The Food and Drug Administration (FDA) has issued an emergency use authorization for the first COVID-19 diagnostic test that it said can be fully administered at home.
The agency announced the authorization on late Tuesday for Lucira’s COVID-19 All-In-One Test Kit, which can be used for individuals at least 14 years of age or older.
The test, the agency said, works “by swirling the self-collected sample swab in a vial that is then placed in the test unit.”
“In 30 minutes or less, 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. Positive results indicate the presence of SARS-CoV-2,” the agency added.
At this time, the agency said the test is only authorized for prescription use.
FDA Commissioner Stephen M. Hahn said in a statement that the newly authorized test 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,” he also said, while adding the new announcement “underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
Jeff Shuren, M.D., J.D., director of the agency’s Center for Devices and Radiological Health, also called the test’s authorization “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,” he said.
The news comes as the nation has seen an uptick in COVID-19 cases, in addition to a rise in hospitalizations, in recent days as the country heads into the colder months.