Quidel Solana™ STREP Complete Kit

Description

Includes

Test Kit: Package insert, Dilution Buffer, Lysis Buffer, Reaction Tubes

Features rapid method of nucleic acid amplification that does not require thermal cycler. For qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes), and pyogenic Group C/G (streptococcus dysgalactiae) nucleic acids.

• Rapid in vitro diagnostic test for 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.
• 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
• Results are displayed on the touchscreen,
• Can be saved to the instrument, printed
• 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 and Benefits

• 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
• HDA Technology
• No need for Culture Confirmation

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Specifications

• Certifications/Compliance: CLIA-Moderate
• Content And Storage: 2°C to 8°C (No ice or cooling block required)
• Clia Complexity: Moderate
• Detectable Analytes: Streptococci (Group A, C, G)
• Sample Type: Throat Swab
• Sensitivity: 98.8% (Pyogenes), 100% (Dysgalactiae)
• Type: Strep Complete Assay
• For Use With (Application): For diagnosis of Group A, C, & G Streptococcus
• Includes: Test Kit: Package insert, Dilution Buffer, Lysis Buffer, Reaction Tubes; Lyophilized Master Mix reagent
• Quantity: 48 Reactions/Pk.
• Specificity: 98.9% (Pyogenes)/99.5% (dysgalactiae)
• Test Time: ≈35 min.