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Published on: March 13, 2015
Evaluation of three different rapid card tests for the detection of hepatitis B surface antigen
Akshita Gupta1, Krithiga Ramachandran1, Diptanu Paul1
1Department of Clinical Virology, 80402Institute of Liver and Biliary Sciences, New Delhi, India.
Insights
Rapid diagnostic card tests are vital for hepatitis B elimination but require careful evaluation. While useful for high signal results, they may miss patients with lower signal/cut-off ratios, necessitating community-based assessments.
Area of Science:
- Hepatology
- Infectious Diseases
- Diagnostic Technologies
Background:
- Rapid diagnostic card tests (RDCTs) are essential for hepatitis B (HB) elimination strategies.
- Incorporating RDCTs into diagnostic algorithms requires understanding their performance limitations.
- Commercial RDCTs vary in accuracy and need pre-clinical evaluation.
Purpose of the Study:
- To compare the performance of three commercial RDCTs against a chemiluminescence immunoassay (CLIA).
- To evaluate the diagnostic accuracy of RDCTs for detecting hepatitis B surface antigen (HBsAg).
Main Methods:
- Comparative performance analysis of three distinct RDCTs.
- Chemiluminescence immunoassay (CLIA) used as the reference standard.
- Detection of hepatitis B surface antigen (HBsAg) as the target analyte.
Main Results:
- RDCTs effectively identify patients with a high signal/cut-off (S/CO) ratio on CLIA.
- Patients with an S/CO ratio below 200 may be missed by RDCTs, indicating potential false negatives.
- Performance varied among the evaluated RDCTs.
Conclusions:
- RDCTs can support decentralized hepatitis B testing when used judiciously.
- RDCTs are suitable for identifying patients with high HBsAg levels but may not be sensitive enough for all cases.
- Community-based evaluation of RDCTs is crucial before widespread clinical adoption.
Abstract:
Rapid diagnostic card tests are crucial steps on the road to hepatitis B elimination and should be incorporated into diagnostic algorithms. However, all commercial rapid diagnostic card tests are not equal and require evaluation before clinical use. Thus, we aimed to compare the performance characteristics of three different rapid diagnostic card tests with chemiluminescence-based assay (CLIA) for the detection of hepatitis B surface antigen.We concluded rapid diagnostic card tests can be used to identify patients with high signal/cut-off ratio on CLIA, but patients with signal/cut-off ratio <200 may be missed. Rapid diagnostic card tests may help pave the way for decentralised testing, but should be used only after evaluation in the community.
