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  6. Quidel™ Lyra SARS-CoV-2 Molecular Assay

Quidel™ Lyra SARS-CoV-2 Molecular Assay
SDP

Catalog No. p-7220814
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Format:
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Microfuge
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This item is not returnable. View return policy
This item is not returnable. View return policy

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
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