Evaluation of the Allplex™ H. pylori & ClariR assay for the detection of clarithromycin-resistant Helicobacter pylori in gastric biopsies

Introduction. Helicobacter pylori colonize the gastrointestinal tract of large proportions of the global population and is associated with the development of gastric ulcers and cancer. Antimicrobial resistance (AMR) to clarithromycin is recognized as a major contributing factor in treatment failure. Hypothesis/Gap Statement. Real-time PCR may be used to detect 23S rRNA gene mutations associated with AMR to clarithromycin in H. pylori and has advantages over classical culture and phenotypic susceptibility testing, including no strict requirement for the transport of gastric biopsies. Aim. In this study, we compare the use of the Allplex™ H. pylori & ClariR assay (Seegene Inc) for detection of clarithromycin-resistant H. pylori with current culture and phenotypic susceptibility testing in 1149 gastric biopsy specimens within our laboratory at the Gastrointestinal Bacteria Reference Unit, UK Health Security Agency. Methodology. PCR was performed using the Allplex™ H. pylori & ClariR assay (Seegene Inc) on genomic DNA recovered from gastric biopsy specimens using the MagNA Pure 96 DNA and Viral NA Small Volume Kit and the Pathogen Universal 200 protocol on an MP96 robotic workstation (Roche). Phenotypic susceptibility to clarithromycin was determined by Etest (bioMérieux). Results. We found 94.6% concordance for the presence of either clarithromycin-resistant or -susceptible strains of H. pylori . Conclusion. We recommend this assay be included in the UK Health Security Agency (UKHSA) H. pylori testing algorithm to improve patient management.