Diagnostic Accuracy of Point of Care Tests for Diagnosing Celiac Disease

AbstractCommercial point-of-care (POC) diagnostic tests for Group A Streptococcus, Streptococcus pneumoniae, and influenza virus have large potential diagnostic and financial impact. Many published reports on test performance, often funded by diagnostics companies, are prone to bias. The Standards for Reporting of Diagnostic Accuracy (STARD 2015) are a protocol to encourage accurate, transparent reporting. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool evaluates risk of bias and transportability of results. We used these tools to evaluate diagnostic test accuracy studies of POC studies for three respiratory pathogens. For the 96 studies analysed, compliance was <25% for 14/34 STARD 2015 standards, and 3/7 QUADAS-2 domains showed a high risk of bias. All reports lacked reporting of at least one criterion. These biases should be considered in the interpretation of study results.

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The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis

Scientific Reports ◽

10.1038/s41598-020-79237-7 ◽

2020 ◽

Vol 10 (1) ◽

Cited By ~ 1

Author(s):

Pakpoom Subsoontorn ◽

Manupat Lohitnavy ◽

Chuenjid Kongkaew

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Diagnostic Test ◽

Point Of Care ◽

Meta Analysis ◽

Isothermal Amplification ◽

Diagnostic Test Accuracy ◽

Test Accuracy ◽

Index Test ◽

Point Of Care Tests

AbstractMany recent studies reported coronavirus point-of-care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy was used as a guideline for conducting this systematic review. We searched peer-reviewed and preprint articles in PubMed, BioRxiv and MedRxiv up to 28 September 2020 to identify studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was applied for assessing quality of included studies and Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) was followed for reporting. We included 81 studies from 65 research articles on POCTs of SARS, MERS and COVID-19. Most studies had high risk of patient selection and index test bias but low risk in other domains. Diagnostic specificities were high (> 0.95) for included studies while sensitivities varied depending on type of assays and sample used. Most studies (n = 51) used reverse transcription loop-mediated isothermal amplification (RT-LAMP) to diagnose coronaviruses. RT-LAMP of RNA purified from COVID-19 patient samples had pooled sensitivity at 0.94 (95% CI: 0.90–0.96). RT-LAMP of crude samples had substantially lower sensitivity at 0.78 (95% CI: 0.65–0.87). Abbott ID Now performance was similar to RT-LAMP of crude samples. Diagnostic performances by CRISPR and RT-LAMP on purified RNA were similar. Other diagnostic platforms including RT- recombinase assisted amplification (RT-RAA) and SAMBA-II also offered high sensitivity (> 0.95). Future studies should focus on the use of un-bias patient cohorts, double-blinded index test and detection assays that do not require RNA extraction.

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Is There a Role of Using a Rapid Finger Prick Antibody Test in Screening for Celiac Disease in Children?

Gastroenterology Research and Practice ◽

10.1155/2019/4504679 ◽

2019 ◽

Vol 2019 ◽

pp. 1-5 ◽

Cited By ~ 1

Author(s):

Kristina Baraba Dekanić ◽

Ivona Butorac Ahel ◽

Lucija Ružman ◽

Jasmina Dolinšek ◽

Jernej Dolinšek ◽

...

Keyword(s):

Celiac Disease ◽

Point Of Care ◽

Tissue Transglutaminase ◽

Rapid Test ◽

Antibody Test ◽

First Grade ◽

Iga Deficiency ◽

Iga Antibodies ◽

Point Of Care Tests

Introduction. Celiac disease (CD) is an autoimmune disease triggered by gluten in genetically predisposed individuals. Despite the increasing prevalence of CD, many patients remain undiagnosed. Standard serology tests are expensive and invasive, so several point-of-care tests (POC) for CD have been developed. We aimed to determine the prevalence of CD in first-grade pupils in Primorje-Gorski Kotar County, Croatia, using a POC test. Methods. A Biocard celiac test that detects IgA antibodies to tissue transglutaminase in whole blood was used to screen for celiac disease in healthy first-grade children born in 2011 and 2012 who consumed gluten without restrictions. Results. 1478 children were tested, and none of them were tested positive with a rapid test. In 10 children (0,6%), IgA deficiency has been suspected; only 4 of them agreed to be tested further for total IgA, anti-tTG, and anti-DGP antibodies. IgA deficiency was confirmed in 3 patients, and in all 4 children, CD has been excluded. Conclusion. Our results have not confirmed the usefulness of the POC test in screening the general population of first-grade schoolchildren. Further research is needed to establish the true epidemiology of CD in Primorje-Gorski Kotar County and to confirm the value of the rapid test in comparison with standard antibody CD testing.

