Intended Use
Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
Who Can Perform Testing
This is a point-of-care authorized test. CLIA-certified laboratories with Waiver, Moderate, or High Complexity certification may perform the test at point-of-care or in a laboratory setting.
Time to Result
10-15 minutes
Sample Types
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Nasopharyngeal swab
Controls
Internal control line appears when test is ready to be read.
Components
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Individually sealed test cassettes in aluminum foil pouch
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Each cassette contains a single lateral flow assay strip
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Extraction solution with vial and cap
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Nasopharyngeal swab
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Positive control swab
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Negative control swab
Storage & Handling
Test kits should be stored at 1 – 30°C. Reagents and materials are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. Do not freeze any contents of the kit.
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