FDA Authorizes First COVID-19 Antibody Test

On April 1, 2020, the U.S. Food and Drug Administration (FDA) authorized an Emergency Use Authorization (EUA) for a serological antibody test for COVID-19 created by Cellex Inc. The antibody tests detect an immune response to the infection caused by the virus, rather than detecting the virus itself. In the early days of an infection, antibodies may not be detected. The FDA used its emergency powers to authorize the Cellex test, meaning a formal review is still needed. The test is available to consumers by prescription.

In addition to Cellex, as of April 7, more than 70 test . . .