Update: SARS-CoV-2 Omicron Variant: Impact on COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 12/03/2021 04:04 PM EST

If your email program has trouble displaying this email, view as a webpage.
FDA - Center for Devices and Radiological Health

Bookmark and Share

Update: SARS-CoV-2 Omicron Variant: Impact on COVID-19 Tests

Today, the U.S. Food and Drug Administration (FDA) updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information.

The update added new information about:

  • SARS-CoV-2 tests whose performance could be impacted by SARS-CoV-2 genetic mutations, specifically those found in the omicron variant, in patient samples.
    • This includes certain tests where viral mutations cause a specific detection pattern that may help to signal the presence of the omicron variant, but genetic sequencing would be needed to confirm.
    • Since these tests are designed to detect multiple genetic targets, it is expected these tests will continue to detect SARS-CoV-2 including when the omicron variant is present.

Read More

Questions?

If you have questions about this update, email COVID19DX@fda.hhs.gov.