Alinity i HIV Ag/Ab Combo - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

The Alinity i HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) used for the simultaneous qualitative detection of HIV p24 antigen and antibodies to human immunodeficiency virus type 1 and/or type 2 (HIV-1/HIV-2) in human serum or plasma including specimens collected post mortem (non-heartbeating) on the Alinity i analyzer. Performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.

Functional description

This assay is a two-step immunoassay for the qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O), and HIV-2 in human serum or plasma using chemiluminescent microparticle immunoassay (CMIA) technology.