Testing HCT/P Donors

for Relevant Communicable Disease Agents and Diseases

For information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases under 1271.80, see Testing HCT/P Donors: Specific Requirements and the Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, dated 8/8/2007

For information about tests licensed or cleared for use in blood donors.

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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) Format Specimen
Collection
Donors Manufacturer Approval Date
Genetic Systems HBsAg EIA 3.0 EIA Living: Serum,
plasma Cadaveric: serum
Living, Cadaveric Bio-Rad Laboratories 1/23/2003
Auszyme Monoclonal* EIA Living: Serum, Plasma Cadaveric: serum (using procedure D only) Living, Cadaveric Abbott Laboratories 12/19/2001
Abbott Prism HBsAg Assay (Screening Test) ChLIA Living: Serum, plasma Cadaveric: serum Living, Cadaveric Abbott Laboratories 7/18/2006
ORTHO Antibody to HBsAg ELISA Test System 3 EIA Living: Serum, Plasma Living Ortho-Clinical Diagnostics, Inc 4/23/2003

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

Anti-HBc Assays
(Detects antibodies to Hetatits 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) Format Specimen
Collection
Donors Manufacturer Approval Date
CORZYME* EIA Living: Serum, Plasma Living Abbott Laboratories 3/19/1991
Ortho HBc ELISA Test System EIA Living: Serum, Plasma Living Ortho-Clinical Diagnostics, Inc 4/18/1991
ABBOTT PRISM HBcore ChLIA Living: Serum, Plasma Living Abbott Laboratories 10/13/2005

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

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

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
COBAS AmpliScreen HBV Test PCR Living: Plasma Cadaveric: Serum, EDTA plasma Living, Cadaveric Roche Molecular Systems Inc. 8/16/2007

 

Hepatitis C Virus (HCV)

Anti-HCV Assays
(Detects antibody to HCV)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Abbott HCV EIA 2.0 EIA Living: Serum, Plasma Cadaveric: Serum Living Cadaveric Abbott Laboratories 7/22/2004
Abbott PRISM HCV ChLIA Living: Serum, Plasma Cadaveric: Serum Living Cadaveric Abbott Laboratories 7/11/2007
Ortho HCV Version 3.0 ELISA Test System EIA Living: Serum, Plasma Living Ortho-Clinical Diagnostics, Inc 5/20/1996

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

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
COBAS Ampliscreen HCV Test Version 2.0 PCR Living: Plasma Cadaveric: Serum, EDTA Plasma Living Cadaveric Roche Molecular Systems 5/22/2007
Procleix HIV-1/HCV TMA Living: Plasma Cadaveric: Serum, EDTA Plasma Living Cadaveric Gen-Probe, Inc. 6/4/2004
Procleix Ultrio TMA Living: Plasma, Serum Cadaveric: Serum, EDTA plasma Living Cadaveric Gen-Probe, Inc. 10/3/2006

 

Human Immunodeficiency Virus (HIV)-1 AND 2

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

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Genetic Systems HIV-1/HIV-2 Plus 0 EIA EIA Living: Serum, Plasma Cadaveric: Serum Living, Cadaveric Bio-Rad Laboratories 8/5/2003
HIVAB HIV-1/ HIV-2 (rDNA) EIA EIA Living: Serum, Plasma Cadaveric: Serum Living, Cadaveric Abbott Laboratories 7/22/2004

 

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

(Detects antibodies to HIV-1)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Genetic Systems rLAV EIA EIA Living: Serum, Plasma Living Bio-Rad Laboratories 6/29/1998

 

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

(Detects antibodies to HIV-2)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Genetic Systems HIV-2 EIA EIA Living: Serum, Plasma Living Bio-Rad Laboratories 4/25/1990

 

HIV-1 Nucleic Acid Tests

(Direct detection of HIV-1 RNA)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
COBAS AmpliScreen HIV-1 Test, version 1.5 PCR Living: Plasma Cadaveric: Serum, EDTA Plasma Living, Cadaveric Roche Molecular Systems 5/23/2007
Procleix HIV-1/HCV TMA Living: Plasma Cadaveric: Serum, EDTA Plasma Living, Cadaveric Gen-Probe, Inc. 6/4/2004
Procleix Ultrio TMA Living: Plasma, Serum Cadaveric: Serum, EDTA Plasma Living, Cadaveric Gen-Probe, Inc. 10/3/2006

 

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

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

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Abbott HTLV-I/HTLV-II EIA EIA Living: Serum Plasma Living Abbott Laboratories 8/15/1997
ABBOTT PRISM HTLV-1/HTLV-II Assay ChLIA Living: Serum Plasma Living Abbott Laboratories 1/16/2008
Vironostika* HTLV-I/II Microelisa System EIA Living: Serum Plasma Living bioMerieux, Inc 1/17/1998

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

 

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

(Detects antibodies to T. cruzi)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
ORTHO T. cruzi ELISA Test System EIA Living: Serum Plasma Living Ortho-Clinical Diagnostics, Inc 12/13/2006

 

West Nile Virus (WNV)

