Home / Clinical Laboratory / Controls / Control / Molecular Diagnostic / Real Time RT-PCR Control Lyra® Direct SARS-CoV-2 Positive Level 1 mLM5274
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Molecular Diagnostic / Real Time RT-PCR Control Lyra® Direct SARS-CoV-2 Positive Level 1 mLM5274

Molecular-Diagnostic--Real-Time-RT-PCR-Control-Lyra®-Direct-SARS-CoV-2-Positive-Level-1-mLM5274

SKU #

#1181004

MPN #

M5274

Brand

Quidel

Stock

In Stock

Quantity

100

Features

CONTROL, POSITIVE LYRA F/M124 1ML D/S

$16.32 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1181004
Manufacturer # M5274
Brand Lyra®
Manufacturer Quidel
Application Control
Container Type Vial
For Use With For use with Lyra® Direct SARS-CoV-2 Assay
Levels Positive Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name Direct SARS-CoV-2
Test Type Molecular Diagnostic / Real Time RT-PCR
UNSPSC Code 41116145
Volume 1 mL
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  • 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 provide
  • 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
  • Positive control may be dipped by placing a dry nasopharyngeal swab into the control for ten seconds and then vigorously swirled for 10 seconds into aliquoted process buffer or 50 µL may be transferred to aliquoted process buffer
  • Must be treated as a patient specimen and be included in every extraction and RT-PCR run
  • Positive Control containing synthetic SARS-CoV-2 RNA