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
CMV
Anti-CMV Assays - Cytomegalovirus
Multiplex
Multiplex Assays
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 Technologies, Inc. Bethlehem, PA | 2/23/2022 | BP910001 |
| OraQuick HIV Self-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 |
| 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 |
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
|---|---|---|---|---|---|---|---|
| Atellica® IM HIV Ag/Ab Combo (CHIV) | HIV-1/2 | in vitro qualitative detection test | Serum, Plasma | in vitro diagnostic test for the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2, in serum and plasma using the Atellica CI Analyzer. | Siemens Healthcare Diagnostics, Inc. | 11/7/2024 | BK241075 |
| 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 |
| 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 |
| 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 |
| 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 |
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
|---|---|---|---|---|---|---|---|
| Elecsys Syphilis, Elecsys Anti-CMV, cobas pro serology solution | Treponema pallidium | Serology | Serum, Plasma | Donor Screening in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. | Roche Diagnostics | 11/6/2024 | BK241132 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Approval Date | STN |
|---|---|---|---|---|---|---|---|
| Elecsys Syphilis, Elecsys Anti-CMV, cobas pro serology solution | Cytomegalovirus | Serology | Serum, Plasma | Donor Screening: in vitro qualitative detection of total antibodies to Cytomegalovirus in human serum and plasma | Roche Diagnostics | 11/6/2024 | BK241132 |
| 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 |
| 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 |
| 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 |