Diagnostic Performance of the Determine^TM HBsAg Rapid Test for the Detection of Hepatitis B Surface Antigen in a Rural Population in Burkina Faso

Introduction: Hepatitis B virus (HBV) infection remains a major public health challenge in sub-Saharan Africa. In resource-limited settings, rapid diagnostic tests provide an alternative to automated assays. This study aimed to evaluate the diagnostic performance of the Determine^TM HBsAg rapid test for the detection of hepatitis B surface antigen (HBsAg) in a rural setting in Burkina Faso. Methods: A cross-sectional diagnostic accuracy study was conducted from April to June 2021 in Moussodougou, Burkina Faso. The Determine^TM HBsAg test results from 770 participants were compared with those obtained using the Architect？ system (Abbott), which served as the reference standard. Sensitivity, specificity, positive and negative predictive values, diagnostic accuracy, and Cohen’s kappa coefficient were calculated. Results: The prevalence of HBsAg was 8.70% with the Determine^TM HBsAg test and 9.61% with the Architect？ assay. The rapid test identified 67 true-positive, 696 true-negative, seven false-negative, and no false-positive results. Sensitivity was 90.54% (95% CI: 81.48 - 96.11), specificity was 100% (95% CI: 99.47 - 100), the positive predictive value was 100% (95% CI: 94.64 - 100), the negative predictive value was 99.00% (95% CI: 97.96 - 99.60), diagnostic accuracy was 99.09% (95% CI: 98.14 - 99.63), and Cohen’s kappa coefficient was 0.9454 (95% CI: 0.8748 - 1.0000). Conclusion: The Determine^TM HBsAg rapid test demonstrated excellent diagnostic performance and is a reliable tool for HBV screening in rural settings. Its excellent specificity and strong agreement with the Architect？ assay support its use in decentralized HBV screening strategies in resource-limited settings.