isolates were used as the source of the NS1 gene cloning, expression, and purification in bacterial expression system. Recombinant NS1 proteins were successfully purified and their antigenicities were assessed. Immunization of mice with recombinant proteins observed the immunogenicity of the NS1 protein. The generated recombinant proteins can be potentially used in the development of NS1 diagnostic test. With minimal modifications, this method can be used for producing NS1 recombinant proteins from isolates obtained from other geographical regions. Copyright © 2016 Elsevier Inc. All rights reserved.

Sample size for positive and negative predictive value in diagnostic research using case–control designs

PubMed Central

Steinberg, David M.; Fine, Jason; Chappell, Rick

2009-01-01

Important properties of diagnostic methods are their sensitivity, specificity, and positive and negative predictive values (PPV and NPV). These methods are typically assessed via case–control samples, which include one cohort of cases known to have the disease and a second control cohort of disease-free subjects. Such studies give direct estimates of sensitivity and specificity but only indirect estimates of PPV and NPV, which also depend on the disease prevalence in the tested population. The motivating example arises in assay testing, where usage is contemplated in populations with known prevalences. Further instances include biomarker development, where subjects are selected from a population with known prevalence and assessment of PPV and NPV is crucial, and the assessment of diagnostic imaging procedures for rare diseases, where case–control studies may be the only feasible designs. We develop formulas for optimal allocation of the sample between the case and control cohorts and for computing sample size when the goal of the study is to prove that the test procedure exceeds pre-stated bounds for PPV and/or NPV. Surprisingly, the optimal sampling schemes for many purposes are highly unbalanced, even when information is desired on both PPV and NPV. PMID:18556677

Perspectives on Advances in Tuberculosis Diagnostics, Drugs, and Vaccines.

PubMed

Schito, Marco; Migliori, Giovanni Battista; Fletcher, Helen A; McNerney, Ruth; Centis, Rosella; D'Ambrosio, Lia; Bates, Matthew; Kibiki, Gibson; Kapata, Nathan; Corrah, Tumena; Bomanji, Jamshed; Vilaplana, Cris; Johnson, Daniel; Mwaba, Peter; Maeurer, Markus; Zumla, Alimuddin

2015-10-15

Despite concerted efforts over the past 2 decades at developing new diagnostics, drugs, and vaccines with expanding pipelines, tuberculosis remains a global emergency. Several novel diagnostic technologies show promise of better point-of-care rapid tests for tuberculosis including nucleic acid-based amplification tests, imaging, and breath analysis of volatile organic compounds. Advances in new and repurposed drugs for use in multidrug-resistant (MDR) or extensively drug-resistant (XDR) tuberculosis have focused on development of several new drug regimens and their evaluation in clinical trials and now influence World Health Organization guidelines. Since the failure of the MVA85A vaccine 2 years ago, there have been no new tuberculosis vaccine candidates entering clinical testing. The current status quo of the lengthy treatment duration and poor treatment outcomes associated with MDR/XDR tuberculosis and with comorbidity of tuberculosis with human immunodeficiency virus and noncommunicable diseases is unacceptable. New innovations and political and funder commitment for early rapid diagnosis, shortening duration of therapy, improving treatment outcomes, and prevention are urgently required. © The Author 2015. 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.

Estimation of infection prevalence and sensitivity in a stratified two-stage sampling design employing highly specific diagnostic tests when there is no gold standard.

PubMed

Miller, Ezer; Huppert, Amit; Novikov, Ilya; Warburg, Alon; Hailu, Asrat; Abbasi, Ibrahim; Freedman, Laurence S

2015-11-10

In this work, we describe a two-stage sampling design to estimate the infection prevalence in a population. In the first stage, an imperfect diagnostic test was performed on a random sample of the population. In the second stage, a different imperfect test was performed in a stratified random sample of the first sample. To estimate infection prevalence, we assumed conditional independence between the diagnostic tests and develop method of moments estimators based on expectations of the proportions of people with positive and negative results on both tests that are functions of the tests' sensitivity, specificity, and the infection prevalence. A closed-form solution of the estimating equations was obtained assuming a specificity of 100% for both tests. We applied our method to estimate the infection prevalence of visceral leishmaniasis according to two quantitative polymerase chain reaction tests performed on blood samples taken from 4756 patients in northern Ethiopia. The sensitivities of the tests were also estimated, as well as the standard errors of all estimates, using a parametric bootstrap. We also examined the impact of departures from our assumptions of 100% specificity and conditional independence on the estimated prevalence. Copyright © 2015 John Wiley & Sons, Ltd.

