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FDA OKs 1st Home COVID-19 Test That Doesn't Require A Prescription


Americans will soon have the easiest way yet to check if they caught the coronavirus. The Food and Drug Administration authorized the first COVID-19 test that people can do completely at home without a prescription. NPR health correspondent Rob Stein is covering this. Hey there, Rob.

ROB STEIN, BYLINE: Hey there, Steve.

INSKEEP: What is this test?

STEIN: It's called the Ellume COVID-19 Home Test, and it's designed to be really simple, easy and fast. You'll be able to buy a kit at, you know, your local drugstore, one of those big discount stores or order it online. And it comes with a special swab that lets you collect a sample just inside your nose. You add a few drops of liquid, put it into a little plastic gizmo that looks like, you know, one of those home pregnancy tests. And within 15 minutes, it transmits the results via Bluetooth to an app on your phone that says either, bad news, you've caught the virus, or nope, you're OK, you're negative. And the app, it's designed to report the results automatically to public health authorities, you know. And that's really important for tracking and trying to control the spread of the virus.

INSKEEP: That's really impressive. It's technology-aided.

STEIN: Yeah.

INSKEEP: Can I ask about a detail, Rob? You said you collect a sample just inside your nose. People who have taken coronavirus tests have described this swab having to go in...

STEIN: Yeah, the brain probe, right?

INSKEEP: ...Quite uncomfortably far. Is this a little different?

STEIN: Yeah, well, this is - just doesn't go that far up your nose. It's just sort of halfway up, so it's a lot easier. And actually, this little swab thingy comes with a little adapter so you can use it on kids, too. So it doesn't, you know, poke them too far up there.

INSKEEP: Oh, that's great. OK.

STEIN: Yeah.

INSKEEP: Well, I'm sure there's someone who now needs to go blow their nose while we continue this conversation.

STEIN: (Laughter).

INSKEEP: Is this different from tests that were already available?

STEIN: Yeah, yeah. Well, there's nothing exactly like this that's so easy out there. You know, there are other tests that you collect your own sample at home, but you have to ship it off to a lab and wait at least a couple of days for the results. The FDA also recently authorized a test that lets you analyze your sample yourself at home, but you need to get a doctor to write a prescription for it first to be able to get it. For this one, no need to get a doctor involved or send it off to a lab and wait for the results, and it's the first one specifically authorized to test people, even if they don't have any symptoms.

INSKEEP: All of which sounds impressive. But in recent months, I have read, as many people have, of course, about problems with rapid tests...

STEIN: Yeah.

INSKEEP: ...With false positives, with false negatives.

STEIN: Right.

INSKEEP: How reliable is this new test?

STEIN: Yeah, so the company that makes it and the FDA say it's very accurate - you know, 96% accurate overall. But it is what's known as an antigen test, and those tend to be less accurate than those PCR tests that people are used to getting. So it could miss more infected people. That's obviously, you know, dangerous because they could end up spreading the virus even more.

And this test can also produce a lot of what's called false positives - you know, telling someone they're infected when they're really not. And that can cause problems, too. You know, you don't want people like doctors and nurses having to skip work because they think they're infected when they're really not, you know, especially these days when hospitals are already getting overwhelmed by lots of sick people. But the FDA and others say those shortcomings are outweighed by the benefits of making it a lot easier for people to get tested really quickly.

INSKEEP: So as it gets easier for some people to be tested quickly, is this going to solve the constant shortage of tests that we've heard about for months?

STEIN: Well, you know, it will help, but unfortunately, it's probably not a panacea. First of all, there's the price. It's going to cost about $30. But that's still nowhere cheap enough to be the kind of test that people, you know, could do over and over and over again, like every morning before they go to work or go to school. A test that would be practical for something like that would have to cost only a few bucks each time. And even if people could afford it that often, there won't be enough of these tests available to test millions of people every day.

The company will only be able to make about 100,000 tests when this test becomes available in January - 100,000 tests a day, that is. And that's supposed to ramp up to a million tests a day by June, but that's still nowhere near the tens of millions of tests that the U.S. really needs to keep the virus in check until enough people can get vaccinated.

INSKEEP: The scale of this pandemic remains amazing. Rob, thank you very much.

STEIN: You bet, Steve.

INSKEEP: NPR health correspondent Rob Stein. Transcript provided by NPR, Copyright NPR.

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