FDA Warns Rapid COVID Tests May Be Less Accurate for Omicron Cases


We still don’t know much about the latest variant of COVID-19, but according to the latest Food and Drug Administration (FDA) opinion, some rapid antigenic tests may be less effective at identifying early strains of Omicron.

On Tuesday, the FDA cited preliminary studies – conducted in partnership with the National Institutes of Health (NIH) – that analyzed how home testing identified the Omicron variant. The agency found that some of these tests were less sensitive in detecting Omicron due to its highly mutated nature.

The FDA said that “early data suggests antigen tests detect the omicron variant but may have reduced sensitivity.”

In other words, these tests could present false negatives by missing the omicron infections present.

“They don’t detect infections from earlier versions,” Gigi Gronvall, senior researcher at the Johns Hopkins Center for Health Security, told NBC News. She suggests that anyone with symptoms should self-isolate a little longer and get tested. again.

The FDA has not completely ruled out rapid antigenic testing and has not identified which test producers were used in the sample.

“The FDA continues to authorize the use of these tests as directed in the authorized labeling and individuals must continue to use them according to the instructions included with the tests,” the agency said in a statement. “Antigen tests are generally less sensitive and less likely to detect infections very early compared to molecular tests.”

Rather, the FDA advises follow-up PCR testing for those who are negative with a rapid antigen test but show symptoms. Those who test positive, according to the FDA, should “self-isolate and seek follow-up care from a health care provider to determine next steps.”

Megan Schaltegger is a writer for Thrillist.


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