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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

Table of Contents
Additional Resources
Information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases under 1271.80:

Note:

  • See product inserts for specific instructions regarding specimen collection.
  • Tests labeled for use in screening living donors are appropriate for use in testing heart-beating organ donors.
  • Abbreviations:
  • ChLIA - Chemiluminescent immunoassay
    EIA - enzyme immunoassay
    PCR - polymerase chain reaction
    TMA - transcription-mediated amplification

 

Licensed Donor Screening Tests

 

Hepatitis B Virus (HBV)

HBsAg Assays
(Detects Hepatitis B surface Antigen)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Genetic Systems HBsAg EIA 3.0EIALiving: Serum,
plasma Cadaveric: serum
Living, CadavericBio-Rad Laboratories1/23/2003
Auszyme Monoclonal*EIALiving: Serum, Plasma Cadaveric: serum (using procedure D only)Living, CadavericAbbott Laboratories12/19/2001
Abbott Prism HBsAg AssayChLIALiving: Serum, plasma Cadaveric: serumLiving, CadavericAbbott Laboratories7/18/2006
ORTHO Antibody to HBsAg ELISA Test System 3EIALiving: Serum, PlasmaLivingOrtho-Clinical Diagnostics, Inc4/23/2003

* Licensed for donor screening, but may not be available.

Anti-HBc Assays (Detects antibodies to Hepatitis B core antigen)

Note: Anti-HBc donor screening assays detect total antibody (IgG + IgM) to HBc. Currently, there is no donor screening test for Anti-HBc specifically licensed for use in testing cadaveric specimens from nonliving donors of HCT/Ps. Under 21 CFR 1271.80 (c) you must use a test specifically labeled for cadaveric specimens instead of a more generally labeled test when applicable and when available.

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
CORZYME*EIALiving: Serum, PlasmaLivingAbbott Laboratories3/19/1991
Ortho HBc ELISA Test SystemEIALiving: Serum, PlasmaLivingOrtho-Clinical Diagnostics, Inc4/18/1991
ABBOTT PRISM HBcoreChLIALiving: Serum, PlasmaLivingAbbott Laboratories10/13/2005

* Licensed for donor screening, but may not be available.

Hepatitis B Virus Nucleic Acid Tests
(Direct detection of HBV DNA)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
COBAS AmpliScreen HBV TestPCRLiving: Plasma Cadaveric: Serum, EDTA plasmaLiving, CadavericRoche Molecular Systems Inc.8/16/2007
Procleix UltrioTMALiving: Plasma, Serum Cadaveric: Serum, EDTA plasmaLiving, CadavericGen-Probe, Inc.10/3/2006

COBAS TaqScreen MPX Test

 

PCRLiving: Plasma Cadaveric: Serum, EDTA PlasmaLiving, CadavericRoche Molecular Systems Inc.8/27/2009
Procleix Ultrio PlusTMALiving: Plasma, Serum Cadaveric: Serum, EDTA plasmaLiving, CadavericGen-Probe, Inc.10/25/2012

Hepatitis C Virus (HCV)

Anti-HCV Assays
(Detects antibody to HCV)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Abbott HCV EIA 2.0EIALiving: Serum, Plasma Cadaveric: SerumLiving, CadavericAbbott Laboratories7/22/2004
Abbott PRISM HCVChLIALiving: Serum, Plasma Cadaveric: SerumLiving, CadavericAbbott Laboratories7/11/2007
Ortho HCV Version 3.0 ELISA Test SystemEIALiving: Serum, PlasmaLiving, CadavericOrtho-Clinical Diagnostics, Inc2/18/2009

Hepatitis C Virus Nucleic Acid Testing
(Direct detection of HCV RNA)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
COBAS Ampliscreen HCV Test Version 2.0PCRLiving: Plasma Cadaveric: Serum, EDTA PlasmaLiving, CadavericRoche Molecular Systems5/22/2007
Procleix HIV-1/HCVTMALiving: Plasma Cadaveric: Serum, EDTA PlasmaLiving, CadavericGen-Probe, Inc.6/4/2004
Procleix UltrioTMALiving: Plasma, Serum Cadaveric: Serum, EDTA plasmaLiving, CadavericGen-Probe, Inc.10/3/2006
COBAS TaqScreen MPX TestPCRLiving: Plasma
Cadaveric: Serum, EDTA Plasma
Living, CadavericRoche Molecular Systems Inc.12/30/2008
Procleix Ultrio PlusTMALiving: Plasma, Serum Cadaveric: Serum, EDTA plasmaLiving, CadavericGen-Probe, Inc.10/25/2012

Human Immunodeficiency Virus (HIV)-1 AND 2

Anti-HIV-1/2 Assays
(Detects antibodies to HIV Types 1 & 2)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Genetic Systems HIV-1/HIV-2 Plus O EIAEIALiving: Serum, Plasma Cadaveric: SerumLiving, CadavericBio-Rad Laboratories8/5/2003
ABBOTT PRISM
HIV O Plus
ChLIALiving: Serum, Plasma Cadaveric: SerumLiving, CadavericAbbott Laboratories9/18/2009
HIVAB HIV-1/ HIV-2 (rDNA) EIAEIALiving: Serum, Plasma Cadaveric: SerumLiving, CadavericAbbott Laboratories7/22/2004

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

(Detects antibodies to HIV-1)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Genetic Systems rLAV EIAEIALiving: Serum, PlasmaLivingBio-Rad Laboratories6/29/1998
HIV-1 (Western Blot)EIALiving: Serum, Plasma, UrineLivingCambridge Biotech Corp5/28/2998

 

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

(Detects antibodies to HIV-2)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Genetic Systems HIV-2 EIAEIALiving: Serum, PlasmaLivingBio-Rad Laboratories4/25/1990

HIV-1 Nucleic Acid Tests

(Direct detection of HIV-1 RNA)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
COBAS AmpliScreen HIV-1 Test, version 1.5PCRLiving: Plasma Cadaveric: Serum, EDTA PlasmaLiving, CadavericRoche Molecular Systems5/23/2007
Procleix HIV-1/HCVTMALiving: Plasma Cadaveric: Serum, EDTA PlasmaLiving, CadavericGen-Probe, Inc.6/4/2004
Procleix UltrioTMALiving: Plasma, Serum Cadaveric: Serum, EDTA PlasmaLiving, CadavericGen-Probe, Inc.10/3/2006
COBAS TaqScreen MPX TestPCRLiving: Plasma
Cadaveric: Serum, EDTA Plasma
Living, CadavericRoche Molecular Systems Inc.12/30/2008
Procleix Ultrio PlusTMALiving: Plasma, Serum Cadaveric: Serum, EDTA PlasmaLiving, CadavericGen-Probe, Inc.10/25/2012

Human T-Lymphotrophic Virus Types I & II (Anti-HTLV-I/II Assays)

(Detects antibodies to Human T-Lymphotropic Virus Types I & II)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
ABBOTT PRISM HTLV-1/HTLV-II AssayChLIALiving: Serum PlasmaLivingAbbott Laboratories1/16/2008
Avioq HTLV I/II Microelisa SystemEIALiving: Serum PlasmaLivingAvioq, Inc.3/26/2012

* Licensed for donor screening, but may not be available.

Trypanosoma cruzi (Chagas Disease) (Anti- T. cruzi Assays)

(Detects antibodies to T. cruzi)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Abbott Prism ChagasChLIALiving: Serum PlasmaLiving, CadavericAbbott Laboratories4/30/2010
ORTHO T. cruzi ELISA Test SystemEIALiving: Serum PlasmaLiving, CadavericOrtho-Clinical Diagnostics, Inc2/18/2009

West Nile Virus (WNV)

West Nile Virus Nucleic Acid Testing
(Direct detection of WNV RNA)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Procleix WNV AssayTMALiving: Plasma Cadaveric: Serum, EDTA PlasmaLiving, CadavericGen-Probe, Inc12/1/2005
Cobas TaqScreen West Nile Virus TestPCRLiving: Plasma
Cadaveric: EDTA Plasma
Living, CadavericRoche Molecular Systems, Inc.4/2/2008

 


 

Cleared Nucleic Acid Tests (NAT) for Chlamydia trachomatis and Neisseria gonorrhea

Note: Although there are diagnostic tests available, there are currently no FDA-licensed, approved, or cleared tests for donor screening. In the absence of such screening tests, you must use an FDA-licensed, approved, or cleared diagnostic test labeled for the detection of these organisms in an asymptomatic, low-prevalence population (§ 1271.80(c)). The use of Chlamydia trachomatis and Neisseria gonorrhea tests utilizing NAT technology adequately and appropriately reduces the risk of transmission of these relevant communicable disease agents (§ 1271.80(c)).

