At-Home Coronavirus Testing Could Be Coming Soon
Tech startups want to provide self-swab kits, but the FDA has stepped in
You may soon be able to swab your nose at home and send the sample away to get tested for coronavirus without having to leave your couch — if U.S. government officials allow it.
Last week, a handful of telemedicine companies announced plans to make at-home collection kits available to patients suspected of having Covid-19. Tech startups like Nurx, Carbon Health, and Everlywell were set to ship thousands of at-home testing kits to customers this week.
But both Nurx and Carbon Health paused sales of their tests after the Food and Drug Administration, which oversees diagnostic tests, issued a strongly worded statement on March 20 warning consumers against what it called “unauthorized fraudulent test kits.” The agency didn’t specify which companies were the target of the notice. Everlywell decided to make its tests available only to hospitals and health care providers for now.
“At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” FDA officials said in the statement. They noted that these tests can pose health risks because they could keep some people from seeking proper medical care.
With coronavirus tests still in short supply around the United States, at-home testing could help people with mild symptoms learn if they have Covid-19 without having to leave home and risk infecting others. They could drop their sample in the mail and receive a result in a few days without even having to interact with a health care worker. Health officials have stressed that widespread testing is crucial for tracking and controlling the pandemic.
That’s part of the reason why, in February, the FDA allowed commercial labs to start developing their own coronavirus tests when it was clear that more testing would be needed around the country.
Nurx, Carbon Health, and Everlywell took that as a green light to make their own tests and get them out to people who health care providers believe have Covid-19 but have been instructed to stay home. Around the country, testing is recommended for at-risk groups like the elderly and those with underlying health conditions, as well as health care workers. Many people who have mild symptoms and are otherwise healthy are being told to stay home so tests can be used for more severe cases.
Though you can’t purchase an at-home test right now, the FDA seems open to allowing it in the future.
Carbon Health’s test cost $167.50 and was advertised to California residents only. Nurx’s test was priced at $181 and Everlywell’s test was $135. Both included a follow-up telemedicine consultation and promised results within 48 hours. On March 18, Everlywell announced that it had 30,000 at-home collection kits that would be available to the public beginning March 23 and would soon have the ability to test a quarter of a million people each week.
But in response to the recent FDA notice and calls to prioritize testing for those who need it most, Everlywell said it would instead give its collection kits to hospitals and health care companies. In a statement on its website, the Austin, Texas-based company says the kits will be used to test high-risk, symptomatic patients affected by the testing shortage as well as health care workers. And instead of being self-administered, the test will have to be given by health care professionals.
Though you can’t purchase an at-home test right now, the FDA seems open to allowing it in the future. “The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space,” the March 20 statement said.
Everlywell says it is “actively working with the FDA on a path forward for COVID-19 sample self-collection in a home setting.”
In a statement provided to Elemental, a Nurx spokesperson says the San Francisco-based company stands “ready to help expand needed and appropriate testing” and is “exploring additional ways to be supportive to both healthcare workers on the front lines and patients.”
Carbon Health, also based in San Francisco, is optimistic too. “We remain hopeful that the FDA will approve at-home sample collection as one of the tools to address this pandemic,” company co-founder and medical director Caesar Djavaherian, MD, said in a March 22 blog post. Meanwhile, the company is still providing telemedicine services for people with Covid-19 symptoms.
Some physicians, however, have cautioned about deploying these tests too hastily. XinQi Dong, MD, MPH, a professor of population health science at Rutgers University, isn’t sure that they are ready for prime time because their accuracy and precision aren’t known. “There are also procedure-related issues we have to consider, such as ensuring that swab collections are done correctly, and the findings are interpreted accurately,” he tells Elemental.
Others think at-home testing is a good idea. In a March 16 article on JAMA Health Forum, two doctors argue that at-home tests would increase the availability of testing, promote social distancing, and lower the risk of exposure to health care professionals.
If you live in the state of Washington, you might be able to get an at-home test soon, but not from a startup. A research effort called the Seattle Coronavirus Assessment Network is beginning to roll out self-test kits to people who want to participate in the project, which has funding from Microsoft co-founder Bill Gates. Since it’s a research project and not a commercial lab, the network’s test does not have to be approved by the FDA.
The coronavirus outbreak is rapidly evolving. For updates, check the U.S. Centers for Disease Control and Prevention as well as your local health department. If you’re feeling emotionally overwhelmed, reach out to the Crisis Text Line.