Vaccines, Blood & Biologics
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Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
Antibody to Hepatitis B Surface Antigen (HBsAg Assay)
Hepatitis B Virus (HBV Nucleic Acid Assay)
Hepatitis B Virus Core Antigen (Anti-HBc Assay)
Hepatitis C Virus (HCV Nucleic Acid Assay)
Hepatitis C Virus Encoded Antigen (Anti-HCV Assay)
Anti-HIV-1 Oral Specimen Collection Device
Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Assay)
Human Immunodeficiency Virus Types 1 (Anti-HIV-1 Assay)
Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)
Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)
Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay) and Anti-HIV-1 (HIV-1 Antigen Assay)
Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay)
Trypanosoma cruzi (T. cruzi) (Anti- T. cruzi Assay)
West Nile Virus (WNV Nucleic Acid Assay)
Return to the Infectious Disease Tests page
| Antibody to Hepatitis B Surface Antigen (HBsAg Assay) | |||||||
|---|---|---|---|---|---|---|---|
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| ABBOTT PRISM HBsAg and ABBOTT PRISM HBsAg Confirmatory | HBV | Chemi-luminescent Immunoassay (ChLIA) | Serum/ Plasma/ Cadaveric | Donor Screen: Qualitative detection of HBsAg in serum and plasma from individual human donors of whole blood and blood components. Also for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart beating) donors. | Abbott Laboratories Abbott Park, IL US License 0043 | 7/18/2006 | BL103766/0 |
| GS HBsAg EIA 3.0 | HBV | EIA | Serum / Plasma / Cadaveric Serum | Donor Screen & Confirmatory Kit: Qualitative detection of HBsAg in human serum or plasma from blood donors. For use in screening blood and blood products intended for transfusion or for further manufacture into plasma products and in testing cadaveric serum specimens. Also indicated for use with the Ortho Summit™ System (OSS) in the screening of blood donors | Bio-Rad Laboratories Redmond, WA US License 1109 | 1/23/2003 | BL103590/0 |
| ORTHO Antibody to HBsAg ELISA Test System | HBV | EIA | Serum / Plasma | Donor Screen / Diagnosis & Confirmatory Kit | Ortho-Clinical Diagnostics, Inc Raritan, NJ US License 1236 | 4/23/2003 | BL103901/0 |
| Hepatitis B Virus Core Antigen (Anti-HBc Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| ABBOTT PRISM HBcore | HBV | Chemi-luminescent Immunoassay (ChLIA) | Serum / Plasma | Donor Screen: Qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma. | Abbott Laboratories Abbott Park, IL US License 0043 | 10/13/2005 | BL103785/0 |
| Hepatitis B Virus (HBV Nucleic Acid Assay) - see Multiplex Assays also, below | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| UltraQual™ HBV PCR Assay | HBV | PCR | Plasma | Donor Screen: In-house HBV assay for Source Plasma. Qualitative detection of HBV DNA in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. | 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 Screen: Qualitative detection of HBV DNA in human plasma from individual donors of whole blood and blood components, Source Plasma and other living donors. Also to screen organ donors when specimens are obtained while the donor's heart is beating and in testing blood specimens from cadaveric (non-heart beating) organ and tissue donors. | Roche Molecular Systems, Inc Pleasanton, CA US License 1636 | 4/21/2005 | BL125090/0 |
| Hepatitis C Virus Encoded Antigen (Anti-HCV Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Abbott PRISM HCV | HCV | Chemi-luminescent Immunoassay (ChLIA) | Serum / Plasma/ Cadaveric serum | Donor screen: Qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens. Also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. | Abbott Laboratories Abbott Park, IL US License 0043 | 7/11/2007 | BL103762/0 |
| Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA), Version 3.0/Recombinant and Synthetic) | HCV | EIA | Serum / Plasma | Donor Screen: Enzyme-linked, immunosorbent assay for the qualitative detection of anti-HCV in human serum, plasma, and cadaveric specimens. | Ortho-Clinical Diagnostics, Inc Raritan, NJ US License 1236 | 4/23/1998 | BL103065/0 |
| Chiron RIBA HCV 3.0 Strip Immunoblot Assay | HCV | SIA | Serum / Plasma | Donor Supplemental: Qualitative detection of antibodies to individual proteins encoded by the hepatitis C virus in human serum or plasma. It is intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed anti-HCV screening procedure, such as ELISA | Novartis Vaccines and Diagnostics, Inc., Emeryville, CA US License 1751 | 2/11/1999 | BL103658/0 |
| Hepatitis C Virus (HCV Nucleic Acid Assay) - see Multiplex Assays also, below | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay | HCV | PCR | Plasma | Donor Screen: In house HCV assay for Source Plasma. Qualitative detection of HCV ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. | BioLife Plasma Services, L.P. Deerfield, IL US License 1640 | 2/9/2007 | BL125101/0 |
| UltraQual HCV RT-PCR Assay | HCV | PCR | Plasma | Donor Screen: In house HCV assay for Source Plasma. Qualitative detection of HCV ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. | National Genetics Institute Los Angeles, CA US License 1582 | 9/18/2001 | BL103868/0 |
| COBAS AmpliScreen HCV Test | HCV | PCR | Plasma/ Cadaveric serum or plasma | Donor Screen: Qualitative detection of HCV RNA in human plasma from individual donors of whole blood and blood components, Source Plasma and other living donors. Also to screen organ donors when specimens are obtained while the donor's heart is beating and in testing blood specimens from cadaveric (non-heart beating) organ and tissue donors. | Roche Molecular Systems, Inc Pleasanton, CA US License 1636 | 12/3/2002 | BL125045/0 |
| Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| GS rLAV EIA | HIV-1 | EIA | Serum / Plasma | Donor Screen (serum/plasma). Diagnostic (Dried blood spot). | Bio-Rad Laboratories Redmond, WA US License 1109 | 6/29/1998 | BL102866/1031, BL102866/1032 |
| Fluorognost HIV-1 IFA | HIV-1 | IFA | Serum / Plasma | Donor Supplemental. Donor Screen (Only in special cases). | Sanochemia Pharmazeutika AG Vienna, Austria US License 1631 | 2/5/1992 | BL103288/0 |
| Cambridge Biotech HIV-1 Western Blot Kit | HIV-1 | WB | Serum / Plasma | Donor Supplemental. Diagnostic supplemental. | Maxim Biomedical, Inc. Rockville, MD US License 1741 | 2/25/1999 | BL103843 |
| GS HIV-1 Western Blot | HIV-1 | WB | Serum / Plasma | Donor Supplemental | Bio-Rad Laboratories Redmond, WA US License 1109 | 11/13/1998 | BL103655/0 |
| Avioq HIV-1 Microelisa System | HIV-1 | EIA | Serum, Plasma, Dried blood spot, Oral Fluid | Diagnostic: For the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with OraSure®.HIV-1 Oral Specimen Collection Device | Avioq Inc., Rockville, MD | 9/21/2009 | BP090022/0 |
| HIVAB HIV-1 EIA | HIV-1 | EIA | Dried Blood Spot | Diagnostic | Abbott Laboratories Abbott Park, IL US License 0043 | 4/22/1992 | BL103404/0 |
| Maxim Biotech HIV-1 Urine EIA | HIV-1 | EIA | Urine | Diagnostic | Maxim Biomedical, Inc. Rockville, MD US License 1741 | 1/3/1991 | BP000009 |
| INSTI™ HIV-1 Antibody Test Kit | HIV-1 | Rapid Immunoassay | Plasma / Whole Blood (veni-puncture and fingerstick) | Diagnostic: For the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human venipuncture whole blood, fingerstick blood, or plasma specimens. | bioLytical Laboratories Inc. British Columbia, Canada V6V 2X7 | 11/29/2010 | BP090032/0 |
| Reveal Rapid HIV-1 Antibody Test | HIV-1 | Rapid Immunoassay | Serum / Plasma | Diagnostic | MedMira Laboratories, Inc. Halifax, Nova Scotia Canada B3S 1B3 | 4/16/2003 | BP000023/0 |
| Uni-Gold Recombigen HIV | HIV-1 | Rapid Immunoassay | Serum / Plasma / Whole Blood (venipuncture and fingerstick) | Diagnostic | Trinity Biotech, plc Bray Co., Wicklow, Ireland | 12/23/2003 | BP030025/0 |
