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FDA opens path for quicker, cheaper COVID-19 tests at home

Medical staff give tests at Hard Rock Stadium in Miami Gardens, Fla., on July 21. Photo by Gary I Rothstein/UPI
Medical staff give tests at Hard Rock Stadium in Miami Gardens, Fla., on July 21. Photo by Gary I Rothstein/UPI | License Photo

July 30 (UPI) -- The Food and Drug Administration for the first time has opened the possibility for at-home and over-the-counter COVID-19 tests outside a lab setting, which could make testing quicker and less expensive.

Testing so far has been restricted to patients with symptoms and those results often take days, during which time they can pass on the virus to others. So far, faster tests have been more expensive and aren't usually covered by insurance.

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The FDA's authorization will allow tests -- if they meet certain requirements -- to be performed at homes, schools and offices.

FDA Commissioner Dr. Stephen Hahn said the agency's move could be a "game-changer."

"The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test," Hahn said in a statement. "We hope that with the innovation we've seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available."

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The agency said a potential drawback is that its recommended sensitivity is lower than lab-based tests, but the benefits of broader access to simple and fast testing "generally" outweigh the risk.

The new rules are another evolution for scientists who are trying to speed up the coronavirus testing process. Earlier this month, the FDA reauthorized emergency use for tests with up to four pooled samples from Quest Diagnostics.

Sample pooling allows multiple people to be tested in a pool or "batch" using one test, rather than running one for each individual sample.

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