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The LumiraDx SARS-CoV-2 Antigen (Ag) Test is a rapid, highly sensitive COVID-19 antigen point of care test. It detects antigen nucleocapsid protein from a nasal and nasopharyngeal swab with results in 12 minutes from sample application. Sample application is from people with COVID-19 symptoms within the first twelve days of symptom onset or from asymptomatic individuals.
The test is designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-19. It uses either a nasal or nasopharyngeal swab specimen from asymptomatic individuals, or from individuals at risk of, or with symptoms of, COVID-19 within the first 12 days of symptom onset. Clinical studies demonstrated a 97.6% positive agreement and 96.6% negative agreement with RT-PCR using nasal swabs and a 97.5% positive agreement and 97.7% negative agreement with RT-PCR using nasopharyngeal swabs
With fast results—in minutes, instead of hours or days—the LumiraDx SARS-CoV-2 Ag test will give infected patients the information they need to get care quickly and limit the amount of time they unknowingly spread the virus to others.