The authorisation also facilitates the use of the test in point-of-care (POC) settings
Lucira Health has secured FDA EUA status for at-home self-testing Covid-19 kit. (Credit: Gerd Altmann from Pixabay)
Lucira Health has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its at-home self-testing Covid-19 diagnostic kit.
Lucira Covid-19 all-in-one test kit is a molecular single-use test developed for the detection of the novel coronavirus SARS-CoV-2, which is responsible for the Covid-19 disease.
The FDA status enables to use the test at home with self-collected nasal swab samples in individuals aged 14 years and older, who are suspected of being infected with Covid-19 by their health care provider.
The authorisation also facilitates the use of the test in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but samples are be collected by a healthcare provider.
The Lucira test is said to work by swirling the self-collected sample swab in a vial, which is then placed in the test unit.
Lucira test delivers results within 30 minutes
The test unit’s light-up display allows to directly read the results within 30 minutes, thereby enabling to determine whether a person is positive or negative for the SARS-CoV-2 virus.
Lucira Health has also designed box labeling, quick reference instructions and health care provider instructions for efficient reporting.
FDA Commissioner Dr Stephen Hahn said: “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.”