Quidel™ Lyra SARS-CoV-2 Molecular Assay

Catalog No.	Format
23-044-011	Control
23-044-026	Microfuge
23-044-027	Microwell

Catalog No. 23-044-011 Supplier Quidel™ Supplier No. M120

Description

For in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal (NP) or oropharyngeal (OP) swab specimens from patients with signs and symptoms of COVID-19, Assay targets non-structural Polyprotein (pp1ab) of SARS-CoV-2 virus

• RT-PCR
• One-step reagent setup
• Results in <75 minutes after extraction
• No freezer necessary
• Refrigration storage
• Flexible testing format
• Includes 12 x 8 master mix, rehydration solution and liquid process controls

Specifications

• Certifications/Compliance: Emergency Use Authorization (EUA)
• Content And Storage: 2°C to 8°C
• Control Sets: Included
• CE Marker: Yes
• Clia Complexity: High
• Detectable Analytes: SARS-CoV-2
• DoA Calibrators: No
• Format: Control
• Sample Type: Nasal, Nasopharyngeal, Oropharyngeal Swab
• Sensitivity: PPA – 92/92 = 100% (95% CI: 95.99 to 100%)
• Type: Molecular Testing
• For Use With (Application): RT-PCR
• For Use With (Equipment): Emergency Use Authorization (EUA) for use on bioMerieux NucliSENS™ easyMAG™ system or EMAG system, followed by RT-PCR on one of six thermocyclers: Applied Biosystems™ 7500 Fast Dx, Applied Biosystems 7500 Standard, QuantStudioTM Real-Time PCR Instrument, Roche LightCycler™ 480, BioRad CFX96 Touch, or Qiagen Rotor-Gene Q
• Includes: Tests and controls
• Packaging Type: Kit
• Quantity: 96 Tests/Kit
• Specificity: NPA – 92/92 = 100% (95% CI: 95.99 to 100%)
• Test Time: <75 min. after extraction
• Form: Liquid