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Description
Description
- Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance on March 8, 2023
- Sofia 2 SARS Antigen+ Fluorescent Immunoassay (FIA), uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2
- The Sofia 2 SARS Antigen+ FIA, with the Sofia 2 analyzer, provides automated and objective results in 10 minutes, allowing for COVID-19 testing of symptomatic patients when serial testing is started within 6 days of symptom onset
- Sofia 2 SARS Antigen+ FIA is the first FDA-cleared, 10-minute rapid antigen test for COVID-19
- Rapid results to support efficient dispositioning of patients
- Reliable results without cross-reactivity to seasonal coronaviruses
- Virena connection: Provides automated tracking, data capture, government reporting, and exclusive disease mapping
- Ready for use with Sofia 2 for nasal swab procedure
- Includes positive and negative controls
- The test does not differentiate between SARS-CoV and SARS-CoV-2
- A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay
- Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions
- Positive results do not rule out co-infection with other respiratory pathogens
- This test is intended for prescription use only and can be used in Point-of-Care settings
- Materials Not Supplied in Kit: Timer or watch, Sofia 2 Instrument, Calibration Cassette
Specifications
Specifications
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Product Document(s)
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ApplicationRespiratory Test Kit
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CLIA ClassificationCLIA Waived
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CLIA ClassifiedCLIA Waived
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Contents 1(25) Individually Packaged Cassettes, (25) Pre-filled Reagent Tubes (Buffer with Detergents, Reducing Agents and Proclin 300), (25) Dropper Tips, (25) Sterile Nasal Swabs, SARS Positive Control Swab, SARS Negative Control Swab, QC Card
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For Use WithFor Sofia 2 Fluorescent Immunoassay Analyzer
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Is_ECATN
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Is_GSAY
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Is_VAN
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Number of Tests25 Tests
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Purchase Program TypeStandard Purchase
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Reading TypeMachine Read
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Sample TypeAnterior Nasal Swab Sample
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SpecialtyImmunoassay
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Test FormatCassette Format
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Test Kit TypeRapid
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Test MethodFluorescence Immunoassay (FIA)
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Test NameSARS Antigen+
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Test TypeAntigen Test
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Time to Results10 Minute Results
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ApplicationRespiratory Test Kit
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CLIA ClassificationCLIA Waived
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CLIA ClassifiedCLIA Waived
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Contents 1(25) Individually Packaged Cassettes, (25) Pre-filled Reagent Tubes (Buffer with Detergents, Reducing Agents and Proclin 300), (25) Dropper Tips, (25) Sterile Nasal Swabs, SARS Positive Control Swab, SARS Negative Control Swab, QC Card
-
For Use WithFor Sofia 2 Fluorescent Immunoassay Analyzer
-
Is_ECATN
-
Is_GSAY
-
Is_VAN
-
Number of Tests25 Tests
-
Purchase Program TypeStandard Purchase
-
Reading TypeMachine Read
-
Sample TypeAnterior Nasal Swab Sample
-
SpecialtyImmunoassay
-
Test FormatCassette Format
-
Test Kit TypeRapid
-
Test MethodFluorescence Immunoassay (FIA)
-
Test NameSARS Antigen+
-
Test TypeAntigen Test
-
Time to Results10 Minute Results
Sofia 2 SARS Antigen+ FIA Now CLIA Waived
Sofia 2 SARS Antigen+ FIA Now CLIA Waived
Return policy
Return policy
Not loving it? We offer returns for most items within 30 days of delivery for a refund or store credit.
