The US Food and Drug Administration (FDA) has issued an emergency use authorization for the first self-test for Covid-19 that can provide rapid results at home.
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.
It uses a molecular amplification technology to search for signs of the coronavirus’s genetic material.
How does it work? The kit includes a sterile swab, a sample vial, a test unit, batteries and a plastic disposal bag.
A user first needs to self-collect a nasal swab sample and insert it 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.
Who can use it? The new test is authorized for people aged 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.
“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.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn added.