WASHINGTON – The United States Food and Drug Administration (FDA) on Wednesday issued a emergency use authorization (US) of the first COVID-19 diagnostic test to self-diagnose at home and provide fast results. The Lucira COVID-19 “all-in-one” test kit is a single-use molecular test (real-time cycle-mediated amplification reaction) that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID- 19.
“The FDA continues to demonstrate unprecedented speed in its response to the pandemic. While there are COVID-19 diagnostic tests that have been licensed for home sample collection, this is the first test that can be fully done and provide results at home. This new testing option is an important diagnostic advance in addressing the pandemic and reducing the public burden of disease transmission, ”said FDA Commissioner Dr. Stephen Hahn, MD in written communication.
“Today’s action underscores the FDA’s continued commitment to expanding access to COVID-19 testing,” he added.
The Lucira COVID-19 “all-in-one” test kit has been licensed for home use with a user-collectible sample with nasal swabs intended for individuals age 14 and older who are suspected of having COVID-19 by their healthcare provider. 19. It is also licensed for use in site-of-care facilities (for example, doctor’s offices, hospitals, urgent care clinics, and emergency rooms) for all ages, but specimens must be collected by a health care provider when required. The test is used at the site of care to screen people under the age of 14. Currently, the test is licensed for prescription use only.
The test works by spinning the swab with the self-collected sample into 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 shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. People who test positive should isolate themselves and seek additional attention from their healthcare provider. People who test negative and experience COVID-19-like symptoms should consult with their healthcare provider, as negative results do not rule out that a person has SARS-CoV-2 infection.
Today’s authorization for a comprehensive home test is a significant step in the FDA’s national response to COVID-19. A test that can be administered entirely outside of a laboratory or healthcare setting has always been one of the FDA’s top priorities in addressing the pandemic. 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, ”said Dr. Jeff Shuren, MD, JD, director of the Center for Devices and Health. FDA Radiological. “We look forward to working proactively with test developers to support the availability of more in-home testing options.”
An important component to successful home testing is the ability to efficiently track and monitor results. As stated in this US authorization, prescribing health care providers must report all test results they receive from individuals using the test to the relevant public health authorities in accordance with local, state, and federal requirements. Lucira Health, the test manufacturer has also developed box labels, quick reference instructions, and healthcare provider instructions to assist with reporting.
Diagnostic testing continues to be one of the pillars of our nation’s response to COVID-19. The FDA continues its commitment to public health and to seeking new actions to help make critical tests available to more Americans through its emergency authorization powers.
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the protection, efficacy, and safety of veterinary and human drugs, vaccines, and other biological products intended for human use. humans, as well as medical devices. The agency is also responsible for the protection and safety of our national food supply, cosmetics, dietary supplements, products that emit electronic radiation, as well as the regulation of tobacco products.