REF:

E4109 (Microwell Plate)

INTENDED USE:

This kit is an enzyme-linked immunosorbent assay for qualitative detection of antibodies to hepatitis B virus e antigen (anti-HBe) in human serum or plasma. It is intended for use in clinical 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 disease 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.

The hepatitis B e antigen (HBeAg), which is a product of the pre-C/C gene, has been found in the hepatocytes during proliferation of the hepatitis B virus. After proteolysis, the HBe protein is secreted into the serum in size varying from 16 kD to 20 kD. The e-antigen is associated with high degree of viral proliferation. HBeAg appears shortly after HBsAg and is detectable from few days to several weeks after infection. After treatment, in the recovery phase following acute hepatitis B, HBeAg -the first serological marker -becomes negative and is replaced by the corresponding antibody (anti-HBe). If HBeAg is considered a specific marker of infectivity, the presence of anti-HBe antibody in blood is recognized to be a clinical sign of recovery from the infection. Acute and persistent HBV infections can also occur without HBeAg being detectable. Demonstration of anti-HBe in these patients is an indication of the presence HBV mutants. These may be associated with high, low, or non-detectable quantities of virus. For this, anti-HBe test is meaningful only in association with the HBeAg test for monitoring the course of an HBV infection.