By Marc Andre Jean
(Clarity Times) The Lucira COVID-19 All-In-One Test Kit, a molecular single-use home test, has been granted an emergency use authorization (EUA) by the U.S Food Drug Administration to perform COVID-19 self-diagnostic test and rapid results at home.
The Lucira COVID-19 All-In-One Test Kit, according to the FDA, is the first test that can be fully self-administered and provide results at home. The FDA Commissioner, Stephen M. Hahn explains that the approval of this test is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Jeff Shuren, M.D., director of the Center for Devices and Radiological Health goes in the same direction. For him, the authorization of a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic, said Mr. Shuren.
To use the Lucira COVID-19 All-In-One Test Kit, a person will need to be 14 years old and older. For people under 14 years old, the test must be performed by an authorized healthcare provider. The test kit is authorized for use at home and in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers and emergency rooms. It is currently authorized for prescription use only.
How does it work?
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. After 30 minutes or less, the results can be read on the test unit’s light-up display that shows whether a person has the virus or not.
An individual with positive results should self-isolate and seek additional care from their health care provider. On the other hand, if an individual is tested negative and experience COVID-like symptoms, he or she must follow up with his/her health care provider as negative results do not preclude an individual from SARS-CoV-2 infection according to Lucira Health.
Evidence based results
According to data on the Lucira Health website, the All-in-One Test Kit is a molecular in vitro diagnostic test that has an analytical sensitivity, or ability to detect the SARS-CoV-2 virus. It is comparable to some of the best molecular tests performed in clinical settings and high complexity labs.
In comparison to other FDA authorized known high sensitivity COVID-19 test, Lucira achieves a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). These numbers exclude test samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieves 100% positive percent agreement, said the company on its website.