Routine pharmacogenetic testing in clinical practice: dream or reality?

Science.gov (United States)

Grossman, Iris

2007-10-01

Pharmacogenetics (PGx) has become progressively popular in recent years, thanks to growing anticipation among scientists, healthcare providers and the general public for the incorporation of genetic tests into the diagnostic arsenal at the physician's disposal. Indeed, much research has been dedicated to elucidation of genetic determinants underlying interindividual variability in pharmacokinetic parameters, as well as drug safety and efficacy. However, few PGx applications have thus far been realized in healthcare management. This review uses examples from PGx research of psychiatric drugs to illustrate why the current published findings are inadequate and insufficient for utilization as routine clinical predictors of treatment safety, efficacy or dosing. I therefore suggest the necessary steps to demonstrate the validity, utility and cost-effectiveness of PGx. These recommendations include a whole range of aspects, starting from standardization of criteria and assessment of the technical quality of genotyping assays, up to design of prospective PGx studies, providing the basis for reimbursement programs to be recognized in routine clinical practice.

Antimicrobial susceptibility testing by Australian veterinary diagnostic laboratories.

Science.gov (United States)

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.

Bayesian estimation of test characteristics of real-time PCR, bacteriological culture and California mastitis test for diagnosis of intramammary infections with Staphylococcus aureus in dairy cattle at routine milk recordings

DEFF Research Database (Denmark)

Mahmmod, Yasser; Toft, Nils; Katholm, Jørgen

2013-01-01

Danish farmers can order a real-time PCR mastitis diagnostic test on routinely takencow-level samples from milk recordings. Validation of its performance in comparison toconventional mastitis diagnostics under field conditions is essential for efficient control ofintramammary infections (IMI......) with Staphylococcus aureus (S. aureus). Therefore, the objec-tive of this study was to estimate the sensitivity (Se) and specificity (Sp) of real-time PCR,bacterial culture (BC) and California mastitis test (CMT) for the diagnosis of the naturallyoccurring IMI with S. aureus in routinely collected milk samples using...... latent class anal-ysis (LCA) to avoid the assumption of a perfect reference test. Using systematic randomsampling, a total of 609 lactating dairy cows were selected from 6 dairy herds with bulktank milk PCR cycle threshold (Ct) value ≤39 for S. aureus. At routine milk recordings, auto-matically obtained...

Assessment of the Diagnostic Potential of Clinotech TB Screen Test ...

African Journals Online (AJOL)

The Clinotech TB Screen test, a 3rd generation multi-antigen rapid chromatographic immunoassay for detection of IgG antibodies in serum against recombinant protein antigens 38kDa, 16kDa and 6kDa, was assessed for its diagnostic potential for diagnosis of active pulmonary TB in routine TB control programme in Abia ...

Implementation of TMA and digitalization in routine diagnostics of breast pathology.

Science.gov (United States)

Rossing, Henrik Holm; Talman, Maj-Lis Møller; Laenkholm, Anne-Vibeke; Wielenga, Vera Timmermans

2012-04-01

To ensure optimal treatment of breast cancer patients, breast tumours are classified based on clinico-pathological features. As part of this process, routine diagnostics of breast tumours includes histological typing and grading, as well as profiling by use of an immunohistochemistry panel of antibodies, probes and in situ hybridization. This will, as a minimum, include assessment of oestrogen receptor (OR) and HER2. The individual preparation and staining of many breast tumours in a large laboratory with this standard panel is thus time consuming and costly. Herein, we show that in breast cancer routine diagnostics the use of the tissue microarray technique in combination with digitalization of the stained multi-slides is not only economical, with a considerable cost reduction, but it also enhances standardization of tumour profiling. We demonstrate that 2 mm breast tumour cores correlate with the corresponding tumour on whole mount slides, regarding staining/hybridizing results with the biomarkers in our panel consisting of human epidermal growth factor receptor 2, OR and Topiomerase IIa. Furthermore, we show that simultaneous staining/hybridizing of multiple breast tumour specimens reduces variation of staining/hybridizing quality, hereby increasing reliability of interpretation. By scanning and digitalization of the stained and hybridized multi-slides, we could optimize documentation and filing of the results. Our work is an example of translational research by implementing a tool in daily diagnostics originally developed for high throughput analyses in the search for prognostic and predictive markers in targeted medicine. © 2012 The Authors APMIS © 2012 APMIS.

Diagnostic accuracy of routine postoperative body temperature measurements

NARCIS (Netherlands)

Vermeulen, Hester; Storm-Versloot, Marja N.; Goossens, Astrid; Speelman, Peter; Legemate, Dink A.

2005-01-01

BACKGROUND: On surgical wards, body temperature is routinely measured, but there is no proof that this is useful for detecting postoperative infection. The aim of this study was to compare temperature measurements (the test) with the confirmed absence or presence of a postoperative infection (the

Parallel Recovery in a Trilingual Speaker: The Use of the Bilingual Aphasia Test as a Diagnostic Complement to the Comprehensive Aphasia Test

Science.gov (United States)

Green, David W.; Ruffle, Louise; Grogan, Alice; Ali, Nilufa; Ramsden, Sue; Schofield, Tom; Leff, Alex P.; Crinion, Jenny; Price, Cathy J.

2011-01-01

We illustrate the value of the Bilingual Aphasia Test in the diagnostic assessment of a trilingual speaker post-stroke living in England for whom English was a non-native language. The Comprehensive Aphasia Test is routinely used to assess patients in English, but only in combination with the Bilingual Aphasia Test is it possible and practical to…

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

Science.gov (United States)

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...

Efficient strategies to find diagnostic test accuracy studies in kidney journals.

Science.gov (United States)

Rogerson, Thomas E; Ladhani, Maleeka; Mitchell, Ruth; Craig, Jonathan C; Webster, Angela C

2015-08-01

Nephrologists looking for quick answers to diagnostic clinical questions in MEDLINE can use a range of published search strategies or Clinical Query limits to improve the precision of their searches. We aimed to evaluate existing search strategies for finding diagnostic test accuracy studies in nephrology journals. We assessed the accuracy of 14 search strategies for retrieving diagnostic test accuracy studies from three nephrology journals indexed in MEDLINE. Two investigators hand searched the same journals to create a reference set of diagnostic test accuracy studies to compare search strategy results against. We identified 103 diagnostic test accuracy studies, accounting for 2.1% of all studies published. The most specific search strategy was the Narrow Clinical Queries limit (sensitivity: 0.20, 95% CI 0.13-0.29; specificity: 0.99, 95% CI 0.99-0.99). Using the Narrow Clinical Queries limit, a searcher would need to screen three (95% CI 2-6) articles to find one diagnostic study. The most sensitive search strategy was van der Weijden 1999 Extended (sensitivity: 0.95; 95% CI 0.89-0.98; specificity 0.55, 95% CI 0.53-0.56) but required a searcher to screen 24 (95% CI 23-26) articles to find one diagnostic study. Bachmann 2002 was the best balanced search strategy, which was sensitive (0.88, 95% CI 0.81-0.94), but also specific (0.74, 95% CI 0.73-0.75), with a number needed to screen of 15 (95% CI 14-17). Diagnostic studies are infrequently published in nephrology journals. The addition of a strategy for diagnostic studies to a subject search strategy in MEDLINE may reduce the records needed to screen while preserving adequate search sensitivity for routine clinical use. © 2015 Asian Pacific Society of Nephrology.

Community-driven demand creation for the use of routine viral load testing: a model to scale up routine viral load testing.

Science.gov (United States)

Killingo, Bactrin M; Taro, Trisa B; Mosime, Wame N

2017-11-01

HIV treatment outcomes are dependent on the use of viral load measurement. Despite global and national guidelines recommending the use of routine viral load testing, these policies alone have not translated into widespread implementation or sufficiently increased access for people living with HIV (PLHIV). Civil society and communities of PLHIV recognize the need to close this gap and to enable the scale up of routine viral load testing. The International Treatment Preparedness Coalition (ITPC) developed an approach to community-led demand creation for the use of routine viral load testing. Using this Community Demand Creation Model, implementers follow a step-wise process to capacitate and empower communities to address their most pressing needs. This includes utlizing a specific toolkit that includes conducting a baseline assessment, developing a treatment education toolkit, organizing mobilization workshops for knowledge building, provision of small grants to support advocacy work and conducting benchmark evaluations. The Community Demand Creation Model to increase demand for routine viral load testing services by PLHIV has been delivered in diverse contexts including in the sub-Saharan African, Asian, Latin American and the Caribbean regions. Between December 2015 and December 2016, ITPC trained more than 240 PLHIV activists, and disbursed US$90,000 to network partners in support of their national advocacy work. The latter efforts informed a regional, community-driven campaign calling for domestic investment in the expeditious implementation of national viral load testing guidelines. HIV treatment education and community mobilization are critical components of demand creation for access to optimal HIV treatment, especially for the use of routine viral load testing. ITPC's Community Demand Creation Model offers a novel approach to achieving this goal. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of

Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial.

Science.gov (United States)

Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

2014-12-01

The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young

Evaluation of a commercial microarray as a confirmation test for the presence of extended-spectrum beta-lactamases in isolates from the routine clinical setting.

NARCIS (Netherlands)

Platteel, T.N.; Stuart, J.W.; Voets, G.M.; Scharringa, J.; Sande, N. van de; Fluit, A.C.; Leverstein-van Hall, M.A.; Sturm, P.D.J.; et al.,

2011-01-01

Since the diagnostic characteristics of the Check-KPC ESBL microarray as a confirmation test on isolates obtained in a routine clinical setting have not been determined, we evaluated the microarray in a random selection of 346 clinical isolates with a positive ESBL screen test (MIC >1 mg/L for

Beyond Diagnostic Accuracy: The Clinical Utility of Diagnostic Tests

NARCIS (Netherlands)

Bossuyt, Patrick M. M.; Reitsma, Johannes B.; Linnet, Kristian; Moons, Karel G. M.

2012-01-01

Like any other medical technology or intervention, diagnostic tests should be thoroughly evaluated before their introduction into daily practice. Increasingly, decision makers, physicians, and other users of diagnostic tests request more than simple measures of a test's analytical or technical

Performance of a real-time PCR assay in routine bovine mastitis diagnostics compared with in-depth conventional culture.

Science.gov (United States)

Hiitiö, Heidi; Riva, Rauna; Autio, Tiina; Pohjanvirta, Tarja; Holopainen, Jani; Pyörälä, Satu; Pelkonen, Sinikka

2015-05-01

Reliable identification of the aetiological agent is crucial in mastitis diagnostics. Real-time PCR is a fast, automated tool for detecting the most common udder pathogens directly from milk. In this study aseptically taken quarter milk samples were analysed with a real-time PCR assay (Thermo Scientific PathoProof Mastitis Complete-12 Kit, Thermo Fisher Scientific Ltd.) and by semi-quantitative, in-depth bacteriological culture (BC). The aim of the study was to evaluate the diagnostic performance of the real-time PCR assay in routine use. A total of 294 quarter milk samples from routine mastitis cases were cultured in the national reference laboratory of Finland and examined with real-time PCR. With BC, 251 out of 294 (85.7%) of the milk samples had at least one colony on the plate and 38 samples were considered contaminated. In the PCR mastitis assay, DNA of target species was amplified in 244 samples out of 294 (83.0%). The most common bacterial species detected in the samples, irrespective of the diagnostic method, was the coagulase negative staphylococci (CNS) group (later referred as Staphylococcus spp.) followed by Staphylococcus aureus. Sensitivity (Se) and specificity (Sp) for the PCR assay to provide a positive Staph. aureus result was 97.0 and 95.8% compared with BC. For Staphylococcus spp., the corresponding figures were 86.7 and 75.4%. Our results imply that PCR performed well as a diagnostic tool to detect Staph. aureus but may be too nonspecific for Staphylococcus spp. in routine use with the current cut-off Ct value (37.0). Using PCR as the only microbiological method for mastitis diagnostics, clinical relevance of the results should be carefully considered before further decisions, for instance antimicrobial treatment, especially when minor pathogens with low amount of DNA have been detected. Introducing the concept of contaminated samples should also be considered.

Virtual microscopy: an evaluation of its validity and diagnostic performance in routine histologic diagnosis of skin tumors

DEFF Research Database (Denmark)

Nielsen, Patricia Switten; Lindebjerg, Jan; Rasmussen, Jan

2010-01-01

Digitization of histologic slides is associated with many advantages, and its use in routine diagnosis holds great promise. Nevertheless, few articles evaluate virtual microscopy in routine settings. This study is an evaluation of the validity and diagnostic performance of virtual microscopy...... in routine histologic diagnosis of skin tumors. Our aim is to investigate whether conventional microscopy of skin tumors can be replaced by virtual microscopy. Ninety-six skin tumors and skin-tumor-like changes were consecutively gathered over a 1-week period. Specimens were routinely processed, and digital...... slides were captured on Mirax Scan (Carl Zeiss MicroImaging, Göttingen, Germany). Four pathologists evaluated the 96 virtual slides and the associated 96 conventional slides twice with intermediate time intervals of at least 3 weeks. Virtual slides that caused difficulties were reevaluated to identify...

Diagnostic validation of selected serological tests for detecting scrub typhus.

Science.gov (United States)

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.

Diagnostic accuracy of physical examination tests of the ankle/foot complex: a systematic review.

Science.gov (United States)

Schwieterman, Braun; Haas, Deniele; Columber, Kirby; Knupp, Darren; Cook, Chad

2013-08-01

Orthopedic special tests of the ankle/foot complex are routinely used during the physical examination process in order to help diagnose ankle/lower leg pathologies. The purpose of this systematic review was to investigate the diagnostic accuracy of ankle/lower leg special tests. A search of the current literature was conducted using PubMed, CINAHL, SPORTDiscus, ProQuest Nursing and Allied Health Sources, Scopus, and Cochrane Library. Studies were eligible if they included the following: 1) a diagnostic clinical test of musculoskeletal pathology in the ankle/foot complex, 2) description of the clinical test or tests, 3) a report of the diagnostic accuracy of the clinical test (e.g. sensitivity and specificity), and 4) an acceptable reference standard for comparison. The quality of included studies was determined by two independent reviewers using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Nine diagnostic accuracy studies met the inclusion criteria for this systematic review; analyzing a total of 16 special tests of the ankle/foot complex. After assessment using the QUADAS-2, only one study had low risk of bias and low concerns regarding applicability. Most ankle/lower leg orthopedic special tests are confirmatory in nature and are best utilized at the end of the physical examination. Most of the studies included in this systematic review demonstrate notable biases, which suggest that results and recommendations in this review should be taken as a guide rather than an outright standard. There is need for future research with more stringent study design criteria so that more accurate diagnostic power of ankle/lower leg special tests can be determined. 3a.

Acceptability of routine offer of HIV testing (opt-out approach) among ...

African Journals Online (AJOL)

Background: With the introduction of the opt out HIV testing policy in Ghana, the HIV test is offered routinely to all pregnant women unless they decline testing. Objective: To assess acceptability of the routine offer of HIV testing antenatal clinic (ANC) clients in the Wa municipality, Ghana. Design: Cross-sectional study of 270 ...

Comparison of a New and Rapid Method: Brucella Coombs Gel Test With Other Diagnostic Tests.

Science.gov (United States)

Kalem, Fatma; Ergün, Ayşe Gül; Durmaz, Süleyman; Doğan, Metin; Ertuğrul, Ömür; Gündem, Seval

2016-09-01

The aim of this study was to detect reliability of Brucella Coombs gel test (BCGT) by comparing with with ELISA (IgG + IgM), Standard agglutination test, and Brucella immunocapture agglutination methods in serological diagnosis of brucellosis. Brucella Coombs gel test (BCGT), Brucella ELISA (IgG + IgM), Standard agglutination test, and Brucella immunocapture agglutination tests of 78 patients with presumptive diagnosis of brucellosis which were sent to Microbiology Laboratory of Konya Numune Hospital from various regions of Konya were studied. Of 78 patients with ELISA IgG and IgM, STA, BICA and BCGT; 26, 21, 10, 12 and 12 were positive. When compared with BICA, the sensitivity and specifity of BCGT were 100% and 100%, respectively. According to results BCGT can be used as a diagnostic test in routine laboratories after more comprehensive studies in control groups and patients. © 2016 Wiley Periodicals, Inc.

Concordance in diagnostic testing for respiratory pathogens of bighorn sheep

Science.gov (United States)

Walsh, Daniel P.; Cassirer, E. Frances; Bonds, Michael D.; Brown, Daniel R.; Edwards, William H.; Weiser, Glen C.; Drew, Mark L.; Briggs, Robert E.; Fox, Karen A.; Miller, Michael W.; Shanthalingam, Sudarvili; Srikumaran, Subramaniam; Besser, Thomas E.

2016-01-01

Reliable diagnostic tests are essential for disease investigation and management. This is particularly true for diseases of free-ranging wildlife where sampling is logistically difficult precluding retesting. Clinical assays for wildlife diseases frequently vary among laboratories because of lack of appropriate standardized commercial kits. Results of diagnostic testing may also be called into question when investigators report different etiologies for disease outbreaks, despite similar clinical and pathologic findings. To evaluate reliability of diagnostic testing for respiratory pathogens of bighorn sheep (Ovis canadensis), we conducted a series of ring tests across 6 laboratories routinely involved in detection of Mycoplasma ovipneumoniae, Pasteurellaceae, lktA (the Pasteurellaceae gene encoding leukotoxin), and 3 reference laboratories. Consistency of results for replicate samples within laboratories was high (median agreement = 1.0). Agreement between laboratories was high for polymerase chain reaction (PCR) detection of M. ovipneumoniae and culture isolation of Mannheimia spp. and Bibersteinia trehalosi(median agreement = 0.89–0.95, Kappa = 0.65–0.74), and lower for PCR detection of Mannheimiaspp. lktA (median agreement = 0.58, Kappa = 0.12). Most errors on defined status samples were false negatives, suggesting test sensitivity was a greater problem than specificity. However, tests for M. haemolytica and lktA yielded some false positive results. Despite differences in testing protocols, median agreement among laboratories and correct classification of controls for most agents was ≥0.80, meeting or exceeding the standard required by federal proficiency testing programs. This information is valuable for interpreting test results, laboratory quality assessments, and advancing diagnosis of respiratory disease in wild sheep. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

Evidence Based Medicine; Positive and Negative Likelihood Ratios of Diagnostic Tests

Directory of Open Access Journals (Sweden)

Alireza Baratloo

2015-10-01

Full Text Available In the previous two parts of educational manuscript series in Emergency, we explained some screening characteristics of diagnostic tests including accuracy, sensitivity, specificity, and positive and negative predictive values. In the 3rd  part we aimed to explain positive and negative likelihood ratio (LR as one of the most reliable performance measures of a diagnostic test. To better understand this characteristic of a test, it is first necessary to fully understand the concept of sensitivity and specificity. So we strongly advise you to review the 1st part of this series again. In short, the likelihood ratios are about the percentage of people with and without a disease but having the same test result. The prevalence of a disease can directly influence screening characteristics of a diagnostic test, especially its sensitivity and specificity. Trying to eliminate this effect, LR was developed. Pre-test probability of a disease multiplied by positive or negative LR can estimate post-test probability. Therefore, LR is the most important characteristic of a test to rule out or rule in a diagnosis. A positive likelihood ratio > 1 means higher probability of the disease to be present in a patient with a positive test. The further from 1, either higher or lower, the stronger the evidence to rule in or rule out the disease, respectively. It is obvious that tests with LR close to one are less practical. On the other hand, LR further from one will have more value for application in medicine. Usually tests with 0.1 < LR > 10 are considered suitable for implication in routine practice.

Comparing diagnostic tests on benefit-risk.

Science.gov (United States)

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.

How to appraise a diagnostic test

Directory of Open Access Journals (Sweden)

Ramanitharan Manikandan

2011-01-01

Full Text Available Urologists frequently encounter problems in making a clinical diagnosis whose resolution requires the use of diagnostic tests. With an ever increasing choice of investigations being available, the urologist often has to decide which diagnostic test(s will best resolve the patient′s diagnostic problem. In this article, we aim to help the urologist understand how to critically appraise studies on diagnostic tests and make a rational choice. This article presents the guiding principles in scientifically assessing studies on diagnostic tests by proposing a clinical scenario. The authors describe a standardized protocol to assess the validity of the test and its relevance to the clinical problem that can help the urologist in decision making. The three important issues to be considered when evaluating the validity of the study are to identify how the study population was chosen, how the test was performed and whether there is a comparison to the gold standard test so as to confirm or refute the diagnosis. Then, the urologist would need to know the probability of the test in providing the correct diagnosis in an individual patient in order to decide about its utility in solving the diagnostic dilemma. By performing the steps described in this article, the urologist would be able to critically appraise diagnostic studies and draw meaningful conclusions about the investigations in terms of validity, results and its applicability to the patient′s problem. This would provide a scientific basis for using diagnostic tests for improving patient care.

SU-E-P-10: Establishment of Local Diagnostic Reference Levels of Routine Exam in Computed Tomography

International Nuclear Information System (INIS)

Yeh, M; Wang, Y; Weng, H

2015-01-01

Introduction National diagnostic reference levels (NDRLs) can be used as a reference dose of radiological examination can provide radiation dose as the basis of patient dose optimization. Local diagnostic reference levels (LDRLs) by periodically view and check doses, more efficiency to improve the way of examination. Therefore, the important first step is establishing a diagnostic reference level. Computed Tomography in Taiwan had been built up the radiation dose limit value,in addition, many studies report shows that CT scan contributed most of the radiation dose in different medical. Therefore, this study was mainly to let everyone understand DRL’s international status. For computed tomography in our hospital to establish diagnostic reference levels. Methods and Materials: There are two clinical CT scanners (a Toshiba Aquilion and a Siemens Sensation) were performed in this study. For CT examinations the basic recommended dosimetric quantity is the Computed Tomography Dose Index (CTDI). Each exam each different body part, we collect 10 patients at least. Carried out the routine examinations, and all exposure parameters have been collected and the corresponding CTDIv and DLP values have been determined. Results: The majority of patients (75%) were between 60–70 Kg of body weight. There are 25 examinations in this study. Table 1 shows the LDRL of each CT routine examination. Conclusions: Therefore, this study would like to let everyone know DRL’s international status, but also establishment of computed tomography of the local reference levels for our hospital, and providing radiation reference, as a basis for optimizing patient dose

SU-E-P-10: Establishment of Local Diagnostic Reference Levels of Routine Exam in Computed Tomography

Energy Technology Data Exchange (ETDEWEB)

Yeh, M; Wang, Y; Weng, H [Chiayi Chang Gung Memorial Hospital of The C.G.M.F, Puzi City, Chiayi County, Taiwan (China)

2015-06-15

Introduction National diagnostic reference levels (NDRLs) can be used as a reference dose of radiological examination can provide radiation dose as the basis of patient dose optimization. Local diagnostic reference levels (LDRLs) by periodically view and check doses, more efficiency to improve the way of examination. Therefore, the important first step is establishing a diagnostic reference level. Computed Tomography in Taiwan had been built up the radiation dose limit value,in addition, many studies report shows that CT scan contributed most of the radiation dose in different medical. Therefore, this study was mainly to let everyone understand DRL’s international status. For computed tomography in our hospital to establish diagnostic reference levels. Methods and Materials: There are two clinical CT scanners (a Toshiba Aquilion and a Siemens Sensation) were performed in this study. For CT examinations the basic recommended dosimetric quantity is the Computed Tomography Dose Index (CTDI). Each exam each different body part, we collect 10 patients at least. Carried out the routine examinations, and all exposure parameters have been collected and the corresponding CTDIv and DLP values have been determined. Results: The majority of patients (75%) were between 60–70 Kg of body weight. There are 25 examinations in this study. Table 1 shows the LDRL of each CT routine examination. Conclusions: Therefore, this study would like to let everyone know DRL’s international status, but also establishment of computed tomography of the local reference levels for our hospital, and providing radiation reference, as a basis for optimizing patient dose.

Screening for transfusion transmissible infections using rapid diagnostic tests in Africa: a potential hazard to blood safety?

Science.gov (United States)

Prugger, C.; Laperche, S.; Murphy, E. L.; Bloch, E. M.; Kaidarova, Z.; Tafflet, M.; Lefrère, J.-J.; Jouven, X.

2016-01-01

Rapid diagnostic tests (RDTs) are routinely used in African blood centres. We analysed data from two cross-sectional studies representing 95 blood centres in 29 African countries. Standardized panels of sera containing varying concentrations of anti-human immunodeficiency virus (HIV) antibodies (Ab), hepatitis B virus antigen (HBsAg) and antihepatitis C virus (HCV) Ab were screened using routine operational testing procedures at the centres. Sensitivity of detection using RDTs was high for HIV Ab-positive samples, but low for intermediately HBsAg (51·5%) and HCV Ab (40·6%)-positive samples. These findings suggest that current RDT use in Africa could pose a hazard to blood safety. PMID:26646317

Implementing a routine, voluntary HIV testing program in a Massachusetts county prison.

Science.gov (United States)

Liddicoat, Rebecca V; Zheng, Hui; Internicola, Jeanne; Werner, Barbara G; Kazianis, Arthur; Golan, Yoav; Rubinstein, Eric P; Freedberg, Kenneth A; Walensky, Rochelle P

2006-11-01

Although U.S. prison inmates have higher rates of HIV infection than the general population, most inmates are not routinely tested for HIV infection at prison entry. The study objective was to implement a routine, voluntary HIV testing program in a Massachusetts county prison. During admission, inmates were given group HIV pre-test counseling and were subsequently offered private HIV testing. This intervention was compared to a control period during which HIV testing was provided only upon inmate or physician request. Between November 2004 and April 2005, 1,004 inmates met inclusion criteria and were offered routine, voluntary HIV testing. Of these, 734 (73.1%) accepted, 2 (0.3%) were HIV-infected, and 457 (45.5%) had been tested for HIV in the previous year. The testing rate of 73.1% was significantly increased from the rate of 18.0% (318 of 1,723) during the control period (pprison setting. Careful attention should be paid to prevent redundancy of testing efforts in the prison population. Implementing a routine HIV testing program among prison inmates greatly increased testing rates compared to on-request testing.

Unrequested information from routine diagnostic chest CT predicts future cardiovascular events

International Nuclear Information System (INIS)

Jacobs, Peter C.; Gondrie, Martijn J.; Grobbee, Diederick E.; Graaf, Yolanda van der; Mali, Willem P.; Oen, Ayke L.; Prokop, Mathias

2011-01-01

An increase in the number of CT investigations will likely result in a an increase in unrequested information. Clinical relevance of these findings is unknown. This is the first follow-up study to investigate the prognostic relevance of subclinical coronary (CAC) and aortic calcification (TAC) as contained in routine diagnostic chest CT in a clinical care population. The follow-up of 10,410 subjects (>40 years) from a multicentre, clinical care-based cohort of patients included 240 fatal to 275 non-fatal cardiovascular disease (CVD) events (mean follow-up 17.8 months). Patients with a history of CVD were excluded. Coronary (0-12) and aortic calcification (0-8) were semi-quantitatively scored. We used Cox proportional-hazard models to compute hazard ratios to predict CVD events. CAC and TAC were significantly and independently predictive of CVD events. Compared with subjects with no calcium, the adjusted risk of a CVD event was 3.7 times higher (95% CI, 2.7-5.2) among patients with severe coronary calcification (CAC score ≥6) and 2.7 times higher (95% CI, 2.0-3.7) among patients with severe aortic calcification (TAC score ≥5). Subclinical vascular calcification on CT is a strong predictor of incident CVD events in a routine clinical care population. (orig.)

The use of a rapid D-dimer blood test in the diagnostic work-up for pulmonary embolism: a management study

NARCIS (Netherlands)

de Groot, M. R.; van Marwijk Kooy, M.; Pouwels, J. G.; Engelage, A. H.; Kuipers, B. F.; Büller, H. R.

1999-01-01

D-dimer assays have a potential to rule out pulmonary embolism in case of a normal test result. We studied the clinical utility of incorporating the SimpliRED D-dimer test result and clinical probability in the routine diagnostic work-up of patients with suspected acute pulmonary embolism. In a

Using rapid diagnostic tests as source of malaria parasite DNA for molecular analyses in the era of declining malaria prevalence

DEFF Research Database (Denmark)

Ishengoma, Deus S; Lwitiho, Sudi; Madebe, Rashid A

2011-01-01

was conducted to examine if sufficient DNA could be successfully extracted from malaria rapid diagnostic tests (RDTs), used and collected as part of routine case management services in health facilities, and thus forming the basis for molecular analyses, surveillance and quality control (QC) testing of RDTs....... continued molecular surveillance of malaria parasites is important to early identify emerging anti-malarial drug resistance, it is becoming increasingly difficult to obtain parasite samples from ongoing studies, such as routine drug efficacy trials. To explore other sources of parasite DNA, this study...

Validation of a simplified carbon-14-urea breath test for routine use for detecting Helicobacter pylori noninvasively

International Nuclear Information System (INIS)

Henze, E.; Malfertheiner, P.; Clausen, M.; Burkhardt, H.; Adam, W.E.

1990-01-01

A carbon-14 ( 14 C) urea breath test for detecting Helicobacter pylori with multiple breath sampling was developed. Carbon-14-urea (110 kBq) administered orally to 18 normal subjects and to 82 patients with Helicobacter infection. The exhaled 14 C-labeled CO 2 was trapped at 10-min intervals for 90 min. The total 14 C activity exhaled over 90 min was integrated and expressed in %activity of the total dose given. In normals, a mean of 0.59% +/- 0.24% was measured, resulting in an upper limit of normal of 1.07%. In 82 patients, a sensitivity of 90.2%, a specificity of 83.8%, and a positive predictive value of 90.2% was found. The single probes at intervals of 40-60 min correlated best with the integrated result, with r ranging from 0.986 to 0.990. The test's diagnostic accuracy did not change at all when reevaluated with the 40-, 50-, or 60-min sample data alone. Thus, the 14 C-urea breath test can be applied routinely as a noninvasive, low-cost and one-sample test with high diagnostic accuracy in detecting Helicobacter pylori colonization

Quality of routine spirometry tests in Dutch general practices

Science.gov (United States)

Schermer, Tjard RJ; Crockett, Alan J; Poels, Patrick JP; van Dijke, Jacob J; Akkermans, Reinier P; Vlek, Hans F; Pieters, Willem R

2009-01-01

Background Spirometry is an indispensable tool for diagnosis and monitoring of chronic airways disease in primary care. Aim To establish the quality of routine spirometry tests in general practice, and explore associations between test quality and patient characteristics. Design of study Analysis of routine spirometry test records. Setting Fifteen general practices which had a working agreement with a local hospital pulmonary function laboratory for spirometry assessment regarding test quality and interpretation. Method Spirometry tests were judged by a pulmonary function technician and a chest physician. Proportions of test adequacy were analysed using markers for manoeuvre acceptability and test reproducibility derived from the 1994 American Thoracic Society spirometry guideline. Associations between quality markers and age, sex, and severity of obstruction were examined using logistic regression. Results Practices performed a mean of four (standard deviation = 2) spirometry tests per week; 1271 tests from 1091 adult patients were analysed; 96.4% (95% confidence interval [CI] = 95.6 to 97.2) of all tests consisted of ≥3 blows. With 60.6% of tests, forced expiratory time was the marker with the lowest acceptability rate. An overall 38.8% (95% CI = 36.0 to 41.6) of the tests met the acceptability as well as reproducibility criteria. Age, sex, and severity of obstruction were associated with test quality markers. Conclusion The quality of routine spirometry tests was better than in previous reports from primary care research settings, but there is still substantial room for improvement. Sufficient duration of forced expiratory time is the quality marker with the highest rate of inadequacy. Primary care professionals should be aware of patient characteristics that may diminish the quality of their spirometry tests. Further research is needed to establish to what extent spirometry tests that are inadequate, according to stringent international expert criteria

Quality assurance in diagnostic radiology in Hungary - first experiences in acceptance testing

International Nuclear Information System (INIS)

Porubszky, T.; Pellet, S.; Ballay, L.; Talian, L.; Giczi, F.

2003-01-01

It is a general experience that optimum imaging with minimum patient doses, moreover, the safe operation and long life of X-ray equipment can be assured by regular measurement of technical parameters and checking of their constancy (routine performance testing) only. These tests are generally known as quality control, while together with the so-called corrective actions and its management it is called (physical-technical) quality assurance (QA). In the European Union, Directive 97/43/EURATOM about radiation protection of patients requires - among others - the good practice of (physical-technical) quality assurance. In Hungary, Decree No. 31/2001. (X.3.) of the Minister of Health harmonizes all of its requirements. Acceptance testing of new diagnostic X-ray equipment is assigned to NPHC-NRIRR. QA has been a daily practice in radiation therapy and nuclear medicine for a long time. A National Patient Dose Assessment Programme has also successfully run since 1989. We had, however, only few preliminaries in QA in diagnostic radiology in the second half of the eighties. Nowadays there are running QA programmes in some hospitals and mammography centres. he testing activity of our institute is independent from manufacturers, it is run within the frame of an accredited testing laboratory, using calibrated measuring instruments and based on valid international standards. So the started way of implementing QA in diagnostic radiology needs a lot of further efforts, adapting experiences of other countries, and also some financial help to reach an acceptable level in the EU. (authors)

Prospective evaluation of three rapid diagnostic tests for diagnosis of human leptospirosis.

Directory of Open Access Journals (Sweden)

Marga G A Goris

Full Text Available BACKGROUND: Diagnosis of leptospirosis by the microscopic agglutination test (MAT or by culture is confined to specialized laboratories. Although ELISA techniques are more common, they still require laboratory facilities. Rapid Diagnostic Tests (RDTs can be used for easy point-of-care diagnosis. This study aims to evaluate the diagnostic performance of the RDTs LeptoTek Dri Dot, LeptoTek Lateral Flow, and Leptocheck-WB, prospectively. METHODOLOGY: During 2001 to 2012, one or two of the RDTs at the same time have been applied prior to routine diagnostics (MAT, ELISA and culture on serum specimens from participants sent in for leptospirosis diagnosis. The case definition was based on MAT, ELISA and culture results. Participants not fulfilling the case definition were considered not to have leptospirosis. The diagnostic accuracy was determined based on the 1(st submitted sample and paired samples, either in an overall analysis or stratified according to days post onset of illness. RESULTS: The overall sensitivity and specificity for the LeptoTek Dri Dot was 75% respectively 96%, for the LeptoTek Lateral Flow 78% respectively 95%, and for the Leptocheck-WB 78% respectively 98%. Based on the 1(st submitted sample the sensitivity was low (51% for LeptoTek Dri Dot, 69% for LeptoTek Lateral Flow, and 55% for Leptocheck-WB, but substantially increased when the results of paired samples were combined, although accompanied by a lower specificity (82% respectively 91% for LeptoTek Dri Dot, 86% respectively 84% for LeptoTek Lateral Flow, and 80% respectively 93% for Leptocheck-WB. CONCLUSIONS: All three tests present antibody tests contributing to the diagnosis of leptospirosis, thus supporting clinical suspicion and contributing to awareness. Since the overall sensitivity of the tested RDTs did not exceed 80%, one should be cautious to rely only on an RDT result, and confirmation by reference tests is strongly recommended.

1968 Prototype Diagnostic Test.

Science.gov (United States)

Veterans Administration Hospital, Bedford, MA.

This true-false diagnostic test was used for pretesting of employees at a Veterans Administration Hospital. The test is comprised of 20 items. An alternate test--Classification Questionnaire--was used for testing after remedial training. (For related document, see TM 002 334.) (DB)

Is Serial Testing Required to Diagnose Imported Malaria in the Era of Rapid Diagnostic Tests?

Science.gov (United States)

Pasricha, Janet M.; Juneja, Surender; Manitta, Joseph; Whitehead, Susan; Maxwell, Ellen; Goh, Wai-Keong; Pasricha, Sant-Rayn; Eisen, Damon P.

2013-01-01

Exclusion of malaria traditionally requires three negative serial thick and thin blood films. However, many clinical laboratories now routinely perform rapid diagnostic tests (RDTs) in addition to blood films when malaria is suspected. We sought to determine whether serial testing is necessary in this setting. We examined 388 cases of malaria diagnosed during 1999–2010 at three laboratories in Melbourne, Australia. For each case, we ascertained whether the diagnosis was made on initial or follow-up testing. Nine cases (3.5%) were diagnosed after a negative initial blood film and RDT: 7 Plasmodium vivax, 1 P. ovale, and 1 P. falciparum. Of four case-patients with P. vivax in which clinical data were available, all had recent exposure to antimalarial medication. Our data suggest that among patients who have not received recent anti-malarial therapy, and when RDTs are performed and blood films are prepared, most malaria diagnoses are made by using the first set of tests. PMID:23208885

Diagnostic accuracy of patch test in children with food allergy.

Science.gov (United States)

Caglayan Sozmen, Sule; Povesi Dascola, Carlotta; Gioia, Edoardo; Mastrorilli, Carla; Rizzuti, Laura; Caffarelli, Carlo

2015-08-01

The gold standard test for confirming whether a child has clinical hypersensitivity reactions to foods is the oral food challenge. Therefore, there is increasing interest in simpler diagnostic markers of food allergy, especially in children, to avoid oral food challenge. The goal of this study was to assess the diagnostic accuracy of atopy patch test in comparison with oral food challenge. We investigated 243 children (mean age, 51 months) referred for evaluation of suspected egg or cow's milk allergy. Skin prick test and atopy patch test were carried out, and after a 2 weeks elimination diet, oral food challenge was performed. Two hundred and forty-three children underwent OFC to the suspected food. We found clinically relevant food allergies in 40 (65%) children to egg and in 22 (35%) to cow's milk. The sensitivity of skin prick test for both milk and egg was 92%, specificity 91%, positive predictive value 35%, and negative predictive value of 93%. Sensitivity, specificity, positive predictive value, and negative predictive value of atopy patch test for both milk and egg were 21%, 73%, 20%, and 74%, respectively. Our study suggests that there is insufficient evidence for the routine use of atopy patch test for the evaluation of egg and cow's milk allergy. OFC remains gold standard for the diagnosis of egg and milk allergy even in the presence of high costs in terms of both time and risks during application. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Myasthenia Gravis: Tests and Diagnostic Methods

Science.gov (United States)

... Focus on MG Newsletter MG Quarterly Test & Diagnostic methods In addition to a complete medical and neurological ... How can I help? About MGFA Test & Diagnostic methods Treatment for MG FAQ's Upcoming Events 2018 MG ...

Quality of routine spirometry tests in Dutch general practices.

NARCIS (Netherlands)

Schermer, T.R.J.; Crockett, A.J.; Poels, P.J.P.; Dijke, J.J. van; Akkermans, R.P.; Vlek, H.F.; Pieters, W.R.

2009-01-01

BACKGROUND: Spirometry is an indispensable tool for diagnosis and monitoring of chronic airways disease in primary care. AIM: To establish the quality of routine spirometry tests in general practice, and explore associations between test quality and patient characteristics. DESIGN OF STUDY: Analysis

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

Science.gov (United States)

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.

Diagnosis of asthma: diagnostic testing.

Science.gov (United States)

Brigham, Emily P; West, Natalie E

2015-09-01

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

Irregular analytical errors in diagnostic testing - a novel concept.

Science.gov (United States)

Vogeser, Michael; Seger, Christoph

2018-02-23

In laboratory medicine, routine periodic analyses for internal and external quality control measurements interpreted by statistical methods are mandatory for batch clearance. Data analysis of these process-oriented measurements allows for insight into random analytical variation and systematic calibration bias over time. However, in such a setting, any individual sample is not under individual quality control. The quality control measurements act only at the batch level. Quantitative or qualitative data derived for many effects and interferences associated with an individual diagnostic sample can compromise any analyte. It is obvious that a process for a quality-control-sample-based approach of quality assurance is not sensitive to such errors. To address the potential causes and nature of such analytical interference in individual samples more systematically, we suggest the introduction of a new term called the irregular (individual) analytical error. Practically, this term can be applied in any analytical assay that is traceable to a reference measurement system. For an individual sample an irregular analytical error is defined as an inaccuracy (which is the deviation from a reference measurement procedure result) of a test result that is so high it cannot be explained by measurement uncertainty of the utilized routine assay operating within the accepted limitations of the associated process quality control measurements. The deviation can be defined as the linear combination of the process measurement uncertainty and the method bias for the reference measurement system. Such errors should be coined irregular analytical errors of the individual sample. The measurement result is compromised either by an irregular effect associated with the individual composition (matrix) of the sample or an individual single sample associated processing error in the analytical process. Currently, the availability of reference measurement procedures is still highly limited, but LC

Estimating diagnostic test accuracies for Brachyspira hyodysenteriae accounting for the complexities of population structure in food animals.

Directory of Open Access Journals (Sweden)

Sonja Hartnack

Full Text Available For swine dysentery, which is caused by Brachyspira hyodysenteriae infection and is an economically important disease in intensive pig production systems worldwide, a perfect or error-free diagnostic test ("gold standard" is not available. In the absence of a gold standard, Bayesian latent class modelling is a well-established methodology for robust diagnostic test evaluation. In contrast to risk factor studies in food animals, where adjustment for within group correlations is both usual and required for good statistical practice, diagnostic test evaluation studies rarely take such clustering aspects into account, which can result in misleading results. The aim of the present study was to estimate test accuracies of a PCR originally designed for use as a confirmatory test, displaying a high diagnostic specificity, and cultural examination for B. hyodysenteriae. This estimation was conducted based on results of 239 samples from 103 herds originating from routine diagnostic sampling. Using Bayesian latent class modelling comprising of a hierarchical beta-binomial approach (which allowed prevalence across individual herds to vary as herd level random effect, robust estimates for the sensitivities of PCR and culture, as well as for the specificity of PCR, were obtained. The estimated diagnostic sensitivity of PCR (95% CI and culture were 73.2% (62.3; 82.9 and 88.6% (74.9; 99.3, respectively. The estimated specificity of the PCR was 96.2% (90.9; 99.8. For test evaluation studies, a Bayesian latent class approach is well suited for addressing the considerable complexities of population structure in food animals.

Methodology of diagnostic tests in hepatology

DEFF Research Database (Denmark)

Christensen, Erik

2009-01-01

The performance of diagnostic tests can be assessed by a number of methods. These include sensitivity, specificity,positive and negative predictive values, likelihood ratios and receiver operating characteristic (ROC) curves. This paper describes the methods and explains which information...... they provide. Sensitivity and specificity provides measures of the diagnostic accuracy of a test in diagnosing the condition. The positive and negative predictive values estimate the probability of the condition from the test-outcome and the condition's prevalence. The likelihood ratios bring together......' and plotting sensitivity as a function of 1-specificity. The ROC-curve can be used to define optimal cut-off values for a test, to assess the diagnostic accuracy of the test, and to compare the usefulness of different tests in the same patients. Under certain conditions it may be possible to utilize a test...

Molecular diagnosis of microbial aetiologies using SepsiTest™ in the daily routine of a diagnostic laboratory.

Science.gov (United States)

Haag, Heike; Locher, Franziska; Nolte, Oliver

2013-08-01

A universal PCR and sequencing test, SepsiTest™ (Molzym, Germany) was evaluated for its applicability during daily diagnostic routine in a privately operated laboratory. In total, 96 specimens originating from 66 patients under suspect of infectious endocarditis, infections of joints, encephalitis/meningitis, systemic infections and infections of unknown genesis were PCR analysed and compared to culture results. Samples comprised cultured and non-cultured blood, synovial fluid, synovial tissue, heart valves, pacemakers, spinal tissue, cerebrospinal fluid, and swabs. PCR and culture were concordant in 26 negative and 8 positive cases (51.5%). A group of 25 patients was culture-negative but PCR-positive (37.9%). In at least 14 of these, common and/or rare aetiologies were identified, while for 4 patients the results of 16S PCR could not be unequivocally linked with the underlying disease. Benefits and limitations of the molecular test are discussed with special emphasis on technical and economic issues. In conclusion, SepsiTest™ proved to be a valuable tool for the diagnosis of aetiologies, particularly in cases of culture-negative patients who are under strong suspicion for an infection. Copyright © 2013 Elsevier Inc. All rights reserved.

Recent Progress in the Development of Diagnostic Tests for Malaria.

Science.gov (United States)

Krampa, Francis D; Aniweh, Yaw; Awandare, Gordon A; Kanyong, Prosper

2017-09-19

The impact of malaria on global health has continually prompted the need to develop effective diagnostic strategies. In malaria endemic regions, routine diagnosis is hampered by technical and infrastructural challenges to laboratories. These laboratories lack standard facilities, expertise or diagnostic supplies; thus, therapy is administered based on clinical or self-diagnosis. There is the need for accurate diagnosis of malaria due to the continuous increase in the cost of medication, and the emergence and spread of drug resistant strains. However, the widely utilized Giemsa-stained microscopy and immunochromatographic tests for malaria are liable to several drawbacks, including inadequate sensitivity and false-positive outcomes. Alternative methods that offer improvements in performance are either expensive, have longer turnaround time or require a level of expertise that makes them unsuitable for point-of-care (POC) applications. These gaps necessitate exploration of more efficient detection techniques with the potential of POC applications, especially in resource-limited settings. This minireview discusses some of the recent trends and new approaches that are seeking to improve the clinical diagnosis of malaria.

Recent Progress in the Development of Diagnostic Tests for Malaria

Directory of Open Access Journals (Sweden)

Francis D. Krampa

2017-09-01

Full Text Available The impact of malaria on global health has continually prompted the need to develop effective diagnostic strategies. In malaria endemic regions, routine diagnosis is hampered by technical and infrastructural challenges to laboratories. These laboratories lack standard facilities, expertise or diagnostic supplies; thus, therapy is administered based on clinical or self-diagnosis. There is the need for accurate diagnosis of malaria due to the continuous increase in the cost of medication, and the emergence and spread of drug resistant strains. However, the widely utilized Giemsa-stained microscopy and immunochromatographic tests for malaria are liable to several drawbacks, including inadequate sensitivity and false-positive outcomes. Alternative methods that offer improvements in performance are either expensive, have longer turnaround time or require a level of expertise that makes them unsuitable for point-of-care (POC applications. These gaps necessitate exploration of more efficient detection techniques with the potential of POC applications, especially in resource-limited settings. This minireview discusses some of the recent trends and new approaches that are seeking to improve the clinical diagnosis of malaria.

Diagnostic outcome following routine genetics clinic referral for the assessment of global developmental delay.

LENUS (Irish Health Repository)

Shahdadpuri, R

2012-02-01

The aim of this study was to ascertain the diagnostic yield following a routine genetics clinic referral for the assessment of global developmental delay. Detailed retrospective review of 119 complete consecutive case notes of patients referred to one single clinical geneticist over a 14 month time period was undertaken (n = 119; 54 males, 65 females). The age at initial review ranged from 2 months to 37 years 3 months (mean 8 y 3 mo [SD 7 y 10 mo]). We made a diagnosis in 36\\/119 (30%); 21\\/36 were new diagnoses and 15\\/36 were confirmations of diagnoses. We removed a wrong diagnostic label in 8\\/119 (7%). In 3\\/8 we were able to achieve a diagnosis but in 5\\/8 no alternative diagnosis was reached. We had a better diagnostic rate where the patients were dysmorphic (odds ratio [OR] 1.825; 95% confidence interval [CI] 1.065 to 3.128, p = 0.044). In the majority, the diagnosis was made by clinical examination only. Molecular diagnosis was reached in seven cases. Five cases were confirmed by cytogenetic analysis. Brain magnetic resonance imaging (MRI) revealed a diagnosis in three cases. This study confirms the importance of a clinical genetics assessment in the investigation of global developmental delay.

The introduction of compulsory compliance testing of medical diagnostic x-ray equipment in Western Australia

International Nuclear Information System (INIS)

Rafferty, M. W.; Jacob, C. S.

1995-01-01

Performance testing of medical diagnostic X-ray equipment can reveal equipment faults which, while not always clinically detectable, may contribute to reduced image quality and unnecessary radiation exposure of both patients and staff. Routine testing of such equipment is highly desirable to identify such faults and allows them to be rectified. The Radiological council of Western Australia is moving towards requiring compulsory compliance testing of all (new and existing) medical diagnostic X-ray equipment that all new mobile radiographic and new mammographic X-ray equipment be issued with a compliance test certificate as a prerequisite for registration. Workbooks which provide details of the tests required and recommended test methods have been prepared for medical radiographic (mobile and fixed), fluoroscopic and mammographic X-ray equipment. It is intended that future workbooks include details of the tests and methods for dental and computed tomography X-ray units. The workbooks are not limited to the compliance testing of items as specified in the Regulations, but include tests for other items such as film processing, darkrooms and image quality (for fluoroscopic equipment). Many of the workbook tests could be used within a regular quality assurance program for diagnostic X-ray equipment. Persons who conduct such compliance tests will need to be licensed and have all test certificates endorsed by a qualified expert. Suitable training and assessment of compliance testers will be required. Notification of such tests (including non-compliant items and corrective actions taken) will be required by the Radiological Council as a condition of equipment registration. 9 refs

Routine intraoperative leak testing for sleeve gastrectomy: is the leak test full of hot air?

Science.gov (United States)

Bingham, Jason; Lallemand, Michael; Barron, Morgan; Kuckelman, John; Carter, Preston; Blair, Kelly; Martin, Matthew

2016-05-01

Staple line leak after sleeve gastrectomy (SG) is a rare but dreaded complication with a reported incidence of 0% to 8%. Many surgeons routinely test the staple line with an intraoperative leak test (IOLT), but there is little evidence to validate this practice. In fact, there is a theoretical concern that the leak test may weaken the staple line and increase the risk of a postop leak. Retrospective review of all SGs performed over a 7-year period was conducted. Cases were grouped by whether an IOLT was performed, and compared for the incidence of postop staple line leaks. The ability of the IOLT for identifying a staple line defect and for predicting a postoperative leak was analyzed. Five hundred forty-two SGs were performed between 2007 and 2014. Thirteen patients (2.4%) developed a postop staple line leak. The majority of patients (n = 494, 91%) received an IOLT, including all 13 patients (100%) who developed a subsequent clinical leak. There were no (0%) positive IOLTs and no additional interventions were performed based on the IOLT. The IOLT sensitivity and positive predictive value were both 0%. There was a trend, although not significant, to increase leak rates when a routine IOLT was performed vs no routine IOLT (2.6% vs 0%, P = .6). The performance of routine IOLT after SG provided no actionable information, and was negative in all patients who developed a postoperative leak. The routine use of an IOLT did not reduce the incidence of postop leak, and in fact was associated with a higher leak rate after SG. Published by Elsevier Inc.

