Description
- The Sofia RSV Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect respiratory syncytial virus (RSV) nucleoprotein antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens
- 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
Product Specs
| Item Number | 853972 |
|---|---|
| Catalog Number | 20260 |
| UOM | CS |
| Level 1 Family Description | Lab-Waived Lab |
| Level 2 Category Description | Lab-Respiratory Testing |
| Level 3 Group Description | RSV Testing |
| Level 4 Sub-Category Description | RSV - Reader Read |
| Application | Respiratory Test Kit |
| Brand | Sofia RSV FIA |
| Buy American Act (BAA) Compliant | Yes |
| 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 |
| Country of Origin | Denmark |
| For Use With | For Sofia or Sofia 2 Fluorescent Immunoassay Analyzer |
| Is_ECAT | N |
| Is_GSA | Y |
| Is_VA | N |
| Manufacturer | Quidel |
| Manufacturer # | 20260 |
| McKesson # | 853972 |
| Number of Tests | 25 Tests |
| Purchase Program Type | Standard Purchase |
| 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 | 3 to 15 Minute Results |
| Trade Agreement Act (TAA) Compliant | Yes |
| UNSPSC Code | 41116144 |