Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
From U.S. Food and Drug Administration
March 17, 2008
| 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 |
| GS HBsAg EIA 3.0
|
EIA |
Serum / Plasma / Cadaveric Serum |
Donor Screen & Conf. Kit |
Bio-Rad Laboratories
Redmond, WA
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
US License 1236 |
4/23/2003 |
ABBOTT PRISM HBsAg
ABBOTT PRISM HBsAg Confirmatory |
Chemiluminescent Immunoassay (ChLIA) |
Serum / Plasma |
Donor screening test to detect HBsAg. Also for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and intesting blood specimens to screen cadaveric (non-heart-beating) donors. |
Abbott Laboratories
Abbott Park, IL
US License 0043 |
7/18/2006 |
| Anti-HIV-1 Oral Specimen Collection Device |
| Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
| OraSure HIV-1 Oral Specimen Collection Device |
Oral Specimen Collection Device |
Oral Fluid |
For Use with HIV diagnostic assays that have been approved for use with this device. |
OraSure Technologies
Bethlehem, PA |
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 EIA |
EIA |
Serum / Plasma |
Anti-HBs |
Abbott Laboratories
Abbott Park, IL
US License 0043 |
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 |
| Abbott PRISM HCV |
Chemiluminescent Immunoassay (ChLIA)
|
Serum / Plasma |
Donor screening test for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens. Also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. |
Abbott Laboratories
Abbott Park, IL
US License 0043 |
7/11/2007 |
| 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
Pleasanton, CA
|
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
US License 1636
|
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
US License 1592 |
6/4/2004 |
| Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System |
HIV-1 Genotyping |
Plasma |
Patient Monitoring |
Siemens Medical Solutions Diagnostics
Berkeley, 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 |
Siemens Medical Solutions Diagnostics
Berkeley, CA |
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, CA
US License 1636 |
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, CA
US License 1636
|
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
US License 1592
|
12/1/2005 |
| Procleix Ultrio |
Nucleic Acid Test (TMA) |
Plasma and Serum |
Qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) 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
US License 1592 |
10/3/2006 |
| Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay |
PCR |
Plasma |
Qualitative detection of HCV ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. |
BioLife Plasma Services, L.P.
Deerfield, IL
US License 1640 |
2/9/2007 |
| Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay |
PCR |
Plasma |
Qualitative detection of HIV-1 ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. |
BioLife Plasma Services, L.P.
Deerfield, IL
US License 1640 |
1/31/2007 |
| Abbott RealTime HIV-1 Amplification Kit |
PCR |
Plasma |
Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System. Not intended to be used as a donor screening test. |
ABBOTT Molecular, Inc
Des Plaines, IL |
5/11/2007 |
| COBAS AmpliPrep/COBAS TaqMan HIV-1 Test |
PCR |
Plasma |
Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid. Not intended to be used as a donor screening test. |
Roche Molecular Systems, Inc
Pleasanton, CA |
5/11/2007 |
| Cobas TaqScreen West Nile Virus Test |
PCR |
Plasma |
For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. Also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. |
Roche Molecular Systems, Inc
Pleasanton, CA
US License 1636 |
8/28/2007 |
| Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay) |
| Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
| GS rLAV EIA |
EIA |
Serum / Plasma |
Donor Screen |
Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109 |
6/29/1998 |
| Cambridge Biotech HIV-1 Western Blot Kit |
WB |
Serum / Plasma |
Donor Supplemental |
Calypte Biomedical Corp
Berkeley, CA
US License 1207 |
1/3/1991 |
| GS HIV-1 Western Blot |
WB |
Serum / Plasma |
Donor Supplemental |
Bio-Rad Laboratories
Redmond, WA
US License 1109 |
11/13/1998 |
| Fluorognost HIV-1 IFA |
IFA |
Plasma / Serum |
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 |
| GS rLAV EIA |
EIA |
Dried Blood Spot |
Diagnostic |
Bio-Rad Laboratories
Redmond, WA |
6/29/1998 |
| Cambridge Biotech HIV-1 Western Blot Kit |
WB |
Urine |
Diagnostic Supplemental |
Maxim Biomedical, Inc |
5/28/1998 |
| GS HIV-1 Western Blot |
WB |
Dried Blood Spot |
Diagnostic Supplemental |
Bio-Rad Laboratories
Redmond, WA |
11/13/1998 |
| OraSure HIV-1 Western Blot Kit |
WB |
Oral Fluid |
Diagnostic Supplemental |
OraSure Technologies
Bethlehem, PA |
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 |
| GS HIV-1/HIV-2 Plus O EIA |
EIA |
Serum / Plasma / Cadaveric Serum |
Donor Screen |
Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109 |
8/5/2003 |
| Multispot HIV-1/HIV-2 Rapid Test |
Rapid Immunoassay |
Serum / Plasma |
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 |
6/22/2004 |
| ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents |
Microparticle Chemiluminometric Immunoassay |
Plasma/Serum |
Diagnostic for qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasma |
Siemens Medical Solutions Diagnostics
Tarrytown, NY |
5/18/2006 |
HIV 1/2 STAT-PAK ASSAY
SURE CHECK HIV 1/2 ASSAY
|
Rapid Immunoassay |
Fingerstick & venous whole blood, serum, plasma |
Diagnostic |
Chembio Diagnostic Systems, Inc
Medford, NY |
5/25/2006 |
| 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 |
| ABBOTT PRISM HTLV-I/HTLV-II |
Chemiluminescent Immunoassay (ChLIA) |
Serum / Plasma |
To be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating. |
Abbott Laboratories
Abbott Park, IL
US License 0043 |
1/16/2008 |
| Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay) |
| Tradename(s) |
Format |
Sample |
Use |
Manufacturer |
Approval Date |
| ORTHO T. cruzi ELISA Test System |
EIA |
Serum / Plasma |
Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors. Also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating |
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236 |
12/13/2006 |
|
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