FDA authorizes first at-home molecular test for COVID-19

November 18, 2020 – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Lucria Health for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results.

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus

That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results.

The Lucira COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health (CA) and Cleveland Clinic Florida (Miami, FL) in the near future and nationally through health care providers by early spring 2021.

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider.

It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

The test is currently authorized for prescription use only.

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