Vaccines, Blood & Biologics

Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

HBV
HBsAg Assays - Hepatitis B Surface Antigen
Anti-HBc Assays - Hepatitis B Virus Core Antigen
HBV Nucleic Acid Assays - Hepatitis B Virus

HCV
Anti-HCV Assays - Hepatitis C Virus Encoded Antigen
HCV Nucleic Acid Assays - Hepatitis C Virus

HIV
Anti-HIV-1 Assays - Human Immunodeficiency Virus Type 1
HIV-1 Nucleic Acid Assays - Human Immunodeficiency Virus Type 1
Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits
Anti-HIV-2 Assays - Human Immunodeficiency Virus Type 2
Anti-HIV-1/2 Assays - Human Immunodeficiency Virus Types 1 and 2
Anti-HIV-1/2 and HIV-1 Antigen Combo Assays

HTLV
Anti-HTLV-I/II Assays - Human T-Lymphotropic Virus Types I and II

T. pallidum
Anti-T. Pallidum Assays - Treponema pallidum (Syphilis)
T. cruzi
Anti- T. cruzi Assays - Trypanosoma cruzi (T. cruzi)
WNV
WNV Nucleic Acid Assays - West Nile Virus
CMV
Anti-CMV Assays - Cytomegalovirus

Multiplex
Multiplex Assays

Return to the Infectious Disease Tests page


HBsAg Assays (detect Hepatitis B Surface Antigen)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg ConfirmatoryHBVChLIA

 

ChLIA - specific antibody neutralization

Serum/ Plasma/ Cadaveric SerumDonor Screening: Qualitative detection of HBsAg.
Confirmatory: To confirm the presence of HBsAg in samples found to be repeatedly reactive by the ABBOTT PRISM HBsAg assay.
Abbott Laboratories
Abbott Park, IL
US License 0043
7/18/2006BL103766
Genetic Systems HBsAg EIA 3.0;
Genetic Systems HBsAg Confirmatory Assay 3.0
HBVEIASerum / Plasma / Cadaveric SerumIn Vitro Diagnostic,
Donor Screening: Qualitative detection of HBsAg.
Confirmatory: To confirm the presence of HBsAg in reactive specimens.
Bio-Rad Laboratories
Redmond, WA
US License 1109
1/23/2003BL103590

Anti-HBc Assays (detect antibodies to Hepatitis B Virus Core Antigen)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
ORTHO HBc ELISA Test SystemHBVELISASerum / PlasmaIn Vitro Diagnostic,
Donor screening: Qualitative detection of total antibody to hepatitis B core antigen.
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
4/23/1998BL103062
ABBOTT PRISM HBcoreHBVChLIASerum / PlasmaDonor Screening: Qualitative detection of total antibody to hepatitis B core antigenAbbott Laboratories
Abbott Park, IL
US License 0043
10/13/2005BL103785

HBV Nucleic Acid Assays (detect Hepatitis B Virus DNA),see also Multiplex Assays
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
UltraQual™ HBV PCR AssayHBVPCRPlasmaSource Plasma Donor Screening: Qualitative detection of HBV DNA. For in-house use only at NGI.National Genetics Institute Los Angeles, CA US License 15829/1/2011BL125193
COBAS AmpliScreen HBV TestHBVPCRPlasma/ cadaveric serum or plasmaDonor Screening: Qualitative detection of HBV DNA.Roche Molecular Systems, Inc
Pleasanton, CA
US License 1636
4/21/2005BL125090

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Anti-HCV Assays (detect antibodies to Hepatitis C Virus Encoded Antigen)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Abbott PRISM HCVHCVChLIASerum / Plasma/ Cadaveric serumDonor screening: Qualitative detection of antibodies to hepatitis C virus.Abbott Laboratories
Abbott Park, IL
US License 0043
7/11/2007BL103762
Ortho HCV Version 3.0 ELISA Test SystemHCVEIASerum / PlasmaDonor Screening: Qualitative detection of antibodies to hepatitis C virus.Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236
4/23/1998
2/18/2009
BL103065

