Ignite Creation Date:
2024-05-06 @ 9:34 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03012217
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2017-01-03
Brief Title:
Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2
Sponsor:
BioFire Diagnostics LLC
Organization:
BioFire Diagnostics LLC
Study Overview
Official Title:
Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 RP2
Status:
COMPLETED
Status Verified Date:
2017-01
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:
RP2
Brief Summary:
This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Respiratory Panel RP 2 The purpose of this study is to prospectively collect and test residual NPS specimens and generate performance data to support regulatory classification of the FilmArray RP2 as an in vitro diagnostic IVD in the US European Union EU Canada and other regions
Detailed Description:
The FilmArray Respiratory Panel 2 RP2 is an automated sample-to-answer PCR-based diagnostic for the identification of common upper respiratory viral and bacterial pathogens in nasopharyngeal swab NPS specimens collected in viral transport media VTM The purpose of this study is to prospectively collect and test residual NPS specimens and generate performance data to support regulatory classification of the FilmArray RP2 as an in vitro diagnostic IVD in the US European Union EU Canada and other regions
Clinical performance evaluations will be initiated at sites in the US andor EU during the 20162017 respiratory illness season approximately September through DecemberPrior to performing the prospective clinical evaluation each participating site will have the necessary Institutional Review Board IRB reviews or equivalent for non-US sites
Specimens for inclusion in this study will be residual de-identified NPS collected in VTM leftover from clinician-ordered respiratory pathogen testing
Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory
This study is funded by BioFire Diagnostics LLC The FilmArray device conforms to the requirements of the European Union In Vitro Diagnostic Directive IVDD This study was designed such that every precaution has been taken to protect the health and safety of patients users and other persons
Clinical performance evaluations will be initiated at sites in the US andor EU during the 20162017 respiratory illness season approximately September through DecemberPrior to performing the prospective clinical evaluation each participating site will have the necessary Institutional Review Board IRB reviews or equivalent for non-US sites
Specimens for inclusion in this study will be residual de-identified NPS collected in VTM leftover from clinician-ordered respiratory pathogen testing
Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory
This study is funded by BioFire Diagnostics LLC The FilmArray device conforms to the requirements of the European Union In Vitro Diagnostic Directive IVDD This study was designed such that every precaution has been taken to protect the health and safety of patients users and other persons
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