Covid-19 : FDA approves first at-home test for emergency use
19 November 2020
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. The U.S. Food and Drug Administration (FDA) has given emergency use approval to the first Covid-19 test that can be conducted entirely at home.
Produced by Lucira Health, a privately held, California-based biotech company, the single-use swab test can provide results within 30 minutes. According to the company’s website, it is “intended to cost less than $50.”
“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,” FDA Commissioner Stephen Hahn said in a press release.
HOW DOES THE TEST WORK
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.
- Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider.
- Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.
Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. According to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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.”
Diagnostic testing remains one of the pillars of our nation’s response to COVID-19. The FDA continues its public health commitment to pursue new approaches that help make critical tests available to more Americans through EUA authority.
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