The US Food and Drug Administration announced Saturday that it has authorized “an at-home sample collection kit that can then be sent to specific laboratories for Covid-19 diagnostic testing.”
In a statement, the FDA said that the kit, manufactured by Everlywell, Inc., received an emergency use authorization “to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit,” according to the FDA statement.
“The FDA has also authorized two Covid-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell Covid-19 Test Home Collection Kit. These tests have been authorized under separate, individual EUAs. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit," the statement said.
"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," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "Today's action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic."