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

Completed

Conditions studied: Lower Resp Tract Infection

In brief

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.

Key facts

Study ID

NCT03361670

Run by

BioFire Diagnostics, LLC

People needed

1689

Starts

2016-10-01

Expected to finish

2017-07-01

Last updated by the study team

2017-12-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• The Ohio State University College of Medicine — Columbus, Ohio, United States
• Wisconsin Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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