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

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
• qPCR
• clarithromycin resistance
• gastric biopsy
• RIDA®GENE Helicobacter pylori

Acknowledgments

We thank r-biopharm® and apDIA® to provide the qPCR kit and reagents to perform the study. Results of this study were presented at a scientific meeting of apDIA® on 27 September 2016, Turnhout, Belgium and tentative results were presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases 2017, Vienna, Austria.

Authors’ contribution

Bea Van den Poel, Sarah Gils, Isabel Micalessi, Annick Smismans and Johan Frans contributed to this article by performing laboratory analysis and interpreting laboratory data. Peter Bossuyt, Saskia Carton, Paul Christiaens, Pieter-Jan Cuyle, Veerle Moons and Gust Van Olmen performed patient sampling and provided clinical data. Claire Bourgain provided histological data. Bea Van den Poel, Johan Frans and Peter Bossuyt are the main authors of this article.

Disclosure statement

No potential conflict of interest was reported by the authors.

Informed consent

Informed consent regarding the use of patient material for method validation was obtained for every patient.

Additional information

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors