On Friday, the Food and Drug Administration issued an emergency use authorization for over-the-counter sale to Lucira Health’s combination COVID-flu disposable at-home test.
The Lucira test is the first such combination kit to be issued over-the-counter emergency authorization by the FDA, and no prescription is required. Users take nasal swabs, collect samples and in 30 minutes know whether or not they have the flu or COVID-19.
A Lucira combination COVID-flu test for point-of-care use in healthcare settings was authorized in November 2022.
The test accurately identified 99.3% of negatives and 90.1% for positives of the influenza A strain, 99.9% of negatives for the influenza B strain and 100% of negatives and 88.3% of positive samples for COVID-19.
Measuring the efficacy for influenza B-positive samples was impossible due to the low circulation of that strain; there were not enough cases to conduct a clinical study.
The FDA urges citizens to remember the possibility of false positives and negatives and to follow up on the at-home tests with a healthcare provider.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests … The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing,” said FDA Center for Devices and Radiological Health Director Jeff Shuren.
The FDA authorization may have come too late for Lucira Health, however.
The company filed for Chapter 11 bankruptcy and announced it was looking to sell its business on Wednesday, partly because they could not collect over-the-counter revenue on the tests during flu season.
The company had initially expected the FDA authorization in August 2022. The slow erosion of COVID restrictions during 2022 also reduced demand for the at-home tests, which are currently being sold on the Lucira website for $99.
For more information, visit The Washington Times COVID-19 resource page.
• Brad Matthews can be reached at bmatthews@washingtontimes.com.
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