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          Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic AssaysVaccines, Blood & Biologics Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
  
  	
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    PrintAlinity s AssayAlinity s Assay

HBVHBsAg Assays - Hepatitis B Surface AntigenAnti-HBc Assays - Hepatitis B Virus Core AntigenHBV Nucleic Acid Assays - Hepatitis B Virus

HCVAnti-HCV Assays - Hepatitis C Virus Encoded AntigenHCV Nucleic Acid Assays - Hepatitis C Virus

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

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

T. pallidumAnti-T. Pallidum Assays - Treponema pallidum (Syphilis)

T. cruziAnti- T. cruzi Assays - Trypanosoma cruzi (T. cruzi)

Babesia Nucleic Acid AssayBabesia Nucleic Acid Assay

Babesia antibody assayBabesia antibody assay

WNVWNV Nucleic Acid Assays - West Nile Virus

ZikaZika Nucleic Acid assay

CMVAnti-CMV Assays - Cytomegalovirus

MultiplexMultiplex Assays

Return to TOC

Alinity s Assay
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNABBOTT Alinity s HBsAg; ABBOTT Alinity s HBsAg Confirmatory
			HBV
			CMIA
			CMIA - specific antibody neutralization
			Serum/ Plasma/ Cadaveric Serum
			Donor Screening: Qualitative detection of HBsAg.
			Confirmatory: To confirm the presence of HBsAg in samples found to be repeatedly reactive by the ABBOTT Alinity s HBsAg assay.
			Abbott Ireland Diagnostics Division
			Sligo, Ireland
			US License 2094
			6/14/2019
			BL125674ABBOTT Alinity s HTLV-I/II
			HTLV-I, HTLV-II
			CMIA
			Serum/ Plasma
			Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II.
			Abbott GbmH & Co KG
			Wiesbaden, Germany
			US License 2095
			6/26/2019
			BL125675ABBOTT Alinity s HIV Ag/Ab Combo
			HIV-1, HIV-2
			CMIA
			Plasma / Serum/ Cadaveric Serum
			Donor Screening: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 groups M and O and/or antibodies to HIV-2.
			Abbott GbmH & Co KG
			Wiesbaden, Germany
			US License 2095
			7/23/2019
			BL125679ABBOTT Alinity s Anti-HCV
			HCV
			CMIA
			Plasma / Serum/ Cadaveric Serum
			Donor Screening: Qualitative detection of antibodies to hepatitis C virus.
			Abbott GbmH & Co KG
			Wiesbaden, Germany
			US License 2095
			7/9/2019
			BL125677ABBOTT Alinity s Anti-HBc
			HBV
			CMIA
			Plasma / Serum/ Cadaveric Serum
			Donor Screening: Qualitative detection of antibody to hepatitis B core antigen
			Abbott GbmH & Co KG
			Wiesbaden, Germany
			US License 2095
			8/2//2019
			BL125681ABBOTT Alinity s Chagas
			T. cruzi
			CMIA
			Plasma / Serum / Cadaveric Serum
			Donor Screening: Qualitative detection of antibodies to T. cruzi.
			Abbott GbmH & Co KG
			Wiesbaden, Germany
			US License 2095
			8/15/2019
			BL125689Alinity s Anti-HCV II assay
			HCV
			CMIA
			Serum / plasma Specimens
			Qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System.
			To screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV.
			In testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing serum and EDTA plasma specimens to screen cadaveric (non-heart-beating) donors.
			Abbott GmbH
			7/15/2022
			125759

HBsAg Assays (detect Hepatitis B Surface Antigen)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory
			HBV
			ChLIA
			ChLIA - specific antibody neutralization
			Serum/ Plasma/ Cadaveric Serum
			Donor 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
			7/18/2006
			BL103766Genetic Systems HBsAg EIA 3.0;
			Genetic Systems HBsAg Confirmatory Assay 3.0
			HBV
			EIA
			Serum / Plasma / Cadaveric Serum
			In 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
			1/23/2003
			BL103590

