LumiraDx’s COVID-19 antigen test gets expanded EUA

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The FDA authorized the expansion of the EUA after reviewing company data on the performance of its SARS-CoV-2 antigen test in individual asymptomatic subjects collected between June 2020 and March 2021. Results indicated high sensitivity and specificity in asymptomatic individuals with the LumiraDx SARS-CoV-2 Ag test, demonstrating an 82.1 percent positive agreement and 100 percent negative agreement with RT-PCR test in 222 subjects.