Sofia 2 Influenza A+B FIA Starter Kit (1 Pack)

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

The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and influenza B viral nucleoprotein antigens.

Sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source. Sofia 2 collects hundreds of data points on the test strip contained inside of a Sofia FIA Test Cassette. Sofia 2 uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to give you an objective result you can rely on.

Features and Benefits

Influenza A+B

CLIA waived for nasal and nasopharyngeal swabs, nasal aspirate and wash: Easy to perform testing
Compatible with RSV Extraction Reagent: A single sample can be used to run both Sofia Influenza A+B and Sofia RSV
Dual work modes: Adjusts to your volume fluctuations
Self-contained test cassette: Clean, easy to use and dispose of
Fixed-volume pipette: Collects and dispenses correct amount of sample needed for testing
Objective result: Eliminates the subjectivity of a visual result
Room temperature storage: No refrigerator space needed. Rapid influenza tests can be run immediately as needed

Sofia 2 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 to an external printer, 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
- Optional printing on an external printer allows for storage of hardcopy results which may enhance post-analytical processes
- Test, QC, and Calibration results stored on-board
- Virena wireless connectivity
Fluorescent technology: Optimized performance
Two development modes: Offers flexibility by accommodating specific workflow demands
Walk away automation: No need for operator to wait for results
Security: 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
Battery: Can be used anywhere testing needs to be done.

Materials Included

1 Leased Sofia 2 Analyzer (Requires contract agreement and visit by a local representative. Click here to fill out this form in order to fulfill this order.)
- Rechargeable Battery
- Power Adapter
- Calibration Cassette
1 Influenza A+B Kit

(25) Individually Packaged Test Cassettes
(25) Reagent Tubes: Lyophilized buffer with detergents and reducing agents
(25) Reagent Solution: Ampoules with salt solution
(25) Sterile Nasal Swabs
(25) Small, Clear 120 µL Fixed Volume Pipettes
(25) Large, Pink 250 µL Fixed Volume Pipettes
(1) Influenza A and Influenza B Positive Control Swab: Swab is coated with non-infectious recombinant influenza A and influenza B antigens
(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

Sofia 2 Analyzer

Dimensions:
- Length: 8.6"
- Width: 4.7"
- Height: 4.7"
Weight: 2 lbs
Power Supply Input: 100-240 VAC, 50-60 Hz, self-switching
Analyzer: 7.5V DC 2.5A
Replacement Battery: Li Po Rechargeable
Display: 4-inch color LCD touchscreen
LAN Interface: RJ45 connector
Operating temperature: 15°C to 30°C/59°F to 86°F
Operating humidity: 20% to 85% RH non condensing
Operating altitude: 2000 m maximum
Shipping and storage temperature: –20°C to 55°C
Shipping and storage humidity: 20% to 85% RH non condensing
Patient test result storage: 1000 tests maximum
QC results storage: 200 results maximum
Calibration results storage: 200 results maximum

Influenza A+B Kit

Sample Type: Nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash
Time of Results: Positive result in as few as 3 minutes, negative result 15 minutes (For Sophia 2)
Kit Storage Conditions: Room temperature (15°C to 30°C/59°F to 86°F)
Controls: Positive and negative
Nasal Swab Sensitivity: A: 90%, B: 89%
Nasopharyngeal Swab Sensitivity: A: 97%, B: 90%
Nasopharyngeal Aspirate/Wash Sensitivity: A: 99%, B: 88%
Nasal Swab Specificity: A: 95%, B: 96%
Nasopharyngeal Swab Specificity: A: 95%, B: 97%
Nasopharyngeal Aspirate/Wash Specificity: A: 96%, B: 96%
Shelf Life: 24 months from date of manufacture