*
COVID-19 test available | Lyra® SARS-CoV-2 Assay
The Quidel Lyra® SARS-CoV-2 Assay has received Emergency Use Authorization (EUA) from the U.S Food and Drug Administration (FDA). It is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal, nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Test Type: rRT-PCR
Specimen Type: Nasopharyngeal and oropharyngeal swab specimens
*Viral transport media (M4, M4-RT, M5, M6, and UTM) are compatible with the Lyra respiratory assays
Specimen Type: Nasopharyngeal and oropharyngeal swab specimens
*Viral transport media (M4, M4-RT, M5, M6, and UTM) are compatible with the Lyra respiratory assays
Lyra SARS-CoV-2
Lyra Direct SARS-CoV-2
Lyra SARS-CoV-2
Turnaround Time: ~2.5 hours (60 minutes for extraction and 75 minutes for amplification and detection)
CLIA complexity: Highly complex
FDA status: EUA granted
CLIA complexity: Highly complex
FDA status: EUA granted
Validation data for material numbers M120, M935, M936, M938, M939:
Nucleic Acid Extraction:
- bioMerieux NucliSENS® easyMAG®
- bioMerieux EMAG®
Nucleic Acid Amplification and Detection:
- Applied Biosystems® 7500 Fast Dx
- Applied Biosystems® 7500 Standard
- Bio-Rad CFX96 Touch
- Qiagen Rotor-Gene® Q
- Roche LightCycler® 480 Instrument II
- Thermo Fisher QuantStudio™ 7 Pro
Ordering information:
Contact your Cardinal Health Laboratory Products Representative to order or complete the form below.
| Material # | Description | Pkg string | Shipping UOM |
|---|---|---|---|
| M120 | Test kit only - Lyra SARS 2 / COVID 19 | 96 tests/bx | BX (Drop ship) |
| M938 | Lyra COV2 assay & NP coll. Set (Bulk) | 96 tests/bx | BX (Drop ship) |
| M939 | Lyra COV2 assay & OP coll. Set (Bulk) | 96 tests/bx | BX (Drop ship) |
| M5153 | Lyra SARS CoV-2 Positive Control | 1 ea/bx | BX (Drop ship) |
| M5275 | Lyra SARS CoV-2 Negative Control | 1 ea/bx | BX (Drop ship) |
Related information
Fact sheet for healthcare providers
Download
164KB – PDF
Fact sheet for patients
Download
121KB – PDF
Instructions for use
Download
1.0MB – PDF
Frequently asked questions
Download
191KB – PDF
During this extraordinary time, Cardinal Health strives to provide customers with accurate product information but relies on the manufacturer for updates. Please visit the manufacturer's product website for the most current information.
Lyra Direct SARS-CoV-2
Turnaround Time: ~2 hours for direct assay (M124VTM, M942, M943, M944, M945)
CLIA Complexity: Highly Complex
FDA status: EUA granted
CLIA Complexity: Highly Complex
FDA status: EUA granted
Validation data for material numbers M124VTM, M942, M943, M944, M945:
Nucleic Acid Amplification and Detection:
- 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
Ordering information:
Contact your Cardinal Health Laboratory Products Representative to order or complete the form below.
| Material # | Description | Pkg string | Shipping UOM |
|---|---|---|---|
| M5153 | Lyra SARS CoV-2 Positive Control | 1 ea/bx | BX (Drop ship) |
| M5275 | Lyra SARS CoV-2 Negative Control | 1 ea/bx | BX (Drop ship) |
| M124VTM | Lyra Direct COV-2 Assay | 96 ea/bx | BX (Drop ship) |
| M942 | Lyra Direct COV2 CDC VTM/Tubes/OP swabs | 96 ea/bx | BX (Drop ship) |
| M943 | Lyra Direct COV2 CDC VTM/Tubes/NP Swabs | 96 ea/bx | BX (Drop ship) |
| M944 | Lyra Direct COV2 CDC VTM/Plate/OP Swabs | 96 ea/bx | BX (Drop ship) |
| M945 | Lyra Direct COV2 CDC VTM/Plate/NP Swabs | 96 ea/bx | BX (Drop ship) |
| M223 | Thermomixer & Block-Microwell | 1 ea/bx | BX (Drop ship) |
| M224 | Thermomixer & Block Tubes | 1 ea/bx | BX (Drop ship) |
Related information
Instructions for use
Download
607KB – PDF
Fact sheet for healthcare providers
Download
250KB – PDF
Fact sheet for patients
Download
190KB – PDF
During this extraordinary time, Cardinal Health strives to provide customers with accurate product information but relies on the manufacturer for updates. Please visit the manufacturer's product website for the most current information.