Anti-HBc Assays (detect antibodies to Hepatitis B Virus Core Antigen)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNORTHO HBc ELISA Test System
			HBV
			ELISA
			Serum / Plasma
			In Vitro Diagnostic,
			Donor screening: Qualitative detection of total antibody to hepatitis B core antigen.
			Ortho-Clinical Diagnostics, Inc
			Raritan, NJ
			4/23/1998
			BL103062ABBOTT PRISM HBcore
			HBV
			ChLIA
			Serum / Plasma
			Donor Screening: Qualitative detection of total antibody to hepatitis B core antigen
			Abbott Laboratories
			Abbott Park, IL
			US License 0043
			10/13/2005
			BL103785

HBV Nucleic Acid Assays (detect Hepatitis B Virus DNA),see also Multiplex Assays
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNProcleix® HIV-1/HCV/HBV Quality Control
			HIV-1/HCV/HBV
			Clinical Microbiology Assay
			HIV-1 RNA;
			HBV DNA;
			HCV RNA
			HIV-1/HBV/HCV controls for Procleix assays performed on the Procleix Panther system.
			Grifols, Diagnostic Solutions, Inc.
			Emeryville, CA
			9/16/2022
			BK220736UltraQualTM HBV PCR Assay
			HBV
			PCR
			Plasma
			Source Plasma Donor Screening: Qualitative detection of HBV DNA. For in-house use only at NGI.
			National Genetics Institute Los Angeles, CA US License 1582
			9/1/2011
			BL125193COBAS AmpliScreen HBV Test
			HBV
			PCR
			Plasma/ cadaveric serum or plasma
			Donor Screening: Qualitative detection of HBV DNA.
			Roche Molecular Systems, Inc
			Pleasanton, CA
			US License 1636
			4/21/2005
			BL125090



Anti-HCV Assays (detect antibodies to Hepatitis C Virus Encoded Antigen)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNAbbott PRISM HCV
			HCV
			ChLIA
			Serum / Plasma/ Cadaveric serum
			Donor screening: Qualitative detection of antibodies to hepatitis C virus.
			Abbott Laboratories
			Abbott Park, IL
			US License 0043
			7/11/2007
			BL103762Ortho HCV Version 3.0 ELISA Test System
			HCV
			EIA
			Serum / Plasma
			Donor 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
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNProcleix® HIV-1/HCV/HBV Quality Control
			HIV-1/HCV/HBV
			Clinical Microbiology Assay
			HIV-1 RNA;
			HBV DNA;
			HCV RNA
			HIV-1/HBV/HCV controls for Procleix assays performed on the Procleix Panther system.
			Grifols, Diagnostic Solutions, Inc.
			Emeryville, CA
			9/16/2022
			BK220736Hepatitis C Virus RT PCR Assay
			HCV
			PCR
			Plasma
			Source 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
			2/9/2007
			BL125101UltraQual HCV RT-PCR Assay
			HCV
			PCR
			Plasma
			Source Plasma Donor Screening: Qualitative detection of HCV RNA. For in house use only at NGI.
			National Genetics Institute
			Los Angeles, CA
			US License 1582
			9/18/2001
			BL103868COBAS AmpliScreen HCV Test, ver 2.0
			HCV
			PCR
			Plasma/ Cadaveric serum or plasma
			Donor 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
			12/3/2002
			BL125045

Return to TOC

Anti-HIV-1 Assays (detect antibodies to Human Immunodeficiency Virus type 1)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNReveal G4 Rapid HIV-1/2 Antibody Test
			HIV-1; HIV-2
			Serology
			Whole Blood, Serum, Plasma
			Single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2)
			MedMira Laboratories, Inc.
			12/13/2023
			BK231015Fluorognost HIV-1 IFA
			HIV-1
			IFA
			Serum / 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
			BL103651Cambridge Biotech HIV-1 Western Blot Kit
			HIV-1
			WB
			Serum / Plasma
			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.
			Maxim Biomedical, Inc.
			Rockville, MD
			US License 1741
			5/28/1998
			BL103843GS HIV-1 Western Blot
			HIV-1
			WB
			Serum / 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
			11/13/1998
			BL103655Avioq HIV-1 Microelisa System
			HIV-1
			EIA
			Serum, Plasma, Dried Blood Spot, Oral Fluid
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1.
			Avioq Inc.,
			Rockville, MD
			9/21/2009
			BP090022Maxim (Calypte) HIV-1 Urine EIA
			HIV-1
			EIA
			Urine
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1.
			Maxim Biomedical, Inc.
			Rockville, MD
			US License 1741
			1/12/2001
			BP000009Reveal Rapid HIV-1 Antibody Test
			HIV-1
			Rapid Immunoassay
			Serum / Plasma
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1; point-of-care test.
			MedMira Laboratories, Inc.
			Halifax, Nova Scotia
			Canada
			4/16/2003
			BP000023OraSure HIV-1 Western Blot Kit
			HIV-1
			WB
			Oral Fluid
			Diagnostic 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
			6/3/1996
			BP950004Cambridge Biotech HIV-1 Urine Western Blot Kit
			HIV-1
			WB
			Urine
			Diagnostic 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 EIA
			Maxim Biomedical, Inc.
			Rockville, MD
			US License 1741
			6/21/2001
			BP010009

