REF:

E2202 (Microwell Plate)

INTENDED USE:

This kit is an enzyme-linked immunosorbent assay for qualitative detection of antibodies to hepatitis C virus in human serum or plasma. It is intended for screening blood donors and diagnosing patients related to infection with hepatitis C virus.

SUMMARY:

Hepatitis C virus (HCV) is an envelope, single stranded positive sense RNA (9.5 kb) virus belonging to the family of Flaviviridae. Six major genotypes and series of subtypes of HCV have been identified. Isolated in 1989, HCV is now recognized as the major cause for transfusion associated non-A, non-B hepatitis. The disease is characterized with acute and chronic form although more than 50% of the infected individuals develop severe, life threatening chronic hepatitis with liver cirrhosis and hepatocellular carcinomas. Since the introduction in 1990 of anti-HCV screening of blood donations, the incidence of this infection in transfusion recipients has been significantly reduced. The first generation of HCV ELISAs showed limited sensitivity and specificity and was produced using recombinant proteins complementary to the NS4 (c100-3) region of the HCV genome as antigens. Second generation tests, which included recombinant / synthetic antigens from the Core (c22) and nonstructural regions NS3 (c33c, c100-3) and NS4 (c100-3, c200) resulted in a remarked improvement in sensitivity and specificity. Clinical studies show that significant amount of HCV infected individuals develop antibodies to NS5 non-structural protein of the virus. For this, the third generation tests include antigens from the NS5 region of the viral genome in addition to NS3 (c200), NS4 (c200) and the Core (c22). Third generation tests have improved sensitivity and shorten the time between infection with HCV and the appearance of detectable antibodies (window period) to 60 days.