NAME AND INTENDED USE
The GS HIV-1/HIV-2 PLUS O EIA is an enzyme immunoassay utilizing recombinant proteins and synthetic peptides for the detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2 in human serum and plasma. It is indicated as a screening test for specimens from individual human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens from cadaveric (non- heartbeating) donors. In addition, it is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. The assay is not intended for use on cord blood specimens.
The GS HIV-1/HIV-2 PLUS O EIA is intended for manual use and also for use with the ORTHO® Summit System (OSS) in the screening of blood donors.
The GS HIV-1/HIV-2 PLUS O EIA is intended for manual use and also for use with the EVOLIS Automated Microplate System as an aid in the diagnosis of infection with HIV-1 and/or HIV-2.
WARNINGS FOR USERS
For In Vitro Diagnostic Use
WARNING: FDA has licensed this test for use with serum, plasma, and cadaveric serum specimens only. Use of this licensed test kit with specimens other than those specifically approved for use with this test kit may cause inaccurate test results.
Enzyme immunoassay utilizing recombinant proteins and synthetic peptides for the detection of antibodies to HIV-1 (groups M and O) and/or HIV-2. Ensures detection of all HIV groups and variants. Includes color changes during protocol steps and microplate strip identification. Kit allows for 960 tests.