05/05/2020: Lab Advisory: FDA Updates Policy about Serology Tests for COVID-19
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 emergencyexternal icon. In particular, this policy outlined new expectations for serology test developers:
- The FDA requires commercial manufacturers to submit Emergency Use Authorizationexternal icon (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.
- Serology Testing for Coronavirus Disease (COVID-19)
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC’s Laboratory Outreach Communication System (LOCS)
- COVID-19 Information for Laboratories
- CDC COVID-19 website
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up