FDA EUA for LumiraDX COVID-19 test expanded to include testing of people without symptoms

Nov. 3, 2021

The U.S. Food and Drug Administration (FDA) expanded an emergency use authorization (EUA) for a point-of-care antigen test from LumiraDX to include testing of asymptomatic people, according to a news release from the company.

LumiraDX says the microfluidic immunofluorescence assay is authorized for screening asymptomatic individuals using a single test with results available in 12 minutes.

This claim builds on the company’s existing claim that covers use of the test within 12 days of symptom onset in individuals suspected of COVID-19 by their healthcare provider. The LumiraDx SARS-CoV-2 Antigen Test initially received EUA from the FDA in August of 2020 after demonstrating a 97.6% positive agreement and 96.6% negative agreement with RT-PCR in symptomatic patients, the company said.

LumiraDx’s high sensitivity SARS-CoV-2 Antigen Test was developed on the LumiraDx point of care platform.

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