REF:

E2205 (Microwell Plate)

INTENDED USE:

This HDV-IgM kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of IgM-class antibodies to hepatitis D virus in human serum or plasma. It is intended for use in clinical laboratory for diagnosis and management of patients related to infection with hepatitis D virus.

SUMMARY:

Hepatitis D is caused by Hepatitis D virus (Delta agent) - a defective (36 nm-43 nm) enveloped RNA virus, which requires co-infection with Hepatitis B virus (HBV) for its replication. Transmitted percutaneously or sexually through contact with infected blood or blood products, HDV is associated with the most severe forms of chronic and acute hepatitis in many HBsAg positive patients. Since the infection with HDV requires infection with HBV, the development of the disease depends on whether the two viruses infect simultaneously (co-infection) or whether the newly infected HDV patient is also a chronic HBV carrier (super-infection). The co-infection with HDV can lead to severe acute hepatitis disease with low risk of chronic stage development. Chronic HBV carrier patients super-infected with HDV are at risk to develop chronic HDV disease, which can lead to cirrhosis in 70%-80% of the patients. The serological diagnosis of Hepatitis D is based on detection of specific HDV antibodies (anti-HDV) or antigens. IgM anti-HDV is the first antibody to appear in acute infection. IgM anti-HDV is transient and rapidly replaced by IgG anti-HDV. However, persistence of IgM anti-HDV will indicate chronic HDV infection, which continues to replicate. During HBV-HDV co-infection, detectable concentrations of HDV anybodies appear after the tenth week of exposure and clearance during convalescence indicates recovery. The serological detection of IgM class antibodies is an important marker for diagnosis and monitoring of patients during early infection period and post treatment recovery. Decreasing or low titers of IgM suggest early recovery during HDV co- and acute super-infection while constantly elevated level of IgM indicates possible progression to chronic carrier stage.