Aim and background: Hepatitis B virus is one of the leading underlying causes of chronic liver disease.Rapid diagnostic tests with improved sensitivity and specificity for detecting hepatitis B infection could aid in large-scale community screening in resource-limited settings.This study was designed to assess the clinical performance of a rapid card test to detect HBsAg.Materials and methods: In this study, archived once-thawed serum samples were tested on the Determine HBsAg 2 card and their performance was evaluated in reference to a chemiluminescence-based assay (HBsAg qualitative assay, Abbott Diagnostics, US).Results: A total of 120 patient samples (46 confirmed HBsAg-positive and 74 confirmed HBsAg-negative) were used in this study.The overall median age of the study population was 44 years (IQR: 36-51 years), with a male gender predominance (90%).A specificity of 100% (74/74) and sensitivity of 84.7% (39/46) was observed for the Determine HBsAg 2 assay compared with the reference assay.The samples that showed false-negative results (n = 7) by the card test had HBsAg levels below the limit-of-detection of the card assay. Conclusion:The Determine HBsAg 2 assay gives rapid results in 15 minutes with good sensitivity and specificity.This makes it a good, affordable tool for large-scale screening and public health surveillance programs.Clinical significance: Accurate and cost-effective rapid card tests for early detection of Hepatitis B infection would enable quick isolation of infected cases, thus reducing transmission in the community.
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Samal et al. (2024) studied this question.
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