- Rapid diagnostic test kit designed for the direct and qualitative detection of RSV fusion protein
- Chromatographic immunoassay that uses an instrumented (machine) read for objective results, eliminating the need for subjective visual interpretation
Short-Dated:
- Minimum Expiry Lead is 60 days; Non-returnable; Non-refundable
Purpose:
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To aid in the diagnosis of RSV infections
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Specifically indicated for in vitro diagnostic use in infants and pediatric patients under the age of 6 years
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For use in point-of-care settings, e.g., doctor's offices, clinics
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It must be used in conjunction with the BD Veritor System Reader/Analyzer
Key Features and Benefits:
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CLIA Waived:
- This classification for specific age groups makes it suitable for a wide range of point-of-care settings
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Rapid Results:
- Provides objective, digital results for RSV in approximately 10 to 11 minutes
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Objective Interpretation:
- The BD Veritor™ System Reader provides a clear digital display of results, reducing potential for human error and subjective interpretation often associated with visually read rapid tests
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Adaptive Read Technology:
- This proprietary technology helps to reduce false-positive results by compensating for background interference and non-specific binding
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Flexible Workflow:
- Offers "Walk Away" mode (for immediate processing) and "Analyze Now" mode (for batch testing), adapting to different clinical workflows
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Traceability:
- Can provide downloadable test records matched to kit lot number, operator, patient, or specimen ID with optional connectivity modules (e.g., BD Veritor™ InfoWiFi module)
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Sample Type:
- Uses direct nasopharyngeal (NP) swab specimens
Contents:
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Veritor System RSV Devices:
- 30 Foil-pouched test devices, each containing a reactive strip with monoclonal antibodies specific to RSV viral antigen and a control line
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RV Reagent D Tubes:
- 30 Prefilled tubes with reagent solution (detergent with <0.1% sodium azide)
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Flexible Minitip Flocked Swabs:
- 30 Swabs for nasopharyngeal sample collection
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1 RSV Positive Control Swab:
- 1 Swab containing non-infectious RSV antigen for quality control
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1 RSV Negative Control Swab:
- 1 Swab contains detergent-treated non-infected cells for quality control
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