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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


Features & Benefits

FeatureBenefit

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

Room temperature set up

No ice or cooling block required

Flexible 96-test format

Kit includes vials of 12x8 Master Mix, Rehydration Solution and liquid Process Controls

Product Specifications

Product Spec NameProduct 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 NumberDescriptionKit Size / Case Size
M120

Lyra SARS-CoV-2 Assay (includes controls)

96 tests
M935

Lyra SARS-CoV-2 Assay and Transport Media with Flocked Swab Set

96 tests, 100 swabs, 100 transport media
M936

Lyra SARS-CoV-2 Assay and Transport Media with Mini-tip Flocked Swab Set

96 tests, 100 swabs, 100 transport media
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