30823 – Hepatitis C Virus Antibody (HCV Ab) EIA | Clinical | Eurofins-Viracor

ORTHO® HCV Version 3.0 ELISA Test System is an enzyme-linked, immunosorbent assay for the qualitative detection of antibody to hepatitis C virus (anti-HCV) in human serum or plasma specimens. This product is intended for use as a donor screening test to detect antibodies to hepatitis C virus in plasma and serum samples from individual human donors, including volunteer donors of Whole Blood, blood components, source plasma, and other living donors. This test is not intended for use on samples of cord blood.

The ORTHO® HCV Version 3.0 ELISA Test System is intended for use in a fully manual mode, in semi-automated mode using the ORTHO VERSEIA® Pipetter, or in automated mode with the ORTHO® Summit System (OSS).The Hepatitis C Virus Encoded Antigen (Recombinant c22-3, c200 and NS5) used in the manufacture of ORTHO® HCV Version 3.0 ELISA Test System is prepared under U.S. License by Novartis Vaccines and Diagnostics, Inc. under a shared manufacturing arrangement.

About Hepatitis C

Three recombinant hepatitis C virus encoded antigens are used in ORTHO® HCV Version 3.0 ELISA Test System. The three recombinant antigens, developed by Novartis Vaccines and Diagnostics, Inc., are c22-3, c200 and NS5. The use of HCV recombinant proteins derived from the core, NS3, NS4 and NS5 regions of the HCV genome has shown to be effective in identifying a greater number of diagnosed acute and chronic non-A, non-B hepatitis patients than single antigen (c100-3) assays.5,6 In addition, the use of these additional proteins allows for earlier detection of seroconversion following HCV infection. Although antibody responses to NS5 region-encoded antigens are not as prevalent in response to HCV infection as those to core and NS3 region-encoded antigens, the addition of NS5 to c22-3 and c200 recombinant proteins in ORTHO® HCV Version 3.0 ELISA Test System affords antibody detection to a greater number of HCV-encoded epitopes. 

Procedure

ORTHO® HCV Version 3.0 ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) which utilizes microwells coated with recombinant hepatitis C virus encoded antigens as the solid phase. ELISA technology utilizes the principle that antigens or antibodies which become bound to the solid phase can be detected by complementary antibody or antigen which is labeled with an enzyme capable of acting on a chromogenic substrate. When enzyme substrate is applied, the presence of antigen or antibody can be detected by the development of a colored end product. Test performed by Eurofins DPT,  6933 S. Revere Parkway, Centennial, CO 80112. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information.