FDA Authorizes 2 Rapid, At-Home Coronavirus Tests

Mar 31, 2021
Originally published on April 1, 2021 8:16 am

Imagine waking up, brushing your teeth, and quickly swabbing your nose to test for the coronavirus — whether you feel sick or not.

That reality just got a bit closer with an announcement from the Food and Drug Administration Wednesday that two rapid antigen at-home tests will soon be sold over the counter on drugstore shelves. The newly authorized tests in the fight against COVID-19 are Abbott's BinaxNOW test and Quidel's QuickVue.

"This is a huge milestone," Dr. Michael Mina, a Harvard epidemiologist who has been a vocal advocate for widespread rapid tests, wrote in a statement responding to the news. "Having an inexpensive over-the-counter test can stop the virus from spreading by detecting people who are infectious and giving them an opportunity to know their status and ideally isolate accordingly."

The authorizations come two weeks after the FDA created a simple pathway for companies that already had authorized tests to be able to apply to sell an over-the-counter version.

"I'm really happy the FDA has undertaken this and decided to go this route," Mina told NPR.

Experts believe that the availability of at-home coronavirus tests could help slow the continued spread of the virus, which is contagious even when people are asymptomatic.

Abbott's test will be available on grocery and drugstore shelves in the "coming weeks," according to a press release from the company. Quidel did not include a timeline in its release.

Neither company mentioned pricing in their statements, although Abbott wrote that its tests "will be priced affordably." Mina's educated guess is that they will be sold for $15-$20 a box for a pack of two tests.

"I think to make it truly accessible and truly deployable to millions of people to use in a frequent way, $7 or $8 [per test] is still too much money," he says. "But I think that this is just such an immense step forward that I'm not going to complain about it."

The only other at-home coronavirus test that has been authorized to be sold without a prescription is made by Ellume and is not yet available in stores. The company told NPR in December the cost would be $30 per test.

Abbott's BinaxNOW tests have been available since August, and Abbott produces 50 million of these tests each month. Quidel says it aims to produce 50 million QuickVue tests per month by the end of 2021. That's not nearly enough tests to have everyone in the U.S. test themselves once a month, let alone several times a week.

Mina told NPR that if "we can stop all the outbreaks from growing, then boom, we can open up businesses and schools without risk because even if a case does come in, it fizzles out very quickly."

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NOEL KING, HOST:

Imagine that you wake up in the morning, go about your usual routine and that routine includes taking a quick nose swab in your bathroom for COVID and getting a result right there. We are a little closer to that. The FDA says two rapid antigen tests will be in pharmacies soon. NPR's Selena Simmons-Duffin is following this story. Good morning, Selena.

SELENA SIMMONS-DUFFIN, BYLINE: Morning, Noel.

KING: What is the benefit of being able to test oneself at home?

SIMMONS-DUFFIN: Well, the answer is that this virus has been so difficult to get a handle on because its stealth. People can spread it when they don't feel sick and they don't know they're infected. And that's why we've all been wearing masks and social distancing because you don't know who might be sick. So the idea that people could easily test themselves at home if they feel sick or even if they don't and then get results in a few minutes and stay home if they get a positive test, that could be really helpful as another way to tamp down the silent spread of the coronavirus.

KING: How do these rapid antigen tests actually work?

SIMMONS-DUFFIN: So antigen tests work by identifying coronavirus proteins in your nose or throat. So the two tests that got authorized yesterday are Abbott's BinaxNOW test and the Quidel QuickVue test. So they both come with test strips, some buffer solution and swabs, not the brain-tickling ones, just regular swabs. So you swab your nose, add the solution, put that on the test strip, and then you see lines like a pregnancy test to know if you're positive about 10 or 15 minutes later. These aren't the first rapid at-home tests to be authorized by FDA for use without a prescription. There's one made by Ellume that's priced at around $30 a test. It's not in stores yet. But the reason why this news is really significant is you're not going to do that morning routine test if you don't feel sick a few times a week just to check with a $30 test. These tests are simpler and cheaper. We don't have pricing from either company yet, but they're expected to be around $10 a test, so sold in drugstores in two packs for maybe 15 or 20 bucks.

KING: Simpler and cheaper. What do we know about whether they're accurate?

SIMMONS-DUFFIN: Well, rapid antigen tests have more false negatives than diagnostic or PCR tests. So there is a risk that the test indicates you're not infected when you actually are. Michael Mina is a Harvard epidemiologist who's been a vocal advocate for easy, affordable at-home tests. And he says even if these tests aren't perfect and even if not everyone who gets a positive test actually changes their plans and stays home, at a population level, these tests could still have a big impact because even if they prevent just a small portion of infected people from going out and spreading the virus, that can help keep outbreaks from spiraling out of control.

MICHAEL MINA: If we can stop all the outbreaks from growing, then, boom, we can open up businesses and schools without risk. Even if a case does come in, it fizzles out very quickly.

KING: Are there enough of these tests for everyone?

SIMMONS-DUFFIN: So at the moment, no. Abbott makes 50 million tests a month currently and has not indicated it's scaling up production. Quidel is working towards 50 million tests a month by the end of the year. But even put together, that's not enough for everyone in the country to test themselves once a month, let alone a few times a week. So we'll have to see if manufacturing kicks up or new companies get authorized by FDA.

KING: Let me ask you about the timing on this. We're a year into the pandemic. We have vaccines now, even though not everyone can get one yet. Is it a little late for the public to add at-home testing to everything else - masks, social distancing, trying to get a vaccine?

SIMMONS-DUFFIN: Yeah, the experts I talked with say it really is a shame that these weren't more available to the public sooner. But they also say it's not too late for these to be really useful. Gigi Gronvall at the Johns Hopkins Center for Health Security pointed out, there is a whole population that doesn't have access to vaccines and won't for a while, and that is kids under age 16.

GIGI GRONVALL: As more people get vaccinated, it might be that these are maybe more often used for kids.

SIMMONS-DUFFIN: So both of these tests can be used on kids as young as 2 years old. And Michael Mina at Harvard told me these at-home rapid tests can help potentially in the fall if the vaccines wear off or variants that can evade vaccines take hold. In either case, easy at-home COVID tests could be a really useful tool.

KING: NPR's Selena Simmons-Duffin. Thanks, Selena.

SIMMONS-DUFFIN: Thank you, Noel. Transcript provided by NPR, Copyright NPR.