The SARS-CoV-2 Antigen Rapid Test is intended for in vitro qualitative detection of SARS-CoV-2 antigen in human nasopharyngeal swab or oropharyngeal swab samples. It is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2. The test provides preliminary test results. Negative results don't preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.