The U.S. Food and Drug Administration approved emergency use for a new, at-home coronavirus testing kit.
On Tuesday, the agency authorized an all-in-one COVID-19 diagnostic test from Lucira Health, Inc, allowing users to receive results in 30 minutes or less. The single-use test swirls a self-collected sample swab inside a vial and then displays a result.
“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 in a statement. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
The test kit was authorized for at-home uses for people 14 years old and above and at points-of-care, such as hospitals and emergency rooms. The test is only authorized for prescription use, according to the FDA. For children younger than 14, a sample must be taken by a healthcare provider.
Healthcare providers are required by the government to report all test results received from those who use the test. “Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting,” the FDA wrote in their announcement.
The announcement came a day before Pfizer and BioNTech announced their candidate for the COVID-19 vaccine to be 95% effective. The companies said they plan to submit a request for emergency use authorization from the FDA within the coming days.