DefinePK

Abstract

Background: Helicobacter pylori infection remains a major public health concern, particularly in developing countries where diagnostic resources are limited. Accurate detection of this pathogen is crucial for managing gastrointestinal disorders, yet the comparative efficacy of non-invasive immunochromatographic tests (ICTs) for antibody (Ab) and antigen (Ag) detection remains underexplored in regional settings like District Mardan, Pakistan. Objective: This study aimed to compare the diagnostic performance of ICT-based H. pylori antibody (blood) and antigen (stool) tests among symptomatic individuals, evaluating their detection rates and assessing suitability for clinical application in low-resource environments. Methods: A cross-sectional diagnostic accuracy study was conducted among 87 patients presenting with gastrointestinal symptoms at Abdul Wali Khan University Mardan from October 2024 to March 2025. Participants were enrolled through convenience sampling after applying defined inclusion and exclusion criteria. Blood and stool samples were collected and tested using commercial ICT kits. Data were analyzed using SPSS version 26.0, and chi-square tests were applied to compare positivity rates, with a significance threshold set at p < 0.05. The study adhered to the ethical principles of the Declaration of Helsinki, and informed consent was obtained from all participants. Results: The antibody test showed 82% positivity (71/87), while the antigen test detected 76% positivity (66/87), with no statistically significant difference (χ² = 0.858, p = 0.354). Gender and age stratification revealed no significant influence on test outcomes (p > 0.05 for both), though the highest prevalence was noted among males and individuals aged 26–50 years. Conclusion: Both ICT-based Ab and Ag tests demonstrated comparable diagnostic accuracy in detecting H. pylori infection. The Ab test may be preferable for screening purposes due to its higher sensitivity, while the Ag test is more appropriate for confirming active infections and post-treatment monitoring. These findings support context-specific diagnostic strategies in resource-constrained healthcare settings.