REF:

E2204 (Microwell Plate)

INTENDED USE:

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

SUMMARY:

Hepatitis D is a liver diseases 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 Hepatitis B -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 (coinfection) or whether the newly infected HDV patient is also a chronic HBV carrier (superinfection). The co-infection with HDV can lead to severe acute hepatitis disease with low risk of chronic stage development. Chronic HBV carrier patients superinfected 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 HDV is based on detection of specific HDV antibodies (anti-HDV) or antigens. The anti-HDV IgG antibodies are indicator of past or current delta infection. High titers of the antibodies may be indicative of chronic or activeinfection. During HBV-HDV, co-infection detectable concentrations of anti-HDV IgG appear after the tenth week of exposure to the viruses and clearance during convalescence indicates recovery. During HDV superinfection, detectable levels of antibodies appear four to six weeks after exposure and failure to clear indicates possible progression to long, chronic carrier stage.