FDA Gives Emergency Approval to Sell At-Home Virus Tests

Saliva sample needs to be sent to lab for results
By Bob Cronin,  Newser Staff
Posted May 8, 2020 4:45 PM CDT
FDA Gives Emergency Approval to Sell At-Home Virus Tests
A technician holds blue preservation solution in a clean room where saliva collection devices are assembled at Spectrum DNA in Draper, Utah, last month.   (AP Photo/Rick Bowmer)

In a step forward for coronavirus tests, the FDA is allowing the sale of the nation's first saliva collection kit for use at home. The test kits have to be ordered by a physician, the New York Times reports, and will sell for about $100. The agency said Friday it had used its emergency powers to authorize the sales. The FDA commissioner and researchers touted the ease of collecting the samples at home. "A patient can open the kit, spit into the tube, put the cap back on and ship it back to our lab," said Dr. Andrew Brooks, head of the Rutgers University lab that helped develop it. But public health experts have pointed out drawbacks: The wait for results can be longer with tests that have to be sent to a lab, which means people could get negative results though they've developed an infection in the meantime.

Only people with coronavirus symptoms should use the tests, Brooks said. The Rutgers lab, which worked with Spectrum Solutions and Accurate Diagnostic Labs on the project, can process 20,000 tests each day. It figures on a 48-hour turnaround. Spectrum makes the preservative liquid the patient spits into, per Live Science. States have said they still don't have enough tests, and this project could narrow that gap. An at-home test keeps people with symptoms away from the rest of the population. In addition, Brooks points out, the test "is less invasive and more comfortable and reliable than sticking a swab up your nose or down your throat"—the current method for testing for the coronavirus. (Read more coronavirus stories.)

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