Neutral Beam Source and Target Plasma for Development of a Local Electric Field Fluctuation Diagnostic

NASA Astrophysics Data System (ADS)

Bakken, M. R.; Burke, M. G.; Fonck, R. J.; Lewicki, B. T.; Rhodes, A. T.; Winz, G. R.

2016-10-01

A new diagnostic measuring local E-> (r , t) fluctuations is being developed for plasma turbulence studies in tokamaks. This is accomplished by measuring fluctuations in the separation of the π components in the Hα motional Stark spectrum. Fluctuations in this separation are expected to be Ẽ / ẼEMSE 10-3EMSE 10-3 . In addition to a high throughput, high speed spectrometer, the project requires a low divergence (Ω 0 .5°) , 80 keV, 2.5 A H0 beam and a target plasma test stand. The beam employs a washer-stack arc ion source to achieve a high species fraction at full energy. Laboratory tests of the ion source demonstrate repeatable plasmas with Te 10 eV and ne 1.6 ×1017 m-3, sufficient for the beam ion optics requirements. Te and ne scalings of the ion source plasma are presented with respect to operational parameters. A novel three-phase resonant converter power supply will provide 6 mA/cm2 of 80 keV H0 at the focal plane for pulse lengths up to 15 ms, with low ripple δV / 80 keV 0.05 % at 280 kHz. Diagnostic development and validation tests will be performed on a magnetized plasma test stand with 0.5 T field. The test chamber will utilize a washer-stack arc source to produce a target plasma comparable to edge tokamak plasmas. A bias-plate with programmable power supply will be used to impose Ẽ within the target plasma. Work supported by US DOE Grant DE-FG02-89ER53296.

The challenges of oral-based diagnostics in extending the role of dentistry as a health care profession: property rights, privacy, and informed consent.

PubMed

Vernillo, Anthony; Welie, Jos V M; Naidoo, Sudeshni; Malamud, Daniel

2011-01-01

Saliva may be a legal and ethical counterpart of other bodily fluids in diagnostic testing to blood and urine, with regard to its role in diagnostic testing. Two paradigms that have been proposed in the literature to address these challenges are reviewed in this paper. The first is centered on ownership and property rights to saliva, including financial compensation from commercially developed products using saliva. The commodification of saliva as property is also discussed. The second paradigm is related to privacy and the potential for genetic discrimination, given the unwarranted disclosure of confidential information. The management of saliva specimens from dental patients and research participants will also require the implementation of innovative approaches to obtain informed consent.

Simultaneous fingerprint and high-wavenumber fiber-optic Raman spectroscopy improves in vivo diagnosis of esophageal squamous cell carcinoma at endoscopy

NASA Astrophysics Data System (ADS)

Wang, Jianfeng; Lin, Kan; Zheng, Wei; Yu Ho, Khek; Teh, Ming; Guan Yeoh, Khay; Huang, Zhiwei

2015-08-01

This work aims to evaluate clinical value of a fiber-optic Raman spectroscopy technique developed for in vivo diagnosis of esophageal squamous cell carcinoma (ESCC) during clinical endoscopy. We have developed a rapid fiber-optic Raman endoscopic system capable of simultaneously acquiring both fingerprint (FP)(800-1800 cm-1) and high-wavenumber (HW)(2800-3600 cm-1) Raman spectra from esophageal tissue in vivo. A total of 1172 in vivo FP/HW Raman spectra were acquired from 48 esophageal patients undergoing endoscopic examination. The total Raman dataset was split into two parts: 80% for training; while 20% for testing. Partial least squares-discriminant analysis (PLS-DA) and leave-one patient-out, cross validation (LOPCV) were implemented on training dataset to develop diagnostic algorithms for tissue classification. PLS-DA-LOPCV shows that simultaneous FP/HW Raman spectroscopy on training dataset provides a diagnostic sensitivity of 97.0% and specificity of 97.4% for ESCC classification. Further, the diagnostic algorithm applied to the independent testing dataset based on simultaneous FP/HW Raman technique gives a predictive diagnostic sensitivity of 92.7% and specificity of 93.6% for ESCC identification, which is superior to either FP or HW Raman technique alone. This work demonstrates that the simultaneous FP/HW fiber-optic Raman spectroscopy technique improves real-time in vivo diagnosis of esophageal neoplasia at endoscopy.

