Alinity i HIV Combo Next Assay - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

The Alinity i HIV Combo Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the simultaneous qualitative detection of human immunodeficiency virus type 1 (HIV-1) p24 antigen and antibodies to HIV-1 group M and O and/or type 2 (HIV-2) in human serum and plasma, including specimens collected postmortem up to 24 hours after death (non-heart beating) on the Alinity i analyzer. The assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection and as a screening test on blood donations and to prevent transmission of HIV-1 and HIV-2 to recipients of blood, blood components, cells, tissues, and organs and as a screening test on specimens collected post-mortem (non-heartbeating).