Vaccines, Blood & Biologics

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

HBV                HBsAg Assays - Hepatitis B Surface Antigen
                        Anti-HBc Assays - Hepatitis B Virus Core Antigen
                        HBV Nucleic Acid Assays - Hepatitis B Virus

HCV                Anti-HCV Assays - Hepatitis C Virus Encoded Antigen
                        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
                        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

T. pallidum     Anti-T. Pallidum Assays - Treponema pallidum (Syphilis)
T. cruzi           Anti- T. cruzi Assays - Trypanosoma cruzi (T. cruzi)
WNV               WNV Nucleic Acid Assays - West Nile Virus
CMV               Anti-CMV Assays - Cytomegalovirus

Multiplex        Multiplex Assays

Return to the Infectious Disease Tests page


 HBsAg Assays (detect Hepatitis B Surface Antigen)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN

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

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Anti-HBc Assays (detect antibodies to Hepatitis B Virus Core Antigen)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN

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

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HBV Nucleic Acid Assays (detect Hepatitis B Virus DNA), see also Multiplex Assays
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN

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

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Anti-HCV Assays (detect antibodies to Hepatitis C Virus Encoded Antigen)
TradenameInfectious AgentFormatSpecimenUseManufacturerApproval DateSTN

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

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

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HCV Nucleic Acid Assays (detect Hepatitis C Virus RNA), see also Multiplex Assays

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

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Anti-HIV-1 Assays (detect antibodies to Human Immunodeficiency Virus type 1)

Tradename)

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

INSTI™ HIV-1 Antibody Test Kit

HIV-1

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

11/29/2010

BP090032

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

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HIV-1 Nucleic Acid Assays (detect Human Immunodeficiency Virus type 1 RNA), see also Multiplex Assays

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

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

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

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Anti-HIV Specimen Collection Devices, Testing Services, and Home Test Kits

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

For Use with HIV diagnostic assays that have been approved for use with this device.

OraSure Technologies
Bethlehem, PA

12/23/1994

BP910001

OraQuick In-Home HIV Test

HIV-1, HIV-2

Immunoassay

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

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Anti-HIV-2 Assays(detect antibodies to Human Immunodeficiency Virus type 2)

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

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Anti-HIV-1/2 Assays (detect antibodies to Human Immunodeficiency Virus types 1 and 2)

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

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
 

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.

Siemens Healthcare Diagnostics, Inc.

5/18/2006

BP050030

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

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Anti-HIV-1/2 and HIV-1 Antigen Combo Assays (detect HIV-1 antigen and antibodies to HIV Types 1 and 2)

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

ARCHITECT HIV Ag/Ab Combo

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.

Abbott Laboratories
Abbott Park, IL
US License 0043

6/18/2010

BP090080

 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

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Anti-HTLV-I/II Assays (detect antibodies to Human T-Lymphotropic Virus types I and II)

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

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Anti-T. pallidum Assays (detect antibodies to Treponema pallidum)and other serological tests for Syphilis

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

Beckman-Coulter (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.

2/24/2014BK 130001
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Anti- T. cruzi Assays (detect antibodies to Trypanosoma cruzi)

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

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WNV Nucleic Acid Assays (detect West Nile Virus RNA

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

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Anti-CMV Assays (detect antibodies to Cytomegalovirus)

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

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Multiplex Assays

Tradename

Infectious Agent

Format

Specimen

Use

Manufacturer

Approval Date

STN

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

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.

Gen-Probe, Inc.,
San Diego, CA
US License 1592

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.

Gen-Probe, Inc.,
San Diego, CA
US License 1592

5/25/2012

BL125113

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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