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

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Procleix WNV Assay TMA Living: Plasma Cadaveric: Serum, EDTA Plasma Living, Cadaveric Gen-Probe, Inc 12/1/2005
Cobas TaqScreen West Nile Virus Test PCR Living: Plasma
Cadaveric: Plasma
Living, Cadaveric Roche 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) Format Specimen
Collection
Donors Manufacturer Approval Date
Aptima Combo2 Assay
Package Insert (PDF - 1 MB)
Summary (PDF) - CDRH
Substantial Equivalence Determination (PDF) - CDRH
TMA Living: Endocervical and vaginal swabs, male urethral swabs, and urine specimens Living Gen-Probe, Inc. 8/9/2005
Aptima Assay for Chlamydia trachomatis
Package Insert (PDF-1.7 MB)
Summary (PDF) - CDRH
Substantial Equivalence Determination (PDF) - CDRH
TMA Living: Endocervical and vaginal swabs, male urethral swabs, and urine specimens Living Gen-Probe, Inc. 1/22/2007
BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhea Amplified DNA Assays
Package Insert (PDF - 916 KB)
Summary (PDF) - CDRH
SDA Living: Endocervical swabs, male urethral swabs, urine specimens Living Becton, Dickinson & Co. 9/18/2001
AMPLICOR CT/NG Test for Chlamydia trachomatis
Package Insert (PDF - 741 KB)
Summary (PDF) - CDRH
PCR Living: Endocervical swabs, male urethral swabs, urine specimens Living Roche Molecular Systems 8/4/1999
4/16/2007
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis
Package Insert (PDF - 898 KB)
Summary (PDF) - CDRH
PCR Living: Endocervical swabs, male urethral swabs, urine specimens Living Roche Molecular Systems 12/15/1998

Note: This list may be incomplete.

 

Neisseria gonorrhea

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

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Aptima Combo2 Assay
Package Insert (PDF - 1 MB)
Summary (PDF) - CDRH
Substantial Equivalence Determination (PDF) - CDRH
TMA Living: Endocervical and vaginal swabs, male urethral swabs, and urine specimens Living Gen-Probe, Inc. 8/9/2005
Aptima Assay for Neisseria gonorrhea
Package Insert (PDF - 1.5 MB)
Substantial Equivalence Determination (PDF) - CDRH
TMA Living: Endocervical and vaginal swabs, male urethral swabs, and urine specimens Living Gen-Probe, Inc. 3/14/2005
BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhea Amplified DNA Assays
Package Insert (PDF - 916 KB)
Summary (PDF) - CDRH
SDA Living: Endocervical swabs, male urethral swabs, urine specimens Living Becton, Dickinson & Co. 9/18/2001
AMPLICOR CT/NG Test for Neisseria gonorrhea
Package Insert (PDF - 624 KB)
Summary (PDF) - CDRH
PCR Living: Endocervical swabs, male urethral swabs, urine specimens Living Roche Molecular Systems 12/1/1999
COBAS AMPLICOR test for Neisseria gonorrhea
Package Insert (PDF - 594 KB)
Summary (PDF) - CDRH
PCR Living: Endocervical swabs, male urethral swabs, urine specimens Living Roche Molecular Systems 5/28/1999

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) Format Specimen
Collection
Donors Manufacturer Clearance Date
BD CMVscan Card Test
Package Insert (PDF - 170 KB)
Latex Agglutination Living: Serum, Plasma Living Becton, Dickinson & Company 12/22/1995
Capture - CMV
Package Insert (PDF - 170 KB)
Solid phase red cell adherence Living: Serum, Plasma Living Immucor, Inc. 12/22/1995
Abbott CMV* Total AB EIA
Package Insert (PDF - 195 KB)
Solid phase enzyme immunoassay Living: Serum, Plasma Living Abbott Laboratories, Diagnostic Division  
Olympus PK CMV-PA System Passive particle agglutination Living: Serum, Plasma Living Fujirebio, 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
Capture®-S
Package Insert (PDF - 498 KB)
Non-treponemal Living: Serum, Plasma Living Immucor 6/22/2000

Cleared confirmatory test for Treponema pallidum (Syphilis)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Clearance Date
FTA-ABS Test System
Package Insert (PDF - 342 KB)
Treponemal Living: Serum Living SCIMEDX Corporation  

Cleared diagnostic serologic tests for Treponema pallidum (Syphilis)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Clearance Date
REMEL RPR Card Test
Package Insert (PDF - 262 KB)
Non-treponemal Living: Serum Diagnostic Abbott Laboratories,
Diagnostic Division
7/29/1996
ASI VDRL Antigen Test
Package Insert (PDF - 73 KB)
Non-treponemal Living: Serum Diagnostic Arlington Scientific, Inc  
ASI RPR Card Test
Package Insert (PDF - 129 KB)
Non-treponemal Living: Serum Diagnostic Arlington Scientific, Inc  
TRUST (Toluidine Red Unheated Serum Test)
Package Insert (PDF - 151 KB)
Non-treponemal Living: Serum, Plasma Diagnostic New Horizons Diagnostics Corporation 9/12/1983

Note: This list may be incomplete.

 
Updated: August 19, 2008