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Licensed / Approved HIV, HTLV and Hepatitis Tests
Antibody to Hepatitis B Surface Antigen (HBsAg Assay)
| Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
| Auszyme Monoclonal |
EIA |
Serum / Plasma |
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 Corp |
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 |
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 |
Hepatitis C Virus Encoded Antigen (Anti-HCV Assay)
| Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
| Abbott HCV EIA 2.0 |
EIA |
Serum / Plasma |
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 Corp
Emeryville, CA
US License 1106 |
2/11/1999 |
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
Durham, NC 27712 |
11/19/2001 |
| COBAS Ampliscreen HIV-1 Test |
PCR |
Plasma |
Donor Screen |
Roche Molecular Systems, Inc
Pleasanton, CA 94566-0990 |
12/20/2002 |
| Procleix |
HIV-1/HCV Nucleic Acid Test (TMA) |
Plasma |
Donor Screen |
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 |
Detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, such as an aid in monitoring and treating HIV infection |
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 |
Roche Molecular Systems, Inc
Pleasanton, California 94566-0990 |
12/3/2002 |
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 |
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, Non-Donor Screen |
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 |
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
Durham, NC 27712 |
4/11/1990 |
| Oral Fluid Vironostika HIV-1 Microelisa System |
EIA |
Oral Fluid |
Non-Donor Screen |
bioMerieux, Inc
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 GmbH |
5/14/1996 |
| OraQuick Rapid HIV-1 Antibody Test |
Rapid EIA |
Fingerstick |
Non-Donor Screen |
OraSure Technologies, Inc
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 |
| Uni-Gold Recombigen HIV |
Rapid Immunoassay |
Serum / Plasma / Whole Blood |
Non-Donor Screen |
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 |
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
Hercules, CA
US License 1109 |
8/5/2003 |
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 |
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