FDA Emergency Use Authorization
The Lyra Direct 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 Lyra Direct SARS-CoV-2 Assay has one-step reagent set-up and a three-step sample prep. Test results are available in less than 70 minutes. Lyra Direct SARS-CoV-2 Assay is a quality real-time PCR available 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.
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 70 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 Process Buffer, 12x8 Master Mix, Rehydration Solution and liquid Positive and Negative Controls |
Product Specifications
| Product Spec Name | Product Spec Data |
|---|---|
Sample type | Nasal, Nasopharyngeal (NP) or Oropharyngeal (OP) swab |
Time to results | Less than 70 minutes after extraction |
Reagent and Controls storage conditions | 2°C to 8°C |
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
M124 | Lyra Direct SARS-CoV-2 Assay (includes controls) | 96 tests |
M942 | Lyra Direct SARS-CoV-2 Assay (Microfuge Format) with Nasal/Oropharyngeal Swabs and Transport Tubes | 96 tests, 100 Microfuge Tubes (1.5 mL), 100 Swabs, 100 Transport Tubes |
M943 | Lyra Direct SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes | 96 tests, 100 Microfuge Tubes (1.5 mL), 100 Swabs, 100 Transport Tubes |
M944 | Lyra Direct SARS-CoV-2 Assay (Microwell Format) with Nasal/Oropharyngeal Swabs and Transport Tubes | 96 tests, 96 Deep-well Plate, 100 Swabs, 100 Transport Tubes |
M945 | Lyra Direct SARS-CoV-2 Assay (Microwell Format) with Nasopharyngeal Swabs and Transport Tubes | 96 tests, 96 Deep-well Plate, 100 Swabs, 100 Transport Tubes |
Product Documentation
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