Clinical Evaluation of a Stool-Based Molecular Point-of-Care Test Kit for Noninvasive Detection of Helicobacter pylori Infection and Clarithromycin Resistance.

AIM: Although molecular point-of-care testing using intragastric fluid has improved the speed and accuracy of Helicobacter pylori (H. pylori) diagnosis and clarithromycin (CAM) resistance detection, it still requires endoscopy, which limits its application in routine screening and settings where invasive procedures cannot be performed. We aimed to evaluate the clinical performance of the Smart Gene™ molecular point-of-care testing kit using stool specimens for H. pylori infection and CAM resistance detection.

METHODS: We used stool specimens from 75 patients with suspected H. pylori infection. All participants underwent conventional diagnostic tests (urea breath test, stool antigen test, culture, and real-time polymerase chain reaction). CAM resistance-associated mutations (Positions 2142 and 2143 in the 23S rRNA gene) were analyzed using pyrosequencing.

RESULTS: The stool-based Smart Gene kit demonstrated a sensitivity of 96.1% and specificity of 100% for H. pylori detection. The sensitivity and specificity for detecting CAM resistance were 100% and 97.0%, respectively, compared to antibiotic susceptibility testing. High concordance was observed between the intragastric polymerase chain reaction and culture results despite the lower stool DNA concentration. The results were obtained within approximately 1 h.

CONCLUSIONS: The Smart Gene™ stool kit offers a rapid, accurate, and noninvasive alternative for diagnosing H. pylori infection and CAM resistance. Its diagnostic performance is comparable to that of the gold-standard invasive methods while offering practical advantages for outpatient use, mass screening, and nonendoscopy-feasible populations. This approach increases early H. pylori detection and improves eradication outcomes and contributes to more effective gastric cancer prevention strategies (approval number: R4-0426001).