| GS HIV-1 Western Blot | HIV-1 | WB | Dried Blood Spot | Diagnostic Supplemental | Bio-Rad Laboratories Redmond, WA US License 1109 | 11/13/1998 | BL103655/0 |
| Fluorognost HIV-1 IFA | HIV-1 | IFA | Dried Blood Spot | Diagnostic Supplemental | Sanochemia Pharmazeutika AG Vienna, Austria US License 1631 | 5/14/1996 | BL103651/0 |
| OraSure HIV-1 Western Blot Kit | HIV-1 | WB | Oral Fluid | Diagnostic Supplemental | OraSure Technologies Bethlehem, PA | 6/3/1996 | BP950004/0 |
| Cambridge Biotech HIV-1 Western Blot Kit | HIV-1 | WB | Urine | Diagnostic Supplemental | Maxim Biomedical, Inc. Rockville, MD US License 1741 | 6/21/2001 | BP010009/0 |
| Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Assay) - see Multiplex Assays also, below | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay | HIV-1 | PCR | Plasma | Donor Screen: Qualitative detection of HIV-1 ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. | BioLife Plasma Services, L.P. Deerfield, IL US License 1640 | 1/31/2007 | BL125100/0 |
| UltraQual HIV-1 RT-PCR Assay | HIV-1 | PCR | Plasma | Donor Screen: Qualitative detection of HIV-1 ribonucleic acid (RNA) in pools of human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples. | National Genetics Institute Los Angeles, CA US License 1582 | 9/18/2001 | BL103902/0 |
| COBAS Ampliscreen HIV-1 Test18 | HIV-1 | PCR | Plasma/ Cadaveric serum or plasma | Donor Screen Expanded Indications For Use: Source Plasma donors, other living donors, and organ donors | Roche Molecular Systems, Inc. Pleasanton, CA US License 1636 | 12/20/2002 | BL125059/0 |
| APTIMA HIV-1 RNA Qualitative Assay | HIV-1 | HIV-1 Nucleic Acid (TMA) | Plasma/ Serum | Diagnostic: For use as an aid in diagnosis of HIV-1 infection, including acute or primary infection. | Gen-Probe, Inc., San Diego, CA US License 1592 | 10/4/2006 | BL103966/5040 |
| Abbott RealTime HIV-1 Amplification Kit | HIV-1 | PCR | Plasma | Patient Monitoring: Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System. Not intended to be used as a donor screening test or as a diagnostic test to confirm the presence of HIV-1 infection. | ABBOTT Molecular, Inc., Des Plaines, IL | 5/11/2007 | BP060002/0 |
| Roche Amplicor HIV-1 Monitor Test | HIV-1 | PCR | Plasma | Patient Monitoring: Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid. Not intended as a donor screening test or as a diagnostic test to confirm the presence of HIV-1 infection. | Roche Molecular Systems, Inc. Pleasanton, CA US License 1636 | 3/2/1999 | BP950005/004 |
| COBAS AmpliPrep/COBAS TaqMan HIV-1 Test | HIV-1 | PCR | Plasma | Patient Monitoring: Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid. Not intended to be used as a donor screening test or as a diagnostic test to confirm the presence of HIV-1 infection. | Roche Molecular Systems, Inc. Pleasanton, CA US License 1636 | 5/11/2007 | BP050069/0 |
| Versant HIV-1 RNA 3.0 (bDNA) | HIV-1 | Signal amplification nucleic acid probe | Plasma | Patient Monitoring: Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid. Not intended to be used as a donor screening test or as a diagnostic test to confirm the presence of HIV-1 infection. | Siemens Healthcare Diagnostics, Inc. | 9/11/2002 | BP000028/0 |
| ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer | HIV-1 | 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 | BK030033/0 |
| Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System | HIV-1 | 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 | BK020005, BK090077, BK080073 |
| Anti-HIV-1 Testing Service | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Home Access HIV-1 Test System | HIV-1 | Dried Blood Spot Collection Device | Dried Blood Spot | Diagnostic: Self-use by people who wish to obtain anonymous HIV testing | Home Access Health Corp., Hoffman Estates, IL | 7/22/1996 | BP950002/0 |
