The FDA has officially authorized the first at-home sample collection kit that can be sent off to two different laboratories for COVID-19 diagnostic testing. Everlywell, Inc. was issued an emergency use authorization (EUA) from the FDA for its at-home COVID-19 sample collection kit. The kit is authorized to be used by individuals in the comfort of their own home that have answered an online questionnaire, which then is reviewed by a healthcare provider to evaluate if a testing kit should be administered. The recipient of the kit is to self-collect a nasal sample, in which they then will ship off to a specific CLIA-certified laboratory (Fulgent Therapeutics and Assurance Scientific Laboratories) that is running one of the in-vitro diagnostic molecular tests authorized under a separate EUA. In the future, additional tests may be authorized for use with the Everlywell at-home collection kit. Currently, this is the only at-home authorized COVID-19 sample collection kit, the kit and its associated lab tests are available by prescription only. The results of the test will be returned to the patient through Everlywell’s own independent physician network and online portal. The authorization of this at-home testing kit keeps the patient and the healthcare provider safe by eliminating the physical contact that typically would be needed to administer this test. It is important to note that this is not a general authorization for at-home collection of patient samples using other (non-Everlywell) collection kits, swabs, media, or tests, or for other tests fully conducted at home.
By: Maggie Vricos, PharmD Candidate 2021
For the full article, visit: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-standalone-home-sample-collection-kit-can-be-used