HCV Nucleic Acid Assays (detect Hepatitis C Virus RNA), see also Multiplex Assays
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Hepatitis C Virus RT PCR AssayHCVPCRPlasmaSource Plasma Donor Screening: Qualitative detection of HCV RNA. For in house use only by Baxter Healthcare International.BioLife Plasma Services, L.P.
Deerfield, IL
US License 1640
2/9/2007BL125101
UltraQual HCV RT-PCR AssayHCVPCRPlasmaSource Plasma Donor Screening: Qualitative detection of HCV RNA. For in house use only at NGI.National Genetics Institute
Los Angeles, CA
US License 1582
9/18/2001BL103868
COBAS AmpliScreen HCV Test, ver 2.0HCVPCRPlasma/ Cadaveric serum or plasmaDonor Screening: Qualitative detection of HCV RNA.
Donor Supplemental: To confirm HCV infection for specimens that are repeatedly reactive on a licensed donor screening test for antibodies to HCV, and reactive on the COBAS® AmpliScreen HCV Test, v2.0.
Roche Molecular Systems, Inc
Pleasanton, CA
US License 1636
12/3/2002BL125045

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Anti-HIV-1 Assays (detect antibodies to Human Immunodeficiency Virus type 1)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Fluorognost HIV-1 IFAHIV-1IFASerum / Plasma
Dried Blood Spot
Diagnostic and Donor Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures.
Donor Screening: Only in special cases.
Sanochemia Pharmazeutika AG
Vienna, Austria
US License 1631
2/5/1992
5/14/1996
BL103288
BL103651
Cambridge Biotech HIV-1 Western Blot KitHIV-1WBSerum / PlasmaDiagnostic and Donor Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures.Maxim Biomedical, Inc.
Rockville, MD
US License 1741
5/28/1998BL103843
GS HIV-1 Western BlotHIV-1WBSerum / Plasma
Dried Blood Spot
Diagnostic and Donor Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures.Bio-Rad Laboratories
Redmond, WA
US License 1109
11/13/1998BL103655
Avioq HIV-1 Microelisa SystemHIV-1EIASerum, Plasma, Dried Blood Spot, Oral FluidIn Vitro Diagnostic: Qualitative detection of antibodies to HIV-1.Avioq Inc.,
Rockville, MD
9/21/2009BP090022
Maxim (Calypte) HIV-1 Urine EIAHIV-1EIAUrineIn Vitro Diagnostic: Qualitative detection of antibodies to HIV-1.Maxim Biomedical, Inc.
Rockville, MD
US License 1741
1/12/2001BP000009
INSTI HIV-1/HIV-2 Antibody TestHIV-1 and HIV-2Rapid ImmunoassayPlasma / Whole Blood (veni-puncture and fingerstick)In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1.bioLytical Laboratories Inc.
British Columbia, Canada
 
1/28/2015BP090032/7
Reveal Rapid HIV-1 Antibody TestHIV-1Rapid ImmunoassaySerum / PlasmaIn Vitro Diagnostic: Qualitative detection of antibodies to HIV-1; point-of-care test.MedMira Laboratories, Inc.
Halifax, Nova Scotia
Canada
4/16/2003BP000023
OraSure HIV-1 Western Blot KitHIV-1WBOral FluidDiagnostic Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in oral fluid specimens found to be repeatedly reactive by the Oral Fluid Vironostika HIV-l Microelisa System.OraSure Technologies
Bethlehem, PA
6/3/1996BP950004
Cambridge Biotech HIV-1 Urine Western Blot KitHIV-1WBUrineDiagnostic Supplemental: Qualitative detection of antibodies to HIV-1 for use as an additional, more specific test in urine specimens found to be repeatedly reactive by Maxim HIV-1 Urine EIAMaxim Biomedical, Inc.
Rockville, MD
US License 1741
6/21/2001BP010009

