Ignite Creation Date:
2024-05-06 @ 8:37 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02786381
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2015-12-04
Brief Title:
Idylla IFV-RSV Panel Clinical Testing
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Idylla Respiratory IFV-RSV Panel Clinical Testing and Sample Collection Protocol in Support of 510k Premarket Submission
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RP1
Brief 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 signssymptoms of influenza like illness ILI and respiratory virus in accordance to the sample collection described in this protocol
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 signssymptoms of influenza like illness ILI and respiratory virus in accordance to the sample collection described in this protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None