NCT02786381

Idylla IFV-RSV Panel Clinical Testing

Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 213 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.

Detailed description

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.

Conditions

• Respiratory Tract Infections
• Influenza, Human
• Respiratory Syncytial Virus Infections

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-06-01
• Last updated: 2016-11-22

Locations

1 site across 1 country: United States