Abstract
BACKGROUND: Helicobacter pylori causes the most common human gastric infection. H. pylori Stool Antigen Lateral Flow Immunochromatography assay (HpSA-LFIA) is considered one of the most cost-effective and rapid non-invasive assays (active tests). Evaluating HpSA-LFIA is of crucial for ensuring accuracy and utility assurance. This study aimed to evaluate the polyclonal antibody-based HpSA-LFIA in comparison to a monoclonal antibody-based ELISA kit. METHODOLOGY: Stool samples were collected from 200 gastric patients for HpSA-LFIA and semiquantitative HpSA-ELISA tests. A statistical analysis of the diagnostic performance was performed using MedCalc software. Chi-square tests were performed to determine the effects of gender and age. RESULTS AND CONCLUSION: The results showed that HpSA-LFIA achieved remarkable sensitivity (93.75%) and NPV (98.00%). However, it had poor specificity, PPV, and accuracy of 59.76%, 31.25%, and 65.31%, respectively. LR+ and LR-were 2.33% & 0.1%, respectively. Gender didn't affect the diagnostic performance of HpSA-LFIA. Age groups had irrelevant sensitivity; however, specificity was significantly higher in patients aged >45 years. We can conclude that HpSA-LFIA was not accurate enough to be the sole test for diagnosis and suggest developing other confirmatory tests in case of positive conditions.