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

Quidel™ Lyra Direct SARS-CoV-2 Molecular Assay
SDP

Catalog No. 23044012
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Includes:
Nasal/oropharyngeal swabs, transport tubes, deep well plates
Nasal/oropharyngeal swabs, transport tubes, microfuge tubes
Nasopharyngeal swabs, transport tubes, deep well plates
Nasopharyngeal swabs, transport tubes, microfuge tubes
Tests and Controls
Sample Type:
Nasal, Nasopharyngeal, Oropharyngeal Swab
Nasal/oropharyngeal Swab
Nasopharyngeal Swab
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 <70 minutes after extraction
  • No freezer necessary
  • Refrigration storage

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
Sample Type Nasal, Nasopharyngeal, Oropharyngeal Swab
Sensitivity Nasopharyngeal: PPA – 29/30 = 97% (95% CI: 83.3 to 99.4%), Oropharyngeal: PPA – 15/15 = 100% (95% CI: 79.6 to 100%)
Type SARS-CoV-2 Assay
For Use With (Application) RT-PCR
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
Includes Tests and Controls
Quantity 96 Tests
Specificity Nasopharyngeal: NPA – 30/30 = 100% (95% CI: 88.6 to 100%), oropharyngeal: NPA – 8/8 = 100% (95% CI: 67.6 to 100%)
Test Time <70 min. after extraction
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