NCT03012217

Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 (RP2)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,612 (actual)
• Sponsor: BioFire Diagnostics, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 and/or EU during the 2016/2017 respiratory illness season, approximately September through December.Prior to performing the prospective clinical evaluation, each participating site will have the necessary Institutional Review Board (IRB) reviews (or equivalent for non-U.S. 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.

Conditions

• Upper Resp Tract Infection

Interventions

Type	Name	Description
OTHER	Observational Study

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2017-01-06
• Last updated: 2017-01-12

Locations

3 sites across 1 country: United States