USA – Standalone at-home COVID-19 nasal swab kit receives EUA

A nasal swab kit that allows individuals to collect their own samples for COVID-19 diagnostic testing has been granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA).
 
The prescription-only kit may be used by individuals after a healthcare provider reviews their responses to an online screening questionnaire. FDA issued the EUA to Everlywell, Inc. for use with two different diagnostic tests to detect SARS-CoV-2, the virus that causes COVID-19. Those tests, to be performed at specific laboratories, were previously authorized under separate EUAs.
 
 “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 Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a FDA press release announcing the EUA for the at-home kit. “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.”…