More than just T₄: diagnostic testing for hyperthyroidism in cats.

Science.gov (United States)

Peterson, Mark E

2013-09-01

In older cats presenting with clinical features of hyperthyroidism, confirmation of a diagnosis of thyroid disease is usually straightforward. However, the potential for false-negative and false-positive results exists with all thyroid function tests (especially in the context of routine screening of asymptomatic cats) and leads to clinical dilemmas. For example, a high serum T₄ value may be found in a cat that lacks clinical signs of hyperthyroidism, or hyperthyroidism may be suspected in a cat with normal total T₄ concentrations. To avoid unnecessary treatment and potentially adverse effects in a euthyroid cat, thyroid function tests must always be interpreted in the light of the cat's history, clinical signs, physical examination findings and other laboratory findings. In this article the author reviews the use of commonly recommended thyroid function tests, focusing on clinical scenarios that present diagnostic difficulties. In doing so, he draws on the veterinary and comparative literature, his own clinical experience, and data, unpublished to date, obtained from a series of 100 hyperthyroid cats consecutively diagnosed at his clinic.

Evaluating next-generation sequencing for direct clinical diagnostics in diarrhoeal disease

DEFF Research Database (Denmark)

Joensen, Katrine Grimstrup; Engsbro, A L Ø; Lukjancenko, Oksana

2017-01-01

The accurate microbiological diagnosis of diarrhoea involves numerous laboratory tests and, often, the pathogen is not identified in time to guide clinical management. With next-generation sequencing (NGS) becoming cheaper, it has huge potential in routine diagnostics. The aim of this study...... was to evaluate the potential of NGS-based diagnostics through direct sequencing of faecal samples. Fifty-eight clinical faecal samples were obtained from patients with diarrhoea as part of the routine diagnostics at Hvidovre University Hospital, Denmark. Ten samples from healthy individuals were also included...

The interpretation of diagnostic tests

International Nuclear Information System (INIS)

Lamk, M.; Lamki, M.D.

1987-01-01

The progress of nuclear and other diagnostic imaging is near rampant. With almost every issue of the major journals in this field, a new diagnostic test, or at least a new utility of an old test is described. Before we accept these innovations, we have to have a clear understanding of the clinical performance of the test. The major criteria are the sensitivity and the specificity of the test. From these derived other statistical parameters such as accuracy or efficiency of that test; also, the receiver operating characteristic (ROC) curves may then be evaluated and used in comparison of different tests. When we know the prevalence of the disease tested in the population we are investigating, we can then derive the predictive value of a positive or a negative result. This introduction tries to explain these parameters to help the reader understand the literature dealing with the subject of efficacy of imaging procedures. It is not intended as a critical review of the literature on the subject or a comprehensive overview of the subject matter. The benefit derived from explaination of statistical concepts to physicians is documented in a recent publication. Explaination of these basic statistical parameters will be followed by a demonstration of the utility of multiple testing with these parameters. The reader is thereby introduced to relevant statistical concepts that must be grasped for full comprehension of published results of a new diagnostic imaging modality, or before clinical decision making

Dual-Routine HCV/HIV Testing: Seroprevalence and Linkage to Care in Four Community Health Centers in Philadelphia, Pennsylvania.

Science.gov (United States)

Coyle, Catelyn; Kwakwa, Helena

2016-01-01

Despite common risk factors, screening for hepatitis C virus (HCV) and HIV at the same time as part of routine medical care (dual-routine HCV/HIV testing) is not commonly implemented in the United States. This study examined improvements in feasibility of implementation, screening increase, and linkage to care when a dual-routine HCV/HIV testing model was integrated into routine primary care. National Nursing Centers Consortium implemented a dual-routine HCV/HIV testing model at four community health centers in Philadelphia, Pennsylvania, on September 1, 2013. Routine HCV and opt-out HIV testing replaced the routine HCV and opt-in HIV testing model through medical assistant-led, laboratory-based testing and electronic medical record modification to prompt, track, report, and facilitate reimbursement for tests performed on uninsured individuals. This study examined testing, seropositivity, and linkage-to-care comparison data for the nine months before (December 1, 2012-August 31, 2013) and after (September 1, 2013-May 31, 2014) implementation of the dual-routine HCV/HIV testing model. A total of 1,526 HCV and 1,731 HIV tests were performed before, and 1,888 HCV and 3,890 HIV tests were performed after dual-routine testing implementation, resulting in a 23.7% increase in HCV tests and a 124.7% increase in HIV tests. A total of 70 currently HCV-infected and four new HIV-seropositive patients vs. 101 HCV-infected and 13 new HIV-seropositive patients were identified during these two periods, representing increases of 44.3% for HCV antibody-positive and RNA-positive tests and 225.0% for HIV-positive tests. Linkage to care increased from 27 currently infected HCV--positive and one HIV-positive patient pre-dual-routine testing to 39 HCV--positive and nine HIV-positive patients post-dual-routine testing. The dual-routine HCV/HIV testing model shows that integrating dual-routine testing in a primary care setting is possible and leads to increased HCV and HIV screening

Diagnostic tests based on human basophils

DEFF Research Database (Denmark)

Kleine-Tebbe, Jörg; Erdmann, Stephan; Knol, Edward F

2006-01-01

-maximal responses, termed 'intrinsic sensitivity'. These variables give rise to shifts in the dose-response curves which, in a diagnostic setting where only a single antigen concentration is employed, may produce false-negative data. Thus, in order to meaningfully utilize the current basophil activation tests....... Diagnostic studies using CD63 or CD203c in hymenoptera, food and drug allergy are critically discussed. Basophil-based tests are indicated for allergy testing in selected cases but should only be performed by experienced laboratories....

Diagnostic grand rounds: A new teaching concept to train diagnostic reasoning

International Nuclear Information System (INIS)

Stieger, Stefan; Praschinger, Andrea; Kletter, Kurt; Kainberger, Franz

2011-01-01

Introduction: Diagnostic reasoning is a core skill in teaching and learning in undergraduate curricula. Diagnostic grand rounds (DGRs) as a subform of grand rounds are intended to train the students' skills in the selection of appropriate tests and in the interpretation of test results. The aim of this study was to test DGRs for their ability to improve diagnostic reasoning by using a pre-post-test design. Methods: During one winter term, all 398 fifth-year students (36.1% male, 63.9% female) solved 23 clinical cases presented in 8 DGRs. In an online questionnaire, a Diagnostic Thinking Inventory (DTI) with 41 items was evaluated for flexibility in thinking and structure of knowledge in memory. Results were correlated with those from a summative multiple-choice knowledge test and of the learning objectives in a logbook. Results: The students' DTI scores in the post-test were significantly higher than those reported in the pre-test. DTI scores at either testing time did not correlate with medical knowledge as assessed by a multiple-choice knowledge test. Abilities acquired during clinical clerkships as documented in a logbook could only account for a small proportion of the increase in the flexibility subscale score. This effect still remained significant after accounting for potential confounders. Conclusion: Establishing DGRs proofed to be an effective way of successfully improving both students' diagnostic reasoning and the ability to select the appropriate test method in routine clinical practice.

Diagnostic grand rounds: A new teaching concept to train diagnostic reasoning

Energy Technology Data Exchange (ETDEWEB)

Stieger, Stefan, E-mail: stefan.stieger@univie.ac.at [Department of Basic Psychological Research, School of Psychology, University of Vienna, Liebiggasse 5, A-1010 Vienna (Austria); Praschinger, Andrea, E-mail: andrea.praschinger@meduniwien.ac.at [Core Unit for Medical Education (BEMAW), Medical University of Vienna, Spitalgasse 23, BT87, P.O. 10, A-1097 Vienna (Austria); Kletter, Kurt, E-mail: kurt.kletter@meduniwien.ac.at [Department of Nuclear Medicine, General Hospital of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria); Kainberger, Franz, E-mail: franz.kainberger@meduniwien.ac.at [Department of Radiology, General Hospital of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria)

2011-06-15

Introduction: Diagnostic reasoning is a core skill in teaching and learning in undergraduate curricula. Diagnostic grand rounds (DGRs) as a subform of grand rounds are intended to train the students' skills in the selection of appropriate tests and in the interpretation of test results. The aim of this study was to test DGRs for their ability to improve diagnostic reasoning by using a pre-post-test design. Methods: During one winter term, all 398 fifth-year students (36.1% male, 63.9% female) solved 23 clinical cases presented in 8 DGRs. In an online questionnaire, a Diagnostic Thinking Inventory (DTI) with 41 items was evaluated for flexibility in thinking and structure of knowledge in memory. Results were correlated with those from a summative multiple-choice knowledge test and of the learning objectives in a logbook. Results: The students' DTI scores in the post-test were significantly higher than those reported in the pre-test. DTI scores at either testing time did not correlate with medical knowledge as assessed by a multiple-choice knowledge test. Abilities acquired during clinical clerkships as documented in a logbook could only account for a small proportion of the increase in the flexibility subscale score. This effect still remained significant after accounting for potential confounders. Conclusion: Establishing DGRs proofed to be an effective way of successfully improving both students' diagnostic reasoning and the ability to select the appropriate test method in routine clinical practice.

Prenatal Genetic Diagnostic Tests

Science.gov (United States)

... are available for many inherited disorders. The main disadvantage is that diagnostic testing carries a very small ... chromosomes, arranged in order of size. Microarray: A technology that examines all of a person’s genes to ...

A new generation of cancer genome diagnostics for routine clinical use: overcoming the roadblocks to personalized cancer medicine.

Science.gov (United States)

Heuckmann, J M; Thomas, R K

2015-09-01

The identification of 'druggable' kinase gene alterations has revolutionized cancer treatment in the last decade by providing new and successfully targetable drug targets. Thus, genotyping tumors for matching the right patients with the right drugs have become a clinical routine. Today, advances in sequencing technology and computational genome analyses enable the discovery of a constantly growing number of genome alterations relevant for clinical decision making. As a consequence, several technological approaches have emerged in order to deal with these rapidly increasing demands for clinical cancer genome analyses. Here, we describe challenges on the path to the broad introduction of diagnostic cancer genome analyses and the technologies that can be applied to overcome them. We define three generations of molecular diagnostics that are in clinical use. The latest generation of these approaches involves deep and thus, highly sensitive sequencing of all therapeutically relevant types of genome alterations-mutations, copy number alterations and rearrangements/fusions-in a single assay. Such approaches therefore have substantial advantages (less time and less tissue required) over PCR-based methods that typically have to be combined with fluorescence in situ hybridization for detection of gene amplifications and fusions. Since these new technologies work reliably on routine diagnostic formalin-fixed, paraffin-embedded specimens, they can help expedite the broad introduction of personalized cancer therapy into the clinic by providing comprehensive, sensitive and accurate cancer genome diagnoses in 'real-time'. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Routine HIV testing in Botswana: a population-based study on attitudes, practices, and human rights concerns.

Directory of Open Access Journals (Sweden)

Sheri D Weiser

2006-07-01

Full Text Available The Botswana government recently implemented a policy of routine or "opt-out" HIV testing in response to the high prevalence of HIV infection, estimated at 37% of adults.We conducted a cross-sectional, population-based study of 1,268 adults from five districts in Botswana to assess knowledge of and attitudes toward routine testing, correlates of HIV testing, and barriers and facilitators to testing, 11 months after the introduction of this policy. Most participants (81% reported being extremely or very much in favor of routine testing. The majority believed that this policy would decrease barriers to testing (89%, HIV-related stigma (60%, and violence toward women (55%, and would increase access to antiretroviral treatment (93%. At the same time, 43% of participants believed that routine testing would lead people to avoid going to the doctor for fear of testing, and 14% believed that this policy could increase gender-based violence related to testing. The prevalence of self-reported HIV testing was 48%. Adjusted correlates of testing included female gender (AOR = 1.5, 95% CI = 1.1-1.9, higher education (AOR = 2.0, 95% CI = 1.5-2.7, more frequent healthcare visits (AOR = 1.9, 95% CI = 1.3-2.7, perceived access to HIV testing (AOR = 1.6, 95% CI = 1.1-2.5, and inconsistent condom use (AOR = 1.6, 95% CI = 1.2-2.1. Individuals with stigmatizing attitudes toward people living with HIV and AIDS were less likely to have been tested for HIV/AIDS (AOR = 0.7, 95% CI = 0.5-0.9 or to have heard of routine testing (AOR = 0.59, 95% CI = 0.45-0.76. While experiences with voluntary and routine testing overall were positive, 68% felt that they could not refuse the HIV test. Key barriers to testing included fear of learning one's status (49%, lack of perceived HIV risk (43%, and fear of having to change sexual practices with a positive HIV test (33%.Routine testing appears to be widely supported and may reduce barriers to testing in Botswana. As routine testing is

Optical diagnostics in the advanced test accelerator (ATA) environment

International Nuclear Information System (INIS)

Chong, Y.P.; Cornish, J.P.; Donnelly, D.

1987-05-01

The ATA is a 50-MeV, 10-kA, 70-ns pulsed electron beam accelerator that generates an extremely harsh environment for diagnostic measurements. Diagnostic targets placed in the beamline are subject to damage, frequently being destroyed by a single pulse. High radiation (x-ray, gamma, and neutron) and electromagnetic interference levels preclude placing components near the beamline that are susceptible to radiation damage. Examples of such components are integrated circuit elements, hydrocarbons such as Teflon insulation, and optical components that darken, resulting in transmission loss. Optical diagnostics play an important part in measuring experimental parameters such as the beam current density profile. A large number of optical lines of sight (LOS) are routinely deployed along the experimental beamlines that use the ATA beam. Gated TV cameras are located outside the accelerator tunnel, because the tunnel is inaccessible during operations. We will describe and discuss the difficulties, problems, and solutions encountered in making optical measurements in the ATA environment

Evaluating Diagnostic Point-of-Care Tests in Resource-Limited Settings

Science.gov (United States)

Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V

2014-01-01

Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389

[Diagnostic test scale SI5: Assessment of sacroiliac joint dysfunction].

Science.gov (United States)

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.

Systematic reviews of diagnostic test accuracy

DEFF Research Database (Denmark)

Leeflang, Mariska M G; Deeks, Jonathan J; Gatsonis, Constantine

2008-01-01

More and more systematic reviews of diagnostic test accuracy studies are being published, but they can be methodologically challenging. In this paper, the authors present some of the recent developments in the methodology for conducting systematic reviews of diagnostic test accuracy studies....... Restrictive electronic search filters are discouraged, as is the use of summary quality scores. Methods for meta-analysis should take into account the paired nature of the estimates and their dependence on threshold. Authors of these reviews are advised to use the hierarchical summary receiver...

Routine testing of Mycoplasma genitalium and Trichomonas vaginalis.

Science.gov (United States)

Jenniskens, Marieke L M; Veerbeek, Jan H W; Deurloo, Koen L; van Hannen, Erik J; Thijsen, Steven F T

2017-06-01

Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) are common sexual transmitted infections (STI). However, most STI screening programmes do not include routinely detection of these pathogens. Consequently, epidemiological data about MG and TV in the general population is lacking. The current study aims to give insight into the prevalence of both infections, thereby guiding decisions whether testing for these pathogens should be included routinely. Between February 2013 and August 2015, all samples sent to the laboratory of Diakonessenhuis Utrecht for STI testing (i.e. testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)) were additionally examined for the presence of MG and TV by means of a laboratory-developed RT-PCR. Samples were collected by our hospital or by regional general practitioners. A total of 5628 PCR's were evaluated. In 7.5%, one or more STI were detected. CT was found in 5% and MG was positive in 1.9%. NG was detected in 0.5% and TV was detected in 0.6% of the samples. CT was found more often in primary care than in hospital setting (9.7% vs. 3.0%, p < .05). The same was shown for NG (1.1% vs. 0.2%, p < .05). More men than women were positive for CT (11.2% vs. 3.8%, p < .05) and NG (1.4% vs. 0.3%, p < .05). MG is more prevalent than NG and TV in a regional Dutch population. Furthermore, TV is equally common as NG. Based on our prevalence data, including MG and TV in STI testing protocols should be considered in the future.

Opportunistic screening for osteoporosis on routine computed tomography? An external validation study

Energy Technology Data Exchange (ETDEWEB)

Buckens, Constantinus F. [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Universitair Medisch Centrum Utrecht, Department of Radiology, Utrecht (Netherlands); Dijkhuis, Gawein; Jong, Pim A. de [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Keizer, Bart de [University Medical Center Utrecht, Department of Nuclear Medicine, Utrecht (Netherlands); Verhaar, Harald J. [University Medical Center Utrecht, Department of Geriatric Medicine, Utrecht (Netherlands)

2015-07-15

Opportunistic screening for osteoporosis using computed tomography (CT) examinations that happen to visualise the spine can be used to identify patients with osteoporosis. We sought to verify the diagnostic performance of vertebral Hounsfield unit (HU) measurements on routine CT examinations for diagnosing osteoporosis in a separate, external population. Consecutive patients who underwent a CT examination of the chest or abdomen and had also received a dual-energy X-ray absorptiometry (DXA) test were retrospectively included. CTs were evaluated for vertebral fractures and vertebral attenuation (density) values were measured. Diagnostic performance measures and the area under the receiver operator characteristics curve (AUC) for diagnosing osteoporosis were calculated. Three hundred and two patients with a mean age of 57.9 years were included, of which 82 (27 %) had osteoporosis according to DXA and 65 (22 %) had vertebral fractures. The diagnostic performance for vertebral HU measurements was modest, with a maximal AUC of 0.74 (0.68 - 0.80). At that optimal threshold the sensitivity was 62 % (51 - 72 %) and the specificity was 79 % (74 - 84 %). We confirmed that simple trabecular vertebral density measurements on routine CT contain diagnostic information related to bone mineral density as measured by DXA, albeit with substantially lower diagnostic accuracy than previously reported. (orig.)

Opportunistic screening for osteoporosis on routine computed tomography? An external validation study

International Nuclear Information System (INIS)

Buckens, Constantinus F.; Dijkhuis, Gawein; Jong, Pim A. de; Keizer, Bart de; Verhaar, Harald J.

2015-01-01

Opportunistic screening for osteoporosis using computed tomography (CT) examinations that happen to visualise the spine can be used to identify patients with osteoporosis. We sought to verify the diagnostic performance of vertebral Hounsfield unit (HU) measurements on routine CT examinations for diagnosing osteoporosis in a separate, external population. Consecutive patients who underwent a CT examination of the chest or abdomen and had also received a dual-energy X-ray absorptiometry (DXA) test were retrospectively included. CTs were evaluated for vertebral fractures and vertebral attenuation (density) values were measured. Diagnostic performance measures and the area under the receiver operator characteristics curve (AUC) for diagnosing osteoporosis were calculated. Three hundred and two patients with a mean age of 57.9 years were included, of which 82 (27 %) had osteoporosis according to DXA and 65 (22 %) had vertebral fractures. The diagnostic performance for vertebral HU measurements was modest, with a maximal AUC of 0.74 (0.68 - 0.80). At that optimal threshold the sensitivity was 62 % (51 - 72 %) and the specificity was 79 % (74 - 84 %). We confirmed that simple trabecular vertebral density measurements on routine CT contain diagnostic information related to bone mineral density as measured by DXA, albeit with substantially lower diagnostic accuracy than previously reported. (orig.)

Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice.

Science.gov (United States)

Jett, James R; Peek, Laura J; Fredericks, Lynn; Jewell, William; Pingleton, William W; Robertson, John F R

2014-01-01

EarlyCDT(®)-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient. Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging. Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity=41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II. EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Integration and acceleration of virtual microscopy as the key to successful implementation into the routine diagnostic process.

Science.gov (United States)

Wienert, Stephan; Beil, Michael; Saeger, Kai; Hufnagl, Peter; Schrader, Thomas

2009-01-09

The virtual microscopy is widely accepted in Pathology for educational purposes and teleconsultation but is far from the routine use in surgical pathology due to the technical requirements and some limitations. A technical problem is the limited bandwidth of a usual network and the delayed transmission rate and presentation time on the screen. In this study the process of secondary diagnostic was evaluated using the "T.Konsult Pathologie" service of the Professional Association of German Pathologists within the German breast cancer screening program. The characteristics of the access to the WSI (Whole Slide Images) have been analyzed to explore the possibilities of prefetching and caching to reduce the presentation and transfer time with the goal to increase user acceptance. The log files of the web server were analyzed to reconstruct the movements of the pathologist on the WSI and to create the observation path. Using a specialized tool the observation paths were extracted automatically from the log files. The attributes linearity, 3-point-linearity, changes per request, and number of consecutive requests were calculated to design, develop and evaluate different caching and prefetching strategies. The analysis of the observation paths showed that a complete accordance of two image requests is a very rare event. But more frequently a partial covering of two requested image areas can be found. In total 257 diagnostic paths from 131 WSI have been extracted and analysed. On average a diagnostic path consists of 16 image requests and takes 189 seconds between first and last image request. The mean linearity was 0,41 and the mean 3-point-linearity 0,85. Three different caching algorithms have been compared with respect to hit rate and additional image requests on the WSI server. Tests demonstrated that 95% of the diagnostic paths could be loaded without any deletion of entries in the cache (cache size 12,2 Megapixel). If the image parts are stored after JPEG compression

Integration and acceleration of virtual microscopy as the key to successful implementation into the routine diagnostic process

Directory of Open Access Journals (Sweden)

Hufnagl Peter

2009-01-01

Full Text Available Abstract Background The virtual microscopy is widely accepted in Pathology for educational purposes and teleconsultation but is far from the routine use in surgical pathology due to the technical requirements and some limitations. A technical problem is the limited bandwidth of a usual network and the delayed transmission rate and presentation time on the screen. Methods In this study the process of secondary diagnostic was evaluated using the "T.Konsult Pathologie" service of the Professional Association of German Pathologists within the German breast cancer screening program. The characteristics of the access to the WSI (Whole Slide Images have been analyzed to explore the possibilities of prefetching and caching to reduce the presentation and transfer time with the goal to increase user acceptance. The log files of the web server were analyzed to reconstruct the movements of the pathologist on the WSI and to create the observation path. Using a specialized tool the observation paths were extracted automatically from the log files. The attributes linearity, 3-point-linearity, changes per request, and number of consecutive requests were calculated to design, develop and evaluate different caching and prefetching strategies. Results The analysis of the observation paths showed that a complete accordance of two image requests is a very rare event. But more frequently a partial covering of two requested image areas can be found. In total 257 diagnostic paths from 131 WSI have been extracted and analysed. On average a diagnostic path consists of 16 image requests and takes 189 seconds between first and last image request. The mean linearity was 0,41 and the mean 3-point-linearity 0,85. Three different caching algorithms have been compared with respect to hit rate and additional image requests on the WSI server. Tests demonstrated that 95% of the diagnostic paths could be loaded without any deletion of entries in the cache (cache size 12,2 Megapixel

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

Science.gov (United States)

Harrington, Jennifer; Palmert, Mark R

2012-09-01

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

Understanding the properties of diagnostic tests - Part 2: Likelihood ratios.

Science.gov (United States)

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.

Country-wide surveillance of molecular markers of antimalarial drug resistance in Senegal by use of positive Malaria Rapid Diagnostic Tests

DEFF Research Database (Denmark)

Ndiaye, Magatte; Sow, Doudou; Nag, Sidsel

2017-01-01

of drug resistance. Therefore, surveillance of drug resistance in the malaria parasites is essential. The objective of this pilot study was to test the feasibility of routinely sampled malaria rapid diagnostic tests (RDTs) at a national scale to assess the temporal changes in the molecular profiles...... of antimalarial drug resistance markers of Plasmodium falciparum parasites. Overall, 9,549 positive malaria RDTs were collected from 14 health facilities across the country. A limited random set of RDTs were analyzed regarding Pfcrt gene polymorphisms at codon 72-76. Overall, a high but varied prevalence (> 50...

Rapid antigen detection test for respiratory syncytial virus diagnosis as a diagnostic tool.

Science.gov (United States)

Mesquita, Flávio da Silva; Oliveira, Danielle Bruna Leal de; Crema, Daniela; Pinez, Célia Miranda Nunes; Colmanetti, Thaís Cristina; Thomazelli, Luciano Matsumia; Gilio, Alfredo Elias; Vieira, Sandra Elisabeth; Martinez, Marina Baquerizo; Botosso, Viviane Fongaro; Durigon, Edison Luiz

The aim of this study was to evaluate the QuickVue ® RSV Test Kit (QUIDEL Corp, CA, USA) as a screening tool for respiratory syncytial virus in children with acute respiratory disease in comparison with the indirect immunofluorescence assay as gold standard. In Brazil, rapid antigen detection tests for respiratory syncytial virus are not routinely utilized as a diagnostic tool, except for the diagnosis of dengue and influenza. The authors retrospectively analyzed 486 nasopharyngeal aspirate samples from children under age 5 with acute respiratory infection, between December 2013 and August 2014, the samples were analyzed by indirect immunofluorescence assay and QuickVue ® RSV Test kit. Samples with discordant results were analyzed by real time PCR and nucleotide sequencing. From 313 positive samples by immunofluorescence assays, 282 (90%) were also positive by the rapid antigen detection test, two were positive only by rapid antigen detection test, 33 were positive only by immunofluorescence assays, and 171 were positive by both methods. The 35 samples with discordant results were analyzed by real time PCR; the two samples positive only by rapid antigen detection test and the five positive only by immunofluorescence assays were also positive by real time PCR. There was no relation between the negativity by QuickVue ® RSV Test and viral load or specific strain. The QuickVue ® RSV Test showed sensitivity of 90%, specificity of 98.8%, predictive positive value of 99.3%, and negative predictive value of 94.6%, with accuracy of 93.2% and agreement κ index of 0.85 in comparison to immunofluorescence assay. This study demonstrated that the QuickVue ® RSV Test Kit can be effective in early detection of Respiratory syncytial virus in nasopharyngeal aspirate and is reliable for use as a diagnostic tool in pediatrics. Copyright © 2016 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Rapid antigen detection test for respiratory syncytial virus diagnosis as a diagnostic tool,

Directory of Open Access Journals (Sweden)

Flávio da Silva Mesquita

Full Text Available Abstract Objective: The aim of this study was to evaluate the QuickVue® RSV Test Kit (QUIDEL Corp, CA, USA as a screening tool for respiratory syncytial virus in children with acute respiratory disease in comparison with the indirect immunofluorescence assay as gold standard. In Brazil, rapid antigen detection tests for respiratory syncytial virus are not routinely utilized as a diagnostic tool, except for the diagnosis of dengue and influenza. Methods: The authors retrospectively analyzed 486 nasopharyngeal aspirate samples from children under age 5 with acute respiratory infection, between December 2013 and August 2014, the samples were analyzed by indirect immunofluorescence assay and QuickVue® RSV Test kit. Samples with discordant results were analyzed by real time PCR and nucleotide sequencing. Results: From 313 positive samples by immunofluorescence assays, 282 (90% were also positive by the rapid antigen detection test, two were positive only by rapid antigen detection test, 33 were positive only by immunofluorescence assays, and 171 were positive by both methods. The 35 samples with discordant results were analyzed by real time PCR; the two samples positive only by rapid antigen detection test and the five positive only by immunofluorescence assays were also positive by real time PCR. There was no relation between the negativity by QuickVue® RSV Test and viral load or specific strain. The QuickVue® RSV Test showed sensitivity of 90%, specificity of 98.8%, predictive positive value of 99.3%, and negative predictive value of 94.6%, with accuracy of 93.2% and agreement κ index of 0.85 in comparison to immunofluorescence assay. Conclusions: This study demonstrated that the QuickVue® RSV Test Kit can be effective in early detection of Respiratory syncytial virus in nasopharyngeal aspirate and is reliable for use as a diagnostic tool in pediatrics.

Dealing with a positive result: routine HIV testing of pregnant women in Vietnam

NARCIS (Netherlands)

Oosterhoff, P.; Hardon, A.P.; Nguyen, T.A.; Pham, N.Y.; Wright, P.

2008-01-01

HIV testing is an essential component of PMTCT. It can be offered to pregnant women through different testing models, ranging from voluntary counseling and testing (VCT) to routine and mandatory testing. This study was conducted in Hanoi, Vietnam, where HIV-prevalence is low among the general

The indication area of a diagnostic test. Part I--discounting gain and loss in diagnostic certainty

NARCIS (Netherlands)

Stalpers, Lukas J. A.; Nelemans, Patty J.; Geurts, Sandra M. E.; Jansen, Erik; de Boer, Peter; Verbeek, André L. M.

2015-01-01

Test performance is conventionally expressed by gain in diagnostic certainty. We propose net diagnostic gain and indication area as more appropriate measures of test performance; then, the loss in certainty due to misclassification and the information of "no test" would be performed are taken into

Rapid diagnostic test for G6PD deficiency in Plasmodium vivax-infected men: a budget impact analysis based in Brazilian Amazon.

Science.gov (United States)

Peixoto, Henry Maia; Brito, Marcelo Augusto Mota; Romero, Gustavo Adolfo Sierra; Monteiro, Wuelton Marcelo; de Lacerda, Marcus Vinícius Guimarães; de Oliveira, Maria Regina Fernandes

2017-01-01

The aim of this study was to estimate the incremental budget impact (IBI) of a rapid diagnostic test to detect G6PDd in male patients infected with Plasmodium vivax in the Brazilian Amazon, as compared with the routine protocol recommended in Brazil which does not include G6PDd testing. The budget impact analysis was performed from the perspective of the Brazilian health system, in the Brazilian Amazon for the years 2013, 2014 and 2015. The analysis used a decision model to compare two scenarios: the first consisting of the routine recommended in Brazil which does not include prior diagnosis of dG6PD, and the second based on the use of RDT CareStart™ G6PD (CS-G6PD) in all male subjects diagnosed with vivax malaria. The expected implementation of the diagnostic test was 30% in the first year, 70% the second year and 100% in the third year. The analysis identified negative IBIs which were progressively smaller in the 3 years evaluated. The sensitivity analysis showed that the uncertainties associated with the analytical model did not significantly affect the results. A strategy based on the use of CS-G6PD would result in better use of public resources in the Brazilian Amazon. © 2016 John Wiley & Sons Ltd.

Value of routine blood tests for prediction of mortality risk in hip fracture patients

DEFF Research Database (Denmark)

Mosfeldt, Mathias; Pedersen, Ole Birger Vesterager; Riis, Troels

2012-01-01

There is a 5- to 8-fold increased risk of mortality during the first 3 months after a hip fracture. Several risk factors are known. We studied the predictive value (for mortality) of routine blood tests taken on admission.......There is a 5- to 8-fold increased risk of mortality during the first 3 months after a hip fracture. Several risk factors are known. We studied the predictive value (for mortality) of routine blood tests taken on admission....

The impact of new trends in POCTs for companion diagnostics, non-invasive testing and molecular diagnostics.

Science.gov (United States)

Huckle, David

2015-06-01

Point-of-care diagnostics have been slowly developing over several decades and have taken on a new importance in current healthcare delivery for both diagnostics and development of new drugs. Molecular diagnostics have become a key driver of technology change and opened up new areas in companion diagnostics for use alongside pharmaceuticals and in new clinical approaches such as non-invasive testing. Future areas involving smartphone and other information technology advances, together with new developments in molecular biology, microfluidics and surface chemistry are adding to advances in the market. The focus for point-of-care tests with molecular diagnostic technologies is focused on advancing effective applications.

Routine clinical knee MR reports: comparison of diagnostic performance at 1.5 T and 3.0 T for assessment of the articular cartilage

Energy Technology Data Exchange (ETDEWEB)

Mandell, Jacob C.; Rhodes, Jeffrey A.; Shah, Nehal; Gaviola, Glenn C.; Smith, Stacy E. [Brigham and Women' s Hospital, Division of Musculoskeletal Imaging and Intervention, Department of Radiology, Boston, MA (United States); Gomoll, Andreas H. [Brigham and Women' s Hospital, Cartilage Repair Center, Department of Orthopedic Surgery, Boston, MA (United States)

2017-11-15

Accurate assessment of knee articular cartilage is clinically important. Although 3.0 Tesla (T) MRI is reported to offer improved diagnostic performance, literature regarding the clinical impact of MRI field strength is lacking. The purpose of this study is to compare the diagnostic performance of clinical MRI reports for assessment of cartilage at 1.5 and 3.0 T in comparison to arthroscopy. This IRB-approved retrospective study consisted of 300 consecutive knees in 297 patients who had routine clinical MRI and arthroscopy. Descriptions of cartilage from MRI reports of 165 knees at 1.5 T and 135 at 3.0 T were compared with arthroscopy. The sensitivity, specificity, percent of articular surfaces graded concordantly, and percent of articular surfaces graded within one grade of the arthroscopic grading were calculated for each articular surface at 1.5 and 3.0 T. Agreement between MRI and arthroscopy was calculated with the weighted-kappa statistic. Significance testing was performed utilizing the z-test after bootstrapping to obtain the standard error. The sensitivity, specificity, percent of articular surfaces graded concordantly, and percent of articular surfaces graded within one grade were 61.4%, 82.7%, 62.2%, and 77.5% at 1.5 T and 61.8%, 80.6%, 59.5%, and 75.6% at 3.0 T, respectively. The weighted kappa statistic was 0.56 at 1.5 T and 0.55 at 3.0 T. There was no statistically significant difference in any of these parameters between 1.5 and 3.0 T. Factors potentially contributing to the lack of diagnostic advantage of 3.0 T MRI are discussed. (orig.)

The diagnostic value of troponin in critically ill.

Science.gov (United States)

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.

Immunochromatographic diagnostic test analysis using Google Glass.

Science.gov (United States)

Feng, Steve; Caire, Romain; Cortazar, Bingen; Turan, Mehmet; Wong, Andrew; Ozcan, Aydogan

2014-03-25

We demonstrate a Google Glass-based rapid diagnostic test (RDT) reader platform capable of qualitative and quantitative measurements of various lateral flow immunochromatographic assays and similar biomedical diagnostics tests. Using a custom-written Glass application and without any external hardware attachments, one or more RDTs labeled with Quick Response (QR) code identifiers are simultaneously imaged using the built-in camera of the Google Glass that is based on a hands-free and voice-controlled interface and digitally transmitted to a server for digital processing. The acquired JPEG images are automatically processed to locate all the RDTs and, for each RDT, to produce a quantitative diagnostic result, which is returned to the Google Glass (i.e., the user) and also stored on a central server along with the RDT image, QR code, and other related information (e.g., demographic data). The same server also provides a dynamic spatiotemporal map and real-time statistics for uploaded RDT results accessible through Internet browsers. We tested this Google Glass-based diagnostic platform using qualitative (i.e., yes/no) human immunodeficiency virus (HIV) and quantitative prostate-specific antigen (PSA) tests. For the quantitative RDTs, we measured activated tests at various concentrations ranging from 0 to 200 ng/mL for free and total PSA. This wearable RDT reader platform running on Google Glass combines a hands-free sensing and image capture interface with powerful servers running our custom image processing codes, and it can be quite useful for real-time spatiotemporal tracking of various diseases and personal medical conditions, providing a valuable tool for epidemiology and mobile health.

Selective versus routine patch metal allergy testing to select bar material for the Nuss procedure in 932 patients over 10years.

Science.gov (United States)

Obermeyer, Robert J; Gaffar, Sheema; Kelly, Robert E; Kuhn, M Ann; Frantz, Frazier W; McGuire, Margaret M; Paulson, James F; Kelly, Cynthia S

2018-02-01

The aim of the study was to determine the role of patch metal allergy testing to select bar material for the Nuss procedure. An IRB-approved (11-04-WC-0098) single institution retrospective, cohort study comparing selective versus routine patch metal allergy testing to select stainless steel or titanium bars for Nuss repair was performed. In Cohort A (9/2004-1/2011), selective patch testing was performed based on clinical risk factors. In Cohort B (2/2011-9/2014), all patients were patch tested. The cohorts were compared for incidence of bar allergy and resultant premature bar loss. Risk factors for stainless steel allergy or positive patch test were evaluated. Cohort A had 628 patients with 63 (10.0%) selected for patch testing, while all 304 patients in Cohort B were tested. Over 10years, 15 (1.8%) of the 842 stainless steel Nuss repairs resulted in a bar allergy, and 5 had a negative preoperative patch test. The incidence of stainless steel bar allergy (1.8% vs 1.7%, p=0.57) and resultant bar loss (0.5% vs 1.3%, p=0.23) was not statistically different between cohorts. An allergic reaction to a stainless steel bar or a positive patch test was more common in females (OR=2.3, pbar allergies occur at a low incidence with either routine or selective patch metal allergy testing. If selective testing is performed, it is advisable in females and patients with a personal or family history of metal sensitivity. A negative preoperative patch metal allergy test does not preclude the possibility of a postoperative stainless steel bar allergy. Level III Treatment Study and Study of Diagnostic Test. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Science.gov (United States)

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

2015-05-14

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

Rapid targeted somatic mutation analysis of solid tumors in routine clinical diagnostics.

Science.gov (United States)

Magliacane, Gilda; Grassini, Greta; Bartocci, Paola; Francaviglia, Ilaria; Dal Cin, Elena; Barbieri, Gianluca; Arrigoni, Gianluigi; Pecciarini, Lorenza; Doglioni, Claudio; Cangi, Maria Giulia

2015-10-13

Tumor genotyping is an essential step in routine clinical practice and pathology laboratories face a major challenge in being able to provide rapid, sensitive and updated molecular tests. We developed a novel mass spectrometry multiplexed genotyping platform named PentaPanel to concurrently assess single nucleotide polymorphisms in 56 hotspots of the 5 most clinically relevant cancer genes, KRAS, NRAS, BRAF, EGFR and PIK3CA for a total of 221 detectable mutations. To both evaluate and validate the PentaPanel performance, we investigated 1025 tumor specimens of 6 different cancer types (carcinomas of colon, lung, breast, pancreas, and biliary tract, and melanomas), systematically addressing sensitivity, specificity, and reproducibility of our platform. Sanger sequencing was also performed for all the study samples. Our data showed that PentaPanel is a high throughput and robust tool, allowing genotyping for targeted therapy selection of 10 patients in the same run, with a practical turnaround time of 2 working days. Importantly, it was successfully used to interrogate different DNAs isolated from routinely processed specimens (formalin-fixed paraffin embedded, frozen, and cytological samples), covering all the requirements of clinical tests. In conclusion, the PentaPanel platform can provide an immediate, accurate and cost effective multiplex approach for clinically relevant gene mutation analysis in many solid tumors and its utility across many diseases can be particularly relevant in multiple clinical trials, including the new basket trial approach, aiming to identify appropriate targeted drug combination strategies.

Quantifying the Accuracy of a Diagnostic Test or Marker

NARCIS (Netherlands)

Linnet, Kristian; Bossuyt, Patrick M. M.; Moons, Karel G. M.; Reitsma, Johannes B. R.

2012-01-01

BACKGROUND: In recent years, increasing focus has been directed to the methodology for evaluating (new) tests or biomarkers. A key step in the evaluation of a diagnostic test is the investigation into its accuracy. CONTENT: We reviewed the literature on how to assess the accuracy of diagnostic

Local Sensitivity and Diagnostic Tests

NARCIS (Netherlands)

Magnus, J.R.; Vasnev, A.L.

2004-01-01

In this paper we confront sensitivity analysis with diagnostic testing.Every model is misspecified, but a model is useful if the parameters of interest (the focus) are not sensitive to small perturbations in the underlying assumptions. The study of the e ect of these violations on the focus is

SU-E-P-08: Establishment of Local Diagnostic Reference Levels of Routine Abdomen Exam in Computed Tomography According to Body Weight

International Nuclear Information System (INIS)

Wang, H; Wang, Y; Weng, H

2015-01-01

Purpose: The national diagnostic reference levels (NDRLs) is an efficient, concise and powerful standard for optimizing radiation protection of a patient. However, for each hospital the dose-reducing potential of focusing on establishment of local DRLs (LDRLs). A lot of study reported that Computed tomography exam contributed majority radiation dose in different medical modalities, therefore, routine abdomen CT exam was choose in initial pilot study in our study. Besides the mAs of routine abdomen CT exam was decided automatic exposure control by linear attenuation is relate to body shape of patient. In this study we would like to establish the local diagnostic reference levels of routine abdomen exam in computed tomography according to body weight of patient. Methods and Materials: There are two clinical CT scanners (a Toshiba Aquilion and a Siemens Sensation) were performed in this study. For CT examinations the basic recommended dosimetric quantity is the Computed Tomography Dose Index (CTDI). The patient sample involved 82 adult patients of both sexes and divided into three groups by their body weight (50–60 kg, 60–70 kg, 70–80 kg).Carried out the routine abdomen examinations, and all exposure parameters have been collected and the corresponding CTDIv and DLP values have been determined. The average values were compared with the European DRLs. Results: The majority of patients (75%) were between 50–70 Kg of body weight, the numbers of patient in each group of weight were 40–50:7; 50–60:29; 60–70:33; 70–80:13. The LDRLs in each group were 10.81mGy, 14.46mGy, 20.27mGy and 21.04mGy, respectively. The DLP were 477mGy, 630mGy, 887mGy and 959mGy, respectively. No matter which group the LDRLs were lower than European DRLs. Conclusions: We would like to state that this was a pioneer work in local hospital in Chiayi. We hope that this may lead the way to further developments in Taiwan

SU-E-P-08: Establishment of Local Diagnostic Reference Levels of Routine Abdomen Exam in Computed Tomography According to Body Weight

Energy Technology Data Exchange (ETDEWEB)

Wang, H; Wang, Y; Weng, H [Chiayi Chang Gung Memorial Hospital of The C.G.M.F, Puzi City, Chiayi County, Taiwan (China)

2015-06-15

Purpose: The national diagnostic reference levels (NDRLs) is an efficient, concise and powerful standard for optimizing radiation protection of a patient. However, for each hospital the dose-reducing potential of focusing on establishment of local DRLs (LDRLs). A lot of study reported that Computed tomography exam contributed majority radiation dose in different medical modalities, therefore, routine abdomen CT exam was choose in initial pilot study in our study. Besides the mAs of routine abdomen CT exam was decided automatic exposure control by linear attenuation is relate to body shape of patient. In this study we would like to establish the local diagnostic reference levels of routine abdomen exam in computed tomography according to body weight of patient. Methods and Materials: There are two clinical CT scanners (a Toshiba Aquilion and a Siemens Sensation) were performed in this study. For CT examinations the basic recommended dosimetric quantity is the Computed Tomography Dose Index (CTDI). The patient sample involved 82 adult patients of both sexes and divided into three groups by their body weight (50–60 kg, 60–70 kg, 70–80 kg).Carried out the routine abdomen examinations, and all exposure parameters have been collected and the corresponding CTDIv and DLP values have been determined. The average values were compared with the European DRLs. Results: The majority of patients (75%) were between 50–70 Kg of body weight, the numbers of patient in each group of weight were 40–50:7; 50–60:29; 60–70:33; 70–80:13. The LDRLs in each group were 10.81mGy, 14.46mGy, 20.27mGy and 21.04mGy, respectively. The DLP were 477mGy, 630mGy, 887mGy and 959mGy, respectively. No matter which group the LDRLs were lower than European DRLs. Conclusions: We would like to state that this was a pioneer work in local hospital in Chiayi. We hope that this may lead the way to further developments in Taiwan.

DiagTest3Grp: An R Package for Analyzing Diagnostic Tests with Three Ordinal Groups

Directory of Open Access Journals (Sweden)

Jingqin Luo

2012-10-01

Full Text Available Medical researchers endeavor to identify potentially useful biomarkers to develop marker-based screening assays for disease diagnosis and prevention. Useful summary measures which properly evaluate the discriminative ability of diagnostic markers are critical for this purpose. Literature and existing software, for example, R packages nicely cover summary measures for diagnostic markers used for the binary case (e.g., healthy vs. diseased. An intermediate population at an early disease stage usually exists between the healthy and the fully diseased population in many disease processes. Supporting utilities for three-group diagnostic tests are highly desired and important for identifying patients at the early disease stage for timely treatments. However, application packages which provide summary measures for three ordinal groups are currently lacking. This paper focuses on two summary measures of diagnostic accuracy—volume under the receiver operating characteristic surface and the extended Youden index, with three diagnostic groups. We provide the R package DiagTest3Grp to estimate, under both parametric and nonparametric assumptions, the two summary measures and the associated variances, as well as the optimal cut-points for disease diagnosis. An omnibus test for multiple markers and a Wald test for two markers, on independent or paired samples, are incorporated to compare diagnostic accuracy across biomarkers. Sample size calculation under the normality assumption can be performed in the R package to design future diagnostic studies. A real world application evaluating the diagnostic accuracy of neuropsychological markers for Alzheimer’s disease is used to guide readers through step-by-step implementation of DiagTest3Grp to demonstrate its utility.

Whole Genome Sequencing Increases Molecular Diagnostic Yield Compared with Current Diagnostic Testing for Inherited Retinal Disease.

Science.gov (United States)

Ellingford, Jamie M; Barton, Stephanie; Bhaskar, Sanjeev; Williams, Simon G; Sergouniotis, Panagiotis I; O'Sullivan, James; Lamb, Janine A; Perveen, Rahat; Hall, Georgina; Newman, William G; Bishop, Paul N; Roberts, Stephen A; Leach, Rick; Tearle, Rick; Bayliss, Stuart; Ramsden, Simon C; Nemeth, Andrea H; Black, Graeme C M

2016-05-01

To compare the efficacy of whole genome sequencing (WGS) with targeted next-generation sequencing (NGS) in the diagnosis of inherited retinal disease (IRD). Case series. A total of 562 patients diagnosed with IRD. We performed a direct comparative analysis of current molecular diagnostics with WGS. We retrospectively reviewed the findings from a diagnostic NGS DNA test for 562 patients with IRD. A subset of 46 of 562 patients (encompassing potential clinical outcomes of diagnostic analysis) also underwent WGS, and we compared mutation detection rates and molecular diagnostic yields. In addition, we compared the sensitivity and specificity of the 2 techniques to identify known single nucleotide variants (SNVs) using 6 control samples with publically available genotype data. Diagnostic yield of genomic testing. Across known disease-causing genes, targeted NGS and WGS achieved similar levels of sensitivity and specificity for SNV detection. However, WGS also identified 14 clinically relevant genetic variants through WGS that had not been identified by NGS diagnostic testing for the 46 individuals with IRD. These variants included large deletions and variants in noncoding regions of the genome. Identification of these variants confirmed a molecular diagnosis of IRD for 11 of the 33 individuals referred for WGS who had not obtained a molecular diagnosis through targeted NGS testing. Weighted estimates, accounting for population structure, suggest that WGS methods could result in an overall 29% (95% confidence interval, 15-45) uplift in diagnostic yield. We show that WGS methods can detect disease-causing genetic variants missed by current NGS diagnostic methodologies for IRD and thereby demonstrate the clinical utility and additional value of WGS. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study.

Directory of Open Access Journals (Sweden)

Kate Birnie

Full Text Available To compare the validity of diagnosis of urinary tract infection (UTI through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory.We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard, was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC for UTI predicted by pre-specified symptoms, signs and dipstick test results (the "index test", separately according to whether samples were obtained by clean catch or nappy (diaper pads.251 (5.2% and 88 (1.8% children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43, and better for clean catch (0.54; 0.45, 0.63 than nappy pad samples (0.20; 0.12, 0.28. In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80 than the research laboratory (0.86; 0.79, 0.92. Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively than clean catch samples.The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples could be due to contamination. Health service laboratories should consider adopting procedures used

A multicenter study of routine versus selective intraoperative leak testing for sleeve gastrectomy.

Science.gov (United States)

Bingham, Jason; Kaufman, Jedediah; Hata, Kai; Dickerson, James; Beekley, Alec; Wisbach, Gordon; Swann, Jacob; Ahnfeldt, Eric; Hawkins, Devon; Choi, Yong; Lim, Robert; Martin, Matthew

2017-09-01

Staple line leaks after sleeve gastrectomy are dreaded complications. Many surgeons routinely perform an intraoperative leak test (IOLT) despite little evidence to validate the reliability, clinical benefit, and safety of this procedure. To determine the efficacy of IOLT and if routine use has any benefit over selective use. Eight teaching hospitals, including private, university, and military facilities. A multicenter, retrospective analysis over a 5-year period. The efficacy of the IOLT for identifying unsuspected staple line defects and for predicting postoperative leaks was evaluated. An anonymous survey was also collected reflecting surgeons' practices and beliefs regarding IOLT. From January 2010 through December 2014, 4284 patients underwent sleeve gastrectomy. Of these, 37 patients (.9%) developed a postoperative leak, and 2376 patients (55%) received an IOLT. Only 2 patients (0.08%) had a positive finding. Subsequently, 21 patients with a negative IOLT developed a leak. IOLT demonstrated a sensitivity of only 8.7%. There was a nonsignificant trend toward increased leak rates when an IOLT was performed versus when IOLT was not performed. Leak rates were not statistically different between centers that routinely perform IOLT versus those that selectively perform IOLT. Routine IOLT had very poor sensitivity and was negative in 91% of patients who later developed postoperative leaks. The use of IOLT was not associated with a decrease in the incidence of postoperative leaks, and routine IOLT had no benefit over selective leak testing. IOLT should not be used as a quality indicator or "best practice" for bariatric surgery. Published by Elsevier Inc.

