- For immediate release:
Today, the U.S. The Food and Drug Administration has issued the Emergency Use Authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and it provides fast results. The Lucira COVID-19 All-in-One test kit is a molecular (real-time loop-mediated amplification reaction) a useful test aimed at detecting the cause of covid-19 in the novel coronavirus Saras-Co-2.
“The FDA continues to demonstrate its unprecedented momentum in responding to the epidemic. While COVID-19 diagnostic tests have been authorized for home storage, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic progression to eradicate the epidemic and reduce the public burden of disease transmission, said FDA Commissioner Stephen M. Han, MDA said. “Today’s action demonstrates the FDA’s ongoing commitment to expanding the reach of the Covid-19 test.”
The Lucira COVID-19 All-in-One Test Kit test has been authorized for home use with self-stored nasal swab samples in individuals 14 years of age who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings for all ages (e.g., doctor’s office fees, hospitals, emergency care centers and emergency rooms) but when testing is used Samples must be collected by the healthcare provider. The POC will test individuals under the age of 14. Testing is currently authorized for prescription use only.
The test works by turning the swab of a self-collected sample into a vial which is then placed in the test unit. In 30 minutes or less, the results can be read directly from the unit’s test unit’s light-up display, which shows whether a person is positive or negative for the SARS-Covy-2 virus. Positive results indicate the presence of SARS-COV-2. Individuals with positive outcomes should self-isolate and seek extra care from their health care provider. Individuals who test negatively and experience symptoms such as COVD should consult with their healthcare provider as negative results do not exclude a person from SARS-CoV-2 infection.
“Today’s authorization for a full domestic test is an important step toward the FDA’s nationwide response to COVID-19. A test that can be conducted entirely outside of a lab or healthcare setting has always been a major priority for the FDA to eradicate the epidemic. Now, more Americans who may have COVID-19, based on their results, will be able to take immediate action to protect themselves and those around them, ”said Jeff Shuren, JD MD, director of the FDA’s Center for Devices and Radiological Health. “We look forward to working actively with test developers to support the availability of more in-house testing options.”
An important component of successful home testing is the ability to effectively track and monitor results. As noted in the EU, health care providers are instructed to report all test results obtained from individuals using the test to their respective public health officials in accordance with local, state and federal requirements. Lucira Health has developed test manufacturer, box box labeling, quick reference instructions and health care provider suggestions that help report.
Diagnostic testing is the cornerstone of our nation’s response to COVID-19. The FDA continues its public health commitment to advancing new approaches that help make critical tests available to more Americans through EU authority.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, electronic radiation products, and the regulation of tobacco products.
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