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2. Technical specifications series for submission to WHO prequalification: diagnostic assessment: Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use and/or self-testing

Technical specifications series for submission to WHO prequalification: diagnostic assessment: Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use and/or self-testing Human Immunodeficiency Virus (‎HIV)‎ rapid diagnostic tests for professional use and/or self-testing JavaScript is disabled for your browser. Some features of this site may not work without it. Toggle navigation Toggle navigation Search Browse Statistics Related Links Human Immunodeficiency Virus (‎HIV (...) )‎ rapid diagnostic tests for professional use and/or self-testing View/ Open Rights View Statistics Altmetrics Share Citation World Health Organization . (‎2016)‎. Human Immunodeficiency Virus (‎HIV)‎ rapid diagnostic tests for professional use and/or self-testing. World Health Organization. . License: CC BY-NC-SA 3.0 IGO Relation Technical specifications series for submission to WHO prequalification: diagnostic assessment, TSS-1 Description 26 p. ISBN 9789241511742 Collections Language English

2016 WHO

3. The Sensitivity and Specificity of Platelet Autoantibody Testing in Immune Thrombocytopenia: A Systematic Review and Meta-Analysis of a Diagnostic Test. (PubMed)

The Sensitivity and Specificity of Platelet Autoantibody Testing in Immune Thrombocytopenia: A Systematic Review and Meta-Analysis of a Diagnostic Test. Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by a low platelet count and an increased risk of bleeding. The sensitivity and specificity of platelet autoantibody tests is variable and their utility is uncertain.The purpose of this study was to perform a systematic review and meta-analysis of platelet autoantibody tests (...) in the diagnosis of ITP.Ovid Medline, PubMed, and Web of Science were searched from inception until May 31, 2018. Two reviewers independently assessed studies for eligibility and extracted data. Studies that reported testing results for anti-platelet autoantibodies on platelets (direct tests) or in plasma/serum (indirect tests) for 20 or more ITP patients were included.Pooled estimates for sensitivity and specificity were calculated using a random effects model. Pooled estimates for the sensitivity

2019 Journal of Thrombosis and Haemostasis

4. Generation and characterization of D-dimer specific monoclonal antibodies for use in latex agglutination test. (PubMed)

Generation and characterization of D-dimer specific monoclonal antibodies for use in latex agglutination test. The commercially available D-dimer assays used in the clinical practice often show differences in the results, and their specificity and sensitivity are rather unsatisfactory. Our aim was to develop a new monoclonal antibody against D-dimer with a proper specificity, and estimating its suitability using in a latex agglutination diagnostic test. Monoclonal antibodies were generated (...) using hybridoma technology. Their titer was determined by a self-developed ELISA method. The cross-reactions of the antibodies were tested. Characterization of the epitope specificity of a selected antibody was performed through digestion of D-dimer followed by Western blotting. The amino acid sequences of the active antigen fragments were determined. According to the ELISA results, 38 cell groups were constated as antibody-producing hybridomas, among them 7 gave raised titer of antibody and were

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2019 PLoS ONE

5. A novel platform for isotype-specific testing of autoantibodies. (PubMed)

A novel platform for isotype-specific testing of autoantibodies. The objective of this study was to test if a novel platform could be used for isotype-specific autoantibody testing in humans. Further, we evaluated if testing with this novel platform enables earlier detection of insulin autoantibodies in individuals that have first-degree relatives with type-1 diabetes than currently used approaches. Longitudinal serum samples from participants were collected before and after they converted (...) to become positive for insulin autoantibodies by the current standardly used assays. Using a novel plasmonic gold chip platform, we tested these samples for IgM isotype-specific autoantibodies. Serial serum samples from individuals without diabetes were also tested as a comparison control cohort. Our results demonstrate proof-of-concept that a plasmonic gold chip can specifically detect the IgM insulin autoantibody. Five out of the six individuals that converted to being positive for insulin

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2019 PLoS ONE

6. Economic evaluation of the introduction of the Prostate Health Index as a rule-out test to avoid unnecessary biopsies in men with prostate specific antigen levels of 4-10 in Hong Kong. (PubMed)

