November 18, 2020
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) Wednesday “for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results,” according to a press release.
The press release from the FDA stated that the new at how test is the Lucira COVID-19 All-In-One Test Kit. The test kit is a molecular “single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.”
“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,” stated 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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