New Delhi (NVI): The US Food and Drug Administration (FDA) has approved emergency use authorization for the first COVID-19 diagnostic at home self-testing kit.
The Lucira COVID-19 All-In-One Test Kit is a molecular single use test that provides rapid results of SARS-CoV-2 that causes COVID-19, the agency said in a statement.
“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 Stephen M Hahn said.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing,” he added.
According to the agency, the test, which works by swirling a self-collected nasal swabbed sample in a vial which is then placed in a hand-held test unit and can provide results in 30 minutes or less. The unit’s light-up display then shows whether a person is positive or negative for the SARS-CoV-2 virus.
The FDA also stated that the test kit is only authorized for individuals of age 14 and above who are suspected of COVID-19 by their health care provider, the FDA said.
Meanwhile, it is also authorized for use in at hospitals point-of-care (POC) settings for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years.
Reportedly, the test is intended to cost less than USD 50 and the kit is manufactured in the United States.
“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health.
“We look forward to proactively working with test developers to support the availability of more at-home test options,” he added.