Euroasian journal of hepato-gastroenterology

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VOLUME 14 , ISSUE 1 ( January-June, 2024 ) > List of Articles

Original Article

Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples

Jasmine Samal, Anushka Soni, Amit Pandey, Gagan Chooramani, Ekta Gupta

Keywords : CLIA, Determine HBsAg 2, Hepatitis B, HBsAg, RDT

Citation Information : Samal J, Soni A, Pandey A, Chooramani G, Gupta E. Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples. Euroasian J Hepatogastroenterol 2024; 14 (1):9-11.

DOI: 10.5005/jp-journals-10018-1403

License: CC BY-NC 4.0

Published Online: 12-06-2024

Copyright Statement:  Copyright © 2024; The Author(s).


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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