Quidel M940 - Molecular Reagent Lyra®… | USA MedPremium
Molecular Reagent Lyra® Direct SARS-CoV-2 For Thermocycler 96 Tests - M940
USAMP#22123676SKU: M940Lyra®
Product Spotlight
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
Lyra Direct SARS kit includes: Viral Transport Media (VTM) with tubes
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
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
