Vaccines, Blood & Biologics

Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Specific Requirements

You must test all donors of HCT/Ps, unless subject to an exception in § 1271.90, for relevant communicable disease agents or diseases, as required in § 1271.85 and further described in applicable FDA guidance documents. You must use an FDA-licensed, approved, or cleared donor screening test when such a test is available, as described in § 1271.80(c). Current FDA-licensed, cleared or approved donor screening tests for use in testing HCT/P donors are listed at the Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases page. Additional tests acceptable for use to screen living donors may also be listed at the Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays page. Our recommendations on specific tests may change in the future due to technological advances or evolving scientific knowledge. The tests listed adequately and appropriately reduce the risk of transmission of relevant communicable disease.

You must test all donors of HCT/Ps for the following diseases:

  1. HIV, type 1 using an FDA-licensed donor screening test either for anti-HIV-1 or combination test for anti-HIV-1 and anti-HIV-2; and FDA-licensed donor screening NAT assay for HIV-1, or combination NAT that includes HIV-1 (establishments not utilizing an FDA-licensed donor screening test that tests for group O antibodies must screen donors for risk associated with HIV group O infection);
  2. HIV, type 2 using an FDA-licensed donor screening test either for anti-HIV-2 or combination test for anti-HIV-1 and anti-HIV-2;
  3. HBV using an FDA-licensed donor screening test for Hepatitis B surface antigen (HBsAg); FDA-licensed donor screening test for total antibody to Hepatitis B core antigen (anti-HBc)(IgG and IgM); and FDA-licensed donor screening NAT assay for HBV, or combination NAT that includes HBV;
  4. HCV using an FDA-licensed donor screening test for anti-HCV; and FDA-licensed donor screening NAT assay for HCV, or combination NAT that includes HCV; and
  5. Treponema pallidum using an FDA-cleared donor screening test for syphilis.

For living donors of HCT/Ps, you must also test for the following diseases:

  1. WNV using an FDA-licensed donor screening NAT assay for WNV.

For donors of viable, leukocyte-rich HCT/Ps, you must also test for the following diseases:

  1. Human T-lymphotropic virus, types I and II using an FDA-licensed donor screening test for anti-HTLV I/II; and
  2. Cytomegalovirus using an FDA-cleared donor screening test for anti-CMV (total IgG and IgM).

For donors of reproductive HCT/Ps (unless excepted in § 1271.90), you must also test for the following diseases:

  1. Chlamydia trachomatis using an FDA-licensed, approved, or cleared test labeled for the detection of those organisms in an asymptomatic, low-prevalence population; and
  2. Neisseria gonorrhea using an FDA-licensed, approved, or cleared test labeled for the detection of those organisms in an asymptomatic, low-prevalence population.

Additional information about donor testing can be found in the following guidance documents:

Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, dated 8/2007;

Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and
Tissue-Based Products for Infection with Treponema pallidum (Syphilis)
, dated 9/2015;

Guidance for Industry: 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
, dated 8/2016; and

Guidance for Industry: 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), dated 9/2016.

Page Last Updated: 03/22/2018
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