BD MAX™ 系统上RIDA®GENE幽门螺杆菌聚合酶链反应的自动化

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

作者信息

Bénéjat Lucie, Giese Alban, Lescaudron Zoé, Bonnac Julien, Ducournau Astrid, Bessède Emilie, Lehours Philippe

机构信息

French National Reference Center for Campylobacters & Helicobacters, Bordeaux Hospital University Center, 33300, Bordeaux, France.

Univ. Bordeaux, INSERM, UMR1312 Bordeaux Institute of Oncology, BRIC, 33076, Bordeaux, France.

出版信息

Eur J Clin Microbiol Infect Dis. 2022 Jun;41(6):875-879. doi: 10.1007/s10096-022-04444-1. Epub 2022 Apr 22.

DOI:10.1007/s10096-022-04444-1

PMID:35460029

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.

摘要

通过聚合酶链反应（PCR）检测胃活检组织中的幽门螺杆菌感染，可检测到该细菌以及与大环内酯类耐药相关的突变。本研究的目的是评估RIDA®GENE幽门螺杆菌PCR检测试剂盒（r - 生物制药公司）在BD MAX™系统（贝克顿·迪金森公司）上的性能。纳入了210份获取的胃活检组织。将这些活检组织在营养肉汤中研磨。取200微升该悬液用蛋白酶K处理；将200微升转移至BD MAX™样品管中，然后使用RIDA®GENE幽门螺杆菌PCR试剂进行检测。内部幽门螺杆菌PCR用作对照。RIDA®GENE幽门螺杆菌PCR在BD MAX™系统上检测幽门螺杆菌的敏感性为100%，特异性为99.08%（95%置信区间（CI），97.21 - 100%），阳性预测值（PPV）为99.02%（95% CI，97.09 - 100%），阴性预测值（NPV）为100%。对于大环内酯类耐药的分类，敏感性为97.14%（95% CI，93.87 - 100%），特异性为100%，PPV为100%，NPV为98.48%（95% CI，96.08 - 100%）。对于试图在其实验室中开展该检测的微生物学家而言，RIDA®GENE幽门螺杆菌PCR在BD MAX™系统上的适配具有相当大的意义。