The Solana Strep complete assay is a rapid in vitro diagnostic test for the qualitative detection of group A β-hemolytic Streptococcus (Streptococcus pyogenes), and pyogenic group C/G (streptococcus dysgalactiae) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.
The Solana Strep complete assay, when performed on the Solana instrument, allows for the rapid, accurate detection of group A and pyogenic group C/G Strep without the need for culture confirmation.
A throat swab sample or an aliquot of liquid transport media is lysed by simple heat treatment, diluted, and added to two reaction tubes, one containing primers and probes specific for Group A Strep, the other containing primers and probes for strep dysgalactiae 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.
Please see chart below for ordering information.
The Solana Strep complete assay is a rapid in vitro diagnostic test for the qualitative detection of group A β-hemolytic Streptococcus (Streptococcus pyogenes), and pyogenic group C/G (streptococcus dysgalactiae) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.
The Solana Strep complete assay, when performed on the Solana instrument, allows for the rapid, accurate detection of group A and pyogenic group C/G Strep without the need for culture confirmation.
A throat swab sample or an aliquot of liquid transport media is lysed by simple heat treatment, diluted, and added to two reaction tubes, one containing primers and probes specific for Group A Strep, the other containing primers and probes for strep dysgalactiae 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.
Please see chart below for ordering information.
| Ordering information | ||
| Catalog number | Description | Kit size / case size |
| M305 | Solana Strep Complete Assay Kit | 48 tests |
| M111 | Quidel Molecular Strep A+G Control Set | 0.5 mL |
Features & benefits
Rapid method of isothermal nucleic acid amplification that does not require thermocycling with RT-HDA technology.
Easy-to-use format, just add processed sample to rehydrate with lyophilized master mix reagent.
Small, easy-to-use instrument eliminates the need for dedicated molecular space and costly capital equipment, allowing for testing in smaller labs.
To access safety data sheets, package inserts, quick reference guides and all other technical and promotional materials, visit our technical documents library.
- Specifications
- Learning hub
| Product specifications | |
| 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 |
| Control 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 Streptococcus pyogenes | 98.8% (95% CI 97.3% to 99.4%) |
| Clinical Specificity Streptococcus pyogenes | 98.9% (95% CI 98.3% to 99.2%) |
| Clinical Sensitivity Streptococcus dysgalactiae | 100% (95% CI 95.3% to 100%) |
| Clinical Specificity Streptococcus dysgalactiae | 99.5% (95% CI 99.1% to 99.7%) |
| LOD Streptococcus pyogenes and Streptococcus dysgalactiae | 8.48x104 CFU/mL and 7.07x105 CFU/mL |
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