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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
Supplier: Quidel™ M124
This item is not returnable.
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Description
- RT-PCR
- One-step reagent setup
- Results in <70 minutes after extraction
- No freezer necessary
- Refrigration storage
Specifications
| Emergency Use Authorization (EUA) | |
| Included | |
| Yes | |
| SARS-CoV-2 | |
| Nasal, Nasopharyngeal, Oropharyngeal Swab | |
| COVID Testing Kit | |
| 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 | |
| 96 Tests | |
| <70 min. after extraction |
| 2°C to 8°C | |
| Lyra Direct SARS-CoV-2 Assay (includes controls) | |
| High | |
| No | |
| Nasopharyngeal: PPA – 29/30 = 97% (95% CI: 83.3 to 99.4%), Oropharyngeal: PPA – 15/15 = 100% (95% CI: 79.6 to 100%) | |
| RT-PCR | |
| Tests and controls | |
| Nasopharyngeal: NPA – 30/30 = 100% (95% CI: 88.6 to 100%), oropharyngeal: NPA – 8/8 = 100% (95% CI: 67.6 to 100%) |
Safety and Handling
ShelfLife : 6 Months from DOM
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