Licensed/Approved HIV Tests

Anti-HIV-1 Assays

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	bioMerieux, Inc. 100 Rodolphe Street Durham, NC 27712 US License 1624	12/18/1987
Vironostika HIV-1 Plus O Microelisa System	EIA	Plasma / Serum / Dried Blood Spots	Diagnostic, Non-Donor Screen	bioMerieux, Inc. 100 Rodolphe Street Durham, NC 27712 US License 1624	6/6/2003
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
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	bioMerieux, Inc. 100 Rodolphe Street Durham, NC 27712	4/11/1990
Oral Fluid Vironostika HIV-1 Microelisa System	EIA	Oral Fluid	Non-Donor Screen	bioMerieux, Inc. 100 Rodolphe Street Durham, NC 27712	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
OraQuick Rapid HIV-1 Antibody Test	Rapid EIA	Fingerstick	Non-Donor Screen	OraSure Technologies, Inc. 150 Webster Street Bethlehem, PA 18015-1389	11/7/2002
Reveal Rapid HIV-1 Antibody Test	Rapid Immunoassay	Serum / Plasma	Non-Donor Screen	MedMira Laboratories, Inc. Halifax, Nova Scotia Canada B3S 1B3	4/16/2003

Anti-HIV-1/2 Assays

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
Genetic Systems HIV-1/HIV-2 PLUS O EIA	EIA	Serum/Plasma	Donor Screen	Bio-Rad Laboratories, Inc 4000 Alfred Nobel Drive Hercules, CA 94547 License 1109	8/5/2003

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

HIV-1 Antigen Assays

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	12/23/1994

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

HIV-1 /HCV Nucleic Acid Testing

Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Roche Amplicor HIV-1 Monitor Test	PCR	Plasma	Prognosis / Patient Management HIV-1 Viral Load Assay	Roche Molecular Systems, Inc. Branchburg Township, NJ	3/2/1999
NucliSens HIV-1 QT	NASBA	Plasma	Prognosis / Patient Management HIV-1 Viral Load Assay	bioMerieux, Inc. 100 Rodolphe Street Durham, NC 27712	11/19/2001
COBAS Ampliscreen HIV-1 Test	PCR	Plasma	Donor Screen	Roche Molecular Systems, Inc 4300 Hacienda Drive Pleasanton, CA 94566	12/20/2002
Procleix	HIV-1/HCV Nucleic Acid Test (TMA)	Plasma	Donor Screen	Gen-Probe 10210 Genetic Center Dr San Diego, CA 92121	2/8/2002
Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing	HIV-1 Genotyping	Plasma	Patient Monitoring	Visible Genetics, Inc. 700 Bay Street , Suite 1000 Toronto, CA	4/24/2002
UltraQual HIV-1 RT-PCR Assay	PCR	Plasma	Donor Screen	National Genetics Institute Los Angeles, CA 92121	9/18/2001
UltraQual HCV RT-PCR Assay	PCR	Plasma	Donor Screen	National Genetics Institute Los Angeles, CA 92121	9/18/2001
ViroSeq HIV-1 Genotyping System	HIV-1 Genotyping	Plasma	Patient Monitoring	Applied Biosystems Foster City, CA 94404	12/10/2002
Versant HIV-1 RNA 3.0 (bDNA)	Signal amplification nucleic acid probe	Plasma	Patient Monitoring	Bayer Corporation Berkeley, CA 94702	9/11/2002
COBAS AmpliScreen HCV Test	PCR	Plasma	Donor Screen	Roche Molecular Systems, Inc 4300 Hacienda Drive Pleasanton, California 94566-0990	12/3/2002