REF:

E2203 (Microwell Plate)

INTENDED USE:

This kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of antigens to hepatitis D virus (HDV-Ag) in human serum or plasma. It is intended for use in clinical laboratories for diagnosis of patients related to infection with hepatitis D virus, and is good for the survey of epidemics. This assay is sensitive, specific, fast, and easy to operate.

SUMMARY:

Hepatitis D is caused by Hepatitis D virus (Delta agent) - a defective (36nm-43nm) 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 (HDV-Ag). During HBV-HDV coinfection, detectable concentrations of HDV specific antigens first appear six to eight week after exposure and clear during convalescence together with elevated levels of HDV antibodies which indicate recovery. The circulating HDV-Ag is indicative of an acute infection. It is typically present only transiently in very low levels. During HDV super infection, detectable levels of HDV antigens appear two weeks after exposure and failure to clear indicates possible progression to long term, chronic carrier stage.