Quidel™ Lyra Direct Strep Molecular Assay

Description

Lyra direct strep assay is RT-PCR IVD for rapid, qualitative detection/differentiation of Streptococcus pyogenes, Streptococcus dysgalactiae, Streptococcus equi, Streptococcus canis nucleic acids isolated from throat swab specimens

• RT-PCR
• One-step reagent setup
• Results in <70 minutes after extraction
• No freezer necessary
• Refrigration storage
• Long shelf-life
• Flexible testing format
• Includes 12 x 8 master mix, rehydration solution and liquid process controls

Specifications

• Certifications/Compliance: FDA approved*
• Content And Storage: 2°C to 8°C
• Control Sets: Included
• Description: Qualitative detection and differentiation of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) and pyogenic Group C and G β-hemolytic Streptococcus nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as a sore throat
• CE Marker: Yes
• Clia Complexity: High
• Detectable Analytes: beta-hemolytic Streptococcus - Streptococcus pyogenes (Group A), beta-hemolytic Streptococcus Nucleic Acids (Group C,G)
• DoA Calibrators: No
• Sample Type: Throat swab specimens obtained from patients symptomatic of acute pharyngitis
• Sensitivity: Group A β-hemolytic Streptococcus 96%, Pyogenic Group C and G β-hemolytic Streptococcus 95%
• Type: Molecular Testing
• For Use With (Application): RT-PCR
• For Use With (Equipment): FDA approved for use on Applied Biosystems™ 7500 series of instruments
• Includes: Tests and controls
• Packaging Type: Kit
• Quantity: 96 Tests/Kit
• Specificity: Group A β-hemolytic Streptococcus 98%, Pyogenic Group C and G β-hemolytic Streptococcus 1.8 x 104 CFU/mL
• Test Time: <70 min. after extraction
• Form: Liquid