Note: This product can only ship to a medical or an educational facility.

The Sofia RSV Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect respiratory syncytial virus (RSV) nucleoprotein antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients.

Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source.

Features and Benefits

RSV FIA Kit

• CLIA Waived (for children less than 7 years of age): Easy to perform testing
• Compatible with Influenza A+B Extraction Reagent: Single specimen can be used to run RSV FIA and Sofia Influenza A+B FIA
• Dual Work Modes: Adjusts to your volume fluctuations
• Self-Contained Test Cassette: Clean, easy to use and disposable
• Fixed-Volume Pipette: Collects and dispenses correct amount of sample needed for testing
• Objective Result: Eliminates the subjectivity of visual result interpretation
• Room Temperature Storage: No refrigerator needed.

Sofia Analyzer

• User Interface: Intuitive, fast, and easy to use interface allows operators to quickly run patient samples or navigate stored data
• Objective, automated results: Eliminates operator to operator variability often associated with interpreting visually-read test results. Results are displayed on-screen, printed, and/or sent to Virena effortlessly
• Data Management: Results can be reported and stored in multiple ways to meet your data management needs:
  • USB storage provides PC storage and analysis capabilities
  • Test, QC, and Calibration results stored on-board
  • Virena wireless connectivity
• Fluorescent technology: Optimized performance
• Two development modes: Offers flexibility by accommodating specific work flow demands
• Walk away automation: No need for operator to wait for results
• Security: Sofia offers supervisors the ability to set access rights by operator to prevent unauthorized use or use by untrained operators
• Barcode technology: Reduce time and errors associated with manually recording patient and operator ID
• Connectivity: Reduce time manually recording test results. Connect to many of existing information systems
• Battery: Can be used anywhere testing needs to be done
• Printer: Integrated Printer

Materials Included

• 1 Leased Sofia with Integrated Printer (Requires contract agreement and visit by a local representative. Click here to fill out this form in order to fulfill this order.)
  • 4 AA Batteries
  • 1 AC Power Cord
  • 1 DC Power Cord
  • 1 Paper Roll
  • 1 Barcode Stand
  • 1 Barcode Scanner
  • 1 Calibration Cassette
• 3 RSV Kits; each kit contains the following:
  • • (25) Individually Packaged Cassettes: Mouse monoclonal anti-RSV antibodies
    • (25) Reagent Tubes: Lyophilized buffer with detergents and reducing agents
    • (25) Reagent Solution: Vials with salt solution
    • (25) Sterile Nasopharyngeal Swabs
    • (25) Large, Pink Fixed Volume Pipettes
    • (25) Small, Clear Fixed Volume Pipettes
    • (1) RSV Positive Control Swab : Swab is coated with non-infectious RSV antigen
    • (1) Negative Control Swab : Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
    • (1) Package Insert
    • (1) Quick Reference Instructions
    • QC Card (located on kit box)
• Installation Pack
• User Manual

Technical Specifications

• Dimensions
  • Length: 9"
  • Width: 6"
  • Height: 4"
• Weight: 3 lbs
• Power Supply Input: 100-240 VAC, 47-63 Hz, self-switching (U.S./ International), 0.9-0.34 Amps max
• Analyzer Input: 6V DC 4:16A max
• Replaceable batteries: 4x LR6-AA + 6V 4.16 A
• Keypad: Numeric
• Display: 3.5 inch diagonal
• LAN Interface: RJ45 connector
• Operating temperature: 15°C to 30°C/59°F to 86°F
• Operating humidity: 20% to 85% non condensing
• Shipping and storage temperature: –20°C to +55°C
• Shipping and storage humidity: 20% to 85% non condensing
• Patient test results storage: 500 tests maximum
• QC results storage: 200 results maximum
• Calibration results storage: 200 results maximum

• Sample type: Nasopharyngeal swab, aspirate/wash
• Time to results: 15 minutes (For Sofia)
• Kit storage conditions: Room temperature (15°C to 30°C/59°F to 86°F)
• Controls: Positive and negative
• Nasopharyngeal swab sensitivity: 86% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 87% [Ages 0 to less than 7 years])
• Nasopharyngeal swab specificity: 97% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 96% [Ages 0 to less than 7 years])
• Aspirate/wash sensitivity: 89% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 92% [Ages 0 to less than 7 years])
• Aspirate/wash specificity: 98% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 98% [Ages 0 to less than 7 years])
• Shelf life: 24 months from date of manufacture