REGULATORY UPDATE: FDA Revises CCP EUA, Adds Abbott Test

March 10, 2021

The Food and Drug Administration reissued the letter of authorization for emergency use (EUA) of COVID-19 convalescent plasma (CCP) on March 9. The reissued letter includes revisions to add the Abbott AdviseDx SARS-CoV-2 IgG II test as an acceptable test to be used for the purpose of qualifying high-titer CCP. The addition of the Abbott assay brings the total number of acceptable tests for use in the manufacture of high-titer CCP to 11. Other revisions were limited to changes in organization and processes.

The EUA authorizes only the use of high-titer CCP for the treatment of hospitalized patients with COVID-19 who are early in the course of disease and those who are hospitalized with impaired humoral immunity. The use of low-titer CCP is not authorized under this EUA. AABB noted no additional significant revisions to the EUA.

AABB has updated the Toolkit for COVID-19 Convalescent Plasma (CCP) Under Emergency Use Authorization to include the additional test. Submit questions to regulatory@aabb.org