Performance of Rapid Diagnostic Tests for Imported Malaria in Clinical Practice: Results of a National Multicenter Study

Science.gov (United States)

Houzé, Sandrine; Boutron, Isabelle; Marmorat, Anne; Dalichampt, Marie; Choquet, Christophe; Poilane, Isabelle; Godineau, Nadine; Le Guern, Anne-Sophie; Thellier, Marc; Broutier, Hélène; Fenneteau, Odile; Millet, Pascal; Dulucq, Stéphanie; Hubert, Véronique; Houzé, Pascal; Tubach, Florence; Le Bras, Jacques; Matheron, Sophie

2013-01-01

We compared the performance of four rapid diagnostic tests (RDTs) for imported malaria, and particularly Plasmodium falciparum infection, using thick and thin blood smears as the gold standard. All the tests are designed to detect at least one protein specific to P. falciparum ( Plasmodium histidine-rich protein 2 (PfHRP2) or Plasmodium LDH (PfLDH)) and one pan-Plasmodium protein (aldolase or Plasmodium LDH (pLDH)). 1,311 consecutive patients presenting to 9 French hospitals with suspected malaria were included in this prospective study between April 2006 and September 2008. Blood smears revealed malaria parasites in 374 cases (29%). For the diagnosis of P. falciparum infection, the three tests detecting PfHRP2 showed high and similar sensitivity (96%), positive predictive value (PPV) (90%) and negative predictive value (NPV) (98%). The PfLDH test showed lower sensitivity (83%) and NPV (80%), despite good PPV (98%). For the diagnosis of non-falciparum species, the PPV and NPV of tests targeting pLDH or aldolase were 94–99% and 52–64%, respectively. PfHRP2-based RDTs are thus an acceptable alternative to routine microscopy for diagnosing P. falciparum malaria. However, as malaria may be misdiagnosed with RDTs, all negative results must be confirmed by the reference diagnostic method when clinical, biological or other factors are highly suggestive of malaria. PMID:24098699

System for routine testing of self-contained and airline breathing equipment

Energy Technology Data Exchange (ETDEWEB)

McDermott, H.J.; Hermens, G.A.

1980-07-01

A system for routine testing of self-contained and airline breathing equipment, developed by Shell Oil Co., for testing breathing equipment at one of its refineries, consists of an 80 psig air supply for airline respirators; a 500-2100 psig air supply for self-contained units; a regulator test system which uses a mannequin head that simulates human inhalation and which tests the ability of the regulator to keep the mask interior at the correct positive pressure; and an exhalation valve test system which identifies a leaky or sticking valve. The testing system has been in use for about 30 mo and has led to increased acceptance of respiratory protective equipment by workers.

Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization.

Science.gov (United States)

Meroni, Pier Luigi; Borghi, Maria Orietta

2018-05-01

Autoantibodies are helpful tools not only for the diagnosis and the classification of systemic autoimmune rheumatic diseases (SARD) but also for sub-grouping patients and/or for monitoring disease activity or specific tissue/organ damage. Consequently, the role of the diagnostic laboratory in the management of SARD is becoming more and more important. The advent of new techniques raised the need of updating and harmonizing our use/interpretation of the assays. We discuss in this opinion paper some of these issues. Indirect immunofluorescence (IIF) was originally suggested as the reference technique for anti-nuclear antibody (ANA) detection as previous solid phase assays (SPA) displayed lower sensitivity. The new available SPA are now offering better results and can represent alternative or even complementary diagnostic tools for ANA detection. The improved sensitivity of SPA technology is also changing our interpretation of the results for other types of autoantibody assays, but we need updating their calibration and new reference materials are going to be obtained in order to harmonize the assays. There is growing evidence that the identification of autoantibody combinations or profiles is helpful in improving diagnosis, patients' subgrouping and predictivity for disease evolution in the field of SARD. We report some explanatory examples to support the idea to make the use of these autoantibody profiles more and more popular. The technological evolution of the autoimmune assays is going to change our routine diagnostic laboratory tests for SARD and validation of new algorithms is needed in order to harmonize our approach to the issue.

Adaptive intrusion data system (AIDS) software routines

International Nuclear Information System (INIS)

Corlis, N.E.

1980-07-01

An Adaptive Intrusion Data System (AIDS) was developed to collect information from intrusion alarm sensors as part of an evaluation system to improve sensor performance. AIDS is a unique digital data-compression, storage, and formatting system; it also incorporates a capability for video selection and recording for assessment of the sensors monitored by the system. The system is software reprogrammable to numerous configurations that may be used for the collection of environmental, bilevel, analog, and video data. This report describes the software routines that control the different AIDS data-collection modes, the diagnostic programs to test the operating hardware, and the data format. Sample data printouts are also included

Diagnostic tests and algorithms used in the investigation of haematuria: systematic reviews and economic evaluation.

Science.gov (United States)

Rodgers, M; Nixon, J; Hempel, S; Aho, T; Kelly, J; Neal, D; Duffy, S; Ritchie, G; Kleijnen, J; Westwood, M

2006-06-01

evaluated nuclear matrix protein 22 or bladder tumour antigen. The sensitivity and specificity ranges suggested that neither of these would be useful either for diagnosing bladder cancer or for ruling out patients for further investigation (cystoscopy). However, the evidence remains sparse and the diagnostic accuracy estimates varied widely between studies. Fifteen studies evaluating urine cytology as a test for urinary tract malignancies were heterogeneous and poorly reported. The calculated specificity values were generally high, suggesting some possible utility in confirming malignancy. However, the evidence suggests that urine cytology has no application in ruling out malignancy or excluding patients from further investigation. Fifteen studies evaluated imaging techniques [computed tomography (CT), intravenous urography (IVU) or ultrasound scanning (US)] to detect the underlying cause of haematuria. The target condition and the reference standard varied greatly between these studies. The diagnostic accuracy data for several individual studies appeared promising but meaningful comparison of the available imaging technologies was impossible. Eight studies met the inclusion criteria but addressed different parts of the diagnostic chain (e.g. screening programmes, laboratory investigations, full urological work-up). No single study addressed the complete diagnostic process. The review also highlighted a number of methodological limitations of these studies, including their lack of generalisability to the UK context. Separate decision analytic models were therefore developed to progress estimation of the optimal strategy for the diagnostic management of haematuria. The economic model for the detection of microhaematuria found that immediate microscopy following a positive dipstick test would improve diagnostic efficiency as it eliminates the high number of false positives produced by dipstick testing. Strategies that use routine microscopy may be associated with high numbers

Is routine antenatal venereal disease research laboratory test still justified? Nigerian experience

Directory of Open Access Journals (Sweden)

Nwosu BO

2015-01-01

Full Text Available Betrand O Nwosu,1 George U Eleje,1 Amaka L Obi-Nwosu,2 Ita F Ahiarakwem,3 Comfort N Akujobi,4 Chukwudi C Egwuatu,4 Chukwudumebi O Onyiuke5 1Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Nnewi Campus, Nnewi, Anambra State, Nigeria; 2Department of Family Medicine, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria; 3Department of Medical Microbiology, Imo State University Teaching Hospital, Orlu, Imo State, Nigeria; 4Department of Medical Microbiology, Nnamdi Azikiwe University, Nnewi Campus, Nnewi, Anambra State, Nigeria; 5Department of Medical Microbiology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, NigeriaObjective: To determine the seroreactivity of pregnant women to syphilis in order to justify the need for routine antenatal syphilis screening.Methods: A multicenter retrospective analysis of routine antenatal venereal disease research laboratory (VDRL test results between 1 September 2010 and 31 August 2012 at three specialist care hospitals in south-east Nigeria was done. A reactive VDRL result is subjected for confirmation using Treponema pallidum hemagglutination assay test. Analysis was by Epi Info 2008 version 3.5.1 and Stata/IC version 10.Results: Adequate records were available regarding 2,156 patients and were thus reviewed. The mean age of the women was 27.4 years (±3.34, and mean gestational age was 26.4 weeks (±6.36. Only 15 cases (0.70% were seropositive to VDRL. Confirmatory T. pallidum hemagglutination assay was positive in 4 of the 15 cases, giving an overall prevalence of 0.19% and a false-positive rate of 73.3%. There was no significant difference in the prevalence of syphilis in relation to maternal age and parity (P>0.05.Conclusion: While the prevalence of syphilis is extremely low in the antenatal care population at the three specialist care hospitals in south-east Nigeria, false-positive rate is high and prevalence did not significantly vary with maternal age or

Reporting Diagnostic Scores in Educational Testing: Temptations, Pitfalls, and Some Solutions

Science.gov (United States)

Sinharay, Sandip; Puhan, Gautam; Haberman, Shelby J.

2010-01-01

Diagnostic scores are of increasing interest in educational testing due to their potential remedial and instructional benefit. Naturally, the number of educational tests that report diagnostic scores is on the rise, as are the number of research publications on such scores. This article provides a critical evaluation of diagnostic score reporting…

Dangers in the practice of defensive medicine in hemostasis testing for investigation of bleeding or thrombosis: part I--routine coagulation testing.

Science.gov (United States)

Lippi, Giuseppe; Favaloro, Emmanuel J; Franchini, Massimo

2014-10-01

Defensive medicine is a term conventionally used for defining the medical (mal)practice of ordering medically questionable diagnostic testing, procedures, or visits, or to avoid high-risk patients or procedures. The practice of defensive medicine may primarily be aimed to reduce exposure to malpractice liability, to avoid patient criticism regarding "medical inaction," or to avoid "missing" some otherwise potential identifiable defect(s). Although the precise impact of defensive medicine in the field of laboratory testing is difficult to estimate from the current literature, the overuse or inappropriate use of laboratory resources ranges from 23 to 67%, and a large part of this can be attributed to medical liability concerns, with apparently little clinical awareness of the adverse consequences that may be associated with this practice. Essentially, performing inappropriate testing remarkably increases the risk of obtaining false-positive results due to statistical, preanalytical, and analytical reasons, thus triggering further and potentially even more invasive follow-up testing, inappropriate patient management, along with incremental increases of expenditure due to misuse of health care resources. As routine coagulation testing is commonly performed for the screening of patients with bleeding or thrombotic disorders, either a false-negative or a false-positive result may significantly impact on clinical outcomes and health care resources. The aim of this article is to describe the leading causes of physiological, pathological, therapeutic, and spurious variations of the prothrombin time, activated partial thromboplastin time, and D-dimer, as well as the potential clinical consequences emerging from the generation of false-negative and false-positive results with these tests. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Factors associated with willingness to accept a routine offer of HIV test in a large referral hospital in Western Kenya.

Science.gov (United States)

Mangeni, J N; Ballidawa, J B; Ndege, S

2012-03-01

Although Voluntary Counseling and Testing (VCT) has existed for more than 10 years, majority of Kenyans still do not know their HIV status, thus necessitating the introduction of other testing strategies to increase the number of people taking the test. The routine offer of an HIV test to all patients in health-care settings has been proposed to increase access to care. The main objective of this study was to identify factors associated with willingness to accept a routine offer of an HIV test. This was a cross sectional study. The Setting was in the Outpatient department at a large Referral Hospital in Western Kenya. A total of 384 adult patients (both males and females) were recruited using systematic random sampling. Information was collected on basic socio demographic characteristics, knowledge about the routine offer of an HIV test, attitudes towards the testing and HIV testing practise. Of the 384 respondents, 64.3% were unaware about the routine offer of HIV testing in Health facilities. Multivariate analysis identified the main predictors of willingness to accept an HIV test offered in hospital as the age (OR 3.7, C.I 0.068-1.075), level of education (OR 3.4, C.I 0.186-62.602), Knowledge about the routine HIV testing (OR 4.6,C.I 2.118-9.847), self-perception of HIV risk (OR 8.4,C.I 3.424-20.496) and attitude towards routine offer of HIV testing (OR 9.2, C.I 0.042-0.284). There is a need to come up with tailored training on the routine offer of an HIV test and devising strategies to address the main factors that influence the decision for patients to test as identified above.

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

Science.gov (United States)

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.

Automation of diagnostic genetic testing: mutation detection by cyclic minisequencing.

Science.gov (United States)

Alagrund, Katariina; Orpana, Arto K

2014-01-01

The rising role of nucleic acid testing in clinical decision making is creating a need for efficient and automated diagnostic nucleic acid test platforms. Clinical use of nucleic acid testing sets demands for shorter turnaround times (TATs), lower production costs and robust, reliable methods that can easily adopt new test panels and is able to run rare tests in random access principle. Here we present a novel home-brew laboratory automation platform for diagnostic mutation testing. This platform is based on the cyclic minisequecing (cMS) and two color near-infrared (NIR) detection. Pipetting is automated using Tecan Freedom EVO pipetting robots and all assays are performed in 384-well micro plate format. The automation platform includes a data processing system, controlling all procedures, and automated patient result reporting to the hospital information system. We have found automated cMS a reliable, inexpensive and robust method for nucleic acid testing for a wide variety of diagnostic tests. The platform is currently in clinical use for over 80 mutations or polymorphisms. Additionally to tests performed from blood samples, the system performs also epigenetic test for the methylation of the MGMT gene promoter, and companion diagnostic tests for analysis of KRAS and BRAF gene mutations from formalin fixed and paraffin embedded tumor samples. Automation of genetic test reporting is found reliable and efficient decreasing the work load of academic personnel.

A web-based test of residents' skills in diagnostic radiology

International Nuclear Information System (INIS)

Finlay, K.; Norman, G.R.; Keane, D.R.; Stolberg, H.

2006-01-01

To develop an objective, Web-based tool for evaluating residents' knowledge of diagnostic radiology. We developed and tested a Web-based evaluation tool (the Diagnostic Radiology Skills Test) that consists of 3 tests, one in each of 3 domains of diagnostic radiology: chest, gastrointestinal, and musculoskeletal imaging. Each test comprises 30 cases representing a range of difficulty in the domain, including normal states, normal variants, typical cases of common diagnoses, and cases with more subtle findings. Cases are presented with a long menu of domain-specific possible diagnoses (response options), each coded for diagnostic appropriateness. Our subjects were 21 residents in postgraduate year (PGY) 2 to 5 and 11 experts in diagnostic radiology. Subjects accessed the tool via a Web site on our Web server. Residents test results were compared for reliability and validity across domain, case, and training level. In addition, results were correlated with commonly used established and objective evaluation tools. The tool demonstrated consistent monotonic improvement in performance with training level. It showed acceptable reliability in discriminating between residents at different performance levels, both within and across training levels (r = 0.53 within level and 0.69 across levels). Test results also had concurrent validity against the American College of Radiology In-Training Examination, a widely accepted objective assessment tool (r = 0.65, P < 0.01), and 2 Objective Structured Clinical Examinations (OSCEs) focusing on diagnostic skills (r = 0.78 and r 0.69, P < 0.01, respectively). Our study demonstrates the feasibility of a Web-based, standardized, objective assessment method for evaluating residents' performance. (author)

Routine clinical knee MR reports: comparison of diagnostic performance at 1.5 T and 3.0 T for assessment of the articular cartilage.

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Mandell, Jacob C; Rhodes, Jeffrey A; Shah, Nehal; Gaviola, Glenn C; Gomoll, Andreas H; Smith, Stacy E

2017-11-01

Accurate assessment of knee articular cartilage is clinically important. Although 3.0 Tesla (T) MRI is reported to offer improved diagnostic performance, literature regarding the clinical impact of MRI field strength is lacking. The purpose of this study is to compare the diagnostic performance of clinical MRI reports for assessment of cartilage at 1.5 and 3.0 T in comparison to arthroscopy. This IRB-approved retrospective study consisted of 300 consecutive knees in 297 patients who had routine clinical MRI and arthroscopy. Descriptions of cartilage from MRI reports of 165 knees at 1.5 T and 135 at 3.0 T were compared with arthroscopy. The sensitivity, specificity, percent of articular surfaces graded concordantly, and percent of articular surfaces graded within one grade of the arthroscopic grading were calculated for each articular surface at 1.5 and 3.0 T. Agreement between MRI and arthroscopy was calculated with the weighted-kappa statistic. Significance testing was performed utilizing the z-test after bootstrapping to obtain the standard error. The sensitivity, specificity, percent of articular surfaces graded concordantly, and percent of articular surfaces graded within one grade were 61.4%, 82.7%, 62.2%, and 77.5% at 1.5 T and 61.8%, 80.6%, 59.5%, and 75.6% at 3.0 T, respectively. The weighted kappa statistic was 0.56 at 1.5 T and 0.55 at 3.0 T. There was no statistically significant difference in any of these parameters between 1.5 and 3.0 T. Factors potentially contributing to the lack of diagnostic advantage of 3.0 T MRI are discussed.

Predictors of Inappropriate Use of Diagnostic Tests and Management of Bronchiolitis

Science.gov (United States)

Sarmiento, Lorena; Rojas-Soto, Gladys E.

2017-01-01

Background The aim of the present study was to determine predictors of inappropriate use of diagnostic tests and management of bronchiolitis in a population of hospitalized infants. Methods In an analytical cross-sectional study, we determined independent predictors of the inappropriate use of diagnostic tests and management of bronchiolitis in a population of hospitalized infants. We defined a composite outcome score as the main outcome variable. Results Of the 303 included patients, 216 (71.3%) experienced an inappropriate use of diagnostic tests and treatment of bronchiolitis. After controlling for potential confounders, it was found that atopic dermatitis (OR 5.30; CI 95% 1.14–24.79; p = 0.034), length of hospital stay (OR 1.48; CI 95% 1.08–2.03; p = 0.015), and the number of siblings (OR 1.92; CI 95% 1.13–3.26; p = 0.015) were independent predictors of an inappropriate use of diagnostic tests and treatment of the disease. Conclusions Inappropriate use of diagnostic tests and treatment of bronchiolitis was a highly prevalent outcome in our population of study. Participants with atopic dermatitis, a longer hospital stay, and a greater number of siblings were at increased risk for inappropriate use of diagnostic tests and management of the disease. PMID:28758127

Performance analysis of automated evaluation of Crithidia luciliae-based indirect immunofluorescence tests in a routine setting - strengths and weaknesses.

Science.gov (United States)

Hormann, Wymke; Hahn, Melanie; Gerlach, Stefan; Hochstrate, Nicola; Affeldt, Kai; Giesen, Joyce; Fechner, Kai; Damoiseaux, Jan G M C

2017-11-27

Antibodies directed against dsDNA are a highly specific diagnostic marker for the presence of systemic lupus erythematosus and of particular importance in its diagnosis. To assess anti-dsDNA antibodies, the Crithidia luciliae-based indirect immunofluorescence test (CLIFT) is one of the assays considered to be the best choice. To overcome the drawback of subjective result interpretation that inheres indirect immunofluorescence assays in general, automated systems have been introduced into the market during the last years. Among these systems is the EUROPattern Suite, an advanced automated fluorescence microscope equipped with different software packages, capable of automated pattern interpretation and result suggestion for ANA, ANCA and CLIFT analysis. We analyzed the performance of the EUROPattern Suite with its automated fluorescence interpretation for CLIFT in a routine setting, reflecting the everyday life of a diagnostic laboratory. Three hundred and twelve consecutive samples were collected, sent to the Central Diagnostic Laboratory of the Maastricht University Medical Centre with a request for anti-dsDNA analysis over a period of 7 months. Agreement between EUROPattern assay analysis and the visual read was 93.3%. Sensitivity and specificity were 94.1% and 93.2%, respectively. The EUROPattern Suite performed reliably and greatly supported result interpretation. Automated image acquisition is readily performed and automated image classification gives a reliable recommendation for assay evaluation to the operator. The EUROPattern Suite optimizes workflow and contributes to standardization between different operators or laboratories.

Evidence of dose saving in routine CT practice using iterative reconstruction derived from a national diagnostic reference level survey.

Science.gov (United States)

Thomas, P; Hayton, A; Beveridge, T; Marks, P; Wallace, A

2015-09-01

To assess the influence and significance of the use of iterative reconstruction (IR) algorithms on patient dose in CT in Australia. We examined survey data submitted to the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) National Diagnostic Reference Level Service (NDRLS) during 2013 and 2014. We compared median survey dose metrics with categorization by scan region and use of IR. The use of IR results in a reduction in volume CT dose index of between 17% and 44% and a reduction in dose-length product of between 14% and 34% depending on the specific scan region. The reduction was highly significant (p sum test) for all six scan regions included in the NDRLS. Overall, 69% (806/1167) of surveys included in the analysis used IR. The use of IR in CT is achieving dose savings of 20-30% in routine practice in Australia. IR appears to be widely used by participants in the ARPANSA NDRLS with approximately 70% of surveys submitted employing this technique. This study examines the impact of the use of IR on patient dose in CT on a national scale.

Perceptions and experiences of pregnant women about routine HIV testing and counselling in Ghimbi town, Ethiopia: a qualitative study.

Science.gov (United States)

Mitiku, Israel; Addissie, Adamu; Molla, Mitike

2017-02-16

Ethiopia has implemented routine HIV testing and counselling using a provider initiated HIV testing ('opt-out' approach) to achieve high coverage of testing and prevention of mother-to-child transmission of HIV. However, women's perceptions and experiences with this approach have not been well studied. We conducted a qualitative study to explore pregnant women's perceptions and experiences of routine HIV testing and counselling in Ghimbi town, Ethiopia, in May 2013. In-depth interviews were held with 28 women tested for HIV at antenatal clinics (ANC), as well as four health workers involved in routine HIV testing and counselling. Data were analyzed using the content analysis approach. We found that most women perceived routine HIV testing and counselling beneficial for women as well as unborn babies. Some women perceived HIV testing as compulsory and a prerequisite to receive delivery care services. On the other hand, health workers reported that they try to emphasise the importance HIV testing during pre-test counselling in order to gain women's acceptance. However, both health workers and ANC clients perceived that the pre-test counselling was limited. Routine HIV testing and counselling during pregnancy is well acceptable among pregnant women in the study setting. However, there is a sense of obligation as women felt the HIV testing is a pre-requisite for delivery services. This may be related to the limited pre-test counselling. There is a need to strengthen pre-test counselling to ensure that HIV testing is implemented in a way that ensures pregnant women's autonomy and maximize opportunities for primary prevention of HIV.

Optimal Combinations of Diagnostic Tests Based on AUC.

Science.gov (United States)

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.

Improving prescribing practices with rapid diagnostic tests (RDTs)

DEFF Research Database (Denmark)

Burchett, Helen E D; Leurent, Baptiste; Baiden, Frank

2017-01-01

OBJECTIVES: The overuse of antimalarial drugs is widespread. Effective methods to improve prescribing practice remain unclear. We evaluated the impact of 10 interventions that introduced rapid diagnostic tests for malaria (mRDTs) on the use of tests and adherence to results in different contexts...... packages, supervision, supplies and community sensitisation. OUTCOME MEASURES: Analysis explored variation in: (1) uptake of mRDTs (% febrile patients tested); (2) provider adherence to positive mRDTs (% Plasmodium falciparum positive prescribed/given Artemisinin Combination Treatment); (3) provider...... characteristics fitted with their own priorities. Goodness of fit of mRDTs with existing consultation and diagnostic practices appeared crucial to maximising the impact of mRDTs on care, as did prior familiarity with malaria testing; adequate human resources and supplies; possible alternative treatments for m...

Influence of the centrifuge time of primary plasma tubes on routine coagulation testing.

Science.gov (United States)

Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Manzato, Franco; Guidi, Gian Cesare

2007-07-01

Preparation of blood specimens is a major bottleneck in the laboratory throughput. Reliable strategies for reducing the time required for specimen processing without affecting quality should be acknowledged, especially for laboratories performing stat analyses. The present investigation was planned to establish a minimal suitable centrifuge time for primary samples collected for routine coagulation testing. Five sequential primary vacuum tubes containing 0.109 mol/l buffered trisodium citrate were collected from 10 volunteers and were immediately centrifuged on a conventional centrifuge at 1500 x g, at room temperature for 1, 2, 5, 10 and 15 min, respectively. Hematological and routine coagulation testing, including prothrombin time, activated partial thromboplastin time and fibrinogen, were performed. The centrifugation time was inversely associated with residual blood cell elements in plasma, especially platelets. Statistically significant variations from the reference 15-min centrifuge specimens were observed for fibrinogen in samples centrifuged for 5 min at most and for the activated partial thromboplastin time in samples centrifuged for 2 min at most. Meaningful biases related to the desirable bias were observed for fibrinogen in samples centrifuged for 2 min at most, and for the activated partial thromboplastin time in samples centrifuged for 1 min at most. According to our experimental conditions, a 5-10 min centrifuge time at 1500 x g may be suitable for primary tubes collected for routine coagulation testing.

Drug sensitivity testing platforms for gastric cancer diagnostics.

Science.gov (United States)

Lau, Vianne; Wong, Andrea Li-Ann; Ng, Christopher; Mok, Yingting; Lakshmanan, Manikandan; Yan, Benedict

2016-02-01

Gastric cancer diagnostics has traditionally been histomorphological and primarily the domain of surgical pathologists. Although there is an increasing usage of molecular and genomic techniques for clinical diagnostics, there is an emerging field of personalised drug sensitivity testing. In this review, we describe the various personalised drug sensitivity testing platforms and discuss the challenges facing clinical adoption of these assays for gastric cancer. 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/

Nanobiosensors in diagnostics

Directory of Open Access Journals (Sweden)

Alejandro Chamorro-Garcia

2016-11-01

Full Text Available Medical diagnosis has been greatly improved thanks to the development of new techniques capable of performing very sensitive detection and quantifying certain parameters. These parameters can be correlated with the presence of specific molecules and their quantity. Unfortunately, these techniques are demanding, expensive, and often complicated. On the other side, progress in other fields of science and technology has contributed to the rapid growth of nanotechnology. Although being an emerging discipline, nanotechnology has raised huge interest and expectations. Most of the enthusiasm comes from new possibilities and properties of nanomaterials. Biosensors (simple, robust, sensitive, cost-effective combined with nanomaterials, also called nanobiosensors, are serving as bridge between advanced detection/diagnostics and daily/routine tests. Here we review some of the latest applications of nanobiosensors in diagnostics field.

Emergency diagnostics of load-carrying structures into the works transport

Directory of Open Access Journals (Sweden)

Artur BLUM

2010-01-01

Full Text Available Sudden increase of exploited cranes since 1970 year and implementation of European standards restricting safety factors ware cause of many breakdowns and accidents. That’s why act about technical supervision from 2000 year impose checkups of technical conditions of supporting structures every 12 months. Checkups include also welded joint and crane tracks. Aim of routine test is to find out if there are no damages which may affect on constructions safe exploitation. Routine tests give information if construction can be exploited. Article presents methodology of diagnostics inspection for defect detection of constructions and its practical application.

Diagnostic accuracy of the Rivalta test for feline infectious peritonitis.

Science.gov (United States)

Fischer, Yvonne; Sauter-Louis, Carola; Hartmann, Katrin

2012-12-01

The Rivalta test has been used routinely in Europe to diagnose feline infectious peritonitis (FIP) in cats with effusions, but its diagnostic accuracy is uncertain. The objectives of this study were to calculate sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of the Rivalta test for FIP and to identify correlations between a positive Rivalta test and variables measured in effusion fluid and peripheral blood. In this retrospective study, medical records of cats with effusions were reviewed, and cats with conclusive results for the Rivalta test were included. The prevalence of FIP in this population was determined, and sensitivity, specificity, and PPV and NPV of the Rivalta test were calculated. Variables measured in effusion fluid and peripheral blood were compared between cats that had positive or negative Rivalta tests using the Mann-Whitney U-test and multivariate analysis. Of 851 cats with effusions, 782 had conclusively positive or negative results for the Rivalta test. A definitive final diagnosis was made in 497 of these cats. Prevalence of FIP in cats with effusion and a conclusive Rivalta test result was 34.6%. The Rivalta test had a sensitivity of 91.3%, specificity of 65.5%, PPV of 58.4%, and NPV of 93.4% for the diagnosis of FIP. These values increased when cats with lymphoma or bacterial infections were excluded, or when only cats ≤ 2 years were considered. Increased effusion cholesterol concentration and specific gravity as well as decreased serum albumin:globulin ratio and hyperbilirubinemia were positively correlated with positive Rivalta test results. Sensitivity, specificity, and PPV of the Rivalta test for the diagnosis of FIP were lower than previously reported except when used in young cats. The components in effusions that lead to a positive Rivalta test remain unknown, but the positivity is not simply related to high total protein concentration. © 2012 American Society for Veterinary Clinical Pathology.

Nonparametric predictive inference for combining diagnostic tests with parametric copula

Science.gov (United States)

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.

ITER diagnostics: Maintenance and commissioning in the hot cell test bed

International Nuclear Information System (INIS)

Walker, C.I.; Barnsley, R.; Costley, A.E.; Gottfried, R.; Haist, B.; Itami, K.; Kondoh, T.; Loesser, G.D.; Palmer, J.; Sugie, T.; Tesini, A.; Vayakis, G.

2005-01-01

In-vessel diagnostic equipment in ITER integrated in six equatorial and 12 upper ports, 16 divertor cassettes and five lower ports is designed to be removed in modules and then repaired, tested and commissioned in the same location at the ITER hot cell. The repair requirements and tests on these components are described along with design features that facilitate repair. The testing establishes the repair strategy, qualifies the refurbishment work and finally checks the mechanical and diagnostic function before the return of the modules. At the hot cell, a dummy port is provided for tests of mechanical and vacuum integrity as well as commissioning of the diagnostic equipment. The scope of the hot cell maintenance and commissioning activities is summarised and an overview of the integration of the diagnostic equipment is given

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

Science.gov (United States)

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.

Comparison of agar gel immunodiffusion test, enzyme-linked immunosorbent assay and PCR in diagnostics of enzootic bovine leukosis

Directory of Open Access Journals (Sweden)

Malovrh Tadej

2005-01-01

Full Text Available Bovine leukaemia virus (BLV is a retrovirus that induces a chronic infection in cattle. Once infected, cattle remain virus carriers for life and start to show an antibody response within a few weeks after infection. Eradication and control of the disease are based on early diagnostics and segregation of the carriers. The choice of a diagnostic method depends on the eradication programme, money resources and characteristics of the herd to be analysed. The agar gel immunodiffusion (AGID test has been the serological test of choice for routine diagnosis of serum samples. Nevertheless, in more recent years, the enzyme-linked immunosorbent assay (ELISA has replaced the AGID for large scale testing. For this purpose, commercially available BLV-ELISA kits were compared to the AGID and to the polymerase chain reaction (PCR method performed with two sets of primers, amplifying env region. The ELISA kit based on the p24 core protein was found to be less specific and served as a screening test. The ELISA kit based on the envelope glycoprotein (gpSI served as a verification test and gave a good correlation with the AGID test and PCR method. However, ELISA showed a higher sensitivity than AGID. The p24 based ELiSA was useful for screening a large number of samples, whereas gp51 based ELISA, AGID and PCR were more important for detecting the antibody response against the individual BLV-proteins and therefore for verification of the infection with BLV.

Computer-aided diagnosis in routine mammography

International Nuclear Information System (INIS)

Sittek, H.; Perlet, C.; Helmberger, R.; Linsmeier, E.; Kessler, M.; Reiser, M.

1998-01-01

Purpose: Computer-aided diagnosis in mammography is a topic many study groups have been concerned with since the first presentation of a system for computer-aided interpretation in 1967. Currently, there is only one system avilable for clinical use in mammography, the CAD-System Image Checker (R2 Technology). The purpose of our prospective study was to evaluate whether the integration of the CAD-system into the routine of a radiological breast diagnosis unit is feasible. Results: After the installation of the CAD-system, 300 patients with 1110 mammograms were included for evaluation in the present study. In 54 of these cases histological examination was indicated due to suspect criteria on conventional mammography. In 39 of 54 cases (72,2%) malignancy could be proven histologically. The CAD-system marked 82,1% of the histologically verified carcinomas correctly 94,3% of all 1797 marks made by the CAD-system indicated normal or benign structures. Routinely performed CAD analysis prolonged patients waiting time by about 15 min because the marks of the CAD system had to be interpreted in addition to the routine diagnostic investigations. Conclusion: Our experience with the use of the CAD-system in daily routine showed that CAD analysis can easily be integrated into a preexisting mammography unit. However, the diagnostic benefit is not yet clearly established. Since the rate of false negative marks by the CAD-system Image Checker is still high, the results of CAD analysis must be checked and corrected by an observer well experienced in mammography reading. (orig.) [de

A diagnostic test for apraxia in stroke patients: internal consistency and diagnostic value.

NARCIS (Netherlands)

Heugten, C.M. van; Dekker, J.; Deelman, B.G.; Stehmann-Saris, F.C.; Kinebanian, A.

1999-01-01

The internal consistency and the diagnostic value of a test for apraxia in patients having had a stroke are presented. Results indicate that the items of the test form a strong and consistent scale: Cronbach's alpha as well as the results of a Mokken scale analysis present good reliability and good

Analysis of the Astronomy Diagnostic Test

Science.gov (United States)

Brogt, Erik; Sabers, Darrell; Prather, Edward E.; Deming, Grace L.; Hufnagel, Beth; Slater, Timothy F.

2007-01-01

Seventy undergraduate class sections were examined from the database of Astronomy Diagnostic Test (ADT) results of Deming and Hufnagel to determine if course format correlated with ADT normalized gain scores. Normalized gains were calculated for four different classroom scenarios: lecture, lecture with discussion, lecture with lab, and lecture…

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

Science.gov (United States)

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

2017-12-01

The WHO recommends pregnant women receive both HIV and syphilis testing at their first antenatal care visit, as untreated maternal infections can lead to severe, adverse pregnancy outcomes. One strategy for increasing testing for both HIV and syphilis is the use of point-of-care (rapid) diagnostic tests that are simple, proven effective and inexpensive. In Malawi, pregnant women routinely receive HIV testing, but only 10% are tested for syphilis at their first antenatal care visit. This evaluation explores stakeholder perceptions of a novel, dual HIV/syphilis rapid diagnostic test and potential barriers to national scale-up of the dual test in Malawi. During June and July 2015, we conducted 15 semistructured interviews with 25 healthcare workers, laboratorians, Ministry of Health leaders and partner agency representatives working in prevention of mother-to-child transmission in Malawi. We asked stakeholders about the importance of a dual rapid diagnostic test, concerns using and procuring the dual test and recommendations for national expansion. Stakeholders viewed the test favourably, citing the importance of a dual rapid test in preventing missed opportunities for syphilis diagnosis and treatment, improving infant outcomes and increasing syphilis testing coverage. Primary technical concerns were about the additional procedural steps needed to perform the test, the possibility that testers may not adhere to required waiting times before interpreting results and difficulty reading and interpreting test results. Stakeholders thought national scale-up would require demonstration of cost-savings, uniform coordination, revisions to testing guidelines and algorithms, training of testers and a reliable supply chain. Stakeholders largely support implementation of a dual HIV/syphilis rapid diagnostic test as a feasible alternative to current antenatal testing. Scale-up will require addressing perceived barriers; negotiating changes to existing algorithms and guidelines

Diagnostic development and support of MHD test facilities

Energy Technology Data Exchange (ETDEWEB)

1990-01-01

The Diagnostic Instrumentation and Analysis Laboratory (DIAL) at Mississippi State University (MSU) is developing diagnostic instruments for MHD power train data acquisition and for support of MHD component development test facilities. Microprocessor-controlled optical instruments, initially developed for Heat Recovery/Seed Recovery support, are being refined, and new systems to measure temperatures and gas-seed-slag stream characteristics are being developed. To further data acquisition and analysis capabilities, the diagnostic systems are being interfaced with DIAL's computers. Technical support for the diagnostic needs of the national MHD research effort is being provided. DIAL personnel will also cooperate with government agencies and private industries to improve the transformation of research and development results into processes, products and services applicable to their needs. 25 figs., 6 tabs.

Diagnostic development and support of MHD test facilities

International Nuclear Information System (INIS)

Shepard, W.S.; Cook, R.L.

1990-01-01

The Diagnostic Instrumentation and Analysis Laboratory (DIAL) at Mississippi State University (MSU) is developing diagnostic instruments for MHD power train data acquisition and for support of MHD component development test facilities. Microprocessor-controlled optical instruments, initially developed for Heat Recovery/ Seed Recovery support, are being refined, and new systems to measure temperatures and gas-seed-slag stream characteristics are being developed. To further data acquisition and analysis capabilities, the diagnostic systems are being interfaced with DIAL's computers. Technical support for the diagnostic needs of the national MHD research effort is being provided. DIAL personnel will also cooperate with government agencies and private industries to improve the transformation of research and development results into processes, products and services applicable to their needs

The diagnostic path, a useful visualisation tool in virtual microscopy.

Science.gov (United States)

Schrader, Thomas; Niepage, Sonja; Leuthold, Thomas; Saeger, Kai; Schluns, Karsten; Hufnagl, Peter; Kayser, Klaus; Dietel, Manfred

2006-11-08

The Virtual Microscopy based on completely digitalised histological slide. Concerning this digitalisation many new features in mircoscopy can be processed by the computer. New applications are possible or old, well known techniques of image analyses can be adapted for routine use. A so called diagnostic path observes in the way of a professional sees through a histological virtual slide combined with the text information of the dictation process. This feature can be used for image retrieval, quality assurance or for educational purpose. The diagnostic path implements a metadata structure of image information. It stores and processes the different images seen by a pathologist during his "slide viewing" and the obtained image sequence ("observation path"). Contemporary, the structural details of the pathology reports were analysed. The results were transferred into an XML structure. Based on this structure, a report editor and a search function were implemented. The report editor compiles the "diagnostic path", which is the connection from the image viewing sequence ("observation path") and the oral report sequence of the findings ("dictation path"). The time set ups of speech and image viewing serve for the link between the two sequences. The search tool uses the obtained diagnostic path. It allows the user to search for particular histological hallmarks in pathology reports and in the corresponding images. The new algorithm was tested on 50 pathology reports and 74 attached histological images. The creation of a new individual diagnostic path is automatically performed during the routine diagnostic process. The test prototype experienced an insignificant prolongation of the diagnosis procedure (oral case description and stated diagnosis by the pathologist) and a fast and reliable retrieval, especially useful for continuous education and quality control of case description and diagnostic work. The Digital Virtual Microscope has been designed to handle 1000 images

Routine testing of liver function before and after elective laparoscopic cholecystectomy: is it necessary?

LENUS (Irish Health Repository)

Ahmad, Nasir Zaheer

2012-01-31

BACKGROUND AND OBJECTIVES: Liver function tests (LFTs) include alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP), and bilirubin. The role of routine testing before and after laparoscopic cholecystectomy was evaluated in this study. PATIENTS AND METHODS: A total of 355 patients were retrospectively analyzed by examining the LFTs the day before, the day after, and 3 weeks after the surgery. The Wilcoxon signed-rank test and Student t test were performed to determine statistical significance. RESULTS: Alterations in the serum AST, ALT, and GGT were seen on the first postoperative day. Minor changes were seen in bilirubin and ALP. An overall disturbance in the LFTs was seen in more than two-thirds of the cases. Repeat LFTs performed after 3 weeks on follow-up were found to be within normal limits. CONCLUSION: Mild-to-moderate elevation in preoperative LFTs may not be associated with any deleterious effect, and, in the absence of clinical indications, routine preoperative or postoperative liver function testing is unnecessary.

System for remote routine monitoring of power equipment at TPP and NPP

International Nuclear Information System (INIS)

Kantsedalov, V.G.; Samojlenko, V.P.; Doroshenko, V.A.

1988-01-01

A system for remote routine monitoring of TPP and NPP pipeline metals is described. The principal functional unit of the system is the unit of remote routine methods and techniques for studying and monitoring the metal and properties. The system is equipped with 5 types of routine monitoring equipment: robots, remote aggregated complexes, periodical diagnostic monitors, other means of metal diagnostics (endoscopes, introscopes). All current information enters the unit for estimating and forecasting the service life of power unit, where it is compared with the standard indices of reliability, duravility and efficiency. The system considered permits to reduce significantly or minimize the scope of works on metal monitoring during overhauls, increase intermonitoring and interrepairing compaigns to 8 years

Comparison between the diagnostic accuracy of clinico-pathological and molecular tests for feline infectious peritonitis (FIP

Directory of Open Access Journals (Sweden)

Angelica Stranieri

2015-07-01

Full Text Available The aim of this study was to compare the diagnostic accuracy for feline infectious peritonitis (FIP of conventional clinic-pathological tests with that of molecular tests such as routine PCR and PCR followed by the sequencing of the Spike (S gene. Blood, effusion and tissues specimens were collected from 21 FIP suspected cats. In vivo examination consisted of CBC, serum protein electrophoresis, AGP measurement, cytological and biochemical examination and the evaluation of the ΔTNC on effusions, and of molecular tests such the screening PCR (target: 3’UTR region and the PCR directed towards the S gene followed by the amplification products sequencing in order to detect the aminoacidic substitution recently considered diagnostic for FIP1. These molecular techniques were applied to tissues collected during necropsy, which also allowed forming an FIP group (13 cats and a non-FIP group (5 cats based on histology and immunohistochemistry. The best test on tissues was immunohistochemistry (sens: 92.3%; spec: 100%, while the screening PCR suffered of low specificity (spec: 33.3% and the S gene sequencing showed low sensitivity (sens: 69.2%.On effusions, the best tests resulted screening PCR and cytology (sens and spec: 100% in comparison with the ΔTNC measurement (sens: 85.7 %; spec: 100% and the S gene sequencing (sens: 42.8%; spec: 100%.On blood, the best test resulted AGP measurement (sens: 81.8%; spec: 100%, while serum protein electrophoresis showed a surprisingly low sensitivity (sens: 41.7%. Screening PCR (sens: 55.6%; spec: 100% and S gene sequencing (sens: 33.3%; spec: 100% proved again low accuracy.

The role of routine preoperative EUS when performed after contrast enhanced CT in the diagnostic work-up in patients suspected of pancreatic or periampullary cancer.

Science.gov (United States)

Cieslak, Kasia P; van Santvoort, Hjalmar C; Vleggaar, Frank P; van Leeuwen, Maarten S; ten Kate, Fibo J; Besselink, Marc G; Molenaar, I Quintus

2014-01-01

In patients suspected of pancreatic or periampullary cancer, abdominal contrast-enhanced computed tomography (CT) is the standard diagnostic modality. A supplementary endoscopic ultrasonography (EUS) is often performed, although there is only limited evidence of its additional diagnostic value. The aim of the study is to evaluate the additional diagnostic value of EUS over CT in deciding on exploratory laparotomy in patients suspected of pancreatic or periampullary cancer. We retrospectively analyzed 86 consecutive patients who routinely underwent CT and EUS before exploratory laparotomy with or without pancreatoduodenectomy for suspected pancreatic or periampullary carcinoma between 2007 and 2010. Primary outcomes were visibility of a mass, resectability on CT/EUS and resection with curative intent. A mass was visible on CT in 72/86 (84%) patients. In these 72 patients, EUS demonstrated a mass in 64/72 (89%) patients. Resectability was accurately predicted by CT in 65/72 (90%) and by EUS in 58/72 (81%) patients. In 14/86 (16%) patients no mass was seen on CT. EUS showed a mass in 12/14 (86%) of these patients. A malignant lesion was histological proven in 11/12 (92%) of these patients. Overall, resectability was accurately predicted by CT and EUS in 90% (77/86) and 84% (72/86), respectively. In patients with a visible mass on CT, suspected for pancreatic or periampullary cancer, EUS has no additional diagnostic value, does not influence the decision to perform laparotomy and should therefore not be performed routinely. In patients without a visible mass on CT, EUS is useful to confirm the presence of a tumor. Copyright © 2014 IAP and EPC. Published by Elsevier B.V. All rights reserved.

9 CFR 147.8 - Procedures for preparing egg yolk samples for diagnostic tests.

Science.gov (United States)

2010-01-01

... samples for diagnostic tests. 147.8 Section 147.8 Animals and Animal Products ANIMAL AND PLANT HEALTH... IMPROVEMENT PLAN Blood Testing Procedures § 147.8 Procedures for preparing egg yolk samples for diagnostic... for diagnostic testing. (b) The authorized laboratory must identify each egg as to the breeding flock...

Rapid diagnostic tests for typhoid and paratyphoid (enteric) fever.

Science.gov (United States)

Wijedoru, Lalith; Mallett, Sue; Parry, Christopher M

2017-05-26

Differentiating both typhoid (Salmonella Typhi) and paratyphoid (Salmonella Paratyphi A) infection from other causes of fever in endemic areas is a diagnostic challenge. Although commercial point-of-care rapid diagnostic tests (RDTs) for enteric fever are available as alternatives to the current reference standard test of blood or bone marrow culture, or to the widely used Widal Test, their diagnostic accuracy is unclear. If accurate, they could potentially replace blood culture as the World Health Organization (WHO)-recommended main diagnostic test for enteric fever. To assess the diagnostic accuracy of commercially available rapid diagnostic tests (RDTs) and prototypes for detecting Salmonella Typhi or Paratyphi A infection in symptomatic persons living in endemic areas. We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, IndMED, African Index Medicus, LILACS, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) up to 4 March 2016. We manually searched WHO reports, and papers from international conferences on Salmonella infections. We also contacted test manufacturers to identify studies. We included diagnostic accuracy studies of enteric fever RDTs in patients with fever or with symptoms suggestive of enteric fever living in endemic areas. We classified the reference standard used as either Grade 1 (result from a blood culture and a bone marrow culture) or Grade 2 (result from blood culture and blood polymerase chain reaction, or from blood culture alone). Two review authors independently extracted the test result data. We used a modified QUADAS-2 extraction form to assess methodological quality. We performed a meta-analysis when there were sufficient studies for the test and heterogeneity was reasonable. Thirty-seven studies met the inclusion criteria and included a total of 5080 participants (range 50 to 1732). Enteric fever prevalence

Antiphospholipid Syndrome Laboratory Testing and Diagnostic Strategies

Science.gov (United States)

Ortel, Thomas L.

2016-01-01

The Antiphospholipid Syndrome (APS) is diagnosed in patients with recurrent thromboembolic events and/or pregnancy loss in the presence of persistent laboratory evidence for antiphospholipid antibodies. Diagnostic tests for the detection of antiphospholipid antibodies include laboratory assays that detect anticardiolipin antibodies, lupus anticoagulants, and anti-β2-glycoprotein I antibodies. These assays have their origins beginning more than sixty years ago, with the identification of the biologic false positive test for syphilis, the observation of ‘circulating anticoagulants’ in certain patients with systemic lupus erythematosus, the identification of cardiolipin as a key component in the serologic test for syphilis, and the recognition and characterization of a ‘cofactor’ for antibody binding to phospholipids. Although these assays have been used clinically for many years, there are still problems with the accurate diagnosis of patients with this syndrome. For example, lupus anticoagulant testing can be difficult to interpret in patients receiving anticoagulant therapy, but most patients with a thromboembolic event will already be anticoagulated before the decision to perform the tests has been made. In addition to understanding limitations of the assays, clinicians also need to be aware of which patients should be tested and not obtain testing on patients unlikely to have APS. New tests and diagnostic strategies are in various stages of development and should help improve our ability to accurately diagnose this important clinical disorder. PMID:22473619

The diagnostic value and accuracy of conjunctival impression cytology, dry eye symptomatology, and routine tear function tests in computer users.

Science.gov (United States)

Bhargava, Rahul; Kumar, Prachi; Kaur, Avinash; Kumar, Manjushri; Mishra, Anurag

2014-07-01

To compare the diagnostic value and accuracy of dry eye scoring system (DESS), conjunctival impression cytology (CIC), tear film breakup time (TBUT), and Schirmer's test in computer users. A case-control study was done at two referral eye centers. Eyes of 344 computer users were compared to 371 eyes of age and sex matched controls. Dry eye questionnaire (DESS) was administered to both groups and they further underwent measurement of TBUT, Schirmer's, and CIC. Correlation analysis was performed between DESS, CIC, TBUT, and Schirmer's test scores. A Pearson's coefficient of the linear expression (R (2)) of 0.5 or more was statistically significant. The mean age in cases (26.05 ± 4.06 years) was comparable to controls (25.67 ± 3.65 years) (P = 0.465). The mean symptom score in computer users was significantly higher as compared to controls (P computer users (P computer users respectively as compared to 8%, 6.7%, and 7.3% symptomatic controls respectively. On correlation analysis, there was a significant (inverse) association of dry eye symptoms (DESS) with TBUT and CIC scores (R (2) > 0.5), in contrast to Schirmer's scores (R(2) computer usage had a significant effect on dry eye symptoms severity, TBUT, and CIC scores as compared to Schirmer's test. DESS should be used in combination with TBUT and CIC for dry eye evaluation in computer users.

30 CFR 250.522 - When do I have to repeat casing diagnostic testing?

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false When do I have to repeat casing diagnostic... Operations Casing Pressure Management § 250.522 When do I have to repeat casing diagnostic testing? Casing diagnostic testing must be repeated according to the following table: When * * * you must repeat diagnostic...

A simple semipaced 3-minute chair rise test for routine exercise tolerance testing in COPD

Directory of Open Access Journals (Sweden)

Aguilaniu B

2014-09-01

Full Text Available Bernard Aguilaniu,1,2 Hubert Roth,3 Jesus Gonzalez-Bermejo,4 Marie Jondot,5 Jocelyne Maitre,5 François Denis,6 Thomas Similowski4,7 1Medicine Faculty, Université Joseph Fourier, Grenoble, France; 2McGill University, Montreal, Canada; 3Centre de Recherche en Nutrition Humaine Rhône-Alpes, CHU Grenoble, France; 4Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Respiratory and Intensive Care Medicine, Paris, France; 5Clinique Universitaire de Pneumologie, CHU Grenoble, France, Grenoble, France; 6Boehringer Ingelheim, 7Université Paris, Paris, France Abstract: The functional work capacity of chronic obstructive pulmonary disease (COPD patients is usually assessed with walk tests such as the 6-minute walk test (6MWT or the shuttle test. Because these exercise modalities require a controlled environment which limits their use by pulmonologists and severely restricts their use among general practitioners, different modalities of a short (1 minute or less sit-to-stand test were recently proposed. In this study, we evaluated a new modality of a semipaced 3-minute chair rise test (3CRT in 40 patients with COPD, and compared the reproducibility of physiological responses and symptoms during the 3CRT and their interchangeability with the 6MWT. The results demonstrate that physiological variables, heart rate, pulse oxygen saturation, work done, and symptoms (Borg dyspnea and fatigue scores, during the 3CRT were highly reproducible, and that the physiological responses and symptoms obtained during the 3CRT and the 6MWT were interchangeable for most patients. Moreover, these preliminary data suggest that patients able to perform more than 50 rises during 3 minutes had no significant disability. The simplicity and ease of execution of the 3CRT will facilitate the assessment of exercise symptoms and disability in COPD patients during routine consultations with pulmonologists and general practitioners, and will thus contribute

42 CFR 493.931 - Routine chemistry.

Science.gov (United States)

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Routine chemistry. 493.931 Section 493.931 Public... Proficiency Testing Programs by Specialty and Subspecialty § 493.931 Routine chemistry. (a) Program content and frequency of challenge. To be approved for proficiency testing for routine chemistry, a program...

More Than Just Accuracy: A Novel Method to Incorporate Multiple Test Attributes in Evaluating Diagnostic Tests Including Point of Care Tests.

