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

• Tissue Safety & Availability
• Tissue & Tissue Products
• Cellular & Gene Therapy Products

Information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases under § 1271.80 and § 1271.85:

• Testing Donors of HCT/Ps: Specific Requirements
• Complete List of Donor Screening Assays
• 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

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Note:

• See product inserts for specific instructions regarding specimen collection.
• Abbreviations:
  • ChLIA - Chemiluminescent immunoassay
  • CMIA - Chemiluminescent magnetic microparticle immunoassay
  • ECLIA - Electrochemiluminescence immunoassay
  • EIA - Enzyme immunoassay
  • ELISA - Enzyme-linked immunosorbent assay
  • NAT - Nucleic Acid Test
  • PCR - Polymerase chain reaction
  • RPR - Rapid plasma reagin
  • SDA - Strand displacement amplification
  • TMA - Transcription-mediated amplification

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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
Elecsys HBsAg II and HBsAg II Auto Confirm	HBV	ECLIA	Living: Plasma, serum	Donor Screening:HBsAg Confirmatory: To confirm the presence of HBsAg in samples repeatedly reactive when tested with the Elecsys HBsAg II assay	Roche Diagnostics, US License 2305	2/21/2024	125802
ABBOTT Alinity s HBsAg; ABBOTT Alinity s HBsAg Confirmatory	HBV	CMIA CMIA – specific antibody neutralization	Living:  Plasma, Serum 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 HBsAg assay	Abbott Ireland Diagnostics Division Sligo, Ireland US License 2094	6/14/2019	BL125674
ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory	HBV	ChLIA ChLIA – specific antibody neutralization	Living:  Plasma, Serum 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: Plasma, Serum 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
Elecsys Anti-HBc II	HBV	ECLIA	Living: Plasma, Serum	Donor Screening: Qualitative detection of antibodies to hepatitis B core antigen	Roche Diagnostics, US License 2305	2/27/2024	125804
ABBOTT Alinity s Anti-HBc	HBV	CMIA	Living: Plasma, Serum Cadaveric: Serum	Donor Screening: Qualitative detection of total antibody to hepatitis B core antigen	Abbott GmbH & Co KG Wiesbaden, Germany US License 2095	8/09/2019	BL125681
ABBOTT PRISM HBcore	HBV	ChLIA	Living: Plasma, Serum	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: Plasma, Serum	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 Agent	Format	Specimen	Use	Manufacturer	Licensure Date	STN
Elecsys Anti-HCV II	HCV	ECLIA	Living: Plasma, serum	Donor Screening: Qualitative detection of antibodies to hepatitis C virus	Roche Diagnostics, US License 2305	2/28/2024	125803
Alinity s Anti- HCV II assay	HCV	CMIA	Living: Plasma, Serum Cadaveric: Plasma, Serum	Donor Screening: Qualitative  detection of antibodies to hepatitis C virus	Abbott GmbH & Co KG Wiesbaden, Germany US License 2095	7/15/2022	BL125759
ABBOTT Alinity s Anti-HCV	HCV	CMIA	Living: Plasma, Serum Cadaveric: Serum	Donor Screening: Qualitative detection of antibodies to hepatitis C virus	Abbott GmbH & Co KG Wiesbaden, Germany US License 2095	7/15/2019	BL125677
Ortho HCV Version 3.0 ELISA Test System	HCV	EIA	Living:  Plasma, Serum Cadaveric: Plasma, Serum	Donor Screening: Qualitative detection of antibodies to hepatitis C virus	Ortho-Clinical Diagnostics, Inc. Raritan, NJ US License 1236	2/18/2009 4/23/1998	BL103065
Abbott PRISM HCV	HCV	ChLIA	Living:  Plasma, Serum  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
Elecsys HIV Duo	HIV-1, HIV-2	ECLIA	Living: Plasma, Serum	Donor Screening:  Qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2	Roche Diagnostics Indianapolis, IN                  US License 2305	6/13/2023	125778
ABBOTT Alinity s HIV Ag/Ab Combo	HIV-1, HIV-2	CMIA	Living:  Plasma, Serum Cadaveric: Serum	Donor Screening: Simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV-1 (including groups O and M) and HIV-2	Abbott GmbH & 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:  Plasma, Serum 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, 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 9/21/2017 10/21/2016	BL125576
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 (see package insert for more information on detection of HIV-1 Group O RNA)	Grifols Diagnostics Solutions, Inc. San Diego, CA US License 2032	5/03/2018	BL125652
cobas TaqScreen MPX Test version 2.0	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	9/21/2017 12/19/2014	BL125459
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 (see package insert for more information on detection of HIV-1 Group O RNA)	Grifols Diagnostics Solutions, Inc. San Diego, CA US License 2032	5/25/2012	BL125113
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	8/27/2009 12/30/2008	BL125255
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 (see package insert for more information on detection of HIV-1 Group O RNA)	Grifols Diagnostics Solutions, Inc. San Diego, CA US License 2032	10/3/2006	BL125113

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 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 11/2/2016	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	Nucleic Acid Test (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
Elecsys HTLV-I/II	HTLV-1, HTLV-2	ECLIA	Living: Plasma, Serum	Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II	Roche Diagnostics Indianapolis, IN US License 2305	10/17/2023	BL125792
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 GmbH & Co KG Wiesbaden, Germany US License 2095	6/27/2019	BL125675
Avioq HTLV-I/II Microelisa System	HTLV-1, HTLV-2	EIA	Living:  Plasma, Serum Cadaveric:  Plasma, Serum	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:  Plasma, Serum	Donor Screening: Qualitative detection of antibodies to HTLV-I and HTLV-II	Abbott Laboratories Abbott Park, IL US License 0043	1/16/2008	BL103761

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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 (CT) and Neisseria gonorrhoeae (NG) tests utilizing NAT technology adequately and appropriately reduces the risk of transmission of these relevant communicable disease agents (§ 1271.80(c)). The lists below are not complete. For additional CT/NG diagnostic tests meeting the regulations in § 1271.80(c), you may search the database at 510(k) Premarket Notification (fda.gov). For example, the term “Chlamydia” can be entered in the “Device Name” field to search for those tests.

