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

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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 includes information about:

  • The impact of the SARS-CoV-2 omicron variant on performance of the Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit:
    • Since the Linea COVID-19 Assay Kit has two targets, both of which cover portions of the S-gene where mutations occur with the omicron variant, the test is expected to fail to detect the SARS-CoV-2 omicron variant.
  • SARS-CoV-2 tests with detection patterns that may be associated with SARS-CoV-2 genetic mutations found in the omicron variant. This detection pattern may help to signal the presence of the omicron variant in a patient sample with a positive result so that sequencing can be considered to characterize the variant.
    • This includes certain tests with either an N-gene drop out or an S-gene drop out due to mutations present in the omicron variant.
    • Since these tests are designed to detect multiple genetic targets, it is expected these tests will continue to detect SARS-CoV-2, including the omicron variant.

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