LumiraDx COVID-19 Antigen Test Achieves CE Mark -- MEDICA - World Forum for Medicine


LumiraDx UK Ltd

LumiraDx COVID-19 Antigen Test Achieves CE Mark

London, UK – LumiraDx, the next-generation point of care diagnostic company, announced today that, in addition to the Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) on August 18, 2020, it had now also achieved CE Marking for its LumiraDx SARS-CoV-2 antigen test. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application in people with COVID-19 symptoms or who are at risk of the infection.  The test is the fastest, most sensitive COVID-19 antigen point of care test currently commercially available – and a crucial resource to European nations as they seek to improve access to rapid, accurate community testing.

The LumiraDx SARS-CoV-2 Ag Test is designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-19. The test uses a nasal swab specimen from individuals at risk of, or with symptoms of, COVID-19 within the first 12 days of symptom onset. Clinical studies were performed at 6 sites across the US and UK with 257 subjects and demonstrated a 97.6% positive agreement and 96.6% negative agreement with RT-PCR.

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