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Automation of RIDA®GENE Helicobacter pylori PCR on the BD MAX™ System

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

PCR detection of Helicobacter pylori infection in gastric biopsies allows the detection of this bacterium and the mutations associated with macrolide resistance. The aim of this study was to evaluate the performance of RIDA®GENE H. pylori PCR (r-Biopharm) on a BD MAX™ System (Becton Dickinson). Two hundred ten gastric biopsies obtained were included. These biopsies were ground in nutrient broth. Two hundred microliters of this suspension was treated with proteinase K; 200 µL was transferred to a BD MAX™ sample tube then tested using RIDA®GENE H. pylori PCR reagents. In-house H. pylori PCR was used as a reference. The sensitivity of RIDA®GENE H. pylori PCR with BD MAX™ was 100%, the specificity was 99.08% (95% confidence interval (CI), 97.21–100%), the PPV was 99.02% (95% CI, 97.09–100%), and the NPV was 100% for the detection of H. pylori. The sensitivity was 97.14% (95% CI, 93.87–100%), the specificity was 100%, the PPV was 100%, and the NPV was 98.48% (95% CI, 96.08–100%) for categorization of macrolides resistance. The adaptation of RIDA®GENE H. pylori PCR on the BD MAX™ System is of considerable interest for microbiologists who seek to establish this assay in their laboratories.

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Data availability

The data included in this study are available upon request by contacting the corresponding author.

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Acknowledgements

The authors want to thank all the clinicians and laboratories who submitted samples to our reference center for H. pylori diagnosis. The current manuscript was edited for proper English language using American Journal Experts services (verification FF37-C726-8E02-9583-293C).

Funding

r-Biopharm (Courtaboeuf, France) and Becton Dickinson (Le Pont de Claix), which commercialize the PCR RIDA®GENE H. pylori kit and the BD MAX™ System, were not involved in the data analysis. The PCR RIDA®GENE H. pylori kit was kindly provided by r-Biopharm. The BD MAX™ ExK DNA-1 strips used for extraction were purchased from the NRCCH using internal funds.

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PL supervised the study. LB, EB, and PL analyzed the data and drafted the paper. LB, AD, AG, JB, and ZL performed the experiments. All authors interpreted the data and critically revised the manuscript for important intellectual content.

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Correspondence to Philippe Lehours.

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The authors declare no competing interests.

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Bénéjat, L., Giese, A., Lescaudron, Z. et al. Automation of RIDA®GENE Helicobacter pylori PCR on the BD MAX™ System. Eur J Clin Microbiol Infect Dis 41, 875–879 (2022). https://doi.org/10.1007/s10096-022-04444-1

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  • DOI: https://doi.org/10.1007/s10096-022-04444-1

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