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.”

In October, Genomics company DxTerity Diagnostics has secured the FDA EUA for a new at-home saliva-based Covid-19 test called SafeWorkDx.