Comparison of ELISA and Rapid Immunochromatographic Tests for Hepatitis B Surface Antigen Detection in Field Settings

Abstract

The Hepatitis B virus (HBV) infection remains a considerable global health issue, with the detection of hepatitis B surface antigen (HBsAg) being crucial for diagnosis and screening. This study aggregates data from numerous investigations to assess the diagnostic effectiveness of enzyme-linked immunosorbent assay (ELISA) and rapid immunochromatographic tests (ICTs) for HBsAg detection, with a focus on field applications. Key findings indicate that ELISA consistently demonstrates remarkable sensitivity and specificity, reinforcing its position as the gold standard, although it requires laboratory equipment. In contrast, ICTs offer advantages in simplicity, speed, and cost-effectiveness, making them suitable for mass screening in resource-limited or high-endemic regions (e.g., Africa and Asia). ICTs have varying sensitivity (17.24%–100%), posing a considerable risk of false negatives in cases of low viral loads or low HBsAg titers, and offer moderate to high specificity, with occasional erroneous positives. Practical solutions endorse the utilization of ICTs for preliminary screening, followed by ELISA confirmation of positive or ambiguous results to enhance diagnostic accuracy. Emerging multiplex ICT systems, capable of concurrently detecting several HBV markers, exhibit promise but require further validation. These findings highlight the imperative of equilibrating performance, resource availability, and context when selecting HBsAg detection methods in field settings.