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

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

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.

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.

Inclusion Criteria:

• Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted under clinician order for standard care LRT testing
• Specimen has not been centrifuged
• Specimen has not been pre-treated
• Specimen has at least 1.5 mL of residual volume
• Specimen was collected from a subject not already enrolled in the study
• Specimen is fresh (stored at ~4°C, not frozen) and was enrolled with 24 hours of collection

Exclusion Criteria:

• Specimen was centrifuged, pre-treated, or is less than 1.5mL
• Specimen was collected from a subject known to have cystic fibrosis
• Specimen was collected from a subject known to have tuberculosis
• Specimen was collected from a subject that was previously enrolled in the study
• Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours.