No at-home test kits for Covid-19 are currently approved, the U.S. Food and Drug Administration warned.
In the last week, a slew of startups have rolled out their own at-home Covid-19 tests, as a national shortage has left many scrambling for answers. Several people with symptoms of the disease have said they were unable to get tested — even doctors and nurses.
At-home test kits might seem like the perfect solution. But not so fast, the FDA said. The agency hasn’t yet approved any self-administered tests, and has begun to see “unauthorized fraudulent test kits” being marketed to detect Covid-19.
“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” FDA Commissioner Dr. Steven Hahn wrote in a statement on Friday. “The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”
Everlywell, a home-testing startup, said last week that it would offer at-home tests for Covid-19 in most states for $135. Two more startups, Wheel and imaware, said they would offer in-home testing administered by clinicians for the same price, starting in Texas.
In an emailed statement, Wheel said it was aware of the FDA’s guidance, and emphasized that its tests were administered by clinicians after an initial telehealth visit.
It’s worth noting that tests administered by the Centers for Disease Control and Prevention, while a scare commodity, are free. Most health insurance plans will also cover the related visit for testing free of charge.
Earlier this month, Vice President Mike Pence had said that 1.5 million test kits would soon be available. But as of Sunday, he said 254,000 tests had been conducted, with many state labs saying they are running short on the swabs and reagents needed to run the tests.
Local health agencies hope to ramp up testing capacity in coming weeks as private companies get involved. Several companies, including Thermo Fisher, Roche and Quest Diagnostics, have received emergency use authorizations from the FDA for their Covid-19 tests.
Photo credit: David Hecker, Getty Images
