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

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 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

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