Detection of Clarithromycin resistance in Helicobacter pylori using MmaxSure™ H. pylori & ClaR Assay.

IF 4.7 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-04-10 DOI:10.1159/000538655

Ilsoo Kim, Yu Ri Shin, Lee-So Maeng, Jung Min Kim, J. Kim, Byung-Wook Kim

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Abstract

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 performance of MmaxSure™ and dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) were compared with 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 was 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 the 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.

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使用 MmaxSure™ 幽门螺杆菌和 ClaR 检测试剂盒检测幽门螺杆菌对克拉霉素的耐药性。

导言：克拉霉素耐药性是根除幽门螺旋杆菌的关键因素。本研究旨在评估 MmaxSure™ 幽门螺杆菌与克拉霉素耐药性检测试剂盒（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 月期间接受食管胃十二指肠镜检查的受试者。比较了MmaxSure™和基于双引物寡核苷酸（DPO）的多重聚合酶链反应（PCR）与快速尿素酶测试和培养的诊断性能。对 PCR 检测不一致的病例进行了二级基因测序分析。结果共分析了 156 份胃活检样本。在幽门螺杆菌检测中，MmaxSure™ 的灵敏度为 95.9%（95%CI 90.6-98.6），特异度为 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），特异度为 93.4%（95%CI：87.5-97.1），Kappa 值为 0.804。与基因测序相比，MmaxSure™的A2143G突变检测共有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。要确认 MmaxSure™ 检测法在根除幽门螺杆菌方面的临床效果，还需要进一步的研究。

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来源期刊

ACS Applied Bio Materials Chemistry-Chemistry (all)

CiteScore

9.40

自引率

2.10%

发文量

464

期刊介绍： ACS Applied Bio Materials is an interdisciplinary journal publishing original research covering all aspects of biomaterials and biointerfaces including and beyond the traditional biosensing, biomedical and therapeutic applications. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrates knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important bio applications. The journal is specifically interested in work that addresses the relationship between structure and function and assesses the stability and degradation of materials under relevant environmental and biological conditions.