- The FD has issued an emergency use authorization (EUA) to the single-use COVID-19 diagnostic test kit from Lucira Health, a California manufacturer.
- The Lucira COVID-19 All-In-One at home test kit provides rapid results. To date, the Agency has authorized nearly 300 tests for coronavirus.
- The test allows users age 14 and older to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed in 30 minutes as lights labeled positive or negative.
- The test is currently authorized for prescription use only.
- https://seekingalpha.com/news/3637350-fda-authorizes-first-home-rapid-covidminus-19-test
Wednesday, November 18, 2020
FDA authorizes first at-home rapid COVID-19 test
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