FDA approves COVID-19 test for at-home use: 'Major game-changer'

A major milestone in testing for the coronavirus, the U.S. Food and Drug Administration has approved the first over-the-counter fully at-home test for COVID-19.

The test can detect the virus in anyone 2 years of age and older, including those who are asymptomatic. Patients collect a nasal sample on a swab, and the results are analyzed with the use of a smartphone app that interprets the results fast.

FOX6's Mary Stoker Smith spoke with Dr. Nathan Ledeboer, one of the medical directors for Wisconsin Diagnostic Laboratories with the Froedtert Health Network, about the test.

Ledeboer: "It’s a huge step forward when it comes to the availability of testing and availability of diagnostics, mostly because it really removes a barrier to people being able to get testing.

"Instead of having to make an appointment, wait in line, get your test and maybe wait a day, maybe three days, maybe five days, this really allows you to test yourself and know within 15 minutes."

Members of the Wisconsin National Guard test residents for COVID-19 at a temporary test facility set up in the parking lot of the UMOS corporate headquarters on Oct. 9, 2020 in Milwaukee, Wisconsin. (Photo by Scott Olson/Getty Images)

Stoker Smith: Is this going to be foolproof for people who take it at home, are they going to get the best results like in a setting like Miller Park?

Ledeboer: "One of the real values of going through your doctor’s office or through the Miller Park (site) is you get counseling. If I have a positive result I get counseling to know what that means.

"They can also tell you 'these are the things you need to be looking out for and these are the things if you experience this,' you might need to go to the emergency room or to an urgent care and be seen by a medical professional.

"Is this test going to perform? We’ve seen so many stories through this pandemic where tests claim to exhibit very high levels of performance and they ultimately don’t meet their needs."

Dr. Nathan Ledeboer

Stoker Smith: The FDA has such stringent standards, and they really are the gold marquee of, say, medicine and approvals and tests, etcetera. Should we have some confidence that you know, they may not be perfect, but it’s going to be close to perfect if I take this over-the-counter test?

Ledeboer: "We really want to know does this test work well in real-world scenarios rather (than) just in a controlled clinical trial."

Stoker Smith: If you had to give it your confidence as somebody who’s studied this, who lives in this world so to speak, what would you say, go for it or hold off?

Ledeboer: "I think if I need a result quickly or I don’t want to go to Miller Park or I don’t want to go to my doctor’s office, and I want a quick result this certainly is a potential.

"The fact that this can deliver a result in under 15 minutes is a major game-changer."

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Ledeboer said the test works a lot like taking a pregnancy test. A little wand gives you a plus or minus result to tell you if you have COVID-19.

It is expected to cost about $30. No word yet on when it may be on store shelves.


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