Solana® Strep Complete Assay
Solana® Molecular Testing Platform
Solana® Strep Complete Assay

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. Solana Strep Complete is supported by the power of Virena®.

Please see chart below for ordering information. 

Contact us

Solana® Molecular Testing Platform
Solana® Strep Complete Assay
Solana® Strep Complete Assay

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. Solana Strep Complete is supported by the power of Virena®.

Please see chart below for ordering information. 

Contact us

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 nucleic acid amplification that does not require thermal cycler with 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.

Find what you need

To access safety data sheets, package inserts, quick reference guides and all other technical and promotional materials, visit our technical documents library.

 

Technical documentation

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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