Smart Gene™ as an effective non‐invasive point‐of‐care test to detect Helicobacter pylori clarithromycin‐resistant mutation

Abstract

Background and Aim: Smart Gene ™ was developed based on the concept of point-ofcare 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.

Personalized Approach in Eradication of Helicobacter pylori Infection

“…Recently, Japanese authors published the results of a study in which Smart Gene™, a method based on the concept of point-of-care genetic testing, was used [74]. The results showed that the detection performance of Smart Gene™ was comparable with that of real-time PCR and sequencing analyses [74].…”

“…Recently, Japanese authors published the results of a study in which Smart Gene™, a method based on the concept of point-of-care genetic testing, was used [74]. The results showed that the detection performance of Smart Gene™ was comparable with that of real-time PCR and sequencing analyses [74]. Although it was not compared with cultures, mentioned method is considerably shorter than real-time PCR tests, thus making it more appropriate for everyday practice [74].…”

Clinical evaluation of a novel molecular diagnosis kit for detecting Helicobacter pylori and clarithromycin‐resistant using intragastric fluid

“…The detection of Mycoplasma pneumoniae and coronavirus by Smart Gene™ with pharyngeal swabs shows high reproducibility and useability and allows quick patient triage 8–11 . In addition, the detection of H. pylori by Smart Gene™ with stool proved to be an effective non‐invasive test 12 . The “ H. pylori gene detection POCT reagent,” a reagent for the fully automatic Smart Gene™, allows for the automatic detection of H. pylori and CAM resistance‐associated mutations based on the Qprobe method 13–15 …”

“…[8][9][10][11] In addition, the detection of H. pylori by Smart Gene™ with stool proved to be an effective non-invasive test. 12 The "H. pylori gene detection POCT reagent," a reagent for the fully automatic Smart Gene™, allows for the automatic detection of H. pylori and CAM resistance-associated mutations based on the Qprobe method. [13][14][15] Our goal was the fast and accurate diagnosis of H. pylori and detection of CAM resistance for the purpose of determining a precise eradication therapy.…”

“… 8 , 9 , 10 , 11 In addition, the detection of H. pylori by Smart Gene™ with stool proved to be an effective non‐invasive test. 12 The “ H. pylori gene detection POCT reagent,” a reagent for the fully automatic Smart Gene™, allows for the automatic detection of H. pylori and CAM resistance‐associated mutations based on the Qprobe method. 13 , 14 , 15 …”