The FDA has authorized emergency use of the first over-the-counter test that can detect both Covid-19 and flu. The test takes about 30 minutes to get results from a nasal swab and can differentiate between influenza A and B as well as Covid.
The single-use test, made by Lucira Health, is able to differentiate between influenza A and B as well as Covid. | Jacquelyn Martin/AP PhotoThe FDA on Friday authorized emergency use of the first over-the-counter test that can detect both Covid-19 and flu.
The single-use test, made by Lucira Health, is able to differentiate between influenza A and B as well as Covid. “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 that can be performed entirely at home,” top FDA medical device regulator Jeff Shuren said in a statement. The FDA noted that all rapid diagnostic tests have a risk of false positive and false negative results..
But there are still a considerable number of Covid-19 infections being recorded each week: more than 236,000 cases and 2,400 deaths were recorded as of the week ended Feb. 22,Earlier this week, Lucira Health filed for Chapter 11 bankruptcy and announced it would try to sell its business. “The Company anticipated an EUA for an OTC indication on the COVID-19 and Flu test in August 2022, though the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season,” Lucira Health said in a press release on Wednesday.
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