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The Idylla™ Respiratory (IFV-RSV) Panel is an in vitro assay intended for the qualitative detection of nucleic acids for Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and Respiratory Syncytial Virus (A and B) from nasopharyngeal swabs in viral transport media of adult and pediatric patients. The test uses the Idylla™ system to aid in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. Negative results do not preclude respiratory virus infection or co-infection with other viruses and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for Influenza A were established when influenza A/2009 H1 and H3 were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.

The Idylla™ Respiratory (IFV-RSV) Panel is a self-contained molecular diagnostic test designed to work with the IdyllaTM System. The assay is performed using a single-use, disposable, multi-chambered fluidic cartridge. This includes hands-off sample preparation/purification, reverse transcription and real-time, multiplex Polymerase Chain Reaction (PCR) for the detection of viral RNA. All steps in this process are fully automated and completely integrated and results are available in less than 50 minutes. The Idylla™ Respiratory (IFV-RSV) Panel identifies virus-specific nucleic acids for Influenza (IFV) A virus, Influenza B virus, and Respiratory Syncytial Virus (RSV). The IFV-RSV Panel targets the following genes within the viruses: matrix gene (Influenza A and Influenza B); hemagglutinin gene (Influenza A subtypes H1 and H3, Influenza A subtype 2009 H1); neuraminidase gene (H275Y mutation of 2009 H1); fusion protein gene RSV (A and B). The System amplifies a targeted region of interest generating a change in fluorescent signal, which is measured and applied against predetermined criteria to provide a qualitative result. The automated process steps in the panel are: Sample processing: Utilizing the automated process of Idylla™ fluidics, sample and Sample Processing Control (SPC) comes in contact with the lysis buffer to release the RNA and solubilize proteins, creating a lysate. Binding buffer is mixed with the lysate to aid in the binding of nucleic acids. Purified RNA is subsequently subject to a RT-PCR reaction within the Cartridge. RT-PCR: Reverse Transcription, amplification and fluorescent detection of viral targets occur during the RT-PCR cycling. RT-PCR reagents are present in a stable formulation in five PCR chambers located within the Cartridge. The Test contains reagents for the simultaneous detection of a sample processing control and detection of various IFV and RSV targets. Detection of these specific targets is performed using fluorescent labeled probes. All amplification, detection of fluorescence, and the interpretation of the signals are done automatically by the Idylla™ instrument system.