Posted by Michael Wonder on 24 Aug 2020
FDA's convalescent plasma EUA requires all donor blood units be tested only with Ortho's COVID-19 IgG antibody test
24 August 2020 - In its August 23 Emergency Use Authorisation for COVID-19 convalescent plasma for the treatment of hospitalised patients with COVID-19, the U.S. FDA requires all units of donor blood to be tested on Ortho Clinical Diagnostics' VITROS Anti-SARS-CoV-2 IgG test for anti SARS-CoV-2 antibodies as a manufacturing step before release to hospitals and patients.
The EUA was based in part on data from the FDA's Expanded Access Program, run by the Mayo Clinic.
