Bulletin 20-14

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FDA Issues Updates for Testing

On July 2, 2020, the FDA notified the American Association of Tissue Banks (AATB) about some updates for tissue banks regarding the COVID-19 pandemic published on the FDA website under the title: “Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic”

The information can also be reached from: 2020 Safety and Availability Communications https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/2020-safety-and-availability-communications.

The highlights of said updates are as follows:

  • There are no reported cases of COVID-19 transmission via HCT/Ps to date (as of July 10, 2020).
  • Routine screening of donors for clinical signs of COVID-19 is in place.
  • The FDA does not recommend using lab tests to screen asymptomatic donors for COVID-19.
  • The FDA recommends that tissue bank medical directors (i.e. the tissue bank’s “responsible person”) responsible for donor eligibility determination “may wish to consider” whether in the 28 days prior to recovery the donor:
    • Had a close contact with individuals diagnosed with, or suspected of having COVID-19; or
    • Had been diagnosed with or suspected of having COVID-19; or
    • Had a positive diagnostic test for SARS-CoV-2 (e.g. NP swab) but never developed symptoms
  • These three groups of findings are recommended for consideration but there is no explicit and definitive requirement laid down by the FDA for a specific eligibility determination to be made based on a specific set of findings.

In addition, the FDA notified AATB about updates for the Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases posted on the FDA web page: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/testing-human-cells-tissues-and-cellular-and-tissue-based-product-hctp-donors-relevant-communicable

Specifically, the list of the licensed donor screening tests has been changed as follows:

  1. For the HBsAg Assays, Abbott Alinity s HBsAg and Alinity s HBsAg confirmatory test have been added to the list, while Abbott Auszyme Monoclonal test and Ortho Ab to HBsAg ELISA Test System 3 have been removed.
  2. For the Anti-HBc-total (IgM+IgG) Assays, Abbott Alinity Anti-HBc-total (IgM+IgG) has been added and CORZME Testing has been removed.
  3. For the HBV NAT tests, COBAS AmpliScreen HBV Test Procleic Ultrio has been removed from the list.
  4. For the anti-HCV Assays, Abbott Alinity s Anti-HCV has been added, and Abbott HCV EIA 2.0 has been removed from the list.
  5. For the HCV NAT tests, COBAS AmpliScreen HCV, Procleix HIV-1 HCV, and Procleix Ultrio have been removed from the list.
  6. For the Anti-HIV-1 and Anti-HIV-2 Assays, Alinity HIV Ag/Ab Combo Reagent Kit has been added, while HIVAB HIV-1/HIV-2 and the Anti HIV-1 Assay and HIV-2 Assay Section have been removed.
  7. For the HBV/HCV/HIV Multiplex NAT, the cadaveric licensure date for COBAS MPX Test has been updated to January 2020.
  8. For the Anti-HTLV-I and Anti-HTLV-II Assays, Abbott Alinity s HTLV-I/II Assay has been added.
  9. For Treponema Pallidum (T. Pallidum), PK7400 TPHA (Treponema pallidum Haemagglutination Assay) has been added to the list.

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