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