Return to TOC

HIV-1 Nucleic Acid Assays (detect Human Immunodeficiency Virus type 1 RNA), see also Multiplex Assays
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNProcleix® HIV-1/HCV/HBV Quality Control
			HIV-1/HCV/HBV
			Clinical Microbiology Assay
			HIV-1 RNA;
			HBV DNA;
			HCV RNA
			HIV-1/HBV/HCV controls for Procleix assays performed on the Procleix Panther system.
			Grifols, Diagnostic Solutions, Inc.
			Emeryville, CA
			9/16/2022
			BK220736Alinity m HIV-1
			HIV-1
			Quantitative PCR
			Plasma
			Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.
			Abbott Molecular, Inc., Des Plaines, IL
			7/2/2020
			BP200455Santosa SQHIV-1 Genotyping Assay
			HIV-1
			Genotyping
			Plasma
			Patient 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.
			Vela Diagnostics. USA, Inc., Fairfield, NJ
			11/5/2019
			BR190330Human Immunodeficiency Virus, Type 1 RT PCR Assay
			HIV-1
			Qualitative PCR
			Plasma
			Source 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
			1/31/2007
			BL125100UltraQual HIV-1 RT-PCR Assay
			HIV-1
			Qualitative PCR
			Plasma
			Source 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
			9/18/2001
			BL103902COBAS AmpliScreen HIV-1 Test, ver 1.5
			HIV-1
			Qualitative PCR
			Plasma/ Cadaveric serum or plasma
			Donor Screening: Qualitative detection of HIV-1 RNA.
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			US License 1636
			12/20/2002
			BL125059APTIMA HIV-1 Quant Assay

			APTIMA HIV-1 Quant Dx Assay
			HIV-1
			TMA
			Plasma/ Serum
			Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.

			Addition of claim for Qualitative detection HIV-1 RND on Panther platform
			Hologic Inc., San Diego, CA
			US License 1592
			12/22/20

			11/5/2020
			BP150318

			BP150318/20APTIMA HIV-1 RNA Qualitative Assay
			HIV-1
			TMA
			Plasma/ Serum
			In Vitro Diagnostic: Qualitative detection of HIV-1 RNA.
			Gen-Probe, Inc.,
			San Diego, CA
			US License 1592
			10/4/2006
			BL103966cobas HIV-1
			HIV-1
			Quantitative PCR
			Plasma
			Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			US License 1636
			12/18/2015
			BP150262Abbott RealTime
			HIV-1
			HIV-1
			Quantitative PCR
			Plasma
			Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.
			ABBOTT Molecular, Inc., Des Plaines, IL
			5/11/2007
			BP060002Amplicor HIV-1 Monitor Test
			HIV-1
			Quantitative PCR
			Plasma
			Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			US License 1636
			3/2/1999
			BP950005COBAS AmpliPrep/COBAS TaqMan HIV-1 Test
			HIV-1
			Quantitative PCR
			Plasma
			Patient Monitoring: Quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals.
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			US License 1636
			5/11/2007
			BP050069Versant HIV-1 RNA 3.0 (bDNA)
			HIV-1
			Quantitative PCR
			Plasma
			Patient Monitoring: Quantification of HIV-1 RNA in plasma of HIV-1 infected individuals.
			Siemens Healthcare Diagnostics, Inc.
			9/11/2002
			BP000028ViroSeq HIV-1 Genotyping System
			HIV-1
			Genotyping
			Plasma
			Patient 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,
			BK080026Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System
			HIV-1
			Genotyping
			Plasma
			Patient 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

