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Description
California Prop 65
WARNING: This product can expose you to chemicals including arsenic, which is known to the State of California to cause cancer. For more information, visit Proposition 65
Specifications
Sample type | Nasal swabs and nasopharyngeal swabs in transport media* obtained from patients symptomatic of respiratory infection *BD/Copan VTM, Remel M4, Remel M4RT, Remel M5, Remel M6, or Copen eSwab |
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Time to results | Approximately 45 minutes |
Reagent storage conditions | Lysis and Reaction Tubes; 2˚C to 8˚C |
Controls storage conditions | 2°C to 8°C |
Sample preparation storage conditions | Specimens should be collected, transported, stored, and processed according to CLSI M41-A. Specimens should be stored at 2°C to 8°C until tested. Specimens collected in BD UTM, Remel M4, M4RT, M5, and M6 (3 mL) are stable at 2°C to 8°C for up to 9 days |
Clinical Sensitivity (culture) | Influenza A: 98.6% (95% CI 96.8% to 99.4%) Influenza B: 100% (95% CI 95.7% to 100%) |
Clinical Specificity (culture) | Influenza A: 95.1% (95% CI 93.7% to 96.3%) Influenza B: 99.3% (95% CI 98.7% to 99.6%) |
Clinical Sensitivity (PCR) | Influenza A: 97.2% (95% CI 95.0% to 98.4%) Influenza B: 100.0% (95% CI 95.4% to 100%) |
Clinical Specificity (PCR) | Influenza A: 96.7% (95% CI 95.4% to 97.7%) Influenza B: 98.9% (95% CI 98.2% to 99.4%) |
LOD (Influenza A) | A/Taiwan/42/06: 7.5x102 TCID50/mL A/California/07/2009: 4.7x102 TCID50/mL A/Texas/50/2012: 6.3x100 TCID50/mL |
LOD (Influenza B) | B/Brisbane/60/08: 8.5x101 TCID50/mL B/Massachusetts/2/2012: 3.3x101 TCID50/mL |
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