Intended UseLateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein and Influenza A & B strains.
Who Can Perform TestingProfessional use only
Time to Result10-15 minutes
Nasopharyngeal swab. (Anterior nasal collection is currently in clinical trial)
ControlsInternal control line appears when test is ready to be read.
-Individually sealed test cassettes in aluminum foil pouch
-Each cassette contains a single lateral flow assay strip
-Extraction solution in individual vial
-Positive control swab
-Negative control swab
Storage & HandlingTest kits should be stored at 35-86°F. 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.
Instructions for Use
FDA EUA Letter
Fact Sheet for Patients
Fact Sheet for Providers