FDA approves 1st COVID-19 test to be used at home
Lucira's COVID-19 All-In-One Test Kit is expected to cost $50 or less, according to the company website.
The Food and Drug Administration has approved the first coronavirus self-test to be administered at home.
The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test and is expected to cost $50 or less, the company said on its website.
“This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider,” according to Lucira. “This test is also authorized for use in Point of Care settings for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider.”
In a statement, FDA Commissioner Stephen M. Hahn writes, “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. 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. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
“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,” according to the FDA. “Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider.”
Individuals who garner negative results but have symptoms are instructed to follow up with their healthcare provider.
“A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Diagnostic testing is a pillar of a national response to the coronavirus pandemic still gripping the country.
To date, more than 11 million Americans have tested positive for COVID-19. Deaths from the virus are expected to top 250,000 in the coming days.