HIV-Syphilis Assay
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNDPP HIV-Syphilis System
			HIV-1/2, T.pallidum
			Rapid Immunochromatographic Assay
			Whole blood, EDTA plasma
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; and/or T. pallidum, point-of-care test.
			Chembio Diagnostic Systems, Inc.
			Medford, NY
			10/1/2020
			BP18191Return to TOC

Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNHome Access HIV-1 Test System
			HIV-1
			Dried Blood Spot Collection Device
			Dried Blood Spot
			In Vitro Diagnostic: Self-use by people who wish to obtain anonymous HIV testing
			Home Access Health Corp.,
			Hoffman Estates, IL
			7/22/1996
			BP950002OraSure HIV-1 Oral Specimen Collection Device
			HIV-1
			Oral Specimen Collection Device
			Oral Fluid
			OraSure HIV-1 Oral Specimen Collection Device is intended for use in the collection of oral fluid specimens by properly trained individuals for the purpose of testing for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1).
				OraSure HIV-1 specimens are intended to be used only with the Avioq HIV-1 Microelisa System screening test manufactured by Avioq, Inc. OraSure HIV-1 is intended for use with subjects 13 years of age or older.
			OraSure Technologies, Inc.
			Bethlehem, PA
			2/23/2022
			BP910001OraQuick In-Home HIV Test
			HIV-1, HIV-2
			Immunoassa
			Oral fluid
			Over-the-counter (OTC) diagnostic home-use test. A positive result is preliminary and follow-up confirmatory testing is needed.
			OraSure Technologies
			Bethlehem, PA
			07/03/2012
			BP120001

Anti-HIV-2 Assays(detect antibodies to Human Immunodeficiency Virus type 2)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNGenetic Systems HIV-2 EIA
			HIV-2
			EIA
			Serum / Plasma
			In Vitro Diagnostic,
			Donor Screening: Qualitative detection of antibodies to HIV-2.
			Bio-Rad Laboratories
			Redmond, WA
			US License 1109
			4/25/1990
			BL103227

Return to TOC

Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNBio-Rad Geenius HIV-1/HIV-2 Supplemental Assay
			HIV
			PCR
			Plasma/Serum
			Used 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 by donor screening assay.
			Bio-Rad Laboratories
			Redmond, WA
			US License 1109
			8/26/2019
			BL125670VioOne HIV Profile Supplemental Assay
			HIV
			ELISA
			Plasma/Serum
			In vitro Diagnostic: Used 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.
			Avioq Inc., Research Triangle Park, NC
			10/19/2020
			BP180279ABBOTT PRISM HIV O Plus assay
			HIV-1, HIV-2
			ChLIA
			Plasma / Serum/ Cadaveric Serum
			In 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
			9/18/2009
			BL125318Geenius HIV 1/2 Supplemental Assay
			HIV-1, HIV-2
			HIV Detection Test
			Blood
			Used 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
			10/24/2014
			BP140120Genetic Systems HIV-1/HIV-2 Plus O EIA
			HIV-1, HIV-2
			EIA
			Serum / Plasma / Cadaveric Serum
			In 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
			8/5/2003
			BL125030INSTI HIV-1/HIV-2 Antibody Test
			HIV-1 and HIV-2
			Rapid Immunoassay
			Plasma / Whole Blood (veni-puncture and fingerstick)
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1.
			bioLytical Laboratories Inc.
			British Columbia, Canada
			1/28/2015
			BP090032/7ADVIA Centaur HIV 1/O/2 Rapid Test
			HIV-1, HIV-2
			Microparticle Chemi-luminometric Immunoassay
			Plasma/Serum
			In Vitro Diagnostic: Qualitative determination of antibodies to HIV-1, including Group O, and/or HIV-2.

