Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
Table of Contents
- Licensed Donor Screening Tests
- Cleared Nucleic Acid Tests for Chlamydia trachomatis and Neisseria gonorrhoeae
- Cleared Donor Screening Tests for Cytomegalovirus
- Cleared Donor Screening Tests for Treponema pallidum
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:
- Testing HCT/P Donors: Specific Requirements
- Blood Donor Screening Tests
- Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 8/2007
- Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests 4/2008
- 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 9/2015
- Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry 8/2016
- Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Product s (HCT/Ps) ; Guidance for Industry 9/2016. Corrected 5/2017
Note:
- See product inserts for specific instructions regarding specimen collection.
- Abbreviations:
- ChLIA - Chemiluminescent immunoassay
- CMIA - Chemiluminescent magnetic microparticle immunoassay
- EIA - Enzyme immunoassay
- ELISA - Enzyme-linked immunosorbent assay
- NAT - Nucleic Acid Test
- RPR - Rapid plasma reagin
- PCR - Polymerase chain reaction
- SDA - Strand displacement amplification
- TMA - Transcription-mediated amplification
Licensed Donor Screening Tests
Hepatitis B Virus (HBV)
HBsAg Assays
(Detects Hepatitis B surface Antigen)
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Licensure Date | STN |
|---|---|---|---|---|---|---|---|
| ABBOTT Alinity s HBsAg; and Alinity s HBsAg Confirmatory | HBV | CMIA | Living: 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 Alinity s assay | Abbott Ireland Diagnostics Division Sligo, Ireland US License 2094 |
6/142019 | BL125674 |
| ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory | HBV | ChLIA ChLIA - specific antibody neutralization |
Living: 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 | Living: 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 |
Anti-HBc Assays
(Detects antibodies to Hepatitis B core antigen)
Note: The following anti-HBc donor screening assays detect total antibody (IgG + IgM) to HBc.
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Licensure Date | STN |
|---|---|---|---|---|---|---|---|
| ABBOTT Alinity s Anti-HBc | HBV | CMIA | Living: Serum, Plasma Cadaveric: Serum |
Donor Screening: Qualitative detection of total antibody to hepatitis B core antigen | Abbott GbmH & Co KG Wiesbaden, Germany US License 2095 |
8/09/2019 | BL125681 |
| ABBOTT PRISM HBcore | HBV | ChLIA | Living: 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 |
| ORTHO HBc ELISA Test System | HBV | ELISA | Living: 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 |
Hepatitis C Virus (HCV)
Anti-HCV Assays
(Detects antibodies to HCV)
| Tradename | Infectious Agen | Format | Specimen | Use | Manufacturer | Licensure Date | STN |
|---|---|---|---|---|---|---|---|
| ABBOTT Alinity s Anti-HCV | HCV | CMIA | Living: Serum, Plasma Cadaveric: Serum |
Qualitative detection of antibodies to hepatitis C virus | Abbott GbmH & Co KG Wiesbaden, Germany US License 2095 |
7/15/2019 | BL125677 |
| Ortho HCV Version 3.0 ELISA Test System | HCV | EIA | Living: Serum, Plasma Cadaveric: Serum, Plasma |
Donor Screening: Qualitative detection of antibodies to hepatitis C virus | Ortho-Clinical Diagnostics, Inc Raritan, NJ US License 1236 |
2/18/2009 | BL103065 |
| Abbott PRISM HCV | HCV | ChLIA | Living: 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 |
Human Immunodeficiency Virus (HIV)-1 and 2
Anti-HIV-1 and Anti-HIV-2 Assays
(Detects antibodies to HIV Types 1 & 2)
