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  3. Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
  1. Vaccines, Blood & Biologics

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

Alinity s Assay
Alinity s Assay

HBV
HBsAg Assays - Hepatitis B Surface Antigen
Anti-HBc Assays - Hepatitis B Virus Core Antigen
HBV Nucleic Acid Assays - Hepatitis B Virus
Elecsys HBsAg II and HBsAg II Auto Confirm

HCV
Anti-HCV Assays - Hepatitis C Virus Encoded Antigen
Elecsys Anti-HCV II
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
HIV-Syphilis Assay
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
Elecsys HTLV- I/II

Malaria
Malaria Nucleic Acid Assay

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

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

Babesia Nucleic Acid Assay
Babesia Nucleic Acid Assay

Babesia antibody assay
Babesia antibody assay

WNV
WNV Nucleic Acid Assays - West Nile Virus

Zika
Zika Nucleic Acid assay

CMV
Anti-CMV Assays - Cytomegalovirus

Multiplex
Multiplex Assays

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Alinity s Assay
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
ABBOTT 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 BL125674
ABBOTT 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 BL125675
ABBOTT 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 BL125679
ABBOTT 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 BL125677
ABBOTT 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 BL125681
ABBOTT 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 BL125689
Alinity 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 STN
ABBOTT 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 BL103766
Genetic 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

Elecsys HBsAg II and HBsAg II Auto Confirm

 Hepatitis B ECLIA Plasma / Serum

Donor Screening:

in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma. Elecsys HBsAg II is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.

The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with the cobas e 801 analytical unit.		 Roche Diagnostics,
US License 2305		 2/21/2024 125802
Anti-HBc Assays (detect antibodies to Hepatitis B Virus Core Antigen)
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Elecsys Anti-HBc II Hepatitis B ECLIA Plasma / Serum

Donor Screening:

Elecsys Anti-HBc II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti‑HBc) in human serum and plasma. Elecsys Anti‑HBc II is intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.

The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with the cobas e 801 analytical unit.		 Roche Diagnostics,
US License 2305		 2/27/2024 125804
ORTHO 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 BL103062
ABBOTT 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 STN
Procleix® 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 BK220736
UltraQual™ 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 BL125193
COBAS 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 STN
Abbott 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 BL103762

Elecsys Anti-HCV II

 Hepatitis C ECLIA Plasma / Serum

Donor Screening:

Elecsys Anti-HCV II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. Elecsys Anti‑HCV II is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.

The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with the cobas e 801 analytical unit...		 Roche Diagnostics,
US License 2305		 2/28/2024 125803
Ortho 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 STN
Procleix® 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 BK220736
Hepatitis 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 BL125101
UltraQual 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 BL103868
COBAS 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

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Anti-HIV-1 Assays (detect antibodies to Human Immunodeficiency Virus type 1)
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Reveal 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 BK231015
Fluorognost 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
BL103651
Cambridge 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 BL103843
GS 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 BL103655
Avioq 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 BP090022
Maxim (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 BP000009
Reveal 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 BP000023
OraSure 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 BP950004
Cambridge 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

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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 STN
Aptima® HIV-1 Quant Dx Assay HIV-1 in vitro nucleic acid amplification test (NAAT) Serum, Plasma in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of human immunodeficiency virus type 1 (HIV-1) on the fully automated Panther® system and Panther Fusion® system Hologic, Inc.
San Diego, CA		 8/6/2024 BK231025
Procleix® 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 BK220736
Alinity 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 BP200455
Santosa 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 BR190330
Human 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 BL125100
UltraQual 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 BL103902
COBAS 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 BL125059

APTIMA 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

BP150318/20
APTIMA 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 BL103966
cobas 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 BP150262
Abbott 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 BP060002
Amplicor 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 BP950005
COBAS 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 BP050069
Versant 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 BP000028
ViroSeq 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,
BK080026
Trugene 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 STN
DPP 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 BP18191

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Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Home 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 BP950002
OraSure 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 BP910001
OraQuick 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 STN
Genetic 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

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Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2)
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Bio-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 BL125670
VioOne 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 BP180279
ABBOTT 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 BL125318
Geenius 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 BP140120
Genetic 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 BL125030
INSTI 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 BP090032/7
ADVIA 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

BP140103/8
VITROS 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 BP050051
Multispot 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 BP040046
SURE 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 BP050009
HIV 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 BP050010
OraQuick 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		 BP010047
Chembio 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 BP120032
Uni-Gold™ 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 STN
Access HIV Ag/Ab combo; Access HIV Ag/Ab combo Calibrators; Access HIV Ag/Ab combo QC HIV Serology Serum and Plasma In Vitro Diagnostic Assay: 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 BK230833
Elecsys 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 125778
Elecsys 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 BK230804
Elecsys 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 BP190403
LIAISON 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 BP190437
Elecsys 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 BP160050
VITROS 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

BP160122/7
BioPlex 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 BP140111
ADVIA 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 BP140103

ARCHITECT 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

BP090080/51
GS 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 BP100064
Alere 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 STN
Avioq 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 BL125394
ABBOTT 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 BL103761
MP 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 STN
Elecsys 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 BK230839
ASI 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 BK200539
ASI 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 BK200488
PK7400 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 BK180301
CAPTIATM 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 K014233
ASI 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 BK020031
Olympus 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 BK030007
TPHA 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 BK120021
ASiManager-AT™ 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 130001

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Anti- T. cruzi Assays (detect antibodies to Trypanosoma cruzi)
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Elecsys Chagas T. cruzi ECLIA Plasma / Serum Donor Screening: in vitro immunoassay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi, the causative agent of the Chagas disease) in human serum and plasma. Elecsys Chagas is intended to be used to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution equipped with cobas e 801 analytical unit. Roche Diagnostics, US License 2305
US License 2305		 2/5/2024 125799
ABBOTT 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 125361/23
Abbott 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 BL125361
ORTHO 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 STN
Procleix® 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 BK220746
Babesia 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 BL125588
Cobas 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

BL125699/5
Procleix 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 STN
Babesia 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 STN
Procleix® 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 BK220746
cobas 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 BL125575
Procleix 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 BL125121
COBAS 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 STN
Cobas 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 BL125653
Procleix 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 STN
Elecsys 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 BK230840
Capture-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 BK200542
PK 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 BK200476
Capture-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 BK180247
Capture - 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 BK950029
Olympus 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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Malaria Nucleic Acid Assay
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
cobas® Malaria Plasmodium Nucleic Acid Test Whole Blood

Donor Screening:

The cobas® Malaria test for use on the cobas® 6800/8800 Systems (cobas® Malaria) is a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. It is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating.

Whole blood samples from all donors are screened as individual samples.

The test is not intended for use as an aid in diagnosis of Plasmodium infection.

This test is not intended for use on samples of cord blood.

This test is not intended for use on cadaveric blood specimens

This test is not intended for use on cadaveric samples		 Roche Molecular Systems, Inc. 3/15/2024 125808

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Multiplex Assays
Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
Cobas 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 BP190360
COBAS 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
BL125459/22
COBAS 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 BL125255
cobas 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
BL125576/11
Procleix 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 BL125652
Procleix 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 BL125113
Procleix 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 BL125113
UltraQual 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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