FDA authorizes 1st at-home rapid test
The Food and Drug Administration has issued an emergency use authorization for the first at-home rapid test for the SARS-CoV2 virus. The Lucira COVID-19 All-In-One Test Kit is authorized for use at home or point of care in a doctor's office, but only with a prescription.
"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,” FDA Commissioner Stephen M. Hahn said in a statement.
FDA says the molecular test "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."
Some experts have pushed for more development of at-home rapid tests, saying that if they were affordable and accessible -- like a pregnancy test -- people could test themselves daily before going to work, school or traveling. Since this test is prescription-only, it likely won't be that widely available yet, but other companies have submitted applications for similar technology and the FDA says that will be a priority.
"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 Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, in a statement. "We look forward to proactively working with test developers to support the availability of more at-home test options."
ABC News' Stephanie Ebbs contributed to this report.