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Licensure Date | STN |
|---|---|---|---|---|---|---|---|
| Alinity s HIV Ag/Ab Combo Reagent Kit | HIV-1, HIV-2 |
CMIA | Living: Plasma, Serum Cadaveric: Serum |
Donor Screening: Qualitative detection of HIV p24 antigen and antibodies to HIV-1 (including groups O and M) and HIV-2 | Abbott GbmH & Co KG Wiesbaden, Germany US License 2095 |
7/23/2019 | BL125679 |
| ABBOTT PRISM HIV O Plus assay | HIV-1, HIV-2 |
ChLIA | Living: 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 | Living: 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 |
HBV/HCV/HIV Multiplex NAT
(Detects HBV/HCV/HIV Nucleic Acids)
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Licensure Date | STN |
|---|---|---|---|---|---|---|---|
| cobas MPX Test | HBV, HCV, HIV-1 (group O and M), HIV-2 | PCR | Living: Plasma, Serum 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 |
1/17/2020 | BL125576 |
| Procleix Ultrio Elite Assay | HBV, HCV, HIV-1, HIV-2 | 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 |
| cobas TaqScreen MPX Test version 2.0 | HBV, HCV, HIV-1 (group O and 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 |
| Procleix Ultrio Plus Assay | HBV, HCV, HIV-1 | 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 |
| cobas TaqScreen MPX Test | HBV, HCV, HIV-1 (group O and M), 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 |
8/27/2009 | BL125255 |
West Nile Virus (WNV)
WNV NAT
(Detects WNV RNA)
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Licensure Date | STN |
|---|---|---|---|---|---|---|---|
| cobas WNV Assay | WNV | PCR | Living: Plasma, Serum Cadaveric: Plasma, Serum |
Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA | Roche Molecular Systems, Inc. Pleasanton, CA US License 1636 |
1/17/2020 | BL125575 |
| cobas TaqScreen West Nile Virus Test | WNV | PCR | Living: Plasma Cadaveric: Plasma |
Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA | Roche Molecular Systems, Inc., Pleasanton, CA US License 1636 |
8/28/2007 | BL125245 |
| Procleix West Nile Virus (WNV) Assay | WNV | TMA | Living: Plasma Cadaveric: Plasma, Serum |
Donor Screening: Qualitative detection of West Nile Virus (WNV) RNA | Gen-Probe, Inc., San Diego, CA US License 1592 |
12/1/2005 | BL125121 |
Human T-Lymphotropic Virus Types I & II (HTLV-I & II)
Anti-HTLV-I and Anti-HTLV-II Assays
(Detects antibodies to HTLV-I & II)
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Licensure Date | STN |
|---|---|---|---|---|---|---|---|
| ABBOTT Alinity s HTLV-I/II Assay | HTLV-1, HTLV-2 | CMIA | Living: Plasma, Serum Cadaveric: Serum |
Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV II | Abbott GbmH & Co KG Wiesbaden, Germany US License 2095 |
6/27/2019 | BL125675 |
| Avioq HTLV-I/II Microelisa System | HTLV-1, HTLV-2 | EIA | Living: Serum, Plasma Cadaveric: Serum, Plasma |
In Vitro Diagnostic, Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II | Avioq, Inc. Research Triangle Park, NC US License 1856 |
03/26/2012 | BL125394 |
| ABBOTT PRISM HTLV-I/HTLV-II | HTLV-1, HTLV-2 | ChLIA | Living: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 |
Cleared NAT for Chlamydia trachomatis and Neisseria gonorrhoeae
Chlamydia trachomatis/Neisseria gonorrhoeae
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 gonorrhoeae tests utilizing NAT technology adequately and appropriately reduces the risk of transmission of these relevant communicable disease agents (§ 1271.80(c)).
C. trachomatis and N. gonorrhoeae NAT
(Detects C. trachomatis and N. gonorrhoeae DNA)
Note: This list may be incomplete.
