05/05/2020: Lab Advisory: FDA Updates Policy about Serology Tests for COVID-19

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

FDA Updates Policy about Serology Tests for COVID-19

On May 4, 2020, the U.S. Food and Drug Administration (FDA) released a revised policy for COVID-19 testing during the public health emergency. In particular, this policy outlined new expectations for serology test developers:

  • The FDA requires commercial manufacturers to submit Emergency Use Authorization (EUA) requests, with validation data, within 10 business days from the date they notified the FDA of their validation testing or from the date of this policy, whichever is later.
  • The FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

Online resources:

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)