FDA Authorizes Emergency Use Of First Fully At-Home COVID Tests

by Cassandra Stone
Sebastian Condrea/Getty

The at-home test is available by prescription with test results in 30 minutes or less.

The U.S. Food and Drug Administration has officially issued an emergency use authorization for the first COVID-19 diagnostic test that can be conducted at home. The all-in-one test kit by pharmaceutical company Lucira is a single-use test intended to detect the presence of SARS-CoV-2. It’s the first time such a test has been made available for at-home use throughout the pandemic.

The rapid test utilizes a molecular amplification technology to detect the virus in people with known or suspected Covid-19 and can return results in 30 minutes, the FDA said in a release.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. 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. 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. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The test is performed with a self-collected nasal swab, just like any other COVID test. The FDA recommends it for anyone over the age of 14 who has suspected COVID-19 according to their healthcare provider. The test is also authorized for use at doctor’s offices, hospitals, and urgent care centers.

According to the FDA, the test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. Results should be available in 30 minutes or less and read directly from the test itself, which has a light-up display right on the unit. Positive results indicate the presence of COVID-19, and individuals who receive a positive result should follow up with their healthcare provider.

While this isn’t the first test authorized for at-home sample collection, it is the first one that provides results at home.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to 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. 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,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, in the organization’s statement. “We look forward to proactively working with test developers to support the availability of more at-home test options.”

The test is expected to cost $50 or less.