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FDA says home COVID tests have ‘reduced sensitivity’ to Omicron variant


Omicron Spread
Omicron Spread(WGEM)
Published: Dec. 29, 2021 at 12:16 AM CST
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(25 NEWS) - Rapid antigen tests to detect COVID-19, such as the ones for home use, can be less sensitive to the Omicron variant, according to results from preliminary studies released Tuesday by the U.S. Food and Drug Administration.

Early data suggest antigen tests “do detect the omicron variant but may have reduced sensitivity,” the FDA said.

“Antigen tests are generally less sensitive and less likely to pick up very early infections compared to molecular tests,” the agency’s report said.

People testing negative with the antigen test, but have COVID symptoms or have a high likelihood of infection due to exposure, are urged to follow-up with the more invasive molecular tests involving a swab and taking a specimen from a patient’s nose.

It’s recommended people testing positive with the antigen test should self-isolate and seek follow-up care with healthcare providers.

The FDA said it’s continuing to evaluate test sensitivity, when tests should be performed, and the frequency of testing.

The agency said it will continue updating the public on the evaluations and making needed recommendations.

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