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FDA recommends repeat at-home Covid tests to reduce risk of false negatives

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August 11, 2022
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FDA recommends repeat at-home Covid tests to reduce risk of false negatives
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The Food and Drug Administration (FDA) issued guidance on Thursday recommending that people testing themselves for COVID-19 at home take a repeat test within 48 hours to rule out a potential false negative.

In its guidance, the FDA noted that at-home tests are less likely to detect the coronavirus than PCR lab tests. This inaccuracy is more likely to occur early on in the infection in people who display no symptoms.

“Currently, all at-home COVID-19 antigen tests are FDA-authorized for repeat, or serial use. This means people should use multiple tests over a certain time period, such as 2-3 days, especially when the people using the tests don’t have COVID-19 symptoms,” the FDA said.

People should keep multiple tests on hand for the purpose of this new guidance, the agency said. Most over-the-counter, at-home COVID-19 tests are sold in multipacks.

The FDA recommended that people take one initial test if they suspect they may be infected or exposed to COVID-19. If they test negative and have some symptoms, then they should test again 48 hours after the first test. If the second test is still negative, a laboratory molecular-based test should be considered.

If a person has no COVID-19 symptoms but believes they have been exposed to the virus, the FDA said they should also test themselves a second time, also 48 hours after their first at-home test. If the second test is negative, they should take an additional third test another 48 hours afterward.

If any of these at-home tests come back positive, then the individual likely has COVID-19 and should follow guidance from the Centers for Disease Control and Prevention.

The agency said these most recent recommendations were based on “the latest study results from people with likely omicron infection showing that repeat testing after a negative at-home COVID-19 antigen test result increases the chance of an accurate result.”

Around a dozen at-home COVID-19 tests have been authorized by the FDA.

Many community health centers across the country have been giving out free at-home COVID-19 tests. Individuals with health insurance can usually either receive free tests at stores and pharmacies or receive reimbursements through their insurers. The Department of Health and Human Services is also distributing free tests through Medicare-certified health clinics.

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