Wednesday, December 6, 2023

FDA Approves First COVID-19 Rapid Self-Test

With results available in 30 minutes or less, the test is set to disrupt others on the market and create less time from test to diagnosis, easing the burden on healthcare providers.  

The Food and Drug Administration (FDA) has announced one of the most promising developments in America’s fight against COVID-19: A home-based rapid self-test. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn, M.D. said in a statement Tuesday. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”  
Focused wholly on reaching people as they quarantine, disabling the spread of the virus, the FDA greenlit the Lucira COVID-19 All-In-One Test Kit for individuals without the use of a trained medical professional for individuals over the age of 14. For children under 14, the test is available in clinical settings, such as hospitals, doctor’s offices and urgent care centers when administered by a professional. With results available in 30 minutes or less, the test is set to disrupt others on the market and create less time from test to diagnosis, easing the burden on healthcare providers, as well as communities as a whole.  
Only available in prescription form, individuals must ask for it from their care provider. Once samples are collected, the swab is placed into a vial that goes into a test unit. Each display uses light to display a positive or negative result, allowing individuals and families a faster, easier path to answering the question if they should quarantine.

The Director of FDA’s Center for Devices and Radiological HealthJeff Shuren, M.D., J.D., explained the remarkable nature of the test, sharing, “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.”  

RELATED: FDA Has Approved A New At-Home Test For COVID-19 

Speed is of the essence as the United States is seeing an alarming spread of the COVID-19 virus with little end in sight. As new restrictions and regulations move from statetostate, leaders are searching for answers in eliminating the threat of a nation-wide lockdown—further hurting businesses. The FDA has expressed since the start of the pandemic that rigorous testing, study of the spread and vaccination could slow Coronavirus’ reach and bring most Americans back to their new normal sooner, though for some, it’s not soon enough.   
With new rapid testing available at home, the Administration is hopeful that more Americans will have access to knowledge if they are positive, staying home and not infecting workplaces, communities or schools.  


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