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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


Features & Benefits

FeatureBenefit

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

Room temperature set up

No ice or cooling block required

Flexible 96-test format

Kit includes Process Buffer, 12x8 Master Mix, Rehydration Solution and liquid Positive and Negative Controls

Product Specifications

Product Spec NameProduct 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 NumberDescriptionKit 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 (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes

96 tests, 96 Deep-well Plate, 100 Swabs, 100 Transport Tubes
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