FDA authorizes first at-home COVID-19 test
by Adrian Mojica, WCYB (TN)
May 18th 2020
The Food and Drug Administration (FDA) has authorized the first at-home COVID-19 collection kit for testing if a person has the virus.
The FDA has issued an Emergency Use Authorization (EUA) to Everlywell, Inc. for their home test collection kit. EUAs provide for authorization of tests due to the current situation but the FDA notes it is different from being approved or cleared by the FDA, which is a lengthy process.
However, the authorization comes after a privately funded study was used to support the granting of the EUA authorization, according to the FDA. To receive the kit, individuals will be screened through an online questionnaire, which is then reviewed by a health care provider.
The individual then will self-collect a nasal sample in the kit and sent off to laboratories approved to test the sample. Results...