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 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.
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.
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:
“Long lines are again forming in some places as the surge of infections drives a surge in demand for testing. Testing companies, lab directors and testing policy experts warn that waiting times for results could soon start to lengthen. In fact, one of the largest commercial testing companies Tuesday reported turnaround times had already started creeping up.”
The approval of at-home self-tests could have a big impact on the testing regime throughout the U.S.