REF:

E4106 (Microwell Plate)

INTENDED USE:

This ELISA kit is an enzyme linked immunosorbent assay (ELISA) for in vitro qualitative detection of antibodies to hepatitis B virus surface antigen (anti-HBs) in human serum or plasma. It is intended for use in medical laboratories for diagnosis and management 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 tests are used for screening, clinical diagnosis and management of the disease.

Hepatitis B surface antigen (HBsAg), which appears shortly after infection, is an important protein of the envelope structure of the virus. HBsAg is a key serological marker for detection and diagnosis of HBV and is detectable in blood during the acute phase of the disease. Clearance after treatment shows recovery while presence for more than half year after infection indicates possible progression to long chronic carrier stage. During the acute phase of the infection, strong immunological response develops and increasing titers of HBsAg neutralizing antibodies (anti-HBs) are marker for recovery. The serological detection of anti-HBs has become important method for the follow up of patients infected by HBV, prospective prevalence studies, and the monitoring of recipients upon vaccination with synthetic and natural HBsAg based vaccines.