Expected use
This kit is an enzyme-linked immunosorbent assay for the qualitative detection of antibodies against hepatitis C virus in human serum or plasma. It is intended for the screening of blood donors and the diagnosis of patients related to hepatitis C virus infection.
Summary and explanation
Hepatitis C virus (HCV) is an enveloped single stranded (9.5 kb) positive sense RNA virus belonging to the Flaviviridae family. Six major HCV genotypes and series of subtypes have been identified. Isolated in 1989, HCV is now recognized as the leading cause of transfusion-associated non-A and non-B hepatitis. The disease is characterized by its acute and chronic forms, although more than 50% of 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 HCV ELISA showed limited sensitivity and specificity and was produced using recombinant proteins complementary to the NS4 region (c100-3) of the HCV genome as antigens. Second-generation tests, which included recombinant / synthetic antigens from the nucleus (c22) and the NS3 (c33c, c100-3) and NS4 (c100-3, c200) nonstructural regions resulted in a marked improvement in sensitivity and specificity.
. Clinical studies show that a significant number of HCV-infected individuals develop antibodies against the non-structural protein NS5 of the virus. For this, third-generation tests include antigens from the NS5 region of the viral genome in addition to NS3 (c200), NS4 (c200) and Core (c22). Third-generation tests have improved sensitivity and shortened the time between HCV infection and the appearance of detectable antibodies (window period) to 60 days.
