REF:

E4105 (Microwell Plate)

INTENDED USE:

This kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of HBsAg in human serum or plasma. It is intended for screening of blood donors and for diagnosing of patients related to infection with hepatitis B virus.

SUMMARY:

Hepatitis B virus (HBV) is an enveloped, double-stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV). Infection with HBV induces a spectrum of clinical manifestations ranging from mild, inapparent disease to fulminant hepatitis, severe chronic liver diseases, which in some cases can lead to cirrhosis and carcinoma of the liver. Classification of a hepatitis B infection requires the identification of several serological markers expressed during three phases (incubation, acute and convalescent) of the infection. Now several diagnostic test are used for screening, clinical diagnosis and management of the disease.

Hepatitis B surface antigen or HBsAg, previously described as Australia antigen, is the most important protein of the envelope of Hepatitis B Virus. The surface antigen contains the determinant “a”, common to all known viral subtypes and immunologically distinguished in two distinct subgroups (ay and ad). HBV has 10 major serotypes and four HBsAg subtypes have been recognized (adw, ady, ayw, and ayr). HBsAg can be detected 2 to 4 weeks before the ALT levels become abnormal and 3 to 5 weeks before symptoms develop. The serological detection of HBsAg is a powerful method for the diagnosis and prevention of HBV infection and ELISA has become an extensively used analytical system for screening of blood donors and clinical diagnosis of HBV in infected individuals.