FDA Authorizes First COVID-19 At-Home Test Kit—Here’s What to Know
In mid-March, 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 it would be the first to distribute at-home COVID-19 tests to consumers, per People.
But just days after the announcements, the FDA 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 home-test sales, and Everlywell has made their at-home tests specifically available for "qualifying hospitals and healthcare companies," according to their website. And 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 on the issue. Even the White House said on March 23 that "self-swabbing" options should be available to citizens sometime during that week, although that never materialized.
Finally, on April 21, the FDA granted emergency authorization for LabCorp's at-home test kit. Specifically, the FDA is allowing the Burlington, N.C.-based diagnostics maker to test consumers' self-collected nasal samples using the company's at-home test kit. Initially, LabCorp will make the kits available to frontline healthcare workers and first responders who have been exposed to COVID-19 or have symptoms of the illness.
LabCorp intends to make its home collection kits available to consumers, in most states, with a doctor's order in the coming weeks, the FDA noted. Per the New York Times, LabCorp has said that the test will cost $119 and that people must pay out of pocket; they would have to ask their health insurer for reimbursement.
The FDA's action is not a blanket approval for at-home collection of patient samples. The agency is still warning consumers to steer clear of fraudulent test kits sold online.
So what does at-home COVID-19 testing involve, and what are the benefits and risks? Here's what we know so far.
What does at-home COVID-19 testing involve?
LabCorp's emergency authorization allows the company to distribute its Pixel by LabCorp COVID-19 test to individuals (initially healthcare workers and first responders) if a healthcare provider recommends testing after a person has completed a COVID-19 questionnaire. As the FDA explains, patients will use the test kit's designated nasal swabs to collect their sample and then mail it back in an insulated packaged to LabCorp for testing.
In the wake of the FDA crackdown, Nurx has paused all new at-home test requests, and Everlywell is only making its kits available in bulk for healthcare professionals. Each describes similar test procedures.
If you were (hypothetically, now) approved for a COVID-19 test through Nurx (which would initially entail answering an online questionnaire about your symptoms, risk factors, and health history), the company's lab partner would send you a kit via overnight mail with instructions on its use: take the included swab, brush both sides of the back of your throat, and return if overnight in a prepaid envelope. After mailing your sample back, Nurx says you could get your results back within 48 hours.
Who would benefit most from an at-home COVID-19 test?
An at-home coronavirus test for consumers 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 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 rely on one of these tests, 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.
There's a chance, says Dr. Elliott, that if you call your healthcare provider right now with symptoms consistent with COVID-19, but you 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, unauthorized 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 to 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.”
If you have symptoms of COVID-19, the FDA, CDC, and other medical professionals still recommend speaking to your medical provider, 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.
But just days after the announcements, the FDA 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 home-test sales, and Everlywell has made their at-home tests specifically available for "qualifying hospitals and healthcare companies," according to their website. And 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 on the issue. Even the White House said on March 23 that "self-swabbing" options should be available to citizens sometime during that week, although that never materialized.
Finally, on April 21, the FDA granted emergency authorization for LabCorp's at-home test kit. Specifically, the FDA is allowing the Burlington, N.C.-based diagnostics maker to test consumers' self-collected nasal samples using the company's at-home test kit. Initially, LabCorp will make the kits available to frontline healthcare workers and first responders who have been exposed to COVID-19 or have symptoms of the illness.
LabCorp intends to make its home collection kits available to consumers, in most states, with a doctor's order in the coming weeks, the FDA noted. Per the New York Times, LabCorp has said that the test will cost $119 and that people must pay out of pocket; they would have to ask their health insurer for reimbursement.
The FDA's action is not a blanket approval for at-home collection of patient samples. The agency is still warning consumers to steer clear of fraudulent test kits sold online.
So what does at-home COVID-19 testing involve, and what are the benefits and risks? Here's what we know so far.
What does at-home COVID-19 testing involve?
LabCorp's emergency authorization allows the company to distribute its Pixel by LabCorp COVID-19 test to individuals (initially healthcare workers and first responders) if a healthcare provider recommends testing after a person has completed a COVID-19 questionnaire. As the FDA explains, patients will use the test kit's designated nasal swabs to collect their sample and then mail it back in an insulated packaged to LabCorp for testing.
In the wake of the FDA crackdown, Nurx has paused all new at-home test requests, and Everlywell is only making its kits available in bulk for healthcare professionals. Each describes similar test procedures.
If you were (hypothetically, now) approved for a COVID-19 test through Nurx (which would initially entail answering an online questionnaire about your symptoms, risk factors, and health history), the company's lab partner would send you a kit via overnight mail with instructions on its use: take the included swab, brush both sides of the back of your throat, and return if overnight in a prepaid envelope. After mailing your sample back, Nurx says you could get your results back within 48 hours.
Who would benefit most from an at-home COVID-19 test?
An at-home coronavirus test for consumers 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 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 rely on one of these tests, 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.
There's a chance, says Dr. Elliott, that if you call your healthcare provider right now with symptoms consistent with COVID-19, but you 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, unauthorized 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 to 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.”
If you have symptoms of COVID-19, the FDA, CDC, and other medical professionals still recommend speaking to your medical provider, 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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