EMERYVILLE, CA — While a C
OVID-19 vaccine remains the Holy Grail on the path to pandemic recovery, rapid testing for the virus is almost as important because the ability to quickly and effectively test large swathes of people as they register for a trade show is a complete gamechanger that will facilitate the return of live events.
On Tuesday, the US Food and Drug Administration issued an emergency use authorization (EUA) for the first self-test for COVID-19 that can provide rapid at home results. Best of all, it provides results in just 30 minutes, the FDA said.
Thus far, rapid tests have often sacrificed accuracy for speed, but in a Community Testing Study, where the Lucira test was compared to an FDA-authorized known high-sensitivity SARS-CoV-2 test, Lucira achieved a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100% positive percent agreement.
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The Lucira COVID-19 All-In-One Test Kit is a single-use test available by prescription for self-diagnosis of the coronavirus that utilizes a molecular amplification technology to detect the virus in people with known or presumed COVID-19.
A self-collected sample swab is swirled in a vial and then placed in the test unit where results can be read directly from the unit’s lit up display in 30 minutes or less where a simple positive or negative for the SARS-CoV-2 virus is indicated. Positive results indicate the presence of SARS-CoV-2 and individuals with positive results are directed to self-isolate and seek additional care from their healthcare provider. A negative test with COVID-like symptoms should follow up with their healthcare provider because negative results does not exclude an individual from SARS-CoV-2 infection.
In a statement, the FDA said that while COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered to provide at home results. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn, M.D., said in a statement.
Reach Lucira at www.lucirahealth.com.