| Anti-HIV-1 Oral Specimen Collection Device | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| OraSure HIV-1 Oral Specimen Collection Device | HIV-1 | Oral Specimen Collection Device | Oral Fluid | For Use with HIV diagnostic assays that have been approved for use with this device. | OraSure Technologies Bethlehem, PA | 12/23/1994 | BP910001/0 |
| Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| GS HIV-2 EIA | HIV-2 | EIA | Serum / Plasma | Donor Screen and diagnostic. | Bio-Rad Laboratories Redmond, WA US License 1109 | 4/25/1990 | BL103227/0 |
| Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA | HIV-1, HIV-2 | EIA | Serum / Plasma / Cadaveric Serum | Donor Screen and diagnostic | Abbott Laboratories Abbott Park, IL US License 0043 | 2/14/1992 | BL103385/0 |
| ABBOTT PRISM HIV O Plus assay | HIV-1, HIV-2 | Chemi-luminescent Immunoassay (ChLIA) | Plasma / Serum/ Cadaveric Serum | Donor Screen: Qualitative detection of antibodies to HIV-1 (anti-HIV-1) groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma specimens. Organ donor screening when specimens are obtained while the donor's heart is still beating, in testing blood specimens to screen cadaveric (non-heart-beating) donors, and as an aid in the diagnosis of HIV- 1 /HIV-2 infection | Abbott Laboratories Abbott Park, IL US License 0043 | 9/18/2009 | BL125318/0 |
| GS HIV-1/HIV-2 Plus O EIA | HIV-1, HIV-2 | EIA | Serum / Plasma / Cadaveric Serum | Use with the Ortho Summit™ System (OSS) in the screening of blood donors, also for diagnostics. Diagnostic detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2 in human serum, plasma, and cadaveric serum specimens. | Bio-Rad Laboratories Redmond, WA US License 1109 | 8/5/2003 | BL125030/0, BL125030/10, BL125030/24 |
| ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents | HIV-1, HIV-2 | Microparticle Chemi-luminometric Immunoassay | Plasma/Serum | Diagnostic: For qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasma | Siemens Healthcare Diagnostics, Inc. | 5/18/2006 | BP050030/0 |
| Ortho VITROS HIV-1/HIV-2 | HIV-1, HIV-2 | EIA | Plasma/Serum | Diagnostic: For use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems | Ortho-Clinical Diagnostics, Inc Raritan, NJ US License 1236 | 3/27/2008 | BP050051/0, BP050051/18 |
| Multispot HIV-1/HIV-2 Rapid Test | HIV-1, HIV-2 | Rapid Immunoassay | Plasma / Serum | Diagnostic | Bio-Rad Laboratories Redmond, WA US License 1109 | 11/12/2004 | BP040046/0 |
| SURE CHECK HIV 1/2 ASSAY | HIV-1, HIV-2 | Rapid Immunoassay | Fingerstick & venous whole blood, serum, plasma | Diagnostic | Chembio Diagnostic Systems, Inc. Medford, NY | 5/25/2006 | BP050009/0 |
| HIV 1/2 STAT-PAK ASSAY | HIV-1, HIV-2 | Rapid Immunoassay | Fingerstick & venous whole blood, serum, plasma | Diagnostic | Chembio Diagnostic Systems, Inc. Medford, NY | 5/25/2006 | BP050010/0 |
| OraQuick ADVANCE Rapid HIV-1/2 Antibody Test | HIV-1, HIV-2 | Rapid Immunoassay | Whole Blood, Plasma, Oral Fluid | Diagnostic | OraSure Technologies Bethlehem, PA | 6/22/2004 | BP010047/16 |
| OraQuick ADVANCE Rapid HIV-1/2 Antibody Test | HIV-1, HIV-2 | Rapid Immunoassay | oral fluid, plasma, venous whole blood | Diagnostic | OraSure Technologies Bethlehem, PA | 11/7/2002 | BP010047/0 |
| Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay) and Anti-HIV-1 (HIV-1 Antigen Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| ARCHITECT HIV Ag/Ab Combo | HIV-1, HIV-2 | Chemi-luminescent Microparticle Immunoassay (CMIA) | Plasma / Serum | Diagnostic: For detection of antibodies to HIV-1 and HIV-2 and HIV-1 antigen | Abbott Laboratories Abbott Park, IL US License 0043 | 6/18/2010 | BP090080 |
