GS HIV Combo Ag/Ab EIA

INTENDED USE

The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay kit for the simultaneous qualitative detection of Human Immuno- deficiency Virus (HIV) p24 antigen and antibodies to HIV Type 1 (HIV-1 Groups M and O) and HIV Type 2 (HIV-2) in human serum or plasma. This kit is intended as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (i.e, children as young as 2 years of age). The GS HIV Combo Ag/Ab EIA is intended for manual use and for use with the Bio-Rad EVOLIS and Elite Automated Microplate Systems.

Results from the GS HIV Combo Ag/Ab EIA cannot be used to distinguish between the presence of HIV-1 p24 antigen, HIV-1 antibody, or HIV-2 antibody in a sample.

The GS HIV Combo Ag/Ab EIA is not intended for routine use in screening blood or plasma donors, as the effectiveness of this test for use in the screening of these donors has not been established. However, in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical, this assay can be used as a blood donor screening assay.

WARNINGS FOR USERS

For In Vitro Diagnostic Use

Warning: FDA has approved this test for use with serum and plasma specimens only. Use of this test kit with specimens other than those specifically approved for use with this test kit may result in inaccurate test results.

This test is not intended for use in children younger than 2 years of age.

PRODUCT DESCRIPTION

The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay kit for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV Type 1 (HIV-1 groups M and O) and HIV Type 2 (HIV-2) in human serum and plasma. This kit is intended as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. This assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (ie. children as young as 2 years of age). The GS HIV Combo Ag/Ab EIA is intended for manual use and with the Bio-Rad EVOLIS Automated Microplate System and Elite System.