FDA Authorizes First At-Home COVID-19 Test

Yesterday, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the first coronavirus 2019 (COVID-19) diagnostic test designed for at-home, self-testing.

The Lucira COVID-19 All-In-One Test Kit, a molecular real-time loop mediated amplification reaction test, can detect novel coronavirus SARS-CoV-2 within 30 minutes.

The new product has been authorized for use in the home setting via self-collected nasal swab samples in persons aged 14 years and older who have been suspected of COVID-19 infection by a healthcare provider. It is also indicated for using in standard point-of-care settings including clinician’s offices, hospitals, urgent care centers, and emergency rooms for all ages when test is collected by a healthcare provider.

Currently, the Lucira test is available by prescription only.

According to the company, the test was observed in a comparative trial to an FDA-authorized, high sensitivity SARS-CoV-2 test, and achieved a 94% positive percent agreement and a 98% negative percent agreement. The test achieved 100% positive percent agreement when investigators excluded samples with very low levels of SARS-CoV-2 that may not reflect active infection.

The capability for at-home testing is a substantial benefit for the diagnostic testing campaign, one of the “pillars of our nation’s response to COVID-19,” the FDA wrote in its announcement.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a 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.

The authorization also requires healthcare providers report in all received test results from individuals in alignment with local, state, and federal mandates. Lucira additionally developed box labeling and intuitive instruction material for both users and providers to simplify the process.

Prior to this authorization, the FDA’s most significant advancement in COVID-19 testing authorization came by way of either at-home collection (submitted to eligible laboratories) or by rapid result readings. The new Lucira test providers matches or improvements on marks of expediency and convenience.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn, MD, said in a statement. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”