| Bio-Rad GS HIV Ag/Ab Combo EIA | HIV-1, HIV-2 | EIA | Plasma / Serum | Diagnostic: For detection of antibodies to HIV-1 and HIV-2 and HIV-1 antigen as an aid in the diagnosis of HIV infection, including in pediatric populations (children as young as two years old). | Bio-Rad Laboratories Redmond, WA US License 1109 | 7/22/2011 | BP100064 |
| Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Abbott HTLV-I/HTLV-II EIA | HTLV-1, HTLV-2 | EIA | Serum / Plasma | Donor Screen | Abbott Laboratories Abbott Park, IL US License 0043 | 8/15/1997 | BL103614/0 |
| ABBOTT PRISM HTLV-I/HTLV-II | HTLV-1, HTLV-2 | Chemi-luminescent Immunoassay (ChLIA) | Serum / Plasma | Donor Screen: Screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. Also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor’s heart is still beating. | Abbott Laboratories Abbott Park, IL US License 0043 | 1/16/2008 | BL103761/0 |
| Trypanosoma cruzi (T. cruzi) (Anti- T. cruzi Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Abbott Prism Chagas [Trypanosoma cruzi (E. coli, Recombinant) Antigen] | T. cruzi | EIA | Serum / Plasma | Donor Screening | Abbott Laboratories Abbott Park, IL US License 0043 | 4/30/2010 | BL125361/0 |
| ORTHO T. cruzi ELISA Test System | T. cruzi | EIA | Serum / Plasma | Donor screening: Test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors. Also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating I think this also has claim to screen donors. | Ortho-Clinical Diagnostics, Inc. Raritan, NJ US License 1236 | 12/13/2006 | BL125161/0 |
| West Nile Virus (WNV RNA Assay) | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Procleix West Nile Virus (WNV) Assay | WNV | Nucleic Acid Test (TMA) | Plasma/ Cadaveric plasma or serum | Donor Screen: Qualitative detection of West Nile Virus (WNV) RNA from volunteer donors of whole blood and blood components, screen organ donors when obtained while donor's heart is still beating, and test blood specimens to screen cadaveric donors | Gen-Probe, Inc., San Diego, CA US License 1592 | 12/1/2005 | BL125121/0 |
| COBAS TaqScreen West Nile Virus Test | WNV | PCR | Plasma/ Cadaveric plasma or serum | Donor Screen: For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. Also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating and test blood specimens to screen cadaveric donors. | Roche Molecular Systems, Inc. Pleasanton, CA US License 1636 | 8/28/2007 | BL125245/0 |
| Multiplex Assays | |||||||
| Tradename(s) with link to original letter and labeling (Labeling may be out of date) | Infec-tious Agent | Format | Current Sample | Use | Manufacturer | Approval Date | STN |
| Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/Nucleic Acid Pooled Testing/Synthetic)- Procleix HIV-1/HCV Assay | HCV, HIV-1 | HIV-1/HCV Nucleic Acid Test (TMA) | Plasma/ Cadaveric plasma or serum | Donor Screen: | Gen-Probe, Inc., San Diego, CA US License 1592 | 2/27/2002 | BL103966/0 |
| COBAS TaqScreen MPX Test | HCV, HIV-1, HIV-2 | PCR | Plasma/ Cadaveric plasma or serum | Donor Screen: Simultaneous detection of HIV-1 Group M and Group O RNA, HIV-2 RNA, HCV RNA | Roche Molecular Systems, Inc. Pleasanton, CA US License 1636 | 12/30/2008 | BL125255/0 |
| Procleix Ultrio Assay | HBV, HCV, HIV-1 | Nucleic Acid Test (TMA) | Plasma/ Serum/ Cadaveric plasma or serum | Donor Screen: Qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA from volunteer donors of whole blood and blood components, screen organ donors when obtained while donor's heart is still beating, and test blood specimens to screen cadaveric donors. Expanded HBV screening claim for individual samples and pooled samples of up to 16 individual donations. To include testing of pools of up to 16 donations from donors of Hematopoietic Progenitor Cells (HPCs) or Donor Lymphocytes for Infusion (DLI). | Gen-Probe, Inc., San Diego, CA US License 1592 | 10/3/2006 | BL125113/0 |
Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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