Canadian journal of gastroenterology & hepatology
Clinical Evaluation of a Stool-Based Molecular Point-of-Care Test Kit for Noninvasive Detection of Helicobacter pylori Infection and Clarithromycin Resistance
By Tsuda M, Watanabe Y, Kubo K and 1 others.
Abstract
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.