On Tuesday, the Food and Drug Administration announced it had approved the first rapid coronavirus test capable of being taken at home.
The FDA stated:
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
The Lucira test was authorized for home use for anyone 14 and older whose health care provider suspects they have the virus. “It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only,” the FDA added.
The person taking the test must swirl the self-collected sample swab in a vial. After placing the vial in the test unit, the person should obtain results in 30 minutes or less.
“The test uses technology similar to genetic laboratory-based tests that are the standard tool for COVID-19 screening. That’s different than most rapid tests currently used in the US, which look for viral proteins called antigens — not the virus itself,” the Daily Mail noted.
Lucira states on its website: “In a Community Testing Study, where the Lucira test was compared to a FDA authorized known high sensitivity SARS-CoV-2 test, Lucira achieved a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100% positive percent agreement.”
“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,” Jeff Shuren, M.D., J.D., the director of FDA’s Center for Devices and Radiological Health, stated. “We look forward to proactively working with test developers to support the availability of more at-home test options.”
“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.”
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