Evaluation of the Allplex™ H pylori and ClariR PCR Assay for Helicobacter pylori detection on gastric biopsies.

Abstract

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). 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). 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. 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.