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.
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 CoV-2 Assay
CLIA complexity: Highly complex
FDA status: EUA granted
Validation data for material numbers M120, M935, M936, M938, M939:
Nucleic Acid Extraction:
- bioMerieux NucliSENS® easyMAG® software version 2.0
- bioMerieux EMAG® system
- Roche MagnaPur® system
Nucleic Acid Amplification and Detection:
- Applied Biosystems® 7500 Fast Dx, software version 1.4
- ABI 7500 Fast®
- ABI 7500 Standard®
- Qiagen Rotor-Gene Q®
- Roche LC480®
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
Fact sheet for patients
Instructions for use
Frequently asked questions
Lyra Direct CoV-2 Assay
CLIA Complexity: Moderately and Highly Complex
FDA status: EUA pending*
Validation data for material numbers M124VTM, M942, M943, M944, M945:
Nucleic Acid Amplification and Detection:
- Applied Biosystems® 7500 Fast Dx software version 1.4
- Applied Biosystems® Standard, software version 2.0.6
- Roche LightCycler® 480 Instrument II, software version 1.5.0.39
- Qiagen Rotor-Gene Q®, software version 2.0.2.4
- Bio-Rad CFX96 Touch, software version 3.1
- Thermo Fisher QuantStudio 7 Pro, software version 2.0
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