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

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.