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Description
- Results in 10 minutes
- High performance - near or exceeding that of traditionally more sensitive reader devices without the need for an instrument
- Sensitivity for flu A: 90.3%; flu B: 88%
- Specificity for flu A: 96.7%; flu B: 99.2%
- Performance characteristics for influenza A were established during the U.S. 2018-2019 influenza season when A/H1N1pdm09 and influenza A/H3N2 were the predominant influenza A viruses in circulation, and the influenza B Yamagata and Victoria lineages were in co-circulation
Specifications
Specifications
| Certifications/Compliance | CLIA waived, 510k approved |
| Content And Storage | Room Temperature (15°C to 30°C, 59°F to 86°F) |
| CPT Code | 87804QW (Flu A), 87804QW-59 (Flu B) |
| Clia Complexity | Waived (Nasal and NP Swab) |
| Detectable Analytes | Influenza A and B |
| Detection Method | Influenza antigens from nasal or NP swabs |
| DoA Calibrators | No |
| Format | Manual Dipstick |
| Sensitivity | A: 90.3% B: 88.0% |
| Type | Rapid Test |
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