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

U.S. Food and Drug Administration sent this bulletin at 12/10/2021 03:25 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 new information about tests with S-gene drop out, specifically:

  • Not all patient samples with the omicron variant display the mutation that leads to an S-gene drop out; and
  • The presence of the S-gene drop out detection pattern is not a definitive confirmation of the presence of the omicron variant.

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Questions?

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