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

The H. pylori Antigen Rapid Test Cassette (Feces) is a chromatographic immunoassay developed for the qualitative detection of Helicobacter pylori (H. pylori) antigens in human fecal specimens. This research intends to conduct a systematic assessment of its performance metrics, such as sensitivity, specificity, accuracy and clinical applicability, in comparison with another commercial rapid test. A total of 180 fecal samples were tested, consisting of 85 H. pylori antigen-positive and 95 H. pylori antigen-negative specimens. The outcomes revealed high relative sensitivity 97.6%, 95%, specificity 97.9% and overall accuracy 97.8%. The test exhibited no cross-reactivity with various common bacteria and viruses, along with excellent intra-assay and inter-assay precision, achieving over 99% correct identification of samples. These results suggest that the H. pylori Antigen Rapid Test Cassette (Feces) is a reliable, rapid, and practical tool for detecting H. pylori antigens, which can facilitate the timely diagnosis and management of H. pylori-related gastrointestinal diseases.