			Use of ADVIA Centaur XPT System

			Use of Atellica IM Analyzer
			Siemens Healthcare Diagnostics, Inc.
			5/18/2006

			11/15/2016

			10/4/2018
			BP050030

			BP140103/2

			BP140103/8VITROS HIV-1/HIV-2 Reagent Pack and Calibrator
			HIV-1, HIV-2
			Immunometric
			Plasma/Serum
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2.
			Ortho-Clinical Diagnostics, Inc
			Raritan, NJ
			US License 1236
			3/27/2008
			BP050051Multispot HIV-1/HIV-2 Rapid Test
			HIV-1, HIV-2
			Rapid Immunoassay
			Plasma / Serum
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2.
			Bio-Rad Laboratories
			Redmond, WA
			US License 1109
			11/12/2004
			BP040046SURE CHECK HIV 1/2 ASSAY
			HIV-1, HIV-2
			Rapid Immunoassay
			Fingerstick & venous whole blood, serum, plasma
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test.
			Chembio Diagnostic Systems, Inc.
			Medford, NY
			5/25/2006
			BP050009HIV 1/2 STAT-PAK ASSAY
			HIV-1, HIV-2
			Rapid Immunoassay
			Fingerstick & venous whole blood, serum, plasma
			In Vitro Diagnostic: Qualitative detection of antibodies to HIV-1 and/or HIV-2; point-of-care test.
			Chembio Diagnostic Systems, Inc.
			Medford, NY
			5/25/2006
			BP050010OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
			HIV-1, HIV-2
			Rapid Immunoassay
			Oral 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
			BP010047Chembio DPP® HIV 1/2 Assay
			HIV-1, HIV-2
			Rapid Immuno-chromatographic Assay
			Oral 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
			12/19/2012
			BP120032Uni-GoldTM Recombigen® HIV-1/2
			HIV-1, HIV-2
			Rapid EIA
			Serum, 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)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNAccess HIV Ag/Ab combo; Access HIV Ag/Ab combo Calibrators; Access HIV Ag/Ab combo QC
			HIV
			Serology
			Serum and Plasma
			Donor Screening: Chemiluminescent immunoassay for the simultaneous qualitative in vitro detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in pediatric populations
			Beckman Coulter, Inc.
			7/27/2023
			BK230833Elecsys HIV Duo
			HIV-1, HIV-1 (Groups M and O) and HIV-2
			ECLIA
			Plasma / Serum
			Donor Screening: in vitro immunoassay for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2
			Roche Diagnostics, US License 2305
			6/13/2023
			125778Elecsys HIV Duo
			HIV-1; HIV-2
			Serology
			HIV-1 RNA; HBV DNA; HCV RNA
			HIV-1/HBV/HCV controls for Procleix assays performed on the Procleix Panther system.
			Roche Diagnostics
			4/4/2023
			BK230804Elecsys HIV Duo
			HIV-1, HIV-2
			Immunocmemiluensence
			Plasma/Serum
			In Vitro Diagnostic: Simultaneous qualitative detection and differentiation of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2
			Roche Diagnostics, Indianapolis, IN
			4/10/2020
			BP190403LIAISON XL MUREX HIV Ab/Ag HT
			HIV-1/HIV-2
			Immunocmemiluensence
			Plasma/Serum
			In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2.
			DiaSorin Inc., Stillwater, MN
			11/25/2020
			BP190437Elecsys HIV Combi PT
			HIV-1, HIV-2
			immunocmemiluensence
			Plasma/Serum
			In Vitro Diagnostic: Simultaneous qualitative detection and differentiation of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2
			Roche Diagnostics, Indianapolis, IN
			6/21/2017
			BP160050VITROS HIV-1/HIV-2 Reagent Pack and Calibrator
			HIV-1, HIV-2
			Immunometric
			Serum/ plasma
			In Vitro Diagnostic: Simultaneous qualitative detection and differentiation of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2

			Use of VITROS 5600 System

			Use of VITROS ECi/ECiQ System

			Use of VITROS XT7600 System
			Ortho-Clinical Diagnostics, Inc
			Raritan, NJ
			US License 1236
			12/13/2017

