Hepatitis C Virus (HCV) BioAssay(TM) ELISA Kit

Hepatitis C virus (HCV) is an envelope, single stranded positive sense RNA (9.5kb) 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. Intended Use: This BioAssay(TM) 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. Sensitivity: 100% Range: Qualitative: Positive & Negative Control & Cut off Specificity: 99.81% Test Principle: This kit is a two-step incubation enzyme immunoassay, which uses polystyrene microwell strips pre-coated with recombinant HCV antigens expressed in E.coli (recombinant Core and NS3/4/5). Serum or plasma sample is added together with biotin-conjugated HCV antigens. During the first incubation step, the specific HCV antibodies, if present, will be captured inside the wells as a double antigen complex comprising of the coated, and the biotin-conjugated HCV antigens. The microwells are then washed to remove unbound serum proteins. During the second incubation step, the captured HCV antibodies are detected by adding of HRP-Conjugate. The microwells are then washed to remove unbound conjugate, and Chromogen solutions are added to the wells. In wells positive for HCV antibodies, the colorless Chromogens are hydrolyzed by the bound HRP conjugate to a blue colored product. The blue color turns yellow after stopping the reaction with sulfuric acid. The amount of color intensity can be measured and is proportional to the amount of antibodies captured in the wells, and to the sample respectively. Wells containing samples negative for anti-HCV remain colorless. Kit Components: 1. Microwell plate, 1x96 wells 2. Negative Control, 1x1ml 3. Positive Control Serum: 1x1ml 4. HRP-Conjugate Reagent, 1x12ml 5. Biotin-Conjugate Reagent, 1x6ml 6. Stock Wash Buffer, 1bottle 7. Chromogen Solution A: 1x6ml 8. Chromogen Solution B, 1x6ml 9. Stop Solution, 1x6ml 10. Cardboard Plate Cover, 3sheets Storage and Stability: Store other components at 4 degrees C. Stable for at least 6 months For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.