FDA Says At-Home Rapid Tests Not as Sensitive to Omicron, Causing False Negative Results

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  • 09/21/2022

The FDA shared Tuesday that at-home rapid tests for COVID-19 have reduced sensitivity to the Omicron variant, causing false negative results. 

The announcement, published just days after Biden said he ordered 500 million rapid at-home tests, said that “early data from a study” shows the RADx program isn’t all that great, per BizPacReview

“RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term. Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity,” the FDA said. 

Unlike PCR tests taken in a lab, rapid tests provide immediate results and have the convenience factor of taking them at home. But, they don’t seem to work as well. 

The FDA noted that those who test positive “should self-isolate and seek follow-up care with a health care provider to determine the next steps.” Those who test negative can either trust the results, or if they’re “experiencing symptoms or have a high likelihood of infection due to exposure,” they can seek a lab test. 

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