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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
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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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