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The Rapid COVID-19 Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
This test has not been reviewed by the FDA. 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.
Qualitative, visually read results in 15 minutes. No instrument required. Room temperature storage or refrigerated (2-30°C / 36-86°F). Procedural internal control included. Sterile Swabs, Extraction Buffer and Extraction Tubes included.
