Molecular detection of Helicobacter pylori and clarithromycin resistance in gastric biopsies: a prospective evaluation of RIDA®GENE Helicobacter pylori assay

Acta Clin Belg. 2021 Jun;76(3):177-183. doi: 10.1080/17843286.2019.1685741. Epub 2019 Oct 29.

Abstract

Background: Empirical treatment of Helicobacter pylori (HP) depends on the local prevalence of clarithromycin resistance but data are lacking and culturing of HP is time-consuming. We evaluated RIDA®GENE Helicobacter pylori assay (r-biopharm), a quantitative PCR assay for detecting HP and clarithromycin resistance mutations in gastric biopsies.Material/methods: Gastric biopsies were obtained from each of 436 consecutive patients referred for gastroscopic investigation and results of qPCR were compared to culture and immunohistochemical staining (IHCS).Results: Of 436 samples, 47 were positive for HP by PCR (11%), 42 by culture (9.7%) and 44 by IHCS (10%). Compared to culture, sensitivity and specificity of the qPCR were 100% and 99%, respectively, and 96% and 99% compared to IHCS. The sensitivity and specificity for clarithromycin resistance detection were 92% and 97%, respectively.Conclusions: RIDA®GENE Helicobacter pylori assay reliably and rapidly detects HP and its resistance to clarithromycin in human gastric biopsies.

Keywords: Helicobacter pylori; RIDA®GENE Helicobacter pylori; clarithromycin resistance; gastric biopsy; qPCR.

MeSH terms

  • Animals
  • Anti-Bacterial Agents / pharmacology
  • Biopsy
  • Clarithromycin / pharmacology
  • Drug Resistance, Bacterial / genetics
  • Helicobacter Infections* / diagnosis
  • Helicobacter Infections* / drug therapy
  • Helicobacter pylori* / genetics
  • Humans
  • Microbial Sensitivity Tests
  • Real-Time Polymerase Chain Reaction
  • Scrapie*
  • Sheep

Substances

  • Anti-Bacterial Agents
  • Clarithromycin