[Diagnostic evaluation of the developmental level in children identified at risk of delay through the Child Development Evaluation Test].

PubMed

Rizzoli-Córdoba, Antonio; Campos-Maldonado, Martha Carmen; Vélez-Andrade, Víctor Hugo; Delgado-Ginebra, Ismael; Baqueiro-Hernández, César Iván; Villasís-Keever, Miguel Ángel; Reyes-Morales, Hortensia; Ojeda-Lara, Lucía; Davis-Martínez, Erika Berenice; O'Shea-Cuevas, Gabriel; Aceves-Villagrán, Daniel; Carrasco-Mendoza, Joaquín; Villagrán-Muñoz, Víctor Manuel; Halley-Castillo, Elizabeth; Sidonio-Aguayo, Beatriz; Palma-Tavera, Josuha Alexander; Muñoz-Hernández, Onofre

The Child Development Evaluation (or CDE Test) was developed in Mexico as a screening tool for child developmental problems. It yields three possible results: normal, slow development or risk of delay. The modified version was elaborated using the information obtained during the validation study but its properties according to the base population are not known. The objective of this work was to establish diagnostic confirmation of developmental delay in children 16- to 59-months of age previously identified as having risk of delay through the CDE Test in primary care facilities. A population-based cross-sectional study was conducted in one Mexican state. CDE test was administered to 11,455 children 16- to 59-months of age from December/2013 to March/2014. The eligible population represented the 6.2% of the children (n=714) who were identified at risk of delay through the CDE Test. For inclusion in the study, a block randomization stratified by sex and age group was performed. Each participant included in the study had a diagnostic evaluation using the Battelle Development Inventory, 2 nd edition. From the 355 participants included with risk of delay, 65.9% were male and 80.2% were from rural areas; 6.5% were false positives (Total Development Quotient ˃90) and 6.8% did not have any domain with delay (Domain Developmental Quotient <80). The proportion of delay for each domain was as follows: communication 82.5%; cognitive 80.8%; social-personal 33.8%; motor 55.5%; and adaptive 41.7%. There were significant differences in the percentages of delay both by age and by domain/subdomain evaluated. In 93.2% of the participants, developmental delay was corroborated in at least one domain evaluated. Copyright © 2015 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

High temperature UF6 RF plasma experiments applicable to uranium plasma core reactors

NASA Technical Reports Server (NTRS)

Roman, W. C.

1979-01-01

An investigation was conducted using a 1.2 MW RF induction heater facility to aid in developing the technology necessary for designing a self critical fissioning uranium plasma core reactor. Pure, high temperature uranium hexafluoride (UF6) was injected into an argon fluid mechanically confined, steady state, RF heated plasma while employing different exhaust systems and diagnostic techniques to simulate and investigate some potential characteristics of uranium plasma core nuclear reactors. The development of techniques and equipment for fluid mechanical confinement of RF heated uranium plasmas with a high density of uranium vapor within the plasma, while simultaneously minimizing deposition of uranium and uranium compounds on the test chamber peripheral wall, endwall surfaces, and primary exhaust ducts, is discussed. The material tests and handling techniques suitable for use with high temperature, high pressure, gaseous UF6 are described and the development of complementary diagnostic instrumentation and measurement techniques to characterize the uranium plasma, effluent exhaust gases, and residue deposited on the test chamber and exhaust system components is reported.

