The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to Lucira Health for its at-home molecular test intended to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This is the first time the Agency has authorized a coronavirus disease 2019 (COVID-19) diagnostic test that provides rapid results at home.
The Lucira™ COVID-19 All-In-One Test Kit includes a battery-operated test device, sample vial, swab, and instructions. Users would need to swab each nostril 5 times then stir the swab in the sample vial which is then pressed down in the test unit to start the test. Results are displayed via a “positive” or “negative” green light that appears within 30 minutes; positive results have been observed as early as 11 minutes.
Over 100 participants were enrolled in Lucira’s Community Testing Study in which patients suspected of having COVID-19 tested themselves under observation by trained professionals. Results from the study showed that 100% of these participants were able to successfully run the test. When compared with other FDA authorized high sensitivity SARS-CoV-2 assays, the positive results agreed 94.1% of the time and the negative results agreed 98.0% of the time across all samples.
In addition to self-testing at home, the Lucira test is authorized for use in point-of-care settings for all ages; however the samples must be collected by a health care provider when the test is used on patients younger than 14 years old.
Availability of the test will initially be limited to point-of-care settings and health care networks that prescribe the test for patients to use at home; the price of the test is around $50. Health care providers are required to report all test results they receive from individuals who use the test, as indicated in the EUA.
For more information visit lucirahealth.com.
1. Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home. [press release]. Silver Spring, MD; November 17, 2020.
2. FDA Authorizes First Prescription at Home Molecular Test for COVID-19. [press release]. Emeryville, CA; November 18, 2020.