The U.S Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Lucira COVID-19 All-In-One Test Kit, which can be administered at home and get immediate results.
The FDA’s decision comes as the United States continues to grapple with the increasing number of people infected by COVID-19. As of Wednesday, the country has more than 11.4 million tested positive for the virus and 248,400 died.
Since the end of September, the hospitalization rates for COVID-19 have been increasing steadily, according to the Centers for Disease for Control and Prevention (CDC).
The rising rates of COVID-19 cases and hospitalizations across the U.S. are alarming thus it is imperative that people have immediate access to testing.
According to the FDA, the Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop-mediated amplification reaction) single-use test, It is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
Individuals age 14 and older need to request a prescription from their doctors to use the Lucira COVID-19 All-In-One Test Kit to find out if they are infected with the virus. They need self-collected nasal swab samples to administer the diagnostic test at home and will get the result within approximately 30 minutes.
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.
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.
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