For immediate release:

Today, the United States Food and Drug Administration issued an Emergency Use Authorization (EUA) for the first COVID-19 diagnostic test for the home self-test that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a single-use molecular (real-time loop-mediated amplification reaction) test for the novel coronavirus SARS-CoV-2 that causes COVID-19 .

“The FDA continues to demonstrate its unprecedented speed in responding to the pandemic. Although COVID-19 diagnostic tests have been authorized for home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important breakthrough in diagnostics for dealing with the pandemic and reducing the public burden of disease transmission, ”said FDA Commissioner Stephen M. Hahn, MD. ‘today highlights the FDA’s continued commitment to expand access to COVID-19 testing. “

The Lucira COVID-19 All-In-One Test Kit has been cleared for home use with self-collected nasal swab specimens from people 14 years of age and older suspected of COVID-19 by their healthcare provider health. It is also cleared for use in place of care (POC) (e.g. doctor’s offices, hospitals, emergency care centers, and emergency rooms) for all ages, but samples must be collected by a healthcare professional when the test is used at the POC to test individuals under the age of 14. The test is currently only licensed for prescription use.

The test works by swirling the self-collected sample swab in a vial which is then placed in the test unit. In 30 minutes or less, results can be read directly from the test unit’s illuminated display that indicates whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. People with positive results should self-isolate and seek additional care from their health care provider. People who test negative and have COVID-like symptoms should follow up with their health care provider, as negative results do not prevent a person from being infected with SARS-CoV-2.

“Today’s clearance for a comprehensive home test is an important step towards the FDA’s national response to COVID-19. A test that can be fully administered outside of a lab or healthcare setting has always been a top priority for the FDA to fight the pandemic. Now, more Americans at risk of having COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them, ”said Jeff Shuren, MD, JD, director of the Center for FDA Devices and Radiological Health. “We look forward to working proactively with test developers to support the availability of more home testing options.”

An important part of successful home testing is the ability to effectively track and monitor results. As stated in this EUA, prescribing healthcare providers are required to report all test results they receive from people using the test to their appropriate public health authorities in accordance with local, state, and federal requirements. Lucira Health, the assay maker, has also developed box labeling, quick reference instructions, and instructions for healthcare providers to facilitate reporting.

Diagnostic testing remains one of the pillars of our country’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 the EUA authority.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

###

Related information