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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

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Catalog No. 23-044-012


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Description

Description

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

Specifications

RT-PCR
Included
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
<70 min. after extraction
Lyra Direct SARS-CoV-2 Assay (includes controls)
Tests and controls
No
Nasopharyngeal: PPA – 29/30 = 97% (95% CI: 83.3 to 99.4%), Oropharyngeal: PPA – 15/15 = 100% (95% CI: 79.6 to 100%)
Emergency Use Authorization (EUA)
Nasopharyngeal: NPA – 30/30 = 100% (95% CI: 88.6 to 100%), oropharyngeal: NPA – 8/8 = 100% (95% CI: 67.6 to 100%)
96 Tests
Yes
SARS-CoV-2
Nasal, Nasopharyngeal, Oropharyngeal Swab
COVID Testing Kit
Highly Complex
Safety and Handling

Safety and Handling

ShelfLife : 6 Months from DOM

SDS
Documents
Product Certifications
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