The United States Food and Drug Administration on Tuesday approved the first self-testing kit for home use for coronavirus that provides results within 30 minutes.
The single-use test, made by Lucira Health, has been given emergency use authorisation for home use with self-collected nasal swab samples in individuals aged 14 and above, the US body said in an official statement.
“The test works by swirling the self-collected sample swab in a vial then placed in the test unit,” the statement said.
“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 kit can also be used at hospitals and point-of-care settings but healthcare provider should collect samples for people younger than 14 years, the health regulator said.
The Food and Drug Administration termed the test “as a significant step toward FDA’s nationwide response to Covid-19”.
“A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” it said.
The US has more than 1.13 crore coronavirus cases and over 2.48 lakh deaths so far.
It is by far the worst affected by the pandemic.
Globally, the coronavirus has infected more than 5.55 crore people and killed 13,36,892, according to the Johns Hopkins University.
Today, we issued an emergency use authorization (EUA) for the first #COVID19 diagnostic test that allows for self-collection & testing at home and provides test results in 30 minutes or less. The test kit for home use is available by prescription only. https://t.co/EXzSa8JyFR pic.twitter.com/Wooy5YBIbZ
— U.S. FDA (@US_FDA) November 18, 2020