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