June 10 LOCS (CDC) Email

Subject: Lab Advisory: FDA Posts Information from Independent Evaluations of COVID-19 Serological Tests
Audience: Clinical Laboratory Professionals
Level: Laboratory Advisory

On Thursday, June 4, 2020, the U.S. Food and Drug Administration (FDA) posted Independent Evaluations of COVID-19 Serological Tests. This page includes performance data for COVID-19 serology tests that have been evaluated through the Independent Evaluation program and for which a decision – authorized, denied, revoked, or otherwise removed from the ‘notified test’ list – has been made. Additional tests and data will be added to this page as evaluations are completed.

For additional information, see the FDA press release.

Online resources:

• 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