Lab Alert and Lab Advisory: FDA Removes Several COVID-19 Antibody Tests and Provides Additional Information and CDC Releases Interim Guidance for Coronavirus Disease (COVID-19) Antibody Testing

COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below are links to the most recent messages about the FDA removing several Coronavirus Disease (COVID-19) antibody tests and providing additional information and CDC interim guidance for antibody testing.

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

On May 21, 2020, the U.S. Food and Drug Administration (FDA) announcedexternal icon 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 Emergencyexternal icon. 

Read more here.

CDC Releases Interim Guidance for Coronavirus Disease (COVID-19) Antibody Testing

CDC has developed interim guidance for antibody testing for SARS-CoV-2, the virus that causes COVID-19. The guidance is for healthcare providers, clinical laboratory professionals, and public health officials and includes information about types of antibody testing, limitations of serologic tests, strategies for optimizing testing outcomes, and recommendations for using serologic tests and interpreting their results.

Read more here.