The Food and Drug Administration has granted emergency use authorization to Viracor Eurofins, a clinical diagnostics lab in Lee’s Summit, Missouri, for an at-home, self-administered COVID-19 test.
The company has begun marketing the kit, which sells for $89, through empowerDX, a direct-to-consumer company.
The process is simple and uses a nasal swab that looks like a Q-tip to rub the inside of each nostril three times. The sample is then sent to a Viracor lab, which emails the results within 24 hours of receipt.
“If people want to go visit relatives, if they want to travel, if they think they’ve been exposed, a test result five days after they submit the sample has much lower value than if you could get it back to them the next day,” says Steve Kleiboeker, Viracor’s vice president of research and development. “So we can hit that rapid turnaround time.”
Besides Viracor, nine companies were selling authorized at-home coronavirus tests under emergency use authorizations as of Oct. 1, according to GoodRx.com, a website that provides drug discount coupons. The tests range in price from $109 to $155, making Viracor’s the cheapest.
Emergency use authorization, or EUA, allows the FDA to approve an unapproved drug or medical device for use during an emergency. Before providing such authorization, the agency weighs the known potential benefits of the drug or device against its known potential risks.
Insurance does not currently cover the Viracor test, but the company is in discussions with insurers and anticipates they will cover it.
The Viracor test is molecular, as opposed to serological. Molecular tests look for the genetic material of the SARS-CoV-2 virus, which causes COVID-19. Serological tests detect antibodies in the blood but do not diagnose active COVID-19 infections.
Kleiboeker says nasal swabs have been shown to be about 95% accurate relative to the “gold standard” of tests, the nasopharyngeal swabs most people get when they’re tested for COVID-19. The latter require the insertion of a long stick far up the nose and, though not necessarily painful, are uncomfortable.
“The nasal swabs are catching the vast majority of positive samples that nasopharyngeal swab will,” Kleiboeker said.
The Viracor at-home test has come on the market as a third surge of coronavirus infections has spread across the country. Health experts say it’s crucial to test for the virus to contain community spread. That way infected individuals can be treated, isolated or hospitalized and those who come in contact with them can be traced and quarantined.
Right now, the number of daily coronavirus tests being conducted in the United States is 61 percent of the level considered necessary to mitigate the spread of the virus, according to The New York Times. Both Kansas and Missouri have fallen far short of the testing target, with Kansas at 11% of the target and Missouri at 42%.
In March, as the novel coronavirus began to spread around the country, Viracor announced that it had developed a test for the coronavirus that was more than 99% accurate. That test, however, was not an at-home test, although like Viracor's at-home test, it was a molecular one.
At the time, only about 19,000 tests had been performed nationwide, or about 23 tests per one million people.
In addition to being more convenient, the at-home test lessens exposure risk for health care workers and minimizes the use of personal protective equipment, which has been in short supply.
“You don’t require a health care provider to collect a specimen,” Kleiboeker says. “And that, of course, has the advantage of not exposing that health care provider to potential COVID-infected patients. It has the advantage of not requiring the mountains of PPE and the shortages there that have impacted the collection of specimens.”
In a comparison of self-collected nasal swabs with nasopharyngeal swabs, University of Washington researchers said that a home-based strategy “should be targeted toward individuals early in illness, when risk of transmission is highest and care seeking less likely.”
The study, which involved 185 participants and was published in JAMA Network Open, a publication of the American Medical Association, concluded that the tests were nearly as accurate as those administered by health care workers.
