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  1. Safety & Availability (Biologics)

Testing Human Cells, Tissues, and Cellular and Tissue Based Product (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.
  • 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

 

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