The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test available by prescription for self-diagnosis of the coronavirus, the agency said Tuesday.
The rapid test utilizes a molecular amplification technology to detect the virus in people with known or suspected Covid-19 and can return results in 30 minutes, the FDA said.
A molecular Covid-19 test searches for signs of the coronavirus genetic material.
“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,” FDA Commissioner Dr. Stephen Hahn said in a statement.
The new test, which uses self-collected nasal swab samples, is authorized for people 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider.
It is also authorized for use in point-of-care settings, such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but must be collected by a health care provider, the FDA said.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn added.
Health and Human Services Secretary Alex Azar agreed.
“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,” Azar said in a statement.
But some health experts urged caution.
“The data is just still emerging, Tom Bollyky, the director of the global health program and senior fellow for global health, economics, and development at the Council on Foreign Relations, told CNN. “Obviously with some past emergency use authorizations it pays to be cautious with what the FDA has put out here, but it’s certainly a promising sign.”
The self Covid-19 home test could be one more step that gets the country closer to a new normality.
“Expanded testing, rapid testing really could be one more tool that brings us back to a life that approaches more normalcy. If we’re able to identify at least on, perhaps even a daily basis, what our current viral load is and it helps us make ourselves safer and others,” he said.
The new self-testing kit includes a sterile swab, a sample vial, a test unit, batteries and a plastic disposal bag.
The sample collected on the nasal swab is inserted into the vial which then enters the test unit where it is analyzed. The results are displayed on the test unit by a color change in the LED indicators, according to the FDA. Instructions on how to use the test are included with the prescription.
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