FDA Emergency Use Authorization
The Lyra SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the 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. The Assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 virus. The authorized testing consists of nucleic acid extraction on the 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.
Quidel General Information for Lyra SARS-CoV-2 Assay
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Information for Healthcare Professionals
Information for Laboratories
Laboratory Biosafety
Isolation Precautions in Healthcare Settings
Specimen Collection
Infection Control
FDA:
General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel” in the search box)
Features & Benefits
| Feature | Benefit |
|---|---|
One-step reagent set-up | Rehydration solution is simply added to the lyophilized Master Mix |
Speed | Results in less than 75 minutes after extraction |
Easy training | Simplified and uniform workflow with standard pipetting volumes |
Refrigerated storage | No freezer needed. 2°C to 8°C storage |
Flexible 96-test format | Kit includes vials of 12x8 Master Mix, Rehydration Solution and liquid Process Controls |
Product Specifications
| Product Spec Name | Product Spec Data |
|---|---|
Sample type | Nasal, Nasopharyngeal (NP) or Oropharyngeal (OP) swab |
Time to results | Less than 75 minutes after extraction |
Reagent and Controls storage conditions | 2°C to 8°C |
Sample volume needed for extraction | 180 µL |
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
M120 | Lyra SARS-CoV-2 Assay (includes controls) | 96 tests |
M938 | Lyra SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes | 96 tests, one 96-well Deep-well Plate, 100 NP Swabs, 100 Transport Media |
M939 | Lyra SARS-CoV-2 Assay (Microwell Format) with Nasal/Oropharyngeal Swabs and Transport Tubes | 96 tests, one 96-well Deep-well Plate, 100 Nasal/OP Swabs, 100 Transport Media |
Product Documentation
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