The clinical performance characteristics of the FIRST SIGN® SARS-CoV-2 Antigen Test were evaluated in a multi-site prospective study in the United States of America in which patients were sequentially enrolled and tested. Testing was performed by operators with no laboratory experience and who are representative of the intended users at point of care (POC) testing sites. Patients who presented within five days of symptom onset and met study protocol criteria were enrolled in the study. At all sites, the standard of care swab eluted in VTM was tested with an EUA RT-PCR assay for the detection of SARS-CoV-2. The performance of the FIRST SIGN® SARS-CoV-2 Antigen Test was determined by testing 146 symptomatic patient samples and evaluating the level of agreement between operator reported antigen test results and results reported by an EUA RT-PCR comparator device.