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FDA Updates List of Licensed Donor Screening Tests

Bulletin 20-15

December 8, 2020

On December 7th 2020, the FDA updated their webpage titled Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases. The updates include the addition of two tests to the list of Licensed Donor Screening Tests as follows:

 

  • ASI Automated RPR test for Syphilis for use on the ASI Evolution; Arlington Scientific, Inc. (BK200488). The test was cleared by the FDA on September 30th, 2020 as a rapid-plasma-reagin non-treponemal screening assay for qualitative detection of reagin antibodies in serum or plasma specimens obtained from living donors. Under AATB Standards for Tissue Banking, F1.140(5) Interpretation of Infectious Disease Test Results and relevant federal regulations (Sec. 1271.80(d)(1)):
    • A donor whose specimen tests negative or nonreactive on this test may be determined eligible for donation. 
    • A donor whose specimen tests positive or reactive on this test and negative or nonreactive on a specific treponemal confirmatory test may be determined eligible for donation provided all other required testing and screening results 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 for donation. 
  • PK CMV-PA System; Fujirebio Diagnostics, Inc (BK200476). The test was cleared by the FDA on October 19th, 2020 as a passive particle agglutination assay for qualitative detection of IgG and IgM antibodies to CMV in serum or plasma specimens from living donors for donor screening purposes. The assay detects total antibody (IgG + IgM) to CMV. 
    • Though CMV is not a relevant communicable disease agent or disease, testing for evidence of CMV infection is required for donors of viable, leukocyte-rich HCT/Ps to reduce the risk of transmission (D4.230(R), D4.231(R) and Sec. 1271.85(b)(2)). 
    • AATB-accredited tissue banks are required to establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for CMV under AATB Standards for Tissue Banking, F1.140(R) (§ 1271.85(b)(2))
    • A reactive CMV antibody test does not necessarily make a donor ineligible.

Clinical interpretation of FDA-licensed screening test results must be performed under the supervision of the tissue bank’s medical director. Accredited AATB institutional members are encouraged to make note of this change to the list of licensed screening tests and update their donor screening protocols accordingly.

 
If you have any questions, please contact Dr. Roman Hitchev, AATB Vice President and Chief Science Officer at hitchevr@aatb.org