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.
- Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home [news release]. Silver Spring, MD: US Food and Drug Administration; November 17, 2020. Accessed November 19, 2020. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-for-self-testing-at-home-301175512.html
- FDA Authorizes First Prescription at Home Molecular Test for COVID-19 [news release]. Emeryville, CA: BusinessWire; November 18, 2020. Accessed November 19, 2020. https://www.businesswire.com/news/home/20201118005547/en/FDA-Authorizes-First-Prescription-at-Home-Molecular-Test-for-COVID-19
This article originally appeared on MPR