Anti-HIV-1 Assays

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

HIVAB HIV-1 EIA

EIA

Serum / Plasma

Donor Screen

Abbott Laboratories
Abbott Park, IL
US License 0043

3/1/1985

Genetic Systems rLAV EIA

EIA

Serum / Plasma

Donor Screen

Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109

6/29/1998

Murex SUDS HIV-1 Test

Rapid EIA

Serum / Plasma

Donor Screen

Murex Diagnostics, Inc.
Norcross, GA
US License 1152

5/22/1992

Vironostika HIV-1 Microelisa System

EIA

Serum / Plasma

Donor Screen

bioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
US License 1624

12/18/1987

Vironostika HIV-1 Plus O Microelisa System

EIA

Plasma / Serum / Dried Blood Spots

Diagnostic, Non-Donor Screen

bioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
US License 1624

6/6/2003

Cambridge Biotech HIV-1 Western Blot Kit

WB

Serum / Plasma

Donor Supplemental

Calypte Biomedical Corp.
Berkeley, CA
US License 1207

1/3/1991

Genetic Systems HIV-1 Western Blot

WB

Serum / Plasma

Donor Supplemental

Bio-Rad Laboratories Blood Virus Division

11/13/1998

Fluorognost HIV-1 IFA

IFA

Serum / Plasma

Donor Supplemental

Waldheim Pharmazeutika G.m.b.H.
Vienna, Austria
US License 1150

2/5/1992

HIVAB HIV-1 EIA

EIA

Dried Blood Spot

Non-Donor Screen

Abbott Laboratories

4/22/1992

HIV-1 Urine EIA

EIA

Urine Screen

Non-Donor Screen

Calypte Biomedical Corp.

8/6/1996

Genetic Systems rLAV EIA

EIA

Dried Blood Spot

Non-Donor Screen

Bio-Rad Laboratories Blood Virus Division

6/29/1998

 

Vironostika HIV-1 Microelisa System

 

EIA

 

Dried Blood Spot

 

Non-Donor Screen

 

bioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712

 

4/11/1990

Oral Fluid Vironostika HIV-1 Microelisa System

EIA

Oral Fluid

Non-Donor Screen

bioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712

12/23/1994

Cambridge Biotech HIV-1 Western Blot Kit

WB

Urine

Non-Donor Supplemental

Calypte Biomedical Corp.

5/28/1998

Genetic Systems HIV-1 Western Blot

WB

Dried Blood Spot

Non-Donor Supplemental

Bio-Rad Laboratories Blood Virus Division

11/13/1998

OraSure HIV-1 Western Blot Kit

WB

Oral Fluid

Non-Donor Supplemental

Epitope, Inc.

6/3/1996

Fluorognost HIV-1 IFA

IFA

Dried Blood Spot

Non-Donor Supplemental

Waldheim Pharmazeutika G.m.b.H.

5/14/1996

OraQuick Rapid HIV-1 Antibody Test

Rapid EIA

Fingerstick

Non-Donor Screen

OraSure Technologies, Inc.
150 Webster Street
Bethlehem, PA 18015-1389

11/7/2002

Reveal Rapid HIV-1 Antibody Test

Rapid Immunoassay

Serum / Plasma

Non-Donor Screen

MedMira Laboratories, Inc.
Halifax, Nova Scotia
Canada B3S 1B3

4/16/2003

 

 

 

 

 

 

Anti-HIV-1/2 Assays

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

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

EIA

Serum / Plasma

Donor Screen

Abbott Laboratories
Abbott Park, IL
US License 0043

2/14/1992

Genetic Systems HIV-1/HIV-2 Peptide EIA

EIA

Serum / Plasma / Cadaveric Serum

Donor Screen

Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109

12/9/2000

Genetic Systems HIV-1/HIV-2 PLUS O EIA

EIA

Serum/Plasma

Donor Screen

Bio-Rad Laboratories, Inc
4000 Alfred Nobel Drive
Hercules, CA 94547
License 1109

 

8/5/2003

Anti-HIV-2 Assay

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Genetic Systems HIV-2 EIA

EIA

Serum / Plasma

Donor Screen

Bio-Rad Laboratories Blood Virus Division
Redmond, WA
US License 1109

4/25/1990


 

 

 

 

 

 

 

 

 

HIV-1 Antigen Assays

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Abbott HIVAG-1 Monoclonal

EIA

Serum / Plasma

Donor Screen / Prognosis & Neut. Kit

Abbott Laboratories
Abbott Park, IL
US License 0043

4/23/1996

Coulter HIV-1 p24 Ag Assay;
HIV-1 p24 Antigen ELISA Test System

EIA

Serum / Plasma

Donor Screen / Prognosis & Neut. Kit

Coulter Corporation
Miami, FL
US License 1185

3/14/1996

Abbott HIVAG-1

EIA

Serum / Plasma

Prognosis & Neut. Kit

Abbott Laboratories

8/3/1989

Coulter HIV-1 p24 Ag Assay

EIA

Viral Culture Supernatant

Prognosis (Quantitative) & Neut. Kit

Coulter Corporation

3/14/1996

Anti-HIV-1 Oral Specimen Collection Device

Tradename(s)

Format

Sample

Use

Manufacturer

Approval Date

Epitope OraSure HIV-1 Oral Specimen Collection Device

Oral Specimen Collection Device

Oral Fluid

For Use in Designated Non-Donor Screen and Non-Donor Supplemental Assays

Epitope, Inc.
Beaverton, OR

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

Non-Donor Screen

Home Access Health Corp.
Hoffman Estates, IL

7/22/1996

 

HIV-1 /HCV 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.
Branchburg Township, NJ

3/2/1999

NucliSens HIV-1 QT

NASBA

Plasma

Prognosis / Patient Management
HIV-1 Viral Load Assay

bioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712

11/19/2001

COBAS Ampliscreen HIV-1 Test

PCR

Plasma

Donor Screen

Roche Molecular Systems, Inc
4300 Hacienda Drive
Pleasanton, CA 94566

12/20/2002

Procleix

HIV-1/HCV Nucleic Acid Test (TMA)

Plasma

Donor Screen

Gen-Probe
10210 Genetic Center Dr
San Diego, CA 92121

2/8/2002

Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing

HIV-1 Genotyping

Plasma

Patient Monitoring

Visible Genetics, Inc.
700 Bay Street , Suite 1000
Toronto, 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

HIV-1 Genotyping

Plasma

Patient Monitoring

Applied Biosystems
Foster City, CA 94404

12/10/2002

Versant HIV-1 RNA 3.0 (bDNA)

Signal amplification nucleic acid probe

Plasma

Patient Monitoring

Bayer Corporation
Berkeley, CA 94702

9/11/2002

COBAS AmpliScreen HCV Test

PCR

Plasma

Donor Screen

Roche Molecular Systems, Inc
4300 Hacienda Drive
Pleasanton, California 94566-0990

12/3/2002