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A systematic review and meta-analysis of the diagnostic accuracy of point-of-care tests for the detection of hyperketonemia in dairy cows

Preventive Veterinary Medicine ◽

10.1016/j.prevetmed.2016.06.002 ◽

2016 ◽

Vol 130 ◽

pp. 18-32 ◽

Cited By ~ 14

Author(s):

Elise H. Tatone ◽

Jessica L. Gordon ◽

Jessie Hubbs ◽

Stephen J. LeBlanc ◽

Trevor J. DeVries ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Dairy Cows ◽

Point Of Care ◽

Meta Analysis ◽

Point Of Care Tests

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Diagnostic accuracy of rapid point-of-care tests for detecting syphilis infection

Sexually Transmitted Diseases ◽

10.1097/olq.0000000000001498 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Edith Angel-Müller ◽

Carlos Fernando Grillo-Ardila ◽

Jairo Amaya-Guio ◽

Nicolas Torres-Montañez

Keyword(s):

Diagnostic Accuracy ◽

Point Of Care ◽

Syphilis Infection ◽

Point Of Care Tests

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Diagnostic Accuracy of Point-of-Care Tests for Detecting Albuminuria

Annals of Internal Medicine ◽

10.7326/m13-2331 ◽

2014 ◽

Vol 160 (8) ◽

pp. 550 ◽

Cited By ~ 15

Author(s):

Malcolm P. McTaggart ◽

Ronald G. Newall ◽

Jennifer A. Hirst ◽

Clare R. Bankhead ◽

Edmund J. Lamb ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Point Of Care ◽

Point Of Care Tests

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Sa1307 Comparison of Three Commercially Available Point of Care Tests for Celiac Disease

Gastroenterology ◽

10.1016/s0016-5085(15)30947-1 ◽

2015 ◽

Vol 148 (4) ◽

pp. S-287-S-288

Author(s):

Peter D. Mooney ◽

Simon H. Wong ◽

Matthew Kurien ◽

Mitchell Burden ◽

David S. Sanders

Keyword(s):

Celiac Disease ◽

Point Of Care ◽

Point Of Care Tests

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Diagnostic Accuracy and User-Friendliness of 5 Point-of-Care D-Dimer Tests for the Exclusion of Deep Vein Thrombosis

Clinical Chemistry ◽

10.1373/clinchem.2010.147892 ◽

2010 ◽

Vol 56 (11) ◽

pp. 1758-1766 ◽

Cited By ~ 25

Author(s):

Geert-Jan Geersing ◽

Diane B Toll ◽

Kristel JM Janssen ◽

Ruud Oudega ◽

Marloes JC Blikman ◽

...

Keyword(s):

Primary Care ◽

Diagnostic Accuracy ◽

Point Of Care ◽

Reference Method ◽

Roc Curves ◽

Color Contrast ◽

User Friendliness ◽

Predictive Values ◽

Point Of Care Tests ◽

D Dimer

BACKGROUND Point-of-care D-dimer tests have recently been introduced to enable rapid exclusion of deep venous thrombosis (DVT) without the need to refer a patient for conventional laboratory-based D-dimer testing. Before implementation in practice, however, the diagnostic accuracy of each test should be validated. METHODS We analyzed data of 577 prospectively identified consecutive primary care patients suspected to have DVT, who underwent 5 point-of-care D-dimer tests—4 quantitative (Vidas®, Pathfast™, Cardiac®, and Triage®) and 1 qualitative (Clearview Simplify®)—and ultrasonography as the reference method. We evaluated the tests for the accuracy of their measurements and submitted a questionnaire to 20 users to assess the user-friendliness of each test. RESULTS All D-dimer tests showed negative predictive values higher than 98%. Sensitivity was high for all point-of-care tests, with a range of 0.91 (Clearview Simplify) to 0.99 (Vidas). Specificity varied between 0.39 (Pathfast) and 0.64 (Clearview Simplify). The quantitative point-of-care tests showed similar and high discriminative power for DVT, according to calculated areas under the ROC curves (range 0.88–0.89). The quantitative Vidas and Pathfast devices showed limited user-friendliness for primary care, owing to a laborious calibration process and long analyzer warm-up time compared to the Cardiac and Triage. For the qualitative Clearview Simplify assay, no analyzer or calibration was needed, but interpretation of a test result was sometimes difficult because of poor color contrast. CONCLUSIONS Point-of-care D-dimer assays show good and similar diagnostic accuracy. The quantitative Cardiac and Triage and the qualitative Clearview Simplify D-dimer seem most user-friendly for excluding DVT in the doctor's office.

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