J. Mitra Hepalisa Elisa 3rd Generation Kit

1. Introduction
The Viral Hepatitis caused by Hepatitis B Virus is termed as “Serum Hepatitis”. 1-5% infected people act as chronic carriers of HBV Virus. Major part of the chronic carriers secrete hepatitis B surface antigen (HBsAg) into blood and other secretions of the body like saliva and vaginal fluid. These chronic carriers are potentially infectious to other seronegative people. Hepatitis B Virus belongs to a family of enveloped DNA virus, the Hepadnavirus. Related viruses in this group cause chronic hepatitis. HBsAg has been accepted as a universal and the most reliable seromarker in case of acute HBV infection due to its appearance almost 2-4 weeks before the ALT level becomes abnormal and 3-5 weeks before the onset of symptoms or jaundice as an early detection system for hepatitis infection. In most cases of HBV infection, the incubation period varies from 40 days to 6 months. Within HBVs, antigenic diversity is recognised in the surface antigens. HBsAg particles contain common “a” antigen, linked to two sets of mutually exclusive determinants, “d” or “y” and “w” or “r” giving the four main types-adw, adr, ayw and ayr.

2. Intended use
Hepalisa is designed for in-vitro qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma and is used as a screening test for testing of collected blood prior to transfusion.

3. Serological markers of clinical significance for hepatitis B virus (HBV)
HBsAg : First detected during the incubation period of 6-8 weeks before the appearance of symptoms. It can appear as early as 2 weeks and generally disappears within 3-4 months after exposure. It is the most reliable & universal marker of HBV infection. In the carrier and chronic state it persists more than6 months.
Anti-HBs : Appearance may take several weeks/months after HBsAg clearance causing a ‘window’ period. Best indicator of recovery & immunity to HBV. Quantitation allows pre-vaccination screening & follow-up of the post-vaccination response.

HBeAg : Appears within 1 week after HBsAg, lasts 3-6 weeks & disappears before HBsAg clearance. Its presence indicates a highly infectious state, except in pre-core mutants. Persistence > 10 weeks suggests progression to chronic carrier state/hepatitis.

Anti-HBe : It appears before clearance of HBsAg, indicates decreasing infectivity and is a good prognosis for the resolution of infection.