Evaluation of Commercially Available Diagnostic Tests for the Detection of Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM Antibody

PubMed Central

Hunsperger, Elizabeth A.; Yoksan, Sutee; Buchy, Philippe; Nguyen, Vinh Chau; Sekaran, Shamala Devi; Enria, Delia A.; Vazquez, Susana; Cartozian, Elizabeth; Pelegrino, Jose L.; Artsob, Harvey; Guzman, Maria G.; Olliaro, Piero; Zwang, Julien; Guillerm, Martine; Kliks, Susie; Halstead, Scott; Peeling, Rosanna W.; Margolis, Harold S.

2014-01-01

Commercially available diagnostic test kits for detection of dengue virus (DENV) non-structural protein 1 (NS1) and anti-DENV IgM were evaluated for their sensitivity and specificity and other performance characteristics by a diagnostic laboratory network developed by World Health Organization (WHO), the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Pediatric Dengue Vaccine Initiative (PDVI). Each network laboratory contributed characterized serum specimens for the panels used in the evaluation. Microplate enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT formats) were represented by the kits. Each ELISA was evaluated by 2 laboratories and RDTs were evaluated by at least 3 laboratories. The reference tests for IgM anti-DENV were laboratory developed assays produced by the Armed Forces Research Institute for Medical Science (AFRIMS) and the Centers for Disease Control and Prevention (CDC), and the NS1 reference test was reverse transcriptase polymerase chain reaction (RT-PCR). Results were analyzed to determine sensitivity, specificity, inter-laboratory and inter-reader agreement, lot-to-lot variation and ease-of-use. NS1 ELISA sensitivity was 60–75% and specificity 71–80%; NS1 RDT sensitivity was 38–71% and specificity 76–80%; the IgM anti-DENV RDTs sensitivity was 30–96%, with a specificity of 86–92%, and IgM anti-DENV ELISA sensitivity was 96–98% and specificity 78–91%. NS1 tests were generally more sensitive in specimens from the acute phase of dengue and in primary DENV infection, whereas IgM anti-DENV tests were less sensitive in secondary DENV infections. The reproducibility of the NS1 RDTs ranged from 92-99% and the IgM anti-DENV RDTs from 88–94%. PMID:25330157

GEM detectors development for radiation environment: neutron tests and simulations

NASA Astrophysics Data System (ADS)

Chernyshova, Maryna; Jednoróg, Sławomir; Malinowski, Karol; Czarski, Tomasz; Ziółkowski, Adam; Bieńkowska, Barbara; Prokopowicz, Rafał; Łaszyńska, Ewa; Kowalska-Strzeciwilk, Ewa; Poźniak, Krzysztof T.; Kasprowicz, Grzegorz; Zabołotny, Wojciech; Wojeński, Andrzej; Krawczyk, Rafał D.; Linczuk, Paweł; Potrykus, Paweł; Bajdel, Barcel

2016-09-01

One of the requests from the ongoing ITER-Like Wall Project is to have diagnostics for Soft X-Ray (SXR) monitoring in tokamak. Such diagnostics should be focused on tungsten emission measurements, as an increased attention is currently paid to tungsten due to a fact that it became a main candidate for the plasma facing material in ITER and future fusion reactor. In addition, such diagnostics should be able to withstand harsh radiation environment at tokamak during its operation. The presented work is related to the development of such diagnostics based on Gas Electron Multiplier (GEM) technology. More specifically, an influence of neutron radiation on performance of the GEM detectors is studied both experimentally and through computer simulations. The neutron induced radioactivity (after neutron source exposure) was found to be not pronounced comparing to an impact of other secondary neutron reaction products (during the exposure).

Development and validation of a smartphone addiction scale (SAS).

PubMed

Kwon, Min; Lee, Joon-Yeop; Won, Wang-Youn; Park, Jae-Woo; Min, Jung-Ah; Hahn, Changtae; Gu, Xinyu; Choi, Ji-Hye; Kim, Dai-Jin

