BACKGROUND: The diagnosis of Helicobacter pylori infection can be made by PCR on gastric biopsies. The objective of this study was to evaluate retrospectively the performance of the Allplex™ H pylori and ClariR PCR Assay (Seegene). MATERIAL AND METHODS: A collection of 180 DNA samples extracted from gastric biopsies was used in this study: 90 DNAs from H pylori-negative patients and 90 from H pylori-positive patients. The Allplex™ H pylori and ClariR Assay was performed on a CFX96™ real-time PCR System and analyzed using the Seegene Viewer software. The real-time PCR used as the reference was our in-house H pylori PCR, and discrepant results were tested by the Amplidiag® H pylori + ClariR PCR (Mobidiag). RESULTS: The performance of the Allplex™ H pylori and ClariR Assay showed 100% sensitivity, 97.6% specificity, 98% PPV, and 100% NPV. Regarding the detection of H pylori in the 90 expected negative samples, eight late amplifications were obtained (Ct > 39). Six of these eight samples were also positive using the Amplidiag® H pylori + ClariR kit and were therefore considered as true positives. For the two remaining cases, non-pathological evidence of H pylori infection was found. H pylori was detected in all 90 positive samples. Compared with our in-house H pylori PCR, all H pylori WT cases or mutated cases were correctly detected. CONCLUSIONS: The Allplex™ H pylori and ClariR Assay showed an excellent performance and can be integrated into the armamentarium of diagnostic tests for H pylori infection. This kit has the advantage of differentiating the main mutations associated with macrolide resistance.
BACKGROUND: The diagnosis of Helicobacter pyloriinfection can be made by PCR on gastric biopsies. The objective of this study was to evaluate retrospectively the performance of the Allplex™ H pylori and ClariR PCR Assay (Seegene). MATERIAL AND METHODS: A collection of 180 DNA samples extracted from gastric biopsies was used in this study: 90 DNAs from H pylori-negative patients and 90 from H pylori-positive patients. The Allplex™ H pylori and ClariR Assay was performed on a CFX96™ real-time PCR System and analyzed using the Seegene Viewer software. The real-time PCR used as the reference was our in-house H pylori PCR, and discrepant results were tested by the Amplidiag® H pylori + ClariR PCR (Mobidiag). RESULTS: The performance of the Allplex™ H pylori and ClariR Assay showed 100% sensitivity, 97.6% specificity, 98% PPV, and 100% NPV. Regarding the detection of H pylori in the 90 expected negative samples, eight late amplifications were obtained (Ct > 39). Six of these eight samples were also positive using the Amplidiag® H pylori + ClariR kit and were therefore considered as true positives. For the two remaining cases, non-pathological evidence of H pylori infection was found. H pylori was detected in all 90 positive samples. Compared with our in-house H pylori PCR, all H pylori WT cases or mutated cases were correctly detected. CONCLUSIONS: The Allplex™ H pylori and ClariR Assay showed an excellent performance and can be integrated into the armamentarium of diagnostic tests for H pylori infection. This kit has the advantage of differentiating the main mutations associated with macrolide resistance.
Authors: Konrad Egli; Karoline Wagner; Peter M Keller; Lorenz Risch; Martin Risch; Thomas Bodmer Journal: Front Cell Infect Microbiol Date: 2020-12-17 Impact factor: 5.293