FDA EUA Sienna Rapid Antigen Test - Box of 25 Tests
Sienna COVID-19 Antigen Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use only
For prescription use only
Summary and Explanation of the Test
Since the first outbreak reported in December 2019, SARS-CoV-2 has spread rapidly worldwide, and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). Due to its highly contagious nature and global health crises, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO). SARS-CoV-2 continues to have devastating impacts on healthcare systems and the world economy including the U.S. The CareStart™ COVID-19 Antigen is a rapid (approximately 10 minutes) chromatographic immunoassay for the direct detection of the presence or absence of SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of COVID-19, or taken from asymptomatic individuals being tested serially, as described in the authorized intended use. The test is intended for interpreted visually in both laboratory and near patient testing environments without an instrument.