FDA Authorizes First Standalone, At-Home Sample Collection Kit for COVID-19

The FDA has authorized Everlywell’s standalone, at-home sample collection kit for COVID-19, the first of its kind to receive an emergency use authorization (EUA) for use with multiple diagnostic tests. 

In the past, kits and tests have been restricted to each other, with each kit authorized for use with a particular test. In contrast, Everlywell has offered its kit independent of any one test or testing lab, opening the door for multiple labs to receive Everlywell’s samples. An at-home testing kit whose results can be sent to multiple labs and analyzed using various tests expands access to testing and prevents potential transmission of the virus. 



Everlywell, a home health testing startup, was one of the first companies to announce the development of an at-home sample collection kit for COVID-19. The FDA has now authorized its kit for at-home use by individuals who have completed an online questionnaire, which acts as a preliminary screening for COVID-19 symptoms. A healthcare provider must review the questionnaire before a testing kit is provided. 

Using Everlywell’s diagnostic kit, an individual can self-collect nasal swabs, which are placed in a saline-filled tube. Samples are transported overnight to a CLIA-certified lab, where they are tested. The FDA has currently authorized—with individual EUAs—two diagnostic tests performed at pre-approved labs for analyzing samples collected using Everlywell’s at-home kit. Results are returned to the patient over the web, using Everlywell’s network of independent physicians. 



The FDA has noted that pairing Everlywell’s kit with other diagnostic tests is a distinct possibility, given that test providers submit the necessary verification for emergency approval. 

For companies who intend to follow Everlywell’s footsteps in developing an at-home testing kit, the FDA has published Everlywell’s data showing that nasal swabs can remain stable during overnight shipping, reducing the burden of proof. 

Opening up testing, whether through self-administered kits or broadened sample-test compatibility, is regarded by the FDA as one of the keys to combating the COVID-19 pandemic.