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

U.S. Food and Drug Administration sent this bulletin at 12/27/2021 01:42 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 removed the Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test from the list of "Tests Expected to Fail to Detect the SARS-CoV-2 Omicron Variant" and added information about the resolution of this issue.

On December 22, 2021, the FDA reissued the Tide Laboratories DTPM COVID-19 RT-PCR Test emergency use authorization. The test has been modified and is now expected to detect the SARS-CoV-2 omicron variant.

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