부산대학교 도서관

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. [ABSTRACT FROM AUTHOR]