FDA Announces Approval Of First Rapid Home-Test For Virus

FDA Announces Approval Of First Rapid Home-Test For Virus


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.

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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

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