The GENEDIA W COVID-19 Ag test is an in vitro diagnostic single-use test and qualitative immunoassay for the detection of SARS-CoV-2 antigen in nasopharyngeal swabs and sputum specimens from humans. This assay is designed for use by professional personnel in laboratories and at point-of-care settings as an aid for screening patients suspected of being infected as well as for asymptomatic patients.