What to Know About At-Home COVID-19 Tests After FDA Warns Against Them
Makers of the tests have suspended sales or changed who they're available for—and it's no longer the general public.
Just last week, multiple start-ups started advertising at-home COVID-19 test kits—a possible remedy to the delayed testing process in the US amid the coronavirus outbreak. Two of the companies—Carbon Health and Nurx—each claimed their at-home kits would let people collect their own samples to send to a lab for testing, according to The New York Times; and another company, Everlywell, shared that they'd be the first to distribute at-home COVID-19 tests to consumers, per People.
But just days after the announcements, the US Food & Drug Administration issued a warning that it had not yet approved any at-home coronavirus tests. "We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19."
Currently, both Nurx and Carbon Health have paused their COVID-19 testing services, and Everlywell has made their at-home tests specifically available for "qualifying hospitals and healthcare companies," according to their website. Even more: According to reporting by TechCrunch, those who have already received previously purchased kits by Carbon Health were told that they should dispose of the kits, and that, if they had already shipped a sample back, it would be destroyed.
There's been a lot of back and forth (even the White House said on Monday that "self-swabbing" options should be available to citizens this week), but the FDA has yet to officially approve and disseminate any at-home coronavirus tests. And while researchers currently try to figure out if any at-home tests are able to replicate trustworthy COVID-19 diagnoses, they're still a question on many people's minds: What would an at-home test for coronavirus look like, when might one be available, and what are the downsides?
What would an at-home COVID-19 test look like?
Nurx—which, again, has recently "paused new test requests" laid out their testing process on their website. The first step: Answering an online questionnaire about your symptoms, risk factors, and health history, which a provider then evaluates to decide if you can benefit from a test. (Hint: The Centers for Disease Control and Prevention also has a Coronavirus Self-Checker to run your symptoms by.)
If you were (hypothetically, now) approved for a COVID-19 test, a lab partnered with Nurx would send you a test kit via overnight mail with instructions on how to use (take the included swab, and brush both sides of the back of your throat), and a prepaid envelope for overnight return. After mailing your sample back, Nurx says you could get your results back within 48 hours.
The kits provided by Everlywell—which are still available in bulk for healthcare professionals—follow a similar testing method, with a "nasopharyngeal swab & saliva collection tube" and promise of results in 48 hours.
Who would benefit most from an at-home COVID-19 test?
If an at-home coronavirus test was to become available to consumers, it would be best for mild or asymptomatic cases, Tania Elliott, MD, a telemedicine and immunology expert in New York City, tells Health. That means people with the less-severe symptoms including cough, low-grade fever, and/or maybe a quick bout of diarrhea or gastrointestinal issues.
People with more severe symptoms, however—extreme shortness of breath, high fever—shouldn't not rely on one of these tests, should they go to market in the future, as they could cause a delay in treatment while you’re waiting for the results and deciding whether to seek medical help. “The earlier patients with severe disease are detected and treated, the better their outcomes,” says Dr. Elliott.
Right now, the tight regulations on testing in the US is a big deal here—it's likely why so many start-ups and companies began developing at-home tests in the first place. There's a chance, says Dr. Elliott, that if you call your healthcare provider right now with symptoms consistent with COVID-19, but are mildly ill, you'll likely be told to self-isolate and recover at home for a certain amount of time (typically 14 days) out of caution. It's in these cases where an at-home test could come in handy: to know if you actually are suffering from COVID-19 or if you have something else, like the flu, says Dr. Elliott.
Are there any downsides to at-home COVID-19 testing?
Well, yes (the FDA issued a warning against them, remember?). Per the administration, these fraudulent tests can pose serious health risks to the American public. "They may keep some patients from seeking care or delay necessary medical treatment," the FDA said in a press release.
According to Dr. Elliott, it's also incredibly easy to exaggerate your symptoms in order to qualify for a test—especially if you're checking boxes in an online symptoms checker. Aside from that, there could also be issues with incorrectly retrieving your own specimen (when a professional swabs your nasal passages or throat, they have to go really deep—likely much deeper than people are willing to go on themselves). Then, if a sample isn't up-to-par with testing regulations, there could be a further delay or no results at all, says Dr. Elliott. Other potential problems: false positive and false negative reporting—giving consumers unnecessary stress or a false sense of security.
Ultimately, though, an expansion of testing is critical in eventually winning against the novel coronavirus—as long as it's approved and reliable. “If you ask any healthcare official, we need to open the floodgates of testing availability,” says Dr. Elliott, “As long as it’s an accurate test and not cumbersome to do.” Until then, however, the FDA, CDC, and other medical professionals still recommend speaking to your medical provider if you have symptoms of COVID-19, who can then advise you about whether you should get tested, and how to go about getting properly tested.
The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.
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