Rally #188-1-2266
Quidel #20260
Respiratory Test Kit Sofia® RSV FIA Respiratory Syncytial Virus Test (RSV) 25 Tests CLIA Waived
TEST KIT, RSV SOFIA (25/KT)
Features
- All components included in the kit
- Compatible with Influenza A&B Extraction Reagent means when testing with Sofia RSV FIA, a single patient sample may also be used to test with Sofia Influenza A&B FIA
- Fixed volume pipette collects and dispenses correct amount of sample needed for testing
- Room temperature storage
- CLIA Waived for children less than 7 years of age
- CLIA Moderate Complexity for pediatric patients 7 to less than 19 years of age
When use with Sofia 2 emloying Advance Result Technology (ART), it delivers accurate, objective and automated results in as few as three minutes.
Product Specifications
| Manufacturer # | 20260 |
| Brand | Sofia® RSV FIA |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Classification | CLIA Waived |
| CLIA Classified | CLIA Waived |
| Contents 1 | (25) Individually Packaged Cassettes, (25) Reagent Tubes, (25) Reagent Solution, (25) Nasopharyngeal Swabs, (25) Large Pipettes, (25) Small Pipettes, Positive Control Swab, Negative Control Swab, Printer Paper, Package Insert |
| 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) |
| UNSPSC Code | 41116144 |
| 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 |
| 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 |
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