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

Features

• The Lyra SARS-CoV-2 Assay with Controls is for use under an FDA EUA:https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Lyra® 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, nasopharyngeal (NP), or oropharyngeal (OP) swab specimens from patients 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; Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• 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 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

More Information

• Quidel Lyra SARS-CoV-2 Assay FDA EUA Letter
• Quidel Lyra SARS-CoV-2 Assay IFU
• Quidel Lyra SARS-CoV-2 Assay Healthcare Providers Fact Sheet
• Quidel Lyra SARS-CoV-2 Assay Patients Fact Sheet