Science.gov (United States)

Thompson, Matthew; Weigl, Bernhard; Fitzpatrick, Annette; Ide, Nicole

2016-01-01

Current frameworks for evaluating diagnostic tests are constrained by a focus on diagnostic accuracy, and assume that all aspects of the testing process and test attributes are discrete and equally important. Determining the balance between the benefits and harms associated with new or existing tests has been overlooked. Yet, this is critically important information for stakeholders involved in developing, testing, and implementing tests. This is particularly important for point of care tests (POCTs) where tradeoffs exist between numerous aspects of the testing process and test attributes. We developed a new model that multiple stakeholders (e.g., clinicians, patients, researchers, test developers, industry, regulators, and health care funders) can use to visualize the multiple attributes of tests, the interactions that occur between these attributes, and their impacts on health outcomes. We use multiple examples to illustrate interactions between test attributes (test availability, test experience, and test results) and outcomes, including several POCTs. The model could be used to prioritize research and development efforts, and inform regulatory submissions for new diagnostics. It could potentially provide a way to incorporate the relative weights that various subgroups or clinical settings might place on different test attributes. Our model provides a novel way that multiple stakeholders can use to visualize test attributes, their interactions, and impacts on individual and population outcomes. We anticipate that this will facilitate more informed decision making around diagnostic tests.

Molecular Diagnostic Tests for Microsporidia

Directory of Open Access Journals (Sweden)

Kaya Ghosh

2009-01-01

Full Text Available The Microsporidia are a ubiquitous group of eukaryotic obligate intracellular parasites which were recognized over 100 years ago with the description of Nosema bombycis, a parasite of silkworms. It is now appreciated that these organisms are related to the Fungi. Microsporidia infect all major animal groups most often as gastrointestinal pathogens; however they have been reported from every tissue and organ, and their spores are common in environmental sources such as ditch water. Several different genera of these organisms infect humans, but the majority of infections are due to either Enterocytozoon bieneusi or Encephalitozoon species. These pathogens can be difficult to diagnose, but significant progress has been made in the last decade in the development of molecular diagnostic reagents for these organisms. This report reviews the molecular diagnostic tests that have been described for the identification of the microsporidia that infect humans.

Use of proficiency samples to assess diagnostic laboratories in France performing a Trichinella digestion assay.

Science.gov (United States)

Vallée, Isabelle; Macé, Pauline; Forbes, Lorry; Scandrett, Brad; Durand, Benoit; Gajadhar, Alvin; Boireau, Pascal

2007-07-01

Routine diagnosis of animal trichinellosis for food safety and trade relies on a method of artificial digestion to free Trichinella muscle larvae from meat for subsequent identification by microscopy. As part of a quality control system, the French National Reference Laboratory (NRL) initiated ring trials to determine the sensitivity of the test performed in the 72 routine diagnostic laboratories in France. A method was devised to obtain calibrated meat samples containing known numbers of capsules with Trichinella spiralis muscle larvae. This method was based on an incomplete artificial digestion of Trichinella-infected mice carcasses to allow the collection of intact Trichinella capsules. Capsules were placed into a meatball of 100 +/- 2 g of pork and horsemeat to produce proficiency samples. Three categories of samples were prepared: small (3 to 5 capsules), medium (7 to 10), and large (12 to 15). The sensitivity was expressed as the percentage of muscle larvae recovered from each proficiency sample. Reproducibility was tested with ring trials organized between two NRLs (France and Canada), and a reference sensitivity of 84.9% was established. National ring trials were then organized in France, with the 72 routine diagnostic laboratories each receiving four proficiency samples per session. After five sessions, an improvement in the digest test sensitivity was observed. Results at the fifth session indicated sensitivities of 78.60% +/- 23.70%, 81.19% +/- 19.59%, and 80.52% +/- 14.71% muscle larvae for small, medium, and large samples, respectively. This study supports the use of proficiency samples to accurately evaluate the performance of routine diagnostic laboratories that conduct digestion tests for animal trichinellosis diagnosis.

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

Science.gov (United States)

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 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 decision making. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Difficult identification of Haemophilus influenzae, a typical cause of upper respiratory tract infections, in the microbiological diagnostic routine.

Science.gov (United States)

Hinz, Rebecca; Zautner, Andreas Erich; Hagen, Ralf Matthias; Frickmann, Hagen

2015-03-01

Haemophilus influenzae is a key pathogen of upper respiratory tract infections. Its reliable discrimination from nonpathogenic Haemophilus spp. is necessary because merely colonizing bacteria are frequent at primarily unsterile sites. Due to close phylogenetic relationship, it is not easy to discriminate H. influenzae from the colonizer Haemophilus haemolyticus. The frequency of H. haemolyticus isolations depends on factors like sampling site, patient condition, and geographic region. Biochemical discrimination has been shown to be nonreliable. Multiplex PCR including marker genes like sodC, fucK, and hpd or sequencing of the 16S rRNA gene, the P6 gene, or multilocus-sequence-typing is more promising. For the diagnostic routine, such techniques are too expensive and laborious. If available, matrix-assisted laser-desorption-ionization time-of-flight mass spectrometry is a routine-compatible option and should be used in the first line. However, the used database should contain well-defined reference spectra, and the spectral difference between H. influenzae and H. haemolyticus is small. Fluorescence in-situ hybridization is an option for less well-equipped laboratories, but the available protocol will not lead to conclusive results in all instances. It can be used as a second line approach. Occasional ambiguous results have to be resolved by alternative molecular methods like 16S rRNA gene sequencing.

Characterization of the Goubau line for testing beam diagnostic instruments

Science.gov (United States)

Kim, S. Y.; Stulle, F.; Sung, C. K.; Yoo, K. H.; Seok, J.; Moon, K. J.; Choi, C. U.; Chung, Y.; Kim, G.; Woo, H. J.; Kwon, J.; Lee, I. G.; Choi, E. M.; Chung, M.

2017-12-01

One of the main characteristics of the Goubau line is that it supports a low-loss, non-radiated surface wave guided by a dielectric-coated metal wire. The dominant mode of the surface wave along the Goubau line is a TM01 mode, which resembles the pattern of the electromagnetic fields induced in the metallic beam pipe when the charged particle beam passes through it. Therefore, the Goubau line can be used for the preliminary bench test and performance optimization of the beam diagnostic instruments without requiring charged particle beams from the accelerators. In this paper, we discuss the basic properties of the Goubau line for testing beam diagnostic instruments and present the initial test results for button-type beam position monitors (BPMs). The experimental results are consistent with the theoretical estimations, which indicates that Goubau line allows effective testing of beam diagnostic equipment.

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

Science.gov (United States)

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

2015-08-01

taking were significant predictors of MRI diagnosis. No physical tests were significant predictors of MRI diagnosis in our multivariate models. The specificity of MRI diagnosis was tested in subgroup of patients who went on to have a knee arthroscopy and was found to be low [0.53 (95% confidence interval 0.28 to 0.77)], although the sensitivity was 1.0. The Thessaly test was no better at diagnosing meniscal tears than other established physical tests. The sensitivity, specificity and diagnostic accuracy of all physical tests was too low to be of routine clinical value as an alternative to MRI. Caution needs to be exercised in the indiscriminate use of MRI scanning in the identification of meniscal tears in the diagnosis of the painful knee, due to the low specificity seen in the presence of concomitant knee pathology. Further research is required to determine the true diagnostic accuracy and cost-effectiveness of MRI for the detection of meniscal tears. Current Controlled Trial ISRCTN43527822. The National Institute for Health Research Health Technology Assessment programme.

Better Tests, Better Care: Improved Diagnostics for Infectious Diseases

Science.gov (United States)

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

Is routine karyotyping required in prenatal samples with a molecular or metabolic referral?

Directory of Open Access Journals (Sweden)

Kooper Angelique JA

2012-01-01

Full Text Available Abstract As a routine, karyotyping of invasive prenatal samples is performed as an adjunct to referrals for DNA mutation detection and metabolic testing. We performed a retrospective study on 500 samples to assess the diagnostic value of this procedure. These samples included 454 (90.8% chorionic villus (CV and 46 (9.2% amniocenteses specimens. For CV samples karyotyping was based on analyses of both short-term culture (STC and long-term culture (LTC cells. Overall, 19 (3.8% abnormal karyotypes were denoted: four with a common aneuploidy (trisomy 21, 18 and 13, two with a sex chromosomal aneuploidy (Klinefelter syndrome, one with a sex chromosome mosaicism and twelve with various autosome mosaicisms. In four cases a second invasive test was performed because of an abnormal finding in the STC. Taken together, we conclude that STC and LTC karyotyping has resulted in a diagnostic yield of 19 (3.8% abnormal cases, including 12 cases (2.4% with an uncertain significance. From a diagnostic point of view, it is desirable to limit uncertain test results as secondary test findings. Therefore, we recommend a more targeted assay, such as e.g. QF-PCR, as a replacement of the STC and to provide parents the autonomy to choose between karyotyping and QF-PCR.

Mixed Portmanteau Test for Diagnostic Checking of Time Series Models

Directory of Open Access Journals (Sweden)

Sohail Chand

2014-01-01

Full Text Available Model criticism is an important stage of model building and thus goodness of fit tests provides a set of tools for diagnostic checking of the fitted model. Several tests are suggested in literature for diagnostic checking. These tests use autocorrelation or partial autocorrelation in the residuals to criticize the adequacy of fitted model. The main idea underlying these portmanteau tests is to identify if there is any dependence structure which is yet unexplained by the fitted model. In this paper, we suggest mixed portmanteau tests based on autocorrelation and partial autocorrelation functions of the residuals. We derived the asymptotic distribution of the mixture test and studied its size and power using Monte Carlo simulations.

HIV testing experience in New York City: offer of and willingness to test in the context of new legal support of routine testing.

Science.gov (United States)

Edelstein, Zoe R; Myers, Julie E; Cutler, Blayne H; Blum, Micheline; Muzzio, Douglas; Tsoi, Benjamin W

2015-01-01

In the United States, routine HIV testing is recommended for persons aged 13-64 years. In 2010, New York State passed a law mandating offer of testing in most health-care settings. We report on the consumer perspective in New York City (NYC) shortly after the law's enactment. We analyzed data from a 2011 telephone survey representative of NYC adults aged 18-64 years (n = 1,846). This analysis focused on respondents' report of HIV test offer at last clinical visit and of willingness to test if recommended by their doctor. Offer and willingness were estimated by age, gender, race/ethnicity, education, income, marital status, sexual identity, partner number, and HIV testing history; associations were examined using multivariable regression. Among NYC adults, 35.7% reported an HIV test in the past year and 31.8% had never tested. Among 86.7% with a clinical visit in the past year, 31.4% reported being offered a test at last visit. Offer was associated with younger age, race/ethnicity other than white, non-Hispanic, lower income, and previous testing. Only 6.7% of never-testers were offered a test at last clinical visit. Willingness to test if recommended was high overall (90.2%) and across factors examined. After a new law was enacted in support of routine HIV testing, approximately 1 in 3 New Yorkers aged 18-64 years were offered a test at last clinical visit; 9 in 10 were willing to test if recommended by their doctor. This suggests that patient attitudes will not be a barrier to complete implementation of the law.

Diagnostic accuracy of a two-item Drug Abuse Screening Test (DAST-2).

Science.gov (United States)

Tiet, Quyen Q; Leyva, Yani E; Moos, Rudolf H; Smith, Brandy

2017-11-01

Drug use is prevalent and costly to society, but individuals with drug use disorders (DUDs) are under-diagnosed and under-treated, particularly in primary care (PC) settings. Drug screening instruments have been developed to identify patients with DUDs and facilitate treatment. The Drug Abuse Screening Test (DAST) is one of the most well-known drug screening instruments. However, similar to many such instruments, it is too long for routine use in busy PC settings. This study developed and validated a briefer and more practical DAST for busy PC settings. We recruited 1300 PC patients in two Department of Veterans Affairs (VA) clinics. Participants responded to a structured diagnostic interview. We randomly selected half of the sample to develop and the other half to validate the new instrument. We employed signal detection techniques to select the best DAST items to identify DUDs (based on the MINI) and negative consequences of drug use (measured by the Inventory of Drug Use Consequences). Performance indicators were calculated. The two-item DAST (DAST-2) was 97% sensitive and 91% specific for DUDs in the development sample and 95% sensitive and 89% specific in the validation sample. It was highly sensitive and specific for DUD and negative consequences of drug use in subgroups of patients, including gender, age, race/ethnicity, marital status, educational level, and posttraumatic stress disorder status. The DAST-2 is an appropriate drug screening instrument for routine use in PC settings in the VA and may be applicable in broader range of PC clinics. Published by Elsevier Ltd.

Development of diagnostic test instruments to reveal level student conception in kinematic and dynamics

Science.gov (United States)

Handhika, J.; Cari, C.; Suparmi, A.; Sunarno, W.; Purwandari, P.

2018-03-01

The purpose of this research was to develop a diagnostic test instrument to reveal students' conceptions in kinematics and dynamics. The diagnostic test was developed based on the content indicator the concept of (1) displacement and distance, (2) instantaneous and average velocity, (3) zero and constant acceleration, (4) gravitational acceleration (5) Newton's first Law, (6) and Newton's third Law. The diagnostic test development model includes: Diagnostic test requirement analysis, formulating test-making objectives, developing tests, checking the validity of the content and the performance of reliability, and application of tests. The Content Validation Index (CVI) results in the category are highly relevant, with a value of 0.85. Three questions get negative Content Validation Ratio CVR) (-0.6), after revised distractors and clarify visual presentation; the CVR become 1 (highly relevant). This test was applied, obtained 16 valid test items, with Cronbach Alpha value of 0.80. It can conclude that diagnostic test can be used to reveal the level of students conception in kinematics and dynamics.

Rapid diagnostic tests for typhoid and paratyphoid (enteric) fever

Science.gov (United States)

Wijedoru, Lalith; Mallett, Sue; Parry, Christopher M

2017-01-01

Background Differentiating both typhoid (Salmonella Typhi) and paratyphoid (Salmonella Paratyphi A) infection from other causes of fever in endemic areas is a diagnostic challenge. Although commercial point-of-care rapid diagnostic tests (RDTs) for enteric fever are available as alternatives to the current reference standard test of blood or bone marrow culture, or to the widely used Widal Test, their diagnostic accuracy is unclear. If accurate, they could potentially replace blood culture as the World Health Organization (WHO)-recommended main diagnostic test for enteric fever. Objectives To assess the diagnostic accuracy of commercially available rapid diagnostic tests (RDTs) and prototypes for detecting Salmonella Typhi or Paratyphi A infection in symptomatic persons living in endemic areas. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, IndMED, African Index Medicus, LILACS, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) up to 4 March 2016. We manually searched WHO reports, and papers from international conferences on Salmonella infections. We also contacted test manufacturers to identify studies. Selection criteria We included diagnostic accuracy studies of enteric fever RDTs in patients with fever or with symptoms suggestive of enteric fever living in endemic areas. We classified the reference standard used as either Grade 1 (result from a blood culture and a bone marrow culture) or Grade 2 (result from blood culture and blood polymerase chain reaction, or from blood culture alone). Data collection and analysis Two review authors independently extracted the test result data. We used a modified QUADAS-2 extraction form to assess methodological quality. We performed a meta-analysis when there were sufficient studies for the test and heterogeneity was reasonable. Main results Thirty-seven studies met the inclusion

Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study

Science.gov (United States)

Birnie, Kate; Hay, Alastair D.; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O’Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C.; Sterne, Jonathan A. C.

2017-01-01

Objectives To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. Population and methods We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the “index test”), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. Results 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. Conclusions The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service

Diagnostic value of serologic tests in celiac screening

Directory of Open Access Journals (Sweden)

Hosein Saneian

2012-01-01

Conclusions: According to our study results, there is no correlation between gastrointestinal symptoms such as vomiting diarrhea, anorexia, bulimia, and failure to thrive (FFT with celiac. TTG was the best screening test method to diagnose celiac disease and other tests such as AGA and EMA do not have high diagnostic value.

Bedside Ultrasonography as an Adjunct to Routine Evaluation of Acute Appendicitis in the Emergency Department

OpenAIRE

Lam, Samuel H.F.; Grippo, Anthony; Kerwin, Chistopher; Konicki, P. John; Goodwine, Diana; Lambert, Michael J.

2014-01-01

Introduction: Appendicitis is a common condition presenting to the emergency department (ED). Increasingly emergency physicians (EP) are using bedside ultrasound (BUS) as an adjunct diagnostic tool. Our objective is to investigate the test characteristics of BUS for the diagnosis of appendicitis and identify components of routine ED workup and BUS associated with the presence of appendicitis. Methods: Patients four years of age and older presenting to the ED with suspect...

Comparison of different references for brain perfusion SPECT quantification in clinical routine

International Nuclear Information System (INIS)

Olivera J, P.; Acton, P.; Costa, D.

1997-01-01

Full text: We used 40 brain perfusion SPECT studies from the INM, UCL database to investigate the performance of several references (denominators) in the calculation of perfusion ratios with single photon emission tomography (S PET) within a routine clinical service. According to clinical diagnosis and previous SPECT findings 4 groups were identified composed of: 10 controls (C, 23 to 84 y old); 10 myalgic-encephalomyelitis / chronic fatigue syndrome (ME/CFS, 22 to 61 y old); 10 major depression (MD, 24 to 68 y old); and 10 temporal lobe epilepsy (TLE, 19 to 39 y old). Routine protocols for processing were used and the analysis was blind to group classification. Brain perfusion ratios were calculated using 7 different references: hemi cerebellum with higher counts (Cer), total counts in a 4 pixel slice through the basal ganglia slice (BG), average counts per pixel in the visual cortex (VC), average counts per pixel in the white matter (WM), total acquired counts (TAC), total reconstructed counts (TRC) and maximum counts per pixel in the entire study (MAXX). Unpaired test to compare different diagnostic groups, coefficient of variation (CV) to assess the reliability to each references followed by ANOVA were the statistical test used. The lowest mean CV's were found with VC (4.8%) and TRC (5.1%), with all the others significantly higher (p<0.0001). The range of CV's for Cer was the lowest (3.7% to 5.9%). Consistent differentiation between diagnostic groups and controls was only obtained with Cer. In conclusion, it appears that for clinical routine services Cer is the most reliable reference, exception made for all diseases affecting the cerebellum. In these cases TRC or VC should be preferred. (authors)

Compare diagnostic tests using transformation-invariant smoothed ROC curves⋆

Science.gov (United States)

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

The diagnostic odds ratio: a single indicator of test performance

NARCIS (Netherlands)

Glas, Afina S.; Lijmer, Jeroen G.; Prins, Martin H.; Bonsel, Gouke J.; Bossuyt, Patrick M. M.

2003-01-01

Diagnostic testing can be used to discriminate subjects with a target disorder from subjects without it. Several indicators of diagnostic performance have been proposed, such as sensitivity and specificity. Using paired indicators can be a disadvantage in comparing the performance of competing

Diagnostic accuracy of temporomandibular disorder pain tests: a multicenter study

NARCIS (Netherlands)

Visscher, C.M.; Naeije, M.; de Laat, A.; Michelotti, A.; Nilner, M.; Craane, B.; Ekberg, E.; Farella, M.; Lobbezoo, F.

2009-01-01

AIMS: To estimate the diagnostic accuracy of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) clinical examination and of the dynamic/static tests for the recognition of TMD pain. Since the diagnosis of TMD pain is especially complicated in persistent orofacial pain

Optimal Sequential Diagnostic Strategy Generation Considering Test Placement Cost for Multimode Systems

Directory of Open Access Journals (Sweden)

Shigang Zhang

2015-10-01

Full Text Available Sequential fault diagnosis is an approach that realizes fault isolation by executing the optimal test step by step. The strategy used, i.e., the sequential diagnostic strategy, has great influence on diagnostic accuracy and cost. Optimal sequential diagnostic strategy generation is an important step in the process of diagnosis system construction, which has been studied extensively in the literature. However, previous algorithms either are designed for single mode systems or do not consider test placement cost. They are not suitable to solve the sequential diagnostic strategy generation problem considering test placement cost for multimode systems. Therefore, this problem is studied in this paper. A formulation is presented. Two algorithms are proposed, one of which is realized by system transformation and the other is newly designed. Extensive simulations are carried out to test the effectiveness of the algorithms. A real-world system is also presented. All the results show that both of them have the ability to solve the diagnostic strategy generation problem, and they have different characteristics.

Optimal Sequential Diagnostic Strategy Generation Considering Test Placement Cost for Multimode Systems

Science.gov (United States)

Zhang, Shigang; Song, Lijun; Zhang, Wei; Hu, Zheng; Yang, Yongmin

2015-01-01

Sequential fault diagnosis is an approach that realizes fault isolation by executing the optimal test step by step. The strategy used, i.e., the sequential diagnostic strategy, has great influence on diagnostic accuracy and cost. Optimal sequential diagnostic strategy generation is an important step in the process of diagnosis system construction, which has been studied extensively in the literature. However, previous algorithms either are designed for single mode systems or do not consider test placement cost. They are not suitable to solve the sequential diagnostic strategy generation problem considering test placement cost for multimode systems. Therefore, this problem is studied in this paper. A formulation is presented. Two algorithms are proposed, one of which is realized by system transformation and the other is newly designed. Extensive simulations are carried out to test the effectiveness of the algorithms. A real-world system is also presented. All the results show that both of them have the ability to solve the diagnostic strategy generation problem, and they have different characteristics. PMID:26457709

Real-Time Remote Diagnostic Monitoring Test-bed in JET

Energy Technology Data Exchange (ETDEWEB)

Castro, R. [Asociation Euratom/CIEMAT para Fusion, Madrid (Spain); Kneupner, K.; Purahoo, K. [EURATOM/UKAEA Fusion Association, Abingdon (United Kingdom); Vega, J.; Pereira, A.; Portas, A. [Association EuratomCIEMAT para Fusion, Madrid (Spain); De Arcas, G.; Lopez, J.M. [Universidad Politecnica de Madrid (Spain); Murari, A. [Consorzio RFX, Padova (Italy); Fonseca, A. [Associacao URATOM/IST, Lisboa (Portugal); Contributors, J.E. [JET-EFDA, Abingdon (United Kingdom)

2009-07-01

Based on the remote experimentation concept oriented to long pulse shots, a test-bed system has been implemented in JET. It integrates 2 functionalities. The first one is the real-time monitoring, on remote, of a reflectometer diagnostic, to visualize different data outputs and status information. The second one is the integration of dotJET (Diagnostic Overview Tool for JET), which internally provides at JET an overview about the current diagnostic systems state, in order to monitor, on remote, JET diagnostics status. The architecture of the system is formed by: the data generator components, the data distribution system, an access control service, and the client applications. In the test-bed there are two data generators: the acquisition equipment associated with the reflectometer diagnostic that generates data and status information, and dotJET server that centralize the access to the status information of JET diagnostics. The data distribution system has been implemented using a publishing-subscribing technology that receives data from data generators and redistributes them to client applications. And finally, for monitoring, a client application based on Java Web Start technology, and a dotJET client application have been used. There are 3 interesting results from this project. The first one is the analysis of different aspects (data formats, data frame rate, data resolution, etc) related with remote real-time diagnostic monitoring oriented to long pulse experiments. The second one is the definition and implementation of a flexible enough architecture, to be applied to different types of data generated from other diagnostics, and that fits with remote access requirements; and the third one is to have achieved a secure system, taking into account internal networks and firewalls aspects in JET, and securing the access from remote users. For this last issue, PAPI technology has been used, enabling access control based on user attributes, enabling mobile users to

The diagnostic path, a useful visualisation tool in virtual microscopy

Directory of Open Access Journals (Sweden)

Hufnagl Peter

2006-11-01

Full Text Available Abstract Background The Virtual Microscopy based on completely digitalised histological slide. Concerning this digitalisation many new features in mircoscopy can be processed by the computer. New applications are possible or old, well known techniques of image analyses can be adapted for routine use. Aims A so called diagnostic path observes in the way of a professional sees through a histological virtual slide combined with the text information of the dictation process. This feature can be used for image retrieval, quality assurance or for educational purpose. Materials and methods The diagnostic path implements a metadata structure of image information. It stores and processes the different images seen by a pathologist during his "slide viewing" and the obtained image sequence ("observation path". Contemporary, the structural details of the pathology reports were analysed. The results were transferred into an XML structure. Based on this structure, a report editor and a search function were implemented. The report editor compiles the "diagnostic path", which is the connection from the image viewing sequence ("observation path" and the oral report sequence of the findings ("dictation path". The time set ups of speech and image viewing serve for the link between the two sequences. The search tool uses the obtained diagnostic path. It allows the user to search for particular histological hallmarks in pathology reports and in the corresponding images. Results The new algorithm was tested on 50 pathology reports and 74 attached histological images. The creation of a new individual diagnostic path is automatically performed during the routine diagnostic process. The test prototype experienced an insignificant prolongation of the diagnosis procedure (oral case description and stated diagnosis by the pathologist and a fast and reliable retrieval, especially useful for continuous education and quality control of case description and diagnostic work

Background review for diagnostic test development for Zika virus infection.

Science.gov (United States)

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.

Can Emergency Medicine Residents Predict Cost of Diagnostic Testing?

Directory of Open Access Journals (Sweden)

Tainter, Christopher R

2017-01-01

Full Text Available Diagnostic testing represents a significant portion of healthcare spending, and cost should be considered when ordering such tests. Needless and excessive spending may occur without an appreciation of the impact on the larger healthcare system. Knowledge regarding the cost of diagnostic testing among emergency medicine (EM residents has not previously been studied. A survey was administered to 20 EM residents from a single ACGME-accredited three-year EM residency program, asking for an estimation of patient charges for 20 commonly ordered laboratory tests and seven radiological exams. We compared responses between residency classes to evaluate whether there was a difference based on level of training. The survey completion rate was 100% (20/20 residents. We noted significant discrepancies between the median resident estimates and actual charge to patient for both laboratory and radiological exams. Nearly all responses were an underestimate of the actual cost. The group median underestimation for laboratory testing was $114, for radiographs $57, and for computed tomography exams was $1,058. There was improvement in accuracy with increasing level of training. This pilot study demonstrates that EM residents have a poor understanding of the charges burdening patients and health insurance providers. In order to make balanced decisions with regard to diagnostic testing, providers must appreciate these factors. Education regarding the cost of providing emergency care is a potential area for improvement of EM residency curricula, and warrants further attention and investigation.

The Diagnostic Value of Routine Contrast Esophagram in Anastomotic Leaks After Esophagectomy.

Science.gov (United States)

Hu, Zhongwu; Wang, Xiaowe; An, Xush; Li, Wenjin; Feng, Yun; You, Zhenbing

2017-08-01

Routine contrast esophagram has been shown to be increasingly limited in diagnosing anastomotic leaks after esophagectomy. Patients undergoing esophagectomy from 2013 to 2014 at Huai'an First Peoples' Hospital were identified. We retrospectively analyzed patients who underwent routine contrast esophagram on postoperative day 7 (range 6-10) to preclude anastomotic leaks after esophagectomy. In 846 patients who underwent esophagectomy, a cervical anastomosis was performed in 286 patients and an intrathoracic anastomosis in 560 patients. There were 57 (6.73%) cases with anastomotic leaks, including cervical leaks in 36 and intrathoracic leaks in 21 patients. In the cervical anastomotic leak patients, 13 were diagnosed by early local clinical symptoms and 23 underwent routine contrast esophagram. There were 7 (30.4%) true-positive, 11 (47.8%) false-negative, and five (21.8%) equivocal cases. In the intrathoracic anastomotic leak patients, four (19%) were diagnosed by clinical symptoms, 16 (76.2%) were true positives, and one (4.8%) was a false negative. Aspiration occurred in five patients with cervical anastomoses and in eight patients with intrathoracic anastomoses; aspiration pneumonitis did not occur in these cases. Gastrografin and barium are safe contrast agents to use in post-esophagectomy contrast esophagram. Because of the low sensitivity in detecting cervical anastomotic leaks, routine contrast esophagram is not advised. For patients with intrathoracic anastomoses, it is still an effective method for detecting anastomotic leaks.

Routine perinatal and paediatric post-mortem radiography: detection rates and implications for practice

Energy Technology Data Exchange (ETDEWEB)

Arthurs, Owen J. [NHS Foundation Trust, Department of Radiology Great Ormond Street Hospital for Children, London (United Kingdom); University College London, Institute of Child Health, London (United Kingdom); Calder, Alistair D. [NHS Foundation Trust, Department of Radiology Great Ormond Street Hospital for Children, London (United Kingdom); Kiho, Liina [Camelia Botnar Laboratories Great Ormond Street Hospital for Children, Department of Paediatric Pathology, London (United Kingdom); Taylor, Andrew M. [Great Ormond Street Hospital for Children, Cardiorespiratory Unit, London (United Kingdom); UCL Institute of Cardiovascular Science, London (United Kingdom); University College London, Institute of Child Health, London (United Kingdom); Sebire, Neil J. [Camelia Botnar Laboratories Great Ormond Street Hospital for Children, Department of Paediatric Pathology, London (United Kingdom); University College London, Institute of Child Health, London (United Kingdom)

2014-03-15

Routine perinatal and paediatric post-mortem plain radiography allows for the diagnosis and assessment of skeletal dysplasias, fractures and other bony abnormalities. The aim of this study was to review the diagnostic yield of this practice. We identified 1,027 cases performed in a single institution over a 21/2-year period, including babygrams (whole-body examinations) and full skeletal surveys. Images were reported prior to autopsy in all cases. Radiology findings were cross-referenced with the autopsy findings using an autopsy database. We scored each case from 0 to 4 according to the level of diagnostic usefulness. The overall abnormality rate was 126/1,027 (12.3%). There was a significantly higher rate of abnormality when a skeletal survey was performed (18%) rather than a babygram (10%; P < 0.01); 90% (665/739) of babygrams were normal. Of the 74 abnormal babygrams, we found 33 incidental non-contributory cases, 19 contributory, 20 diagnostic, and 2 false-positive cases. There were only 2 cases out of 739 (0.27%) in whom routine post-mortem imaging identified potentially significant abnormalities that would not have been detected if only selected imaging had been performed. A policy of performing selected, rather than routine, foetal post-mortem radiography could result in a significant cost saving. Routine post-mortem paediatric radiography in foetuses and neonates is neither diagnostically useful nor cost-effective. A more evidence-based, selective protocol should yield significant cost savings. (orig.)

Routine perinatal and paediatric post-mortem radiography: detection rates and implications for practice

International Nuclear Information System (INIS)

Arthurs, Owen J.; Calder, Alistair D.; Kiho, Liina; Taylor, Andrew M.; Sebire, Neil J.

2014-01-01

Routine perinatal and paediatric post-mortem plain radiography allows for the diagnosis and assessment of skeletal dysplasias, fractures and other bony abnormalities. The aim of this study was to review the diagnostic yield of this practice. We identified 1,027 cases performed in a single institution over a 21/2-year period, including babygrams (whole-body examinations) and full skeletal surveys. Images were reported prior to autopsy in all cases. Radiology findings were cross-referenced with the autopsy findings using an autopsy database. We scored each case from 0 to 4 according to the level of diagnostic usefulness. The overall abnormality rate was 126/1,027 (12.3%). There was a significantly higher rate of abnormality when a skeletal survey was performed (18%) rather than a babygram (10%; P < 0.01); 90% (665/739) of babygrams were normal. Of the 74 abnormal babygrams, we found 33 incidental non-contributory cases, 19 contributory, 20 diagnostic, and 2 false-positive cases. There were only 2 cases out of 739 (0.27%) in whom routine post-mortem imaging identified potentially significant abnormalities that would not have been detected if only selected imaging had been performed. A policy of performing selected, rather than routine, foetal post-mortem radiography could result in a significant cost saving. Routine post-mortem paediatric radiography in foetuses and neonates is neither diagnostically useful nor cost-effective. A more evidence-based, selective protocol should yield significant cost savings. (orig.)

Routine blood tests are associated with short term mortality and can improve emergency department triage

DEFF Research Database (Denmark)

Kristensen, Michael; Iversen, Anne Kristine Servais; Gerds, Thomas Alexander

2017-01-01

BACKGROUND: Prioritization of acutely ill patients in the Emergency Department remains a challenge. We aimed to evaluate whether routine blood tests can predict mortality in unselected patients in an emergency department and to compare risk prediction with a formalized triage algorithm. METHODS...... registration. Multiple logistic regressions were used to predict 30-day mortality. Validation was performed by applying the regression models on the 2013 validation cohort. RESULTS: Thirty-day mortality was 5.3%. The routine blood tests had a significantly stronger discriminative value on 30-day mortality...... compared to the formalized triage (AUC 88.1 [85.7;90.5] vs. 63.4 [59.1;67.5], p blood tests was able to identify a larger number of low risk patients (n = 2100, 30-day mortality 0.1% [95% CI 0.0;0.3%]) compared to formalized triage (n = 1591, 2.8% [95% CI 2...

Laboratory development and testing of spacecraft diagnostics

Science.gov (United States)

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.

30 CFR 250.523 - How long do I keep records of casing pressure and diagnostic tests?

Science.gov (United States)

2010-07-01

... and diagnostic tests? 250.523 Section 250.523 Mineral Resources MINERALS MANAGEMENT SERVICE... casing pressure and diagnostic tests? Records of casing pressure and diagnostic tests must be kept at the field office nearest the well for a minimum of 2 years. The last casing diagnostic test for each casing...

Microfluidic Sample Preparation for Diagnostic Cytopathology

Science.gov (United States)

Mach, Albert J.; Adeyiga, Oladunni B.; Di Carlo, Dino

2014-01-01

The cellular components of body fluids are routinely analyzed to identify disease and treatment approaches. While significant focus has been placed on developing cell analysis technologies, tools to automate the preparation of cellular specimens have been more limited, especially for body fluids beyond blood. Preparation steps include separating, concentrating, and exposing cells to reagents. Sample preparation continues to be routinely performed off-chip by technicians, preventing cell-based point-of-care diagnostics, increasing the cost of tests, and reducing the consistency of the final analysis following multiple manually-performed steps. Here, we review the assortment of biofluids for which suspended cells are analyzed, along with their characteristics and diagnostic value. We present an overview of the conventional sample preparation processes for cytological diagnosis. We finally discuss the challenges and opportunities in developing microfluidic devices for the purpose of automating or miniaturizing these processes, with particular emphases on preparing large or small volume samples, working with samples of high cellularity, automating multi-step processes, and obtaining high purity subpopulations of cells. We hope to convey the importance of and help identify new research directions addressing the vast biological and clinical applications in preparing and analyzing the array of available biological fluids. Successfully addressing the challenges described in this review can lead to inexpensive systems to improve diagnostic accuracy while simultaneously reducing overall systemic healthcare costs. PMID:23380972

Aquifer test interpretation using derivative analysis and diagnostic plots

Science.gov (United States)

Hernández-Espriú, Antonio; Real-Rangel, Roberto; Cortés-Salazar, Iván; Castro-Herrera, Israel; Luna-Izazaga, Gabriela; Sánchez-León, Emilio

2017-04-01

Pumping tests remain a method of choice to deduce fundamental aquifer properties and to assess well condition. In the oil and gas (O&G) industry, well testing has been the core technique in examining reservoir behavior over the last 50 years. The pressure derivative by Bourdet, it is perhaps, the most significant single development in the history of well test analysis. Recently, the so-called diagnostics plots (e.g. drawdown and drawdown derivative in a log-log plot) have been successfully tested in aquifers. However, this procedure is still underutilized by groundwater professionals. This research illustrates the applicability range, advantages and drawbacks (e.g. smoothing procedures) of diagnostic plots using field examples from a wide spectrum of tests (short/long tests, constant/variable flow rates, drawdown/buildup stages, pumping well/observation well) in dissimilar geological conditions. We analyze new and pre-existent aquifer tests in Mexico, USA, Canada, Germany, France and Saudi Arabia. In constant flow rate tests, our results show that derivative analysis is an easy, robust and powerful tool to assess near-borehole damage effects, formation heterogeneity, boundaries, flow regimes, infinite-acting radial stages, i.e., valid Theisian framework, and fracture-driven flow. In step tests, the effectiveness relies on high-frequency drawdown measurements. Moreover, we adapt O&G analytical solutions to cater for the conditions in groundwater systems. In this context, further parameters can be computed analytically from the plots, such as skin factor, head losses, wellbore storage, distance to the boundary, channel-aquifer and/or fracture zone width, among others. Therefore, diagnostic plots should be considered a mandatory tool for pumping tests analysis among hydrogeologists. This project has been supported by DGAPA (UNAM) under the research project PAPIIT IN-112815.

Routine HIV Testing of Family Members of Hospitalized Patients in Nigeria

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Olusegun Busari

2012-04-01

Full Text Available Background: HIV testing for family members of HIV-positive patients may enhance disclosure of status of spouses, encourage family social support and improve access to HIV services. Objective was to employ the approach of routine HIV testing to determine the prevalence of HIV among family members of both HIV positive and negative patients on admission in a federal HIV treatment designated hospital in Western Nigeria Methodology: This prospective study was conducted between January 2006 and June 2009. Ethical clearance was obtained from the Research and Ethics committee of the hospital prior to the study. Informed consent was obtained from each participant. HIV testing was offered to consenting family members of HIV positive and negative patients on admission. The family members included spouses, children of patients, parents of paediatric patients and other family members. Analysis was done in frequencies and percentages Results: 162 family members of 184 patients were tested. Spouses were, 81 (50.0%; fathers, 14 (8.6%; mothers, 20 (12.3%; children, 19 (11.7% and others family members, 28 (17.3%. 151 (93.2% of testers were first timers. Majority of those tested (82.1% had post-test counseling. The overall HIV prevalence was 12.3% (20/162. HIV prevalence within different family members was 14.8% (12/81, 20% (4/20, 7.1% (1/14, 10.5% (2/19 and 3.6% (1/28 for spouses, mothers, fathers, children and others respectively.In addition, the prevalence of HIV among family members of HIV positive and negative patients was 15.6% (14/90 and 8.3% (6/72 respectively. Of 12 spouses that were positive, 7 (13.5% were HIV-discordant; and in 71.4% (5/7 of discordant couples, the spouse was positive while the patient on admission was negative. Conclusion: The results indicate that routine HIV testing of family members of patients on admission is a strategy for identification of vast number of HIV infected persons. This method is not only innovative, but also a novel

Viral hepatitis and rapid diagnostic test based screening for HBsAg in HIV-infected patients in rural Tanzania.

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Fabian C Franzeck

Full Text Available BACKGROUND: Co-infection with hepatitis B virus (HBV is highly prevalent in people living with HIV in Sub-Saharan Africa. Screening for HBV surface antigen (HBsAg before initiation of combination antiretroviral therapy (cART is recommended. However, it is not part of diagnostic routines in HIV programs in many resource-limited countries although patients could benefit from optimized antiretroviral therapy covering both infections. Screening could be facilitated by rapid diagnostic tests for HBsAg. Operating experience with these point of care devices in HIV-positive patients in Sub-Saharan Africa is largely lacking. We determined the prevalence of HBV and Hepatitis C virus (HCV infection as well as the diagnostic accuracy of the rapid test device Determine HBsAg in an HIV cohort in rural Tanzania. METHODS: Prospectively collected blood samples from adult, HIV-1 positive and antiretroviral treatment-naïve patients in the Kilombero and Ulanga antiretroviral cohort (KIULARCO in rural Tanzania were analyzed at the point of care with Determine HBsAg, a reference HBsAg EIA and an anti-HCV EIA. RESULTS: Samples of 272 patients were included. Median age was 38 years (interquartile range [IQR] 32-47, 169/272 (63% subjects were females and median CD4+ count was 250 cells/µL (IQR 97-439. HBsAg was detected in 25/272 (9.2%, 95% confidence interval [CI] 6.2-13.0% subjects. Of these, 7/25 (28% were positive for HBeAg. Sensitivity of Determine HBsAg was rated at 96% (95% CI 82.8-99.6% and specificity at 100% (95% CI, 98.9-100%. Antibodies to HCV (anti-HCV were found in 10/272 (3.7%, 95% CI 2.0-6.4% of patients. CONCLUSION: This study reports a high prevalence of HBV in HIV-positive patients in a rural Tanzanian setting. The rapid diagnostic test Determine HBsAg is an accurate assay for screening for HBsAg in HIV-1 infected patients at the point of care and may further help to guide cART in Sub-Saharan Africa.

Assessing Old and New Diagnostic Tests for Gastroesophageal Reflux Disease.

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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.

Microbiopsy a first-level diagnostic test to rule out oral dysplasia or carcinoma in general dental practice.

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Pentenero, M; Val, M; Rosso, S; Gandolfo, S

2018-03-01

Diagnostic delay in oral oncology could be improved if general dentists had a reliable and easy-to-use first-level diagnostic test to rule out the presence of oral dysplasia or carcinoma. Microbiopsy has been proved to have high sensitivity and high negative predictive value in a clinical setting characterized by high prevalence of disease. Moreover, it has been proved to be easily performed by general dentists. This study aimed to determine the negative predictive value of microbiopsy in routine dental practice: a clinical setting characterized by low prevalence of disease. Within the frame of a previous study, general dentists from the Metropolitan Area of Turin performed microbiopsy for each oral mucosal lesion detected during their practice. The clinical outcome of 129 lesions negative at microbiopsy was checked by a query performed through the database of the Piedmont Cancer Registry, covering the population of the Metropolitan Area of Turin, with particular reference to cancer involving the mouth (ICD-10:C03-06). This allowed us to define "true negative" cases and to calculate the negative predictive value of microbiopsy. In a mean follow-up of 7.5 years (range 7-9 years), with a dropout rate of 7.7%, no case of tumour involving the mouth was observed, thus revealing a negative predictive value approaching 100%. Microbiopsy represents an easy-to-use and reliable first-level test able to aid general dentists to select patients requiring an oral medicine assessment in a short time and definitely to avoid diagnostic delay in oncologically relevant oral mucosal lesions. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. All rights reserved.

Dry Eye Disease: Concordance Between the Diagnostic Tests in African Eyes.

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Onwubiko, Stella N; Eze, Boniface I; Udeh, Nnenma N; Onwasigwe, Ernest N; Umeh, Rich E

2016-11-01

To assess the concordance between the diagnostic tests for dry eye disease (DED) in a Nigerian hospital population. The study was a hospital-based cross-sectional survey of adults (≥18 years) presenting at the eye clinic of the University of Nigeria Teaching Hospital (UNTH), Enugu; September-December, 2011. Participants' socio-demographic data were collected. Each subject was assessed for DED using the "Ocular Surface Disease Index" (OSDI) questionnaire, tear-film breakup time (TBUT), and Schirmer test. The intertest concordance was assessed using kappa statistic, correlation, and regression coefficients. The participants (n=402; men: 193) were aged 50.1±19.1 standard deviation years (range: 18-94 years). Dry eye disease was diagnosed in 203 by TBUT, 170 by Schirmer test, and 295 by OSDI; the concordance between the tests were OSDI versus TBUT (Kappa, κ=-0.194); OSDI versus Schirmer (κ=-0.276); and TBUT versus Schirmer (κ=0.082). Ocular Surface Disease Index was inversely correlated with Schirmer test (Spearman ρ=-0.231, P<0.001) and TBUT (ρ=-0.237, P<0.001). In the linear regression model, OSDI was poorly predicted by TBUT (β=-0.09; 95% confidence interval (CI): -0.26 to -0.03, P=0.14) and Schirmer test (β=-0.35, 95% CI: -0.53 to -0.18, P=0.18). At UNTH, there is poor agreement, and almost equal correlation, between the subjective and objective tests for DED. Therefore, the selection of diagnostic test for DED should be informed by cost-effectiveness and diagnostic resource availability, not diagnostic efficiency or utility.

Genetic test utilization and diagnostic yield in adult patients with neurological disorders.

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Bardakjian, Tanya M; Helbig, Ingo; Quinn, Colin; Elman, Lauren B; McCluskey, Leo F; Scherer, Steven S; Gonzalez-Alegre, Pedro

2018-03-28

To determine the diagnostic yield of different genetic test modalities in adult patients with neurological disorders, we evaluated all adult patients seen for genetic diagnostic evaluation in the outpatient neurology practice at the University of Pennsylvania between January 2016 and April 2017 as part of the newly created Penn Neurogenetics Program. Subjects were identified through our electronic medical system as those evaluated by the Program's single clinical genetic counselor in that period. A total of 377 patients were evaluated by the Penn Neurogenetics Program in different settings and genetic testing recommended. Of those, 182 (48%) were seen in subspecialty clinic setting and 195 (52%) in a General Neurogenetics Clinic. Genetic testing was completed in over 80% of patients in whom it was recommended. The diagnostic yield was 32% across disease groups. Stratified by testing modality, the yield was highest with directed testing (50%) and array comparative genomic hybridization (45%), followed by gene panels and exome testing (25% each). In conclusion, genetic testing can be successfully requested in clinic in a large majority of adult patients. Age is not a limiting factor for a genetic diagnostic evaluation and the yield of clinical testing across phenotypes (almost 30%) is consistent with previous phenotype-focused or research-based studies. These results should inform the development of specific guidelines for clinical testing and serve as evidence to improve reimbursement by insurance payers.

Efficient Noninferiority Testing Procedures for Simultaneously Assessing Sensitivity and Specificity of Two Diagnostic Tests

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Guogen Shan

2015-01-01

Full Text Available Sensitivity and specificity are often used to assess the performance of a diagnostic test with binary outcomes. Wald-type test statistics have been proposed for testing sensitivity and specificity individually. In the presence of a gold standard, simultaneous comparison between two diagnostic tests for noninferiority of sensitivity and specificity based on an asymptotic approach has been studied by Chen et al. (2003. However, the asymptotic approach may suffer from unsatisfactory type I error control as observed from many studies, especially in small to medium sample settings. In this paper, we compare three unconditional approaches for simultaneously testing sensitivity and specificity. They are approaches based on estimation, maximization, and a combination of estimation and maximization. Although the estimation approach does not guarantee type I error, it has satisfactory performance with regard to type I error control. The other two unconditional approaches are exact. The approach based on estimation and maximization is generally more powerful than the approach based on maximization.

An 8-year experience with routine SL mix patch testing supplemented with Compositae mix in Denmark

DEFF Research Database (Denmark)

Paulsen, E; Andersen, Klaus Ejner; Hausen, B M

2001-01-01

Routine patch testing with sesquiterpene lactone (SL) mix, supplemented with Compositae mix (CM) and other Compositae extracts and allergens where appropriate, was evaluated over an 8-year period. 190 of 4386 patients tested (4.3%) were Compositae-sensitive, 143 females (mean age 51.5 years) and ...

Soft x-ray virtual diagnostics for tokamak simulations

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Kim, J. S.; Zhao, L.; Bogatu, I. N.; In, Y.; Turnbull, A.; Osborne, T.; Maraschek, M.; Comer, K.

2009-11-01

The numerical toolset, FAR-TECH Virtual Diagnostic Utility, for generating virtual experimental data based on theoretical models and comparing it with experimental data, has been developed for soft x-ray diagnostics on DIII-D. The virtual (or synthetic) soft x-ray signals for a sample DIII-D discharge are compared with the experimental data. The plasma density and temperature radial profiles needed in the soft x-ray signal modeling are obtained from experimental data, i.e., from Thomson scattering and electron cyclotron emission. The virtual soft x-ray diagnostics for the equilibriums have a good agreement with the experimental data. The virtual diagnostics based on an ideal linear instability also agree reasonably well with the experimental data. The agreements are good enough to justify the methodology presented here for utilizing virtual diagnostics for routine comparison of experimental data. The agreements also motivate further detailed simulations with improved physical models such as the nonideal magnetohydrodynamics contributions (resistivity, viscosity, nonaxisymmetric error fields, etc.) and other nonlinear effects, which can be tested by virtual diagnostics with various stability modeling.

Soft x-ray virtual diagnostics for tokamak simulations

International Nuclear Information System (INIS)

Kim, J. S.; Zhao, L.; Bogatu, I. N.; In, Y.; Turnbull, A.; Osborne, T.; Maraschek, M.; Comer, K.

2009-01-01

The numerical toolset, FAR-TECH Virtual Diagnostic Utility, for generating virtual experimental data based on theoretical models and comparing it with experimental data, has been developed for soft x-ray diagnostics on DIII-D. The virtual (or synthetic) soft x-ray signals for a sample DIII-D discharge are compared with the experimental data. The plasma density and temperature radial profiles needed in the soft x-ray signal modeling are obtained from experimental data, i.e., from Thomson scattering and electron cyclotron emission. The virtual soft x-ray diagnostics for the equilibriums have a good agreement with the experimental data. The virtual diagnostics based on an ideal linear instability also agree reasonably well with the experimental data. The agreements are good enough to justify the methodology presented here for utilizing virtual diagnostics for routine comparison of experimental data. The agreements also motivate further detailed simulations with improved physical models such as the nonideal magnetohydrodynamics contributions (resistivity, viscosity, nonaxisymmetric error fields, etc.) and other nonlinear effects, which can be tested by virtual diagnostics with various stability modeling.

Compounding diagnostic delays: a qualitative study of point-of-care testing in South Africa.

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Engel, Nora; Davids, Malika; Blankvoort, Nadine; Pai, Nitika Pant; Dheda, Keertan; Pai, Madhukar

2015-04-01

Successful point-of-care (POC) testing (completion of test-and-treat cycle in one patient encounter) has immense potential to reduce diagnostic and treatment delays, and improve patient and public health outcomes. We explored what tests are done and how in public/private, rural/urban hospitals and clinics in South Africa and whether they can ensure successful POC testing. This qualitative research study examined POC testing across major diseases in Cape Town, Durban and Eastern Cape. We conducted 101 semi-structured interviews and seven focus group discussions with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers and diagnostic manufacturers. In South Africa, diagnostics are characterised by a centralised system. Most tests conducted on the spot can be made to work successfully as POC tests. The majority of public/private clinics and smaller hospitals send samples via couriers to centralised laboratories and retrieve results the same way, via internet, fax or phone. The main challenge to POC testing lies in transporting samples and results, while delays risk patient loss from diagnostic/treatment pathways. Strategies to deal with associated delays create new problems, such as artificially prolonged turnaround times, strains on human resources and quality of testing, compounding additional diagnostic and treatment delays. For POC testing to succeed, particular characteristics of diagnostic ecosystems and adaptations of professional practices to overcome associated challenges must be taken into account. © 2014 John Wiley & Sons Ltd.

