US FDA Authorizes First At-Home Rapid Coronavirus Test Kit

On November 17, 2020 (Tuesday), the U.S Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first coronavirus testing kit for home use and it can provide the test results in 30 minutes or less.

“Today, we issued an emergency use authorization (EUA) for the first #COVID diagnostic test that allows for self-collection & testing at home and provides test results in 30 minutes or less. The test kit for home use is available by prescription only.”

-US FDA on Facebook

Furthermore, the test kit for self-testing at home is available by prescription only according to US FDA.

According to FDA Commissioner Stephen M. Hahn, M.D., he said that “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID diagnostic tests have been authorized for at-home collection, 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.”

Also, the Director of FDA’s Center for Devices and Radiological Health Jeff Shuren, M.D., J.D. said that the authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID and more Americans who may have coronavirus will be able to take immediate action.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID. 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 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.”

-Jeff Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health

Lucira COVID All-In-One Test Kit

According to the US FDA, the Lucira COVID All-In-One Test Kit, manufactured by Lucira Health is a molecular or real-time loop-mediated amplification reaction single-use test that is intended to detect SARS-CoV-2, the virus that causes coronavirus.

More about Lucira COVID All-In-One Test Kit according to US FDA:

• Authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID by their health care provider.
• Authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.
• The testing kit is currently authorized for prescription use only.
• Using the Lucira COVID All-In-One Test KiLucira COVID All-In-One Test Ki, the test works by swirling the self-collected sample swab in a vial that is then placed in the test unit.
• 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 in 30 minutes or less.

Source: US FDA