Background and Aim
Smart Gene™ was developed based on the concept of point‐of‐care genetic testing. We evaluated the detection performance of a reagent for Helicobacter pylori (H. pylori) clarithromycin (CAM)‐resistant mutation assessment and determined the association between the results of Smart Gene™ and those of eradication therapy for H. pylori.
Methods
In 2020, the present study was conducted on participants of the H. pylori test and treat project in Saga Prefecture. The submitted stool samples were measured for H. pylori gene and CAM‐resistant mutation by Smart Gene™, and the results were compared with real‐time polymerase chain reaction (PCR) and sequencing analysis. Finally, the results of the eradication therapy were examined for each result of Smart Gene™.
Results
Stool samples were obtained from 139 patients who were tested positive by stool antigen test and were analyzed. The H. pylori detection rate was 95.7% by Smart Gene™, 92.8% by real‐time PCR (P < 0.01), and 89.2% by sequencing analysis (P = 0.06). The overall concordance rate for CAM‐resistant mutation between Smart Gene™ and sequencing analysis was 96.7%. Moreover, 35 of 48 students with CAM‐resistant mutation and 33 of the 35 students with a mutation without CAM resistance succeeded in CAM‐containing triple therapy, and the success rate was significantly higher for the mutation without CAM resistance (P = 0.012).
Conclusions
The detection performance of Smart Gene™ was comparable with that of real‐time PCR and sequencing analysis. It is expected that the success rate of eradication would be further improved by using the reagent.