Ilsoo Kim, Yu Ri Shin, Lee-So Maeng, Jung Min Kim, J. Kim, Byung-Wook Kim
{"title":"Detection of Clarithromycin resistance in Helicobacter pylori using MmaxSure™ H. pylori & ClaR Assay.","authors":"Ilsoo Kim, Yu Ri Shin, Lee-So Maeng, Jung Min Kim, J. Kim, Byung-Wook Kim","doi":"10.1159/000538655","DOIUrl":null,"url":null,"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.","PeriodicalId":11294,"journal":{"name":"Digestive Diseases","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Digestive Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000538655","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍:
Each issue of this journal is dedicated to a special topic of current interest, covering both clinical and basic science topics in gastrointestinal function and disorders. The contents of each issue are comprehensive and reflect the state of the art, featuring editorials, reviews, mini reviews and original papers. These individual contributions encompass a variety of disciplines including all fields of gastroenterology. ''Digestive Diseases'' bridges the communication gap between advances made in the academic setting and their application in patient care. The journal is a valuable service for clinicians, specialists and physicians-in-training.