Evaluation of the Allplex™ H pylori and ClariR PCR Assay for Helicobacter pylori detection on gastric biopsies
Open Access
- 19 May 2020
- journal article
- research article
- Published by Wiley in Helicobacter
- Vol. 25 (4), e12702
- https://doi.org/10.1111/hel.12702
Abstract
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.Keywords
This publication has 12 references indexed in Scilit:
- Genetic Determinants and Prediction of Antibiotic Resistance Phenotypes in Helicobacter pyloriJournal of Clinical Medicine, 2019
- Molecular diagnosis of Helicobacter pylori infection in gastric biopsies: Evaluation of the Amplidiag®H. pylori + ClariR assayHelicobacter, 2018
- Real‐time PCR for Helicobacter pylori diagnosis. The best tools availableHelicobacter, 2018
- Management ofHelicobacter pyloriinfection—the Maastricht V/Florence Consensus ReportGut, 2016
- Helicobacter pyloriresistance to antibiotics in Europe and its relationship to antibiotic consumptionGut, 2012
- Helicobacter pylorimolecular diagnosisExpert Review of Molecular Diagnostics, 2011
- Quadruplex Real-Time PCR Assay Using Allele-Specific Scorpion Primers for Detection of Mutations Conferring Clarithromycin Resistance to Helicobacter pyloriJournal of Clinical Microbiology, 2008
- Helicobacter pyloriDetection and Antimicrobial Susceptibility TestingClinical Microbiology Reviews, 2007
- Real-Time PCR Assay for Rapid and Accurate Detection of Point Mutations Conferring Resistance to Clarithromycin in Helicobacter pyloriJournal of Clinical Microbiology, 2003
- PCR-Restriction Fragment Length Polymorphism Can Also Detect Point Mutation A2142C in the 23S rRNA Gene, Associated with Helicobacter pylori Resistance to ClarithromycinAntimicrobial Agents and Chemotherapy, 2002