			11/1/2018

			11/21/2018

			7/29/2019
			BP160122

			BP160122/3

			BP160122/4

			BP160122/7BioPlex 2200 HIV Ag-Ab Assay
			HIV-1 and HIV-2
			multiplex flow immunoassay
			Serum, Plasma
			In Vitro Diagnostic: Simultaneous qualitative detection and differentiation 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
			7/23/2015
			BP140111ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay
			HIV-1, HIV-2
			Microparticle Chemi-luminometric Immunoassay
			Serum
			In Vitro Diagnostic: Simultaneous qualitative detection and differentiation of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2
			Siemens Healthcare Diagnostics, Inc.
			6/8/2015
			BP140103ARCHITECT HIV Ag/Ab Combo

			Alinity i HIV Ag/Ab Combo Assay
			HIV-1, HIV-2
			CMIA
			Plasma / Serum
			In Vitro Diagnostic: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (group M and group O) and/or HIV-2.

			A new platform Alinity i, for high throughput highly automated system
			Abbott Laboratories
			Abbott Park, IL
			US License 0043
			6/18/2010

			8/22/2019
			BP090080

			BP090080/51GS HIV Ag/Ab Combo EIA
			HIV-1, HIV-2
			EIA
			Plasma / Serum
			In 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
			7/22/2011
			BP100064Alere DetermineTM
			HIV-1/2 Ag/Ab Combo
			HIV-1, HIV-2
			Immunoassay
			Serum, 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
			8/8/2013
			BP120037

Anti-HTLV-I/II Assays (detect antibodies to Human T-Lymphotropic Virus types I and II)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNAvioq HTLV-I/II Microelisa System
			HTLV-1, HTLV-2
			EIA Lysate
			Serum / Plasma
			In Vitro Diagnostic,
			Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II.
			Avioq, Inc.
			Research Triangle Park, NC 27709
			US License 1856
			03/26/2012
			BL125394ABBOTT PRISM HTLV-I/HTLV-II
			HTLV-1, HTLV-2
			ChLIA
			Serum / Plasma
			Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II.
			Abbott Laboratories
			Abbott Park, IL
			US License 0043
			1/16/2008
			BL103761MP Diagnostic HTLV Blot 2.4
			HTLV-I, HTLV-II
			WB
			Serum/Plasma
			Donor 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. LTD
			12/11/2014
			BL125475

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Anti-T. pallidum Assays (detect antibodies to Treponema pallidum)and other serological tests for Syphilis
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNElecsys Syphilis; PreciControl Syphilis; PreciControl Release Syphilis
			Treponema pallidium
			Serology
			Serum and Plasma
			Donor Screening: in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma
			Roche Diagnostics
			7/31/2023
			BK230839ASI Automated RPR test for Syphilis for use on the ASI Evolution
			T. pallidum
			Rapid Plasma Reagin Test
			Serum, Plasma
			Cadaveric: Serum, Plasma
			Donor Screening: Qualitative detection of reagin antibodies
			Arlington Scientific, Inc.
			Springville, UT
			2/2/2021
			BK200539ASI Automated RPR test for Syphilis for use on the ASI Evolution
			T. pallidum
			Rapid Plasma Reagin Test
			Serum, Plasma
			Donor Screening: Qualitative detection of reagin antibodies
			Arlington Scientific, Inc.
			Springville, UT
			9/30/2020
			BK200488PK7400 TP HA Controls and PK7400 TP HA Reagent
			Treponema pallidum
			Micro-hemagglutination
			Human serum, EDTA plasma and CPDA plasma
			Donor Screening: Qualitative detection of IgG and IgM antibodies to syphilis.
			Newmarket Biomedical Ltd.
			United Kingdom
			8/1/2019
			BK180301CAPTIATM Syphilis (T. Pallidum)-G
			T. pallidum
			EIA
			Serum, Plasma
			Donor Screening: Qualitative detection of IgG antibodies to Treponema pallidum.
			Trinity Biotech
			Jamestown, NY
			01/24/2002
			K014233ASI TPHA Test
			T. pallidum
			Micro-hemagglutination
			Serum
			Donor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum.
			Arlington Scientific, Inc
			Springville,UT
			1/30/2003
			BK020031Olympus PK TP System
			T. pallidum
			Micro-hemagglutination
			Serum, Plasma
			Donor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum.
			Fujirebio Diagnostics Inc..
			Malvern, PA
			2/21/2003
			BK030007TPHA Screen
			T. pallidum
			Hemagglutination
			Serum, Plasma
			Donor Screening: Qualitative detection of IgG and IgM antibodies to Treponema pallidum.
			Immucor, Inc
			Norcross, GA
			10/24/2012
			BK120021ASiManager-ATTM
			T. pallidum
			Rapid Plasma Reagin (RPR) Test
			Serum, Plasma
			Donor Screening: Qualitative detection of reagin antibodies.
			Arlington Scientific, Inc.
			Springville, UT.
			2/24/2014
			BK 130001Return to TOC

