The Food and Drug Administration yesterday issued an emergency use authorization for the Lucira COVID-19 All-In-One Test Kit, the first rapid test to detect the COVID-19 virus that one can administer completely at home when prescribed by a health care provider to individuals age 14 or older. Previously authorized at-home test kits allow the user to collect a sample at home and send it to a lab for testing. 

Health care providers prescribing the Lucira test are required to report the results they receive from users to their relevant public health authorities in accordance with local, state and federal requirements. The test also is authorized for use in patient care settings operating under a CLIA certificate of waiver, compliance or accreditation, with nasal swab specimens in individuals under age 14 collected by the provider.

“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,” said Jeff Shuren, M.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.”

Related News Articles

Headline
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…
Headline
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following…
Headline
The Advisory Committee on Immunization Practices Sept. 19 recommended that patients should consult their health care provider if they want to receive a COVID-…
Headline
The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a…
Headline
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore…
Headline
The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory…