Respiratory Tract Infections Clinical Trial
Official title:
Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission
This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.
The Idylla console, instrument, and Respiratory (IFV-RSV) Panel cartridge constitute the
Idylla respiratory diagnostic system. The IFV-RSV Panel is an in vitro PCR-based molecular
diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A
(including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory
Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal
swabs (NP) in viral transport media (VTM) in adults, adolescents, and children.
This clinical study will collect data in support of regulatory submission and the
indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol
will demonstrate that the results of this assay, in conjunction with clinical information,
may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV
in persons having both a high and low risk for respiratory viral infection.
During this study, participating sites will collect fresh samples, conduct a Reproducibility
Study and test the fresh and previously collected frozen samples from individuals presenting
with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to
the sample collection described in this protocol.
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Time Perspective: Cross-Sectional
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