FDA authorizes first at-home COVID-19 test
The FDA announced it has issued emergency use authorization for the Lucira COVID-19 All-In-One Test Kit, a molecular, single-use test that can be used at home and provides results in 30 minutes or less.
“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,” FDA Commissioner Stephen M. Hahn, MD, said in a press release. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
The Lucira COVID-19 All-In-One Test Kit (Lucira Health) is authorized for prescription use only and can be self-administered at home by individuals aged 14 years and older who are suspected of having COVID-19 by their health care provider. It can also be used in point-of-care settings such as doctor’s offices, hospitals, urgent care centers and emergency rooms for patients of all ages; however, it must be administered by a health care provider for those aged under 14 years.
For the test, patients or health care providers need to collect a nasal swab sample then swirl the swab in a vial and place it in the test unit. The results will appear on the test unit’s light-up display in 30 minutes or less.
The FDA said that prescribing health care providers must report all test results to public health authorities. Lucira Health developed box labeling, quick-reference instructions and directions for health care providers to help with reporting.
“A test that can be fully administered entirely outside of a lab or health care 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,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in the release. “We look forward to proactively working with test developers to support the availability of more at-home test options.”