FDA Authorizes COVID-19 Home Testing Kits With Results in 30 Minutes

Federal administrators Tuesday approved a COVID-19 testing kit that can be done in the privacy of your home, and results can be determined within 30 minutes.

The U.S. Food and Drug Administration (FDA) Tuesday authorized the emergency use of the first such self-testing with approval of the Lucira COVID-19 All-In-One-Test Kit. It's a single-use kit that's designed to rapidly detect the coronavirus SARS-CoV-2, which causes COVID-19.

"The FDA continues to demonstrate its unprecedented speed in response to the pandemic," FDA Commissioner Stephen M. Hahn, M.D., said in a statement. "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.

"Today's action underscores the FDA's ongoing commitment to expand access to COVID-19 testing."

This also comes on the heels of various pharmaceutical companies closing in to creating a vaccine for COVID-19, which has affected more than 50 million people worldwide, including more than a million deaths across the globe. In the United States, there have been more than 11 million infections and 250,000 deaths.

The Lucira test kit is approved for home use for people aged 14 years and older, and who are suspected of having the coronavirus, per their health care provider. For now, it's by prescription only, per the FDA. The all-in-one kit has a swab and a test unit that can read the swab. Within 30 minutes, the person should know if they test positive or negative for SARS-CoV-2 virus.

COVID-19 Test Kits
The U.S. Food and Drug Administration on Tuesday approved a COVID-19 testing kit that can be done at home, and results can be determined within 30 minutes, preventing long lines at doctor offices and free clinics. Photo by Mario Tama/Getty Images

The kit is also authorized for point-of-care locations like doctor's offices, hospitals, emergency rooms and urgent care centers.

"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 health care provider," the FDA stated on its website.

Should someone test negative with the home kit and still feel COVID-like symptoms, they should follow up with a doctor or preferred health care physician to further evaluate the symptoms or have more tests performed.

"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, M.D., J.D., 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."

Along with the kit, Lucira developed box labeling, quick reference instructions and what you should tell your health care provider after taking the test.