Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests (from CDC, updated May 22, 2020)

Key points:

  1. 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.
  2. The list of the removed antibody tests is posted on FDA’s frequently asked questions website.
  3. Antibody tests on this removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer, and those for which there is not a pending Emergency Use Authorization (EUA) request or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.
  4. FDA expects that the tests on the removal list will not be marketed or distributed.

Read the entire document here. FDA Transparency for Covid-19 Antibody Tests

Additional information can be found at the following links:

FDA Frequently Asked Questions

FDA Policy for Covid-19 Testing

FDA EUA Authorized Serology Test Performance

Questions? Reach out to info@hfap.org.