2013-01-01

The aim of this study was to develop a self-diagnostic scale that could distinguish smartphone addicts based on the Korean self-diagnostic program for Internet addiction (K-scale) and the smartphone's own features. In addition, the reliability and validity of the smartphone addiction scale (SAS) was demonstrated. A total of 197 participants were selected from Nov. 2011 to Jan. 2012 to accomplish a set of questionnaires, including SAS, K-scale, modified Kimberly Young Internet addiction test (Y-scale), visual analogue scale (VAS), and substance dependence and abuse diagnosis of DSM-IV. There were 64 males and 133 females, with ages ranging from 18 to 53 years (M = 26.06; SD = 5.96). Factor analysis, internal-consistency test, t-test, ANOVA, and correlation analysis were conducted to verify the reliability and validity of SAS. Based on the factor analysis results, the subscale "disturbance of reality testing" was removed, and six factors were left. The internal consistency and concurrent validity of SAS were verified (Cronbach's alpha = 0.967). SAS and its subscales were significantly correlated with K-scale and Y-scale. The VAS of each factor also showed a significant correlation with each subscale. In addition, differences were found in the job (p<0.05), education (p<0.05), and self-reported smartphone addiction scores (p<0.001) in SAS. This study developed the first scale of the smartphone addiction aspect of the diagnostic manual. This scale was proven to be relatively reliable and valid.

Virtual Diagnostic Interface: Aerospace Experimentation in the Synthetic Environment

NASA Technical Reports Server (NTRS)

Schwartz, Richard J.; McCrea, Andrew C.

2009-01-01

The Virtual Diagnostics Interface (ViDI) methodology combines two-dimensional image processing and three-dimensional computer modeling to provide comprehensive in-situ visualizations commonly utilized for in-depth planning of wind tunnel and flight testing, real time data visualization of experimental data, and unique merging of experimental and computational data sets in both real-time and post-test analysis. The preparation of such visualizations encompasses the realm of interactive three-dimensional environments, traditional and state of the art image processing techniques, database management and development of toolsets with user friendly graphical user interfaces. ViDI has been under development at the NASA Langley Research Center for over 15 years, and has a long track record of providing unique and insightful solutions to a wide variety of experimental testing techniques and validation of computational simulations. This report will address the various aspects of ViDI and how it has been applied to test programs as varied as NASCAR race car testing in NASA wind tunnels to real-time operations concerning Space Shuttle aerodynamic flight testing. In addition, future trends and applications will be outlined in the paper.

Virtual Diagnostic Interface: Aerospace Experimentation in the Synthetic Environment

NASA Technical Reports Server (NTRS)

Schwartz, Richard J.; McCrea, Andrew C.

2010-01-01

The Virtual Diagnostics Interface (ViDI) methodology combines two-dimensional image processing and three-dimensional computer modeling to provide comprehensive in-situ visualizations commonly utilized for in-depth planning of wind tunnel and flight testing, real time data visualization of experimental data, and unique merging of experimental and computational data sets in both real-time and post-test analysis. The preparation of such visualizations encompasses the realm of interactive three-dimensional environments, traditional and state of the art image processing techniques, database management and development of toolsets with user friendly graphical user interfaces. ViDI has been under development at the NASA Langley Research Center for over 15 years, and has a long track record of providing unique and insightful solutions to a wide variety of experimental testing techniques and validation of computational simulations. This report will address the various aspects of ViDI and how it has been applied to test programs as varied as NASCAR race car testing in NASA wind tunnels to real-time operations concerning Space Shuttle aerodynamic flight testing. In addition, future trends and applications will be outlined in the paper.

Biomarker Discovery in Gulf War Veterans: Development of a War Illness Diagnostic Panel

DTIC Science & Technology

2016-12-01

with GWI reflect a persistent disruption in central nervous system (CNS) proinflammatory and neuroendocrine parameters. These processes can...differences in these systems are more subtle than the frank “abnormalities” identified with standard diagnostic tests (e.g., measures indicating...the coagulation system in Gulf War Illness: a potential pathophysiologic link with chronic fatigue syndrome. A laboratory approach to diagnosis. Blood

Using a Multi-Tier Diagnostic Test to Explore the Nature of Students' Alternative Conceptions on Reaction Kinetics

ERIC Educational Resources Information Center

Yan, Yaw Kai; Subramaniam, R.

2018-01-01

This study focused on grade 12 students' understanding of reaction kinetics. A 4-tier diagnostic instrument was developed for this purpose and administered to 137 students in the main study. Findings showed that reaction kinetics is a difficult topic for these students, with a total of 25 alternative conceptions (ACs) being uncovered. Except for…