Chlamydia trachomatis

Chlamydia trachomatis Nucleic Acid Assays
(Direct detection of C. trachomatis)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Aptima Combo2 Assay
Package Insert (PDF - 1 MB)
Summary (PDF) - CDRH
Substantial Equivalence Determination (PDF) - CDRH
TMALiving: Endocervical and vaginal swabs, male urethral swabs, and urine specimensLivingGen-Probe, Inc.8/9/2005
Aptima Assay for Chlamydia trachomatis
Package Insert (PDF-1.7 MB)
Summary
(PDF) - CDRH
Substantial Equivalence Determination
(PDF) - CDRH
TMALiving: Endocervical and vaginal swabs, male urethral swabs, and urine specimensLivingGen-Probe, Inc.1/22/2007
BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhea Amplified DNA Assays
Package Insert (PDF - 916 KB)
Summary (PDF) - CDRH
SDALiving: Endocervical swabs, male urethral swabs, urine specimensLivingBecton, Dickinson & Co.9/18/2001
AMPLICOR CT/NG Test for Chlamydia trachomatis
Package Insert (PDF - 741 KB)
Summary (PDF - 282 KB) - CDRH
PCRLiving: Endocervical swabs, male urethral swabs, urine specimensLivingRoche Molecular Systems8/4/1999
4/16/2007
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis
Package Insert (PDF - 898 KB)
Summary
(PDF) - CDRH
PCRLiving: Endocervical swabs, male urethral swabs, urine specimensLivingRoche Molecular Systems12/15/1998

Note: This list may be incomplete.

Neisseria gonorrhea

Neisseria gonorrhea Nucleic Acid Assays
(Direct detection of N. gonorrhea)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerApproval Date
Aptima Combo2 Assay
Package Insert (PDF - 1 MB)
Summary (PDF) - CDRH
Substantial Equivalence Determination (PDF) - CDRH
TMALiving: Endocervical and vaginal swabs, male urethral swabs, and urine specimensLivingGen-Probe, Inc.8/9/2005
Aptima Assay for Neisseria gonorrhea
Package Insert (PDF - 1.5 MB)
Substantial Equivalence Determination (PDF) - CDRH
TMALiving: Endocervical and vaginal swabs, male urethral swabs, and urine specimensLivingGen-Probe, Inc.3/14/2005
BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhea Amplified DNA Assays
Package Insert (PDF - 916 KB)
Summary (PDF) - CDRH
SDALiving: Endocervical swabs, male urethral swabs, urine specimensLivingBecton, Dickinson & Co.9/18/2001
AMPLICOR CT/NG Test for Neisseria gonorrhea
Package Insert (PDF - 624 KB)
Summary (PDF) - CDRH
PCRLiving: Endocervical swabs, male urethral swabs, urine specimensLivingRoche Molecular Systems12/1/1999
COBAS AMPLICOR test for Neisseria gonorrhea
Package Insert (PDF - 594 KB)
Summary (PDF) - CDRH
PCRLiving: Endocervical swabs, male urethral swabs, urine specimensLivingRoche Molecular Systems5/28/1999

Note: This list may be incomplete.

EIA - enzyme immunoassay
PCR - polymerase chain reaction
SDA - strand displacement amplification
TMA - transcription-mediated amplification


 

Cleared Donor Screening Tests for Cytomegalovirus (CMV)

Note: CMV donor screening assays detect total antibody (IgG + IgM) to CMV. Though CMV is not a relevant communicable disease agent or disease, you must test a specimen from donors of viable, leukocyte-rich HCT/Ps for evidence of infection due to CMV, to adequately and appropriately reduce the risk of transmission (§ 1271.85(b)(2)). You must establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for CMV (§ 1271.85(b)(2)). A reactive CMV antibody test does not necessarily make a donor ineligible.

