Quidel™ Lyra RSV+hMPV Molecular Assay

Multiplex RT-PCR assay for qualitative detection/ID of respiratory syncytial virus/human metapneumovirus viral RNA extracted from nasal/nasopharyngeal swab specimens, FDA approved for use on Applied Biosystems™ 7500 FastDx RT-PCR, QuantStudioDx RT-PCR, Cepheid™ SmartCycler™ II

Manufacturer:  Quidel™ M103

Catalog No. 23-044-002

Description

• 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*
• Description: Qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection
• Clia Complexity: Highly Complex
• DoA Calibrators: No
• Sample Type: Throat swab specimens obtained from patients symptomatic of acute pharyngitis
• Type: Molecular Testing
• For Use With (Equipment): FDA approved for use on Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument, QuantStudioTM Dx Real-Time PCR Instrument and Cepheid™ SmartCycler™ II
• Packaging Type: Kit
• Specificity: Group A β-hemolytic Streptococcus 98%, Pyogenic Group C and G β-hemolytic Streptococcus 1.8x104 CFU/mL, Negative Percent Agreement: hMPV: 98.9%

• Control Sets: Included
• CE Marker: Yes
• Detectable Analytes: Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA)
• Format: Molecular Testing
• Sensitivity: Group A β-hemolytic Streptococcus 96%, Pyogenic Group C and G β-hemolytic Streptococcus 95%, Positive Percent Agreement: hMPV: 98.0%
• For Use With (Application): RT-PCR
• Includes: Tests and controls
• Quantity: 96 Tests/Kit
• Test Time: <70 min. after extraction

Safety and Handling

ShelfLife : 2 Years from DOM