Reagent Kit Lyra® Molecular Diagnostic / Real Time RT-PCR SARS-CoV-2 For use with BioMerieux NucliSENS® easyMAG® System or EMAG® System / Thermocycler 96 Tests

Lyra® SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal, nasopharyngeal (NP), or oropharyngeal (OP) 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

Positive results do not rule out bacterial infection or co-infection with other viruses; Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information

The Lyra SARS-CoV-2 Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures

Results in less than 75 minutes after extraction

Simplified and uniform workflow with standard pipetting volumes

No ice or cooling block required

Lyra SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes includes: 96 tests, one 96-well Deep-well Plate, 100 NP Swabs, 100 Transport Media

For use with BioMerieux NucliSENS® easyMAG® System or EMAG® System / Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche 100 LightCycler 480, Qiagen Rotor-Gene Q, Bio-Rad CFX96 Touch, Thermofisher QuantStudio 7 Pro Thermocyclers