The Rapid Response™ COVID-19 Antigen Rapid Test Device is an in vitro
immunochromatographic assay for the direct and qualitative detection of
SARS-CoV-2 viral nucleoprotein antigens from nasal and nasopharyngeal
secretions from individuals suspected of COVID-19 within 6 days of
symptom onset and from individuals without symptoms or other
epidemiological reasons to suspect COVID-19 infection, when tested twice
over two (or three) days with at least 24 hours (and no more than 36
hours) between tests. This test is authorized for use at the Point of
Care i.e., in patient care setting.
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