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Clearance Date | STN |
|---|---|---|---|---|---|---|---|
| Aptima Combo 2 Assay | C. trachomatis, N. gonorrhoeae | TMA | Living: Endocervical and vaginal swabs, male urethral swabs, male and female and urine specimens, extragenital sites (i.e. throat, rectum) | In Vitro qualitative detection rRNA from C. trachomatis and/or N. gonorrhoeae to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System | Hologic Inc., San Diego, CA |
6/13/2019 | K180681 |
| Xpert CT/NG Assay | C. trachomatis, N. gonorrhoeae | PCR | Living: Female and male urine, vaginal swab, endocervical, rectal, pharyngeal | In vitro qualitative detection and differentiation of DNA from C. trachomatis and/or N. gonorrhoeae to aid in the diagnosis of chlamydial and/or gonococcal disease using the GeneXpert Instrument System | Cepheid Sunnyvale, CA |
5/23/2019 | K190441 |
| COBAS CT/NG Assay | C. trachomatis, N. gonorrhoeae | PCR | Living: Vaginal swabs, Endocervical swabs, male and female urine, cervical specimens | In vitro qualitative detection of C. trachomatis and/or N. gonorrhoeae DNA to aid in the diagnosis of chlamydial and/or gonococcal disease using the cobas® 6800/8800 system | Roche Molecular Systems Pleasanton, CA |
3/21/2018 | K173887 |
| Amplicor CT/NG Test for Neisseria gonorrhoeae | N. gonorrhoeae | PCR | Living: Endocervical and urethral swab | In vitro qualitative in vitro test for the detection of N. gonorrhoeae DNA to aid in the diagnosis of chlamydial disease | Roche Diagnostics Corporation Indianapolis, IN |
4/17/2007 | K070172 |
| Aptima Combo 2 Assay CDRH Summary |
C. trachomatis, N. gonorrhoeae | TMA | Living: Endocervical and vaginal swabs, male urethral swabs, and urine specimens | In vitro qualitative assay for the detection and differentiation of ribosomal RNA (rRNA) from C. trachomatis and/or N. gonorrhoeae in specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified | Gen-Probe, Inc. San Diego, CA |
8/9/2005 | K043224 |
| BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays | C. trachomatis, N. gonorrhoeae | SDA | Living: Endocervical swabs, male urethral swabs, urine specimens | In Vitro qualitative detection of C. trachomatis and N. gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in male and female urine specimens as evidence of infection with one or both organisms | Becton, Dickinson & Co. Sparks, MD |
9/18/2001 | K012351 |
Chlamydia trachomatis
C. trachomatis NAT
(Detects C. trachomatis DNA)
Note: This list may be incomplete.
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Clearance Date | STN |
|---|---|---|---|---|---|---|---|
| BD ProbeTec Chlamydia trachomatis (CT Q* amplified DNA assay) | C. trachomatis | SDA | Living: Endocervical and vaginal swabs, male urethral swabs, and male and female urine specimens | Direct qualitative detection of C. trachomatis | Becton, Dickinson & Co. Sparks, MD |
5/20/2014 | K140446 |
| Aptima Assay for Chlamydia trachomatis | C. trachomatis | TMA | Living: Endocervical and vaginal swabs, male urethral swabs, and urine specimens | In vitro qualitative detection of C. trachomatis ribosomal RNA (rRNA) to aid in the diagnosis of chlamydial disease | Gen-Probe, Inc. San Diego, CA |
1/22/2007 | K063451 |
| AMPLICOR CT/NG Test for Chlamydia trachomatis | C. trachomatis | PCR | Living: Endocervical swabs, male urethral swabs, urine specimens | In vitro qualitative in vitro test for the detection of C. trachomatis plasmid DNA to aid in the diagnosis of chlamydial disease | Roche Diagnostics Corporation Indianapolis, IN |
4/16/2007 | K070174 |
Neisseria gonorrhoeae
N. gonorrhoeae NAT
(Detects N. gonorrhoeae DNA)
Note: This list may be incomplete.
