The U.S. Food and Drug Administration (FDA) today issued an Emergency Use Authorization (EUA) of the first Covid-19 diagnostic test to self-diagnose at home and that provides fast results.
“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 M. Hahn, MD” Today’s action underscores the FDA’s continued commitment to expanding access to testing for Covid-19. “
The Lucira Covid-19 “all-in-one” test kit has been licensed for home use with a sample that can be collected by the user with nasal swabs intended for people over 14 years of age suspected of having Covid 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 symptoms similar to Covid-19 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 at-home test is a significant step in the FDA’s national response to Covid-19. A test that can be completely administered 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 the coronavirus will be able to immediately take action, based on their results, to protect themselves and those around them, “said Dr. Jeff Shuren, MD, JD. , director of the FDA’s Center for Devices and Radiological Health. “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 tests remain 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.