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

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

Return to the Infectious Disease Tests page

Antibody to Hepatitis B Surface Antigen (HBsAg Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Auszyme Monoclonal

 EIA Serum / Plasma / Cadaveric Serum Donor Screen & Conf Kit Abbott Laboratories
Abbott Park, IL
US License 0043		 4/1/1985

GS HBsAg EIA 3.0

 EIA Serum / Plasma / Cadaveric Serum Donor Screen & Conf Kit Bio-Rad Laboratories
Redmond, WA
US License 1109		 1/23/2003

ORTHO Antibody to HBsAg ELISA Test System 3

 EIA Serum / Plasma Donor Screen / Diagnosis & Conf Kit Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236		 4/23/2003

ABBOTT PRISM HBsAg
ABBOTT PRISM HBsAg Confirmatory

 Chemiluminescent Immunoassay (ChLIA) Serum/Plasma Donor screening test to detect HBsAg. 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 intesting blood specimens to screen cadaveric (non-heart-beating) donors. Abbott Laboratories
Abbott Park, IL
US License 0043		 7/18/2006

 

Anti-HIV-1 Oral Specimen Collection Device

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

OraSure HIV-1 Oral Specimen Collection Device

 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

 

Anti-HIV-1 Testing Service

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Home Access HIV-1 Test System

 Dried Blood Spot Collection Device Dried Blood Spot Diagnostic Home Access Health Corp
Hoffman Estates, IL		 7/22/1996

 

Hepatitis B Surface Antigen (Anti-HBs Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Ausab EIA

 EIA Serum / Plasma Anti-HBs Abbott Laboratories
Abbott Park, IL
US License 0043		 11/18/1982

 

Hepatitis B Virus Core Antigen (Anti-HBc Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

CORZYME

 EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043		 3/19/1991

Ortho HBc ELISA Test System

 EIA Serum / Plasma Donor Screen Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236		 4/18/1991

ABBOTT PRISM HBcore

 Chemiluminescent Immunoassay (ChLIA) Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043		 10/13/2005

 

Hepatitis C Virus Encoded Antigen (Anti-HCV Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Abbott HCV EIA 2.0

 EIA Serum / Plasma / Cadaveric Serum Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043		 5/6/1992

Ortho HCV Version 3.0 ELISA Test System

 EIA Serum / Plasma Donor Screen Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236		 5/20/1996

Chiron RIBA HCV 3.0 Strip Immunoblot Assay

 SIA Serum / Plasma Donor Supplemental Chiron Corp
Emeryville, CA
US License 1106		 2/11/1999

Abbott PRISM HCV

 Chemiluminescent Immunoassay (ChLIA) Serum / Plasma Donor screening test for the 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

 

Nucleic Acid Testing

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Roche Amplicor HIV-1 Monitor Test

 PCR Plasma Prognosis / Patient Management
HIV-1 Viral Load Assay		 Roche Molecular Systems, Inc
Pleasanton, CA		 3/2/1999

NucliSens HIV-1 QT

 NASBA Plasma Prognosis / Patient Management
HIV-1 Viral Load Assay		 bioMerieux, Inc
Durham, NC		 11/19/2001

COBAS Ampliscreen HIV-1 Test

 PCR 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

Procleix HIV-1/HCV Assay

 HIV-1/HCV Nucleic Acid Test (TMA) Plasma Donor Screen
Expanded Indications For Use: Source Plasma donors, living organ donors and cadaveric samples		 Gen-Probe
San Diego, CA
US License 1592		 6/4/2004

Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing System

 HIV-1 Genotyping Plasma Patient Monitoring Siemens Medical Solutions Diagnostics
Berkeley, CA		 4/24/2002

UltraQual HIV-1 RT-PCR Assay

 PCR Plasma Donor Screen National Genetics Institute
Los Angeles, CA 92121		 9/18/2001

UltraQual HCV RT-PCR Assay

 PCR Plasma Donor Screen National Genetics Institute
Los Angeles, CA 92121		 9/18/2001

ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer

 HIV-1 Genotyping Plasma Patient Monitoring Celera Diagnostics
Alameda, CA		 6/11/2003

Versant HIV-1 RNA 3.0 (bDNA)

 Signal amplification nucleic acid probe Plasma Patient Monitoring

Siemens Medical Solutions Diagnostics

Berkeley, CA

 9/11/2002

COBAS AmpliScreen HCV Test

 PCR 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		 12/3/2002

COBAS AmpliScreen HBV Test

 PCR Plasma Donor Screen
Indications For Use: Source Plasma donors, other living donors, and organ donors		 Roche Molecular Systems, Inc
Pleasanton, CA
US License 1636		 4/21/2005

Procleix West Nile Virus (WNV) Assay

 Nucleic Acid Test (TMA) Plasma 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
San Diego, CA
US License 1592		 12/1/2005
APTIMA HIV-1 RNA Qualitative Assay HIV-1 and HCV/Nucleic Acid Pooled Testing/Synthetic Plasma For use as an aid in diagnosis of HIV-1 infection, including acute or primary infection. Gen-Probe, Inc
US License 1592		 10/4/2006

Procleix Ultrio Assay

 Nucleic Acid Test (TMA) Plasma and Serum 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.
8/12/2008 Additional Indication:  Revision of Intended Use to include an HBV screening claim for individual samples and pooled samples of up to 16 individual donations. An Intended Use 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
San Diego, CA
US License 1592		 10/3/2006

Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay

 PCR 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

Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay

 PCR Plasma 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

Abbott RealTime HIV-1 Amplification Kit

 PCR Plasma Quantitation of Human Immunodeficiency Virus type 1 (HIV- 1) on the automated m2000 System. Not intended to be used as a donor screening test. ABBOTT Molecular, Inc
Des Plaines, IL		 5/11/2007

COBAS AmpliPrep/COBAS TaqMan HIV-1 Test

 PCR Plasma Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid. Not intended to be used as a donor screening test. Roche Molecular Systems, Inc
Pleasanton, CA		 5/11/2007

COBAS TaqScreen West Nile Virus Test

 PCR Plasma 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. Roche Molecular Systems, Inc
Pleasanton, CA
US License 1636		 8/28/2007

 

Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

GS rLAV EIA

 EIA Serum / Plasma Donor Screen Bio-Rad Laboratories Redmond, WA
US License 1109		 6/29/1998

Cambridge Biotech HIV-1 Western Blot Kit

 WB Serum / Plasma Donor Supplemental Calypte Biomedical Corp
Berkeley, CA
US License 1207		 1/3/1991

GS HIV-1 Western Blot

 WB Serum / Plasma Donor Supplemental Bio-Rad Laboratories
Redmond, WA
US License 1109		 11/13/1998

Fluorognost HIV-1 IFA

 IFA Serum / Plasma Donor Supplemental Waldheim Pharmazeutika GmbH
Vienna, Austria
US License 1150		 2/5/1992

HIVAB HIV-1 EIA

 EIA Dried Blood Spot Diagnostic Abbott Laboratories 4/22/1992

HIV-1 Urine EIA

 EIA Urine Screen Diagnostic Calypte Biomedical Corp 8/6/1996

GS rLAV EIA

 EIA Dried Blood Spot Diagnostic Bio-Rad Laboratories
Redmond, WA		 6/29/1998

Cambridge Biotech HIV-1 Western Blot Kit

 WB Urine Diagnostic Supplemental Maxim Biomedical, Inc 5/28/1998

GS HIV-1 Western Blot

 WB Dried Blood Spot Diagnostic Supplemental Bio-Rad Laboratories
Redmond, WA		 11/13/1998

OraSure HIV-1 Western Blot Kit

 WB Oral Fluid Diagnostic Supplemental OraSure Technologies
Bethlehem, PA		 6/3/1996

Fluorognost HIV-1 IFA

 IFA Dried Blood Spot Diagnostic Supplemental Waldheim Pharmazeutika GmbH 5/14/1996

Reveal Rapid HIV-1 Antibody Test

 Rapid Immunoassay Serum / Plasma Diagnostic MedMira Laboratories, Inc
Halifax, Nova Scotia
Canada B3S 1B3		 4/16/2003

Uni-Gold Recombigen HIV

 Rapid Immunoassay Serum / Plasma / Whole Blood
(venipuncture and fingerstick)		 Diagnostic Trinity Biotech, plc
Bray Co., Wicklow
Ireland		 12/23/2003

 

Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA

 EIA Serum / Plasma / Cadaveric Serum Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043		 2/14/1992

GS HIV-1/HIV-2 Plus O EIA

 EIA Serum / Plasma / Cadaveric Serum Donor Screen Bio-Rad Laboratories
Redmond, WA
US License 1109		 8/5/2003

Multispot HIV-1/HIV-2 Rapid Test

 Rapid Immunoassay Plasma / Serum Diagnostic Bio-Rad Laboratories
Redmond, WA		 11/12/2004

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

 Rapid Immunoassay Whole Blood, Plasma, Oral Fluid Diagnostic OraSure Technologies
Bethlehem, PA		 6/22/2004

ABBOTT PRISM HIV O Plus

 

 Chemiluminescent immunoassay (ChLIA) Serum / Plasma / Cadaveric Serum To be used to screen individual human donors, including volunteer donors of Whole Blood and blood components and other living donors, for the presence of anti-HIV-1 Groups M and O and/or anti-HIV-2. The assay is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, in testing blood specimens to screen cadaveric (non–heart-beating) donors. Abbott Laboratories 9/18/2009

ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents

 Microparticle Chemiluminometric 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 Medical Solutions Diagnostics
Tarrytown, NY		 5/18/2006

HIV 1/2 STAT-PAK ASSAY

SURE CHECK HIV 1/2 ASSAY

 Rapid Immunoassay Fingerstick & venous whole blood, serum, plasma Diagnostic Chembio Diagnostic Systems, Inc
Medford, NY		 5/25/2006

 

Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

GS HIV-2 EIA

 EIA Serum / Plasma Donor Screen Bio-Rad Laboratories
Redmond, WA
US License 1109		 4/25/1990

 

Human T-Lymphotropic Virus Types I & II (Anti-HTLV-I/II Assay)

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Abbott HTLV-I/HTLV-II EIA

 EIA Serum / Plasma Donor Screen Abbott Laboratories
Abbott Park, IL
US License 0043		 8/15/1997
ABBOTT PRISM HTLV-I/HTLV-II Chemiluminescent Immunoassay (ChLIA) Serum / Plasma To be used as a 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. It is 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

 

 

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

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

ORTHO T. cruzi ELISA Test System

 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 Ortho-Clinical Diagnostics, Inc
Raritan, NJ
US License 1236		 12/13/2006

 

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