FDA Approves First COVID-19 Self-Test Kit That Can Be Used at Home

The U.S. Food and Drug Administration announced on Tuesday that the country’s first at-home COVID-19 self-testing kit has been approved by the agency.

Results from said kit arrives in around 30 minutes, the FDA said in a statement posted to their website. “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 statement said.

Lucira Health is the maker behind the kit, which is single-use. It’s been approved for use at home for anyone over the age of 14. Samples are collected through nasal swab samples. The kit was also authorized for individuals of all ages at place’s besides the home, such as doctor’s officers and urgent care centers, as long as it was administered by a healthcare provider .

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in the statement. “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. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them… We look forward to proactively working with test developers to support the availability of more at-home test options.”