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

Intended purpose

The Alinity s HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) used for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heart-beating), on the Alinity s System.

Functional description

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