The Solana GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.
The Solana GAS Assay, when performed on the Solana instrument, allows for the rapid, accurate detection of Group A Strep without the need for culture confirmation.
The assay utilizes helicase-dependent amplification (HDA) of the DNase B (sdaB) sequence and fluorescent probe-based detection in the Solana instrument to determine assay results.
A throat swab sample or an aliquot of liquid transport media is lysed by simple heat treatment, diluted, and added to a Reaction Tube containing the lyophilized HDA reagents including primers specific for the amplification of the DNAase B (sdaB) sequence as well as sequence specific probes. Competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or instrument failure.
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 GAS is supported by the power of Virena®.
Features & Benefits
| Feature | Benefit |
|---|---|
HDA technology | Rapid method of 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 | Throat swab specimens obtained from patients symptomatic of acute pharyngitis |
Time to results | Approximately 35 minutes |
Reagent storage conditions | Lysis, Dilution and Reaction Tubes; 2˚C to 8˚C |
Controls storage conditions | 2˚C to 8˚C |
Sample preparation storage conditions (cultured enriched broth) | 25˚C to 2˚C for up to 2 days and then at 2˚C to 8˚C for up to 6 more days before testing or at ≤–15˚C or ≤–70˚C for up to 34 days before testing |
Clinical Sensitivity | 98.2% (95% CI 95.5% to 99.3%) |
Clinical Specificity | 97.2% (95% CI 95.9% to 98.1%) |
LOD | 6.81 x 104 CFU/mL |
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
M301 | Assay Kit | 48 tests |
M111 | Quidel Molecular Strep A+G Control Set | 0.5 mL |
Product Documentation
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