Anti- T. cruzi Assays (detect antibodies to Trypanosoma cruzi)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNABBOTT ESA Chagas
			T. cruzi
			multi-step enzyme strip immunoassay
			Serum, plasma
			An 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
			11/18/2011
			125361/23Abbott Prism Chagas
			T. cruzi
			EIA
			Serum / Plasma
			Donor Screening: Qualitative detection of antibodies to T. cruzi.
			Abbott Laboratories
			Abbott Park, IL
			US License 0043
			4/30/2010
			BL125361ORTHO T. cruzi ELISA Test System
			T. cruzi
			EIA
			Serum / Plasma / Cadaveric
			Donor Screening: Qualitative detection of antibodies to T. cruzi.
			Ortho-Clinical Diagnostics, Inc.
			Raritan, NJ
			US License 1236
			12/13/2006
			BL125161

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Babesia Nucleic Acid Assay
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNProcleix® WNV/Babesia Quality Control
			*Babesia microti* and West Nile Virus
			Clinical Microbiology Assay
			Babesia and WNV RNA
			Qualitative detection of RNA from *Babesia microti* and West Nile Virus
			Grifols, Diagnostic Solutions, Inc.
			Emeryville, CA
			10/14/2022
			BK220746Babesia Microti-NAT
			B. microti
			PCR
			Whole blood
			Donor Screening: Qualitative detection of B. microti DNA
			Oxford Immunotec Ltd. Norwood, MA
			US license 2021
			3/6/2018
			BL125588Cobas Babesia Test
			Babesia species
			PCR
			Whole blood
			Donor Screening: Babesia DNA and RNA for use on cobas 6800/8800

			Addition of testing in pools of six samples
			Roche Molecular Systems, Inc. Pleasanton, CA US License 1636
			9/29/2019

			5/6/2020
			BL 125699

			BL125699/5Procleix Babesia Assay
			Babesia species
			Nucleic Acid Test (TMA)
			Whole blood/ cadaveric blood
			Donor Screening: Babesia RNA
			Grifols Diagnostics Solution,
			San Diego, CA
			US License 2032
			01/24/2019
			BL125673

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Babesia antibody assay
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNBabesia Microti-AFIA
			B. microti
			Arrayed Immunofluorescence Assay
			EDTA Plasma
			Donor Screening: Qualitative detection of antibodies to B. microti
			Oxford Immunotec Ltd. Norwood, MA
			US license 2021
			3/6/2018
			BL125589

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WNV Nucleic Acid Assays (detect West Nile Virus RNA)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNProcleix® WNV/Babesia Quality Control
			*Babesia microti* and West Nile Virus
			Clinical Microbiology Assay
			Babesia and WNV RNA
			Qualitative detection of RNA from *Babesia microti* and West Nile Virus
			Grifols, Diagnostic Solutions, Inc.
			Emeryville, CA
			10/14/2022
			BK220746cobas WNV
			WNV
			PCR
			Plasma/ Cadaveric plasma or serum
			Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA.
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			US License 1636
			11/2/2016
			BL125575Procleix West Nile Virus (WNV) Assay
			WNV
			Nucleic Acid Test (TMA)
			Plasma/ Cadaveric plasma or serum
			Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA.
			Gen-Probe, Inc.,
			San Diego, CA
			US License 1592
			12/1/2005
			BL125121COBAS TaqScreen West Nile Virus Test
			WNV
			PCR
			Plasma/ Cadaveric plasma or serum
			Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA.
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			US License 1636
			8/28/2007
			BL125245

