The Food and Drug Administration (FDA) has granted emergency clearance for a coronavirus testing kit that allows people to take a nasal sample in their own home and send it to a laboratory for diagnostic testing.
The FDA granted the clearance to the company Everlywell Inc.
Christina Song, an Everlywell spokeswoman, told The New York Times, “From the moment that you hit the order button, to the moment that you get the test results on your phone or device, that process is designed to take three to five days.”
The test is “authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider,” according to a Saturday announcement from the FDA.
“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Saturday statement.
Once a patient collects a nasal sample, they will put it in a saline solution and ship it overnight to a certified lab authorized to run specific tests on the kit. Results will be given to patients “through Everlywell’s independent physician network and their online portal,” according to the Saturday statement.
The FDA said the authorization announced Saturday follows two recent authorizations for at-home tests, including another nasal swab test and a test that uses saliva. The agency also said that Everlywell’s emergency use request “leveraged data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipping.”
However, some public health researchers have cautioned that at-home nasal swab tests may be less accurate than those performed by health care providers. Those tests involve inserting a swab through the nose into the throat, according to the Times.
The kits will cost $135 and will be available later this month, according to the outlet.