Clinical practice of a novel molecular diagnostic method for detecting Helicobacter pylori and clarithromycin resistance

Abstract

Abstract

Objective: The Smart Gene^TM system enables the rapid polymerase chain reaction-based detection of Helicobacter pylori (H. pylori) in gastric juice and determines clarithromycin (CAM) resistance. This study evaluated the clinical utility of the Smart Gene^TM system for diagnosing and managing H. pylori infection.

Methods:H. pylori diagnosis was obtained using the Smart Gene^TM system and the effectiveness of individualized eradication therapy was evaluated. Treatment regimens were chosen based on CAM sensitivity in the Smart Gene^TM test.

Results: A total of forty-nine patients were assessed. Among them, 28 had H. pylori infection, while 3 had CAM resistance. Seventeen patients underwent H. pylori eradication therapy. Fourteen patients with CAM-sensitive strains underwent eradication therapy with vonoprazan (VPZ), amoxicillin (AMPC), and CAM. Two patients with CAM-resistant strains were treated with VPZ and AMPC, while one received VPZ, AMPC, and metronidazole. The eradication achievement rate was 100%. Of 31 outpatients, 61.5% began H. pylori eradication therapy on the same day as the Smart Gene^TM test.

Conclusion: Smart Gene^TM enables rapid diagnosis of H. pylori infection and the detection of CAM resistance, allowing for personalized eradication regimens.