- Designed for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasopharyngeal and nasal swab specimens
Key Features:
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Rapid Results:
- Provides results in as little as 3 to 15 minutes, depending on the specific assay and mode used
- This allows for quick patient dispositioning
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CLIA-Waived:
- This classification means it can be used in a wide range of point-of-care settings that hold a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
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Fluorescent Immunoassay (FIA) Technology:
- Uses advanced immunofluorescence-based lateral flow technology to detect SARS-CoV-2 antigens
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Objective Results:
- The Sofia 2 Analyzer provides automated, digital results, eliminating the subjectivity that can occur with visual interpretation of rapid tests
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Room Temperature Storage:
- Test kits can generally be stored at room temperature, simplifying storage requirements.
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Sample Types:
- Typically uses nasopharyngeal (NP) and nasal (NS) swab specimens
Contents:
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Leased Sofia 2 Fluorescent Immunoassay Analyzer:
- This is the main instrument (PST-QUI-20299) that reads and interprets the fluorescent immunoassay test cassettes
- Provides objective and automated results
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Sofia 2 Installation Pack:
- Contains:
- QuickStart Guide
- Calibration Cassette
- Addendum for the Sofia 2 Analyzer, essential for setting up and calibrating the instrument
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Sofia SARS Antigen FIA Test Kits:
- (25) Individually Packaged Test Cassettes
- (25) Reagent Tubes
- (25) Ampoules of Reagent Solution
- (25) Sterile Nasal Swabs
- (25) X 120 µL Fixed Volume Pipettes
- Positive Control Swab
- Negative Control Swab
- Package Insert
- Quick Reference Instructions
- QC Card