Rally #188-1-2313
Quidel #20313
Sofia 2 RSV FIA Starter Kit (1/KT)
Promotional Startup Kit, RSV Kits with Analyzer and Install Pack, Fluorescent Immunoassay, CLIA Complexity - Age Dependent.
Quidel Promotional Starter Kit Bundle
Bundle Offer Valid Through December 31, 2025- Delivers reliable and objective results
- Advanced algorithm generates results in minutes
- Intuitive touchscreen interface for workflow customization
- Features WALK AWAY mode for automatic result reporting
- READ NOW mode allows analysis of multiple tests efficiently
- Automatically stores patient results for easy access
- Integrated barcode scanner for user and patient info
- Capability to export data and integrate with LIS
- CLIA waived for children less than 7 years of age with easy to perform test.
- Self-contained test cassette is clean, easy to use and disposable.
- Positive result in as few as 3 minutes.
- May be used with Sofia or Sofia 2.
- High Sensitivity and Specificity.
- Fixed volume pipette collects and dispenses correct amount of sample needed for testing.
The Sofia RSV Fluorescent Immunoassay (FIA) is a test that detects the respiratory syncytial virus (RSV) directly from nasal samples of symptomatic patients using advanced technology. It is highly sensitive and provides reliable results quickly. The test is easy to perform, CLIA waived for children under 7, and uses a clean, disposable test cassette for ease of use.
Important Notes:
- Rx Only
- For professional in-vitro diagnostic use.
- This item is non-returnable. Please verify your ordering information before making a purchase.
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
Rally # | 188-1-2313 |
Manufacturer # | 20313 |
Brand | Sofia® 2 |
Manufacturer | Quidel |
Country of Origin | Unknown |
Application | Promotional Bundle Kit |
Analyzer Type | Benchtop |
CLIA Complexity | Waived for children less than 7 years of age. Moderate for pediatric patients 7 to less than 19 years of age. |
Contents | (1) Leased Analyzer, (1) Install Pack, (3) RSV Kits |
Number of Tests | 3 X 25 Tests |
Purchase Program Type | Promotional Bundle |
Readout Type | Digital and Printout |
Sample Type | Nasopharyngeal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample |
Test Name | Respiratory Syncytial Virus Test (RSV) |
Time to Results | Sofia 2: Positive result in as few as 3 minutes, negative result 15 minutes Sofia: 15 minutes |
Sofia® 2 Fluorescent Immunoassay Analyzer
Manufacturer # | 20299 |
Brand | Sofia® 2 |
Manufacturer | Quidel |
Country of Origin | Unknown |
Analyzer Type | Benchtop |
Application | Fluorescent Immunoassay Analyzer |
Readout Type | Digital and Printout |
Dimensions | 22 cm deep x 12 cm wide x 12 cm high |
Weight | 2 lbs (1 kg) |
Power Supply Input | 100-240 VAC 50/60 Hz Self-Switching (U.S./International) 2.93 Amp maximum |
Sofia 2 Input | 7.5V DC, 2.5A |
Replaceable Battery | LiPo rechargeable battery |
Display | 4-inch color LCD touchscreen |
LAN Interface | RJ45 connector |
Patient Test Result Storage | 1,000 tests maximum |
QC Results Storage | 200 results maximum |
Calibration Results Storage | 200 results maximum |
User Storage | 1000 users maximum |
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 |
Sofia® RSV Fluorescent Immunoassay
Rally # | 188-1-2266 |
Manufacturer # | 20260 |
Brand | Sofia® RSV FIA |
Manufacturer | Quidel |
Country of Origin | United States |
Application | Respiratory Test Kit |
CLIA Complexity |
Waived for children less than 7 years of age. Moderate for pediatric patients 7 to less than 19 years of age. |
For Use With | For Sofia® or Sofia 2® Fluorescent Immunoassay Analyzer |
Number of Tests | 25 Tests |
Reading Type | Machine Read |
Sample Type | Nasopharyngeal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample |
Specialty | Immunoassay |
Test Format | Cassette Format |
Test Kit Type | Rapid |
Test Name | Respiratory Syncytial Virus Test (RSV) |
Test Type | Fluorescence Immunoassay (FIA) |
Time to results | Sofia 2: Positive result in as few as 3 minutes, negative result 15 minutes Sofia: 15 minutes |
Kit Storage Conditions | Room Temperature: 15°C to 30°C (59°F to 86°F) |
Controls | Positive and Negative |
Shelf life | 24 months from date of manufacture |
Ages 0 to less than 19 years | Ages 0 to less than 7 years* | |
Nasopharyngeal Swab Sensitivity | 86% | 87% |
Nasopharyngeal Swab Specificity | 97% | 96% |
Aspirate/wash Sensitivity | 89% | 92% |
Aspirate/wash Specificity | 98% | 98% |
*CLIA Waiver Studies
Sofia® 2 Fluorescent Immunoassay Analyzer:
- Sofia 2 with Rechargeable Battery
- Power Adapter (Meanwell P/N: GSM25B07-P1J or equivalent)
- QuickStart Guide
- Calibration Cassette
- Individually Packaged Test Cassettes (25): Mouse monoclonal anti-RSV antibodies
- Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
- Reagent Solution (25): Ampoules with salt solution
- Sterile Nasopharyngeal Swabs (25)
- Small, Clear 120 µL Fixed Volume Pipettes (25)
- Large, Pink 250 µL Fixed Volume Pipettes (25)
- RSV Positive Control Swab (1): Swab is coated with non-infectious RSV antigen
- Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
- Package Insert (1)
- Quick Reference Instructions (1)
- QC Card (located on kit box)
- Printer Paper (1)
Optional Ancillaries (Sofia 2 Analyzer)
- Dymo LabelWriter 450 Printer (Part #1752264)
- Dymo LabelWriter 4XL Printer (Part #1755120) for Firmware 1.13.4 or higher only
- Dymo Vinyl Label Roll, 2 5/16” x 4” (Part #30256)
- Replacement Battery
Sofia® 2 FIA Analyzer Documentation Links
General Information
- 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
- User Manual - Sofia 2 Fluorescent Immunoassay Analyzer FW 1.12 or higher
- User Manual - 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
Sofia® RSV FIA Test Kit Documentation Links
Sofia® 2 FIA Analyzer Video Links Sofia® RSV FIA
Reimbursements Information
This product maybe reimbursable, depending on various factors including current laws and policies. Rally Inc. does not handle these reimbursements; instead, each reimbursement is handled solely between you, the customer, and the manufacturer, Quidel. Rally Inc. does not oversee these reimbursements. To check eligibility and get your reimbursements, please follow the manufacturer's reimbursements instructions.
You can find more informations on reimbursement details here.