Economic evaluation of the introduction of the Prostate Health Index as a rule-out test to avoid unnecessary biopsies in men with prostate specific antigen levels of 4-10 in Hong Kong. A recent study showed that the Prostate Health Index may avoid unnecessary biopsies in men with prostate specific antigen 4-10ng/ml and normal digital rectal examination in the diagnosis of prostate cancer in Hong Kong. This study aimed to conduct an economic evaluation of the impact of adopting this commercially (...) -available test in the Hong Kong public health service to determine whether further research is justified. A cost-consequence analysis was undertaken comparing the current diagnostic pathway with a proposed diagnostic pathway using the Prostate Health Index. Data for the model was taken from a prospective cohort study recruited at a single-institution and micro-costing studies. Using a cut off PHI score of 35 to avoid biopsy would cost HK$3,000 and save HK$7,988 per patient in biopsy costs and HK$511

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2019 PLoS ONE

7. Testing the potential of 50 kHz rat calls as a species-specific rat attractant. (PubMed)

Testing the potential of 50 kHz rat calls as a species-specific rat attractant. The control of mammalian pests relies heavily on the use of pesticides that are often avoided and are not species-specific. These problems are particularly acute for pesticides used to control rats (Rattus spp.). The efficacy and targeting of control could be improved by attracting animals to control measures using species-specific cues. One cue that has the potential to attract rats is the 50 kHz calls they emit (...) in positive social situations. Here we test the potential of these rat calls as a species-specific attractant by examining the response of laboratory rats (Rattus norvegicus; n = 48) and non-target bank voles (Myodes glareolus; n = 16) to 50 kHz calls from either sex in a compartmentalised laboratory arena. Sounds of rat movement and white noise acted as control treatments, with each sound tested against a silent control in the opposite side of the arena. When sound cues were played above an empty bait

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2019 PLoS ONE

8. Repeat prostate-specific antigen test before prostate biopsy: a 20% decrease in prostate specific antigen values is associated with a reduced risk of cancer and particularly of high-grade cancer. (PubMed)

Repeat prostate-specific antigen test before prostate biopsy: a 20% decrease in prostate specific antigen values is associated with a reduced risk of cancer and particularly of high-grade cancer. To analyse the impact of repeating a prostate-specific antigen (PSA) level assessment on prostate biopsy decision in a cohort of men undergoing prostate biopsy.From 2015 onwards, we consecutively enrolled, at a single institution in Italy, men undergoing 12-core transrectal ultrasonography-guided (...) prostate needle biopsy. Indication for prostate biopsy was a PSA level of ≥4 ng/mL. Demographic, clinical, and histopathological data were collected. The PSA level was tested at enrolment (PSA1 ) and 4 weeks later on the day before biopsy (PSA2 ). Variations in PSA level were defined as: stable PSA2 within a 10% variation, stable PSA2 within a 20% variation, PSA2 decreased by ≥10%, PSA2 decreased by ≥20%, PSA2 increased by ≥10%, PSA2 increased by ≥20%, and PSA2 <4 ng/mL. Percentages and multinomial

2018 BJU international

9. Sensitive and specific detection of Crimean-Congo Hemorrhagic Fever Virus (CCHFV)—Specific IgM and IgG antibodies in human sera using recombinant CCHFV nucleoprotein as antigen in μ-capture and IgG immune complex (IC) ELISA tests (PubMed)

Sensitive and specific detection of Crimean-Congo Hemorrhagic Fever Virus (CCHFV)—Specific IgM and IgG antibodies in human sera using recombinant CCHFV nucleoprotein as antigen in μ-capture and IgG immune complex (IC) ELISA tests As the most widespread tick-borne arbovirus causing infections in numerous countries in Asia, Africa and Europe, Crimean-Congo Hemorrhagic Fever Virus (CCHFV, family Nairoviridae) was included in the WHO priority list of emerging pathogens needing urgent Research (...) & Development attention. To ensure preparedness for potential future outbreak scenarios, reliable diagnostic tools for identification of acute cases as well as for performance of seroprevalence studies are necessary. Here, the CCHFV ortholog of the major bunyavirus antigen, the nucleoprotein (NP), was recombinantly expressed in E.coli, purified and directly labeled with horseradish peroxidase (HRP). Employing this antigen, two serological tests, a μ-capture ELISA for the detection of CCHFV-specific IgM

