REF:

E4112 (Microwell Plate)

INTENDED USE:

This kit is an enzyme -linked immunosorbent assay (ELISA) for qualitative detection of HBV pre-S1 antigen and core antigen in hepatitis B virus nucleic acid related antigen (HBV NRAg) 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 infe ction 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 virus particle is composed of outer membrane proteins (S protein, pre-S1 protein, pre-S2 protein) and core-shell. HBV pre-S1 antigen and core antigen are not only the marker of HBV infection, also the marker of viral replication, and they are highly correlated with HBV DNA, collectively known as hepatitis B virus nucleic acid related antigen (HBV NRAg).