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Zika Nucleic Acid assay (detects Zika virus RNA)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNCobas Zika
			Zika
			PCR
			Plasma/Cadaveric plasma or serum
			Donor Screening: Qualitative detection of Zika Virus RNA.
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			US License 1636
			10/6/2017
			BL125653Procleix Zika Assay
			Zika virus
			Nucleic Acid Test (TMA)
			Plasma/ Serum/ Cadaveric plasma or serum
			Donor Screening: Zika RNA.
			Grifols Diagnostics Solution.,
			San Diego, CA
			US License 2032
			07/05/2018
			BL125667

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Anti-CMV Assays (detect antibodies to Cytomegalovirus)
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNElecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV
			Cytomegalovirus
			Serology
			Serum and Plasma
			Donor Screening: in vitro qualitative detection of total antibodies to Cytomegalovirus in human serum and plasma
			Roche Diagnostics
			Indianapolis, IN
			11/3/2023
			BK230840Capture-CMV
			CMV
			Solid phase red cell adherence
			Human Serum and Plasma
			Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV
			Immucor, Inc.
			Norcross, GA
			2/8/2021
			BK200542PK CMV-PA System
			CMV
			Passive particle agglutination
			EDTA plasma, Serum
			Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV
			Fujirebio Diagnostics, Inc.
			Malvern, PA
			10/19/2020
			BK200476Capture-CMV
			CMV
			Solid phase red cell adherence
			Human serum and Plasma
			Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV.
			Immucor, Inc.
			Norcross, GA
			11/20/2018
			BK180247Capture - CMV
			CMV
			Solid phase red cell adherence
			Serum, Plasma
			Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV.
			Immucor, Inc.
			Norcross, GA
			12/22/1995
			BK950029Olympus PK CMV-PA System
			CMV
			Passive particle agglutination
			Serum, Plasma
			Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV.
			Fujirebio Diagnostics, Inc.
			Malvern, PA
			9/20/2007
			BK070030

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Multiplex Assays
	Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Approval Date
			STNCobas HIV-1/HIV-2 Qualitative Assay
			HIV-1/HIV-2
			PCR
			Serum/Plasma
			In Vitro Diagnostic: Qualitative detection and differentiation of HIV-1 and HIV-2 RNA
			Roche Molecular Systems, Inc.
			Pleasanton, CA
			8/12/2020
			BP190360COBAS TaqScreen MPX Test version 2.0
			HBV, HCV, HIV-1, HIV-2
			PCR
			Plasma
			Donor 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
			12/19/2014
			9/21/2017
			BL125459
			BL125459/22COBAS TaqScreen MPX Test
			HBV, HCV, HIV-1, HIV-2
			PCR
			Plasma/ Cadaveric plasma or serum
			Donor 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
			12/30/2008
			BL125255cobas MPX Test
			HBV, HCV, HIV-1, HIV-2
			PCR
			Plasma/ Cadaveric plasma or serum
			Donor 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
			10/21/2016
			9/21/2017
			BL125576
			BL125576/11Procleix Ultrio Elite Assay
			HBV, HCV, HIV-1, HIV-2
			Nucleic Acid Test (TMA)
			Plasma/ Serum/ Cadaveric plasma or serum
			Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, HIV-1 RNA and HIV-2 RNA.
			Grifols Diagnostics Solution.,
			San Diego, CA
			US License 2032
			5/03/2018
			BL125652Procleix Ultrio Assay
			HBV, HCV, HIV-1
			Nucleic Acid Test (TMA
			Plasma/ Serum/ Cadaveric plasma or serum
			Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA.
			Grifols Diagnostics Solution.,
			San Diego, CA
			US License 2032
			10/3/2006
			BL125113Procleix Ultrio Plus Assay
			HBV, HCV, HIV-1
			Nucleic Acid Test (TMA)
			Plasma/ Serum/ Cadaveric plasma or serum
			Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA.
			Grifols Diagnostics Solution.,
			San Diego, CA
			US License 2032
			5/25/2012
			BL125113UltraQual Multiplex PCR Assay
			HBV, HCV, HIV-1, HIV-2
			Nucleic Acid Test (PCR)
			Plasma
			Source Plasma Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, HIV-1 RNA and HIV-2 RNA.
			National Genetics Institute
			Los Angeles, CA
			US License 1582
			5/30/2018
			BL125658

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                                                                                  Content current as of:
      12/14/2023
              
              
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