FDA Approves First Home Coronavirus Test
People will be able to get tested for the coronavirus and get their results in a matter of minutes in the privacy of their home
The first COVID-19 home diagnostic self-test that provides rapid results has been cleared by the Food and Drug Administration (FDA ), the agency announced Tuesday.
The Lucira COVID-19 All-In-One Test Kit is a single-use molecular test.
“While COVID-19 diagnostic tests have been licensed for collection at home, this is the first that can be 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 advance in addressing the pandemic and reducing the public burden of disease transmission.”
The test, which works by spinning a swab sample in a vial that is then placed in a portable test unit, can provide results in 30 minutes or less , according to the agency.
The lighted display on the unit 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 other location to collect a sample, or collect a sample at home to mail it to a laboratory for analysis.
The test will be available by prescription for people 14 and older who have symptoms that could indicate COVID-19.
Patients under the age of 14 could undergo the test if administered by a healthcare provider, the FDA said.
Initially, it will be available on a limited basis in Florida and California .
It is expected to be widely available in the spring across the country.
Health and Human Services Secretary Alex Azar said in a statement Tuesday that the new test adds “to our ever-expanding arsenal of COVID-19 testing options.”