REGULATORY UPDATE: FDA Revises the EUA for CCP

December 02, 2020

The Food and Drug Administration issued a Nov. 30 emergency use authorization (EUA) for COVID-19 convalescent plasma (CCP) for the treatment of hospitalized patients with COVID-19 to update testing options by adding the Mount Sinai COVID-19 ELISA Immunoglobulin G (IgG) Antibody Test (Mount Sinai Test), which was not available at the time of the Aug. 23 EUA. 

In the Nov. 30  EUA, FDA reissued the Aug. 23, 2020, Letter of Authorization in its entirety and revised Section II, Scope of Authorization, to authorize the release of CCP that is shown to contain antibodies to SARS-CoV-2 when tested by the Mount Sinai Test as follows: 

  • “Serum samples found to have an ELISA titer of 1:2880 or greater qualify the associated units as high-titer COVID-19 convalescent plasma.”  
  • “Serum samples found to contain anti-SARS-CoV-2 antibodies with an ELISA titer below 1:2880 qualify the associated units as low-titer COVID-19 convalescent plasma.”

In the same section, FDA revised previous language to clarify the testing requirements for labeling of low-titer CCP, stating the following:

  • “Units containing anti-SARS-CoV-2 antibodies must be labeled as high- or low-titer according to the results of the tests” and 
  • For the Ortho VITROS SARS-CoV-2 IgG Test, “Serum samples found to contain anti-SARS-CoV-2 antibodies with an S/C value below 12 qualify the associated units as low-titer COVID-19 convalescent plasma.”

The November 2020 investigational COVID-19 convalescent plasma guidance will not be updated because the guidance states that, under the EUA, all plasma donations must be tested for anti-SARS-CoV-2 antibodies using a test referenced in the EUA Letter of Authorization. The EUA for CCP will be updated again if additional tests are found acceptable to qualify CCP as high and low titer. As described during the live CCP regulatory landscape Annual Meeting session, FDA is committed to adding additional assays to the EUA as they become available.

AABB will update the Nov. 19 Toolkit for COVID-19 Convalescent Plasma under Emergency Use Authorization to reflect this new information. Contact regulatory@aabb.org with questions.