A comparison of rapid diagnostic testing (by plasmodium lactate ...

African Journals Online (AJOL)

Background: The World Health Organization (WHO) considers early and rapid diagnosis as one of the strategies to control malaria. This study compared the performance of Quantitative Buffy Coat (QBC) test and the Plasmodium lactate dehydrogenase (pLDH) rapid diagnostic test (RDT) with microscopy as the gold ...

Technology diffusion and diagnostic testing for prostate cancer

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Schroeck, Florian R.; Kaufman, Samuel R.; Jacobs, Bruce L.; Skolarus, Ted A.; Miller, David C.; Weizer, Alon Z.; Montgomery, Jeffrey S.; Wei, John T.; Shahinian, Vahakn B.; Hollenbeck, Brent K.

2013-01-01

Purpose While the dissemination of robotic prostatectomy and intensity-modulated radiotherapy (IMRT) may fuel increased use of prostatectomy and radiotherapy, these new technologies may also have spillover effects related to diagnostic testing for prostate cancer. Therefore, we examined the association of regional technology penetration with receipt of prostate specific antigen (PSA) testing and prostate biopsy. Methods In this retrospective cohort study, we included 117,857 men age 66 and older from the 5% sample of Medicare beneficiaries living in the Surveillance Epidemiology and End Results (SEER) areas from 2003 – 2007. Regional technology penetration was measured as the number of providers performing robotic prostatectomy or IMRT per population in a healthcare market (i.e., hospital referral region). We assessed the association of technology penetration with rates of PSA testing and prostate biopsy with generalized estimating equations. Results High technology penetration was associated with increased rates of PSA testing (442 versus 425 per 1,000 person-years, pimpact of technology penetration on PSA testing and prostate biopsy was much smaller than the effect of age, race, and comorbidity (e.g., PSA testing rate per 1,000 person-years: 485 versus 373 for men with only one versus 3+ co-morbid conditions, ppenetration was associated with slightly higher rates of PSA testing and no change in prostate biopsy rates. Collectively, our findings temper concerns that adoption of new technology accelerates diagnostic testing for prostate cancer. PMID:23669564

Efficacy of a chairside diagnostic test kit for estimation of C-reactive protein levels in periodontal disease.

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Nagarale, Girish; Ravindra, S; Thakur, Srinath; Setty, Swati

2010-10-01

C-reactive protein [CRP] levels increase to hundreds of mg/mL within hours following infection. Studies have shown that serum CRP levels were elevated in periodontal disease. However, in all the previous studies, CRP levels were measured by using high-sensitivity CRP assay kits with minimal detection limits of 0.1 to 3 mg/L, which was much below the normal value of 10 mg/L. These high-sensitivity CRP assays need a proper laboratory setup, and these methods cannot be used as a routine chair-side test in the dental office. The purpose of this study was to investigate the serum CRP levels in subjects with periodontal disease by using a rapid chair-side diagnostic test kit with a lower detection limit of 6 mg/L and to compare the CRP levels before and after periodontal therapy. A total of 45 systemically healthy subjects were selected for the study. Subjects were divided into three groups: group A: healthy controls, group B: gingivitis, group C: periodontitis. Serum levels of CRP were determined by using a latex slide agglutination method with commercially available kit with lower detection limit of 6 mg/L. CRP was negative in all the 15 subjects in groups A and B at baseline, 7th and 30th day. CRP was positive only in 2 subjects in Group C at baseline and 7th day. Estimation of serum CRP by using a rapid chair-side diagnostic test kit is not of any significance in subjects with periodontitis.

Evaluation of Diagnostic Tests Using Information Theory for Multi-Class Diagnostic Problems and its Application for the Detection of Occlusal Caries Lesions

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Umut Arslan

2014-09-01

Full Text Available Background: Several methods are available to evaluate the performance of the tests when the purpose of the diagnostic test is to discriminate between two possible disease states. However multi-class diagnostic problems frequently appear in many areas of medical science. Hence, there is a need for methods which will enable us to characterize the accuracy of diagnostic tests when there are more than two possible disease states. Aims: To show that two information theory measures, information content (IC and proportional reduction in diagnostic uncertainty (PRDU, can be used for the evaluation of the performance of diagnostic tests for multi-class diagnostic problems that may appear in different areas of medical science. Study Design: Diagnostic accuracy study. Methods: Sixty freshly extracted permanent human molar and premolar teeth suspected to have occlusal caries lesions were selected for the study and were assessed by two experienced examiners. Each examiner performed two evaluations. Histological examination was used as the gold standard. The scores of the histological examination were defined as sound (n=11, enamel caries (n=22 and dentin caries (n=27. Diagnostic performance of i visual inspection, ii radiography, iii laser fluorescence (LF and iv micro-computed tomography (M-CT caries detection methods was evaluated by calculating IC and PRDU. Results: Micro-computed tomography examination was the best method among the diagnostic techniques for the diagnosis of occlusal caries in terms of both IC and PRDU. M-CT examination supplied the maximum diagnostic information about the diagnosis of occlusal caries in the first (IC: 1.056; p<0.05, (PRDU: 70.5% and second evaluation (IC: 1.105; p<0.05, (PRDU: 73.8% for the first examiner. M-CT examination was the best method among the diagnostic techniques for the second examiner in both the first (IC:1.105; p<0.05, (PRDU:73.8% and second evaluation (IC:1.061; p<0.05, (PRDU:70.8%. IC and PRDU were

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

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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.

Developing and Standardization of a Diagnostic Reading Test

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Tahereh Sima-Shirazi

2004-06-01

Full Text Available Objective: This paper is a report on the development, structure and content of a diagnostic dyslexia reading test. The target population of this test is persian children who have problems in learning reading and may be considered as dyslexic. This diagnostic test is the first reading test developed for the native speakers of persian. Materials & Methods: The theoretical framework of the test is based on two well- established reading tests for the English speaking children, namely Durrell Analysis of Reading and Neale Analysis of Reading Ability. The linguistic content of the subtests is selected from the vocabulary and texts of the textbook used in the primary schools. Both the vocabulary and the sentences of the parrallel passeges were controlled for frequency, phonemic/graphemic regularity, syllable structure, morphology, syntax and semantics. They were also controlled for value judgement by two linguistics and three first grader teachers.The first version of the test is normed on 605 boy and girl first graders from different educational sectors and schools selected randomly.The method used in this research is cross- sectional, descriptive- analytic and the data analysis is based on pearson, and mann-whitney u. Results: Reliability of the test is calculated based on parrallel forms (~ 90% and validity is based on content validity.This test has a supplementary section including spelling, graphem/ phoneme correspondness, nonword reading, irregular word reading, and copy subtests. Conclusion: Considering highreliability and precise validation of the test it can be used to diagnose the dyslexia and related linguistic impairments.

Systematic reviews of diagnostic tests in endocrinology: an audit of methods, reporting, and performance.

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Spencer-Bonilla, Gabriela; Singh Ospina, Naykky; Rodriguez-Gutierrez, Rene; Brito, Juan P; Iñiguez-Ariza, Nicole; Tamhane, Shrikant; Erwin, Patricia J; Murad, M Hassan; Montori, Victor M

2017-07-01

Systematic reviews provide clinicians and policymakers estimates of diagnostic test accuracy and their usefulness in clinical practice. We identified all available systematic reviews of diagnosis in endocrinology, summarized the diagnostic accuracy of the tests included, and assessed the credibility and clinical usefulness of the methods and reporting. We searched Ovid MEDLINE, EMBASE, and Cochrane CENTRAL from inception to December 2015 for systematic reviews and meta-analyses reporting accuracy measures of diagnostic tests in endocrinology. Experienced reviewers independently screened for eligible studies and collected data. We summarized the results, methods, and reporting of the reviews. We performed subgroup analyses to categorize diagnostic tests as most useful based on their accuracy. We identified 84 systematic reviews; half of the tests included were classified as helpful when positive, one-fourth as helpful when negative. Most authors adequately reported how studies were identified and selected and how their trustworthiness (risk of bias) was judged. Only one in three reviews, however, reported an overall judgment about trustworthiness and one in five reported using adequate meta-analytic methods. One in four reported contacting authors for further information and about half included only patients with diagnostic uncertainty. Up to half of the diagnostic endocrine tests in which the likelihood ratio was calculated or provided are likely to be helpful in practice when positive as are one-quarter when negative. Most diagnostic systematic reviews in endocrine lack methodological rigor, protection against bias, and offer limited credibility. Substantial efforts, therefore, seem necessary to improve the quality of diagnostic systematic reviews in endocrinology.

A general diagnostic model applied to language testing data.

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von Davier, Matthias

2008-11-01

Probabilistic models with one or more latent variables are designed to report on a corresponding number of skills or cognitive attributes. Multidimensional skill profiles offer additional information beyond what a single test score can provide, if the reported skills can be identified and distinguished reliably. Many recent approaches to skill profile models are limited to dichotomous data and have made use of computationally intensive estimation methods such as Markov chain Monte Carlo, since standard maximum likelihood (ML) estimation techniques were deemed infeasible. This paper presents a general diagnostic model (GDM) that can be estimated with standard ML techniques and applies to polytomous response variables as well as to skills with two or more proficiency levels. The paper uses one member of a larger class of diagnostic models, a compensatory diagnostic model for dichotomous and partial credit data. Many well-known models, such as univariate and multivariate versions of the Rasch model and the two-parameter logistic item response theory model, the generalized partial credit model, as well as a variety of skill profile models, are special cases of this GDM. In addition to an introduction to this model, the paper presents a parameter recovery study using simulated data and an application to real data from the field test for TOEFL Internet-based testing.

Usefulness of component resolved analysis of cat allergy in routine clinical practice.

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Eder, Katharina; Becker, Sven; San Nicoló, Marion; Berghaus, Alexander; Gröger, Moritz

2016-01-01

Cat allergy is of great importance, and its prevalence is increasing worldwide. Cat allergens and house dust mite allergens represent the major indoor allergens; however, they are ubiquitous. Cat sensitization and allergy are known risk factors for rhinitis, bronchial hyperreactivity and asthma. Thus, the diagnosis of sensitization to cats is important for any allergist. 70 patients with positive skin prick tests for cats were retrospectively compared regarding their skin prick test results, as well as their specific immunoglobulin E antibody profiles with regard to their responses to the native cat extract, rFel d 1, nFel d 2 and rFel d 4. 35 patients were allergic to cats, as determined by positive anamnesis and/or nasal provocation with cat allergens, and 35 patients exhibited clinically non-relevant sensitization, as indicated by negative anamnesis and/or a negative nasal allergen challenge. Native cat extract serology testing detected 100% of patients who were allergic to cats but missed eight patients who showed sensitization in the skin prick test and did not have allergic symptoms. The median values of the skin prick test, as well as those of the specific immunoglobulin E antibodies against the native cat extract, were significantly higher for allergic patients than for patients with clinically non-relevant sensitization. Component based diagnostic testing to rFel d 1 was not as reliable. Sensitization to nFel d 2 and rFel d 4 was seen only in individual patients. Extract based diagnostic methods for identifying cat allergy and sensitization, such as the skin prick test and native cat extract serology, remain crucial in routine clinical practice. In our study, component based diagnostic testing could not replace these methods with regard to the detection of sensitization to cats and differentiation between allergy and sensitization without clinical relevance. However, component resolved allergy diagnostic tools have individual implications, and future

Comparing Diagnostic Accuracy of Cognitive Screening Instruments: A Weighted Comparison Approach

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A.J. Larner

2013-03-01

Full Text Available Background/Aims: There are many cognitive screening instruments available to clinicians when assessing patients' cognitive function, but the best way to compare the diagnostic utility of these tests is uncertain. One method is to undertake a weighted comparison which takes into account the difference in sensitivity and specificity of two tests, the relative clinical misclassification costs of true- and false-positive diagnosis, and also disease prevalence. Methods: Data were examined from four pragmatic diagnostic accuracy studies from one clinic which compared the Mini-Mental State Examination (MMSE with the Addenbrooke's Cognitive Examination-Revised (ACE-R, the Montreal Cognitive Assessment (MoCA, the Test Your Memory (TYM test, and the Mini-Mental Parkinson (MMP, respectively. Results: Weighted comparison calculations suggested a net benefit for ACE-R, MoCA, and MMP compared to MMSE, but a net loss for TYM test compared to MMSE. Conclusion: Routine incorporation of weighted comparison or other similar net benefit measures into diagnostic accuracy studies merits consideration to better inform clinicians of the relative value of cognitive screening instruments.

Common pitfalls in statistical analysis: Understanding the properties of diagnostic tests - Part 1.

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Ranganathan, Priya; Aggarwal, Rakesh

2018-01-01

In this article in our series on common pitfalls in statistical analysis, we look at some of the attributes of diagnostic tests (i.e., tests which are used to determine whether an individual does or does not have disease). The next article in this series will focus on further issues related to diagnostic tests.

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

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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.

Deamidated gliadin peptide antibodies as a routine test for celiac disease: a prospective analysis.

Science.gov (United States)

Volta, Umberto; Granito, Alessandro; Parisi, Claudia; Fabbri, Angela; Fiorini, Erica; Piscaglia, Maria; Tovoli, Francesco; Grasso, Valentina; Muratori, Paolo; Pappas, Georgios; De Giorgio, Roberto

2010-03-01

This study was designed to establish whether deamidated gliadin peptide antibodies (DGP-AGA) could improve the serologic workup for celiac disease (CD). The best serologic approach for CD screening is currently based on the combined detection of tissue transglutaminase (tTGA), endomysial (EmA), and gliadin antibodies (AGA). One hundred forty-four consecutive patients with gastrointestinal and extraintestinal signs suggestive for CD were investigated using serologic tests, that is, IgG and IgA DGP-AGA, IgA tTGA, IgA EmA, and duodenal biopsy. Forty-eight out of 144 patients (33%) had CD with different severity of villous atrophy. IgA tTGA showed 93.7% sensitivity compared with 91.6% for IgA EmA, 84.3% for IgA DGP-AGA, and 82.3% for IgG DGP-AGA. Of the 3 cases negative for IgA tTGA, IgA EmA, and IgA DGP-AGA, 2 had total IgA deficiency, although both were positive for IgG DGP-AGA. IgG DGP-AGA showed a very high specificity for CD (98.9%), not only superior to IgA DGP-AGA (79.8%), but also to IgA tTGA (96.6%) and very close to IgA EmA (100%). Our prospective study shows that the combined search for IgA tTGA and IgG DGP-AGA provides the best diagnostic accuracy for CD, allowing the identification of all CD cases---except one---with a very high specificity. The serologic workup for CD screening could be significantly improved by the routine introduction of IgG DGP-AGA together with IgA tTGA, thus reducing the number of tests and with an obvious advantage in terms of cost-efficacy.

Diagnostic development and support of MHD (magnetohydrodynamics) test facilities

Energy Technology Data Exchange (ETDEWEB)

1989-07-01

Mississippi State University (MSU) is developing diagnostic instruments for Magnetohydrodynamics (MHD) power train data acquisition and for support of MHD component development test facilities. Microprocessor-controlled optical instruments, initially developed for HRSR support, are being refined, and new systems to measure temperatures and gas-seed-slag stream characteristics are being developed. To further data acquisition and analysis capabilities, the diagnostic systems are being interfaced with MHD Energy Center computers. Technical support for the diagnostic needs of the national MHD research effort is being provided. MSU personnel will also cooperate with government agencies and private industries to improve the transformation of research and development results into processes, products and services applicable to their needs.

The glucose breath test: a diagnostic test for small bowel stricture(s) in Crohn's disease.

Science.gov (United States)

Mishkin, Daniel; Boston, Francis M; Blank, David; Yalovsky, Morty; Mishkin, Seymour

2002-03-01

The aim of this study was to determine whether an indirect noninvasive indicator of proximal bacterial overgrowth, the glucose breath test, was of diagnostic value in inflammatory bowel disease. Twenty four of 71 Crohn's disease patients tested had a positive glucose breath test. No statistical conclusions could be drawn between the Crohn's disease activity index and glucose breath test status. Of patients with radiologic evidence of small bowel stricture(s), 96.0% had a positive glucose breath test, while only one of 46 negative glucose breath test patients had a stricture. The positive and negative predictive values for a positive glucose breath test as an indicator of stricture formation were 96.0% and 97.8%, respectively. This correlation was not altered in Crohn's disease patients with fistulae or status postresection of the terminal ileum. The data in ulcerative colitis were nondiagnostic. In conclusion, the glucose breath test appears to be an accurate noninvasive inexpensive diagnostic test for small bowel stricture(s) and secondary bacterial overgrowth in Crohn's disease.

Practical issues in implementing whole-genome-sequencing in routine diagnostic microbiology

NARCIS (Netherlands)

Rossen, J. W. A.; Friedrich, A. W.; Moran-Gilad, J.

Background: Next generation sequencing (NGS) is increasingly being used in clinical microbiology. Like every new technology adopted in microbiology, the integration of NGS into clinical and routine workflows must be carefully managed. Aim: To review the practical aspects of implementing bacterial

30 CFR 250.520 - When do I have to perform a casing diagnostic test?

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false When do I have to perform a casing diagnostic... Operations Casing Pressure Management § 250.520 When do I have to perform a casing diagnostic test? (a) You must perform a casing diagnostic test within 30 days after first observing or imposing casing pressure...

[Pathogenic Mechanism and Diagnostic Testing for Drug Allergies].

Science.gov (United States)

Uno, Katsuji

2018-01-01

　Three stages of the pathogenic mechanism of drug allergies can be considered: antigen formation, immune reaction and inflammation/disorder reaction. Drugs are thought to form 4 types of antigens: drug only, polymers, drug-carrier conjugates, and metabolite-carrier complexes. Antigens are recognized by B cell receptors and T cell receptors. Helper T cells (Th) are differentiated into four subsets, namely, Th1, Th2, Th17 and regulatory T cells (Treg). Th1 produces interleukin (IL)-2 and interferon (IFN)-γ, and activates macrophages and cytotoxic T cells (Tc). Macrophages induce type IV allergies, and Tc lead to serious type IV allergies. On the other hand, Th2 produces IL-4, IL-5, and IL-6, etc., and activates B cells. B cells produce IgE antibodies, and the IgE antibody affects mast cells and induces type I allergies. Activated eosinophil leads to the chronic state of type I allergy. Diagnostic testing for allergenic drugs is necessary for patients with drug allergies. Because in vivo diagnostic tests for allergenic drugs are associated with a risk and burden to the patient, in vitro allergy tests are recommended to identify allergenic drugs. In allergy tests performed in vitro, cytological tests are more effective than serological tests, and the leukocyte migration test (LMT) presently has the highest efficacy. An LMT-chamber is better than LMT-agarose in terms of usability and sensitivity, and it can detect about 80% of allergenic drugs.

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

Science.gov (United States)

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/.

What is the role of clinical tests and ultrasound in acetabular labral tear diagnostics?

DEFF Research Database (Denmark)

Troelsen, Anders; Mechlenburg, Inger; Gelineck, John

2009-01-01

BACKGROUND AND PURPOSE: An acetabular labral tear is a diagnostic challenge. Various clinical tests have been described, but little is known about their diagnostic sensitivity and specificity. We investigated the diagnostic validity of clinical tests and ultrasound as compared with MR arthrography...... no or only slight signs of osteoarthritis (Tönnis grade 0-1). RESULTS: MR arthrography identified labral tears in 17 of the 18 hips. Ultrasound had a sensitivity of 94%, a positive predictive value of 94%, and was false negative in only 1 case compared to MR arthrography. The impingement test had the best...... diagnostic ability of the clinical tests, with a sensitivity of 59% and a specificity of 100%. The positive predictive value was 100% while the negative predictive value was 13%. INTERPRETATION: The impingement test is helpful in identifying acetabular labral tears. If this test is negative and if a labral...

COMPARATIVE EFFICIENCY OF SOME INDIRECT DIAGNOSTIC TESTS FOR THE DETECTION OF SUB-CLINICAL MASTITIS IN COWS AND BUFFALOES

Directory of Open Access Journals (Sweden)

M. IQBAL, M. AMJED1, M. A. KHAN, M. S. QURESHI1 AND U. SADIQUE1

2006-04-01

Full Text Available The present study was undertaken to compare five laboratory diagnostic tests for sub-clinical mastitis in cattle and buffaloes and to compute cost, time taken by each test and its ranking for availability, adoptability, interpretability and sensitivity. There were 352 cases with each test type viz. California Mastitis Test (CMT, White Side Test (WST, White Side + Dye (WSTD, Surf Test and Surf + Dye, and 880 cases with each species type (cattle and buffaloes. Result scores (1760 for sub-clinical mastitis in each category of negative, trace, single positive, double positive and triple positive by species, and laboratory tests, were analyzed using nonparametric tests. Chi-square statistics showed that CMT was equally effective at both locations (farm vs. laboratory. Correlation further suggested that the association was highly significant. Moreover, cases in category of negative, trace and single positive strongly differed (P0.05. The study further suggested that CMT was the most sensitive test, followed by WST/WSTD and Surf/Surf + Dye. Although, the five tests showed slight discrepancy in the trace category reaction, a strong relationship of Surf Test to CMT, its low cost, easy availability and readily adoptable qualities should spur the relevant authorities to recommend the use of Surf test as a routine practice in dairy farming and add this test in the curriculum of diploma and degree programmes.

Practical Issues in Implementing Whole-Genome-Sequencing in Routine Diagnostic Microbiology

NARCIS (Netherlands)

Rossen, John W A; Friedrich, Alexander W; Moran-Gilad, Jacob

BACKGROUND: next generation sequencing (NGS) is increasingly being used in clinical microbiology. Like every new technology that is being adopted in microbiology, the integration of NGS into clinical and routine workflows needs to be carefully managed. AIM: to review the practical aspects of

Routine Radiological Environmental Monitoring Plan

International Nuclear Information System (INIS)

Bechtel Nevada

1998-01-01

The U.S. Department of Energy manages the Nevada Test Site in a manner that meets evolving DOE Missions and responds to the concerns of affected and interested individuals and agencies. This Routine Radiological Monitoring Plan addressess complicance with DOE Orders 5400.1 and 5400.5 and other drivers requiring routine effluent monitoring and environmental surveillance on the Nevada Test Site. This monitoring plan, prepared in 1998, addresses the activities conducted onsite NTS under the Final Environmental Impact Statement and Record of Decision. This radiological monitoring plan, prepared on behalf of the Nevada Test Site Landlord, brings together sitewide environmental surveillance; site-specific effluent monitoring; and operational monitoring conducted by various missions, programs, and projects on the NTS. The plan provides an approach to identifying and conducting routine radiological monitoring at the NTS, based on integrated technical, scientific, and regulatory complicance data needs

Technology diffusion and diagnostic testing for prostate cancer.

Science.gov (United States)

Schroeck, Florian R; Kaufman, Samuel R; Jacobs, Bruce L; Skolarus, Ted A; Miller, David C; Weizer, Alon Z; Montgomery, Jeffrey S; Wei, John T; Shahinian, Vahakn B; Hollenbeck, Brent K

2013-11-01

While the dissemination of robotic prostatectomy and intensity modulated radiotherapy may fuel the increased use of prostatectomy and radiotherapy, these new technologies may also have spillover effects related to diagnostic testing for prostate cancer. Therefore, we examined the association of regional technology penetration with the receipt of prostate specific antigen testing and prostate biopsy. In this retrospective cohort study we included 117,857 men 66 years old or older from the 5% sample of Medicare beneficiaries living in Surveillance, Epidemiology and End Results (SEER) areas from 2003 to 2007. Regional technology penetration was measured as the number of providers performing robotic prostatectomy or intensity modulated radiotherapy per population in a health care market, ie hospital referral region. We assessed the association of technology penetration with the prostate specific antigen testing rate and prostate biopsy using generalized estimating equations. High technology penetration was associated with an increased rate of prostate specific antigen testing (442 vs 425/1,000 person-years, pimpact of technology penetration on prostate specific antigen testing and prostate biopsy was much less than the effect of age, race and comorbidity, eg the prostate specific antigen testing rate per 1,000 person-years was 485 vs 373 for men with only 1 vs 3+ comorbid conditions (ppenetration is associated with a slightly higher rate of prostate specific antigen testing and no change in the prostate biopsy rate. Collectively, our findings temper concerns that adopting new technology accelerates diagnostic testing for prostate cancer. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Requirements for appropriate evaluation of diagnostic tests in suspected pulmonary embolism

NARCIS (Netherlands)

Sanson, B. J.; Meinders, A. J.; Kraaijenhagen, R. A.; van Beek, E. J.; Büller, H. R.

1999-01-01

In contrast to the development of new drugs, strict guidelines for the development of new diagnostic methods do not exist. A diagnostic test can be made available without proper evaluation of its clinical utility, which can lead to its premature introduction and inappropriate use. In this review

Is routine pregnancy test necessary in women of reproductive age admitted to the emergency department?

Science.gov (United States)

Köksal, Ozlem; Ozdemir, Fatma; Armağan, Erol; Oner, Nuran; Sert, Pınar Çinar; Sigirli, Deniz

2013-01-01

This study aimed to determine the necessity of pregnancy test in women of reproductive age admitted to emergency department (ED) in routine practice. We retrospectively reviewed the records of patients who presented to the ED between January 1, 2006 and December 31, 2010 and received a pregnancy test. The median age of 1 586 patients enrolled into the study was 27 years. Of these patients, 19.55% had a positive result of pregnancy test. The most common complaint at admission was abdominal pain in 60.15% of the patients, and pregnancy test was prescribed. 15.83% of the patients with abdominal pain had a positive result of pregnancy test. Of the patients, 30.64% had nausea-vomiting at admission, and 11.52% had a positive result of pregnancy test. When other complaints were considered, the most commonly observed complaints were non-specific symptoms such as dizziness, malaise and respiratory problems. Of the patients, 70.93% were not remembering the date of last menstruation, and 9.51% showed a positive result of pregnancy test. Urinary tract infection (UTI) was commonly diagnosed with an incidence of 17.65%, which was followed by non-specific abdominal pain (NSAP) (16.77%) and gastrointestinal disorders such as gastritis and peptic ulcer (6.87%). Of the patients, 88.40% were discharged from ED, and 11.60% were hospitalized. Pregnancy test should be given to women of reproductive age as a routine practice in ED in developing countries like Turkey.

Implementation of a companion diagnostic in the clinical laboratory

DEFF Research Database (Denmark)

Mancini, Irene; Pinzani, Pamela; Simi, Lisa

2015-01-01

A companion diagnostic test provides information that is essential for the safe and effective use of a corresponding therapeutic product as indicated in the drug instructions. The implementation of a companion diagnostic follows the rules of a molecular test for somatic mutations in a routine...... clinical laboratory environment and needs guidance on practical aspects, including the choice of the proper analytical method and the procedures for internal and external quality controls. Selection of the appropriate assay for detection of genetic alterations depends on several factors: the type...... on restrictions of the method used. In relation to these aspects herein we report an opinion paper of the Working Group Personalized Laboratory Medicine jointly constituted by the European Federation of Laboratory Medicine (EFLM) and by the European Society of Pharmacogenomics and Theranostics (ESPT) using...

Routine clinical heart examinations using SQUID magnetocardiography at University of Tsukuba Hospital

Science.gov (United States)

Inaba, T.; Nakazawa, Y.; Yoshida, K.; Kato, Y.; Hattori, A.; Kimura, T.; Hoshi, T.; Ishizu, T.; Seo, Y.; Sato, A.; Sekiguchi, Y.; Nogami, A.; Watanabe, S.; Horigome, H.; Kawakami, Y.; Aonuma, K.

2017-11-01

A 64-channel Nb-based DC-SQUID magnetocardiography (MCG) system was installed at the University of Tsukuba Hospital (UTH) in March 2007 after obtaining Japanese pharmaceutical approval and insurance reimbursement approval. In the period between 2008 and 2016, the total number of patients was 10 085. The heart diseases diagnosed in fetuses as well as adults are mainly atrial arrhythmia, abnormal repolarization, ventricular arrhythmia, and fetal arrhythmia. In most cases of insufficient diagnostic accuracy with electrocardiography, SQUID MCG precisely revealed these heart diseases as an abnormal electrical current distribution. Based on success in routine examinations, SQUID MCG is now an indispensable clinical instrument with diagnostic software tuned up during routine use at UTH.

Beam Diagnostics for the BNL Energy Recovery Linac Test Facility

International Nuclear Information System (INIS)

Cameron, Peter; Ben-Zvi, Ilan; Blaskiewicz, Michael; Brennan, Michael; Connolly, Roger; Dawson, William; Degen, Chris; DellaPenna, Al; Gassner, David; Kesselman, Martin; Kewish, Jorg; Litvinenko, Vladimir; Mead, Joseph; Oerter, Brian; Russo, Tom; Vetter, Kurt; Yakimenko, Vitaly

2004-01-01

An Energy Recovery Linac (ERL) test facility is presently under construction at BNL. The goals of this test facility are first to demonstrate stable intense CW electron beam with parameters typical for the RHIC e-cooling project (and potentially for eRHIC), second to test novel elements of the ERL (high current CW photo-cathode, superconducting RF cavity with HOM dampers, and feedback systems), and finally to test lattice dependence of stability criteria. Planned diagnostics include position monitors, loss monitors, transverse profile monitors (both optical and wires), scrapers/halo monitors, a high resolution differential current monitor, phase monitors, an energy spread monitor, and a fast transverse monitor (for beam break-up studies and the energy feedback system). We discuss diagnostics challenges that are unique to this project, and present preliminary system specifications. In addition, we include a brief discussion of the timing system

How to save costs by reducing unnecessary testing: Lean thinking in clinical practice

NARCIS (Netherlands)

Vegting, I.L.; van Beneden, M.; Kramer, M.H.H.; Thijs, A.; Kostense, P.J.; Nanayakkara, P.W.B.

2012-01-01

Background: The burden of health care expenditure on national budgets has increased dramatically over the past decade. A pilot study in our hospital demonstrated that many unnecessary diagnostic tests were performed routinely. The aim of this study was to reduce the costs of unnecessary diagnostic

Bovine paratuberculosis: a review of the advantages and disadvantages of different diagnostic tests.

Science.gov (United States)

Gilardoni, Liliana R; Paolicchi, Fernando A; Mundo, Silvia L

2012-01-01

Paratuberculosis (PTB), or Johne's disease, is a chronic infectious granulomatous enteritis of ruminants, caused by Mycobacterium avium subspecies paratuberculosis (Map). It is characterized by diarrhea and progressive cachexia, which may cause the death of the animal. Calves are the most susceptible to infection. Infected animals excrete Map mainly by the feces. PTB is endemic worldwide, with high prevalence levels, strong economic impact and public health relevance because of its possible association with Crohn's disease. Although the current reference diagnostic test is identification of Map in the bacterial culture, there are different diagnostic tests to identify infected individuals and/or herds. The sensitivity and specificity of these tests vary according to the stage of the disease in the animals to be evaluated. The correct choice and application of each of these diagnostic tests will ensure their success and may allow to establish a control program. The aim of this work is to review and discuss the different diagnostic tests used in the detection of Map-infected animals, focusing on their advantages and disadvantages.

Divergence-based tests for model diagnostic

Czech Academy of Sciences Publication Activity Database

Hobza, Tomáš; Esteban, M. D.; Morales, D.; Marhuenda, Y.

2008-01-01

Roč. 78, č. 13 (2008), s. 1702-1710 ISSN 0167-7152 R&D Projects: GA MŠk 1M0572 Grant - others:Instituto Nacional de Estadistica (ES) MTM2006-05693 Institutional research plan: CEZ:AV0Z10750506 Keywords : goodness of fit * devergence statistics * GLM * model checking * bootstrap Subject RIV: BB - Applied Statistics, Operational Research Impact factor: 0.445, year: 2008 http://library.utia.cas.cz/separaty/2008/SI/hobza-divergence-based%20tests%20for%20model%20diagnostic.pdf

[Unnecessary routine laboratory tests in patients referred for surgical services].

Science.gov (United States)

Mata-Miranda, María del Pilar; Cano-Matus, Norberto; Rodriguez-Murrieta, Margarita; Guarneros-Zapata, Idalia; Ortiz, Mario

2016-01-01

To question the usefulness of the lab analysis considered routine testing for the identification of abnormalities in the surgical care. To determine the percentage of unnecessary laboratory tests in the preoperative assessment as well as to estimate the unnecessary expenses. A descriptive, cross-sectional study of patients referred for surgical evaluation between January 1st and March 31st 2013. The database of laboratory testing and electronic files were reviewed. Reference criteria from surgical services were compared with the tests requested by the family doctor. In 65% of the patients (n=175) unnecessary examinations were requested, 25% (n=68) were not requested the tests that they required, and only 10% of the patients were requested laboratory tests in accordance with the reference criteria (n=27). The estimated cost in unnecessary examinations was $1,129,552 in a year. The results were similar to others related to this theme, however, they had not been revised from the perspective of the first level of attention regarding the importance of adherence to the reference criteria which could prevent major expenditures. It is a priority for leaders and operational consultants in medical units to establish strategies and lines of action that ensure compliance with institutional policies so as to contain spending on comprehensive services, and which in turn can improve the medical care. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Value of routine investigations to predict loop diuretic down-titration success in stable heart failure.

Science.gov (United States)

Martens, Pieter; Verbrugge, Frederik H; Boonen, Levinia; Nijst, Petra; Dupont, Matthias; Mullens, Wilfried

2018-01-01

Guidelines advocate down-titration of loop diuretics in chronic heart failure (CHF) when patients have no signs of volume overload. Limited data are available on the expected success rate of this practice or how routine diagnostic tests might help steering this process. Fifty ambulatory CHF-patients on stable neurohumoral blocker/diuretic therapy for at least 3months without any clinical sign of volume overload were prospectively included to undergo loop diuretic down-titration. All patients underwent a similar pre-down-titration evaluation consisting of a dyspnea scoring, physical examination, transthoracic echocardiography (diastolic function, right ventricular function, cardiac filling pressures and valvular disease), blood sample (serum creatinine, plasma NT-pro-BNP and neurohormones). Loop diuretic maintenance dose was subsequently reduced by 50% or stopped if dose was ≤40mg furosemide equivalents. Successful down-titration was defined as a persistent dose reduction after 30days without weight increase >1.5kg or new-onset symptoms of worsening heart failure. At 30-day follow-up, down-titration was successful in 62% (n=31). In 12/19 patients exhibiting down-titration failure, this occurred within the first week. Physical examination, transthoracic echocardiography and laboratory analysis had limited predictive capability to detect patients with down-titration success/failure (positive likelihood-ratios below 1.5, or area under the curve [AUC] non-statically different from AUC=0.5). Loop diuretic down-titration is feasible in a majority of stable CHF patients in which the treating clinician felt continuation of loops was unnecessary to sustain euvolemia. Importantly, routine diagnostics which suggest euvolemia, have limited diagnostic impact on the post-test probability. Copyright © 2017 Elsevier B.V. All rights reserved.

Real-time remote diagnostic monitoring test-bed in JET

International Nuclear Information System (INIS)

Castro, R.; Kneupner, K.; Vega, J.; De Arcas, G.; Lopez, J.M.; Purahoo, K.; Murari, A.; Fonseca, A.; Pereira, A.; Portas, A.

2010-01-01

Based on the remote experimentation concept oriented to long pulse shots, a test-bed system has been implemented in JET. Its main functionality is the real-time monitoring, on remote, of a reflectometer diagnostic, to visualize different data outputs and status information. The architecture of the system is formed by: the data generator components, the data distribution system, an access control service, and the client applications. In the test-bed there is one data generator, which is the acquisition equipment associated with the reflectometer diagnostic that generates data and status information. The data distribution system has been implemented using a publishing-subscribing technology that receives data from data generators and redistributes them to client applications. And finally, for monitoring, a client application based on JAVA Web Start technology has been used. There are three interesting results from this project. The first one is the analysis of different aspects (data formats, data frame rate, data resolution, etc) related with remote real-time diagnostic monitoring oriented to long pulse experiments. The second one is the definition and implementation of an architecture, flexible enough to be applied to different types of data generated from other diagnostics, and that fits with remote access requirements. Finally, the third result is a secure system, taking into account internal networks and firewalls aspects of JET, and securing the access from remote users. For this last issue, PAPI technology has been used, enabling access control based on user attributes, enabling mobile users to monitor diagnostics in real-time, and enabling the integration of this service into the EFDA Federation (Castro et al., 2008 ).

Real-time remote diagnostic monitoring test-bed in JET

Energy Technology Data Exchange (ETDEWEB)

Castro, R., E-mail: rodrigo.castro@ciemat.e [Asociacion EURATOM/CIEMAT para Fusion, Madrid (Spain); Kneupner, K. [EURATOM/UKAEA Fusion Association, Culham Science Centre, Abingdon, OX14 3DB (United Kingdom); Vega, J. [Asociacion EURATOM/CIEMAT para Fusion, Madrid (Spain); De Arcas, G.; Lopez, J.M. [Universidad Politecnica de Madrid, Grupo I2A2, Madrid (Spain); Purahoo, K. [EURATOM/UKAEA Fusion Association, Culham Science Centre, Abingdon, OX14 3DB (United Kingdom); Murari, A. [Associazione EURATOM-ENEA per la Fusione, Consorzio RFX, 4-35127 Padova (Italy); Fonseca, A. [Associacao EURATOM/IST, Lisbon (Portugal); Pereira, A.; Portas, A. [Asociacion EURATOM/CIEMAT para Fusion, Madrid (Spain)

2010-07-15

Based on the remote experimentation concept oriented to long pulse shots, a test-bed system has been implemented in JET. Its main functionality is the real-time monitoring, on remote, of a reflectometer diagnostic, to visualize different data outputs and status information. The architecture of the system is formed by: the data generator components, the data distribution system, an access control service, and the client applications. In the test-bed there is one data generator, which is the acquisition equipment associated with the reflectometer diagnostic that generates data and status information. The data distribution system has been implemented using a publishing-subscribing technology that receives data from data generators and redistributes them to client applications. And finally, for monitoring, a client application based on JAVA Web Start technology has been used. There are three interesting results from this project. The first one is the analysis of different aspects (data formats, data frame rate, data resolution, etc) related with remote real-time diagnostic monitoring oriented to long pulse experiments. The second one is the definition and implementation of an architecture, flexible enough to be applied to different types of data generated from other diagnostics, and that fits with remote access requirements. Finally, the third result is a secure system, taking into account internal networks and firewalls aspects of JET, and securing the access from remote users. For this last issue, PAPI technology has been used, enabling access control based on user attributes, enabling mobile users to monitor diagnostics in real-time, and enabling the integration of this service into the EFDA Federation (Castro et al., 2008 ).

Predicament in detection and reporting of extended spectrum beta lactamase production in routine antibiotic susceptibility testing

International Nuclear Information System (INIS)

Butt, T.; Butt, E.; Raza, S.

2017-01-01

This descriptive and cross-sectional study was planned to determine the dilemma of inadvertent detection of extended spectrum beta lactamase (ESBL) production in Enterobacteriaceaewhen using inhibition zone size of antibiotic disks of Cefotaxime or Aztreonam in routine antibiotic susceptibility testing as recommended by Clinical Laboratory Standards Institute (CLSI). Screening and double disk tests were adopted as per CLSI. Escherichia coli ATCC 25922 was used as control strain. Among total specimens of 5346, there were 348 isolates of Escherichia coli(n=235), Klebsiella pneumonia (n=92), Klebsiella oxytoca(n=3) or Proteus mirabilus(n=18). The screening method recommended by CLSI significantly falsely detected ESBL production in 79 (32.3%) isolates (p<0.0001). ESBL detection is important as its frequency is high and treatment of the infection varies with the presence and absence of ESBL. To avoid false reporting, proper phenotypic detection of ESBL confirmatory method-like double-disk synergy test, should be used routinely. (author)

Diagnostic Accuracy of Obstructive Airway Adult Test for Diagnosis of Obstructive Sleep Apnea.

Science.gov (United States)

Gasparini, Giulio; Vicini, Claudio; De Benedetto, Michele; Salamanca, Fabrizio; Sorrenti, Giovanni; Romandini, Mario; Bosi, Marcello; Saponaro, Gianmarco; Foresta, Enrico; Laforì, Andreina; Meccariello, Giuseppe; Bianchi, Alessandro; Toraldo, Domenico Maurizio; Campanini, Aldo; Montevecchi, Filippo; Rizzotto, Grazia; Cervelli, Daniele; Moro, Alessandro; Arigliani, Michele; Gobbi, Riccardo; Pelo, Sandro

2015-01-01

The gold standard for the diagnosis of Obstructive Sleep Apnea (OSA) is polysomnography, whose access is however reduced by costs and limited availability, so that additional diagnostic tests are needed. To analyze the diagnostic accuracy of the Obstructive Airway Adult Test (OAAT) compared to polysomnography for the diagnosis of OSA in adult patients. Ninety patients affected by OSA verified with polysomnography (AHI ≥ 5) and ten healthy patients, randomly selected, were included and all were interviewed by one blind examiner with OAAT questions. The Spearman rho, evaluated to measure the correlation between OAAT and polysomnography, was 0.72 (p diagnostic accuracy for the diagnosis of OSA. It has also been shown to be able to discriminate among the different degrees of severity of OSA. Additional large studies aiming to validate this questionnaire as a screening or diagnostic test are needed.

Technical Note: A new phantom design for routine testing of Doppler ultrasound.

Science.gov (United States)

Grice, J V; Pickens, D R; Price, R R

2016-07-01

The objective of this project is to demonstrate the principle and operation for a simple, inexpensive, and highly portable Doppler ultrasound quality assurance (QA) phantom intended for routine QA testing. A prototype phantom has been designed, fabricated, and evaluated. The phantom described here is powered by gravity alone, requires no external equipment for operation, and produces a stable fluid velocity useful for quality assurance. Many commercially available Doppler ultrasound testing systems can suffer from issues such as a lengthy setup, prohibitive cost, nonportable size, or difficulty in use. This new phantom design aims to address some of these problems and create a phantom appropriate for assessing Doppler ultrasound stability. The phantom was fabricated using a 3D printer. The basic design of the phantom is to provide gravity-powered flow of a Doppler fluid between two reservoirs. The printed components were connected with latex tubing and then seated in a tissue mimicking gel. Spectral Doppler waveforms were sampled to evaluate variations in the data, and the phantom was evaluated using high frame rate video to find an alternate measure of mean fluid velocity flowing in the phantom. The current system design maintains stable flow from one reservoir to the other for approximately 7 s. Color Doppler imaging of the phantom was found to be qualitatively consistent with laminar flow. Using pulsed spectral Doppler, the average fluid velocity from a sample volume approximately centered in the synthetic vessel was measured to be 56 cm/s with a standard deviation of 3.2 cm/s across 118 measurements. An independent measure of the average fluid velocity was measured to be 51.9 cm/s with a standard deviation of 0.7 cm/s over 4 measurements. The developed phantom provides stable fluid flow useful for frequent clinical Doppler ultrasound testing and attempts to address several obstacles facing Doppler phantom testing. Such an ultrasound phantom can make routine

Imaging tests in staging and surveillance of non-metastatic breast cancer: changes in routine clinical practice and cost implications.

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De Placido, S; De Angelis, C; Giuliano, M; Pizzi, C; Ruocco, R; Perrone, V; Bruzzese, D; Tommasielli, G; De Laurentiis, M; Cammarota, S; Arpino, G; Arpino, G

2017-03-14

Although guidelines do not recommend computerised tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) for the staging or follow-up of asymptomatic patients with non-metastatic breast cancer, they are often requested in routine clinical practice. The aim of this study was to determine the staging and follow-up patterns, and relative costs in a large population of breast cancer patients living and treated in a Southern Italian region. We analysed the clinical computerised information recorded by 567 primary-care physicians assisting about 650 000 inhabitants in the Campania region. Patients with non-metastatic breast cancer were identified and divided into calendar years from 2001 to 2010. The number of diagnostic tests prescribed per 100 patients (N/Pts) and the mean cost per patient was determined 3 months before diagnosis and up to 1 year after diagnosis. Costs are expressed in constant 2011 euros. We identified 4680 newly diagnosed cases of asymptomatic non-metastatic breast cancer. N/Pts increased significantly (Ptests'), and costs was unchanged. However, the number of CT, PET scans and MRI ('new tests')prescriptions almost quadrupled and the mean cost per patient related to these procedures significantly increased from [euro ]357 in 2001 to [euro ]830 in 2010 (Ptest prescriptions and relative costs significantly and steadily increased throughout the study period. At present there is no evidence that the delivery of new tests to asymptomatic patients improves breast cancer outcome. Well-designed clinical trials are urgently needed to shed light on the impact of these tests on clinical outcome and overall survival.

An interferon-gamma release assay test performs well in routine screening for tuberculosis

DEFF Research Database (Denmark)

Vestergaard Danielsen, Allan; Fløe, Andreas; Lillebæk, Troels

2014-01-01

Introduction: A positive interferon-gamma release assay (IGRA) is regarded as proof of latent Mycobacterium tuberculosis infection. We conducted an evaluation of the IGRA test “T-SPOT.TB” to test its performance during clinical routine use by analysing the positivity rate and odds, effect of season...... and sensitivity. Material and methods: Data from T-SPOT.TB testing together with age and test indications (anti-tumour necrosis factor alpha (TNFα) candidate, contact investigation or suspicion of tuberculosis (TB)) were combined with mycobac­teria culture results. Results: A total of 1,809 patients were tested....... Conclusive results were achieved for 1,780 patients (98.4%). Among these, 4.6% of anti-TNFα candidates, 19.3% of contacts and 24.4% of TB suspects tested positive. Compared with anti-TNFα candidates, the odds for a positive result were significantly higher for contact investigations (odds ratio (OR), mean...

Integrated Rapid-Diagnostic-Test Reader Platform on a Cellphone

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Mudanyali, Onur; Dimitrov, Stoyan; Sikora, Uzair; Padmanabhan, Swati; Navruz, Isa; Ozcan, Aydogan

2012-01-01

We demonstrate a cellphone based Rapid-Diagnostic-Test (RDT) reader platform that can work with various lateral flow immuno-chromatographic assays and similar tests to sense the presence of a target analyte in a sample. This compact and cost-effective digital RDT reader, weighing only ~65 grams, mechanically attaches to the existing camera unit of a cellphone, where various types of RDTs can be inserted to be imaged in reflection or transmission modes under light-emitting-diode (LED) based illumination. Captured raw images of these tests are then digitally processed (within less than 0.2 sec/image) through a smart application running on the cellphone for validation of the RDT as well as for automated reading of its diagnostic result. The same smart application running on the cellphone then transmits the resulting data, together with the RDT images and other related information (e.g., demographic data) to a central server, which presents the diagnostic results on a world-map through geo-tagging. This dynamic spatio-temporal map of various RDT results can then be viewed and shared using internet browsers or through the same cellphone application. We tested this platform using malaria, tuberculosis (TB) as well as HIV RDTs by installing it on both Android based smart-phones as well as an iPhone. Providing real-time spatio-temporal statistics for the prevalence of various infectious diseases, this smart RDT reader platform running on cellphones might assist health-care professionals and policy makers to track emerging epidemics worldwide and help epidemic preparedness. PMID:22596243

A comparison of diagnostic tests for lactose malabsorption - which one is the best?

Directory of Open Access Journals (Sweden)

Hovde Øistein

2009-10-01

Full Text Available Abstract Background Perceived milk intolerance is a common complaint, and tests for lactose malabsorption (LM are unreliable. This study assesses the agreement between diagnostic tests for LM and describes the diagnostic properties of the tests. Methods Patients above 18 years of age with suspected LM were included. After oral intake of 25 g lactose, a combined test with measurement of serum glucose (s-glucose and hydrogen (H2 and methane (CH4 in expired air was performed and symptoms were recorded. In patients with discrepancies between the results, the combined test was repeated and a gene test for lactose non-persistence was added. The diagnosis of LM was based on an evaluation of all tests. The following tests were compared: Increase in H2, CH4, H2+CH4 and H2+CH4x2 in expired air, increase in s-glucose, and symptoms. The agreement was calculated and the diagnostic properties described. Results Sixty patients were included, seven (12% had LM. The agreement (kappa-values between the methods varied from 0.25 to 0.91. The best test was the lactose breath test with measurement of the increase in H2 + CH4x2 in expired air. With a cut-off level Conclusion The agreement between commonly used methods for the diagnosis of LM was unsatisfactory. A lactose breath test with measurement of H2 + CH4x2 in expired air had the best diagnostic properties.

Accuracy of molecular diagnostics in pemphigus and bullous pemphigoid: comparison of commercial and modified mosaic indirect immunofluorescence tests as well as enzyme-linked immunosorbent assays.

Science.gov (United States)

Gornowicz-Porowska, Justyna; Seraszek-Jaros, Agnieszka; Bowszyc-Dmochowska, Monika; Kaczmarek, Elżbieta; Pietkiewicz, Paweł; Bartkiewicz, Paweł; Dmochowski, Marian

2017-02-01

Pemphigus and bullous pemphigoid (BP) are identified by autoantibodies (abs) against desmoglein 1, 3 (DSG1/3) and BP180/BP230, respectively. A novel mosaic to indirect immunofluorescence (IIF) using purified BP180 recombinant proteins spotted on slide and transfected cells expressing BP230, DSG1, DSG3 is available. The commercial (IgG detection) and modified (IgG4 detection) mosaic for indirect immunofluorescence (IIFc - IIF commercial, IIFm - IIF modified) and IgG ELISAs were evaluated in pemphigus and bullous pemphigoid (BP) molecular diagnostics. To compare diagnostic accuracy of commercial (IgG detection) and modified (IgG4 detection) mosaic IIF assay and to examine the diagnostic value of ELISAs in relation to mosaic IIF in routine laboratory diagnostics of pemphigus and BP. Sera from 37 BP and 19 pemphigus patients were studied. Associations between tests were assessed using Fisher's exact test. There are associations between the positive/negative samples detected by IIFc with desmoglein1 (DSG1)/desmoglein3 (DSG3)/BP230 transfected cells and ELISAs and no association between anti-BP180 IgG detection by IIFc and ELISA. IIFm with DSG1 and DSG3 showed both 100% sensitivity and 100% and 78% specificity, respectively, and 100% and 83% positive predictive value in relation to IIFc. IIFm with BP230 had 87% specificity, 55% sensitivity, whereas IIFm with BP180 had a 100% sensitivity and 13% specificity in relation to IIFc. The IIFc with DSG1/DSG3/BP230 transfected cells, excluding BP180 spots, is an alternative method to ELISA in pemphigus/BP diagnostics. IgG4 antibodies, both pathogenically and diagnostically important, are inconsistently detectable with IIFm.

