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Fujifilm Gets CE Mark for Point-of-Care Coronavirus Antigen Test

NEW YORK — Fujifilm said on Monday that it has received CE marking for a rapid, point-of-care SARS-CoV-2 antigen test.

The silver amplification immunochromatography-based test is designed to detect SARS-CoV-2 antigens in nasopharyngeal swab samples, with results provided within 13 minutes. With the CE mark, the test is now available from Fujifilm's German subsidiary in nations that accept the designation.

"We can provide further support for the early detection of COVID-19 through a rapid antigen test that can provide a highly sensitive result for early detection," Masaharu Fukumoto, senior VP of Fujifilm Europe's medical systems division, said in a statement. "We used our proprietary silver amplification immunochromatographic method, that amplifies signal particles more than 100 times … increases the sensitivity, and has the potential to enhance detection in more asymptomatic patients carrying the COVID-19 virus at an early stage."