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