Cytomegalovirus (CMV) (Anti-CMV Assay)

(Detects antibodies to CMV)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerClearance Date
BD CMVscan Card Test
Package Insert (PDF - 170 KB)
Latex AgglutinationLiving: Serum, PlasmaLivingBecton, Dickinson & Company12/22/1995
Capture - CMV
Package Insert (PDF - 170 KB)
Solid phase red cell adherenceLiving: Serum, PlasmaLivingImmucor, Inc.12/22/1995
Abbott CMV* Total AB EIA
Package Insert (PDF - 195 KB)
Solid phase enzyme immunoassayLiving: Serum, PlasmaLivingAbbott Laboratories, Diagnostic Division 
Olympus PK CMV-PA SystemPassive particle agglutinationLiving: Serum, PlasmaLivingFujirebio, Inc.9/20/2007

* Licensed for donor screening, but may not be available.


 

Cleared Tests for Treponema pallidum (Syphilis)

Note: You may determine to be eligible a donor whose specimen tests negative or nonreactive on a non-treponemal screening test for syphilis. Under § 1271.80(d)(1), you may also determine to be eligible a donor whose specimen tests positive or reactive on a non-treponemal screening test for syphilis and negative or nonreactive on a specific treponemal confirmatory test (e.g., fluorescent treponemal antibody with absorption test (FTA-ABS), so long as all other required testing and screening are negative or nonreactive. A donor whose specimen tests positive or reactive on either a specific treponemal confirmatory test for syphilis or on a treponemal screening test is not eligible. Currently, there is no donor screening test for syphilis specifically labeled for use in testing cadaveric specimens from nonliving donors of HCT/Ps. Under 21 CFR 1271.80 (c) you must use a test specifically labeled for cadaveric specimens instead of a more generally labeled test when applicable and when available. If a cadaveric specimen is too hemolyzed to interpret the Rapid Plasma Reagin (RPR) test result, you should use another test, such as the FTA-ABS test result.

At this time, we consider FDA-cleared diagnostic serological tests to be adequate for use in donor screening for syphilis.

For more information about syphilis testing, see section VI. A. of FDA Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.

Cleared donor screening tests for Treponema pallidum (Syphilis)


Tradename(s)

Format

Specimen
Collection

Donors

Manufacturer

Clearance Date

Olympus PK TP System

Treponemal

Living: Serum, Plasma

Living

Fujirebio Inc.

2/21/2003

ASI TPHA Test

Treponemal

Living: Serum

Living

Arlington Scientific, Inc

1/30/2003

CAPTIA TM Syphilis(T. Pallidum)-G
Package Insert (PDF - 355 KB)

Treponemal

Living: Serum, Plasma

Living

Trinity Biotech

4/2010

TPHA Screen

Treponemal

Living: Serum, Plasma

Living

Immucor

10/24/2012

ASiManager-ATNon-treponemalLiving: Serum, Plasma

Living

Arlington Scientific, Inc

2/24/2014

Cleared confirmatory test for Treponema pallidum (Syphilis)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerClearance Date
FTA-ABS Test System
Package Insert (PDF - 342 KB)
TreponemalLiving: SerumLivingSCIMEDX Corporation 

Cleared diagnostic serologic tests for Treponema pallidum (Syphilis)

Tradename(s)FormatSpecimen
Collection
DonorsManufacturerClearance Date
REMEL RPR Card Test
Package Insert (PDF - 262 KB)
Non-treponemalLiving: SerumDiagnosticAbbott Laboratories,
Diagnostic Division
7/29/1996
ASI VDRL Antigen Test
Package Insert (PDF - 73 KB)
Non-treponemalLiving: SerumDiagnosticArlington Scientific, Inc 
ASI RPR Card Test
Package Insert (PDF - 129 KB)
Non-treponemalLiving: SerumDiagnosticArlington Scientific, Inc 
TRUST (Toluidine Red Unheated Serum Test)
Package Insert (PDF - 151 KB)
Non-treponemalLiving: Serum, PlasmaDiagnosticNew Horizons Diagnostics Corporation9/12/1983

Note: This list may be incomplete.