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

Intended purpose

The ARCHITECT Anti-HCV assay is intended to be used as an aid in the diagnosis of Hepatitis C infection and as a screening test to prevent transmission of Hepatitis C virus (HCV) to recipients of blood, blood components, cells, tissue and organs.

Functional description

The ARCHITECT Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) 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).