The Solana Influenza A+B Assay is a rapid qualitative in vitro diagnostic test for the detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.
The Solana Influenza A+B Assay amplifies and detects viral RNA present in transport media containing nasopharyngeal or nasal swab specimens obtained from symptomatic patients.
The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to influenza A and/or influenza B using isothermal Reverse Transcriptase — Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which is performed in the Solana instrument.
Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports. Solana Influenza A+B is also supported by the power of Virena®.
Features & Benefits
| Feature | Benefit |
|---|---|
RT-HDA technology | Rapid method of isothermal nucleic acid amplification that does not require thermal cycler |
Lyophilized Master Mix reagent | Easy-to-use format, just add processed sample to rehydrate |
Small, easy-to-use instrument | Eliminates the need for dedicated molecular space and costly capital equipment, allowing for testing in smaller labs |
CLIA moderately complex | Requires minimal training |
Refrigerated storage | No freezer needed, 2˚C to 8˚C storage |
Long shelf life | 24 months from date of manufacture |
Room temperature set up | No ice or cooling block required |
Product Specifications
| Product Spec Name | Product Spec Data |
|---|---|
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 |
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 |
Note: Specimens collected in Copan eSwab transport media are stable at 2° C to 8°C for up to 48 hours | |
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 |
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
M300 | Solana Influenza A+B Assay Kit | 48 tests |
M122 | Solana Influenza A+B Control Set | 20 reactions |
Product Documentation
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