商品编号


M305



品牌


Quidel



公司


Quidel,inc.



公司分类


Solana



Size

48 tests

商品信息

Description:
Solana Strep Complete Assay Kit
Features & Benefits:







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
?
.










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
Currently 12 months from date of manufacture



Room temperature at 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



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
8.48x10
4
CFU/mL and 7.07x10
5
CFU/mL