The Rapid COVID-19 Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 through direct nasopharyngeal (NP) swab specimens directly collected from individuals who are suspected of having COVID-19 by their healthcare professional. This test is designed to assist in the rapid diagnosis of SARS-CoV-2 infections. The Rapid COVID-19 Antigen Test does not determine between SARS-CoV and SARS-CoV-2.
Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.
Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.
This test is not for home-use or at-home specimen collection.