NCT03361670

Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel

Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,689 (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 Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively collect and test residual Bronchoalveolar lavage (BAL) and sputum specimens and generate performance data to support regulatory classification of the FilmArray LRTI as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.

Detailed description

BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray. The FilmArray Lower Respiratory Tract Infection (LRTI) Panel is a test designed for use with the FilmArray that identifies common bacterial, viral, and fungal microorganisms as well as antimicrobial resistance gene targets associated with lower respiratory tract infections. The FilmArray LRTI Panel also provides quantitation for some bacterial analytes. Clinical performance evaluations will be initiated at a minimum of three sites to determine the clinical performance of the FilmArray LRTI Panel for each of the analytes on the panel when testing bronchoalveolar lavage (BAL, including mini-BAL) and sputum (including endotracheal aspirates) specimens from subjects with suspected lower respiratory tract (LRT) infections. The intention is for these performance data to support regulatory classifications of the FilmArray LRTI Panel as an in vitro diagnostic device in the US, European Union (EU), Canada, and other regions. The study sites selected will have expertise in the diagnosis of LRTIs, and will be able to conduct the evaluation in accordance with this protocol and Good Clinical Practices (GCP). Prior to performing the prospective clinical evaluation, each participating site will have the necessary Institutional Review Board (IRB) or Ethics Committee (EC) reviews. Specimens for inclusion in this study will be residual, de-identified BAL or sputum specimens leftover from clinician-ordered lower respiratory pathogen testing. Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory and at BioFire. This study is funded by BioFire Diagnostics, LLC.

Conditions

• Lower Resp Tract Infection

Interventions

Type	Name	Description
OTHER	Observational Study

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-12-05
• Last updated: 2017-12-05

Locations

8 sites across 1 country: United States