Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

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U.S. Food and Drug Administration

Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

January 9, 2006

Antibody to Hepatitis B Surface Antigen (HBsAg Assay)
Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Auszyme Monoclonal	EIA	Serum / Plasma / Cadaveric Serum	Donor Screen & Conf. Kit	Abbott Laboratories Abbott Park, IL US License 0043	4/1/1985
Genetic Systems HBsAg EIA 3.0	EIA	Serum / Plasma / Cadaveric Serum	Donor Screen & Conf. Kit	Bio-Rad Laboratories Redmond, WA 98052 US License 1109	1/23/2003
ORTHO Antibody to HBsAg ELISA Test System 3	EIA	Serum / Plasma	Donor Screen/Diagnosis & Conf. Kit	Ortho-Clinical Diagnostics, Inc. Raritan, NJ 08869 US License 1236	4/23/2003

Antibody to Human Immunodeficiency Virus (HIV-1 Antigen Assay)
Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
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
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	Diagnostic	Home Access Health Corp. Hoffman Estates, IL	7/22/1996

Hepatitis B Surface Antigen (Anti-HBs Assay)
Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Ausab	RIA	Serum / Plasma	Anti-HBs	Abbott Laboratories Abbott Park, IL US License 0043	2/5/1975
Ausab EIA	EIA	Serum / Plasma	Anti-HBs	Abbott Laboratories	11/18/1982

Hepatitis B Virus Core Antigen (Anti-HBc Assay)
Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Corzyme	EIA	Serum / Plasma	Donor Screen	Abbott Laboratories Abbott Park, IL US License 0043	3/19/1991
Ortho HBc ELISA Test System	EIA	Serum / Plasma	Donor Screen	Ortho-Clinical Diagnostics, Inc. Raritan, NJ US License 1236	4/18/1991
ABBOTT PRISM HBcore	Chemiluminescent Immunoassay (ChLIA)	Serum / Plasma	Donor Screen	Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 US License 0043	10/13/2005

Hepatitis C Virus Encoded Antigen (Anti-HCV Assay)
Tradename(s)	Format	Sample	Use	Manufacturer	Approval Date
Abbott HCV EIA 2.0	EIA	Serum / Plasma / Cadaveric Serum	Donor Screen	Abbott Laboratories Abbott Park, IL US License 0043	5/6/1992
Ortho HCV Version 3.0 ELISA Test System	EIA	Serum / Plasma	Donor Screen	Ortho-Clinical Diagnostics, Inc. Raritan, NJ US License 1236	5/20/1996
Chiron RIBA HCV 3.0 Strip Immunoblot Assay	SIA	Serum / Plasma	Donor Supplemental	Chiron Corporation Emeryville, CA US License 1106	2/11/1999

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 Durham, NC 27712	11/19/2001
COBAS Ampliscreen HIV-1 Test	PCR	Plasma	Donor Screen Expanded Indications For Use: Source Plasma donors, other living donors, and organ donors	Roche Molecular Systems, Inc Pleasanton, CA 94566-0990	12/20/2002
Procleix	HIV-1/HCV Nucleic Acid Test (TMA)	Plasma	Donor Screen Expanded Indications For Use: Source Plasma donors, living organ donors and cadaveric samples	Gen-Probe San Diego, CA 92121	2/8/2002
Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System	HIV-1 Genotyping	Plasma	Patient Monitoring	Visible Genetics, Inc 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 with the 3700 Genetic Analyzer	HIV-1 Genotyping	Plasma	Patient Monitoring	Celera Diagnostics Alameda, CA 94502	6/11/2003
Versant HIV-1 RNA 3.0 (bDNA)	Signal amplification nucleic acid probe	Plasma	Patient Monitoring	Bayer Corp Berkeley, CA 94702	9/11/2002
COBAS AmpliScreen HCV Test	PCR	Plasma	Donor Screen Expanded Indications For Use: Source Plasma donors, other living donors, and organ donors	Roche Molecular Systems, Inc Pleasanton, California 94566-0990	12/3/2002
COBAS AmpliScreen HBV Test	PCR	Plasma	Donor Screen Indications For Use: Source Plasma donors, other living donors, and organ donors	Roche Molecular Systems, Inc Pleasanton, California 94566-0990	4/21/2005
Procleix WNV Assay	Nucleic Acid Test (TMA)	Plasma	Qualitative detection of West Nile Virus (WNV) RNA from volunteer donors of whole blood and blood components, screen organ donors when obtained while donor?s heart is still beating, and test blood specimens to screen cadaveric donors	Gen-Probe San Diego, CA 92121	12/1/2005

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 Immunoassay	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 Durham, NC 27712 US License 1624	12/18/1987
Vironostika HIV-1 Plus O Microelisa System	EIA	Plasma / Serum / Dried Blood Spots	Diagnostic	bioMerieux, Inc 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 GmbH Vienna, Austria US License 1150	2/5/1992
HIVAB HIV-1 EIA	EIA	Dried Blood Spot	Diagnostic	Abbott Laboratories	4/22/1992
HIV-1 Urine EIA	EIA	Urine Screen	Diagnostic	Calypte Biomedical Corp	8/6/1996
Genetic Systems rLAV EIA	EIA	Dried Blood Spot	Diagnostic	Bio-Rad Laboratories Blood Virus Division	6/29/1998
Vironostika HIV-1 Microelisa System	EIA	Dried Blood Spot	Diagnostic	bioMerieux, Inc Durham, NC 27712	4/11/1990
Oral Fluid Vironostika HIV-1 Microelisa System	EIA	Oral Fluid	Diagnostic	bioMerieux, Inc Durham, NC 27712	12/23/1994
Cambridge Biotech HIV-1 Western Blot Kit	WB	Urine	Diagnostic Supplemental	Calypte Biomedical Corp	5/28/1998
Genetic Systems HIV-1 Western Blot	WB	Dried Blood Spot	Diagnostic Supplemental	Bio-Rad Laboratories Blood Virus Division	11/13/1998
OraSure HIV-1 Western Blot Kit	WB	Oral Fluid	Diagnostic Supplemental	Epitope, Inc	6/3/1996
Fluorognost HIV-1 IFA	IFA	Dried Blood Spot	Diagnostic Supplemental	Waldheim Pharmazeutika GmbH	5/14/1996
Reveal Rapid HIV-1 Antibody Test	Rapid Immunoassay	Serum / Plasma	Diagnostic	MedMira Laboratories, Inc Halifax, Nova Scotia Canada B3S 1B3	4/16/2003
Uni-Gold Recombigen HIV	Rapid Immunoassay	Serum / Plasma / Whole Blood (venipuncture and fingerstick)	Diagnostic	Trinity Biotech, plc Bray Co., Wicklow Ireland	12/23/2003

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 / Cadaveric Serum	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 / Cadaveric Serum	Donor Screen	Bio-Rad Laboratories Inc Redmond, WA US License 1109	8/5/2003
Multispot HIV-1/HIV-2 Rapid Test	Rapid Immunoassay	Plasma / Serum	Diagnostic	Bio-Rad Laboratories Redmond, WA	11/12/2004
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test	Rapid Immunoassay	Whole Blood, Plasma, Oral Fluid	Diagnostic	OraSure Technologies Bethlehem, PA 18015-1360	6/22/2004

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	bioMerieux, Inc Durham, NC 27712 US License 1624	1/17/1998

This article was provided by U.S. Food and Drug Administration.

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