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2018 PLoS neglected tropical diseases

10. Developing new age-specific prostate-specific antigen thresholds for testing for prostate cancer (PubMed)

Developing new age-specific prostate-specific antigen thresholds for testing for prostate cancer To examine whether age-related reference ranges for "normal" prostate-specific antigen (PSA) change (determined in men without prostate cancer) can be used to identify men at high risk of having prostate cancer.Subjects were men aged 50-69 years with PSA < 10 ng/mL from the UK-based Prostate Testing for cancer and Treatment (ProtecT) study. Men with prostate cancer were categorized as high or low (...) risk of progression (Low risk: Gleason score ≤ 6 and stage T1-T2a; High risk: Gleason score 7-10 or stage T2C). Men without prostate cancer were those with no histological confirmation of prostate cancer. Previously developed longitudinal reference ranges for normal age-related PSA change were used to calculate an age-specific PSA threshold. We compared the ability of our age-specific PSA threshold to discriminate between high- and no/low-risk prostate cancer with that of two existing thresholds

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2018 Cancer Causes & Control

11. Responsiveness of Nasal Provocation Testing-But Not Skin Test and Specific Immunoglobulin E Blood Level-Correlates With Severity of Allergic Rhinitis in Dermatophagoides Species-Sensitized Patients. (PubMed)

Responsiveness of Nasal Provocation Testing-But Not Skin Test and Specific Immunoglobulin E Blood Level-Correlates With Severity of Allergic Rhinitis in Dermatophagoides Species-Sensitized Patients. Background The results of skin and blood allergen testing are not consistently relevant to clinical manifestations in allergic patients. Objective The aim of the study was to investigate the relationship between severity of allergic rhinitis and different allergen diagnostic tests (...) in Dermatophagoides species-sensitized patients. Methods Study subjects included 65 rhinitis patients-50 with Dermatophagoides pteronyssinus (DP) sensitization (DP+) and 15 without DP sensitization (DP-), and 15 DP+ and 37 DP- healthy controls (HCs) confirmed by allergen skin prick (SPT) and blood specific immunoglobulin E (sIgE) tests. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was tested. All subjects underwent DP nasal provocation test (DP-NPT). Visual analogue scoring (VAS) of nasal symptoms

2018 American journal of rhinology & allergy

12. Demand for Colonoscopy in Colorectal Cancer Screening Using a Quantitative Fecal Immunochemical Test and Age-Sex-Specific Thresholds for Test Positivity. (PubMed)

Demand for Colonoscopy in Colorectal Cancer Screening Using a Quantitative Fecal Immunochemical Test and Age-Sex-Specific Thresholds for Test Positivity. Background: Despite age and sex differences in fecal hemoglobin (f-Hb) concentrations, most fecal immunochemical test (FIT) screening programs use population-average cut-points for test positivity. The impact of age/sex-specific threshold on FIT accuracy and colonoscopy demand for colorectal cancer screening are unknown.Methods: Using data (...) from 723,113 participants enrolled in a Taiwanese population-based colorectal cancer screening with single FIT between 2004 and 2009, sensitivity and specificity were estimated for various f-Hb thresholds for test positivity. This included estimates based on a "universal" threshold, receiver-operating-characteristic curve-derived threshold, targeted sensitivity, targeted false-positive rate, and a colonoscopy-capacity-adjusted method integrating colonoscopy workload with and without age/sex

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2018 Cancer Epidemiology & Biomarkers and Prevention

13. Evaluation of Galactomannan Testing, the Aspergillus-Specific Lateral-Flow Device Test and Levels of Cytokines in Bronchoalveolar Lavage Fluid for Diagnosis of Chronic Pulmonary Aspergillosis (PubMed)

