Accuracy of Rapid Helicobacter Pylori Antigen Tests for the Surveillance of the Updated Prevalence of H. Pylori in Taiwan

Background: The updated prevalence of Helicobacter pylori (H. pylori) is lacking in Taiwan. We aimed to assess the accuracy of Vstrip (R) H. pylori Stool Antigen Rapid Test (Vstrip (R) HpSA) in the detection and surveillance of the updated prevalence of H. pylori in Taiwan. Methods: A total of 347 adult subjects including 152 volunteers and 195 symptomatic patients were recruited. Stool samples were collected for detection of H. pylori using Vstrip (R) HpSA, ImmunoCard STAT!(R) HpSA and Premier Platinum HpSA (R) PLUS. All subjects who have completed the stool sample collections were included in the ITT analysis. The sensitivity, specificity, and accuracy of Vstrip (R) HpSA were calculated compared to gold standard test with C-13-Urea breath test. Results: The un-adjusted prevalence of H. pylori infection was 22.5% (95% CI: 18.3-27%) in 2018. The age-standardized prevalence of H. pylori was 21.8% in asymptomatic adults in Taiwan. The sensitivity, specificity, and accuracy of the Vstrip (R) HpSA, and ImmunoCard STAT!(R) HpSA tests were 91% (95% CI: 82-96%) versus 76.9% (95% CI: 66-86%), 97% (95% CI: 94.1-98.6%) versus 97% (95% CI: 94.1-98.6%), and 95.7% (95% CI: 92-97%) versus 92.5% (95% CI: 89-95%), respectively. Conclusion: The age-standardized prevalence of H. pylori infection in Taiwan was 21.8% in asymptomatic adults in 2018. The Vstrip (R) HpSA had equivalent performance as the ImmunoCard STAT!(R) HpSA, and can be used in future mass screening of H. pylori infection for gastric cancer prevention. Copyright (C) 2020, Formosan Medical Association. Published by Elsevier Taiwan LLC.