FDA authorizes first COVID-19 test for self-testing at home

Yesterday afternoon, the U.S. FDA issued an Emergency Use Authorization (EUA) to a COVID-19 molecular diagnostic test that provides individuals with a result within 30 minutes, in the comfort of their home.

As opposed to currently available at-home testing products, which have patients self-collect a nasal swab sample and ship it for processing in a lab, the Lucira COVID-19 All-in-One Test Kit includes all the materials and instructions necessary for individuals to conduct the test themselves.

To do so, they self-collect a nasal swab sample and then swirl it within an included sample vial, according to the FDA EUA letter. The vial is then placed into a battery-powered test unit device that eventually displays an LED light next to the positive or negative indicator (or a light next to each one, if the test was inconclusive).

The single-use test requires a prescription, and is intended for home use among those aged 14 years or above with suspected COVID-19. The kit is also authorized for use in a point-of-care setting, but in that case a provider must collect samples when the test is used for those under the age of 14.

Lucira said in its announcement that it anticipates