Introduction
The Hepatitis B Surface Antigen (HBsAg) ELISA Kit is a vital in vitro diagnostic (IVD) tool used for the qualitative detection of HBsAg in human serum or plasma. This kit plays a crucial role in screening blood donors, diagnosing hepatitis B infections, and monitoring treatment responses.
The HBsAg ELISA Kit is designed for the qualitative detection of HBsAg in human serum or plasma samples. It aids in diagnosing hepatitis B virus (HBV) infections and screening individuals at risk.
Principle of the Assay
The assay is based on the enzyme-linked immunosorbent assay (ELISA) technique. It utilizes monoclonal and polyclonal antibodies specific to HBsAg, coated on microtiter wells, to capture the antigen present in the sample. After incubation and washing steps, an enzyme-conjugated secondary antibody binds to the antigen-antibody complex. The addition of a substrate solution leads to a colorimetric reaction, which is measured spectrophotometrically. The intensity of the color is proportional to the concentration of HBsAg in the sample.
Clinical Significance
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). It can lead to both acute and chronic disease, increasing the risk of cirrhosis, liver failure, and hepatocellular carcinoma (WHO, 2023). Detecting hepatitis B surface antigen (HBsAg) is crucial for early diagnosis, preventing disease transmission, and managing affected individuals (Seeger & Mason, 2015). Early detection enables timely intervention, including antiviral therapy and vaccination, to mitigate disease progression (Schweitzer et al., 2015).
References
- Schweitzer, A., Horn, J., Mikolajczyk, R. T., Krause, G., & Ott, J. J. (2015). Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. The Lancet, 386(10003), 1546-1555. https://doi.org/10.1016/S0140-6736(15)61412-X
- Seeger, C., & Mason, W. S. (2015). Molecular biology of hepatitis B virus infection. Virology, 479-480, 672-686. https://doi.org/10.1016/j.virol.2015.02.031
- World Health Organization (WHO). (2023). Hepatitis B. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

