Device Dossier
Alinity s Anti-HCV II Assay - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Device Dossier for Alinity s Anti-HCV II Assay - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay (Hepatitis C virus total antibody IVD,…
Intended purpose
The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma, including specimens collected postmortem (non-heart-beating) that have been collected up to 24 hours after death, on the Alinity s System.
Functional description
This assay is an automated one-step immunoassay for the qualitative detection of anti-HCV in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.