The role of molecular diagnostic testing in the management of thyroid nodules.

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Moore, Maureen D; Panjwani, Suraj; Gray, Katherine D; Finnerty, Brendan M; Zarnegar, Rasa; Fahey, Thomas J

2017-06-01

Fine needle aspiration (FNA) with cytologic examination remains the standard of care for investigation of thyroid nodules. However, as many as 30% of FNA samples are cytologically indeterminate for malignancy, which confounds clinical management. To reduce the burden of repeat diagnostic testing and unnecessary surgery, there has been extensive investigation into molecular markers that can be detected on FNA specimens to more accurately stratify a patient's risk of malignancy. Areas covered: In this review, the authors discuss recent evidence and progress in molecular markers used in the diagnosis of thyroid cancer highlighting somatic gene alterations, molecular technologies and microRNA analysis. Expert commentary: The goal of molecular markers is to improve diagnostic accuracy and aid clinicians in the preoperative management of thyroid lesions. Modalities such as direct mutation analysis, mRNA gene expression profiling, next-generation sequencing, and miRNA expression profiling have been explored to improve the diagnostic accuracy of thyroid nodule FNA. Although no perfect test has been discovered, molecular diagnostic testing has revolutionized the management of thyroid nodules.

Usefullness of routine use of fecal occult blood test in a hospital setting

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Simona Ravnik

2006-12-01

Full Text Available Background: Fecal occult blood test, hematest, is a well excepted non-invasive method used for detecting different diseases of the gastrointestinal tract. It was proven in different randomized studies that usage of this simple method may facilitate further diagnostic and therapeutic treatment.Patients and methods: The retrospective analysis includes patients, which were admitted to the gastroenterological and endoscopy department of the General hospital Maribor in the last quarter of the year 2005. In all patients fecal occult blood test was performed.Results: We examined 200 patients, 104 women and 96 men, average age 63.9 years, SD±16.9, ranging from 21 to 97 years. Positive hematest was discovered in 76 patients (38 %. The source of hemorrhage from the upper digestive tract was confirmed in 37 patients (48.6 % of all positive tests and from the lower digestive tract in 34 patients (46 % of all positive tests. The most frequent causes of hemorrhage from the lower digestive tract were chronic inflammatory bowel disease (13.1 % of all positive tests, colorectal cancer (10.5 % and polyps (6.6 %. The source of hemorrhage was not located in five patients (6.6 % of all positive tests despite the accurate diagnostic procedure.Conclusions: By performing a fecal occult blood screening in non-symptomatic patients, we can make an essential step towards discovering different gastrointestinal diseases, even colorectal cancer in its early, limited form, when the effect of treatment is greatest.

Routine Responses to Disruption of Routines

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Guha, Mahua

2015-01-01

"Organisational routines" is a widely studied research area. However, there is a dearth of research on disruption of routines. The few studies on disruption of routines discussed problem-solving activities that are carried out in response to disruption. In contrast, this study develops a theory of "solution routines" that are a…

A systematic review of the diagnostic performance of orthopedic physical examination tests of the hip.

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Rahman, Labib Ataur; Adie, Sam; Naylor, Justine Maree; Mittal, Rajat; So, Sarah; Harris, Ian Andrew

2013-08-30

Previous reviews of the diagnostic performances of physical tests of the hip in orthopedics have drawn limited conclusions because of the low to moderate quality of primary studies published in the literature. This systematic review aims to build on these reviews by assessing a broad range of hip pathologies, and employing a more selective approach to the inclusion of studies in order to accurately gauge diagnostic performance for the purposes of making recommendations for clinical practice and future research. It specifically identifies tests which demonstrate strong and moderate diagnostic performance. A systematic search of Medline, Embase, Embase Classic and CINAHL was conducted to identify studies of hip tests. Our selection criteria included an analysis of internal and external validity. We reported diagnostic performance in terms of sensitivity, specificity, predictive values and likelihood ratios. Likelihood ratios were used to identify tests with strong and moderate diagnostic utility. Only a small proportion of tests reported in the literature have been assessed in methodologically valid primary studies. 16 studies were included in our review, producing 56 independent test-pathology combinations. Two tests demonstrated strong clinical utility, the patellar-pubic percussion test for excluding radiologically occult hip fractures (negative LR 0.05, 95% Confidence Interval [CI] 0.03-0.08) and the hip abduction sign for diagnosing sarcoglycanopathies in patients with known muscular dystrophies (positive LR 34.29, 95% CI 10.97-122.30). Fifteen tests demonstrated moderate diagnostic utility for diagnosing and/or excluding hip fractures, symptomatic osteoarthritis and loosening of components post-total hip arthroplasty. We have identified a number of tests demonstrating strong and moderate diagnostic performance. These findings must be viewed with caution as there are concerns over the methodological quality of the primary studies from which we have extracted our

Diagnosis of antiphospholipid syndrome in routine clinical practice

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Hills, J; Machin, SJ; Cohen, H

2013-01-01

The updated international consensus criteria for definite antiphospholipid syndrome (APS) are useful for scientific clinical studies. However, there remains a need for diagnostic criteria for routine clinical use. We audited the results of routine antiphospholipid antibodies (aPLs) in a cohort of 193 consecutive patients with aPL positivity-based testing for lupus anticoagulant (LA), IgG and IgM anticardiolipin (aCL) and anti-ß2glycoprotein-1 antibodies (aß2GPI). Medium/high-titre aCL/aβ2GPI was defined as >99th percentile. Low-titre aCL/aβ2GPI positivity (>95th < 99th percentile) was considered positive for obstetric but not for thrombotic APS. One hundred of the 145 patients fulfilled both clinical and laboratory criteria for definite APS. Twenty-six women with purely obstetric APS had persistent low-titre aCL and/or aβ2GPI. With the inclusion of these patients, 126 of the 145 patients were considered to have APS. Sixty-seven out of 126 patients were LA-negative, of whom 12 had aCL only, 37 had aβ2GPI only and 18 positive were for both. The omission of aCL or aβ2GPI testing from investigation of APS would have led to a failure to diagnose APS in 9.5% and 29.4% of patients, respectively. Our data suggest that LA, aCL and aβ2GPI testing are all required for the accurate diagnosis of APS and that low-titre antibodies should be included in the diagnosis of obstetric APS. PMID:22988029

The MOAHLFA index of irritant sodium lauryl sulfate reactions: first results of a multicentre study on routine sodium lauryl sulfate patch testing.

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Uter, Wolfgang; Geier, Johannes; Becker, Detlef; Brasch, Jochen; Löffler, Harald

2004-01-01

In a multicentre study of the German Contact Dermatitis Research Group, sodium lauryl sulfate (SLS) 0.25% and 0.5% aq. has been added to routine allergen patch tests to assess its properties as a convenient diagnostic indicator of individual susceptibility to irritation at the time of patch testing. Previous studies indicated that irritant SLS reactivity may be related to individual factors such as age and sex. As these factors are, in turn, among the important predictors of contact allergy to many allergens, e.g. summarized in the 'MOAHLFA index', the impact of the MOAHLFA factors on irritant SLS patch test reactivity, and thus a potential for confounding, was assessed in the 5971 participating patients. As a result of 2 logistic regression analyses with an irritant reaction to 0.25% and 0.5% SLS, respectively, as outcome, male sex was identified as a relatively weak but significant risk factor (OR 1.38), while age 40 years or older was an even weaker risk factor (OR 1.22 and 1.15, respectively). Upon detailed analysis, no clear age gradient could, however, be identified. 1-day exposure time almost halved the odds of an irritant SLS reaction. In conclusion, this type of SLS patch test can be regarded as robust, indicating individual irritability relatively independent from the individual factors analysed here.

Effect of Remote Back-Up Protection System Failure on the Optimum Routine Test Time Interval of Power System Protection

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Y Damchi

2013-12-01

Full Text Available Appropriate operation of protection system is one of the effective factors to have a desirable reliability in power systems, which vitally needs routine test of protection system. Precise determination of optimum routine test time interval (ORTTI plays a vital role in predicting the maintenance costs of protection system. In the most previous studies, ORTTI has been determined while remote back-up protection system was considered fully reliable. This assumption is not exactly correct since remote back-up protection system may operate incorrectly or fail to operate, the same as the primary protection system. Therefore, in order to determine the ORTTI, an extended Markov model is proposed in this paper considering failure probability for remote back-up protection system. In the proposed Markov model of the protection systems, monitoring facility is taken into account. Moreover, it is assumed that the primary and back-up protection systems are maintained simultaneously. Results show that the effect of remote back-up protection system failures on the reliability indices and optimum routine test intervals of protection system is considerable.

Quality of information accompanying on-line marketing of home diagnostic tests.

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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.

Detection of PAX8/PPARG and RET/PTC Rearrangements Is Feasible in Routine Air-Dried Fine Needle Aspiration Smears

DEFF Research Database (Denmark)

Ferraz, Carolina; Rehfeld, Christian; Krogdahl, Annelise

2012-01-01

Background: The diagnostic limitations of fine needle aspiration (FNA), like the indeterminate category, can be partially overcome by molecular analysis. As PAX8/PPARG and RET/PTC rearrangements have been detected in follicular thyroid carcinomas (FTCs) and papillary thyroid carcinomas (PTCs......), their detection in FNA smears could improve the FNA diagnosis. To date, these rearrangements have never been analyzed in routine air-dried FNA smears, but only in frozen tissue, formalin-fixed paraffin-embedded (FFPE) tissue, and in fresh FNA material. Fixed routine air-dried FNA samples have hitherto been judged...... as generally not suitable for testing these rearrangements in a clinical setting. Therefore, the objective of the present study was to investigate the feasibility of extracting RNA from routine air-dried FNA smears for the detection of these rearrangements with real-time polymerase chain reaction (RT...

Establishing diagnostic cut-off criteria for the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative test through validation against the Amplicor DNA test v1.5 for infant diagnosis using dried blood spots.

Science.gov (United States)

Maritz, Jean; Preiser, Wolfgang; van Zyl, Gert U

2012-02-01

As antibody testing cannot confirm HIV-1 infection in children less than 18 months of age, diagnosis in these children depends on nucleic acid testing. The COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) (CAP/CTM, Roche(®) Molecular Systems, Inc., Branchburg, NJ) HIV-1 Qualitative test is a total nucleic acid real-time PCR assay utilising whole EDTA blood or dried blood spots (DBS), which recently replaced the Roche(®) AMPLICOR(®) DNA test v1.5 (Amplicor) as the diagnostic HIV PCR assay in many South African laboratories. For the Amplicor assay, stringent diagnostic criteria were previously formulated for the local population, and a comparison reported the CAP/CTM's sensitivity at 99.7% and specificity at 100% for both sample types compared to these Amplicor criteria. To validate the assay prior to introduction in our laboratory and to define stringent diagnostic cut-off criteria. Whole EDTA blood samples from patients younger than 18 months sent for routine HIV-1 diagnosis were tested by Amplicor, and positive results were confirmed from DBS. CAP/CTM assays were subsequently performed from DBS. The CAP/CTM had a sensitivity of 98.8% and a specificity of 97.1%, but a positive predictive value (PPV) of only 78.7% compared to the Amplicor assay. Samples positive by CAP/CTM but negative by Amplicor displayed poor amplification curves compared to concordant positive samples. Upon re-testing those with sufficient material available by CAP/CTM, all showed negative results. The decreased PPV may either be due to false positive CAP/CTM results, or increased sensitivity compared to the Amplicor assay. Criteria were formulated for defining presumed false-positive results. Copyright © 2011 Elsevier B.V. All rights reserved.

The dilemma of diagnostic testing for Prader-Willi syndrome

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Hung, Dorothy

2017-01-01

Although Prader-Willi syndrome (PWS) is a well-described clinical dysmorphic syndrome, DNA testing is required for a definitive diagnosis. A definitive diagnosis can be made in approximately 99% of cases using DNA testing; there are a number of DNA tests that can be used for this purpose, although there is no set standard algorithm of testing. The dilemma arises because of the complex genetic mechanisms at the basis of PWS, which need to be elucidated. To establish the molecular mechanism with a complete work up, involves at least 2 tests. Here we discuss the commonly used tests currently available and suggest a cost—effective approach to diagnostic testing. PMID:28164030

Feasibility of using microbiology diagnostic tests of moderate or high complexity at the point - of - care in a delivery suite.

Science.gov (United States)

Gray, J W; Milner, P J; Edwards, E H; Daniels, J P; Khan, K S

2012-07-01

Point-of-care testing (POCT) is one of the fastest growing sectors of laboratory diagnostics. Most tests in routine use are haematology or biochemistry tests that are of low complexity. Microbiology POCT has been constrained by a lack of tests that are both accurate and of low complexity. We describe our experience of the practical issues around using more complex POCT for detection of Group B streptococci (GBS) in swabs from labouring women. We evaluated two tests for their feasibility in POCT: an optical immune assay (Biostar OIA Strep B, Inverness Medical, Princetown, NJ) and a PCR (IDI-Strep B, Cepheid, Sunnyvale, CA), which have been categorised as being of moderate and high complexity, respectively. A total of 12 unqualified midwifery assistants (MA) were trained to undertake testing on the delivery suite. A systematic approach to the introduction and management of POC testing was used. Modelling showed that the probability of test results being available within a clinically useful timescale was high. However, in the clinical setting, we found it impossible to maintain reliable availability of trained testers. Implementation of more complex POC testing is technically feasible, but it is expensive, and may be difficult to achieve in a busy delivery suite.

Test objects for evaluating the performance of radiological imaging systems. Leeds radiological test objects

International Nuclear Information System (INIS)

Cowen, A.R.; Clarke, O.F.; Haywood, J.M.; Parker, R.P.

1985-01-01

A range of test objects has been developed to assess the imaging performance of conventional and digital radiological imaging systems. These test objects have arisen as a result of involvement in both the laboratory evaluation of radiological imaging systems and the routine maintenance of such equipment in a large diagnostic radiology department. The philosophy behind the design and application of the test objects is briefly described. Particular attention is paid to the advantages of using the threshold-contrast detail-detectability technique to assess overall imaging performance. The great importance of ensuring optimum imaging performance prior to clinical acceptance is stressed. A strategy for implementing the test objects in a clinical department is present. The diagnostic information content of the clinical images which result measures the success of the quality control procedure adopted. (author)

The Evaluation of Diagnostic Tests for Sexually Transmitted Infections

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Max A Chernesky

2005-01-01

Full Text Available Diagnostic tests should receive method- and use-effectiveness evaluations. Method-effectiveness evaluations determine sensitivity, specificity and predictive values for new tests. Use-effectiveness evaluations determine how practical or convenient a new test will be in a specific setting and may not be performed in a formal way in North American laboratories. To perform a clinical method evaluation of diagnostic tests, a good relationship between laboratory and clinical personnel is essential. Studies are usually conducted separately on populations of men and women, and should include sampling from different prevalence groups. Test performance comparisons may be made on a single specimen type or on more than one specimen from the same patient, which allows for the expansion of a reference standard and includes the ability of a particular assay, performed on a specimen type to diagnose an infected individual. The following components of the evaluation should be standardized and carefully followed: specimen identification; collection; transportation; processing; quality control; reading; proficiency testing; confirmatory testing; discordant analysis -- sensitivity, specificity and predictive value calculations; and record keeping. Methods are available to determine whether sample results are true or false positives or negatives. Use-effectiveness evaluations might determine the stability or durability of supplies and equipment; the logistics of shipping, receiving and storing supplies; the clarity and completeness of test instructions; the time and effort required to process and read results; the subjectivity factors in interpretation and reporting; and the costs. These determinations are usually more apparent for commercial assays than for homemade tests.

Diagnostic Tests for Entering and Departing Undergraduate Students

Science.gov (United States)

Waltham, Chris; Kotlicki, A.

2006-12-01

A diagnostic test administered at the start of a class should test basic concepts which are recognized as course prerequisites. The questions should not be over-packaged: e.g. students should be required to create models, rather than this being done for them each time. Students should be allowed great latitude in their answers, so we can discover what they are thinking. When administered at the end of a class the goals should be similar: testing concepts taught in the class itself and the retention of necessary concepts from previous classes. Great care has to be taken to avoid teaching to the test. In assessing an entire program, for example an undergraduate majors degree in physics, then one looks for very general skills and knowledge not specific to any one course. The purpose of an undergraduate degree in physics (or indeed any science) is to equip the students with a set of problem-solving skills and basic knowledge which can be applied in a large variety of workplace settings and to allow that student to contribute to civic society as a science-literate person. The creator of any diagnostic test should always have these big goals in mind. We have developed a set of questions which we think fulfill these criteria, yet are not specific to any particular level of science education. They have been administered to students in secondary schools across Canada, incoming first-year science students and final-year physics students at the University of British Columbia. The results will be presented.

Beyond the 2×2 -contingency table: a primer on entropies and mutual information in various scenarios involving m diagnostic categories and n categories of diagnostic tests.

Science.gov (United States)

Reibnegger, Gilbert

2013-10-21

Usual evaluation tools for diagnostic tests such as, sensitivity/specificity and ROC analyses, are designed for the discrimination between two diagnostic categories, using dichotomous test results. Information theoretical quantities such as mutual information allow in depth-analysis of more complex discrimination problems, including continuous test results, but are rarely used in clinical chemistry. This paper provides a primer on useful information theoretical concepts with a strong focus on typical diagnostic scenarios. Information theoretical concepts are shortly explained. Mathematica CDF documents are provided which compute entropies and mutual information as function of pretest probabilities and the distribution of test results among the categories, and allow interactive exploration of the behavior of these quantities in comparison with more conventional diagnostic measures. Using data from a previously published study, the application of information theory to practical diagnostic problems involving up to 4×4 -contingency tables is demonstrated. Information theoretical concepts are particularly useful for diagnostic problems requiring more than the usual binary classification. Quantitative test results can be properly analyzed, and in contrast to popular concepts such as ROC analysis, the effects of variations of pre-test probabilities of the diagnostic categories can be explicitly taken into account. © 2013 Elsevier B.V. All rights reserved.

Accuracy of molecular diagnostics in pemphigus and bullous pemphigoid: comparison of commercial and modified mosaic indirect immunofluorescence tests as well as enzyme-linked immunosorbent assays

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Justyna Gornowicz-Porowska

2017-02-01

Full Text Available Introduction : Pemphigus and bullous pemphigoid (BP are identified by autoantibodies (abs against desmoglein 1, 3 (DSG1/3 and BP180/BP230, respectively. A novel mosaic to indirect immunofluorescence (IIF using purified BP180 recombinant proteins spotted on slide and transfected cells expressing BP230, DSG1, DSG3 is available. The commercial (IgG detection and modified (IgG4 detection mosaic for indirect immunofluorescence (IIFc – IIF commercial, IIFm – IIF modified and IgG ELISAs were evaluated in pemphigus and bullous pemphigoid (BP molecular diagnostics. Aim : To compare diagnostic accuracy of commercial (IgG detection and modified (IgG4 detection mosaic IIF assay and to examine the diagnostic value of ELISAs in relation to mosaic IIF in routine laboratory diagnostics of pemphigus and BP. Material and methods : Sera from 37 BP and 19 pemphigus patients were studied. Associations between tests were assessed using Fisher’s exact test. Results: There are associations between the positive/negative samples detected by IIFc with desmoglein1 (DSG1/desmoglein3 (DSG3/BP230 transfected cells and ELISAs and no association between anti-BP180 IgG detection by IIFc and ELISA. IIFm with DSG1 and DSG3 showed both 100% sensitivity and 100% and 78% specificity, respectively, and 100% and 83% positive predictive value in relation to IIFc. IIFm with BP230 had 87% specificity, 55% sensitivity, whereas IIFm with BP180 had a 100% sensitivity and 13% specificity in relation to IIFc. Conclusions : The IIFc with DSG1/DSG3/BP230 transfected cells, excluding BP180 spots, is an alternative method to ELISA in pemphigus/BP diagnostics. IgG4 antibodies, both pathogenically and diagnostically important, are inconsistently detectable with IIFm.

Diagnostic time in digital pathology: A comparative study on 400 cases

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Aleksandar Vodovnik

2016-01-01

Full Text Available Background: Numerous validation studies in digital pathology confirmed its value as a diagnostic tool. However, a longer time to diagnosis than traditional microscopy has been seen as a significant barrier to the routine use of digital pathology. As a part of our validation study, we compared a digital and microscopic diagnostic time in the routine diagnostic setting. Materials and Methods: One senior staff pathologist reported 400 consecutive cases in histology, nongynecological, and fine needle aspiration cytology (20 sessions, 20 cases/session, over 4 weeks. Complex, difficult, and rare cases were excluded from the study to reduce the bias. A primary diagnosis was digital, followed by traditional microscopy, 6 months later, with only request forms available for both. Microscopic slides were scanned at ×20, digital images accessed through the fully integrated laboratory information management system (LIMS and viewed in the image viewer on double 23” displays. A median broadband speed was 299 Mbps. A diagnostic time was measured from the point slides were made available to the point diagnosis was made or additional investigations were deemed necessary, recorded independently in minutes/session and compared. Results: A digital diagnostic time was 1841 and microscopic 1956 min; digital being shorter than microscopic in 13 sessions. Four sessions with shorter microscopic diagnostic time included more cases requiring extensive use of magnifications over ×20. Diagnostic time was similar in three sessions. Conclusions: A diagnostic time in digital pathology can be shorter than traditional microscopy in the routine diagnostic setting, with adequate and stable network speeds, fully integrated LIMS and double displays as default parameters. This also related to better ergonomics, larger viewing field, and absence of physical slide handling, with effects on both diagnostic and nondiagnostic time. Differences with previous studies included a design

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

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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.

Quality of information accompanying on-line marketing of home diagnostic tests

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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

Automation of the linear array HPV genotyping test and its application for routine typing of human papillomaviruses in cervical specimens of women without cytological abnormalities in Switzerland.

Science.gov (United States)

Dobec, Marinko; Bannwart, Fridolin; Kaeppeli, Franz; Cassinotti, Pascal

2009-05-01

There is a need for reliable, automated high throughput HPV detection and genotyping methods for pre- and post-prophylactic vaccine intervention analyses. To optimize the linear array (LA) HPV genotyping test (Roche Diagnostics, Rotkreuz) in regard to possible automation steps for the routine laboratory diagnosis of HPV infections and to analyze the HPV genotype distribution in cervical specimens of women without cytological abnormalities in Switzerland. 680 cervical cell specimens with normal cytology, obtained from women undergoing routine cervical screening by liquid-based Pap smear, were analyzed by the LA HPV genotyping test for HPV-DNA. The automation of the LA HPV genotyping test resulted in a total hands-on time reduction of 255 min (from 480 to 225 min; 53%). Any of 37 HPV genotypes were detected in 117 (17.2%) and high-risk (HR) HPV in 55 (8.1%) of 680 women with normal cytology. The highest prevalence of any HPV (28.1%) and HR-HPV (15.1%) was observed in age-group 21-30 and showed a continuous decrease in older age-groups. The most common HR-HPV genotypes were HPV-16 (12%), HPV-31 (9.4%), HPV-52 (6%), HPV-51 (5.1%), HPV-45 (4.3%), HPV-58 (4.3%) and HPV-59 (4.3%). The optimization and automation of the LA HPV genotyping test makes it suited for high throughput HPV detection and typing. The epidemiological data provides information about distribution of HPV genotypes in women without cytological abnormalities in Switzerland and may be important for determining the future impact of vaccines and potential changes in the country's epidemiological HPV profile.

Diagnostic significance of haematological testing in patients presenting at the Emergency Department

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Giuseppe Lippi

2012-03-01

Full Text Available The use of simple and economic tests to rule out diseases of sufficient clinical severity is appealing in emergency department (ED, since it would be effective for contrasting ED overcrowding and decreasing healthcare costs. The aim of this study was to assess the diagnostic performance of simple and economic haematological testing in a large sample of adult patients presenting at the ED of the Academic Hospital of Parma during the year 2010 with the five most frequent acute pathologies (i.e., acute myocardial infarction, renal colic, pneumonia, trauma and pancreatitis. Both leukocyte count and hemoglobin showed a good diagnostic performance (Area Under the Curve [AUC] of 0.85 for leukocyte count and 0.76 for hemoglobin; both p < 0.01. Although the platelet count was significantly increased in all patients groups except pancreatitis, the diagnostic performance did not achieve statistical significance (AUC 0.53; p = 0.07. We also observed an increased RDW in all groups, except in those with trauma and the diagnostic performance was acceptable (AUC 0.705; p < 0.01. The mean platelet volume (MPV was consistently lower in all patients groups and also characterized by an efficient diagnostic performance (AUC 0.76; p < 0.01. This evidence led us to design an arbitrary formula, whereby MPV and hemoglobin were multiplied, and further divided by the leukocyte count, obtaining a remarkable AUC (0.91; p < 0.01. We conclude that simple, rapid and cheap hematological tests might provide relevant clinical information for decision making to busy emergency physicians, and the their combination into an arbitrary formula might further increase the specific diagnostic potential of each of them.

Auditory Automotive Mechanics Diagnostic Achievement Test. Center Technical Paper No. 2.

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Swanson, Richard Arthur

The Auditory Automotive Mechanics Diagnostic Achievement Test assesses an automobile mechanic's ability to determine mechanical faults from auditory cues alone. The 44-item test and its instructions are recorded on magnetic tape; answer choices are presented on tape, and are also written in the printed test booklets. The norming and validity…

Decision making about healthcare-related tests and diagnostic test strategies. Paper 2: a review of methodological and practical challenges.

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Mustafa, Reem A; Wiercioch, Wojtek; Cheung, Adrienne; Prediger, Barbara; Brozek, Jan; Bossuyt, Patrick; Garg, Amit X; Lelgemann, Monika; Büehler, Diedrich; Schünemann, Holger J

2017-12-01

In this first of a series of five articles, we provide an overview of how and why healthcare-related tests and diagnostic strategies are currently applied. We also describe how our findings can be integrated with existing frameworks for making decisions that guide the use of healthcare-related tests and diagnostic strategies. We searched MEDLINE, references of identified articles, chapters in relevant textbooks, and identified articles citing classic literature on this topic. We provide updated frameworks for the potential roles and applications of tests with suggested definitions and practical examples. We also discuss study designs that are commonly used to assess tests' performance and the effects of tests on people's health. These designs include diagnostic randomized controlled trials and retrospective validation. We describe the utility of these and other currently suggested designs, which questions they can answer and which ones they cannot. In addition, we summarize the challenges unique to decision-making resulting from the use of tests. This overview highlights current challenges in the application of tests in decision-making in healthcare, provides clarifications, and informs the proposed solutions. Copyright © 2017 Elsevier Inc. All rights reserved.

Performance Evaluation of Commercial Dengue Diagnostic Tests for Early Detection of Dengue in Clinical Samples

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Tuan Nur Akmalina Mat Jusoh

2017-01-01

Full Text Available The shattering rise in dengue virus infections globally has created a need for an accurate and validated rapid diagnostic test for this virus. Rapid diagnostic test (RDT and reverse transcription-polymerase chain reaction (RT-PCR diagnostic detection are useful tools for diagnosis of early dengue infection. We prospectively evaluated the diagnostic performance of nonstructural 1 (NS1 RDT and real-time RT-PCR diagnostic kits in 86 patient serum samples. Thirty-six samples were positive for dengue NS1 antigen while the remaining 50 were negative when tested with enzyme-linked immunosorbent assay (ELISA. Commercially available RDTs for NS1 detection, RTK ProDetect™, and SD Bioline showed high sensitivity of 94% and 89%, respectively, compared with ELISA. GenoAmp® Trioplex Real-Time RT-PCR and RealStar® Dengue RT-PCR tests presented a comparable kappa agreement with 0.722. The result obtained from GenoAmp® Real-Time RT-PCR Dengue test showed that 14 samples harbored dengue virus type 1 (DENV-1, 8 samples harbored DENV-2, 2 samples harbored DENV-3, and 1 sample harbored DENV-4. 1 sample had a double infection with DENV-1 and DENV-2. The NS1 RDTs and real-time RT-PCR tests were found to be a useful diagnostic for early and rapid diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.

Diagnostic and laboratory test ordering in Northern Portuguese Primary Health Care: a cross-sectional study

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Sá, Luísa; Teixeira, Andreia Sofia Costa; Tavares, Fernando; Costa-Santos, Cristina; Couto, Luciana; Costa-Pereira, Altamiro; Hespanhol, Alberto Pinto; Santos, Paulo

2017-01-01

Objectives To characterise the test ordering pattern in Northern Portugal and to investigate the influence of context-related factors, analysing the test ordered at the level of geographical groups of family physicians and at the level of different healthcare organisations. Design Cross-sectional study. Setting Northern Primary Health Care, Portugal. Participants Records about diagnostic and laboratory tests ordered from 2035 family physicians working at the Northern Regional Health Administration, who served approximately 3.5 million Portuguese patients, in 2014. Outcomes To determine the 20 most ordered diagnostic and laboratory tests in the Northern Regional Health Administration; to identify the presence and extent of variations in the 20 most ordered diagnostic and laboratory tests between the Groups of Primary Care Centres and between health units; and to study factors that may explain these variations. Results The 20 most ordered diagnostic and laboratory tests almost entirely comprise laboratory tests and account for 70.9% of the total tests requested. We can trace a major pattern of test ordering for haemogram, glucose, lipid profile, creatinine and urinalysis. There was a significant difference (P<0.001) in test orders for all tests between Groups of Primary Care Centres and for all tests, except glycated haemoglobin (P=0.06), between health units. Generally, the Personalised Healthcare Units ordered more than Family Health Units. Conclusions The results from this study show that the most commonly ordered tests in Portugal are laboratory tests, that there is a tendency for overtesting and that there is a large variability in diagnostic and laboratory test ordering in different geographical and organisational Portuguese primary care practices, suggesting that there may be considerable potential for the rationalisation of test ordering. The existence of Family Health Units seems to be a strong determinant in decreasing test ordering by Portuguese family

The impact of communication barriers on diagnostic confidence and ancillary testing in the emergency department.

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Garra, Gregory; Albino, Hiram; Chapman, Heather; Singer, Adam J; Thode, Henry C

2010-06-01

Communication barriers (CBs) compromise the diagnostic power of the medical interview and may result in increased reliance on diagnostic tests or incorrect test ordering. The prevalence and degree to which these barriers affect diagnosis, testing, and treatment are unknown. To quantify and characterize CBs encountered in the Emergency Department (ED), and assess the effect of CBs on initial diagnosis and perceived reliance on ancillary testing. This was a prospective survey completed by emergency physicians after initial adult patient encounters. CB severity, diagnostic confidence, and reliance on ancillary testing were quantified on a 100-mm Visual Analog Scale (VAS) from least (0) to most (100). Data were collected on 417 ED patient encounters. CBs were reported in 46%; with a mean severity of 50 mm on a 100-mm VAS with endpoints of "perfect communication and "no communication." Language was the most commonly reported form of CB (28%). More than one CB was identified in 6%. The 100-mm VAS rating of diagnostic confidence was lower in patients with perceived CBs (64 mm) vs. those without CBs (80 mm), p Communication barriers in our ED setting were common, and resulted in lower diagnostic confidence and increased perception that ancillary tests are needed to narrow the diagnosis. Copyright 2010 Elsevier Inc. All rights reserved.

Radiation measurement and risk estimation for pediatrics during routine diagnostic examination in some hospitals of Khartoum state

International Nuclear Information System (INIS)

Saeed, E. B. Y.

2010-01-01

Patient dose monitoring was formalized in the national protocol for patient dose measurement in Diagnostic Radiology. Entrance Skin Dose (ESD) and Effective Dose have been measured for pediatric patient under going some routine pediatric x-ray examination in five Hospitals in Sudan namely (Ahmed Gasim for Paediatric Hospital, Khartoum state for main paediatric Hospital (Omdurman, Khartoum , Ah Gassim, Ab naof) Paediatric Hospitals. Two examination projection have been investigated, namely anterior posterior (AP) and posterior Anterior ( PA). Patient were classed into three different age groups 0-2 year, 2-5 year, 5-15 year. The result have been obtained with the use of the TLD as first time in Sudan. The mean of ESD and thyroid dose are represented and comparisons were made between these dose and international standard dose, local study also between doses and those from other counters. The mean of ESD and ED in Ah Gasim and Khartoum Hospital are higher than reference dose and low than other counters. The reason for the higher dose have been discussed and suggestions are given to reduced dosed to pediatric patient during x-ray examination especially in developing countries. (Author)

Mirror fusion test facility plasma diagnostics system

International Nuclear Information System (INIS)

Thomas, S.R. Jr.; Coffield, F.E.; Davis, G.E.; Felker, B.

1979-01-01

During the past 25 years, experiments with several magnetic mirror machines were performed as part of the Magnetic Fusion Energy (MFE) Program at LLL. The latest MFE experiment, the Mirror Fusion Test Facility (MFTF), builds on the advances of earlier machines in initiating, stabilizing, heating, and sustaining plasmas formed with deuterium. The goals of this machine are to increase ion and electron temperatures and show a corresponding increase in containment time, to test theoretical scaling laws of plasma instabilities with increased physical dimensions, and to sustain high-beta plasmas for times that are long compared to the energy containment time. This paper describes the diagnostic system being developed to characterize these plasma parameters

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

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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.

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

Science.gov (United States)

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

Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach.

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Payne, Deborah A; Baluchova, Katarina; Peoc'h, Katell H; van Schaik, Ron H N; Chan, K C Allen; Maekawa, Masato; Mamotte, Cyril; Russomando, Graciela; Rousseau, François; Ahmad-Nejad, Parviz

2017-04-01

Multiple organizations produce guidance documents that provide opportunities to harmonize quality practices for diagnostic testing. The International Organization for Standardization ISO 15189 standard addresses requirements for quality in management and technical aspects of the clinical laboratory. One technical aspect addresses the complexities of the pre-examination phase prior to diagnostic testing. The Committee for Molecular Diagnostics of the International Federation for Clinical Chemistry and Laboratory Medicine (also known as, IFCC C-MD) conducted a survey of international molecular laboratories and determined ISO 15189 to be the most referenced guidance document. In this review, the IFCC C-MD provides case-based examples illustrating the value of select pre-examination processes as these processes relate to molecular diagnostic testing. Case-based examples in infectious disease, oncology, inherited disease and pharmacogenomics address the utility of: 1) providing information to patients and users, 2) designing requisition forms, 3) obtaining informed consent and 4) maintaining sample integrity prior to testing. The pre-examination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. The clinical vignettes presented in this paper illustrate the value of applying select ISO 15189 recommendations for general laboratory to the more specialized area of Molecular Diagnostics. Copyright © 2016 Elsevier B.V. All rights reserved.

Progress in diagnostic techniques for sc cavities

International Nuclear Information System (INIS)

Reece, C.E.

1988-01-01

While routinely achieved performance characteristics of superconducting cavities have now reached a level which makes them useful in large scale applications, achieving this level has come only through the knowledge gained by systematic studies of performance limiting phenomena. Despite the very real progress that has been made, the routine performance of superconducting cavities still falls far short of both the theoretical expectations and the performance of a few exception examples. It is the task of systematically applied diagnostic techniques to reveal additional information concerning the response of superconducting surfaces to applied RF fields. Here recent developments in diagnostic techniques are discussed. 18 references, 12 figures

Radiogenomics: Creating a link between molecular diagnostics and diagnostic imaging

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Rutman, Aaron M. [Department of Radiology, University of California San Diego Medical Center, San Diego, CA 92103 (United States); Kuo, Michael D. [Department of Radiology, University of California San Diego Medical Center, San Diego, CA 92103 (United States); Center for Translational Medical Systems, University of California San Diego Medical Center, San Diego, CA 92103 (United States)], E-mail: mkuo@ucsd.edu

2009-05-15

Studies employing high-throughput biological techniques have recently contributed to an improved characterization of human cancers, allowing for novel sub-classification, better diagnostic accuracy, and more precise prognostication. However, requirement of surgical procurement of tissue among other things limits the clinical application of such methods in everyday patient care. Radiographic imaging is routine in clinical practice but is currently histopathology based. The use of routine radiographic imaging provides a potential platform for linking specific imaging traits with specific gene expression patterns that inform the underlying cellular pathophysiology; imaging features could then serve as molecular surrogates that contribute to the diagnosis, prognosis, and likely gene-expression-associated treatment response of various forms of human cancer. This review focuses on high-throughput methods such as microarray analysis of gene expression, their role in cancer research, and in particular, on novel methods of associating gene expression patterns with radiographic imaging phenotypes, known as 'radiogenomics.' These findings underline a potential future role of both diagnostic and interventional radiologists in genetic assessment of cancer patients with radiographic imaging studies.

Radiogenomics: Creating a link between molecular diagnostics and diagnostic imaging

International Nuclear Information System (INIS)

Rutman, Aaron M.; Kuo, Michael D.

2009-01-01

Studies employing high-throughput biological techniques have recently contributed to an improved characterization of human cancers, allowing for novel sub-classification, better diagnostic accuracy, and more precise prognostication. However, requirement of surgical procurement of tissue among other things limits the clinical application of such methods in everyday patient care. Radiographic imaging is routine in clinical practice but is currently histopathology based. The use of routine radiographic imaging provides a potential platform for linking specific imaging traits with specific gene expression patterns that inform the underlying cellular pathophysiology; imaging features could then serve as molecular surrogates that contribute to the diagnosis, prognosis, and likely gene-expression-associated treatment response of various forms of human cancer. This review focuses on high-throughput methods such as microarray analysis of gene expression, their role in cancer research, and in particular, on novel methods of associating gene expression patterns with radiographic imaging phenotypes, known as 'radiogenomics.' These findings underline a potential future role of both diagnostic and interventional radiologists in genetic assessment of cancer patients with radiographic imaging studies.

Estimating prevalence and diagnostic test characteristics of bovine cysticercosis in Belgium in the absence of a 'gold standard' reference test using a Bayesian approach.

Science.gov (United States)

Jansen, Famke; Dorny, Pierre; Gabriël, Sarah; Eichenberger, Ramon Marc; Berkvens, Dirk

2018-04-30

A Bayesian model was developed to estimate values for the prevalence and diagnostic test characteristics of bovine cysticercosis (Taenia saginata) by combining results of four imperfect tests. Samples of 612 bovine carcases that were found negative for cysticercosis during routine meat inspection collected at three Belgian slaughterhouses, underwent enhanced meat inspection (additional incisions in the heart), dissection of the predilection sites, B158/B60 Ag-ELISA and ES Ab-ELISA. This Bayesian approach allows for the combination of prior expert opinion with experimental data to estimate the true prevalence of bovine cysticercosis in the absence of a gold standard test. A first model (based on a multinomial distribution and including all possible interactions between the individual tests) required estimation of 31 parameters, while only allowing for 15 parameters to be estimated. Including prior expert information about specificity and sensitivity resulted in an optimal model with a reduction of the number of parameters to be estimated to 8. The estimated bovine cysticercosis prevalence was 33.9% (95% credibility interval: 27.7-44.4%), while apparent prevalence based on meat inspection is only 0.23%. The test performances were estimated as follows (sensitivity (Se) - specificity (Sp)): enhanced meat inspection (Se 2.87% - Sp 100%), dissection of predilection sites (Se 69.8% - Sp 100%), Ag-ELISA (Se 26.9% - Sp 99.4%), Ab-ELISA (Se 13.8% - Sp 92.9%). Copyright © 2018 Elsevier B.V. All rights reserved.

Appraising and applying evidence about a diagnostic test during a performance-based assessment

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Franklin Ellen

2004-10-01

Full Text Available Abstract Background The practice of Evidence-based Medicine requires that clinicians assess the validity of published research and then apply the results to patient care. We wanted to assess whether our soon-to-graduate medical students could appraise and apply research about a diagnostic test within a clinical context and to compare our students with peers trained at other institutions. Methods 4th year medical students who previously had demonstrated competency at probability revision and just starting first-year Internal Medicine residents were used for this research. Following an encounter with a simulated patient, subjects critically appraised a paper about an applicable diagnostic test and revised the patient's pretest probability given the test result. Results The medical students and residents demonstrated similar skills at critical appraisal, correctly answering 4.7 and 4.9, respectively, of 6 questions (p = 0.67. Only one out of 28 (3% medical students and none of the 15 residents were able to correctly complete the probability revision task (p = 1.00. Conclusions This study found that most students completing medical school are able to appraise an article about a diagnostic test but few are able to apply the information from the article to a patient. These findings raise questions about the clinical usefulness of the EBM skills possessed by graduating medical students within the area of diagnostic testing.

Sequential Test Selection by Quantifying of the Reduction in Diagnostic Uncertainty for the Diagnosis of Proximal Caries

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Umut Arslan

2013-06-01

Full Text Available Background: In order to determine the presence or absence of a certain disease, multiple diagnostic tests may be necessary. Performance of these tests can be sequentially evaluated. Aims: The aim of the study is to determine the contribution of the test in each step, in reducing diagnostic uncertainty when multiple tests are sequentially used for the diagnosis. Study Design: Diagnostic accuracy study Methods: Radiographs of seventy-three patients of the Department of Dento-Maxillofacial Radiology of Hacettepe University Faculty of Dentistry were assessed. Panoramic (PAN, full mouth intraoral (FM, and bitewing (BW radiographs were used for the diagnosis of proximal caries in the maxillary and mandibular molar regions. Diagnostic performance of radiography was sequentially evaluated by using the reduction in diagnostic uncertainty. Results: FM provided maximum diagnostic information for ruling in potential in the maxillary and mandibular molar regions in the first step. FM provided more diagnostic information than BW radiographs for ruling in the mandibular region in the second step. In the mandibular region, BW radiographs provided more diagnostic information than FM for ruling out in the first step. Conclusion: The presented method in this study provides the clinicians with a solution for the decision of the sequential selection of diagnostic tests for the correct diagnosis of the presence or absence of a certain disease.

Privacy and equality in diagnostic genetic testing.

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Nyrhinen, Tarja; Hietala, Marja; Puukka, Pauli; Leino-Kilpi, Helena

2007-05-01

This study aimed to determine the extent to which the principles of privacy and equality were observed during diagnostic genetic testing according to views held by patients or child patients' parents (n = 106) and by staff (n = 162) from three Finnish university hospitals. The data were collected through a structured questionnaire and analysed using the SAS 8.1 statistical software. In general, the two principles were observed relatively satisfactorily in clinical practice. According to patients/parents, equality in the post-analytic phase and, according to staff, privacy in the pre-analytic phase, involved the greatest ethical problems. The two groups differed in their views concerning pre-analytic privacy. Although there were no major problems regarding the two principles, the differences between the testing phases require further clarification. To enhance privacy protection and equality, professionals need to be given more genetics/ethics training, and patients individual counselling by genetics units staff, giving more consideration to patients' world-view, the purpose of the test and the test result.

Biomarkers in routine diagnosis of pleural effusions

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Tiva Nemanič

2018-03-01

Full Text Available Background: Pleural fluid biochemical analysis is the first step in pleural effusion (PE diagnostics. Our purpose was to analyse the utility of the biomarkers used at our clinic in the routine diagnosis of PE. Methods: We retrospectively reviewed the PE levels of proteins, lactate dehydrogenase (LDH, alpha amylase (AA, pH and glucose in 433 patients who were treated at the University Clinic Golnik in a one-year period and compared these values with the final identified aetiology of the effusions. Results: The majority of the effusions were determined to be a consequence of malignancy (n = 154 or infection (n = 108. In 94 cases the aetiology of the effusions was heart failure and in 54 cases other diseases, while 23 effusions remained aetiologically undetermined. Considering Light’s criteria, the vast majority of the effusions were correctly classified as exudates or transudates (97.1 %. Comparing paramalignant and malignant effusions, we detected significantly lower values of pleural fluid LDH (p < 0.0005 and proteins (p < 0.0005, and higher pH (p < 0.0005 values in the paramalignant effusions. Conclusion: We have found that pleural LDH and proteins are the most helpful biochemical parameters in our routine diagnosis of pleural effusions and helped us to correctly narrow the aetiological spectrum. Furthermore, significantly higher pleural LDH and protein values and a pH below 7.32 additionally facilitated distinguishing between malignant and paramalignant effusions. Parameters such as glucose and AA are useful in selected cases and have a limited role in routine diagnostics.

Diagnostic accuracy of scapular physical examination tests for shoulder disorders: a systematic review.

Science.gov (United States)

Wright, Alexis A; Wassinger, Craig A; Frank, Mason; Michener, Lori A; Hegedus, Eric J

2013-09-01

To systematically review and critique the evidence regarding the diagnostic accuracy of physical examination tests for the scapula in patients with shoulder disorders. A systematic, computerised literature search of PubMED, EMBASE, CINAHL and the Cochrane Library databases (from database inception through January 2012) using keywords related to diagnostic accuracy of physical examination tests of the scapula. The Quality Assessment of Diagnostic Accuracy Studies tool was used to critique the quality of each paper. Eight articles met the inclusion criteria; three were considered to be of high quality. Of the three high-quality studies, two were in reference to a 'diagnosis' of shoulder pain. Only one high-quality article referenced specific shoulder pathology of acromioclavicular dislocation with reported sensitivity of 71% and 41% for the scapular dyskinesis and SICK scapula test, respectively. Overall, no physical examination test of the scapula was found to be useful in differentially diagnosing pathologies of the shoulder.

The institutionalization of a routine

DEFF Research Database (Denmark)

Nickelsen, Niels Christian

2008-01-01

-which has before largely been treated in overview by institutionalism-plays an important role in the making of a routine. In my empirical study, I demonstrate that the concept and practice of the valve changes, and that it is identified in a number of ways, as it passes through the testing phase...... of production. I argue that the negotiation of these changes during test production is the fulcrum in the routinization of the production procedure. It is through these identity shifts that the valve is both reified, and rendered producible and applicable in the customer world....

The diagnostic sensitivity of dengue rapid test assays is significantly enhanced by using a combined antigen and antibody testing approach.

Directory of Open Access Journals (Sweden)

Scott R Fry

2011-06-01

Full Text Available BACKGROUND: Serological tests for IgM and IgG are routinely used in clinical laboratories for the rapid diagnosis of dengue and can differentiate between primary and secondary infections. Dengue virus non-structural protein 1 (NS1 has been identified as an early marker for acute dengue, and is typically present between days 1-9 post-onset of illness but following seroconversion it can be difficult to detect in serum. AIMS: To evaluate the performance of a newly developed Panbio® Dengue Early Rapid test for NS1 and determine if it can improve diagnostic sensitivity when used in combination with a commercial IgM/IgG rapid test. METHODOLOGY: The clinical performance of the Dengue Early Rapid was evaluated in a retrospective study in Vietnam with 198 acute laboratory-confirmed positive and 100 negative samples. The performance of the Dengue Early Rapid in combination with the IgM/IgG Rapid test was also evaluated in Malaysia with 263 laboratory-confirmed positive and 30 negative samples. KEY RESULTS: In Vietnam the sensitivity and specificity of the test was 69.2% (95% CI: 62.8% to 75.6% and 96% (95% CI: 92.2% to 99.8 respectively. In Malaysia the performance was similar with 68.9% sensitivity (95% CI: 61.8% to 76.1% and 96.7% specificity (95% CI: 82.8% to 99.9% compared to RT-PCR. Importantly, when the Dengue Early Rapid test was used in combination with the IgM/IgG test the sensitivity increased to 93.0%. When the two tests were compared at each day post-onset of illness there was clear differentiation between the antigen and antibody markers. CONCLUSIONS: This study highlights that using dengue NS1 antigen detection in combination with anti-glycoprotein E IgM and IgG serology can significantly increase the sensitivity of acute dengue diagnosis and extends the possible window of detection to include very early acute samples and enhances the clinical utility of rapid immunochromatographic testing for dengue.

The evaluation and impact of diagnostic tests

International Nuclear Information System (INIS)

Royal, H.D.; McNeil, B.J.

1989-01-01

The authors describe the usefulness of the techniques that are applied to study the role of tests and point out their limitations. In many instances, complex tasks must be oversimplified in order to use currently available analytic tools. Certain tools, such as decision analysis, are useful not only because they can provide insight regarding the most favorable diagnostic/therapeutic strategies but also because they can identify areas where present knowledge is inadequate and thereby help put priorities on areas of research

Real-time whole-genome sequencing for routine typing, surveillance, and outbreak detection of verotoxigenic Escherichia coli.

OpenAIRE

Joensen, Katrine Grimstrup; Scheutz, Flemming; Lund, Ole; Hasman, Henrik; Kaas, Rolf Sommer; Nielsen, Eva M.; Aarestrup, Frank Møller

2014-01-01

Fast and accurate identification and typing of pathogens are essential for effective surveillance and outbreak detection. The current routine procedure is based on a variety of techniques, making the procedure laborious, time-consuming, and expensive. With whole-genome sequencing (WGS) becoming cheaper, it has huge potential in both diagnostics and routine surveillance. The aim of this study was to perform a real-time evaluation of WGS for routine typing and surveillance of verocytotoxin-prod...

Real-Time Whole-Genome Sequencing for Routine Typing, Surveillance, and Outbreak Detection of Verotoxigenic Escherichia coli

OpenAIRE

Joensen, Katrine Grimstrup; Scheutz, Flemming; Lund, Ole; Hasman, Henrik; Kaas, Rolf S.; Nielsen, Eva M.; Aarestrup, Frank M.

2014-01-01

Fast and accurate identification and typing of pathogens are essential for effective surveillance and outbreak detection. The current routine procedure is based on a variety of techniques, making the procedure laborious, time-consuming, and expensive. With whole-genome sequencing (WGS) becoming cheaper, it has huge potential in both diagnostics and routine surveillance. The aim of this study was to perform a real-time evaluation of WGS for routine typing and surveillance of verocytotoxin-prod...

