Detection of Clarithromycin Resistance in <i>Helicobacter pylori</i> Using MmaxSure™ <i>H. pylori</i> &amp; ClaR Assay

Abstract

<b><i>Introduction:</i></b> Clarithromycin resistance is a crucial factor in the eradication of <i>Helicobacter pylori</i>. This study aimed to evaluate the performance of MmaxSure™ <i>H. pylori</i> &amp; ClaR Assay (MmaxSure™) in the diagnosis and detection of clarithromycin resistance in <i>H. pylori</i>. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> A total of 156 gastric biopsy samples were analyzed. In <i>H. pylori</i> 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™. <b><i>Conclusion:</i></b> In this study, MmaxSure™ showed comparable diagnostic performance to DPO-PCR in the detection of the <i>H. pylori</i> and A2143G mutation. Further research is needed to confirm the clinical effectiveness of the MmaxSure™ assay in <i>H. pylori</i> eradication.