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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®.

Features & Benefits

FeatureBenefit
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

Currently 12 months from date of manufacture

Room temperature at set up

No ice or cooling block required

Product Specifications

Product Spec NameProduct 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

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

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
M305

Solana Strep Complete Assay Kit

48 tests
M111

Quidel Molecular Strep A+G Control Set

0.5 mL