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

U.S. Food and Drug Administration sent this bulletin at 12/09/2021 11:12 AM 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:

  • The Meridian Bioscience, Inc. Revogene SARS-CoV-2 test, including:
    • The impact of the SARS-CoV-2 omicron variant on test performance. Since the Revogene SARS-CoV-2 test is a single target test that targets a portion of the N-gene where deletions occur with the omicron variant, the test is expected to fail to detect the SARS-CoV-2 omicron variant.
    • Meridian Biosciences has not yet distributed this test and does not intend to distribute this test, within or outside the United States, until this issue is resolved.

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Questions?

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