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HIV-1 Nucleic Acid Assays (detect Human Immunodeficiency Virus type 1 RNA), see also Multiplex Assays
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Human Immunodeficiency Virus, Type 1 RT PCR AssayHIV-1Qualitative PCRPlasmaSource Plasma Donor Screening: Qualitative detection of HIV-1 RNA. For in-house use only by Baxter Healthcare International.BioLife Plasma Services, L.P.
Deerfield, IL
US License 1640
1/31/2007BL125100
UltraQual HIV-1 RT-PCR AssayHIV-1Qualitative PCRPlasmaSource Plasma Donor Screening: Qualitative detection of HIV-1 RNA. For in house use only at NGI.>National Genetics Institute
Los Angeles, CA
US License 1582
9/18/2001BL103902
COBAS AmpliScreen HIV-1 Test, ver 1.5HIV-1Qualitative PCRPlasma/ Cadaveric serum or plasmaDonor Screening: Qualitative detection of HIV-1 RNA.Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
12/20/2002BL125059
APTIMA HIV-1 RNA Qualitative AssayHIV-1TMAPlasma/ SerumIn Vitro Diagnostic: Qualitative detection of HIV-1 RNA.Gen-Probe, Inc.,
San Diego, CA
US License 1592
10/4/2006BL103966
cobas HIV-1HIV-1Quantitative PCRPlasmaPatient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
12/18/2015BP150262
Abbott RealTime
HIV-1
HIV-1Quantitative PCRPlasmaPatient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.ABBOTT Molecular, Inc., Des Plaines, IL5/11/2007BP060002
Amplicor HIV-1 Monitor TestHIV-1Quantitative PCRPlasmaPatient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
3/2/1999BP950005
COBAS AmpliPrep/COBAS TaqMan HIV-1 TestHIV-1Quantitative PCRPlasmaPatient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
5/11/2007BP050069
Versant HIV-1 RNA 3.0 (bDNA)HIV-1Quantitative PCRPlasmaPatient Monitoring: Quantification of HIV-1 RNA in plasma of HIV-1 infected individuals.Siemens Healthcare Diagnostics, Inc.9/11/2002BP000028
ViroSeq HIV-1 Genotyping SystemHIV-1GenotypingPlasmaPatient Monitoring: For detecting HIV genomic mutations (in the protease and part of the reverse transcriptase regions of HIV) that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection.Celera Diagnostics
Alameda, CA
6/11/2003
7/10/2008
BK030033,
BK080026
Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing SystemHIV-1GenotypingPlasmaPatient Monitoring: For detecting HIV genomic mutations (in the protease and part of the reverse transcriptase regions of HIV) that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection.Siemens Healthcare Diagnostics, Inc.4/24/2002
3/27/2012
BK020005,
BK120013

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Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Home Access HIV-1 Test SystemHIV-1Dried Blood Spot Collection DeviceDried Blood SpotIn Vitro Diagnostic: Self-use by people who wish to obtain anonymous HIV testingHome Access Health Corp.,
Hoffman Estates, IL
7/22/1996BP950002
OraSure HIV-1 Oral Specimen Collection DeviceHIV-1Oral Specimen Collection DeviceOral FluidFor Use with HIV diagnostic assays that have been approved for use with this device.OraSure Technologies
Bethlehem, PA
12/23/1994BP910001
OraQuick In-Home HIV TestHIV-1, HIV-2ImmunoassaOral fluidOver-the-counter (OTC) diagnostic home-use test. A positive result is preliminary and follow-up confirmatory testing is needed.OraSure Technologies
Bethlehem, PA
07/03/2012BP120001

Anti-HIV-2 Assays(detect antibodies to Human Immunodeficiency Virus type 2)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Genetic Systems HIV-2 EIAHIV-2EIASerum / PlasmaIn Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HIV-2.
Bio-Rad Laboratories
Redmond, WA
US License 1109
4/25/1990BL103227

