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On Tuesday November 22, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Lucira COVID-19 & Flu Test for use in a point-of-care (POC) setting. The Lucira COVID-19 & Flu Test is the first molecular COVID-19 test authorized following collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP).
- The Lucira COVID-19 & Flu Test is a single use molecular test that is intended to identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B (commonly known as the flu), along with SARS-CoV-2 (the virus that causes COVID-19), in individuals suspected of respiratory viral infection consistent with COVID-19.
- The signs and symptoms of the flu and COVID-19 can be similar, and it is helpful to health care providers to know which virus a patient has to create the best treatment plan.
The test can be used for people aged 2 years or older and is collected by nasal swab by a health care provider in a POC setting.
Negative test results should be confirmed with another FDA-authorized molecular test, if necessary for patient management. Negative test results must be combined with clinical observations, patient history, and epidemiological information.
The Emergency Use Authorization (EUA) issued for this test demonstrates FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable COVID-19 diagnostic tests, and to facilitate access to these tests for all Americans.
Questions?
If you have questions about this EUA announcement, contact the Division of Industry and Consumer Education.
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