Helicobacter pylori is a zoonotic gut pathogen that affects humans and animals. Half of the world's population is infected with H. pylori. Helicobacter pylori stool antigen lateral flow immunochromatographic assay is the most common rapid test for disease diagnosis. This study aimed to evaluate the commercial Helicobacter pylori stool antigen lateral flow immunochromatographic assay using a gold standard test, a Hemi-nested 16srRNA PCR.
Methodology: 200 stool and fecal samples were collected from dyspeptic humans, dogs, and cats. HpSA-LFIA and 16srRNA Hemi-nested PCR were performed on the collected samples. Statistical analysis was applied to get the sensitivity and specificity of the test under evaluation. The sample size was calculated with a power of 80% (online calculator). The stool and fecal samples were preserved at -20°C until the test performance.
Results: The obtained Se and Sp were 91.89% and 59.51%, respectively.
Conclusion: HpSA-LFIA in our country is a highly sensitive test with low specificity and low accuracy to be the sole test for diagnosis. The test was intended to be used as a screening test and provided a preliminary result which was not enough for precision and final diagnosis.