User-Friendly Self-Testing Evaluation of H. pylori Antigen Detection in Feces

Abstract

The Helicobacter pylori Antigen Rapid Test Cassette (Feces) is a chromatographic immunoassay designed for qualitative detection of H. pylori antigens in human fecal specimens. This study evaluated its performance using 180 fecal samples (85 positive, 95 negative) compared to a commercial reference test. Results showed high sensitivity (97.6%), specificity (97.9%), and accuracy (97.8%). No cross-reactivity or interference was observed with common pathogens or compounds, and intra-/inter-assay reproducibility exceeded 99%. These findings confirm the assay’s clinical utility as a rapid, reliable, and user-friendly diagnostic tool for H. pylori detection.