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The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first ten days of symptom onset, and asymptomatic individuals. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Negative results from patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.

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Kits stored between 4 - 40°C will have a shelf-life of 24 months after manufacture.