Molecular Reagent Lyra® Direct SARS-CoV-2 For Thermocycler 96 Tests

Features

• The Lyra® Direct SARS-CoV-2 Assay is for in vitro Diagnostic use under Emergency Use Authorization only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• 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
• Simplified and uniform workflow with standard pipetting volumes
• No ice or cooling block required
• Kit includes Process Buffer, 12x8 Master Mix, Rehydration Solution and liquid Positive and Negative Controls
• 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

More Information

• Quidel Lyra Direct SARS-CoV-2 Assay FDA EUA Letter
• Quidel Lyra Direct SARS-CoV-2 Assay IFU
• Quidel Lyra Direct SARS-CoV-2 Assay Healthcare Providers Fact Sheet
• Quidel Lyra Direct SARS-CoV-2 Assay Patients Fact Sheet
• Quidel Molecular SARS-Cov-2 Assays Variant Detection Bulletin June 2021