Comparison of three different molecular biology assays (AllPlexTMH. pylori & ClariR assay, Amplidiag® H. pylori + ClariR and RIDA®GENE Helicobacter pylori) to detect Helicobacter pylori and clarithromycin resistance in stool samples

Diagn Microbiol Infect Dis. 2025 Jun;112(2):116771. doi: 10.1016/j.diagmicrobio.2025.116771. Epub 2025 Feb 25.

Abstract

Helicobacter pylori detection and susceptibility profile using feces could optimize guided therapy, when endoscopy is not necessary. This study evaluated the performances of three tests: AllPlexH.pylori&ClariR, RIDAGENEHelicobacterpylori and AmplidiagH.pylori+ClariR assays on stool samples. Stool samples from a documented cohort (50 positive and 25 negative) were analyzed. The gold standard was a composite based on PCR targeting H. pylori and 23S rDNA mutations (A2142C, A2142G, A2143G) on gastric biopsies; and biopsy culture for H.pylori and susceptibility testing. For AllPlex, RidaGene and Amplidiag assays respectively: 55 (73.3%), 75 (100%), 54 (72%) samples could be analyzed; (for detection of H. pylori), sensitivity was 36% (95%CI]28;52%[); 32% (95%CI]21;46%[) and 93% (95%CI]87;100%[); specificity was 100% (95%CI]81;100%[), 83% (95%CI]68;91%[) and 57% (95%CI]33;79%[). (for the Clarithromycin resistance), sensitivity was 18% (95%CI]5;48%[), 25% (95%CI]9;53%[) and 67% (95%CI]39;86%[); specificity was 100% (95%CI]92;100%[). 92% (95%CI]83;97%[) and 97% (95%CI]89;99%[). Innovative technologies could become invaluable tools for mass testing after improvement.

Keywords: Antibiotic resistance; Clarithromycin; Helicobacter pylori; Molecular biology.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Anti-Bacterial Agents* / pharmacology
  • Clarithromycin* / pharmacology
  • Drug Resistance, Bacterial*
  • Feces* / microbiology
  • Female
  • Helicobacter Infections* / diagnosis
  • Helicobacter Infections* / microbiology
  • Helicobacter pylori* / drug effects
  • Helicobacter pylori* / genetics
  • Helicobacter pylori* / isolation & purification
  • Humans
  • Male
  • Microbial Sensitivity Tests / methods
  • Middle Aged
  • Molecular Diagnostic Techniques* / methods
  • RNA, Ribosomal, 23S / genetics
  • Sensitivity and Specificity

Substances

  • Clarithromycin
  • Anti-Bacterial Agents
  • RNA, Ribosomal, 23S