[ad_1]
- For immediate release:
Today, the US Food and Drug Administration issued an Emergency Use Authorization (EUA) for the first COVID-19 diagnostic test for self-assessment at home and providing rapid results. The Lucira COVID-19 All-In-One Test Kit is a single-use molecular test (real-time loop-mediated amplification reaction) that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 .
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While 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 diagnostic advance in addressing the pandemic and reducing the public burden of disease transmission, “said FDA Commissioner Stephen M. Hahn, MD.” Today’s action underscores the continued commitment of the FDA to expand access to COVID-19 testing. “
The Lucira COVID-19 All-In-One Test Kit has been licensed for home use with self-collected nasal swab samples from individuals 14 years of age and older who are suspected of COVID-19 by their healthcare provider . It is also licensed for use in point of care (POC) settings (for example, doctor’s offices, hospitals, urgent care centers, and emergency rooms) for all ages, but specimens must be collected by a healthcare provider when The test is used at the POC to evaluate people under the age of 14. Currently, the test is licensed for prescription use only.
The test works by spinning the self-collected sample swab into a vial which is then placed in the test unit. In 30 minutes or less, results can be read directly from the illuminated display of the test unit 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-like symptoms should consult with their healthcare provider, as negative results do not prevent a person from contracting SARS-CoV-2 infection.
Today’s authorization for a comprehensive home test is a significant step toward 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 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 for successful home testing is the ability to efficiently track and monitor results. As outlined in this USA, prescribing health care providers must report all test results they receive from individuals using the test to the appropriate public health authorities in accordance with local, state, and federal requirements. Lucira Health, the test manufacturer, has also developed box labeling, 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 public health commitment to seek new approaches that help make critical testing available to more Americans through US authority.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use and medical devices for human use. and veterinarian. The agency is also responsible for the safety and security of our nation’s supply of food, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.
###
