Reagent Kit Lyra® Molecular Diagnostic / Real Time RT-PCR Direct SARS-CoV-2 For use with Thermocycler 96 Tests

The Lyra® Direct 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 (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals 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

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 Direct 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

Rehydration solution is simply added to the lyophilized Master Mix

Results in less than 70 minutes after extraction

Lyra Direct SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes includes: 96 tests, 100 Microfuge Tubes (1.5 mL), 100 Swabs, 100 Transport Tubes

Simplified and uniform workflow with standard pipetting volumes

No ice or cooling block required

For use with Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler 480, Roche Cobas z480, Qiagen Rotor-Gene Q, Bio-Rad CFX96 Touch, Thermofisher QuantStudio 7 Pro Thermocyclers