Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

Table of Contents

• 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

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:

• Testing HCT/P Donors: Specific Requirements
• Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (8/8/2007)
• Blood Donor Screening Tests

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)

* Licensed for donor screening, but may not be available.

Anti-HBc Assays (Detects antibodies to Hepatitis 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.

* Licensed for donor screening, but may not be available.

Hepatitis B Virus Nucleic Acid Tests
(Direct detection of HBV DNA)

Hepatitis C Virus (HCV)

Anti-HCV Assays
(Detects antibody to HCV)

Hepatitis C Virus Nucleic Acid Testing
(Direct detection of HCV RNA)

Human Immunodeficiency Virus (HIV)-1 AND 2

Anti-HIV-1/2 Assays
(Detects antibodies to HIV Types 1 & 2)

Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)

(Detects antibodies to HIV-1)

Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)

(Detects antibodies to HIV-2)

HIV-1 Nucleic Acid Tests

(Direct detection of HIV-1 RNA)

Human T-Lymphotrophic Virus Types I & II (Anti-HTLV-I/II Assays)

(Detects antibodies to Human T-Lymphotropic Virus Types I & II)

* Licensed for donor screening, but may not be available.

Trypanosoma cruzi (Chagas Disease) (Anti- T. cruzi Assays)

(Detects antibodies to T. cruzi)

West Nile Virus (WNV)

West Nile Virus Nucleic Acid Testing
(Direct detection of WNV RNA)

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)

Note: This list may be incomplete.

Neisseria gonorrhea

Neisseria gonorrhea Nucleic Acid Assays
(Direct detection of N. gonorrhea)

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)

* 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)

Cleared confirmatory test for Treponema pallidum (Syphilis)

Cleared diagnostic serologic tests for Treponema pallidum (Syphilis)

Note: This list may be incomplete.