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

U.S. Food and Drug Administration sent this bulletin at 12/22/2021 12:00 PM EST

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FDA - Center for Devices and Radiological Health

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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:

  • Background on the SARS-CoV-2 omicron variant
  • Information on the impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests

The update revised:

  • The FDA’s recommendations for clinical laboratory staff and health care providers
  • Information on the impact of the SARS-CoV-2 omicron variant on molecular diagnostic tests.

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Questions?

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