REF:

E4110 (Microwell Plate) 

INTENDED USE:

This Anti-HBV Core Antigen IgM Antibody ELISA Test is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of IgM class antibodies to hepatitis B virus core antigen 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 diseases, which in some cases can lead to cirrhosis and carcinoma of the liver. Classification of a hepatitis B infection requires the identificationof a number of 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 “core” antigen (HBcAg) is a major component of the viral structure. HBcAg is composed of a single polypeptide of about 17 kD that is released upon disaggregation of the core particles; the antigen contains at least one immunological determinant. Antibodies to HBcAg (anti-HBc total antibody and IgM) appear shortly after the appearance of HBsAg and persist for life both in persons who have recovered from a hepatitis B infection and in those who develop HBsAg-carrier status but in rare cases, an HBV infection can also run its course without the appearance of immunologically detectable anti-HBc (usually in immunosuppressed patients).

In chronic hepatitis, however, spikes of anti-HBc IgM synthesis are present, confirming reactivation of HBV in hepatocites and giving origin to permanent IgM low titers. Presence of IgM and total anti-HBc indicates an ongoing or recent HBV infection. When used in conjunction with tests for other HBV serological markers, a laboratory diagnosis or a rule out of HBV infection can be achieved.