Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

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 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 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

Procleix Ultrio

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.

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

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

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

 
Updated: March 17, 2008