Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Antibody to Hepatitis B Surface Antigen (HBsAg Assay)
Tradename(s)FormatSampleUseManufacturerApproval Date
Auszyme MonoclonalEIASerum / Plasma / Cadaveric SerumDonor Screen & Conf. KitAbbott Laboratories
Abbott Park, IL
US License 0043
4/1/1985
GS HBsAg EIA 3.0EIASerum / Plasma / Cadaveric SerumDonor Screen & Conf. KitBio-Rad Laboratories
Redmond, WA
US License 1109
1/23/2003
ORTHO Antibody to HBsAg ELISA Test System 3EIASerum / PlasmaDonor Screen/Diagnosis & Conf. KitOrtho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
4/23/2003
ABBOTT PRISM HBsAg
ABBOTT PRISM HBsAg Confirmatory
Chemiluminescent Immunoassay (ChLIA)Serum / PlasmaDonor 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)FormatSampleUseManufacturerApproval Date
OraSure HIV-1 Oral Specimen Collection DeviceOral Specimen Collection DeviceOral FluidFor 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)FormatSampleUseManufacturerApproval Date
Home Access HIV-1 Test SystemDried Blood Spot Collection DeviceDried Blood SpotDiagnosticHome Access Health Corp.
Hoffman Estates, IL
7/22/1996
Hepatitis B Surface Antigen (Anti-HBs Assay)
Tradename(s)FormatSampleUseManufacturerApproval Date
Ausab EIAEIASerum / PlasmaAnti-HBsAbbott Laboratories
Abbott Park, IL
US License 0043
11/18/1982
Hepatitis B Virus Core Antigen (Anti-HBc Assay)
Tradename(s)FormatSampleUseManufacturerApproval Date
CORZYMEEIASerum / PlasmaDonor ScreenAbbott Laboratories
Abbott Park, IL
US License 0043
3/19/1991
Ortho HBc ELISA Test SystemEIASerum / PlasmaDonor ScreenOrtho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
4/18/1991
ABBOTT PRISM HBcoreChemiluminescent Immunoassay (ChLIA)Serum / PlasmaDonor ScreenAbbott 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)FormatSampleUseManufacturerApproval Date
Abbott HCV EIA 2.0EIASerum / Plasma / Cadaveric SerumDonor ScreenAbbott Laboratories
Abbott Park, IL
US License 0043
5/6/1992
Ortho HCV Version 3.0 ELISA Test SystemEIASerum / PlasmaDonor ScreenOrtho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
5/20/1996
Chiron RIBA HCV 3.0 Strip Immunoblot AssaySIASerum / PlasmaDonor SupplementalChiron Corporation
Emeryville, CA
US License 1106
2/11/1999
Abbott PRISM HCVChemiluminescent Immunoassay (ChLIA)Serum / PlasmaDonor 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)FormatSampleUseManufacturerApproval Date
Roche Amplicor HIV-1 Monitor TestPCRPlasmaPrognosis / Patient Management
HIV-1 Viral Load Assay
Roche Molecular Systems, Inc
Pleasanton, CA
3/2/1999
NucliSens HIV-1 QTNASBAPlasmaPrognosis / Patient Management
HIV-1 Viral Load Assay
bioMerieux, Inc
Durham, NC 27712
11/19/2001
COBAS Ampliscreen HIV-1 TestPCRPlasmaDonor 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
ProcleixHIV-1/HCV Nucleic Acid Test (TMA)PlasmaDonor 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 SystemHIV-1 GenotypingPlasmaPatient MonitoringSiemens Medical Solutions Diagnostics
Berkeley, CA
4/24/2002
UltraQual HIV-1 RT-PCR AssayPCRPlasmaDonor ScreenNational Genetics Institute
Los Angeles, CA 92121
9/18/2001
UltraQual HCV RT-PCR AssayPCRPlasmaDonor ScreenNational Genetics Institute
Los Angeles, CA 92121
9/18/2001
ViroSeq HIV-1 Genotyping System with the 3700 Genetic AnalyzerHIV-1 GenotypingPlasmaPatient MonitoringCelera Diagnostics
Alameda, CA 94502
6/11/2003
Versant HIV-1 RNA 3.0 (bDNA)Signal amplification nucleic acid probePlasmaPatient MonitoringSiemens Medical Solutions Diagnostics
Berkeley, CA
9/11/2002
