FDA identifies molecular tests impacted by COVID-19 omicron variant

Mutations in the omicron variant of the SARS-CoV-2 virus may impact certain molecular tests for COVID-19, the Food and Drug Administration announced yesterday. Specifically, FDA expects a Tide Laboratories test to produce false negative results for the omicron variant and is working with the manufacturer to address the issue. The agency said it does not believe the test is used for high-volume testing, and lists laboratories that perform the test. FDA also identifies certain tests that are less sensitive to a mutation in the omicron variant, but said it does not expect the variant to impact the overall sensitivity of those tests. The update includes recommendations for clinical laboratory staff and health care providers using these tests.