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.”

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