FDA Authorizes Everlywell At-Home Sample Collector

FDA has granted an emergency use authorization (EUA) for Everlywell’s at-home sample collection kit that can then be sent to specified laboratories for Covid-19 diagnostic testing. The Everlywell Covid-19 Test Home Collection Kit is authorized to be used by individuals at home to collect a nasal sample after being screened using an online questionnaire that is reviewed by a health care provider, an FDA release says. “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,” the agency said. This action follows two recent EUAs for diagnostic tests that also use at-home specimen collection — one that uses a sample collected from the patient’s nose with a nasal swab and transported in saline and another that permits testing of a saliva sample collected by the patient at home.