Idylla IFV-RSV Panel Clinical Testing (RP1)
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|ClinicalTrials.gov Identifier: NCT02786381|
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : November 22, 2016
|Condition or disease|
|Respiratory Tract Infections Influenza, Human Respiratory Syncytial Virus Infections|
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.
|Study Type :||Observational|
|Actual Enrollment :||213 participants|
|Official Title:||Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
- Product performance as measured by positive and negative agreement to a predicate [ Time Frame: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months. ]Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786381
|United States, Florida|
|Sacred Heart Hospital - Pensacola|
|Pensacola, Florida, United States, 32513|
|Study Director:||Theresa Pattery, MD||Janssen Diagnostics|