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

Helicobacter. 2020 Aug;25(4):e12702. doi: 10.1111/hel.12702. Epub 2020 May 19.


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: Helicobacter pylori; macrolide resistance; molecular diagnosis.

Publication types

  • Evaluation Study

MeSH terms

  • Bacteriological Techniques / methods*
  • Biopsy
  • Diagnostic Tests, Routine
  • Drug Resistance, Bacterial / genetics
  • Helicobacter Infections / diagnosis*
  • Helicobacter pylori / genetics
  • Helicobacter pylori / isolation & purification*
  • Humans
  • Molecular Diagnostic Techniques / methods*
  • Predictive Value of Tests
  • Reagent Kits, Diagnostic
  • Real-Time Polymerase Chain Reaction
  • Retrospective Studies
  • Sensitivity and Specificity
  • Stomach / microbiology*
  • Stomach / pathology


  • Reagent Kits, Diagnostic