FDA approves first at-home coronavirus self-testing kit

pharmafile | November 18, 2020 | News story | Research and Development  

The FDA has issued an Emergency Use Authorization for the first coronavirus self-testing kit for use at home that produces rapid results. 

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test. It collects samples via a nasal swab and has been authorised for people over 14 with suspected coronavirus infection to test themselves at home. It is authorised for all ages in care settings such as hospitals, emergency offices and doctor’s offices. 

“While COVID-19 diagnostic tests have been authorised for at-home collection, this is the first that can be fully self-administered and provide results at home,” remarked FDA Commissioner Stephen M Hahn. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The test works by putting the swab into a vial that is placed in a test unit. In 30 minutes or less, the results can be read directly from the unit’s light-up display which shows if a person is positive or negative. 

Jeff Shuren, Director of FDA’s Center for Devices and Radiological Health, also commented: “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.”

Conor Kavanagh

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