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

Intended purpose

The Alinity i Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma, including specimens collected postmortem (non-heart beating) on the Alinity i analyzer.

Functional description

The Alinity i Anti-HCV Next assay is intended for the detection of antibodies to hepatitis C virus (HCV) in human serum and plasma samples, including specimens collected postmortem (non-beating heart). The assay uses chemiluminescent immunoassay method, which is a variation of the enzyme immunoassay (EIA) principle.