COBAS AmpliScreen HCV TestPCRPlasmaDonor 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 TestPCRPlasmaDonor 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 AssayNucleic Acid Test (TMA)PlasmaQualitative 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 UltrioNucleic Acid Test (TMA)Plasma and SerumQualitative 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) assayPCRPlasmaQualitative 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) assayPCRPlasmaQualitative 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 KitPCRPlasmaQuantitation 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 TestPCRPlasmaQuantitation 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 TestPCRPlasmaFor 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)FormatSampleUseManufacturerApproval Date
GS rLAV EIAEIASerum / PlasmaDonor ScreenBio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109
6/29/1998
Cambridge Biotech HIV-1 Western Blot KitWBSerum / PlasmaDonor SupplementalCalypte Biomedical Corp
Berkeley, CA
US License 1207
1/3/1991
GS HIV-1 Western BlotWBSerum / PlasmaDonor SupplementalBio-Rad Laboratories
Redmond, WA
US License 1109
11/13/1998
Fluorognost HIV-1 IFAIFAPlasma / SerumDonor SupplementalWaldheim Pharmazeutika GmbH
Vienna, Austria
US License 1150
2/5/1992
HIVAB HIV-1 EIAEIADried Blood SpotDiagnosticAbbott Laboratories4/22/1992
HIV-1 Urine EIAEIAUrine ScreenDiagnosticCalypte Biomedical Corp8/6/1996
GS rLAV EIAEIADried Blood SpotDiagnosticBio-Rad Laboratories
Redmond, WA
6/29/1998
Cambridge Biotech HIV-1 Western Blot KitWBUrineDiagnostic SupplementalMaxim Biomedical, Inc5/28/1998
GS HIV-1 Western BlotWBDried Blood SpotDiagnostic SupplementalBio-Rad Laboratories
Redmond, WA
11/13/1998
OraSure HIV-1 Western Blot KitWBOral FluidDiagnostic SupplementalOraSure Technologies
Bethlehem, PA
6/3/1996
Fluorognost HIV-1 IFAIFADried Blood SpotDiagnostic SupplementalWaldheim Pharmazeutika GmbH5/14/1996
Reveal Rapid HIV-1 Antibody TestRapid ImmunoassaySerum / PlasmaDiagnosticMedMira Laboratories, Inc
Halifax, Nova Scotia
Canada B3S 1B3
4/16/2003
Uni-Gold Recombigen HIVRapid ImmunoassaySerum / Plasma / Whole Blood (venipuncture and fingerstick)DiagnosticTrinity Biotech, plc
Bray Co., Wicklow
Ireland
12/23/2003
Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)
Tradename(s)FormatSampleUseManufacturerApproval Date
Abbott HIVAB HIV-1/HIV-2 (rDNA) EIAEIASerum / Plasma / Cadaveric SerumDonor ScreenAbbott Laboratories
Abbott Park, IL
US License 0043
2/14/1992
GS HIV-1/HIV-2 Plus O EIAEIASerum / Plasma / Cadaveric SerumDonor ScreenBio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109
8/5/2003
Multispot HIV-1/HIV-2 Rapid TestRapid ImmunoassaySerum / PlasmaDiagnosticBio-Rad Laboratories
Redmond, WA
11/12/2004
OraQuick ADVANCE Rapid HIV-1/2 Antibody TestRapid ImmunoassayWhole Blood, Plasma, Oral FluidDiagnosticOraSure Technologies
Bethlehem, PA
6/22/2004
ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack ReagentsMicroparticle Chemiluminometric ImmunoassayPlasma/SerumDiagnostic for qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasmaSiemens Medical Solutions Diagnostics
Tarrytown, NY
5/18/2006
HIV 1/2 STAT-PAK ASSAY
SURE CHECK HIV 1/2 ASSAY
Rapid ImmunoassayFingerstick & venous whole blood, serum, plasmaDiagnosticChembio Diagnostic Systems, Inc
Medford, NY
5/25/2006
Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)
Tradename(s)FormatSampleUseManufacturerApproval Date
Genetic Systems HIV-2 EIAEIASerum / PlasmaDonor ScreenBio-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)FormatSampleUseManufacturerApproval Date
Abbott HTLV-I/HTLV-II EIAEIASerum / PlasmaDonor ScreenAbbott Laboratories
Abbott Park, IL
US License 0043
8/15/1997
ABBOTT PRISM HTLV-I/HTLV-IIChemiluminescent Immunoassay (ChLIA)Serum / PlasmaTo 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)FormatSampleUseManufacturerApproval Date
ORTHO T. cruzi ELISA Test SystemEIASerum / PlasmaDonor 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 beatingOrtho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236
12/13/2006