06/10/2020: Lab Advisory: FDA Posts Information from Independent Evaluations of COVID-19 Serological Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

FDA Posts Information from Independent Evaluations of COVID-19 Serological Tests

On Thursday, June 4, 2020, the U.S. Food and Drug Administration (FDA) posted Independent Evaluations of COVID-19 Serological Testsexternal icon. 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 releaseexternal icon.

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)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: June 10, 2020