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Updated: Mar 15, 2026

Author Spotlight: Detection and Treatment of Helicobacter pylori Infection
Published on: July 28, 2023
Usefulness of Molecular Diagnostic Kits for Detecting Helicobacter pylori Infection in Patients Receiving Proton Pump
Kentaro Wakamatsu1, Tsutomu Nishiyama2, Kunio Yamada3
1Department of Respiratory Medicine, National Hospital Organization Omuta National Hospital, Fukuoka, Japan, hosp.go.jp.
Background:
Helicobacter pylori infection is associated with gastric cancer; therefore, therapies that eradicate H. pylori are crucial for its prevention. This study investigated the effects of clarithromycin (CAM)-resistance gene mutations on the success rate of H. pylori eradication and the usefulness of the Smart Gene H. pylori G (Mizuho Medy Co. Ltd., Saga, Japan) molecular diagnostic kit for H. pylori infection, which detects CAM-resistance mutations.
Methods:
This study enrolled patients who underwent esophagogastroduodenoscopy, during which intragastric fluid was collected. The Smart Gene kit was used to diagnose H. pylori infection and CAM-resistance mutations, and results were compared with those of the conventional urea breath test (UBT) and real-time polymerase chain reaction (PCR) results.
Results:
The study included 253 patients. H. pylori infection was confirmed by real-time PCR in 23 (9.1%) patients, and 99 (39.1%) patients were receiving a proton pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB). The sensitivities and specificities of the Smart Gene test and UBT were 87.0% and 82.6%, as well as 99.6% and 93.0%, respectively. PPI/P-CAB use did not affect the distribution of H. pylori DNA levels measured by real-time PCR, but the UBT values were significantly lower in the medicated group than in the unmedicated group (p < 0.05). Thirteen patients underwent treatment to eradicate H. pylori, with successful eradication in 11 (84.6%). The Smart Gene test identified three patients with CAM-resistance mutations. One patient was successfully treated with a metronidazole-based regimen, whereas CAM-based eradication therapy failed in two patients.
Conclusions:
The Smart Gene molecular diagnostic test using intragastric fluid was useful for patients requiring PPI/P-CAB to manage gastrointestinal symptoms. It could also confirm an H. pylori infection and CAM-resistance mutations within 1 h of testing. This diagnostic test may help reduce side effects and the emergence of resistant strains due to unnecessary eradication therapy.
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