Note: This product can only ship to a medical or an educational facility. It should only be used to test RSV, this is NOT intended to for COVID testing.

The Sofia RSV Fluorescent Immunoassay (FIA), for Sofia and Sofia 2 analyzers, 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. The high sensitivity of the Sofia RSV FIA offers confidence in rapid RSV testing.

Features and Benefits

• CLIA Waived (For children less than 7 years of age): Easy to perform testing
• Compatible with Influenza A+B Extraction Reagent: A single specimen can be used to run both Sofia 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 disposible
• Fixed-Volume Pipette: Collects and dispenses correct amount of sample needed for testing
• Objective Result: Eliminates the subjectivity of a visual result interpretation
• Room Temperature Storage: No refrigerator space needed. No need to wait for reagents to warm up

Materials Included

• (25) Package Test Cassettes
• (25) Reagent Tube
• (25) Reagent Solution
• (25) Sterile Nasopharyngeal Swabs
• (25) Large Pink Fixed Volume Pipettes
• (25) Small Clear Fixed Volume Pipettes
• (1) RSV Positive Control Swab
• (1) Negative Control Swab
• (1) Package Insert
• (1) Quick Reference Instructions
• (1) QC Card
• (1) Printer Paper

Technical Specifications

• Sample Type: Nasopharyngeal Swab, Aspirate/Wash
• Time of results:
  • Sofia 2:
    • Positive Result: 3 Minutes
    • Negative Result
  • Sofia: 15 minutes
• Room Temperature: 15°C to 30°C/59°F to 86°F
• Controls: Positive and Negative
• Nasopharyngeal Swab Sensitivity (-): 97% [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 96% [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 the date of manufacture