The Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization for the first COVID-19 diagnostic at-home test.
The move will not have an immediate impact on in-home care providers, but it could give them one more tool in their pandemic toolbox in weeks to come.
The FDA specifically signed off on the Lucira COVID-19 “All-In-One Test Kit,” a molecular test that provides results in 30 minutes or less. Currently, the test is authorized for use by prescription only.
In an announcement on the authorization, U.S. Health and Human Services (HHS) officials described the news as another major advancement for the country’s COVID-19 testing ecosystem. The newfound availability of the Lucira test “represents a leap ahead” in terms of bringing the convenience of home testing to Americans, they noted.
“Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options,” HHS Secretary Alex Azar said.
Moving forward, the Lucira All-In-One Test Kit test will be authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider.
Although the idea is for individuals to test themselves, home health and home care professionals will likely play a huge role in supporting their high-risk patient populations during the process. If agencies can secure the newly authorized Lucira test themselves, it could also serve as a safer and more accurate method for screening in-home workers.
Due to accessibility and cost challenges, many agencies are using digital screening tools to best identify COVID-positive workers.
“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said. “A test that can be fully administered entirely outside of a lab or health care setting has always been a major priority for the FDA to address the pandemic.”
The Lucira at-home 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, which shows whether a person is positive or negative for the coronavirus.
Lucira said in a news release that the test will be available on a limited basis while it builds up further manufacturing capabilities.
“We look forward to proactively working with test developers to support the availability of more at-home test options,” Shuren continued.
Aging services providers across the continuum of care continue to face COVID-19 hardships.
In a new survey from Washington, D.C.-based trade group LeadingAge, for example, over half of respondents said they currently have diagnosed or suspected COVID-19 cases among residents or clients. Nearly all of them — 91% — said they have current diagnosed or suspected cases among staff.
The survey included 193 respondents from nursing homes, senior living communities, home health agencies and other senior care organizations.
While the FDA’s emergency use authorization for the Lucira at-home test is encouraging, some experts have called for caution, pointing out that at-home tests aren’t always as accurate as those carried out in a facility or office.
“Some of these tests have never been checked for reliability or accuracy,” Liz Richardson, who studies the regulation of medical products for the Pew Charitable Trusts, told the Los Angeles Times. “Even very good tests sometimes get it wrong.”
The Lucira All-In-One Test Kit test costs about $50, according to USA Today.