www.fdanews.com/articles/205205-lumiradxs-covid-19-antigen-test-expands-indication-to-asymptomatic-people
LumiraDx’s COVID-19 Antigen Test Expands Indication to Asymptomatic People
November 5, 2021
The FDA has granted an expanded Emergency Use Authorization for LumiraDx’s COVID-19 antigen test to include testing of asymptomatic people.
In asymptomatic individuals, the 12-minute test was 82.1 percent agreement on positive results and 100 percent agreement on negative results, when compared with results from a laboratory polymerase chain-reaction test, according to the UK-based company
LumiraDx said it has the manufacturing capacity to “enable rapid, high-sensitivity mass screening programs” in schools, events, travel and other settings.