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.
Similar content being viewed by others
Data availability
The data included in this study are available upon request by contacting the corresponding author.
References
Megraud F, Lehours P (2007) Helicobacter pylori detection and antimicrobial susceptibility testing. Clin Microbiol Rev 20(2):280–322. https://doi.org/10.1128/CMR.00033-06
Bénéjat L, Ducournau A, Lehours P, Mégraud F (2018) Real-time PCR for Helicobacter pylori diagnosis The best tools available. Helicobacter 23:e12512. https://doi.org/10.1111/hel.12512
Jehanne Q, Bénéjat L, Mégraud F, Bessède E, Lehours P (2020) Evaluation of the Allplex™ H pylori and ClariR PCR Assay for Helicobacter pylori detection on gastric biopsies. Helicobacter 25:e12702. https://doi.org/10.1111/hel.12702
Hays C, Delerue T, Lamarque D, Burucoa C, Collobert G, Billöet A et al (2019) Molecular diagnosis of Helicobacter pylori infection in gastric biopsies: evaluation of the Amplidiag® H. pylori + ClariR assay. Helicobacter 24:e12560. https://doi.org/10.1111/hel.12560
Lauener FN, Imkamp F, Lehours P, Buissonnière A, Benejat L, Zbinden R et al (2019) Genetic determinants and prediction of antibiotic resistance phenotypes in Helicobacter pylori. J Clin Med 7:8. https://doi.org/10.3390/jcm8010053
Bénéjat L, Ducournau A, Domingues-Martins C, Lecoeur M, Blosse A, Mégraud F et al (2021) Adaptation of an in-house PCR for the detection of Helicobacter pylori and the mutations associated with macrolide resistance into ready-to-use PCR microwell strips. Helicobacter 26:e12855. https://doi.org/10.1111/hel.12855
Ducournau A, Bénéjat L, Sifré E, Bessède E, Lehours P, Mégraud F (2016) Helicobacter pylori resistance to antibiotics in 2014 in France detected by phenotypic and genotypic methods. Clin Microbiol Infect Off Publ Eur Soc Clin Microbiol Infect Dis 22:715–718. https://doi.org/10.1016/j.cmi.2016.06.003
Berenger BM, Chui L, Ferrato C, Lloyd T, Li V, Pillai DR (2021) Performance of four commercial real-time PCR assays for the detection of bacterial enteric pathogens in clinical samples. Int J Infect Dis IJID Off Publ Int Soc Infect Dis 23;S1201–9712(21)00831–6. https://doi.org/10.1016/j.ijid.2021.10.035
Mégraud F, Alix C, Charron P, Bénéjat L, Ducournau A, Bessède E et al (2021) Survey of the antimicrobial resistance of Helicobacter pylori in France in 2018 and evolution during the previous 5 years. Helicobacter 26:e12767. https://doi.org/10.1111/hel.12767
Oleastro M, Menard A, Santos A, Lamouliatte H, Monteiro L, Barthelemy P, et al (2003) Real-time PCR assay for rapid and accurate detection of point mutations conferring resistance to clarithromycin in Helicobacter pylori. J Clin Microbiol [Internet] 41:397–402. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=12517879
Lehours P, Mégraud F (2021) Culture-based antimicrobial susceptibility testing for Helicobacter pylori. Methods Mol Biol Clifton NJ 2283:45–50. https://doi.org/10.1007/978-1-0716-1302-3_6
Megraud F, Bruyndonckx R, Coenen S, Wittkop L, Huang T-D, Hoebeke M, et al (2021) Helicobacter pylori resistance to antibiotics in Europe in 2018 and its relationship to antibiotic consumption in the community. Gut 9; https://doi.org/10.1136/gutjnl-2021-324032
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.
Author information
Authors and Affiliations
Contributions
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.
Corresponding author
Ethics declarations
Conflict of interest
The authors declare no competing interests.
Additional information
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10096-022-04444-1