Quidel™ Lyra Direct SARS-CoV-2 Molecular Assay

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

Manufacturer:  Quidel™ M124

Catalog No. 23-044-012

Description

• RT-PCR
• One-step reagent setup
• Results in <70 minutes after extraction
• No freezer necessary
• Refrigration storage

Specifications

• For Use With (Application): RT-PCR
• Control Sets: Included
• For Use With (Equipment): Emergency Use Authorization (EUA) for use on Applied Biosystems™ 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler™ 480 Instrument II, Roche cobas™ z 480, Qiagen Rotor-Gene™ Q, Bio-Rad CFX96 Touch™, Thermo Fisher QuantStudio™ 7 Pro
• Test Time: <70 min. after extraction
• Description: Lyra Direct SARS-CoV-2 Assay (includes controls)
• Includes: Tests and controls
• DoA Calibrators: No
• Sensitivity: Nasopharyngeal: PPA – 29/30 = 97% (95% CI: 83.3 to 99.4%), Oropharyngeal: PPA – 15/15 = 100% (95% CI: 79.6 to 100%)

• Certifications/Compliance: Emergency Use Authorization (EUA)
• Specificity: Nasopharyngeal: NPA – 30/30 = 100% (95% CI: 88.6 to 100%), oropharyngeal: NPA – 8/8 = 100% (95% CI: 67.6 to 100%)
• Quantity: 96 Tests
• CE Marker: Yes
• Detectable Analytes: SARS-CoV-2
• Sample Type: Nasal, Nasopharyngeal, Oropharyngeal Swab
• Type: COVID Testing Kit
• Clia Complexity: Highly Complex

Safety and Handling

ShelfLife : 6 Months from DOM