Quidel™ Lyra 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: Fischer Scientific
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Certifications/Compliance
Emergency Use Authorization (EUA)
Control Sets
Included
Clia Complexity
High
DoA Calibrators
No
Type
Molecular Testing
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
Packaging Type
Kit
Specificity
NPA – 92/92 = 100% (95% CI: 95.99 to 100%)
Content And Storage
2°C to 8°C
CE Marker
Yes
Detectable Analytes
SARS-CoV-2
Sensitivity
PPA – 92/92 = 100% (95% CI: 95.99 to 100%)
For Use With (Application)
RT-PCR
Includes
Tests and controls
Quantity
96 Tests/Kit
Test Time
<75 min. after extraction
Related Products
Description
- 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
SAFETY INFORMATION
- ShelfLife : 6 Months from DOM
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Certifications/Compliance: Emergency Use Authorization (EUA)
Control Sets: Included
Clia Complexity: High
DoA Calibrators: No
Type: Molecular Testing
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
Packaging Type: Kit
Specificity: NPA – 92/92 = 100% (95% CI: 95.99 to 100%)
Content And Storage: 2°C to 8°C
CE Marker: Yes
Detectable Analytes: SARS-CoV-2
Sensitivity: PPA – 92/92 = 100% (95% CI: 95.99 to 100%)
For Use With (Application): RT-PCR
Includes: Tests and controls
Quantity: 96 Tests/Kit
Test Time: <75 min. after extraction
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Includes: Internal Pressure Reducer
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