FDA Gives Emergency Approval To First COVID-19 Self-Testing Kit For Use At Home
EMERYVILLE (CBS SF) -- People will soon be able to test themselves for coronavirus and get their results in a matter of minutes in the privacy of their own homes.
The U.S. Food and Drug Administration has given emergency approval to Emeryville-based Lucira Health's COVID-19 All-In-One Test Kit.
"This is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," said FDA Commissioner Stephen M. Hahn, M.D. in a statement.
The test is administered by swirling a nasal swab similar to those used by public and private health providers. After collecting the sample, the patient places the swab in a vial which is then placed into a test unit. After thirty minutes, a light on the unit's display indicates whether the individual is positive or negative for 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," said said Jeff Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health. "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."
The Lucira COVID-19 All-In-One Test Kit will be available by prescription only and is also authorized for use at doctor's offices, hospitals and urgent care centers.
A healthcare provider must administer the test to patients under 14 years old.
