The accuracy of stool antigen rapid test for diagnosis of Helicobacter pylori infection among different subgroups

Accurate diagnosis and treatment of Helicobacter pylori ( H. pylori ) are essential for the optimal prevention of gastric cancer and peptic ulcer disease. While the H. pylori stool rapid test is easy to perform, its diagnostic accuracy among different population groups needs to be thoroughly validated. In this study, we enrolled adult volunteers aged 20 and above to undergo screening for H. pylori infection. Participants underwent serology, 13 C‐urea breath test (UBT), and H. pylori stool antigen test. The one‐step stool antigen rapid test was conducted using a commercial HelicotecAG® kit, while H. pylori serology was determined through ELISA. Sensitivity, specificity, and accuracy of the serology and stool antigen tests were calculated using 13 C‐UBT as the reference standard, with subgroup analyses. Logistic regression was employed to identify risk factors associated with untreated H. pylori infection. Between January 2018 and June 2020, 357 adult participants were included. The H. pylori prevalence was higher in symptomatic participants (36.9%–37.5%) compared to asymptomatic subjects (22.3%–28.9%). Sensitivity, specificity, and diagnostic accuracy for the stool antigen rapid test (SAT) were 80.6%, 87.8%, and 85.7%, respectively, and were 87.4%, 90.6%, and 89.6% for serology, respectively. Sensitivity, NPV, and accuracy of SAT were higher in the asymptomatic group compared to the symptomatic group (88.6% versus 74.6%, 96.4% versus 85.4%, and 88.3% versus 82.5%, respectively). Upper abdominal pain and older age were significant risk factors for H. pylori infection in treatment‐naïve individuals. The HelicotecAG® stool rapid test is a reliable tool for screening of H. pylori infection. Asymptomatic individuals and those with prior H. pylori eradication were associated with higher test performance.