On Tuesday, the U.S. Food and Drug Administration issued an emergency use authorization for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. Manufactured by California-based Lucira Health, the test provides 30-minute results when self-administered at home.
The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop-mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
Approved for people 14 and older, the test requires the user to take a nasal swab first, which they then place into a vial that plugs into a portable testing unit. Within 30 minutes, the device interprets the results and displays whether the person tested positive or negative for COVID-19.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
According to several experts, this approval will allow people to test themselves at home and will help reduce turnaround times and curb the possible spread of the virus to healthcare workers.
“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”
As mentioned by the FDA on an official blog post, after self-administering the test, individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.