Evaluation of Galactomannan Testing, the Aspergillus-Specific Lateral-Flow Device Test and Levels of Cytokines in Bronchoalveolar Lavage Fluid for Diagnosis of Chronic Pulmonary Aspergillosis Background: Diagnosis of chronic pulmonary aspergillosis (CPA) is challenging. Symptoms are unspecific or missing, radiological findings are variable and proof of mycological evidence is limited by the accuracy of diagnostic tests. The goal of this study was to investigate diagnostic performance (...) of galactomannan (GM), the newly formatted Aspergillus-specific lateral-flow-device test (LFD), and a number of cytokines in bronchoalveolar lavage fluid (BALF) samples obtained from patients with CPA, patients with respiratory disorders without CPA and healthy individuals. Methods: Patients with CPA (n = 27) and controls (n = 27 with underlying respiratory diseases but without CPA, and n = 27 healthy volunteers) were recruited at the Medical University of Graz, Austria and the Research Center Borstel, Germany

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2018 Frontiers in microbiology

14. Digit Symbol Substitution Test: The Case for Sensitivity Over Specificity in Neuropsychological Testing. (PubMed)

Digit Symbol Substitution Test: The Case for Sensitivity Over Specificity in Neuropsychological Testing. Development of the Digit Symbol Substitution Test (DSST) was initiated over a century ago as an experimental tool to understand human associative learning. Its clinical utility, owing to its brevity and high discriminant validity, was first recognized in the 1940s, and now the DSST is among the most commonly used tests in clinical neuropsychology.Specific studies and articles were reviewed (...) to illustrate what the test measures, to evaluate its sensitivity to change, and to discuss its use in clinical practice.The DSST is a valid and sensitive measure of cognitive dysfunction impacted by many domains. Performance on the DSST correlates with real-world functional outcomes (eg, the ability to accomplish everyday tasks) and recovery from functional disability in a range of psychiatric conditions including schizophrenia and major depressive disorder. Importantly, the DSST has been demonstrated

2018 Journal of Clinical Psychopharmacology

15. Effect of More vs Less Frequent Follow-up Testing on Overall and Colorectal Cancer-Specific Mortality in Patients With Stage II or III Colorectal Cancer: The COLOFOL Randomized Clinical Trial. (PubMed)

Effect of More vs Less Frequent Follow-up Testing on Overall and Colorectal Cancer-Specific Mortality in Patients With Stage II or III Colorectal Cancer: The COLOFOL Randomized Clinical Trial. Intensive follow-up of patients after curative surgery for colorectal cancer is common in clinical practice, but evidence of a survival benefit is limited.To examine overall mortality, colorectal cancer-specific mortality, and colorectal cancer-specific recurrence rates among patients with stage II or III (...) , -1.7% to 3.3%]; P = .52). The colorectal cancer-specific recurrence rate was 21.6% (265/1248) in the high-frequency group compared with 19.4% (238/1250) in the low-frequency group (risk difference, 2.2% [95% CI, -1.0% to 5.4%]; P = .15).Among patients with stage II or III colorectal cancer, follow-up testing with computed tomography and carcinoembryonic antigen more frequently compared with less frequently did not result in a significant rate reduction in 5-year overall mortality or colorectal

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2018 JAMA

16. Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. (PubMed)

Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. To investigate the efficacy and safety of prostate-specific antigen (PSA) testing to screen for prostate cancer.Systematic review and meta-analysis.Electronic search of Cochrane Central Register of Controlled Trials, Web of Science, Embase, Scopus, OpenGrey, LILACS, and Medline, and search of scientific meeting abstracts and trial registers to April 2018.Randomised controlled trials (...) mortality (IRR 0.99, 95% CI 0.98 to 1.01; moderate certainty) and may have no effect on prostate-specific mortality (IRR 0.96, 0.85 to 1.08; low certainty). Sensitivity analysis of studies at lower risk of bias (n=1) also demonstrates that screening seems to have no effect on all-cause mortality (IRR 1.0, 0.98 to 1.02; moderate certainty) but may have a small effect on prostate-specific mortality (IRR 0.79, 0.69 to 0.91; moderate certainty). This corresponds to one less death from prostate cancer per

