FDA authorizes the first prescription at-home COVID-19 test kit

November 24, 2020 · Clinical Team

The U.S. Food and Drug Administration (FDA) authorized the use of the Lucira™ COVID-19 All-In-One Test Kit under an Emergency Use Authorization (EUA) on November 17, 2020. This is the first at-home nasal swab test kit to detect SARS-CoV-2 - the virus that causes the coronavirus disease 2019 (COVID-19).

Marketed by Lucira Health, Inc., when prescribed by a healthcare provider, this single-use test kit can be used at home for individuals 14 years of age and older with known or suspected COVID-19. It can also be used in point-of-care settings, such as doctors’ offices, urgent care settings, and hospitals for any individual, regardless of age, although patients 13 years of age and younger must have their nasal swab sample collected by a healthcare provider on the premises.

Test results are displayed in less than thirty minutes. If the results are positive - indicating the presence of SARS-CoV-2 - individuals should self-isolate and seek additional care from their healthcare provider. Because negative test results do not preclude COVID-19 infection, individuals should seek follow up care if COVID-19 symptoms continue.

Availability

According to Lucira Health, their prescription at-home test kit is expected to be “available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers.”

Impact on workers’ compensation and auto no-fault

Because the Lucira COVID-19 All-In-One Test Kit will be available for use as a take-home prescription, we expect this diagnostic test to be dispensed to claimants at retail pharmacies in select states in the near future and nationally by early spring 2021. Therefore, the Optum Pharmacy and Therapeutics (P&T) Committee will evaluate the impact on our standard formularies, including our viral infection (COVID-19) supplemental formulary, by the end of fourth quarter 2020.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

1. U.S. Food and Drug Administration (FDA). News & Events. Newsroom. Press Announcements. FDA News Release. Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home. November 17, 2020. Available at: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home?utm_medium=email&utm_source=govdelivery. Accessed on November 18, 2020.

2. Lucira Health, Inc. [website]. Available at: https://www.lucirahealth.com/. Accessed on November 18, 2020.

3. Lucira Health, Inc. [website]. Lucira News Release. FDA Authorizes First Prescription At Home Molecular Test for COVID-19 Lucira Health test provides lab-quality result in 30 minutes or less from home. November 18, 2020. Available at: https://2nyvwd1bf4ct4f787m3leist-wpengine.netdna-ssl.com/wp-content/uploads/2020/11/FDA-Authorizes-First-Prescription-At-Home-Molecular-Test-for-COVID-19-released-20201118.pdf. Accessed on November 18, 2020.