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  1. Safety & Availability (Biologics)

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) 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 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 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) 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
Procleix Ultrio TMA Living: Plasma, Serum Cadaveric: Serum, EDTA plasma Living, Cadaveric Gen-Probe, Inc. 10/3/2006

COBAS TaqScreen MPX Test

PCR Living: Plasma Cadaveric: Serum, EDTA Plasma Living, Cadaveric Roche Molecular Systems Inc. 8/27/2009
Procleix Ultrio Elite Assay TMA Living: Plasma or Serum Cadaveric: Plasma or Serum Living, Cadaveric Grifols Diagnostics Solution 5/03/2018
Procleix Ultrio Plus TMA Living: Plasma, Serum Cadaveric: Serum, EDTA plasma Living, Cadaveric Gen-Probe, Inc. 10/25/2012

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, Cadaveric Ortho-Clinical Diagnostics, Inc 2/18/2009

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
COBAS TaqScreen MPX Test PCR Living: Plasma
Cadaveric: Serum, EDTA Plasma
Living, Cadaveric Roche Molecular Systems Inc. 12/30/2008
Procleix Ultrio Plus TMA Living: Plasma, Serum Cadaveric: Serum, EDTA plasma Living, Cadaveric Gen-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) Format Specimen
Collection
Donors Manufacturer Approval Date
Genetic Systems HIV-1/HIV-2 Plus O EIA EIA Living: Serum, Plasma Cadaveric: Serum Living, Cadaveric Bio-Rad Laboratories 8/5/2003
ABBOTT PRISM
HIV O Plus
ChLIA Living: Serum, Plasma Cadaveric: Serum Living, Cadaveric Abbott Laboratories 9/18/2009
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
HIV-1 (Western Blot) EIA Living: Serum, Plasma, Urine Living Cambridge Biotech Corp 5/28/2998

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
COBAS TaqScreen MPX Test PCR Living: Plasma
Cadaveric: Serum, EDTA Plasma
Living, Cadaveric Roche Molecular Systems Inc. 12/30/2008
Procleix Ultrio Plus TMA Living: Plasma, Serum Cadaveric: Serum, EDTA Plasma Living, Cadaveric Gen-Probe, Inc. 10/25/2012

Multiplex Assays

Tradename Infectious Agent Format Specimen Use Manufacturer Approval Date STN
COBAS TaqScreen MPX Test version 2.0 HBV, HCV, HIV-1 (including HIV-1 group O, group M), HIV-2 PCR Living: Plasma
Cadaveric:
Serum, Plasma
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
12/19/2014 BL125459
COBAS TaqScreen MPX Test HBV, HCV, HIV-1, HIV-2 PCR Living:
Plasma
Cadaveric:
Plasma, 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
2/29/2009
8/27/2009
BL125255
cobas® MPX Test HBV, HCV, HIV-1 (including group O), HIV-2 PCR Living:
Plasma, 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
10/21/2016
9/21/2017
BL125576
BL125576/11
Procleix Ultrio Elite Assay HBV, HCV, HIV-1, HIV-2 Nucleic Acid Test (TMA) Living:
Plasma, Serum
Cadaveric:
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, HIV-1 RNA and HIV-2 RNA. Grifols Diagnostics Solution.,
San Diego, CA
US License 2032
5/03/2018 BL125652
Procleix Ultrio Plus Assay HBV, HCV, HIV-1 Nucleic Acid Test (TMA) Living:
Plasma, Serum
Cadaveric:
Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA. Grifols Diagnostics Solution.,
San Diego, CA
US License 2032
5/25/2012 BL125113
Procleix Ultrio Assay HBV, HCV, HIV-1 Nucleic Acid Test TMA Living:
Plasma, Serum
Cadaveric: Plasma, Serum
Donor Screening: Simultaneous qualitative detection of HBV DNA, HCV RNA, and HIV-1 RNA. Grifols Diagnostics Solution.,
San Diego, CA
US License 2032
10/3/2006 BL125113

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 PRISM HTLV-1/HTLV-II Assay ChLIA Living: Serum Plasma Living Abbott Laboratories 1/16/2008
Avioq HTLV I/II Microelisa System EIA Living: Serum Plasma
Cadaveric: Serum, Plasma
Living,
Cadaveric
Avioq, Inc. 3/26/2012

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

(Detects antibodies to T. cruzi)

Tradename(s) Format Specimen
Collection
Donors Manufacturer Approval Date
Abbott Prism Chagas ChLIA Living: Serum Plasma Living, Cadaveric Abbott Laboratories 4/30/2010
ORTHO T. cruzi ELISA Test System EIA Living: Serum Plasma Living, Cadaveric Ortho-Clinical Diagnostics, Inc 2/18/2009

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: EDTA 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)
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 - 282 KB) - 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)
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)
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, 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.

For more information about syphilis testing, see Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.

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-AT Non-treponemal Living: Serum, Plasma
Cadaveric: Serum, Plasma
Living,
Cadaveric
Arlington Scientific, Inc

2/24/2014