FDA-Approved Tests for HIV

FDA- Approved Tests for HIV

Antibody to Human Immunodeficiency Virus (HIV-1 Antigen Assay)

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Abbott HIVAG-1 Monoclonal	EIA	Serum / Plasma	Donor Screen / Prognosis & Neut. Kit	Abbott Laboratories Abbott Park, IL US License 0043	4/23/1996
Coulter HIV-1 p24 Ag Assay; HIV-1 p24 Antigen ELISA Test System	EIA	Serum / Plasma	Donor Screen / Prognosis & Neut. Kit	Coulter Corporation Miami, FL US License 1185	3/14/1996
Abbott HIVAG-1	EIA	Serum / Plasma	Prognosis & Neut. Kit	Abbott Laboratories	8/3/1989
Coulter HIV-1 p24 Ag Assay	EIA	Viral Culture Supernatant	Prognosis (Quantitative) & Neut. Kit	Coulter Corporation	3/14/1996

Anti-HIV-1 Oral Specimen Collection Device

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Epitope OraSure HIV-1 Oral Specimen Collection Device	Oral Specimen Collection Device	Oral Fluid	For Use in Designated Non-Donor Screen and Non-Donor Supplemental Assays	Epitope, Inc. Beaverton, OR	5/9/1991

Anti-HIV-1 Testing Service

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Home Access HIV-1 Test System	Dried Blood Spot Collection Device	Dried Blood Spot	Non-Donor Screen	Home Access Health Corp. Hoffman Estates, IL	7/22/1996

Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
HIVAB HIV-1 EIA	EIA	Serum / Plasma	Donor Screen	Abbott Laboratories Abbott Park, IL US License 0043	3/1/1985
Genetic Systems rLAV EIA	EIA	Serum / Plasma	Donor Screen	Bio-Rad Laboratories Blood Virus Division Redmond, WA US License 1109	6/29/1998
Murex SUDS HIV-1 Test	Rapid EIA	Serum / Plasma	Donor Screen	Murex Diagnostics, Inc. Norcross, GA US License 1152	5/22/1992
Vironostika HIV-1 Microelisa System	EIA	Serum / Plasma	Donor Screen	Organon Teknika Corp. Durham, NC US License 0956	12/18/1987
Novapath HIV-1 Immunoblot	WB	Serum / Plasma	Donor Supplemental	Bio-Rad Laboratories Hercules, CA US License 1109	6/15/1990
Cambridge Biotech HIV-1 Western Blot Kit	WB	Serum / Plasma	Donor Supplemental	Calypte Biomedical Corp. Berkeley, CA US License 1207	1/3/1991
Genetic Systems HIV-1 Western Blot	WB	Serum / Plasma	Donor Supplemental	Bio-Rad Laboratories Blood Virus Division	11/13/1998
EPIblot HIV-1	WB	Serum / Plasma	Donor Supplemental	Epitope, Inc. Beaverton, OR US License 1133	3/20/1991
Fluorognost HIV-1 IFA	IFA	Serum / Plasma	Donor Supplemental	Waldheim Pharmazeutika G.m.b.H. Vienna, Austria US License 1150	2/5/1992
HIVAB HIV-1 EIA	EIA	Dried Blood Spot	Non-Donor Screen	Abbott Laboratories	4/22/1992
HIV-1 Urine EIA	EIA	Urine Screen	Non-Donor Screen	Calypte Biomedical Corp.	8/6/1996
Genetic Systems rLAV EIA	EIA	Dried Blood Spot	Non-Donor Screen	Bio-Rad Laboratories Blood Virus Division	6/29/1998
Vironostika HIV-1 Microelisa System	EIA	Dried Blood Spot	Non-Donor Screen	Organon Teknika Corp.	4/11/1990
Oral Fluid Vironostika HIV-1 Microelisa System	EIA	Oral Fluid	Non-Donor Screen	Organon Teknika Corp.	12/23/1994
Cambridge Biotech HIV-1 Western Blot Kit	WB	Urine	Non-Donor Supplemental	Calypte Biomedical Corp.	5/28/1998
Genetic Systems HIV-1 Western Blot	WB	Dried Blood Spot	Non-Donor Supplemental	Bio-Rad Laboratories Blood Virus Division	11/13/1998
OraSure HIV-1 Western Blot Kit	WB	Oral Fluid	Non-Donor Supplemental	Epitope, Inc.	6/3/1996
Fluorognost HIV-1 IFA	IFA	Dried Blood Spot	Non-Donor Supplemental	Waldheim Pharmazeutika G.m.b.H.	5/14/1996

Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA	EIA	Serum / Plasma	Donor Screen	Abbott Laboratories Abbott Park, IL US License 0043	2/14/1992
Genetic Systems HIV-1/HIV-2 Peptide EIA	EIA	Serum / Plasma / Cadaveric Serum	Donor Screen	Bio-Rad Laboratories Blood Virus Division Redmond, WA US License 1109	12/9/2000

Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Genetic Systems HIV-2 EIA	EIA	Serum / Plasma	Donor Screen	Bio-Rad Laboratories Blood Virus Division Redmond, WA US License 1109	4/25/1990

Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay)

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Abbott HTLV-I/HTLV-II EIA	EIA	Serum / Plasma	Donor Screen	Abbott Laboratories Abbott Park, IL US License 0043	8/15/1997
Vironostika HTLV-I/II Microelisa System	EIA	Serum / Plasma	Donor Screen	Organon Teknika Corp. Durham, NC US License 0956	1/17/1998

Source
US Food and Drug Administration (FDA)

Return to HIV/AIDS
Main Page