Diagnostic accuracy of three monoclonal stool tests in a large series of untreated Helicobacter pylori infected patients

Clinical Biochemistry
Sergio LarioXavier Calvet

Abstract

Immunochromatographic tests need to be improved in order to enhance their reliability. Recently, several new kits have appeared on the market. The objective was to evaluate the diagnostic accuracy of three monoclonal rapid stool tests - the new Uni-Gold™ H.pylori Antigen (Trinity Biotech, Ireland), the RAPID Hp StAR (Oxoid Ltd., UK) and the ImmunoCard STAT! HpSA (Meridian Diagnostics, USA) - for detecting H. pylori infection prior to eradication treatment. Diagnostic accuracy (sensitivity and specificity) and reliability (concordance between observers) were evaluated in 250 untreated consecutive dyspeptic patients. The gold standard for diagnosing H. pylori infection was defined as the concordance of two or more of rapid urease test (RUT), histopathology and urease breath test (UBT) or positive culture in isolation. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated. Sensitivity and specificity were compared using the McNemar test. The three tests showed a good correlation, with Kappa values>0.9. RAPID Hp StAR had a sensitivity of 91%-92% and a specificity ranging from 77% to 85%. Its se...Continue Reading

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Citations

Aug 18, 2016·Helicobacter·Francis MégraudPhilippe Lehours
Sep 12, 2017·Helicobacter·Emilie BessèdeLuiz Gonzaga Coelho
Jun 29, 2018·Journal of Pathogens·Amin Talebi Bezmin Abadi
Jun 3, 2021·Journal of Clinical Medicine·Maria Pina Dore, Giovanni Mario Pes
Aug 16, 2021·Brazilian Journal of Microbiology : [publication of the Brazilian Society for Microbiology]·Enming QiuShuai Han

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