The Solana Bordetella Complete Assay is an in vitro diagnostic test for the qualitative detection of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to Bordetella pertussis and Bordetella parapertussis.
The Solana Bordetella Complete Assay, when performed on the Solana instrument, allows for the rapid, accurate detection of Bordetella pertussis and Bordetella parapertussis.
A nasopharyngeal swab specimen in transport media is transferred to a Process Buffer Tube, lysed by simple heat treatment, diluted, and added to a Reaction Tube containing lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the processed sample, the Reaction Tube is placed in Solana for amplification and detection of Bordetella pertussis and Bordetella parapertussis.
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 four USB ports. Solana Bordetella Complete is supported by the power of Virena®.
Features & Benefits
| Feature | Benefit |
|---|---|
Universal buffer solution | Test for two common Bordetella species using a single patient sample |
Small, easy-to-use instrument | Great for smaller labs. Saves space at 9.4" x 9.4" x 5.9". Eliminates the need for dedicated molecular space and costly capital equipment. |
Power of Virena | Manage data and resources for a single site, or multiple sites from any web-enabled device. Report and monitor disease prevalence in your community. |
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 |
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 setup | No ice or cooling block required. |
Product Specifications
| Product Spec Name | Product Spec Data |
|---|---|
Sample type | Nasopharyngeal swabs in transport media* obtained from patients symptomatic of respiratory infection attributed to B. pertussis or B. parapertussis *Saline (0.85%), Tris EDTA, Molecular Grade Water, Amies liquid media, i.e. E-Swab |
Time to results | Approximately 50 minutes |
Reagent storage conditions | Lysis and Reaction Tubes; 2˚C to 8˚C |
Control storage conditions | 2°C to 8°C |
Sample preparation storage conditions | Swabs can be eluted in either saline (0.85%), Tris EDTA, Molecular Grade Water, Amies liquid media (i.e. E-Swab), or UTM, M4, M4-RT, or M6 viral transport media |
Specimens can be stored at 2° to 8°C for up to 97 hours, up to 49 hours at 25°C before processing, or up to 5 months at ≤ -70°C | |
PPA (PCR) | B. pertussis fresh: 100% (95% CI 74.1% to 100%) B. pertussis frozen: 98.1% (95% CI 94.6% to 99.4%) B. parapertussis fresh: 100% (95% CI 98.8% to 99.9%) B. parapertussis frozen: 100% (95% CI 75.7% to 100%) |
NPA (PCR) | B. pertussis fresh: 99.6% (95% CI 98.8% to 99.9%) B. pertussis frozen: 92.0% (95% CI 83.6% to 96.3%) B. parapertussis fresh: 100% (95% CI 99.5% to 100%) B. parapertussis frozen: 98.6% (95% CI 96.1% to 99.5%) |
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
M308 | Solana Bordetella Complete Assay | 48 test |
M117 | Quidel Molecular Bordetella Control Set | 40 reactions |
Product Documentation
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