Lyra® Direct SARS-CoV-2 Assay
Lyra® Assays
Lyra® Direct SARS-CoV-2 Assay

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 - QuidelOrtho EUA COVID-19 Products  (Scroll down to the list of EUA products and enter “Quidel" or "Ortho” in the search box)

The Lyra Direct SARS-CoV-2 assay has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.

Please see chart below for ordering information.

Contact us

Lyra® Assays
Lyra® Direct SARS-CoV-2 Assay
Lyra® Direct SARS-CoV-2 Assay

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 - QuidelOrtho EUA COVID-19 Products  (Scroll down to the list of EUA products and enter “Quidel" or "Ortho” in the search box)

The Lyra Direct SARS-CoV-2 assay has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.

Please see chart below for ordering information.

Contact us

 
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

Features & benefits

Rehydration solution is simply added to the lyophilized Master Mix for one-step reagent set-up.

Speedy results in less than 75 minutes after extraction.

Simplified and uniform workflow with standard pipetting volumes for easy training.

Find what you need

To access safety data sheets, package inserts, quick reference guides and all other technical and promotional materials, visit our technical documents library.

 

Technical documentation

Product specifications
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

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