The Food and Drug Administration today issued an emergency use authorization 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 (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes 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 Hahn. "Today's action underscores the FDA's ongoing commitment to expand access to COVID-19 testing."
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 years old and older who are suspected of COVID-19 by their healthcare provider. It also is authorized for use in such point-of-care settings as 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.
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. 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.
Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their healthcare provider. Individuals who test negative and experience COVID-like symptoms should follow up with their healthcare provider as negative results do not preclude an individual from SARS-CoV-2 infection.
"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," said Jeff Shuren, director of FDA's Center for Devices and Radiological Health. "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. We look forward to proactively working with test developers to support the availability of more at-home test options."
Lucira Health also has developed box labeling, quick reference instructions and healthcare provider instructions to assist with reporting.