定量多重实时聚合酶链反应检测幽门螺杆菌和克拉霉素耐药性。
Quantitative multiplex real-time polymerase chain reaction assay for the detection of Helicobacter pylori and clarithromycin resistance.
机构信息
Divison of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.
Department of Hospital Pathology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
出版信息
BMC Microbiol. 2023 May 27;23(1):155. doi: 10.1186/s12866-023-02868-z.
BACKGROUND
Identifying clarithromycin resistance is essential for eradicating Helicobacter pylori (HP). Therefore, we evaluated the performance of Allplex™ H.pylori & ClariR Assay (Allplex™) for diagnosing and detecting clarithromycin resistance in HP.
METHODS
Subjects who underwent esophagogastroduodenoscopy between April 2020 and August 2021 at Incheon St. Mary's hospital were enrolled in this study. The diagnostic performances of Allplex™ and dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) were compared with sequencing as the gold standard.
RESULTS
A total of 142 gastric biopsy samples were analyzed. Gene sequencing revealed 124 HP infections, 42 A2143G mutations, 2 A2142G mutations, one dual mutation, and no A2142C mutation. DPO-PCR showed 96.0% sensitivity and 100.0% specificity for HP detection; the corresponding rates for Allplex™ were 99.2% and 100.0%. DPO-PCR showed 88.3% sensitivity and 82.0% specificity for A2143G mutation, and Allplex™ showed 97.6% and 96.0%. The Cohen's Kappa coefficient for overall test results was 0.56 for DPO-PCR and 0.95 for Allplex™.
CONCLUSION
Allplex™ showed comparable diagnostic performance with direct gene sequencing and non-inferior diagnostic performance to DPO-PCR. Further research is required to confirm whether Allplex™ is an effective diagnostic tool for the eradication of HP.
背景
明确克拉霉素耐药性对于根除幽门螺杆菌（HP）至关重要。因此，我们评估了 Allplex™ H.pylori & ClariR Assay（Allplex™）用于诊断和检测 HP 克拉霉素耐药性的性能。
方法
本研究纳入了 2020 年 4 月至 2021 年 8 月期间在仁川圣玛丽医院接受上消化道内镜检查的患者。将 Allplex™和基于双重引物寡核苷酸（DPO）的多重聚合酶链反应（PCR）的诊断性能与测序作为金标准进行比较。
结果
共分析了 142 个胃活检样本。基因测序显示 124 例 HP 感染，42 例 A2143G 突变，2 例 A2142G 突变，1 例双重突变，无 A2142C 突变。DPO-PCR 对 HP 检测的敏感性为 96.0%，特异性为 100.0%；Allplex™ 的相应比率分别为 99.2%和 100.0%。DPO-PCR 对 A2143G 突变的敏感性为 88.3%，特异性为 82.0%；Allplex™ 的相应比率分别为 97.6%和 96.0%。DPO-PCR 的总体检测结果的 Cohen's Kappa 系数为 0.56，Allplex™ 的系数为 0.95。
结论
Allplex™ 与直接基因测序的诊断性能相当，与 DPO-PCR 的诊断性能非劣效。需要进一步的研究来证实 Allplex™ 是否是根除 HP 的有效诊断工具。
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