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 Lyra Direct SARS-CoV-2 Assay (Microfuge Format) with Nasal/Oropharyngeal Swabs and Transport Tubes includes: 96 tests
• 100 Microfuge Tubes (1.5 mL)
• 100 Swabs
• 100 Transport Tubes 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