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Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in
Jasmine Samal1, Anushka Soni1, Amit Pandey1
1Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India.
Insights
The Determine HBsAg 2 rapid card test shows 100% specificity and 84.7% sensitivity for detecting Hepatitis B surface antigen (HBsAg). This affordable test is suitable for large-scale community screening in resource-limited settings.
Area of Science:
- Hepatology
- Virology
- Clinical Diagnostics
Background:
- Hepatitis B virus (HBV) is a major cause of chronic liver disease globally.
- Effective community screening requires sensitive and specific rapid diagnostic tests, especially in resource-limited settings.
- Early detection of Hepatitis B infection is crucial for reducing transmission and managing liver disease.
Purpose of the Study:
- To evaluate the clinical performance of the Determine HBsAg 2 rapid card test.
- To assess the sensitivity and specificity of the rapid test against a chemiluminescence-based assay.
- To determine the utility of the Determine HBsAg 2 assay for large-scale Hepatitis B screening.
Main Methods:
- Archived serum samples were tested using the Determine HBsAg 2 rapid card test.
- Performance was evaluated by comparing results with a reference chemiluminescence-based assay (Abbott Diagnostics).
- A total of 120 samples (46 HBsAg-positive, 74 HBsAg-negative) were analyzed.
Main Results:
- The Determine HBsAg 2 assay demonstrated 100% specificity (74/74).
- The assay achieved a sensitivity of 84.7% (39/46).
- Seven false-negative results were associated with HBsAg levels below the card assay's limit of detection.
Conclusions:
- The Determine HBsAg 2 assay provides rapid (15-minute) results with good sensitivity and specificity.
- It is a cost-effective tool for public health surveillance and large-scale screening programs.
- The test's performance supports its use in early Hepatitis B detection and transmission reduction efforts.
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.
How To Cite This Article:
Samal J, Soni A, Pandey A, et al. Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples. Euroasian J Hepato-Gastroenterol 2024;14(1):9-11.
