Testing HCT/P Donors
for Relevant Communicable Disease Agents and Diseases
- Licensed Donor Screening Tests
- Cleared Nucleic Acid Tests (NAT) for Chlamydia trachomatis and Neisseria gonorrhea
- Cleared Donor Screening Tests for Cytomegalovirus (CMV)
- Cleared Tests for Syphilis
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.