Photo: Lucira Health

FDA Approves the First At-Home COVID-19 Test

United States News
by Eben Diskin Nov 19, 2020

On Tuesday, the FDA approved the first COVID-19 diagnostic at-home self-test that provides rapid results, making it easier for people to quickly determine whether or not they are infected by the novel coronavirus.

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use kit that works by swirling a self-collected swabbed sample in a vial. The sample is then placed in a hand-held test unit and can provide results in 30 minutes or less. A light on the display will show whether the sample tested positive or negative for COVID-19.

“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,” said FDA Commissioner Stephen Hahn in a statement. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

Prior to this test’s approval, people have had to visit a doctor’s office, clinic, or hospital to get their sample taken, or were required to mail their sample to a lab for analysis. This at-home test will make things much more convenient.

The test will be available by prescription to those 14 and older who have symptoms and those under 14 if administered by a healthcare provider. At first, the test will only be available in Florida and California, but it’s expected to be available nationally by spring.

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