Updated at 11:45 a.m. ET
The first COVID-19 diagnostic at-home self-test that provides rapid results has been approved by the U.S. Food and Drug Administration, the agency announced Tuesday.
The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test.
“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 Hahn said in a statement.
Hahn added: “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
The test, which works by swirling the self-collected sample in a vial which is then placed in a hand-held test unit, can provide results in 30 minutes or less, according to the agency. The unit’s light-up display shows whether a person is positive or negative for the SARS-CoV-2 virus.
Until now, people have had to visit a doctor’s office, clinic, hospital or some other site to have a sample taken, or else collect a sample at home for mailing to a lab for analysis.
The test will be available by prescription to people 14 and older who have symptoms that could indicate COVID-19. Patients under 14 could be given the test if it’s administered by a health care provider, the FDA said.
Initially, the test will be available on a limited basis in Florida and California. It is expected to be available widely by the spring.
Testing shortages have been a massive problem since the pandemic began, crippling the nation’s ability to fight the spread of the virus. The recent surge in cases has again put additional strain on the nation’s precarious coronavirus testing system, especially as more people try to get tested ahead of the holidays.
As NPR’s Rob Stein reported:
The approval of at-home self-tests could have a big impact on the testing regime throughout the U.S.