FDA authorizes first at-home COVID-19 test
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first at-home novel coronavirus (COVID-19) diagnostic test that provides rapid results, according to an announcement made earlier this week.
The Lucira COVID-19 All-In-One Test Kit has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider. It is also authorized for use in point-of-care settings, including doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a healthcare provider when the test is used for individuals younger than 14 years old. The test is currently authorized for prescription use only, according to the FDA.
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up 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. Individuals with positive results should self-isolate and seek additional care from their healthcare provider. Individuals who test negative and experience COVID-like symptoms should follow up with their healthcare provider as negative results do not preclude an individual from SARS-CoV-2 infection.
As noted in this EUA, prescribing healthcare providers are required to report all test results they receive from individuals who use the test to their relevant 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.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” said Stephen Hahn, MD, FDA Commissioner, in a statement. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”