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FDA Authorizes 1st Home Coronavirus Test That Doesn't Require A Prescription

AILSA CHANG, HOST:

Today, the Food and Drug Administration authorized the first COVID-19 test, which you can take at home and get a result quickly and which doesn't require a prescription. Joining us now with more details is NPR health correspondent Rob Stein.

Hey, Rob.

ROB STEIN, BYLINE: Hey, Ailsa.

CHANG: All right. So what I want to understand is, you know, there are lots of different coronavirus tests available these days. So what is so unique about this one?

STEIN: Yeah, so this will be the easiest way so far for people to find out fast if they are infected or not. There are other tests that let people, you know, avoid long lines by collecting their own samples themselves at home. They still have to send it off to a lab and wait at least a couple of days for the results to come back. There's even another new one like that that doesn't have to be sent off to a lab, but people need a prescription to get it. This is the first one you'll be able to get just by, you know, walking into a drugstore or order it online and do it all at home.

CHANG: I mean, it sounds amazing. So tell us exactly how this test works.

STEIN: Yeah. Yeah. So it's called an antigen test because instead of looking for genetic material from the virus, like the test that people are used to getting, this test looks for a protein from the virus called an antigen. And it's pretty simple and easy to use. All you have to do is use a swab that comes with a test, swab just inside your nose, add a few drops of liquid and put it into a little plastic device that looks like one of those home pregnancy tests. And in 15 minutes - voila - it sends the results wirelessly to an app on your phone.

Here's Sean Parsons. He's the CEO of Ellume, the Australian company that makes the Ellume COVID-19 home test.

SEAN PARSONS: The test could be used for people to test themselves - for example, going to a sporting event or a concert or going to a church - to decrease the chance that they spread it to other people.

STEIN: And he says it'll be available starting in January.

CHANG: That's great. I mean, I don't want to overstate things. This sounds like a big deal. Is this the test that's really finally going to let the U.S. screen - what? - millions of people on a regular basis every single day?

STEIN: Well, you know, it'll help, but it costs about $30, which is probably too expensive, really, to make it practical for millions of people to test themselves every day, like, you know, before they go to work or to school. And the company initially says it can only make probably about a hundred thousand tests a day. So that's not really enough to make a huge dent. You know, by March, that'll increase to about 250,000 tests a day and, by June, a million a day. But that's still not the tens of millions that this country really needs every day. I talked about this with Dr. Michael Mina from the Harvard T.H. Chan School of Public Health.

MICHAEL MINA: It will be a game changer, I think, to help people quickly identify if their symptoms are due to COVID. But from the perspective of truly stopping or massively slowing this pandemic, this test isn't designed for that.

STEIN: Mina - you know, he wants the FDA to OK even cheaper, simpler tests that could be produced and used in the tens of millions every day for just a few bucks a pop.

CHANG: Yeah. Are there any other concerns about this new test?

STEIN: You know, so the company and the FDA say it's 96% accurate in spotting infected people, but it still can miss more people than those more sophisticated genetic tests. I talked about this with Dr. Gary Procop. He's a testing expert at the Cleveland Clinic.

GARY PROCOP: What you worry about is telling somebody, no, you don't have COVID when, in fact, they do. And if that was the case, they could continue to spread it.

STEIN: You know, and obviously, that could be a big problem. And Procop says the tests can also often incorrectly say someone is infected when they're really not. And that can cause all kinds of problems, too. So, you know, he thinks it's a - you know, it's good to have this test, but it's really important people realize its possible shortcomings.

CHANG: That is NPR's Rob Stein.

Thank you, Rob.

STEIN: You bet, Ailsa.

(SOUNDBITE OF HANIA RANI'S "GLASS") Transcript provided by NPR, Copyright NPR.

Rob Stein is a correspondent and senior editor on NPR's science desk.