ARCHITECT HIV Ag/Ab Combo assay - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Intended purpose

The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) 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-heart-beating) on the ARCHITECT analyser. 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

For the qualitative detection of HIV p24 antigen and antibodies to human immunodeficiency virus type 1 and/or type 2 (HIV-1/HIV-2) in clinical specimens.