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