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, plasma, and cadaveric 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. It is also intended for use to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) 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® Summit Sample Handling System (ORTHO® Summit Pipetter) and/or the ORTHO VERSEIA™ Pipetter, or in automated mode with the ORTHO® Summit System (OSS).
CAUTION: HANDLE AS IF CAPABLE OF TRANSMITTING INFECTIOUS AGENTS.
The Ortho® HCV Version 3.0 ELISA Test System uses three recombinant antigens developed by Chiron® Corporation to detect antibodies to hepatitis C virus (HCV) with excellent sensitivity and enhanced specificity (99.95 percent). These antigens (c22-3, c200 and NS5) cover 60 percent of the HCV genome, allowing broad detection of HCV antibodies. Early detection of HCV helps to eliminate potentially infectious units and improves the safety of the world’s blood supply.