Alinity i Anti-HCV Assay - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Intended purpose

The Alinity i Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibody to Hepatitis C virus (anti-HCV) in human serum and plasma, including specimens collected post mortem (non-heart beating) on the Alinity i analyzer. Performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heartbeating) that have been collected up to 24 hours after death.

Functional description

The Alinity i Anti-HCV assay is for the detection of antibodies to hepatitis C virus (HCV). Chemiluminescent immunoassays are a variation of the enzyme immunoassay (EIA) principle.