Rally #188-1-2310
Quidel #20310
Fluorescent Immunoassay Analyzer Sofia® 2 CLIA Waived
STARTER KIT, INFLUENZA SOFIA 2 A+B FIA (1/KT)
Contents:
1 Leased Sofia 2 Analyzer, 1 Install Kit, 1 Influenza A&B FIA Test Kit (25 Test)
Quidel™ Sofia™ 2 Fluorescent Immunoassay Analyzer - 20299 (1 Unit)
Features
- 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.
- 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
- Virena™ Connectivity: Reduce time manually recording test results
- Li Po rechargeable Battery: Can be used anywhere testing needs to be done
Product Specifications
Dimensions (D x W x H) | 22 x 12 x 12cm |
Weight | 2 lb. (1kg) |
Power supply input | 100-240 VAC, 50-60 Hz, self-switching (U.S./ International), 2.93 |
Analyzer input | 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 |
Quidel™ Sofia™ Influenza A+B FIA Kit - 20218 (1 x 25 Test)
Features
- The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients
- All components included in the kit
- Compatible with RSV Extraction Reagent means when testing with Sofia Influenza A+B FIA, a single patient sample may also be used to test with Sofia RSV FIA
- Fixed volume pipette collects and dispenses correct amount of sample needed for testing
- Room temperature storage
- Product should be kept in temperature between 59 to 86 degrees
Sample type | Nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash |
Time to results - Sofia 2 | Positive result in as few as 3 minutes, negative result 15 minutes |
Time to results - Sofia | 15 minutes |
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 |
Transport Media Compatibility | Copan Universal Transport Media, Hank’s Balanced Salt Solution, M4, M4–RT, M5, M6, Modified Liquid Stuarts, Saline, Starplex Multitrans |
CLIA complexity | Waived |
Sofia 2 Fluorescent Immunoassay Analyzer Documentations (20299)
- FAQ - Sofia 2 Analyzer Automatic Updates FW 1.12 or higher
- FAQ - Sofia 2 Fluorescent Immunoassay Analyzer
- Installation Instructions - Sofia 2 Fluorescent Immunoassay Analyzer
- QuickStart Guide - Sofia 2 Fluorescent Immunoassay Analyzer
- QuickStart Guide - Sofia 2 Fluorescent Immunoassay Analyzer FW 1.12 or higher
- SDS - Sofia 2 Fluorescent Immunoassay Analyzer
- Sales Sheet - Sofia 2 Fluorescent Immunoassay Analyzer
- Technical Bulletin - Accessing Patient Data
- Technical Bulletin - Firmware Update 1.12
- Technical Bulletin - Firmware Update 1.13
- Technical Bulletin - Firmware Update 1.14
- Technical Bulletin - Firmware Update 1.15
- Technical Bulletin - Firmware Update 1.15.2
- Technical Bulletin - Running External QC
- User Manual - Sofia 2 Fluorescent Immunoassay Analyzer FW 1.12 or higher
- User Manual - Sofia 2 Fluorescent Immunoassay Analyzer
- CLSI - Sofia Influenza A+B FIA
- FAQ - Sofia Influenza A+B FIA
- Package Insert - Sofia Influenza A+B FIA
- Quick Reference Instructions - Sofia Influenza A+B FIA
- SDS - Sofia Influenza A+B FIA
- Sales Sheet - Sofia Influenza A+B FIA
- Sample Collection - Sofia Influenza A+B FIA
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Aspirate (Sofia 2)
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Aspirate (Sofia)
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Swab (Sofia 2)
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Swab (Sofia)
- Technical Bulletin - Compatible Swabs
- Technical Bulletin - FluMist
- Technical Bulletin - New Blue Color
- Technical Bulletin - Test for Both Influenza and RSV With One Patient Sample
- Technical Bulletin - Transport Media