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FDA Issues Updated Guidance for Convalescent Plasma, Outlines How Donors and Plasma Should Be Tested

FDA maze of regulations

Updated FDA guidance on investigational COVID-19 convalescent plasma describes testing required for donors

The US Food and Drug Administration (FDA) released an update for the use of investigational COVID-19 convalescent plasma. This update published Nov. 16, 2020, and supersedes the initial guidance that the FDA released on this topic Sept. 2, 2020.

Several testing considerations are addressed in the FDA’s November 2020 updated guidance. Testing for donors is specifically addressed, and testing is explicitly required to be a convalescent plasma donor. Individuals who wish to be donors must either:

  • Have a positive diagnostic COVID-19 test and have been symptomatic for COVID-19, or
  • Have two positive COVID-19 antibody tests using different tests.

The guidance also specifies that donors must be symptom free for 14 days prior to donating, and that a negative COVID-19 test result is not needed to be a donor.

One significant change in this updated guidance is that it is recommended that those who have received a vaccine for COVID-19 not be considered as potential donors.

The November 2020 updated guidelines also specify that convalescent plasma must be tested for antibodies. While a specific test is not named in this update, the guidance does state “all plasma donations must be tested by registered or licensed blood establishments for anti-SARS-CoV-2 antibodies as a manufacturing step to determine suitability before release, using a test referenced in the EUA Letter of Authorization.”

The only COVID-19 antibody test referenced in the EUA for convalescent plasma was the Ortho VITROS SARS-CoV-2 IgG test. While the guidance recognizes that other antibody tests may be appropriate, use of these tests requires amendment of the original emergency use authorization (EUA).

Related Resources:

Investigational COVID-19 Convalescent Plasma: Guidance for Industry

FDA: Coronavirus (COVID-19) Update: November 16, 2020

Emergency Use Authorization for COVID-19 convalescent plasma