At-home COVID-19 sample collection kit gains FDA authorization

At-home COVID-19 sample collection kit gains FDA authorization tjordan_drupal May 18, 2020

The Food and Drug Administration Saturday authorized the emergency use of Everlywell, Inc.’s COVID-19 Test Home Collection Kit. The product is a standalone, at-home, nasal-swab sample collection kit that can be sent to specified labs for subsequent COVID-19 diagnostic testing using certain tests separately authorized by FDA for use with the new kit.

The labs authorized to test specimens collected using the authorized kit are Fulgent Therapeutics and Assurance Scientific Laboratories. Individuals must be screened via an online questionnaire, the results of which are