Bayesian analysis of longitudinal Johne's disease diagnostic data without a gold standard test

DEFF Research Database (Denmark)

Wang, C.; Turnbull, B.W.; Nielsen, Søren Saxmose

2011-01-01

the posterior estimates of the model parameters that provide the basis for inference concerning the accuracy of the diagnostic procedure. Based on the Bayesian approach, the posterior probability distribution of the change-point onset time can be obtained and used as a criterion for infection diagnosis......-point process with a Weibull survival hazard function was used to model the progression of the hidden disease status. The model adjusted for the fixed effects of covariate variables and random effects of subject on the diagnostic testing procedure. Markov chain Monte Carlo methods were used to compute....... An application is presented to an analysis of ELISA and fecal culture test outcomes in the diagnostic testing of paratuberculosis (Johne's disease) for a Danish longitudinal study from January 2000 to March 2003. The posterior probability criterion based on the Bayesian model with 4 repeated observations has...

Evaluation of microscopy and rapid diagnostic tests in screening ...

African Journals Online (AJOL)

Malaria is a life-threatening disease caused by the protozoa of the genus Plasmodium. Infection of individual is through the bites of infected female Anopheles mosquitoes. This study evaluated the performance of microscopy and rapid diagnostic tests (RDTs) in diagnosing malaria. A total of 400 clinically suspected malaria ...

Routine failures in the process for blood testing and the communication of results to patients in primary care in the UK: a qualitative exploration of patient and provider perspectives.

Science.gov (United States)

Litchfield, Ian; Bentham, Louise; Hill, Ann; McManus, Richard J; Lilford, Richard; Greenfield, Sheila

2015-11-01

The testing and result communication process in primary care is complex. Its successful completion relies on the coordinated efforts of a range of staff in primary care and external settings working together with patients. Despite the importance of diagnostic testing in provision of care, this complexity renders the process vulnerable in the face of increasing demand, stretched resources and a lack of supporting guidance. We conducted a series of focus groups with patients and staff across four primary care practices using process-improvement strategies to identify and understand areas where either unnecessary delay is introduced, or the process may fail entirely. We then worked with both patients and staff to arrive at practical strategies to improve the current system. A total of six areas across the process were identified where improvements could be introduced. These were: (1) delay in phlebotomy, (2) lack of a fail-safe to ensure blood tests are returned to practices and patients, (3) difficulties in accessing results by telephone, (4) role of non-clinical staff in communicating results, (5) routine communication of normal results and (6) lack of a protocol for result communication. A number of potential failures in testing and communicating results to patients were identified, and some specific ideas for improving existing systems emerged. These included same-day phlebotomy sessions, use of modern technology methods to proactively communicate routine results and targeted training for receptionists handling sensitive data. There remains an urgent need for further work to test these and other potential solutions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Evaluation of a rapid test for HIV antibodies in saliva and blood ...

African Journals Online (AJOL)

Objective. To test whole blood and saliva for HIV antibodies (anti-HIV) using a rapid test strip capillary flow . immunoassay, and to correlate the test strip results with blood specimen results obtained from routine diagnostic antiHIV assays. Design. A prospective pilot study of selected HIV-positive and HIV-negative individuals ...

Evaluation of the Roche prototype 454 HIV-1 ultradeep sequencing drug resistance assay in a routine diagnostic laboratory.

Science.gov (United States)

Garcia-Diaz, A; Guerrero-Ramos, A; McCormick, A L; Macartney, M; Conibear, T; Johnson, M A; Haque, T; Webster, D P

2013-10-01

Studies have shown that low-frequency resistance mutations can influence treatment outcome. However, the lack of a standardized high-throughput assay has precluded their detection in clinical settings. To evaluate the performance of the Roche prototype 454 UDS HIV-1 drug resistance assay (UDS assay) in a routine diagnostic laboratory. 50 plasma samples, previously characterized by population sequencing and that had shown ≥1 resistance associated mutation (RAM), were retrospectively tested by the UDS assay, including 18 B and 32 non-B subtypes; viral loads between 114-1,806,407 cp/ml; drug-naive (n=27) and drug-experienced (n=23) individuals. The UDS assay was successful for 37/50 (74%) samples. It detected all RAMs found by population sequencing at frequencies above 20%. In addition, 39 low-frequency RAMs were exclusively detected by the UDS assay at frequencies below 20% in both drug-naïve (19/26, 73%) and drug-experienced (9/18, 50%) individuals. UDS results would lead to changes from susceptible to resistant to efavirenz (EFV) in one drug-naive individual with suboptimal response to an EFV-containing regimen and from susceptible to resistance to lamivudine (3TC) in one drug naïve subject who subsequently failed a 3TC-containing regimen and in a treatment experienced subject who had failed a 3TC-containing regimen. The UDS assay performed well across a wide range of subtypes and viral loads; it showed perfect agreement with population sequencing for all RAMs analyzed. In addition, the UDS assay detected additional mutations at frequencies below 20% which correlate with patients' treatment history and had in some cases important prognostic implications. Copyright © 2013 Elsevier B.V. All rights reserved.

Comparison of Pre-Analytical FFPE Sample Preparation Methods and Their Impact on Massively Parallel Sequencing in Routine Diagnostics

Science.gov (United States)

Heydt, Carina; Fassunke, Jana; Künstlinger, Helen; Ihle, Michaela Angelika; König, Katharina; Heukamp, Lukas Carl; Schildhaus, Hans-Ulrich; Odenthal, Margarete; Büttner, Reinhard; Merkelbach-Bruse, Sabine

2014-01-01

Over the last years, massively parallel sequencing has rapidly evolved and has now transitioned into molecular pathology routine laboratories. It is an attractive platform for analysing multiple genes at the same time with very little input material. Therefore, the need for high quality DNA obtained from automated DNA extraction systems has increased, especially to those laboratories which are dealing with formalin-fixed paraffin-embedded (FFPE) material and high sample throughput. This study evaluated five automated FFPE DNA extraction systems as well as five DNA quantification systems using the three most common techniques, UV spectrophotometry, fluorescent dye-based quantification and quantitative PCR, on 26 FFPE tissue samples. Additionally, the effects on downstream applications were analysed to find the most suitable pre-analytical methods for massively parallel sequencing in routine diagnostics. The results revealed that the Maxwell 16 from Promega (Mannheim, Germany) seems to be the superior system for DNA extraction from FFPE material. The extracts had a 1.3–24.6-fold higher DNA concentration in comparison to the other extraction systems, a higher quality and were most suitable for downstream applications. The comparison of the five quantification methods showed intermethod variations but all methods could be used to estimate the right amount for PCR amplification and for massively parallel sequencing. Interestingly, the best results in massively parallel sequencing were obtained with a DNA input of 15 ng determined by the NanoDrop 2000c spectrophotometer (Thermo Fisher Scientific, Waltham, MA, USA). No difference could be detected in mutation analysis based on the results of the quantification methods. These findings emphasise, that it is particularly important to choose the most reliable and constant DNA extraction system, especially when using small biopsies and low elution volumes, and that all common DNA quantification techniques can be used for

Comparison of pre-analytical FFPE sample preparation methods and their impact on massively parallel sequencing in routine diagnostics.

Directory of Open Access Journals (Sweden)

Carina Heydt

Full Text Available Over the last years, massively parallel sequencing has rapidly evolved and has now transitioned into molecular pathology routine laboratories. It is an attractive platform for analysing multiple genes at the same time with very little input material. Therefore, the need for high quality DNA obtained from automated DNA extraction systems has increased, especially to those laboratories which are dealing with formalin-fixed paraffin-embedded (FFPE material and high sample throughput. This study evaluated five automated FFPE DNA extraction systems as well as five DNA quantification systems using the three most common techniques, UV spectrophotometry, fluorescent dye-based quantification and quantitative PCR, on 26 FFPE tissue samples. Additionally, the effects on downstream applications were analysed to find the most suitable pre-analytical methods for massively parallel sequencing in routine diagnostics. The results revealed that the Maxwell 16 from Promega (Mannheim, Germany seems to be the superior system for DNA extraction from FFPE material. The extracts had a 1.3-24.6-fold higher DNA concentration in comparison to the other extraction systems, a higher quality and were most suitable for downstream applications. The comparison of the five quantification methods showed intermethod variations but all methods could be used to estimate the right amount for PCR amplification and for massively parallel sequencing. Interestingly, the best results in massively parallel sequencing were obtained with a DNA input of 15 ng determined by the NanoDrop 2000c spectrophotometer (Thermo Fisher Scientific, Waltham, MA, USA. No difference could be detected in mutation analysis based on the results of the quantification methods. These findings emphasise, that it is particularly important to choose the most reliable and constant DNA extraction system, especially when using small biopsies and low elution volumes, and that all common DNA quantification techniques can

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

Science.gov (United States)

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).

Lacrimination in Sjogren′s syndrome. Is Schirmer′s test really a useful diagnostic tool?

Directory of Open Access Journals (Sweden)

Bhadoria D

1988-01-01

Full Text Available In the past, Schinier′s test was used as a diagnostic tool in Sjogren′s Syndrome. In this study, a comparison of 100 normal patients with 2l patients with Sjogren′s Syndrome has been made to study its reliability. It has been concluded that Schimer′s test is of a poor diagnostic value in Sjogren′s Syndrome.

Diagnostic investigations in 101 dogs with pyrexia of unknown origin

International Nuclear Information System (INIS)

Dunn, K.J.; Dunn, J.K.

1998-01-01

Records from 101 dogs presented for investigation of unexplained pyrexia were reviewed. The most common diagnosis was immune-mediated disease (22 per cent of cases), with immune-mediated polyarthritis accounting for 20 per cent of all diagnoses. The frequency of positive results obtained in investigative tests was also assessed. Cytological and radiological examinations provided a high diagnostic success rate, although routine haematology and plasma biochemistry were also useful screening tests. On the basis of these results it is suggested that, in the investigation of unexplained pyrexia, a diagnosis of immune-mediated polyarthritis should be excluded before less common diagnoses are considered

Diagnostic Accuracy of Tests for Polyuria in Lithium-Treated Patients.

Science.gov (United States)

Kinahan, James Conor; NiChorcorain, Aoife; Cunningham, Sean; Freyne, Aideen; Cooney, Colm; Barry, Siobhan; Kelly, Brendan D

2015-08-01

In lithium-treated patients, polyuria increases the risk of dehydration and lithium toxicity. If detected early, it is reversible. Despite its prevalence and associated morbidity in clinical practice, it remains underrecognized and therefore undertreated. The 24-hour urine collection is limited by its convenience and practicality. This study explores the diagnostic accuracy of alternative tests such as questionnaires on subjective polyuria, polydipsia, nocturia (dichotomous and ordinal responses), early morning urine sample osmolality (EMUO), and fluid intake record (FIR). This is a cross-sectional study of 179 lithium-treated patients attending a general adult and an old age psychiatry service. Participants completed the tests after completing an accurate 24-hour urine collection. The diagnostic accuracy of the individual tests was explored using the appropriate statistical techniques. Seventy-nine participants completed all of the tests. Polydipsia severity, EMUO, and FIR significantly differentiated the participants with polyuria (area under the receiver operating characteristic curve of 0.646, 0.760, and 0.846, respectively). Of the tests investigated, the FIR made the largest significant change in the probability that a patient experiences polyuria (3500 mL/24 hours; interval likelihood ratio, 14). Symptomatic questioning, EMUO, and an FIR could be used in clinical practice to inform the prescriber of the probability that a lithium-treated patient is experiencing polyuria.

Concordance in diagnostic testing for respiratory pathogens of Bighorn Sheep

Science.gov (United States)

Reliable diagnostic tests are essential for disease investigation and management. This is particularly true for diseases of free-ranging wildlife where sampling is logistically difficult precluding retesting. Clinical assays for wildlife diseases frequently vary among laboratories because of lack ...

Establishing a Timeline to Discontinue Routine Testing of Asymptomatic Pregnant Women for Zika Virus Infection - American Samoa, 2016-2017.

Science.gov (United States)

Hancock, W Thane; Soeters, Heidi M; Hills, Susan L; Link-Gelles, Ruth; Evans, Mary E; Daley, W Randolph; Piercefield, Emily; Anesi, Magele Scott; Mataia, Mary Aseta; Uso, Anaise M; Sili, Benjamin; Tufa, Aifili John; Solaita, Jacqueline; Irvin-Barnwell, Elizabeth; Meaney-Delman, Dana; Wilken, Jason; Weidle, Paul; Toews, Karrie-Ann E; Walker, William; Talboy, Phillip M; Gallo, William K; Krishna, Nevin; Laws, Rebecca L; Reynolds, Megan R; Koneru, Alaya; Gould, Carolyn V

2017-03-24

The first patients with laboratory-confirmed cases of Zika virus disease in American Samoa had symptom onset in January 2016 (1). In response, the American Samoa Department of Health (ASDoH) implemented mosquito control measures (1), strategies to protect pregnant women (1), syndromic surveillance based on electronic health record (EHR) reports (1), Zika virus testing of persons with one or more signs or symptoms of Zika virus disease (fever, rash, arthralgia, or conjunctivitis) (1-3), and routine testing of all asymptomatic pregnant women in accordance with CDC guidance (2,3) . All collected blood and urine specimens were shipped to the Hawaii Department of Health Laboratory for Zika virus testing and to CDC for confirmatory testing. Early in the response, collection and testing of specimens from pregnant women was prioritized over the collection from symptomatic nonpregnant patients because of limited testing and shipping capacity. The weekly numbers of suspected Zika virus disease cases declined from an average of six per week in January-February 2016 to one per week in May 2016. By August, the EHR-based syndromic surveillance (1) indicated a return to pre-outbreak levels. The last Zika virus disease case detected by real-time, reverse transcription-polymerase chain reaction (rRT-PCR) occurred in a patient who had symptom onset on June 19, 2016. In August 2016, ASDoH requested CDC support in assessing whether local transmission had been reduced or interrupted and in proposing a timeline for discontinuation of routine testing of asymptomatic pregnant women. An end date (October 15, 2016) was determined for active mosquito-borne transmission of Zika virus and a timeline was developed for discontinuation of routine screening of asymptomatic pregnant women in American Samoa (conception after December 10, 2016, with permissive testing for asymptomatic women who conceive through April 15, 2017).

[Autopsy and blood testing for alcohol and drugs/medicine after traffic fatalities is not routinely conducted].

Science.gov (United States)

Uhrenholt, Lars; Schumacher, Bente; Freeman, Michael

2010-09-27

In some road traffic crashes with fatal outcome, the police investigations lead to charges against and prosecution of a person. The police can request a medico-legal autopsy as well as a toxicological examination, but the extent to which this is done, and the role here of in the legal setting is unknown. Information concerning traffic crashes with fatal outcome in the period 2000-2004 in Aarhus Police District was retrieved and compared. The information included comprised crash specific and legal information, as well as medical data concerning autopsy, examination for alcohol, drugs and/or medicine. In all, 81 traffic crashes had a fatal outcome for 92 persons, of whom 17 (18%) were autopsied, 55 (60%) were tested for alcohol, and five (5%) were examined for drugs/medicine. Twenty-six were charged with negligent homicide, of which 18 were convicted. Autopsy was performed in four of these cases, 19 were tested for alcohol and one was tested for drugs/medicine. This study shows that the police requests few medico-legal autopsies following road traffic fatalities, and that testing for alcohol as well as drugs/medicine is not conducted routinely. As a consequence, important information may not come to the knowledge of the police in cases of negligent homicide. We recommend that postmortem examination be conducted routinely in traffic-related homicide cases to secure the best possible conditions for a legal evaluation.

The Diagnostic and Prognostic Value of Hematological and Chemical Abnormalities in Soft Tissue Sarcoma: A Comparative Study in Patients with Benign and Malignant Soft Tissue Tumors.

Science.gov (United States)

Ariizumi, Takashi; Kawashima, Hiroyuki; Ogose, Akira; Sasaki, Taro; Hotta, Tetsuo; Hatano, Hiroshi; Morita, Tetsuro; Endo, Naoto

2018-01-01

The value of routine blood tests in malignant soft tissue tumors remains uncertain. To determine if these tests can be used for screening, the routine pretreatment blood test findings were retrospectively investigated in 359 patients with benign and malignant soft tissue tumors. Additionally, the prognostic potential of pretreatment blood abnormalities was evaluated in patients with soft tissue sarcomas. We compared clinical factors and blood tests findings between patients with benign and malignant soft tissue tumors using univariate and multivariate analysis. Subsequently, patients with malignant tumors were divided into two groups based on blood test reference values, and the prognostic significance of each parameter was evaluated. In the univariate analysis, age, tumor size, and tumor depth were significant clinical diagnostic factors. Significant increases in the granulocyte count, C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR), and γ-glutamyl transpeptidase (γ-GTP) levels were found in patients with malignant soft tissue tumors. Multiple logistic regression showed that tumor size and ESR were independent factors that predicted malignant soft tissue tumors. The Kaplan-Meier survival analysis revealed that granulocyte counts, γ-GTP levels, and CRP levels correlated significantly with overall survival. Thus, pretreatment routine blood tests are useful diagnostic and prognostic markers for diagnosing soft tissue sarcoma. © 2018 by the Association of Clinical Scientists, Inc.

Diagnostic Accuracy of the Slump Test for Identifying Neuropathic Pain in the Lower Limb.

Science.gov (United States)

Urban, Lawrence M; MacNeil, Brian J

2015-08-01

Diagnostic accuracy study with nonconsecutive enrollment. To assess the diagnostic accuracy of the slump test for neuropathic pain (NeP) in those with low to moderate levels of chronic low back pain (LBP), and to determine whether accuracy of the slump test improves by adding anatomical or qualitative pain descriptors. Neuropathic pain has been linked with poor outcomes, likely due to inadequate diagnosis, which precludes treatment specific for NeP. Current diagnostic approaches are time consuming or lack accuracy. A convenience sample of 21 individuals with LBP, with or without radiating leg pain, was recruited. A standardized neurosensory examination was used to determine the reference diagnosis for NeP. Afterward, the slump test was administered to all participants. Reports of pain location and quality produced during the slump test were recorded. The neurosensory examination designated 11 of the 21 participants with LBP/sciatica as having NeP. The slump test displayed high sensitivity (0.91), moderate specificity (0.70), a positive likelihood ratio of 3.03, and a negative likelihood ratio of 0.13. Adding the criterion of pain below the knee significantly increased specificity to 1.00 (positive likelihood ratio = 11.9). Pain-quality descriptors did not improve diagnostic accuracy. The slump test was highly sensitive in identifying NeP within the study sample. Adding a pain-location criterion improved specificity. Combining the diagnostic outcomes was very effective in identifying all those without NeP and half of those with NeP. Limitations arising from the small and narrow spectrum of participants with LBP/sciatica sampled within the study prevent application of the findings to a wider population. Diagnosis, level 4-.

Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: The PRISMA-DTA Statement.

Science.gov (United States)

McInnes, Matthew D F; Moher, David; Thombs, Brett D; McGrath, Trevor A; Bossuyt, Patrick M; Clifford, Tammy; Cohen, Jérémie F; Deeks, Jonathan J; Gatsonis, Constantine; Hooft, Lotty; Hunt, Harriet A; Hyde, Christopher J; Korevaar, Daniël A; Leeflang, Mariska M G; Macaskill, Petra; Reitsma, Johannes B; Rodin, Rachel; Rutjes, Anne W S; Salameh, Jean-Paul; Stevens, Adrienne; Takwoingi, Yemisi; Tonelli, Marcello; Weeks, Laura; Whiting, Penny; Willis, Brian H

2018-01-23

Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy. To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews. Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group. The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted. The 27-item

Transitioning high sensitivity cardiac troponin I (hs-cTnI) into routine diagnostic use: More than just a sensitivity issue

LENUS (Irish Health Repository)

Lee, Graham R

2016-04-01

High sensitivity cardiac troponin T and I (hs-cTnT and hs-cTnI) assays show analytical, diagnostic and prognostic improvement over contemporary sensitive cTn assays. However, given the importance of troponin in the diagnosis of myocardial infarction, implementing this test requires rigorous analytical and clinical verification across the total testing pathway. This was the aim of this study.

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

Science.gov (United States)

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.

Vanishing "tattoo" multisensor for biomedical diagnostics

Science.gov (United States)

Moczko, E.; Meglinski, I.; Piletsky, S.

2008-02-01

Currently, precise non-invasive diagnostics systems for the real-time multi detection and monitoring of physiological parameters and chemical analytes in the human body are urgently required by clinicians, physiologists and bio-medical researchers. We have developed a novel cost effective smart 'vanishing tattoo' (similar to temporary child's tattoos) consisting of environmental-sensitive dyes. Painlessly impregnated into the skin the smart tattoo is capable of generating optical/fluorescence changes (absorbance, transmission, reflectance, emission and/or luminescence within UV, VIS or NIR regions) in response to physical or chemical changes. These changes allow the identification of colour pattern changes similar to bar-code scanning. Such a system allows an easy, cheap and robust comprehensive detection of various parameters and analytes in a small volume of sample (e.g. variations in pH, temperature, ionic strength, solvent polarity, presence of redox species, surfactants, oxygen). These smart tattoos have possible applications in monitoring the progress of disease and transcutaneous drug delivery. The potential of this highly innovative diagnostic tool is wide and diverse and can impact on routine clinical diagnostics, general therapeutic management, skin care and cosmetic products testing as well as fundamental physiological investigations.

Reversed field pinch diagnostics

International Nuclear Information System (INIS)

Weber, P.G.

1986-01-01

The Reversed Field Pinch (RFP) is a toroidal, axisymmetric magnetic confinement configuration characterized by a magnetic field configuration in which the toroidal magnetic field is of similar strength to the poloidal field, and is reversed at the edge compared to the center. The RFP routinely operates at high beta, and is a strong candidate for a compact fusion device. Relevant attributes of the configuration will be presented, together with an overview of present and planned experiments and their diagnostics. RFP diagnostics are in many ways similar to those of other magnetic confinement devices (such as tokamaks); these lectures will point out pertinent differences, and will present some diagnostics which provide special insights into unique attributes of the RFP

Need to improve routine HIV testing of U.S. Veterans in care: results of an Internet survey.

Science.gov (United States)

Valdiserri, Ronald O; Nazi, Kim; McInnes, D Keith; Ross, David; Kinsinger, Linda

2010-06-01

Late diagnosis of HIV infection contributes to poor medical outcomes and helps sustain continued transmission of virus. Published evidence suggests that despite current public health recommendations, patients receiving care in the Veterans Health Administration (VHA) system are not being routinely tested for HIV infection. Using a sample of computer-literate veterans, we conducted a survey of recent testing experiences. My HealtheVet (MHV) is a secure website allowing registered Veterans to access limited personal VHA health information. Using the American Customer Satisfaction Index (ACSI) Survey, an electronic questionnaire on "health screening" was conducted in late Fall/early winter 2008-2009. A random sample (4%) of MHV users were surveyed; approximately 17% completed the survey and responses ranged from 31,237 to 33,074. Only 9% of the respondents indicated that they had been offered a test for HIV in the last 12 months compared to 83% who had been offered cholesterol screening, 65% blood sugar screening and 19% who had been offered testing for Hepatitis C virus (HCV). Of those who had been offered HIV testing, 91% indicated that they'd had the test performed. Of note, the percentage of respondents who indicated that they would "very likely" accept a test, if offered, was similar for HIV (73%), HCV (79%), cholesterol (75%), and blood sugar (75%). Although these results cannot be generalized to all Veterans in care, they suggest that routine testing for HIV has not been taking place and support recent VHA policy changes to remove barriers to HIV testing.

Are daily routine chest radiographs useful in critically ill, mechanically ventilated patients? A randomized study.

Science.gov (United States)

Clec'h, Christophe; Simon, Paul; Hamdi, Aïcha; Hamza, Lilia; Karoubi, Philippe; Fosse, Jean-Philippe; Gonzalez, Frédéric; Vincent, François; Cohen, Yves

2008-02-01

Whether chest radiographs (CXRs) in mechanically ventilated patients should be routinely obtained or only when an abnormality is anticipated remains debated. We aimed to compare the diagnostic, therapeutic and outcome efficacy of a restrictive prescription of CXRs with that of a routine prescription, focusing on delayed diagnoses and treatments potentially related to the restrictive prescription. Randomized controlled trial. Intensive care unit of the Avicenne Teaching Hospital, Bobigny, France. All consecutive patients mechanically ventilated for > or = 48h between January and June 2006. Patients were randomly assigned to have daily routine CXRs (routine prescription group) or clinically indicated CXRs (restrictive prescription group). For each CXR, a questionnaire was completed addressing the reason for the CXR, the new findings, and any subsequent therapeutic intervention. The endpoints were the rates of new findings, the rates of new findings that prompted therapeutic intervention, the rate of delayed diagnoses, and mortality. Eighty-four patients were included in the routine prescription group and 81 in the restrictive prescription group. The rates of new findings and the rates of new findings that prompted therapeutic intervention in the restrictive prescription group and in the routine prescription group were 66% vs. 7.2% (p < 0.0001), and 56.4% vs. 5.5% (p < 0.0001) respectively. The rate of delayed diagnoses in the restrictive prescription group was 0.7%. Mortality was similar. Restrictive use of CXRs in mechanically ventilated patients was associated with better diagnostic and therapeutic efficacies without impairing outcome.

Indications and expectations for neuropsychological assessment in routine epilepsy care: Report of the ILAE Neuropsychology Task Force, Diagnostic Methods Commission, 2013-2017.

Science.gov (United States)

Wilson, Sarah J; Baxendale, Sallie; Barr, William; Hamed, Sherifa; Langfitt, John; Samson, Séverine; Watanabe, Masako; Baker, Gus A; Helmstaedter, Christoph; Hermann, Bruce P; Smith, Mary-Lou

2015-05-01

The International League Against Epilepsy (ILAE) Diagnostic Methods Commission charged the Neuropsychology Task Force with the job of developing a set of recommendations to address the following questions: (1) What is the role of a neuropsychological assessment? (2) Who should do a neuropsychological assessment? (3) When should people with epilepsy be referred for a neuropsychological assessment? and (4) What should be expected from a neuropsychological assessment? The recommendations have been broadly written for health care clinicians in established epilepsy settings as well as those setting up new services. They are based on a detailed survey of neuropsychological assessment practices across international epilepsy centers, and formal ranking of specific recommendations for advancing clinical epilepsy care generated by specialist epilepsy neuropsychologists from around the world. They also incorporate the latest research findings to establish minimum standards for training and practice, reflecting the many roles of neuropsychological assessment in the routine care of children and adults with epilepsy. The recommendations endorse routine screening of cognition, mood, and behavior in new-onset epilepsy, and describe the range of situations when more detailed, formal neuropsychological assessment is indicated. They identify a core set of cognitive and psychological domains that should be assessed to provide an objective account of an individual's cognitive, emotional, and psychosocial functioning, including factors likely contributing to deficits identified on qualitative and quantitative examination. The recommendations also endorse routine provision of feedback to patients, families, and clinicians about the implications of the assessment results, including specific clinical recommendations of what can be done to improve a patient's cognitive or psychosocial functioning and alleviate the distress of any difficulties identified. By canvassing the breadth and depth

The diagnostic value of the Clarke sign in assessing chondromalacia patella.

Science.gov (United States)

Doberstein, Scott T; Romeyn, Richard L; Reineke, David M

2008-01-01

Various techniques have been described for assessing conditions that cause pain at the patellofemoral (PF) joint. The Clarke sign is one such test, but the diagnostic value of this test in assessing chondromalacia patella is unknown. To (1) investigate the diagnostic value of the Clarke sign in assessing the presence of chondromalacia patella using arthroscopic examination of the PF joint as the "gold standard," and (2) provide a historical perspective of the Clarke sign as a clinical diagnostic test. Validation study. All patients of one of the investigators who had knee pain or injuries unrelated to the patellofemoral joint and were scheduled for arthroscopic surgery were recruited for this study. A total of 106 otherwise healthy individuals with no history of patellofemoral pain or dysfunction volunteered. The Clarke sign was performed on the surgical knee by a single investigator in the clinic before surgery. A positive test was indicated by the presence of pain sufficient to prevent the patient from maintaining a quadriceps muscle contraction against manual resistance for longer than 2 seconds. The preoperative result was compared with visual evidence of chondromalacia patella during arthroscopy. Sensitivity was 0.39, specificity was 0.67, likelihood ratio for a positive test was 1.18, likelihood ratio for a negative test was 0.91, positive predictive value was 0.25, and negative predictive value was 0.80. Diagnostic validity values for the use of the Clarke sign in assessing chondromalacia patella were unsatisfactory, supporting suggestions that it has poor diagnostic value as a clinical examination technique. Additionally, an extensive search of the available literature for the Clarke sign reveals multiple problems with the test, causing significant confusion for clinicians. Therefore, the use of the Clarke sign as a routine part of a knee examination is not beneficial, and its use should be discontinued.

Routine Radiological Environmental Monitoring Plan. Volume 1

Energy Technology Data Exchange (ETDEWEB)

Bechtel Nevada

1999-12-31

The U.S. Department of Energy manages the Nevada Test Site in a manner that meets evolving DOE Missions and responds to the concerns of affected and interested individuals and agencies. This Routine Radiological Monitoring Plan addressess complicance with DOE Orders 5400.1 and 5400.5 and other drivers requiring routine effluent monitoring and environmental surveillance on the Nevada Test Site. This monitoring plan, prepared in 1998, addresses the activities conducted onsite NTS under the Final Environmental Impact Statement and Record of Decision. This radiological monitoring plan, prepared on behalf of the Nevada Test Site Landlord, brings together sitewide environmental surveillance; site-specific effluent monitoring; and operational monitoring conducted by various missions, programs, and projects on the NTS. The plan provides an approach to identifying and conducting routine radiological monitoring at the NTS, based on integrated technical, scientific, and regulatory complicance data needs.

Access to diphtheria antitoxin for therapy and diagnostics.

Science.gov (United States)

Both, L; White, J; Mandal, S; Efstratiou, A

2014-06-19

The most effective treatment for diphtheria is swift administration of diphtheria antitoxin (DAT) with conjunct antibiotic therapy. DAT is an equine immunoglobulin preparation and listed among the World Health Organization Essential Medicines. Essential Medicines should be available in functioning health systems at all times in adequate amounts, in appropriate dosage forms, with assured quality, and at prices individuals and the community can afford. However, DAT is in scarce supply and frequently unavailable to patients because of discontinued production in several countries, low economic viability, and high regulatory requirements for the safe manufacture of blood-derived products. DAT is also a cornerstone of diphtheria diagnostics but several diagnostic reference laboratories across the European Union (EU) and elsewhere routinely face problems in sourcing DAT for toxigenicity testing. Overall, global access to DAT for both therapeutic and diagnostic applications seems inadequate. Therefore--besides efforts to improve the current supply of DAT--accelerated research and development of alternatives including monoclonal antibodies for therapy and molecular-based methods for diagnostics are required. Given the rarity of the disease, it would be useful to organise a small stockpile centrally for all EU countries and to maintain an inventory of DAT availability within and between countries.

Routine oblique radiography of the pediatric lumbar spine: is it necessary

International Nuclear Information System (INIS)

Roberts, F.F.; Kishore, P.R.S.; Cunningham, M.E.

1978-01-01

A series of 86 pediatric lumbar spine abnormalities was evaluated to determine the diagnostic benefit of radiography in oblique projection as compared to frontal-lateral projections alone. In only four patients was an abnormality apparent on the oblique view which had not already been demonstrated by the frontal-lateral series; each of these represented an isolated spondylolysis. Because the diagnostic yield was low at a patient cost of more than double the gonadal radiation dose, it is recommended that oblique views be eliminated in the routine radiography of the pediatric lumbar spine

Routine chest X-ray in the allergy clinic

International Nuclear Information System (INIS)

Garcia-Barredo, M.R.; Usamentiaga, E.; Fidalgo, I.

1997-01-01

To determine whether routine chest X-ray is indicated in allergy patients when there is no evidence of cardiopulmonary involvement. A retrospective study to analyze the indications and radiologic findings in 515 consecutive patients who underwent chest X-ray: Positive findings were considered to be any radiological sing that led to the performance of additional diagnostic measures or a change in the therapeutic management of the patient. Positive radiologic findings were observed in 39 cases (7.59%). Only two patients (0.38%) were diagnosed as having diseases that were susceptible to proper treatment. In one of them (0.19%), the failure to perform chest X-ray would have impeded the introduction of proper treatment. We do not recommend carrying out routine chest X-ray in this patient population. (Author) 7 refs

Can rapid integrated polymerase chain reaction-based diagnostics for gastrointestinal pathogens improve routine hospital infection control practice? A diagnostic study.

Science.gov (United States)

Pankhurst, Louise; Macfarlane-Smith, Louissa; Buchanan, James; Anson, Luke; Davies, Kerrie; O'Connor, Lily; Ashwin, Helen; Pike, Graham; Dingle, Kate E; Peto, Timothy Ea; Wordsworth, Sarah; Walker, A Sarah; Wilcox, Mark H; Crook, Derrick W

2014-08-01

Every year approximately 5000-9000 patients are admitted to a hospital with diarrhoea, which in up to 90% of cases has a non-infectious cause. As a result, single rooms are 'blocked' by patients with non-infectious diarrhoea, while patients with infectious diarrhoea are still in open bays because of a lack of free side rooms. A rapid test for differentiating infectious from non-infectious diarrhoea could be very beneficial for patients. To evaluate MassCode multiplex polymerase chain reaction (PCR) for the simultaneous diagnosis of multiple enteropathogens directly from stool, in terms of sensitivity/specificity to detect four common important enteropathogens: Clostridium difficile, Campylobacter spp., Salmonella spp. and norovirus. A retrospective study of fixed numbers of samples positive for C. difficile (n = 200), Campylobacter spp. (n = 200), Salmonella spp. (n = 100) and norovirus (n = 200) plus samples negative for all these pathogens (n = 300). Samples were sourced from NHS microbiology laboratories in Oxford and Leeds where initial diagnostic testing was performed according to Public Health England methodology. Researchers carrying out MassCode assays were blind to this information. A questionnaire survey, examining current practice for infection control teams and microbiology laboratories managing infectious diarrhoea, was also carried out. MassCode assays were carried out at Oxford University Hospitals NHS Trust. Further multiplex assays, carried out using Luminex, were run on the same set of samples at Leeds Teaching Hospitals NHS Trust. The questionnaire was completed by various NHS trusts. Sensitivity and specificity to detect C. difficile, Campylobacter spp., Salmonella spp., and norovirus. Nucleic acids were extracted from 948 clinical samples using an optimised protocol (200 Campylobacter spp., 199 C. difficile, 60 S. enterica, 199 norovirus and 295 negative samples; some samples contained more than one pathogen). Using the Mass

Cost-effectiveness of using a molecular diagnostic test to improve preoperative diagnosis of thyroid cancer.

Science.gov (United States)

Najafzadeh, Mehdi; Marra, Carlo A; Lynd, Larry D; Wiseman, Sam M

2012-12-01

Fine-needle aspiration biopsy (FNAB) is a safe and inexpensive diagnostic procedure for evaluating thyroid nodules.Up to 25% of the results from an FNAB, however, may not be diagnostic or may be indeterminate, leading to a subsequent diagnostic thyroid surgery. A new molecularly based diagnostic test could potentially reduce indeterminate cytological results and, with high accuracy, provide a definitive diagnosis for cancer in thyroid nodules. The aim of the study was to estimate the cost-effectiveness of utilizing a molecular diagnostic (DX) test as an adjunct to FNAB, compared with NoDX, to improve the preoperative diagnosis of thyroid nodules. We constructed a patient-level simulation model to estimate the clinical and economic outcomes of using a DX test compared with current practice (NoDX) for the diagnosis of thyroid nodules. By using a cost-effectiveness framework, we measured incremental clinical benefits in terms of quality-adjusted life-years and incremental costs over a 10-year time horizon. Assuming 95% sensitivity and specificity of the Dx test when used as an adjunct to FNAB, the utilization of the DX test resulted in a gain of 0.046 quality-adjusted life-years (95% confidence interval 0.019-0.078) and a saving of $1087 (95% confidence interval $691-$1533) in direct costs per patient. If the cost of the Dx test is less than $1087 per test, we expect to save quality-adjusted life-years and reduce costs when it is utilized. Sensitivity of the DX test, compared with specificity, had a larger influence on the overall outcomes. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Classification of chronic orofacial pain using an intravenous diagnostic test

NARCIS (Netherlands)

Tjakkes, G. -H. E.; De Bont, L. G. M.; van Wijhe, M.; Stegenga, B.

The aim of this study was to evaluate the ability of a preliminary intravenous diagnostic test to classify chronic orofacial pain patients into different subgroups. Patients with chronic orofacial pain conditions that could not be unambiguously diagnosed. A retrospective evaluation of series of

DIAGNOSTIC VALUE OF SEROLOGICAL MARKERS OF RHEUMATOID ARTHRITIS

Directory of Open Access Journals (Sweden)

Aleksei Leonidovich Maslaynski

2012-01-01

Full Text Available Rheumatoid arthritis (RA is a classic autoimmune disease associated with the production of wide range of autoantibodies, and their detection has diagnostic and prognostic implication. The objective of this study was to estimate the diagnostic value of antibodies against modified citrullinated vimentin (AMCV and nuclear antigen RA33 of the IgA rheumatoid factor (RF versus the value of routinely used profile of autoantibodies in diagnostic work-up of RA. Material and methods. 253 patients with RA prehistory of varying duration were included into the study group. The control group was comprised of 92 patients, including patients with seronegative spondyloarthropathies and diffuse connective tissue diseases, as well as sex and age matched healthy controls. Serum levels of IgM and IgA RF, antibodies against cyclic citrullinated peptide (ACCP, ACMV, anti-keratin antibodies (AKA, antibodies against RA33 antigen (ARA33 and antinuclear factor (ANF were measured in all patients and controls. Results and discussion. Diagnostic sensitivity of AMCV equaled 78%, ACCP — 77%, IgM RF — 71%, IgA RF — 43%, AKA — 43%, ARA33 — 31% and ANF — 31%. All anti-citrullinic antibodies (AKA, ACCP, ACMV were significantly more commonly associated with IgM RF. Among RF and ACCP seronegative patients ACMV were found in 24% cases with 20 IU/Ml detection threshold, and in 21% — with 30 IU/Ml, allowing to increase diagnostic specificity of the test up to 91% with the increment of diagnostic threshold. Incidence of ARA33 was not significantly different among the RF and ACCP positive or negative subgroups, thus making ARA33 an independent RA marker. Specificity of this marker was 87,9%, thus making it inferior to RF and ACCP by a composite of diagnostic characteristics. Conclusions. Integrated measurement of ACMV and ARA33 is a rational approach at the second stage of serologic testing work-up in suspected cases of RA onset, when initial RF and ACCP tests were negative.

Portuguese Family Physicians' Awareness of Diagnostic and Laboratory Test Costs: A Cross-Sectional Study.

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Luísa Sá

Full Text Available Physicians' ability to make cost-effective decisions has been shown to be affected by their knowledge of health care costs. This study assessed whether Portuguese family physicians are aware of the costs of the most frequently prescribed diagnostic and laboratory tests.A cross-sectional study was conducted in a representative sample of Portuguese family physicians, using computer-assisted telephone interviews for data collection. A Likert scale was used to assess physician's level of agreement with four statements about health care costs. Family physicians were also asked to estimate the costs of diagnostic and laboratory tests. Each physician's cost estimate was compared with the true cost and the absolute error was calculated.One-quarter (24%; 95% confidence interval: 23%-25% of all cost estimates were accurate to within 25% of the true cost, with 55% (95% IC: 53-56 overestimating and 21% (95% IC: 20-22 underestimating the true actual cost. The majority (76% of family physicians thought they did not have or were uncertain as to whether they had adequate knowledge of diagnostic and laboratory test costs, and only 7% reported receiving adequate education. The majority of the family physicians (82% said that they had adequate access to information about the diagnostic and laboratory test costs. Thirty-three percent thought that costs did not influence their decision to order tests, while 27% were uncertain.Portuguese family physicians have limited awareness of diagnostic and laboratory test costs, and our results demonstrate a need for improved education in this area. Further research should focus on identifying whether interventions in cost knowledge actually change ordering behavior, in identifying optimal methods to disseminate cost information, and on improving the cost-effectiveness of care.

Portuguese Family Physicians’ Awareness of Diagnostic and Laboratory Test Costs: A Cross-Sectional Study

Science.gov (United States)

Sá, Luísa; Costa-Santos, Cristina; Teixeira, Andreia; Couto, Luciana; Costa-Pereira, Altamiro; Hespanhol, Alberto; Santos, Paulo; Martins, Carlos

2015-01-01

Background Physicians’ ability to make cost-effective decisions has been shown to be affected by their knowledge of health care costs. This study assessed whether Portuguese family physicians are aware of the costs of the most frequently prescribed diagnostic and laboratory tests. Methods A cross-sectional study was conducted in a representative sample of Portuguese family physicians, using computer-assisted telephone interviews for data collection. A Likert scale was used to assess physician’s level of agreement with four statements about health care costs. Family physicians were also asked to estimate the costs of diagnostic and laboratory tests. Each physician’s cost estimate was compared with the true cost and the absolute error was calculated. Results One-quarter (24%; 95% confidence interval: 23%–25%) of all cost estimates were accurate to within 25% of the true cost, with 55% (95% IC: 53–56) overestimating and 21% (95% IC: 20–22) underestimating the true actual cost. The majority (76%) of family physicians thought they did not have or were uncertain as to whether they had adequate knowledge of diagnostic and laboratory test costs, and only 7% reported receiving adequate education. The majority of the family physicians (82%) said that they had adequate access to information about the diagnostic and laboratory test costs. Thirty-three percent thought that costs did not influence their decision to order tests, while 27% were uncertain. Conclusions Portuguese family physicians have limited awareness of diagnostic and laboratory test costs, and our results demonstrate a need for improved education in this area. Further research should focus on identifying whether interventions in cost knowledge actually change ordering behavior, in identifying optimal methods to disseminate cost information, and on improving the cost-effectiveness of care. PMID:26356625

Dual Processing Model for Medical Decision-Making: An Extension to Diagnostic Testing.

Science.gov (United States)

Tsalatsanis, Athanasios; Hozo, Iztok; Kumar, Ambuj; Djulbegovic, Benjamin

2015-01-01

Dual Processing Theories (DPT) assume that human cognition is governed by two distinct types of processes typically referred to as type 1 (intuitive) and type 2 (deliberative). Based on DPT we have derived a Dual Processing Model (DPM) to describe and explain therapeutic medical decision-making. The DPM model indicates that doctors decide to treat when treatment benefits outweigh its harms, which occurs when the probability of the disease is greater than the so called "threshold probability" at which treatment benefits are equal to treatment harms. Here we extend our work to include a wider class of decision problems that involve diagnostic testing. We illustrate applicability of the proposed model in a typical clinical scenario considering the management of a patient with prostate cancer. To that end, we calculate and compare two types of decision-thresholds: one that adheres to expected utility theory (EUT) and the second according to DPM. Our results showed that the decisions to administer a diagnostic test could be better explained using the DPM threshold. This is because such decisions depend on objective evidence of test/treatment benefits and harms as well as type 1 cognition of benefits and harms, which are not considered under EUT. Given that type 1 processes are unique to each decision-maker, this means that the DPM threshold will vary among different individuals. We also showed that when type 1 processes exclusively dominate decisions, ordering a diagnostic test does not affect a decision; the decision is based on the assessment of benefits and harms of treatment. These findings could explain variations in the treatment and diagnostic patterns documented in today's clinical practice.

Dual Processing Model for Medical Decision-Making: An Extension to Diagnostic Testing.

Directory of Open Access Journals (Sweden)

Athanasios Tsalatsanis

Full Text Available Dual Processing Theories (DPT assume that human cognition is governed by two distinct types of processes typically referred to as type 1 (intuitive and type 2 (deliberative. Based on DPT we have derived a Dual Processing Model (DPM to describe and explain therapeutic medical decision-making. The DPM model indicates that doctors decide to treat when treatment benefits outweigh its harms, which occurs when the probability of the disease is greater than the so called "threshold probability" at which treatment benefits are equal to treatment harms. Here we extend our work to include a wider class of decision problems that involve diagnostic testing. We illustrate applicability of the proposed model in a typical clinical scenario considering the management of a patient with prostate cancer. To that end, we calculate and compare two types of decision-thresholds: one that adheres to expected utility theory (EUT and the second according to DPM. Our results showed that the decisions to administer a diagnostic test could be better explained using the DPM threshold. This is because such decisions depend on objective evidence of test/treatment benefits and harms as well as type 1 cognition of benefits and harms, which are not considered under EUT. Given that type 1 processes are unique to each decision-maker, this means that the DPM threshold will vary among different individuals. We also showed that when type 1 processes exclusively dominate decisions, ordering a diagnostic test does not affect a decision; the decision is based on the assessment of benefits and harms of treatment. These findings could explain variations in the treatment and diagnostic patterns documented in today's clinical practice.

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

Science.gov (United States)

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.

In Search of Optimal Cognitive Diagnostic Model(s) for ESL Grammar Test Data

Science.gov (United States)

Yi, Yeon-Sook

2017-01-01

This study compares five cognitive diagnostic models in search of optimal one(s) for English as a Second Language grammar test data. Using a unified modeling framework that can represent specific models with proper constraints, the article first fit the full model (the log-linear cognitive diagnostic model, LCDM) and investigated which model…

Consensus-based reporting standards for diagnostic test accuracy studies for paratuberculosis in ruminants

DEFF Research Database (Denmark)

Gardner, Ian A.; Nielsen, Søren Saxmose; Whittington, Richard

2011-01-01

The Standards for Reporting of Diagnostic Accuracy (STARD) statement (www.stard-statement.org) was developed to encourage complete and transparent reporting of key elements of test accuracy studies in human medicine. The statement was motivated by widespread evidence of bias in test accuracy...... studies and the finding that incomplete or absent reporting of items in the STARD checklist was associated with overly optimistic estimates of test performance characteristics. Although STARD principles apply broadly, specific guidelines do not exist to account for unique considerations in livestock...... for Reporting of Animal Diagnostic Accuracy Studies for paratuberculosis), should facilitate improved quality of reporting of the design, conduct and results of paratuberculosis test accuracy studies which were identified as “poor” in a review published in 2008 in Veterinary Microbiology...

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

Science.gov (United States)

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

Science.gov (United States)

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.

2012 HIV Diagnostics Conference: the molecular diagnostics perspective.

Science.gov (United States)

Branson, Bernard M; Pandori, Mark

2013-04-01

2012 HIV Diagnostic Conference Atlanta, GA, USA, 12-14 December 2012. This report highlights the presentations and discussions from the 2012 National HIV Diagnostic Conference held in Atlanta (GA, USA), on 12-14 December 2012. Reflecting changes in the evolving field of HIV diagnostics, the conference provided a forum for evaluating developments in molecular diagnostics and their role in HIV diagnosis. In 2010, the HIV Diagnostics Conference concluded with the proposal of a new diagnostic algorithm which included nucleic acid testing to resolve discordant screening and supplemental antibody test results. The 2012 meeting, picking up where the 2010 meeting left off, focused on scientific presentations that assessed this new algorithm and the role played by RNA testing and new developments in molecular diagnostics, including detection of total and integrated HIV-1 DNA, detection and quantification of HIV-2 RNA, and rapid formats for detection of HIV-1 RNA.

The rapid evolution of molecular genetic diagnostics in neuromuscular diseases.

Science.gov (United States)

Volk, Alexander E; Kubisch, Christian

2017-10-01

The development of massively parallel sequencing (MPS) has revolutionized molecular genetic diagnostics in monogenic disorders. The present review gives a brief overview of different MPS-based approaches used in clinical diagnostics of neuromuscular disorders (NMDs) and highlights their advantages and limitations. MPS-based approaches like gene panel sequencing, (whole) exome sequencing, (whole) genome sequencing, and RNA sequencing have been used to identify the genetic cause in NMDs. Although gene panel sequencing has evolved as a standard test for heterogeneous diseases, it is still debated, mainly because of financial issues and unsolved problems of variant interpretation, whether genome sequencing (and to a lesser extent also exome sequencing) of single patients can already be regarded as routine diagnostics. However, it has been shown that the inclusion of parents and additional family members often leads to a substantial increase in the diagnostic yield in exome-wide/genome-wide MPS approaches. In addition, MPS-based RNA sequencing just enters the research and diagnostic scene. Next-generation sequencing increasingly enables the detection of the genetic cause in highly heterogeneous diseases like NMDs in an efficient and affordable way. Gene panel sequencing and family-based exome sequencing have been proven as potent and cost-efficient diagnostic tools. Although clinical validation and interpretation of genome sequencing is still challenging, diagnostic RNA sequencing represents a promising tool to bypass some hurdles of diagnostics using genomic DNA.

Mother-Son Communication About Sex and Routine Human Immunodeficiency Virus Testing Among Younger Men of Color Who Have Sex With Men.

Science.gov (United States)

Bouris, Alida; Hill, Brandon J; Fisher, Kimberly; Erickson, Greg; Schneider, John A

2015-11-01

The purposes of this study were to document the HIV testing behaviors and serostatus of younger men of color who have sex with men (YMSM) and to explore sociodemographic, behavioral, and maternal correlates of HIV testing in the past 6 months. A total of 135 YMSM aged 16-19 years completed a close-ended survey on HIV testing and risk behaviors, mother-son communication, and sociodemographic characteristics. Youth were offered point-of-care HIV testing, with results provided at survey end. Multivariate logistic regression analyzed the sociodemographic, behavioral, and maternal factors associated with routine HIV testing. A total of 90.3% of YMSM had previously tested for HIV, and 70.9% had tested in the past 6 months. In total, 11.7% of youth reported being HIV positive, and 3.3% reported unknown serostatus. When offered an HIV test, 97.8% accepted. Of these, 14.7% had a positive oral test result, and 31.58% of HIV-positive YMSM (n = 6) were seropositive unaware. Logistic regression results indicated that maternal communication about sex with males was positively associated with routine testing (odds ratio = 2.36; 95% confidence interval = 1.13-4.94). Conversely, communication about puberty and general human sexuality was negatively associated (odds ratio = .45; 95% confidence interval = .24-.86). Condomless anal intercourse and positive sexually transmitted infection history were negatively associated with routine testing; however, frequency of alcohol use was positively associated. Despite high rates of testing, we found high rates of HIV infection, with 31.58% of HIV-positive YMSM being seropositive unaware. Mother-son communication about sex needs to address same-sex behavior as this appears to be more important than other topics. YMSM with known risk factors for HIV are not testing at the recommended time intervals. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Culture-independent diagnostic testing: have we opened Pandora's box for good?

