Evaluation of reliability and performance of hepatitis B virus-e-antigen assays in tertiary care setting

ABSTRACT

Hepatitis B virus-e-antigen (HBeAg) is a viral marker to assess hepatitis B virus (HBV) replication. We have evaluated the reliability of three commonly available HBeAg immunoassays using World Health Organization-International Standard and clinical samples. In addition the performance of enzyme immunoassays (EIAs) was assessed by kinetic binding and reagent exchange experiments. Analytical and diagnostic sensitivity were significantly different among HBeAg assays (P < 0.01). The affinity of capture/detector antibodies varied significantly between EIAs (P < 0.01). Our findings suggest that significant difference in the affinity of capture/detector antibodies to HBeAg may impact the overall performance and the reliability of currently available HBeAg assays in HBV diagnosis and management.

KEYWORDS:

• HBeAg
• immunoassay
• HBV
• antibody
• affinity

Acknowledgments

This study was funded by the DCV, CMC, Vellore. Sincere thanks to Dr. Hubert Darius Daniel (Consultant Virologist) for his valuable advice and suggestion.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This study was funded by the Department of Clinical Virology (DCV), Christian Medical College (CMC), Vellore