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2018 BMJ

17. Psychometric evaluation of commonly used game-specific skills tests in rugby: A systematic review. (PubMed)

Psychometric evaluation of commonly used game-specific skills tests in rugby: A systematic review. To (1) give an overview of commonly used game-specific skills tests in rugby and (2) evaluate available psychometric information of these tests.The databases PubMed, MEDLINE CINAHL and Africa Wide information were systematically searched for articles published between January 1995 and March 2017. First, commonly used game-specific skills tests were identified. Second, the available psychometrics (...) of these tests were evaluated and the methodological quality of the studies assessed using the Consensus-based Standards for the selection of health Measurement Instruments checklist. Studies included in the first step had to report detailed information on the construct and testing procedure of at least one game-specific skill, and studies included in the second step had additionally to report at least one psychometric property evaluating reliability, validity or responsiveness.287 articles were identified

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2017 BMJ open sport & exercise medicine

18. PET-CT has low specificity for mediastinal staging of non-small-cell lung cancer in an endemic area for tuberculosis: a diagnostic test study (LACOG 0114). (PubMed)

PET-CT has low specificity for mediastinal staging of non-small-cell lung cancer in an endemic area for tuberculosis: a diagnostic test study (LACOG 0114). The present study aims to assess the performance of 18F-FDG PET-CT on mediastinal staging of non-small cell lung cancer (NSCLC) in a location with endemic granulomatous infectious disease.Diagnostic test study including patients aged 18 years or older with operable stage I-III NSCLC and indication for a mediastinal lymph node biopsy. All (...) patients underwent a 18F-FDG PET-scan before invasive mediastinal staging, either through mediastinoscopy or thoracotomy, which was considered the gold-standard. Surgeons and pathologists were blinded for scan results. Primary endpoint was to evaluate sensitivity, specificity and positive and negative predictive values of PET-CT with images acquired in the 1st hour of the exam protocol, using predefined cutoffs of maximal SUV, on per-patient basis.Overall, 85 patients with operable NSCLC underwent PET

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2019 BMC Cancer

19. Understanding medical tests: A new addition to our toolkit addressing sensitivity, specificity, and other core concepts

Understanding medical tests: A new addition to our toolkit addressing sensitivity, specificity, and other core concepts Understanding medical tests-A new addition to our toolkit on sensitivity, specificity and positive predictive value Note to our followers: Our nearly 13-year run of daily publication of new content on HealthNewsReview.org came to a close at the end of 2018. Publisher Gary Schwitzer and other contributors may post new articles periodically. But all of the 6,000+ articles we (...) have published contain lessons to help you improve your critical thinking about health care interventions. And those will be still be alive on the site for a couple of years. 6093 Posts Menu June 21, 2018 Understanding medical tests: A new addition to our toolkit addressing sensitivity, specificity, and other core concepts Posted By Categories , , Tags Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino. Hardly a day goes by without some media outlet making

2018 HealthNewsReview

20. Development and testing of species-specific ELISA assays to measure IFN-γ and TNF-α in bottlenose dolphins (Tursiops truncatus). (PubMed)

Development and testing of species-specific ELISA assays to measure IFN-γ and TNF-α in bottlenose dolphins (Tursiops truncatus). Monitoring the immune status of cetaceans is important for a variety of health conditions. Assays to quantify cytokines, especially pro-inflammatory cytokines, could be employed, in addition to currently available diagnostic assays, to screen for alterations in the health status of an animal. Though a number of immunological assays are readily available for humans (...) and mice, specific assays for many veterinary species, including cetaceans such as bottlenose dolphins (Tursiops truncatus), are more limited. Herein, we describe the development of IFN-gamma (IFN-γ) and TNF-alpha (TNF-α) enzyme-linked immunosorbent assays (ELISAs) specific to bottlenose dolphins. Utilizing these assays, we monitored the immune status of bottlenose dolphins from a managed population over a period of eleven months. The ELISA assays developed for bottlenose dolphins were used to measure

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2018 PLoS ONE

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