FDA Approves First In-Home Test for Coronavirus
The Food and Drug Administration announced Tuesday that it gave the green light to the first in-home test for the coronavirus, a nasal swab kit sold by LabCorp, according to an FDA press release.
The agency said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor's office, hospital or other testing site. The authorization is the first time the agency has issued emergency clearance for an at-home COVID-19 test, as STAT reported. It comes after weeks of back-and-forth between the FDA and companies trying to create their own versions of an at-home sample collection.
The FDA approved the LabCorp test after a previous spate of activity between the agency and companies including Nurx, Carbon Health and Everlywell. All of them sought to have their own COVID-19 tests approved for at-home use in March, as STAT reported.
The LabCorp test approved by the FDA will initially be available to health care workers and first responders who may have been exposed to the novel coronavirus. It will be more widely available in coming weeks.
To use the test, patients will swab their own nose using a testing kit sent by the company, and will mail it in an insulated package back to the company, as The New York Times reported. The Pixel by LabCorp COVID-19 test will be available to consumers in most states with a doctor's order, the FDA said. Patients also must first complete a questionnaire.
The test uses a specific Q-tip-style cotton nose swab. Other tests, like what's used in a flu test, use longer swabs that require patients to sample themselves deep in the back of the nose, which is uncomfortable when done properly, as STAT reported.
As the AP noted, allowing people to self-swab at home would help reduce infection risks for front-line health care workers and help conserve protective gear.
"Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," said FDA Commissioner Stephen M. Hahn, MD, in an agency press release.
"The FDA's around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor's office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home."
LabCorp said the test will cost $119 and consumers will have to pay out of pocket and then ask their insurer for reimbursement, according to The New York Times. The Trump administration has often said that diagnostic tests for the coronavirus will be covered so that consumers are not responsible for the bill.
Some of the hardest hit areas though will not have the test. The kits will not be available in Maryland, New Jersey, New York and Rhode Island, where laws prohibit testing with at-home sample collection kits, according to LabCorp, as the AP reported.
"This is not a game-changer, but it's potentially another piece of the large and rather messy puzzle we're assembling to test enough people to stop Covid-19," Dr. Sheldon Campbell, associate director of the Yale School of Medicine's Clinical Microbiology Laboratory, said of the at-home nasal self-swabbing kits, to The New York Times. "A home-collection testing procedure will support telemedicine and help patients with transportation difficulties and in hard-to-reach places to access testing."
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