Antigen tests may be less sensitive to omicron, FDA warns

Rapid antigen tests may have reduced sensitivity in detecting the omicron COVID-19 variant, the FDA said in a Dec. 28 update

The agency said it has been collaborating with the National Institutes of Health to evaluate the potential effect genetic variants of COVID-19 have on antigen tests. Early findings based on laboratory data involving samples from patients infected with omicron suggest that antigen tests "do detect the omicron variant but may have reduced sensitivity," the agency said, adding that clinical study evaluations to further explore antigen tests' performance in detecting the variant are ongoing. 

"The FDA continues to authorize the use of these tests as directed in the authorized labeling and individuals should continue to use them in accordance with the instructions included with the tests," the agency said. "Antigen tests are generally less sensitive and less likely to pick up very early infections compared to molecular tests."

The FDA also reiterated its longstanding recommendations for rapid tests, which encourage people to seek a molecular test if they have had a high-risk exposure or have symptoms after a negative antigen test. 

The update comes amid unprecedented demand for at-home rapid tests as U.S. COVID-19 cases surge. The nation's seven-day case average was 267,305 on Dec. 28, marking a record for new daily cases. 

To view the full update, click here


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