•COVID-19
Anterior Nasal - Sensitivity 93.8%, Specificity 100%
Nasopharyngeal - Sensitivity 93.1%, Specificity 100% • Flu A - Sensitivity 91.4%, Specificity 95.7% • Flu B - Sensitivity 87.6%, Specificity 95.9%
**See Instructions for Use for Flu strain clinical data
CPT CODES:
COVID-19: 87811QW
FLU A: 87804QW
FLU B: 87804QW-59
Intended Use:
Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein and Influenza A & B strains.
Who Can Perform Testing:
Professional use only
Time to Result:
10-15 minutes
Sample Types:
Anterior nasal swab/Nasopharyngeal Swab
Controls:
Internal control line appears when the test is ready to be read.
Components:
- Individually sealed test cassettes in an aluminum foil pouch
- Each cassette contains a single lateral flow assay strip
- Extraction solution in an individual vial
- Anterior Nasal/Nasopharyngeal swab
- Positive control swab
- Negative control swab
Storage & Handling:
Test 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.
Important Information:
Instructions for Use
Quick Reference Instructions
FDA EUA Letter
Fact Sheet for Patients
Fact Sheet for Providers
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