FDA approves emergency use of Lucira COVID-19 All-In-One Test Kit that can be administered at home

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The FDA said the test 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. However, health care providers must collect the nasal swab samples when it is used at the POC to test individuals younger than 14 years old.

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The Lucira COVID-19 All-In-One Test Kit works by swirling the self-collected sample swab in a vial that is then placed in the test unit. The light-up display will show whether a person is positive or negative for the SARS-CoV-2 virus.

In a statement, FDA Commissioner Stephen Hahn, M.D. said the agency “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

The FDA is advising individuals with positive results to self-isolate and seek additional care from their health care provider.

Those who test negative and experience COVID-like symptoms should follow up with their health care provider.  Negative results do not prevent an individual from getting infected with SARS-CoV-2.