Testing HCT/P Donors: Specific Requirements
You must test all donors of HCT/Ps, unless subject to an exemption in § 1271.90(a), for relevant communicable disease agents or diseases, as required in § 1271.85(a). You must use an FDA-licensed, approved, or cleared screening test, as described in section V. (§ 1271.80(c)). Current FDA-licensed, cleared or approved donor screening tests for use in testing HCT/P donors are listed at http://www.fda.gov/cber/tissue/prod.htm. 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:
- HIV, type 1 (FDA-licensed screening test either for anti-HIV-1 or combination test for anti-HIV-1 and anti-HIV-2; and FDA-licensed screening NAT test for HIV-1, or combination NAT that includes HIV-1) (establishments not utilizing an FDA-licensed screening test that tests for group O antibodies must evaluate donors for risk associated with HIV group O infection);
- HIV, type 2 (FDA-licensed screening test either for anti-HIV-2 or combination test for anti-HIV-1 and anti-HIV-2);
- HBV (FDA-licensed screening test for Hepatitis B surface antigen (HBsAg) (Ref. 72) and for total antibody to Hepatitis B core antigen (anti-HBc)(IgG and IgM);
- HCV (FDA-licensed screening test for anti-HCV; and FDA-licensed screening NAT test for HCV, or combination NAT that includes HCV); and
- Treponema pallidum (FDA-cleared screening test for syphilis or FDA-cleared diagnostic serologic test for syphilis).
You must test donors of viable, leukocyte-rich HCT/Ps for the following diseases, in addition to those listed for all HCT/P donors (§ 1271.85(b)). You must use an FDA-licensed, cleared, or approved donor screening test when such a test is available (§ 1271.80(c)). The tests listed adequately and appropriately reduce the risk of transmission of relevant communicable diseases:
- Human T-lymphotropic virus, types I and II (FDA-licensed screening test for anti-HTLV I/II).
- Cytomegalovirus (FDA-cleared screening test for anti-CMV) (total IgG and IgM).
In addition to the testing required for all HCT/P donors, and, if applicable, the testing required for donors of viable, leukocyte-rich HCT/Ps, you must test donors of reproductive HCT/Ps (who are not sexually intimate partners) to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract (§ 1271.85(c)). These include:
- Chlamydia trachomatis; and
- Neisseria gonorrhea.
Additional information about donor testing can be found in the Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, dated 8/8/2007 (http://www.fda.gov/cber/gdlns/tissdonor.htm#v).