Sienna™ COVID-19 Rapid Antigen Test
General Details
Test type: Antigen
Run time: 10-20 minutes
Collection type: Nasopharyngeal swab
Authorization: FDA EUA for professional use. CLIA required.
Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
Manufacturer: Salofa Oy (Finland)
CPT Codes: Covid-19 87811QW
Clinical Details
SARS-CoV-2: 93.8% Sensitivity, 99.2% Specificity
Specificity: No cross-reaction with species tested
Interference: No interfering factors tested
*See Instructions For Use for detailed clinical data.
Box Components
Nasopharyngeal swabs (25)
Test cassettes (25)
Extraction reagent capsules (25)
Workstation for mass testing (1)
Instructions for use (1)
Storage & Handling
Test kits should be stored at 2-30°C (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.
Manuals and Instructions
Product Images
Intended Use
The Sienna™ COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasopharyngeal swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid protein of SARS-CoV-2. It is intended to aid in the rapid diagnosis of COVID-19 infections.