The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home.
The Lucira COVID-19 All-In-One Test Kit has been authorized for home use with self-collected nasal swab samples in individuals aged 14 years and older who are suspected of COVID-19 by their health care provider. The test is also authorized for use in point-of-care (POC) settings for all ages but samples must be collected by a health care provider when the test is used at the POC to test individuals younger than 14 years of age.
The test is currently authorized for prescription use only. Prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state and federal requirements.
Food and Drug Administration (FDA). Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home [news release]. November 17, 2020. Available at: click here. Accessed November 18, 2020.