C. trachomatis and N. gonorrhoeae NAT
(Detects C. trachomatis and N. gonorrhoeae DNA)

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, swabs of extragenital sites (i.e. throat, rectum), female and male urine specimens	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:  Endocervical and vaginal swabs, pharyngeal and rectal swabs, female and male urine specimens	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:  Endocervical and vaginal swabs, female and male urine specimens, 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
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)

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
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
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

Neisseria gonorrhoeae

N. gonorrhoeae NAT
(Detects N. gonorrhoeae DNA)

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 female and male urine specimens	Direct qualitative detection of N. gonorrhoeae	Becton, Dickinson & Co. Sparks, MD	5/20/2014	K140448
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 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

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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)
*Duplicate trade names may appear in table below due to updates to the assay.

Tradename*	Infectious Agent	Format	Specimen	Use	Manufacturer	Clearance Date	STN
Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV	CMV	ECLIA	Living: Plasma, Serum	Donor Screening: Qualitative detection of antibodies to CMV	Roche Diagnostics Indianapolis, IN US License 2305	11/3/2023	BK230840
Capture-CMV	CMV	Solid phase red cell adherence	Living:  Plasma, Serum	Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV	Immucor, Inc. Norcross, GA	2/8/2021	BK200542
PK CMV-PA System	CMV	Passive particle agglutination	Living:  Plasma, Serum	Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV	Fujirebio Diagnostics, Inc. Malvern, PA	10/19/2020	BK200476
Capture-CMV	CMV	Solid phase red cell adherence	Living:  Plasma, Serum	Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV	Immucor, Inc. Norcross, GA	11/20/2018	BK180247
Olympus PK CMV-PA System	CMV	Passive particle agglutination	Living:  Plasma, Serum	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:  Plasma, Serum	Donor Screening: detection of antibodies to CMV	Abbott Laboratories Abbott Park, IL	03/24/1997	K954301
BD CMV scan Card Test	CMV	Latex Agglutination	Living:  Plasma, Serum	Donor Screening: Qualitative detection of IgM and IgG antibodies to CMV	Becton, Dickinson & Company Franklin Lakes, NJ	12/22/1995	BK950068
Capture-CMV	CMV	Solid phase red cell adherence	Living:  Plasma, Serum	Donor Screening: Qualitative detection of IgG and IgM antibodies to CMV	Immucor, Inc. Norcross, GA	12/22/1995	BK950029

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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 assays)

*Duplicate trade names may appear in table below due to updates to the assay.

Tradename*	Infectious Agent	Format	Specimen	Use	Manufacturer	Clearance Date	STN
Elecsys Syphilis; PreciControl Syphilis; PreciControl Release Syphilis	T. pallidum	Serology (Treponemal)	Living: Serum and Plasma	Donor Screening:    Qualitative detection of IgG and IgM antibodies to T. pallidum	Roche Diagnostics Indianapolis, IN	7/31/2023	BK230839
ASI Automated RPR test for Syphilis for use on the ASI Evolution	T. pallidum	Rapid Plasma Reagin (RPR) Test RPR (Non-treponemal)	Living:  Plasma, Serum Cadaveric: Plasma, Serum	Donor Screening: Qualitative detection of reagin antibodies	Arlington Scientific, Inc. Springville, UT	2/2/2021	BK200539
ASI Automated RPR test for Syphilis for use on the ASI Evolution	T. pallidum	Rapid Plasma Reagin (RPR) Test RPR (Non-treponemal)	Living:  Plasma, Serum	Donor Screening: Qualitative detection of reagin antibodies	Arlington Scientific, Inc. Springville, UT	9/30/2020	BK200488
PK7400 TP HA Controls and PK7400 TP HA Reagent	T. pallidum	Hemagglutination (Treponemal)	Living:  Plasma, Serum	Donor Screening: detection of IgG and IgM antibodies to T. pallidum	Newmarket Biomedical, Ltd. United Kingdom	8/1/2019	BK180301
ASiManager-AT™	T. pallidum	Rapid Plasma Reagin (RPR) Test RPR (Non-treponemal)	Living:  Plasma, Serum Cadaveric: Plasma, Serum	Donor Screening: Qualitative detection of reagin antibodies	Arlington Scientific, Inc. Springville, UT	2/19/2015	BK140192
TPHA Screen	T. pallidum	Hemagglutination (Treponemal)	Living:  Plasma, Serum	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:  Plasma, Serum	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:  Plasma, Serum	Donor Screening: Qualitative detection of IgG antibodies to T. pallidum	Trinity Biotech Wicklow, Ireland	01/24/2002	K014233