LumiraDx COVID-19 & Flu A/B Rapid Antigen Test Gains CE Mark

December 30, 2021

London, UK-based LumiraDx’s SARS-CoV-2 & Flu A/B antigen test has received CE mark certification.

For the SARS-CoV-2 coronavirus, which causes COVID-19 infection, the test has a positive agreement of up to 95.5 percent and a negative agreement of up to 99.2 percent with results from polymerase chain reaction (PCR) tests, based on clinical data collected up to 12 days after the onset of symptoms.

 For influenza, the test demonstrated a positive agreement of 83.3 percent for Flu A and 80 percent for Flu B and a negative agreement of 97.5 percent for Flu A and 95.3 percent for Flu B with PCR tests, based on retrospective samples collected during the 2019-2020 influenza season.

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