The latest information on the potential impact of the omicron variant on SARS-CoV-2 test performance, including Tide Laboratories' test.

If your email program has trouble displaying this email, view as a webpage. 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: FDA recommendations for clinical laboratory staff and health care providers. The Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test, including: The impact of the SARS-CoV-2 omicron variant on test performance. Since the Tide Laboratories 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. Laboratories where the test is performed (it is not believed to be used for high volume testing). Updates to the list of tests with S-gene drop out. Since these tests are designed to detect multiple genetic targets, the overall test sensitivity should not be impacted. Read More Questions? If you have questions about this update, email COVID19DX@fda.hhs.gov.

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