Proper Name: Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen, Antibody (p24) and Synthetic PeptideB megaterium, Recombinant) Antigen, Antibody (p24) and Synthetic Peptides
Tradename: Alinity s HIV Ag/Ab Combo assay
Manufacturer: Abbott Laboratories
- 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 specimens on the Alinity s System.
- The Alinity s HIV Ag/Ab Combo assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HIV-1/HIV-2 and HIV-1 p24 antigen. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.
- September 11, 2020 Approval Letter - Alinity s HIV Ag/Ab Combo assay
- July 23, 2019 Approval Letter - Alinity s HIV Ag/Ab Combo assay
- July 22, 2019 Summary Basis for Regulatory Action - Alinity s HIV Ag/Ab Combo assay