'Game-Changer': FDA Authorizes First At-Home Coronavirus Test
PITTSBURGH (KDKA) -- A rapid do-it-yourself coronavirus test could be a game-changer.
"It will be a game-changer in the fact that we'll be able to have the test sent to your house. You'll be able to do them in real-time," says Dr. Brian Lamb, a primary care internist at the Allegheny Health Network.
The FDA granted emergency use authorization for this $50 test for people 14 years and older. It's not an antigen test, but rather uses technology similar to genetic lab-based tests.
"It's going to be a nasal swab. So you're still going to have to make sure that the testing device itself gets into where you need it to be to get a good sample," Dr. Lamb says.
A nasal sample goes into a vial, the vial plugs into a portable device, and light displays a positive or negative result within 30 minutes.
"This test is only truly valuable in telling you that you have it when you have symptoms," says Dr. Lamb. "If you have symptoms and you test negative, it doesn't rule it out."
It will be available by prescription only.
"You're still going to have to talk to your doctor. They're then going to have to order the test," Dr. Lamb said. "These results still need to be reported to the health department."
The FDA has authorized 300 coronavirus tests so far. Other home kits require shipment to a lab and results could take days.
"If you can have your positive test result right then, it's a little bit easier to understand why you have to stay home, why you can't be out in public," says Dr. Lamb.
The FDA did not disclose accuracy information.
"None of the studies that I've seen yet have shown the actual numbers behind it," Dr. Lamb said. "We're going to want to see that before we say, 'Hey, let's use this test widespread.'"
An at-home test also makes it easier for people who have mobility or transportation issues.
At first, the kits will be available in Florida and California, and then widely available in the spring.