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Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
ABBOTT PRISM HIV O Plus assayHIV-1, HIV-2ChLIAPlasma / Serum/ Cadaveric SerumIn Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HIV-1 groups M and O and/or antibodies to HIV-2.
Abbott Laboratories
Abbott Park, IL
US License 0043
9/18/2009BL125318
Geenius HIV 1/2 Supplemental AssayHIV-1, HIV-2HIV Detection TestBloodUsed as specific test to confirm the presence of antibodies of HIV-1 and HIV-2 for the detection of specimens to be repeatedly reactive by screening procedures.Bio-Rad Laboratories, Inc
Redmond, WA
US License 1109
10/24/2014BP140120
Genetic Systems HIV-1/HIV-2 Plus O EIAHIV-1, HIV-2EIASerum / Plasma / Cadaveric SerumIn Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2.
Bio-Rad Laboratories
Redmond, WA
US License 1109
8/5/2003BL125030
ADVIA Centaur HIV 1/O/2 Rapid TestHIV-1, HIV-2Microparticle Chemi-luminometric ImmunoassayPlasma/SerumIn Vitro Diagnostic: Qualitative determination of antibodies to HIV-1, including Group O, and/or HIV-2.Siemens Healthcare Diagnostics, Inc.5/18/2006BP050030
VITROS HIV-1/HIV-2 Reagent Pack and CalibratorHIV-1, HIV-2ImmunometricPlasma/SerumIn Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2.Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236
3/27/2008BP050051
Multispot HIV-1/HIV-2 Rapid TestHIV-1, HIV-2Rapid ImmunoassayPlasma / SerumIn Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2.Bio-Rad Laboratories
Redmond, WA
US License 1109
11/12/2004BP040046
SURE CHECK HIV 1/2 ASSAYHIV-1, HIV-2Rapid ImmunoassayFingerstick & venous whole blood, serum, plasmaIn Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test.Chembio Diagnostic Systems, Inc.
Medford, NY
5/25/2006BP050009
HIV 1/2 STAT-PAK ASSAYHIV-1, HIV-2Rapid ImmunoassayFingerstick & venous whole blood, serum, plasmaIn Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test.Chembio Diagnostic Systems, Inc.
Medford, NY
5/25/2006BP050010
OraQuick ADVANCE Rapid HIV-1/2 Antibody TestHIV-1, HIV-2Rapid ImmunoassayOral Fluid, Plasma, Whole Blood (venipuncture and fingerstick)In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test.OraSure Technologies
Bethlehem, PA
11/7/2002
6/22/2004
BP010047
Chembio DPP® HIV 1/2 AssayHIV-1, HIV-2Rapid Immuno-chromatographic AssayOral Fluid, Serum, Plasma,
Whole Blood (Venipuncture, Fingerstick)
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test.Chembio Diagnostic Systems, Inc.
Medford, NY
12/19/2012BP120032
Uni-Gold™ Recombigen® HIV-1/2HIV-1, HIV-2Rapid EIASerum, Plasma,
Whole Blood (Venipuncture, Fingerstick)
In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test.Trinity Biotech
Jamestown, NY
12/23/2003
02/04/2013
BP030025

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Anti-HIV-1/2 and HIV-1 Antigen Combo Assays (detect HIV-1 antigen and antibodies to HIV Types 1 and 2)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
BioPlex 2200 HIV Ag-Ab AssayHIV-1 and HIV-2multiplex flow immunoassaySerum, PlasmaIn Vitro Diagnostic: Simultaneous qualitative detection and differentiation of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2Bio-Rad Laboratories
Redmond, WA
US License 1109
7/23/2015BP140111
ADVIA Centaur HIV Ag/Ab Combo (CHIV) AssayHIV-1, HIV-2Microparticle Chemi-luminometric ImmunoassaySerumIn Vitro Diagnostic: Simultaneous qualitative detection and differentiation of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2Siemens Healthcare Diagnostics, Inc.6/8/2015BP140103
ARCHITECT HIV Ag/Ab ComboHIV-1, HIV-2CMIAPlasma / SerumIn Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2.Abbott Laboratories
Abbott Park, IL
US License 0043
6/18/2010BP090080
GS HIV Ag/Ab Combo EIAHIV-1, HIV-2EIAPlasma / SerumIn Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2.Bio-Rad Laboratories
Redmond, WA
US License 1109
7/22/2011BP100064
Alere DetermineTM
HIV-1/2 Ag/Ab Combo
HIV-1, HIV-2ImmunoassaySerum, Plasma,
Whole Blood (Venipuncture, Fingerstick)
In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 and/or HIV-2; point-of-care test.Alere Scarborough, Inc.
Scarborough, ME
8/8/2013BP120037

Anti-HTLV-I/II Assays (detect antibodies to Human T-Lymphotropic Virus types I and II)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Avioq HTLV-I/II Microelisa SystemHTLV-1, HTLV-2EIA LysateSerum / PlasmaIn Vitro Diagnostic,
Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II.
Avioq, Inc.
Research Triangle Park, NC 27709
US License 1856
03/26/2012BL125394
ABBOTT PRISM HTLV-I/HTLV-IIHTLV-1, HTLV-2ChLIASerum / PlasmaDonor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II.Abbott Laboratories
Abbott Park, IL
US License 0043
1/16/2008BL103761
MP Diagnostic HTLV Blot 2.4HTLV-I, HTLV-IIWBSerum/PlasmaDonor Supplemental: Qualitative detection and differentiation of antibodies to HTLV-I and HTLV-II for use as an additional, more specific test in specimens found to be repeatedly reactive by screening procedures.MP Biomedicals Asia Pacific PTE. LTD12/11/2014BL125475

