05/22/2020: Lab Alert: FDA Removes Several COVID-19 Antibody Tests and Provides Additional Information

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

FDA Removes Several COVID-19 Antibody Tests and Provides Additional Information

On May 21, 2020, the U.S. Food and Drug Administration (FDA) announced that it has removed a number of antibody tests from the “notification list” of tests offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. The list of the removed antibody tests is posted on FDA’s frequently asked questions website. Antibody tests on this removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer, and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed.

FDA has also published a summary of the expected performance of the serology tests that FDA has authorized based on the information FDA reviewed when it decided whether or not to grant these tests an EUA.

In addition, FDA has described the specimens and panels that have been used in validation studies of serology tests that have been conducted by FDA, CDC, National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) in this report.

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)