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          Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and DiseasesSafety & Availability (Biologics) Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
  
  	
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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 ProductsInformation about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases under § 1271.80:

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 Industry9/2015
	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
		PCR - Polymerase chain reaction
		RPR - Rapid plasma reagin
		SDA - Strand displacement amplification
		TMA - Transcription-mediated amplificationLicensed Donor Screening Tests

Hepatitis B Virus (HBV)

**HBsAg Assays
(Detects Hepatitis B surface Antigen)**

Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Licensure Date
			STNABBOTT Alinity s HBsAg; and Alinity s HBsAg Confirmatory
			HBV
			CMIA
			*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 assay
			Abbott Ireland Diagnostics Division
			Sligo, Ireland
			US License 2094
			6/14/2019
			BL125674ABBOTT 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
			BL103766Genetic 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
			STNABBOTT Alinity s Anti-HBc
			HBV
			CMIA
			*Living:* Plasma, Serum*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
			BL125681ABBOTT 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
			BL103785ORTHO 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
			STNABBOTT Alinity s Anti- HCV II
			HCV
			CMIA
			*Living:* Plasma, Serum*Cadaveric:* Plasma, Serum
			Donor Screening: Qualitative detection of antibodies to hepatitis C virus
			Abbott GbmH & Co KG
			Wiesbaden, Germany
			US License 2095
			7/15/2022
			BL125759ABBOTT Alinity s Anti-HCV
			HCV
			CMIA
			*Living:* Plasma, Serum*Cadaveric:* Serum
			Donor Screening: Qualitative detection of antibodies to hepatitis C virus
			Abbott GbmH & Co KG
			Wiesbaden, Germany
			US License 2095
			7/15/2019
			BL125677Ortho 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
			BL103065Abbott 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
			STNAlinity 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
			BL125679ABBOTT 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
			BL125318Genetic 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
			STNcobas 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
			BL125576Procleix 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
			BL125652cobas TaqScreen MPX Test version 2.0
			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
			12/19/2014
			BL125459Procleix 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
			BL125113cobas 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
			BL125255Procleix Ultrio 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
			10/3/2006
			BL125113

West Nile Virus (WNV)

**WNV NAT
(Detects WNV RNA)**

Tradename
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Licensure Date
			STNcobas 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
			BL125575cobas 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
			BL125245Procleix 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
			STNABBOTT 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
			BL125675Avioq 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
			BL125394ABBOTT 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

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
			STNAptima 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
			K180681Xpert 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
			K190441COBAS 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
			K173887Aptima Combo 2 AssayCDRH 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
			K043224BD 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
			STNBD 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
			K140446AMPLICOR 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
			K070174Aptima 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
			STNBD 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
			K140448Amplicor 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
			K070172Aptima 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
			K063664COBAS 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)**

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

Tradename*
			Infectious Agent
			Format
			Specimen
			Use
			Manufacturer
			Clearance Date
			STNCapture-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
			BK200542PK 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
			BK200476Capture-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
			BK180247Olympus 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
			BK070030Abbott CMV Total AB EIA
			CMV
			EIA
			*Living:* Plasma, Serum
			Donor Screening: detection of antibodies to CMV
			Abbott Laboratories
			Abbott Park, IL
			03/24/1997
			K954301BD CMVscan 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
			BK950068Capture-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

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
			STNASI Automated RPR test for Syphilis for use on the ASI Evolution
			*T. pallidum*
			RPR (Non-treponemal)
			*Living: Plasma, Serum**Cadaveric:* Plasma, Serum
			Donor Screening: Qualitative detection of reagin antibodies
			Arlington Scientific, Inc.
			Springville, UT
			2/2/2021
			BK200539ASI Automated RPR test for Syphilis for use on the ASI Evolution
			*T. pallidum*
			RPR (Non-treponemal)
			*Living:* Plasma, Serum
			Donor Screening: Qualitative detection of reagin antibodies
			Arlington Scientific, Inc. Springville, UT
			9/30/2020
			BK200488PK7400 TP HA
			*T. pallidum*
			Hemagglutination
			(Treponemal)
			*Living:* Plasma, Serum
			Donor Screening: detection of IgG and IgM antibodies to *T. pallidum*
			Newmarket Biomedical, Ltd.
			Kentford, Suffolk, UK
			8/1/2019
			BK180301ASiManager-ATTM
			*T. pallidum*
			RPR (Non-treponemal)
			*Living:* Plasma, Serum*Cadaveric:* Plasma, Serum
			Donor Screening: Qualitative detection of reagin antibodies
			Arlington Scientific, Inc.
			Springville, UT
			2/19/2015
			BK140192TPHA 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
			BK120021Olympus 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
			BK030007ASI 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
			BK020031CAPTIA 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

                                                                                  Content current as of:
      11/04/2022
              
              
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