Science.gov (United States)

Janda, J Michael; Abbott, Sharon A

2014-11-01

The ability to accurately and quickly identify microbial agents associated with infectious diseases has been a longstanding and continuous goal of diagnostic microbiology laboratories. Over the course of several decades, technology and testing methodologies in this field have gradually evolved from traditional- or classic-based culture and identification approaches to antigen capture systems and more molecular-oriented applications. Recently, these molecular-based applications have signaled a new era in clinical diagnostic microbiology with the commercial introduction of culture-independent diagnostic testing (CIDT) systems. The first major commercial venture into the CIDT arena involves the detection of acute bacterial gastroenteritis. Several commercial products are now on the market globally with at least 4 Food and Drug Administration approved since January of 2013. These new systems offer the direct detection of a variety of enteropathogens quickly without the need for traditional culture. In Greek mythology, Pandora opened a "jar" or "box" out of curiosity thereby releasing all of humanity's evils most notably diseases and plagues according to Hesiod's Theogony. While not ill-intentioned the only thing left in the box was Hope. Copyright © 2014 Elsevier Inc. All rights reserved.

Usage of Latent Class Analysis in Diagnostic Microbiology in the Absence of Gold Standard Test

Directory of Open Access Journals (Sweden)

Gul Bayram Abiha

2016-12-01

Full Text Available The evaluation of performance of various tests diagnostic tests in the absence of gold standard is an important problem. Latent class analysis (LCA is a statistical analysis method known for many years, especially in the absence of a gold standard for evaluation of diagnostic tests so that LCA has found its wide application area. During the last decade, LCA method has widely used in for determining sensivity and specifity of different microbiological tests. It has investigated in the diagnosis of mycobacterium tuberculosis, mycobacterium bovis, human papilloma virus, bordetella pertussis, influenza viruses, hepatitis E virus (HEV, hepatitis C virus (HCV and other various viral infections. Researchers have compared several diagnostic tests for the diagnosis of different pathogens with LCA. We aimed to evaluate performance of latent class analysis method used microbiological diagnosis in various diseases in several researches. When we took into account all of these tests' results, we suppose that LCA is a good statistical analysis method to assess different test performances in the absence of gold standard. [Archives Medical Review Journal 2016; 25(4.000: 467-488

Laboratory evaluation of immunochromatographic rapid diagnostic tests for cholera in Haiti.

Directory of Open Access Journals (Sweden)

Wilfredo R Matias

Full Text Available Rapid diagnostic tests (RDT for cholera are promising tools for detecting cholera in areas with limited laboratory infrastructure. However, evidence on the characteristics of the many available RDTs is scarce, and their use has been limited by suboptimal performance. We evaluated the performance characteristics of three cholera RDTs from Span Diagnostics, Artron Laboratories, and Standard Diagnostics in a regional laboratory in Haiti.We retrospectively reviewed records from May 2014 to October 2015 of a laboratory-based surveillance program for Vibrio cholerae at Hôpital Saint-Nicolas in Saint-Marc, Haiti. We compared the results of 511 Crystal VC, 129 Artron and 451 SD Bioline RDTs to bacterial culture as the gold standard. Of 905 cultures, 477 (52.7% were positive for V. cholerae O1, of which 27.7% were serotype Inaba. No cultures grew V. cholerae O139. Sensitivity and specificity of Crystal VC were 98.6% (95%CI: 96.5%-99.6% and 71.1% (95%CI: 64.7%-76.9%, respectively. Artron demonstrated a sensitivity of 98.6% (95%CI: 92.7%-100% and specificity of 69.1% (95%CI: 55.2%-80.9%. SD Bioline demonstrated a sensitivity of 81.1% (95%CI: 75.6%-85.8% and specificity of 92.8% (95%CI: 88.4%-95.9%. Crystal VC and Artron frequently showed false positive O139 bands, whereas none were seen with SD Bioline.There is significant variation in the performance of different cholera diagnostic RDTs. Artron and Crystal VC RDTs have high sensitivity and low specificity, while SD Bioline RDT has low to moderate sensitivity and high specificity when performed by laboratory technicians in Haiti. Study limitations included its retrospective design. The suboptimal characteristics of these tests limit their use as clinical point-of-care tests; however, they may be useful in outbreak response, surveillance, and research in resource-limited settings.

Comparison of clinical judgment and diagnostic ultrasonography in the diagnosis of acute appendicitis

DEFF Research Database (Denmark)

Jahn, H; Mathiesen, F K; Neckelmann, K

1997-01-01

, and diagnostic aids are desirable to reduce the negative appendicectomy rate. Diagnostic US performed poorly as a routine procedure. Application of an up to date scoring system might be of some help to patients with a high or low probability of acute appendicitis, but any conclusion about its clinical......OBJECTIVE: To evaluate the diagnostic accuracy of clinical judgment and diagnostic ultrasonography (US) used routinely and to create a scoring system to aid diagnosis. DESIGN: Prospective, double-blind study. SETTING: University hospital, Denmark. SUBJECTS: 222 Consecutive patients suspected...... of having acute appendicitis admitted between 0800 and midnight from June 1990 to June 1992. INTERVENTIONS: 148 Patients (67%) underwent appendicectomy and the remaining 74 patients were observed. 193 Patients (87%) had a diagnostic US examination. 21 Predictive variables were collected prospectively...

Current levels of gonadal irradiation from a selection of routine diagnostic X-ray examinations in Great Britain

International Nuclear Information System (INIS)

Wall, B.F.; Fisher, E.S.; Shrimpton, P.C.; Rae, S.

1980-07-01

The gonadal doses from 13 types of diagnostic examination have been measured at 21 hospitals throughout the country in preparation for a new assessment of the genetically significant dose to the population of Great Britain from diagnostic radiology. Thermoluminescent dosemeters, consisting of lithium borate powder contained in adhesive polythene sachets, were used for the measurements. They were attached to patients to monitor the testes dose directly or the entrance skin dose at the level of the ovaries. Skin doses were converted to ovarian doses using factors obtained by measurements in an anthropomorphic phantom exposed to a range of typical diagnostic X-ray fields. The results indicate that for some types of examination there has been an increase and for others there has been a reduction in the mean gonadal dose delivered per examination since a similar survey was made 20 years ago. Individual gonadal doses for the same examination still ranged over 3 or 4 orders of magnitude throughout the country with distributions described by coefficients of variation that were no less than those found in the late 1950s. This large variability in patient exposure, together with the observation that examinations were satisfactorily conducted on children with a much higher degree of gonadal protection than that offered to young adults, indicates that many patients must be receiving doses that are unnecessarily high. (author)

An update on the use of cerebrospinal fluid analysis as a diagnostic tool in multiple sclerosis.

Science.gov (United States)

Gastaldi, Matteo; Zardini, Elisabetta; Franciotta, Diego

2017-01-01

Intrathecal B-lymphocyte activation is a hallmark of multiple sclerosis (MS), a multi-factorial inflammatory-demyelinating disease of the central nervous system. Such activation has a counterpart in the cerebrospinal fluid (CSF) oligoclonal IgG bands (OCB), whose diagnostic role in MS has been downgraded within the current McDonald's criteria. With a theoretico-practical approach, the authors review the physiopathological basis of the CSF dynamics, and the state-of-the-art of routine CSF analysis and CSF biomarkers in MS. Areas covered: The authors discuss pros and cons of CSF analysis, including critical evaluations of both well-established, and promising diagnostic and prognostic laboratory tools. New acquisitions on the CSF and cerebral interstitial fluid dynamics are also presented. The authors searched the PubMed database for English-language articles reported between January 2010 and June 2016, using the key words 'multiple sclerosis', 'cerebrospinal fluid', 'oligoclonal bands'. Reference lists of relevant articles were scanned for additional studies. Expert commentary: The availability of performing high-quality, routine CSF tests in specialized laboratories, the emerging potential of novel CSF biomarkers, and the trend for early treatments should induce a reappraisal of CSF analysis for diagnostic and prognostic purposes in MS. Further procedural and methodological improvements seem to be necessary in both research and translational diagnostic CSF settings.

General practitioners' needs for ongoing support for the interpretation of spirometry tests.

NARCIS (Netherlands)

Poels, P.J.P.; Schermer, T.R.J.; Akkermans, R.P.; Jacobs, A.; Bogart-Jansen, M.; Bottema, B.J.A.M.; Weel, C. van

2007-01-01

BACKGROUND: Although one out of three general practitioners (GPs) carries out spirometry, the diagnostic interpretation of spirometric test results appears to be a common barrier for GPs towards its routine application. METHODS: Multivariate cross-sectional analysis of a questionnaire survey among

A compliance testing program for diagnostic X-ray equipment

International Nuclear Information System (INIS)

Hutchinson, D.E.; Cobb, B.J.; Jacob, C.S.

1999-01-01

Compliance testing is nominally that part of a quality assurance program dealing with those aspects of X-ray equipment performance that are subject to radiation control legislation. Quality assurance programs for medical X-ray equipment should be an integral part of the quality culture in health care. However while major hospitals and individual medical centers may implement such programs with some diligence, much X-ray equipment can remain unappraised unless there is a comprehensive regulatory inspection program or some form of compulsion on the equipment owner to implement a testing program. Since the late 1950s all X-ray equipment in the State of Western Australia has been inspected by authorized officers acting on behalf of the Radiological Council, the regulatory authority responsible for administration of the State's Radiation Safety Act. However, economic constraints, coupled with increasing X-ray equipment numbers and a geographically large State have significantly affected the inspection rate. Data available from inspections demonstrate that regular compliance and performance checks are essential in order to ensure proper performance and to minimize unnecessary patient and operator dose. To ensure that diagnostic X-ray equipment complies with accepted standards and performance criteria, the regulatory authority introduced a compulsory compliance testing program for all medical, dental and chiropractic diagnostic X-ray equipment effective from 1 January 1997

Cost effectiveness analysis of clinically driven versus routine laboratory monitoring of antiretroviral therapy in Uganda and Zimbabwe.

Directory of Open Access Journals (Sweden)

Antonieta Medina Lara

Full Text Available Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART have rarely been evaluated.Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779. Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM or laboratory and clinical monitoring (LCM; individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial.3316 (1660LCM;1656CDM symptomatic, immunosuppressed ART-naive adults (median (IQR age 37 (32,42; CD4 86 (31,139 cells/mm(3 were followed for median 4.9 years. LCM had a mean 0.112 year (41 days survival benefit at an additional mean cost of $765 [95%CI:685,845], translating into an adjusted incremental cost of $7386 [3277,dominated] per life-year gained and $7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below $3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks. CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term.There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African countries. CD4 monitoring

42 CFR 493.841 - Standard; Routine chemistry.

Science.gov (United States)

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Routine chemistry. 493.841 Section 493.841 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.841 Standard; Routine chemistry. (a) Failure to attain a score of at least 80 percent...

Comparative analysis of two rapid diagnostic tests for diagnosis of ...

African Journals Online (AJOL)

This study aims at comparing the diagnostic efficiencies of two commercially available kits for detecting Plasmodium falciparum infection in urine and blood of febrile patients for malaria diagnosis. This was an observational study in which matched blood and urine from symptomatic patients were tested for malaria using two ...

An audit of diagnostic tests performed in medical microbiology, and ...

African Journals Online (AJOL)

Clinical audit is an important tool for reviewing and improving the quality of service in clinical laboratories. This is a three year audit of diagnostic test carried out in Medical Microbiology and Immunology laboratories of University of Maiduguri Teaching Hospital, Maiduguri, Nigeria. The objectives were to document and ...

Implementing the Xpert® MTB/RIF Diagnostic Test for Tuberculosis and Rifampicin Resistance: Outcomes and Lessons Learned in 18 Countries.

Directory of Open Access Journals (Sweden)

Elisa Ardizzoni

Full Text Available The Xpert® MTB/RIF (Xpert is an automated molecular test for simultaneous detection of tuberculosis (TB and rifampicin resistance, recommended by the World Health Organization as the preferred diagnostic method for individuals presumed to have multi-drug resistant TB (MDR-TB or HIV-associated TB. We describe the performance of Xpert and key lessons learned during two years of implementation under routine conditions in 33 projects located in 18 countries supported by Médecins Sans Frontières across varied geographic, epidemiological and clinical settings.Xpert was used following three strategies: the first being as the initial test, with microscopy in parallel, for all presumptive TB cases; the second being only for patients at risk of MDR-TB, or with HIV- associated TB, or presumptive paediatric TB; and the third being as the initial test for these high-risk patients plus as an add-on test to microscopy in others. Routine laboratory data were collected, using laboratory registers. Qualitative data such as logistic aspects, human resources, and tool acceptance were collected using a questionnaire.In total, 52,863 samples underwent Xpert testing from April 2011 to December 2012. The average MTB detection rate was 18.5%, 22.3%, and 11.6% for the three different strategies respectively. Analysis of the results on samples tested in parallel showed that using Xpert as add-on test to microscopy would have increased laboratory TB confirmation by 49.7%, versus 42.3% for Xpert replacing microscopy. The main limitation of the test was the high rate of inconclusive results, which correlated with factors such as defective modules, cartridge version (G3 vs. G4 and staff experience. Operational and logistical hurdles included infrastructure renovation, basic computer training, regular instrument troubleshooting and maintenance, all of which required substantial and continuous support.The implementation of Xpert was feasible and significantly increased TB

The agony of choice in dermatophyte diagnostics-performance of different molecular tests and culture in the detection of Trichophyton rubrum and Trichophyton interdigitale.

Science.gov (United States)

Kupsch, C; Ohst, T; Pankewitz, F; Nenoff, P; Uhrlaß, S; Winter, I; Gräser, Y

2016-08-01

Dermatophytosis caused by dermatophytes of the genera Trichophyton and Microsporum belong to the most frequent mycoses worldwide. Molecular detection methods proved to be highly sensitive and enable rapid and accurate detection of dermatophyte species from clinical specimens. For the first time, we compare the performance of different molecular methods with each other and with conventional diagnostics in the detection of dermatophytoses caused by Trichophyton rubrum and Trichophyton interdigitale in clinical specimens (nail, skin and hair). The compared molecular methods comprise two already published PCR-ELISAs, a published quantitative RT-PCR as well as a newly developed PCR-ELISA targeting the internal transcribed spacer region. We investigated the sensitivity of the assays by analysing 375 clinical samples. In 148 specimens (39.5%) a positive result was gained in at least one of the four molecular tests or by culture, but the number of detected agents differed significantly between some of the assays. The most sensitive assay, a PCR-ELISA targeting a microsatellite region, detected 81 T. rubrum infections followed by an internal transcribed spacer PCR-ELISA (60), quantitative RT-PCR (52) and a topoisomerase II PCR-ELISA (51), whereas cultivation resulted in T. rubrum identification in 37 samples. The pros and cons of all four tests in routine diagnostics are discussed. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Evaluation of the menisci of the knee joint using three-dimensional isotropic resolution fast spin-echo imaging: diagnostic performance in 250 patients with surgical correlation

Energy Technology Data Exchange (ETDEWEB)

Kijowski, Richard; Davis, Kirkland W.; Blankenbaker, Donna G.; Woods, Michael A.; De Smet, Arthur A. [University of Wisconsin School of Medicine and Public Health, Department of Radiology, Madison, WI (United States); Munoz del Rio, Alejandro [University of Wisconsin School of Medicine and Public Health, Department of Radiology, Madison, WI (United States); University of Wisconsin School of Medicine and Public Health, Department of Statistics, Madison, WI (United States)

2012-02-15

To compare the diagnostic performance of FSE-Cube, a three-dimensional isotropic resolution intermediate-weighted fast spin-echo sequence, with a routine magnetic resonance (MR) protocol at 3.0 T for detecting surgically confirmed meniscal tears of the knee joint in a large patient population. FSE-Cube was added to a routine MR protocol performed at 3.0 T on 250 patients who underwent subsequent knee arthroscopy. Three radiologists independently used FSE-Cube during one review and the routine MR protocol during a second review to detect medial and lateral meniscal tears. Using arthroscopy as the reference standard, the sensitivity and specificity of FSE-Cube and the routine MR protocol for detecting meniscal tears were determined for all readers combined. McNemar's tests were used to compare diagnostic performance between FSE-Cube and the routine MR protocol. FSE-cube and the routine MR protocol had similar sensitivity (95.5%/95.3% respectively, P=0.94) and similar specificity (69.8%/74.0% respectively, P=0.10) for detecting 156 medial meniscal tears. FSE-Cube had significantly lower sensitivity than the routine MR protocol (79.4%/85.0% respectively, P < 0.05) but similar specificity (83.9%/82.2% respectively, P=0.37) for detecting 89 lateral mensical tears. For lateral meniscal tears, FSE-Cube had significantly lower sensitivity (P < 0.05) than the routine MR protocol for detecting 19 root tears but similar sensitivity (P=0.17-1.00) for detecting all other tear locations and types. FSE-Cube had diagnostic performance similar to a routine MR protocol for detecting meniscal tears except for a significantly lower sensitivity for detecting lateral meniscal tears, which was mainly attributed to decreased ability to identify lateral meniscus root tears. (orig.)

Evaluation of the menisci of the knee joint using three-dimensional isotropic resolution fast spin-echo imaging: diagnostic performance in 250 patients with surgical correlation

International Nuclear Information System (INIS)

Kijowski, Richard; Davis, Kirkland W.; Blankenbaker, Donna G.; Woods, Michael A.; De Smet, Arthur A.; Munoz del Rio, Alejandro

2012-01-01

To compare the diagnostic performance of FSE-Cube, a three-dimensional isotropic resolution intermediate-weighted fast spin-echo sequence, with a routine magnetic resonance (MR) protocol at 3.0 T for detecting surgically confirmed meniscal tears of the knee joint in a large patient population. FSE-Cube was added to a routine MR protocol performed at 3.0 T on 250 patients who underwent subsequent knee arthroscopy. Three radiologists independently used FSE-Cube during one review and the routine MR protocol during a second review to detect medial and lateral meniscal tears. Using arthroscopy as the reference standard, the sensitivity and specificity of FSE-Cube and the routine MR protocol for detecting meniscal tears were determined for all readers combined. McNemar's tests were used to compare diagnostic performance between FSE-Cube and the routine MR protocol. FSE-cube and the routine MR protocol had similar sensitivity (95.5%/95.3% respectively, P=0.94) and similar specificity (69.8%/74.0% respectively, P=0.10) for detecting 156 medial meniscal tears. FSE-Cube had significantly lower sensitivity than the routine MR protocol (79.4%/85.0% respectively, P < 0.05) but similar specificity (83.9%/82.2% respectively, P=0.37) for detecting 89 lateral mensical tears. For lateral meniscal tears, FSE-Cube had significantly lower sensitivity (P < 0.05) than the routine MR protocol for detecting 19 root tears but similar sensitivity (P=0.17-1.00) for detecting all other tear locations and types. FSE-Cube had diagnostic performance similar to a routine MR protocol for detecting meniscal tears except for a significantly lower sensitivity for detecting lateral meniscal tears, which was mainly attributed to decreased ability to identify lateral meniscus root tears. (orig.)

Using Meta-Analysis to Inform the Design of Subsequent Studies of Diagnostic Test Accuracy

Science.gov (United States)

Hinchliffe, Sally R.; Crowther, Michael J.; Phillips, Robert S.; Sutton, Alex J.

2013-01-01

An individual diagnostic accuracy study rarely provides enough information to make conclusive recommendations about the accuracy of a diagnostic test; particularly when the study is small. Meta-analysis methods provide a way of combining information from multiple studies, reducing uncertainty in the result and hopefully providing substantial…

Recent diagnostic developments on LHD

International Nuclear Information System (INIS)

Sudo, S.; Nagayama, Y.; Peterson, B.J.

2003-01-01

Standard diagnostics for fundamental plasma parameters and for plasma physics are routinely utilized for daily operation and physics study in the large helical device (LHD) with high reliability. Diagnostics for steady state plasma are intensively developed, especially for T e , n e (YAG laser Thomson, CO 2 laser polarimeter), data acquisition in steady state, heat resistant probes. To clarify the plasma property of the helical structure, 2-D or 3-D diagnostics are intensively developed: Tangential cameras (Fast SX TV, Photon counting CCD, H α TV); Tomography (Tangential SX CCD, Bolometer); Imaging (Bolometer, ECE, Reflectometer). Divertor and edge physics are one of important key issues for steady state operation. Diagnostics for neutral flux (H α array, Zeeman spectroscopy) and n e (Fast scanning probe, Li beam probe, Pulsed radar reflectometer). In addition to these, advanced diagnostics are being intensively developed with national and international collaborations in LHD. (author)

Vanishing tattoo multi-sensor for biomedical diagnostics

Science.gov (United States)

Moczko, E.; Meglinski, I.; Piletsky, S.

2008-04-01

Currently, precise non-invasive diagnostics systems for the real-time multi detection and monitoring of physiological parameters and chemical analytes in the human body are urgently required by clinicians, physiologists and bio-medical researchers. We have developed a novel cost effective smart 'vanishing tattoo' (similar to temporary child's tattoos) consisting of environmental-sensitive dyes. Painlessly impregnated into the skin the smart tattoo is capable of generating optical/fluorescence changes (absorbance, transmission, reflectance, emission and/or luminescence within UV, VIS or NIR regions) in response to physical or chemical changes. These changes allow the identification of colour pattern changes similar to bar-code scanning. Such a system allows an easy, cheap and robust comprehensive detection of various parameters and analytes in a small volume of sample (e.g. variations in pH, temperature, ionic strength, solvent polarity, presence of redox species, surfactants, oxygen). These smart tattoos have possible applications in monitoring the progress of disease and transcutaneous drug delivery. The potential of this highly innovative diagnostic tool is wide and diverse and can impact on routine clinical diagnostics, general therapeutic management, skin care and cosmetic products testing as well as fundamental physiological investigations.

The diagnostic accuracy of three rapid diagnostic tests for typhoid fever at Chittagong Medical College Hospital, Chittagong, Bangladesh.

Science.gov (United States)

Maude, Rapeephan R; de Jong, Hanna K; Wijedoru, Lalith; Fukushima, Masako; Ghose, Aniruddha; Samad, Rasheda; Hossain, Mohammed Amir; Karim, Mohammed Rezaul; Faiz, Mohammed Abul; Parry, Christopher M

2015-10-01

To determine the diagnostic accuracy of three rapid diagnostic tests (RDTs) for typhoid fever in febrile hospitalised patients in Bangladesh. Febrile adults and children admitted to Chittagong Medical College Hospital, Bangladesh, were investigated with Bact/Alert(®) blood cultures and real-time PCR to detect Salmonella enterica Typhi and Paratyphi A and assays for Rickettsia, leptospirosis and dengue fever. Acute serum samples were examined with the LifeAssay (LA) Test-it™ Typhoid IgM lateral flow assay detecting IgM antibodies against S. Typhi O antigen, CTKBiotech Onsite Typhoid IgG/IgM Combo Rapid-test cassette lateral flow assay detecting IgG and IgM antibodies against S. Typhi O and H antigens and SD Bioline line assay for IgG and IgM antibodies against S. Typhi proteins. In 300 malaria smear-negative febrile patients [median (IQR) age of 13.5 (5-31) years], 34 (11.3%) had confirmed typhoid fever: 19 positive by blood culture for S. Typhi (three blood PCR positive) and 15 blood culture negative but PCR positive for S. Typhi in blood. The respective sensitivity and specificity of the three RDTs in patients using a composite reference standard of blood culture and/or PCR-confirmed typhoid fever were 59% and 61% for LifeAssay, 59% and 74% for the CTK IgM and/or IgG, and 24% and 96% for the SD Bioline RDT IgM and/or IgG. The LifeAssay RDT had a sensitivity of 63% and a specificity of 91% when modified with a positive cut-off of ≥2+ and analysed using a Bayesian latent class model. These typhoid RDTs demonstrated moderate diagnostic accuracies, and better tests are needed. © 2015 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

Proton (1H) MR spectroscopy for routine diagnostic evaluation of brain lesions

International Nuclear Information System (INIS)

Burtscher, I.M.; Holtaas, S.; Staahlberg, F.; Univ. Hospital, Lund

1997-01-01

Purpose: To describe the introduction and performance of proton MR spectroscopy ( 1 H-MRS) in the daily routine of a modern standard MR unit. Material and Methods: Over an 8-month period, 52 patients with brain lesions were studied with 1 H-MRS, using SE and STEAM sequences for chemical-shift imaging and single-volume spectroscopy. The quality of the spectra was graded from 1 (best) to 3, and the main factors influencing the quality of the spectra were evaluated. Results: Of the measurements: 85% were graded as 1; 12% as 2; and 3% as 3. The main reasons for poor spectral quality were: the unfortunate positioning of the VOI; hemorrhage; and/or postoperative changes within the VOI. Of 40 patients with a final diagnosis: MRS provided an increased confidence in MR diagnosis in 18 cases; MRS contributed significantly to preoperative diagnosis in 3 cases; and the spectra were not specific (n=10) or were difficult to evaluate (n=9) owing to reduced quality (grade 2 or 3) in 19 cases. Conclusion: MRS of the brain can provide a high percentage of interpretable spectra and frequently can increase confidence in the MR diagnosis of brain lesions in clinical routine. (orig.)

Diagnostic pitfalls in newborns and babies with blisters and erosions.

Science.gov (United States)

Nischler, Elke; Klausegger, Alfred; Hüttner, Clemens; Pohla-Gubo, Gabriele; Diem, Anja; Bauer, Johann W; Hintner, Helmut

2009-01-01

Establishing the correct diagnosis in newborns presenting with blisters and erosions is not always a straightforward process. Many different disease entities including acquired (i.e., infectious, immunobullous, traumatic) and inherited disorders have to be taken into consideration. Similarities in clinical appearance, colonization and/or superinfections of preexisting skin lesions, as well as the absence of late changes in the neonate often pose significant diagnostic challenges. In this paper we discuss by giving examples the process of making an accurate diagnosis of blistering skin diseases in the neonatal period on the basis of a diagnostic algorithm. In addition, we provide an overview of the rational use and the limitations of laboratory procedures such as microbial testing, routine light microscopy, immunofluorescence antigen mapping, transmission electron microscopy, and molecular genetic analysis.

Diagnostic Pitfalls in Newborns and Babies with Blisters and Erosions

Directory of Open Access Journals (Sweden)

Elke Nischler

2009-01-01

Full Text Available Establishing the correct diagnosis in newborns presenting with blisters and erosions is not always a straightforward process. Many different disease entities including acquired (i.e., infectious, immunobullous, traumatic and inherited disorders have to be taken into consideration. Similarities in clinical appearance, colonization and/or superinfections of preexisting skin lesions, as well as the absence of late changes in the neonate often pose significant diagnostic challenges. In this paper we discuss by giving examples the process of making an accurate diagnosis of blistering skin diseases in the neonatal period on the basis of a diagnostic algorithm. In addition, we provide an overview of the rational use and the limitations of laboratory procedures such as microbial testing, routine light microscopy, immunofluorescence antigen mapping, transmission electron microscopy, and molecular genetic analysis.

Aminopenicillin-associated exanthem: lymphocyte transformation testing revisited.

Science.gov (United States)

Trautmann, A; Seitz, C S; Stoevesandt, J; Kerstan, A

2014-12-01

The lymphocyte transformation test (LTT) has been promoted as in-vitro test for diagnosis of drug hypersensitivity. For determination of statistical LTT sensitivity, series of patients with clinically uniform reactions followed by complete drug hypersensitivity work-up are mandatory. Assessment of LTT specificity requires control patients who tolerated exposure to the drug studied. To prospectively determine the diagnostic value of the LTT in a clinically and diagnostically well-defined series of patients. Patients with exanthematous skin eruptions after ampicillin (AMP) intake were included in this study. After exclusion or confirmation of delayed-onset allergic AMP hypersensitivity by skin and provocation testing, two independent LTTs were performed: one standard LTT and a modified LTT with additional anti-CD3/anti-CD28 monoclonal antibody stimulation. By testing, delayed-onset allergic AMP hypersensitivity was diagnosed in 11 patients and definitely ruled out in 26. The standard LTT reached a diagnostic sensitivity of 54.5% while the modified LTT yielded 72.7%. However, the methodical test modification resulted in a decline of specificity from 92.3% (standard LTT) to 76.9%. In cases of AMP-associated exanthems, the diagnostic value of the LTT compared with routine allergy testing is limited. When evaluating such exanthems, provocation testing remains the gold standard. Delayed reading of intradermal skin tests remains most useful to avoid positive provocation reactions. © 2014 John Wiley & Sons Ltd.

Systematic Review of Health Economic Evaluations of Diagnostic Tests in Brazil: How accurate are the results?

Science.gov (United States)

Oliveira, Maria Regina Fernandes; Leandro, Roseli; Decimoni, Tassia Cristina; Rozman, Luciana Martins; Novaes, Hillegonda Maria Dutilh; De Soárez, Patrícia Coelho

2017-08-01

The aim of this study is to identify and characterize the health economic evaluations (HEEs) of diagnostic tests conducted in Brazil, in terms of their adherence to international guidelines for reporting economic studies and specific questions in test accuracy reports. We systematically searched multiple databases, selecting partial and full HEEs of diagnostic tests, published between 1980 and 2013. Two independent reviewers screened articles for relevance and extracted the data. We performed a qualitative narrative synthesis. Forty-three articles were reviewed. The most frequently studied diagnostic tests were laboratory tests (37.2%) and imaging tests (32.6%). Most were non-invasive tests (51.2%) and were performed in the adult population (48.8%). The intended purposes of the technologies evaluated were mostly diagnostic (69.8%), but diagnosis and treatment and screening, diagnosis, and treatment accounted for 25.6% and 4.7%, respectively. Of the reviewed studies, 12.5% described the methods used to estimate the quantities of resources, 33.3% reported the discount rate applied, and 29.2% listed the type of sensitivity analysis performed. Among the 12 cost-effectiveness analyses, only two studies (17%) referred to the application of formal methods to check the quality of the accuracy studies that provided support for the economic model. The existing Brazilian literature on the HEEs of diagnostic tests exhibited reasonably good performance. However, the following points still require improvement: 1) the methods used to estimate resource quantities and unit costs, 2) the discount rate, 3) descriptions of sensitivity analysis methods, 4) reporting of conflicts of interest, 5) evaluations of the quality of the accuracy studies considered in the cost-effectiveness models, and 6) the incorporation of accuracy measures into sensitivity analyses.

Quality control of diagnostic X-ray installations for conventional radiography in the period of their clinical use-methods and results of their implementation

International Nuclear Information System (INIS)

Vassileva, J.

2000-01-01

A guide on the qualify assurance in x-ray diagnostics, developed for Bulgarian medical physicists and other specialists is presented. All measurement described have been testing for three years in the Department of Radiology in the Regional Hospital in Shoumen. The guide covers only tests on the x-ray equipment. A list of test measurements as well as recommendations for the minimum frequency of a routine performance testing are given

LOGICAL CONDITIONS ANALYSIS METHOD FOR DIAGNOSTIC TEST RESULTS DECODING APPLIED TO COMPETENCE ELEMENTS PROFICIENCY

Directory of Open Access Journals (Sweden)

V. I. Freyman

2015-11-01

Full Text Available Subject of Research.Representation features of education results for competence-based educational programs are analyzed. Solution importance of decoding and proficiency estimation for elements and components of discipline parts of competences is shown. The purpose and objectives of research are formulated. Methods. The paper deals with methods of mathematical logic, Boolean algebra, and parametrical analysis of complex diagnostic test results, that controls proficiency of some discipline competence elements. Results. The method of logical conditions analysis is created. It will give the possibility to formulate logical conditions for proficiency determination of each discipline competence element, controlled by complex diagnostic test. Normalized test result is divided into noncrossing zones; a logical condition about controlled elements proficiency is formulated for each of them. Summarized characteristics for test result zones are imposed. An example of logical conditions forming for diagnostic test with preset features is provided. Practical Relevance. The proposed method of logical conditions analysis is applied in the decoding algorithm of proficiency test diagnosis for discipline competence elements. It will give the possibility to automate the search procedure for elements with insufficient proficiency, and is also usable for estimation of education results of a discipline or a component of competence-based educational program.

Implementation aspects of image management, archiving, and communication systems in routine clinical use

NARCIS (Netherlands)

Haar Romenij, ter B.M.

1991-01-01

Implementation of a digital imaging network in routine clinical use is a difficult task. Not only the high technical requirements, but especially the complexity of the organization of the diagnostic information flow in a hospital makes commitment essential in PACS implementation. The application of

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

Science.gov (United States)

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.

A massive parallel sequencing workflow for diagnostic genetic testing of mismatch repair genes

Science.gov (United States)

Hansen, Maren F; Neckmann, Ulrike; Lavik, Liss A S; Vold, Trine; Gilde, Bodil; Toft, Ragnhild K; Sjursen, Wenche

2014-01-01

The purpose of this study was to develop a massive parallel sequencing (MPS) workflow for diagnostic analysis of mismatch repair (MMR) genes using the GS Junior system (Roche). A pathogenic variant in one of four MMR genes, (MLH1, PMS2, MSH6, and MSH2), is the cause of Lynch Syndrome (LS), which mainly predispose to colorectal cancer. We used an amplicon-based sequencing method allowing specific and preferential amplification of the MMR genes including PMS2, of which several pseudogenes exist. The amplicons were pooled at different ratios to obtain coverage uniformity and maximize the throughput of a single-GS Junior run. In total, 60 previously identified and distinct variants (substitutions and indels), were sequenced by MPS and successfully detected. The heterozygote detection range was from 19% to 63% and dependent on sequence context and coverage. We were able to distinguish between false-positive and true-positive calls in homopolymeric regions by cross-sample comparison and evaluation of flow signal distributions. In addition, we filtered variants according to a predefined status, which facilitated variant annotation. Our study shows that implementation of MPS in routine diagnostics of LS can accelerate sample throughput and reduce costs without compromising sensitivity, compared to Sanger sequencing. PMID:24689082

PR.Latent-class methods to evaluate diagnostics tests for echinococcus infections in dogs.

NARCIS (Netherlands)

Hartnack, S.; Budke, C.M.; Craig, P.S.; Jiamin, Q.; Boufana, B.; Campos Ponce, M.; Torgerson, P.R.

2013-01-01

Background: The diagnosis of canine echinococcosis can be a challenge in surveillance studies because there is no perfect gold standard that can be used routinely. However, unknown test specificities and sensitivities can be overcome using latent-class analysis with appropriate data. Methodology: We

An audit to investigate the impact of false positive breast screening results and diagnostic work-up on re-engagement with subsequent routine screening

International Nuclear Information System (INIS)

Nightingale, Julie M.; Borgen, Rita; Porter-Bennett, Lisa; Szczepura, Katy

2015-01-01

Introduction: Women attending breast screening may have suspicious mammographic findings that are subsequently found at assessment clinic to be normal (false positive, FP). A false positive diagnosis is not harmless, with short and long term negative psychosocial consequences reported. Women are at increased relative risk of breast cancer therefore their attendance at subsequent screening is essential. Aims: To assess the impact of FP breast screening diagnosis and diagnostic work-up on re-attendance rates across four consecutive screening rounds at a typical breast screening centre. Method: Diagnostic interventions and screening re-attendance rates at one prior and two consecutive rounds were analysed for women receiving an FP diagnosis between 2004 and 2006. Results: 397 women (5.57%) were referred for further assessment, including 228 (57.43%) false positives. 34 eligible women failed to re-attend routine screening (+3 years), with 17 failing to re-attend subsequently (+6 years). 70.6% (24/34) of non-attenders had attended at least two screening rounds prior to FP assessment. 75% of FP women had an imaging-only assessment with 17.5% (30/171) failing to re-attend, and 25% received a biopsy, with 7% (4/57) failing to re-attend subsequently. Conclusion: This study is unique as it follows FP women through four consecutive screening rounds. FP non-attendance rates were considerably lower compared to the general screening population, with diagnostic work-up having limited influence. FP non-attendance may appear insignificant in comparison to total screened population, but these women are at greater risk of subsequent cancer so should be actively encouraged to re-engage with the screening programme

Empirical evidence of design-related bias in studies of diagnostic tests

NARCIS (Netherlands)

Lijmer, J. G.; Mol, B. W.; Heisterkamp, S.; Bonsel, G. J.; Prins, M. H.; van der Meulen, J. H.; Bossuyt, P. M.

1999-01-01

CONTEXT: The literature contains a large number of potential biases in the evaluation of diagnostic tests. Strict application of appropriate methodological criteria would invalidate the clinical application of most study results. OBJECTIVE: To empirically determine the quantitative effect of study

An Indian test facility to characterise diagnostic neutral beam for ITER

International Nuclear Information System (INIS)

Singh, M.J.; Bandyopadhyay, M.; Rotti, C.; Singh, N.P.; Shah, Sejal; Bansal, G.; Gahlaut, A.; Soni, J.; Lakdawala, H.; Waghela, Harshad; Ahmed, I.; Roopesh, G.; Baruah, U.K.; Chakraborty, A.K.

2011-01-01

The diagnostic neutral beam (DNB) line shall be used to diagnose the He ash content in the D-T phase of the ITER machine using the charge exchange recombination spectroscopy (CXRS). Implementation of a successful DNB at ITER requires several challenges related to the production, neutralization and transport of the neutral beam over path lengths of 20.665 m, to be overcome. The delivery is aided if the above effects are tested prior to onsite commissioning. As DNB is a procurement package for INDIA, an ITER approved Indian test facility, INTF, is under construction at Institute for Plasma Research (IPR), India and is envisaged to be operational in 2015. The timeline for this facility is synchronized with the RADI, ELISE (IPP, Garching), SPIDER (RFX, Padova) in a manner that best utilization of configurational inputs available from them are incorporated in the design. This paper describes the facility in detail and discusses the experiments planned to optimise the beam transmission and testing of the beam line components using various diagnostics.

External quality assessment of dengue and chikungunya diagnostics in the Asia Pacific region, 2015

Directory of Open Access Journals (Sweden)

Li Ting Soh

2016-04-01

Full Text Available Objective: To conduct an external quality assessment (EQA of dengue and chikungunya diagnostics among national-level public health laboratories in the Asia Pacific region following the first round of EQA for dengue diagnostics in 2013. Methods: Twenty-four national-level public health laboratories performed routine diagnostic assays on a proficiency testing panel consisting of two modules. Module A contained serum samples spiked with cultured dengue virus (DENV or chikungunya virus (CHIKV for the detection of nucleic acid and DENV non-structural protein 1 (NS1 antigen. Module B contained human serum samples for the detection of anti-DENV antibodies. Results: Among 20 laboratories testing Module A, 17 (85% correctly detected DENV RNA by reverse transcription polymerase chain reaction (RT-PCR, 18 (90% correctly determined serotype and 19 (95% correctly identified CHIKV by RT-PCR. Ten of 15 (66.7% laboratories performing NS1 antigen assays obtained the correct results. In Module B, 18/23 (78.3% and 20/20 (100% of laboratories correctly detected anti-DENV IgM and IgG, respectively. Detection of acute/recent DENV infection by both molecular (RT-PCR and serological methods (IgM was available in 19/24 (79.2% participating laboratories. Discussion: Accurate laboratory testing is a critical component of dengue and chikungunya surveillance and control. This second round of EQA reveals good proficiency in molecular and serological diagnostics of these diseases in the Asia Pacific region. Further comprehensive diagnostic testing, including testing for Zika virus, should comprise future iterations of the EQA.

[The Offer of Medical-Diagnostic Self-Tests on German Language Websites: Results of a Systematic Internet Search].

Science.gov (United States)

Kuecuekbalaban, P; Schmidt, S; Muehlan, H

2018-03-01

The aim of the current study was to provide an overview of medical-diagnostic self-tests which can be purchased without a medical prescription on German language websites. From September 2014 to March 2015, a systematic internet research was conducted with the following search terms: self-test, self-diagnosis, home test, home diagnosis, quick test, rapid test. 513 different self-tests for the diagnostics of 52 diverse diseases or health risks were identified, including chronic diseases (e. g. diabetes, chronic disease of the kidneys, liver, and lungs), sexually transmitted diseases (e. g. HIV, chlamydia, gonorrhea), infectious diseases (e. g. tuberculosis, malaria, Helicobacter pylori), allergies (e. g. house dust, cats, histamine) and cancer as well as tests for the diagnostics of 12 different psychotropic substances. These were sold by 90 companies in Germany and by other foreign companies. The number of medical-diagnostic self-tests which can be bought without a medical prescription on the Internet has increased enormously in the last 10 years. Further studies are needed for the identification of the determinants of the use of self-tests as well as the impact of the application on the experience and behavior of the user. © Georg Thieme Verlag KG Stuttgart · New York.

Changes in the ocular surface: initial observations from a pilot study of diagnostic radiology technicians (radiographers)

International Nuclear Information System (INIS)

Guerdal, Canan; Aydin, Sevda; Sengoer, Tomris; Onmus, Hale; Oezarar, Muemtaz

2002-01-01

The purpose of this study was to evaluate the clinical and cytological changes in the ocular surface of radiology technicians (radiographers) exposed to diagnostic doses of radiation. The Schirmer, Rose Bengal staining and Tear-Break-Up-Time tear function tests were carried out following routine ophthalmic examination in 15 radiology technicians (group I) and 15 controls (group II). Impression cytology was performed by placing 5-mm-thick half-circular cellulose acetate filter paper in the upper and lower quadrants around the limbus. The cytological evaluation was made using the mapping technique. Significantly increased dry eye was detected in group I. In the impression cytology investigation, squamous metaplasia and intraepithelial lymphocytic infiltration was noted in all the group-I cases. A distinct change was observed between the regions showing squamous metaplasia and neigbouring normal epithelial cell structure. Dry eye and ocular surface cytological changes were observed in diagnostic radiology technicians. Routine ophthalmic evaluation of radiology technicians would be beneficial in detecting early cytological changes and dry eye. (orig.)

Current status and future perspectives on molecular and serological methods in diagnostic mycology.

Science.gov (United States)

Lau, Anna; Chen, Sharon; Sleiman, Sue; Sorrell, Tania

2009-11-01

Invasive fungal infections are an important cause of infectious morbidity. Nonculture-based methods are increasingly used for rapid, accurate diagnosis to improve patient outcomes. New and existing DNA amplification platforms have high sensitivity and specificity for direct detection and identification of fungi in clinical specimens. Since laboratories are increasingly reliant on DNA sequencing for fungal identification, measures to improve sequence interpretation should support validation of reference isolates and quality control in public gene repositories. Novel technologies (e.g., isothermal and PNA FISH methods), platforms enabling high-throughput analyses (e.g., DNA microarrays and Luminex xMAP) and/or commercial PCR assays warrant further evaluation for routine diagnostic use. Notwithstanding the advantages of molecular tests, serological assays remain clinically useful for patient management. The serum Aspergillus galactomannan test has been incorporated into diagnostic algorithms of invasive aspergillosis. Both the galactomannan and the serum beta-D-glucan test have value for diagnosing infection and monitoring therapeutic response.

Evaluation performance of diagnostic methods of intestinal parasitosis in school age children in Ethiopia.

Science.gov (United States)

Yimer, Mulat; Hailu, Tadesse; Mulu, Wondemagegn; Abera, Bayeh

2015-12-26

Although the sensitivity of Wet mount technique is questionable, it is the major diagnostic technique for routine diagnosis of intestinal parasitosis in Ethiopia. Therefore, the aim of this study was the evaluation performance of diagnostic methods of intestinal parasitosis in school age children in Ethiopia. A cross sectional study was conducted from May to June 2013. Single stool sample was processed for direct, Formol ether concentration (FEC) and Kato Katz methods. The sensitivity and negative predictive value (NPV) of diagnostic tests were calculated in terms of the "Gold" standard method (the combined result of the three methods altogether). A total of 422 school age children were participated in this study. The prevalence of intestinal parasites was high (74.6%) with Kato Katz technique. The sensitivity of Wet mount, FEC and Kato Katz tests against the Gold standard test was 48.9, 63.1 and 93.7%, respectively. Kato Katz technique revealed a better NPV 80.4 (80.1-80.6) as compared to the Wet mount (33.7%) and FEC techniques (41.3%). In this study, the Kato Katz technique outperformed the other two methods but the true values for sensitivity, specificity and diagnostic values are not known. Moreover, it is labor intensive and not easily accessible. Hence, it is preferable to use FEC technique to complement the Wet mount test.

A clinical evaluation of placental growth factor in routine practice in high-risk women presenting with suspected pre-eclampsia and/or fetal growth restriction.

Science.gov (United States)

Ormesher, L; Johnstone, E D; Shawkat, E; Dempsey, A; Chmiel, C; Ingram, E; Higgins, L E; Myers, J E

2018-03-13

To evaluate the use of plasma Placental Growth Factor (PlGF), recommended by the recent NICE guidance, in women with suspected pre-eclampsia (PE) and/or fetal growth restriction (FGR). Non-randomised prospective clinical evaluation study in high-risk antenatal clinics in a tertiary maternity unit. PlGF testing was performed in addition to routine clinical assessment in 260 women >20 weeks' gestation with chronic disease (hypertension, renal disease ± diabetes) with a change in maternal condition or in women with suspected FGR to determine the impact on clinical management. Results were revealed and standardised care pathways followed. Outcome of pregnancies with a low PlGF (women had an adverse outcome (PE/birthweight women with PlGF 14 days. The PlGF result altered clinical management (surveillance or timing of birth) in 196/260 (75.4%) cases. Alternative PlGF thresholds did not significantly improve diagnostic performance. Our evaluation confirms the value of PlGF as a diagnostic tool for placental dysfunction. However, low PlGF in isolation should not trigger iatrogenic delivery. Further research linking placental pathology, maternal disease and maternal PlGF levels is urgently needed before this test can be implemented in routine clinical practice. Copyright © 2018. Published by Elsevier B.V.

Evaluation of Elecsys Syphilis Assay for Routine and Blood Screening and Detection of Early Infection.

Science.gov (United States)

Kremastinou, J; Polymerou, V; Lavranos, D; Aranda Arrufat, A; Harwood, J; Martínez Lorenzo, M J; Ng, K P; Queiros, L; Vereb, I; Cusini, M

2016-09-01

Treponema pallidum infections can have severe complications if not diagnosed and treated at an early stage. Screening and diagnosis of syphilis require assays with high specificity and sensitivity. The Elecsys Syphilis assay is an automated treponemal immunoassay for the detection of antibodies against T. pallidum The performance of this assay was investigated previously in a multicenter study. The current study expands on that evaluation in a variety of diagnostic settings and patient populations, at seven independent laboratories. The samples included routine diagnostic samples, blood donation samples, samples from patients with confirmed HIV infections, samples from living organ or bone marrow donors, and banked samples, including samples previously confirmed as syphilis positive. This study also investigated the seroconversion sensitivity of the assay. With a total of 1,965 syphilis-negative routine diagnostic samples and 5,792 syphilis-negative samples collected from blood donations, the Elecsys Syphilis assay had specificity values of 99.85% and 99.86%, respectively. With 333 samples previously identified as syphilis positive, the sensitivity was 100% regardless of disease stage. The assay also showed 100% sensitivity and specificity with samples from 69 patients coinfected with HIV. The Elecsys Syphilis assay detected infection in the same bleed or earlier, compared with comparator assays, in a set of sequential samples from a patient with primary syphilis. In archived serial blood samples collected from 14 patients with direct diagnoses of primary syphilis, the Elecsys Syphilis assay detected T. pallidum antibodies for 3 patients for whom antibodies were not detected with the Architect Syphilis TP assay, indicating a trend for earlier detection of infection, which may have the potential to shorten the time between infection and reactive screening test results. Copyright © 2016 Kremastinou et al.

Evaluation of Elecsys Syphilis Assay for Routine and Blood Screening and Detection of Early Infection

Science.gov (United States)

Kremastinou, J.; Polymerou, V.; Lavranos, D.; Aranda Arrufat, A.; Harwood, J.; Martínez Lorenzo, M. J.; Ng, K. P.; Queiros, L.; Vereb, I.

2016-01-01

Treponema pallidum infections can have severe complications if not diagnosed and treated at an early stage. Screening and diagnosis of syphilis require assays with high specificity and sensitivity. The Elecsys Syphilis assay is an automated treponemal immunoassay for the detection of antibodies against T. pallidum. The performance of this assay was investigated previously in a multicenter study. The current study expands on that evaluation in a variety of diagnostic settings and patient populations, at seven independent laboratories. The samples included routine diagnostic samples, blood donation samples, samples from patients with confirmed HIV infections, samples from living organ or bone marrow donors, and banked samples, including samples previously confirmed as syphilis positive. This study also investigated the seroconversion sensitivity of the assay. With a total of 1,965 syphilis-negative routine diagnostic samples and 5,792 syphilis-negative samples collected from blood donations, the Elecsys Syphilis assay had specificity values of 99.85% and 99.86%, respectively. With 333 samples previously identified as syphilis positive, the sensitivity was 100% regardless of disease stage. The assay also showed 100% sensitivity and specificity with samples from 69 patients coinfected with HIV. The Elecsys Syphilis assay detected infection in the same bleed or earlier, compared with comparator assays, in a set of sequential samples from a patient with primary syphilis. In archived serial blood samples collected from 14 patients with direct diagnoses of primary syphilis, the Elecsys Syphilis assay detected T. pallidum antibodies for 3 patients for whom antibodies were not detected with the Architect Syphilis TP assay, indicating a trend for earlier detection of infection, which may have the potential to shorten the time between infection and reactive screening test results. PMID:27358468

Diagnostic x-ray equipment compliance and facility survey. Recommended procedures for equipment and facility testing

International Nuclear Information System (INIS)

1994-01-01

The Radiation Protection Bureau has set out guidelines for the testing of diagnostic x-ray equipment and facilities. This guide provides information for the x-ray inspector, test engineer, technologist, medical physicist and any other person responsible for verifying the regulatory compliance or safety of diagnostic x-ray equipment and facilities. Diagnostic x-radiation is an essential part of present day medical practice. The largest contributor of irradiation to the general population comes from diagnostic x-radiation. Although individual irradiations are usually small, there is a concern of possible excess cancer risk when large populations are irradiated. Unnecessary irradiations to patients from radiological procedures can be significantly reduced with little or no decrease in the value of medical diagnostic information. This can be achieved by using well designed x-ray equipment which is installed, used and maintained by trained personnel, and by the adoption of standardized procedures. In general, when patient surface dose is reduced, there is a corresponding decrease in dose to x-ray equipment operators and other health care personnel. 2 tabs., 4 figs