Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

The COVID-19 Antigen Rapid Test Device is a rapid visual immunoassay for the direct and qualitative detection of viral SARS-CoV-2 nucleoprotein antigens in nasal swabs. This test is intended for personal use by people aged 2 and over who are suspected to be infected with COVID-19. Children aged between 2 and 17 years old, must be supervised or aided by an adult when carrying out the test. Do not use this test on children under 2 years of age. The test procedure is not automated. Test results should not be used as a sole basis for diagnosis but should always be interpreted by a physician in the clinical context. This test is intended for people who with symptoms of COVID-19 within the first 7 days of symptom onset. The COVID-19 Antigen Rapid Test Device is for self-testing use