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Clearance Date | STN |
|---|---|---|---|---|---|---|---|
| BD ProbeTec Neisseria gonorrhoeae (GC Q* amplified DNA assay) | N. gonorrhoeae | SDA | Living: Endocervical and vaginal swabs, male urethral swabs, and male and female urine specimens | Direct qualitative detection of N. gonorrhoeae | Becton, Dickinson & Co. Sparks, MD |
5/20/2014 | K140448 |
| Aptima Assay for Neisseria gonorrhoeae | N. gonorrhoeae | TMA | Living: Endocervical and vaginal swabs, male urethral swabs, and urine specimens | In vitro qualitative detection of ribosomal RNA (rRNA) from N. gonorrhoeae to aid in the diagnosis of gonococcal urogenital disease | Gen-Probe, Inc. San Diego, CA |
1/25/2007 | K063664 |
| COBAS AMPLICOR test for Neisseria gonorrhoeae | N. gonorrhoeae | PCR | Living: Endocervical swabs, male urethral swabs, urine specimens | In vitro qualitative detection of N. gonorrhoeae in clinical specimens. The test is intended for use with the COBAS AMPLICOR Analyzer (K964506) | Roche Molecular Systems Somerville, NJ |
5/28/1999 | K974342 |
Cleared Donor Screening Tests for Cytomegalovirus
Cytomegalovirus (CMV)
Note: The following 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.
Anti-CMV Assays
(Detects antibodies to CMV)
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Clearance Date | STN |
|---|---|---|---|---|---|---|---|
| Immucor, Inc. Capture CMV | CMV | Solid phase red cell adherence | Living: Serum Plasma | Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV | Immucor, Inc. Norcross, GA |
11/20/2018 2/4/2019 |
BK180247 K183571 |
| Olympus PK CMV-PA System | CMV | Passive particle agglutination | Living: Serum, Plasma |
Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV | Fujirebio Diagnostics, Inc. Malvern, PA |
9/20/2007 | BK070030 |
| Abbott CMV Total AB EIA | CMV | EIA | Living: Serum, Plasma | Donor Screening: detection of antibodies to CMV | Abbott Laboratories Abbott Park, IL |
03/24/1997 | K954301 |
| BD CMVscan Card Test | CMV | Latex Agglutination | Living: Serum, Plasma | Donor Screening: Qualitative detection of IgM and IgG antibodies to CMV | Becton, Dickinson & Company Franklin Lakes, NJ |
12/22/1995 | BK950068 |
Cleared Donor Screening Tests for Treponema pallidum
Treponema pallidum (T. pallidum)
Note: T. pallidum is the etiologic agent of syphilis. 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.
Specific Treponemal Confirmatory and Non-treponemal Screening Assays
(Detects antibodies to T. pallidum and other serological tests)
| Tradename | Infectious Agent | Format | Specimen | Use | Manufacturer | Clearance Date | STN |
|---|---|---|---|---|---|---|---|
| PK7400 TP HA | T. pallidum | Hemagglutination (Treponemal) |
Living: Serum, Plasma | Donor Screening: detection of IgG and IgM antibodies to T. pallidum | Newmarket Biomedical, Ltd. Kentford, Suffolk, UK |
8/1/2019 | BK180301 |
| ASiManager-AT™ | T. pallidum | RPR (Non-treponemal) | Living: Serum, Plasma Cadaveric: Serum, Plasma |
Donor Screening: Qualitative detection of reagin antibodies | Arlington Scientific, Inc. Springville, UT |
2/19/2015 | BK140192 |
| TPHA Screen | T. pallidum | Hemagglutination (Treponemal) |
Living: Serum, Plasma | Donor Screening: Qualitative detection of IgG and IgM antibodies to T. pallidum | Immucor, Inc Norcross, GA |
10/24/2012 | BK120021 |
| Olympus PK TP System | T. pallidum | Micro-hemagglutination (Treponemal) |
Living: Serum, Plasma | Donor Screening: Qualitative detection of IgG and IgM antibodies to T. pallidum | Fujirebio Diagnostics Inc. Malvern, PA |
2/21/2003 | BK030007 |
| ASI TPHA Test | T. pallidum | Micro-hemagglutination (Treponemal) |
Living: Serum | Donor Screening: Qualitative detection of IgG and IgM antibodies to T. pallidum | Arlington Scientific, Inc Springville, UT |
1/30/2003 | BK020031 |
| CAPTIA Syphilis (T. Pallidum)-G | T. pallidum | EIA (Treponemal) |
Living: Serum, Plasma | Donor Screening: Qualitative detection of IgG antibodies to T. pallidum | Trinity Biotech Wicklow, Ireland |
01/24/2002 | K014233 |