"We continue to demonstrate unprecedented speed in response to #COVID19", tweeted FDA commissioner Stephen Hahn.
While the Lucira test provides results on the spot, it still isn't the kind of cheap and rapid antigen test that some researchers have called to use for large-scale population screening.
"FDA authorized the first #COVID19 test that's fully self-administered & provides results at home".
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit.
The U.S. gave the greenlight for the first COVID-19 diagnostic kit for self-testing at home, adding an additional tool to battle the pandemic as nationwide testing capabilities come under more strain.
"We look forward to proactively working with test developers to support the availability of more at-home test options", saidJeff Shuren, the director of the FDA's Center for Devices and Radiological Health.
The prescription-only test can be used at home by people ages 14 and older, though it is available to all ages when given in a doctor's office, clinic or emergency room, with the swabbing being performed by a trained healthcare provider. "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", the FDA continued. In addition, Lucira plans to file with the FDA next year to allow the test to be prescribed through a telehealth visit, with the kit delivered through the mail.
"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".
In POC settings, the sample collection must be carried out by a healthcare provider to test individuals aged younger than 14.
Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to help with reporting, according to the agency. "Positive results indicate the presence of SARS-CoV-2".
According to Lucira Health, the tests have a sensitivity of about 94.1 percent and a specificity of 98 percent.