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 specimens directly 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. The Rapid COVID-19 Antigen Test does not differentiate between SARS-CoV and SARS-CoV-2. 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 has “notified status” and has not been reviewed by the FDA.

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