FDA: 3 at-home COVID-19 tests needed to confirm negative result

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The Food and Drug Administration said the latest research suggests that taking just two antigen tests misses too many infections and could result in people inadvertently spreading the virus to others, especially if they don’t develop symptoms. Photo courtesy of HealthDay

People who test at home after being exposed to COVID-19 should take the test three, not two, times to make sure they’re not infected, the U.S. Food and Drug Administration said.

In issuing its new safety communication, the agency said Thursday the latest research suggests that taking just two antigen tests misses too many infections and could result in people inadvertently spreading the virus to others, especially if they don’t develop symptoms.

In its announcement, the agency pointed to a preliminary government government study that found adding a third test improved accuracy from 62% to 79%.

“The FDA’s new recommendations for at-home COVID-19 antigen tests underscore the importance of repeat testing after a negative test result in order to increase the chances of detecting an infection,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release.

The FDA recommended taking the three tests every 48 hours, until you have a negative test and no symptoms.

The recommendations were made after the FDA collaborated with government and academic partners to assess the performance of at-home antigen tests, Shuren said.

“Throughout the pandemic, we have continued to learn about COVID-19 and the impact of variants on the performance of diagnostic tests designed to detect the virus, and we are committed to keeping the public updated so they can make the most informed healthcare decisions,” Shuren said.

The U.S. Centers for Disease Control and Prevention has more on testing for COVID-19 at home.

SOURCE: U.S. Food and Drug Administration, news release, Aug. 11, 2022

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