使用 MmaxSure™ H. pylori & ClaR 检测试剂盒检测幽门螺杆菌克拉霉素耐药性。
Detection of Clarithromycin Resistance in Helicobacter pylori Using MmaxSure™ H. pylori & ClaR Assay.
机构信息
Division of Gastroenterology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea,
Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea,
出版信息
Dig Dis. 2024;42(4):292-298. doi: 10.1159/000538655. Epub 2024 Apr 10.
INTRODUCTION
Clarithromycin resistance is a crucial factor in the eradication of Helicobacter pylori. This study aimed to evaluate the performance of MmaxSure™ H. pylori & ClaR Assay (MmaxSure™) in the diagnosis and detection of clarithromycin resistance in H. pylori.
METHODS
Subjects who underwent esophagogastroduodenoscopy between April 2020 and October 2022 were enrolled. The diagnostic performances of MmaxSure™ and dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) were compared with the rapid urease test and culture. Secondary gene sequencing analysis was performed in discordant cases of PCR tests.
RESULTS
A total of 156 gastric biopsy samples were analyzed. In H. pylori detection, MmaxSure™ showed a 95.9% sensitivity (95% CI: 90.6-98.6), a 42.7% specificity (95% CI: 26.3-60.7), and a kappa value of 0.457. For the detection of A2143G mutation samples, MmaxSure™ showed a 91.2% sensitivity (95% CI: 76.3-98.1), a 93.4% specificity (95% CI: 87.5-97.1), and a kappa value of 0.804. There were a total of 10 discordant cases compared to gene sequencing in A2143G mutation detection for MmaxSure™.
CONCLUSION
In this study, MmaxSure™ showed comparable diagnostic performance to DPO-PCR in the detection of the H. pylori and A2143G mutation. Further research is needed to confirm the clinical effectiveness of the MmaxSure™ assay in H. pylori eradication.
简介
克拉霉素耐药性是根除幽门螺杆菌的关键因素。本研究旨在评估 MmaxSure™ H. pylori & ClaR 检测试剂盒（MmaxSure™）在诊断和检测幽门螺杆菌克拉霉素耐药性方面的性能。
方法
纳入 2020 年 4 月至 2022 年 10 月间接受胃镜检查的受试者。比较了 MmaxSure™与双引物寡核苷酸（DPO）-多重聚合酶链反应（PCR）对快速尿素酶试验和培养的诊断性能。对 PCR 检测结果不一致的病例进行二次基因测序分析。
结果
共分析了 156 个胃活检样本。在幽门螺杆菌检测中，MmaxSure™ 的灵敏度为 95.9%（95%CI：90.6-98.6），特异性为 42.7%（95%CI：26.3-60.7），kappa 值为 0.457。对于 A2143G 突变样本的检测，MmaxSure™ 的灵敏度为 91.2%（95%CI：76.3-98.1），特异性为 93.4%（95%CI：87.5-97.1），kappa 值为 0.804。与基因测序相比，MmaxSure™ 在 A2143G 突变检测中有 10 个不一致的病例。
结论
在本研究中，MmaxSure™ 在检测幽门螺杆菌和 A2143G 突变方面的诊断性能与 DPO-PCR 相当。需要进一步研究来证实 MmaxSure™ 检测试剂盒在幽门螺杆菌根除方面的临床效果。
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