Quidel Sofia 2 Flu A/B + SARS Antigen FIA
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Description
The Sofia 2 Flu + SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2. The Sofia 2 Flu + SARS Antigen FIA with the Sofia 2 analyzer provides automated and objective results in 15 minutes, allowing for testing of patients suspected of influenza A, influenza B, and COVID-19/2019-nCoV at the Point of Care.
Features
- Time savings, material conservation, and patient comfort.
- Rapid results to support efficient dispositioning of patients.
- Reliable results without cross-reactivity to seasonal coronaviruses.
- Adjusts to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode.
- Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays.
- Provides automated tracking, data capture, government reporting, and exclusive disease mapping.
- Objective result that eliminates the subjectivity of a visual result.
- Ready for use with Sofia 2 for nasal or nasopharyngeal swab procedure.
- Clean, easy to use and dispose of.
Product Specifications and Resources
| Time to results | 15 minutes |
| Sample type | Nasal swab, nasopharyngeal swab |
| Kit storage conditions | Room temperature (15°C to 35°C / 59°F to 86°F) |
| PPA (sensitivity) | NS - 90%, NPS - 97.1% |
| PPA (sensitivity) | NS - 89%, NPS - 90% |
| PPA (sensitivity) | 95.2% |
| NPA (specificity) | NS - 95%, NPS - 94.6% |
| NPA (specificity) | NS - 96%, NPS - 97% |
| NPA (specificity) | 100% |
| Shelf life | 12 months from date of manufacture |
| CLIA complexity | Waived, Moderate, or High |
| FDA status | EUA granted |
