FDA Says Rapid At-Home COVID-19 Tests Not as Sensitive to Omicron

WEDNESDAY, Dec. 29, 2021 (HealthDay News) -- Early research suggests that some rapid COVID-19 tests may be less able to detect the omicron variant, the U.S. Food and Drug Administration said Tuesday.

To come to that conclusion, the agency used samples from patients confirmed to be infected with the omicron variant to see how well the rapid antigen tests work.

In a statement, the FDA said that antigen tests "do detect the omicron variant, but may have reduced sensitivity." That is not good news, as the omicron variant fuels surging case numbers across the country and people are scrambling to find at-home rapid testing. Antigen tests can be done within minutes at home, while the more accurate polymerase chain reaction (PCR) tests have longer turnaround times. Still, the FDA stopped short of saying that people should stop using antigen tests.

"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 [PCR] tests." The FDA did not specify what rapid at-home tests were used in its early research.

The FDA encouraged follow-up testing for anyone who tests negative with a rapid antigen test but is experiencing symptoms. "If a person tests positive with an antigen test, they should self-isolate and seek follow-up care with a health care provider to determine the next steps," the agency said.

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