Device Dossier

Hepatitis C virus total antibody test for dried blood spot (Abbott Alinity i Anti-HCV) - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Device Dossier for Hepatitis C virus total antibody test for dried blood spot (Abbott Alinity i Anti-HCV) - Hepatitis C virus total antibody IVD, kit,…

Intended purpose

Alinity i Anti-HCV DBS, performed on the Abbott Alinity i analyzer by a trained laboratory operator, is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibody to Hepatitis C virus (anti-HCV) in human dried blood spot (DBS) specimens.

Functional description

The Alinity i Anti-HCV DBS assay enables the detection of antibodies to hepatitis C virus (HCV) in dried blood spots (DBS). Chemiluminescent microparticle immunoassays (CMIA) are a variation of the enzyme immunoassay (EIA) principle. The assay requires the use of a positive and a negative control.

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