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Anti-T. pallidum Assays (detect antibodies to Treponema pallidum)and other serological tests for Syphilis
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
CAPTIATM Syphilis (T. Pallidum)-GT. pallidumEIASerum, PlasmaDonor Screening: Qualitative detection of IgG antibodies to Treponema pallidum.Trinity Biotech
Jamestown, NY
01/24/2002K014233
ASI TPHA TestT. pallidumMicro-hemagglutinationSerumDonor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum.Arlington Scientific, Inc
Springville,UT
1/30/2003BK020031
Olympus PK TP SystemT. pallidumMicro-hemagglutinationSerum, PlasmaDonor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum.Fujirebio Diagnostics Inc..
Malvern, PA
2/21/2003BK030007
TPHA ScreenT. pallidumHemagglutinationSerum, PlasmaDonor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum.Immucor, Inc
Norcross, GA
10/24/2012BK120021
ASiManager-AT™T. pallidumRapid Plasma Reagin (RPR) TestSerum, PlasmaDonor Screening: Qualitative detection of reagin antibodies.Arlington Scientific, Inc.
Springville, UT.
2/24/2014BK 130001

Anti- T. cruzi Assays (detect antibodies to Trypanosoma cruzi)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
ABBOTT ESA ChagasT. cruzimulti-step enzyme strip immunoassaySerum, plasmaAn additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed screening test for antibodies to T. cruzi.Abbott Laboratories
Abbott Park, IL
US License 0043
11/18/2011125361/23
Abbott Prism ChagasT. cruziEIASerum / PlasmaDonor Screening: Qualitative detection of antibodies to T. cruzi.Abbott Laboratories
Abbott Park, IL
US License 0043
4/30/2010BL125361
ORTHO T. cruzi ELISA Test SystemT. cruziEIASerum / Plasma / CadavericDonor Screening: Qualitative detection of antibodies to T. cruzi.Ortho-Clinical Diagnostics, Inc.
Raritan, NJ
US License 1236
12/13/2006BL125161

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WNV Nucleic Acid Assays (detect West Nile Virus RNA
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Procleix West Nile Virus (WNV) AssayWNVNucleic Acid Test (TMA)Plasma/ Cadaveric plasma or serumDonor Screening: Qualitative detection of West Nile Virus (WNV) RNA.Gen-Probe, Inc.,
San Diego, CA
US License 1592
12/1/2005BL125121
COBAS TaqScreen West Nile Virus TestWNVPCRPlasma/ Cadaveric plasma or serumDonor Screening: Qualitative detection of West Nile Virus (WNV) RNA.Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
8/28/2007BL125245

Anti-CMV Assays (detect antibodies to Cytomegalovirus)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
Capture - CMVCMVSolid phase red cell adherenceSerum, PlasmaDonor Screening: Qualitative detection of IgG and IgM antibodies to CMV.Immucor, Inc.
Norcross, GA
12/22/1995BK950029
Olympus PK CMV-PA SystemCMVPassive particle agglutinationSerum, PlasmaDonor Screening: Qualitative detection of IgG and IgM antibodies to CMV.Fujirebio Diagnostics, Inc.
Malvern, PA
9/20/2007BK070030

Multiplex Assays
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN
COBAS TaqScreen MPX TestHBV, HCV, HIV-1, HIV-2PCRPlasma/ Cadaveric plasma or serumDonor Screening: Simultaneous qualitative detection of HBV DNA, HIV-1 Group M and Group O RNA, HIV-2 RNA, and HCV RNA.Roche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
12/30/2008BL125255
COBAS TaqScreen MPX Test version 2.0HBV, HCV, HIV-1, HIV-2PCRPlasmaDonor Screening: Simultaneous qualitative detection of HBV DNA, HIV-1 Group M and Group O RNA, HIV-2 RNA, and HCV RNARoche Molecular Systems, Inc.
Pleasanton, CA
US License 1636
12/19/2014BL 125459
Procleix Ultrio AssayHBV, HCV, HIV-1Nucleic Acid Test (TMAPlasma/ Serum/ Cadaveric plasma or serumDonor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA.Gen-Probe, Inc.,
San Diego, CA
US License 1592
10/3/2006BL125113
Procleix Ultrio Plus AssayHBV, HCV, HIV-1Nucleic Acid Test (TMA)Plasma/ Serum/ Cadaveric plasma or serumDonor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA.Gen-Probe, Inc.,
San Diego, CA
US License 1592
5/25/2012BL125113

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Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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