Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

Completed

Conditions studied: Upper Resp Tract Infection

In brief

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.

Key facts

Study ID

NCT03012217

Run by

BioFire Diagnostics, LLC

People needed

1612

Starts

2016-09-01

Expected to finish

2016-12-01

Last updated by the study team

2017-01-12

Who can join

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

You may qualify if…

• Specimen is residual NPS in VTM left over from standard of care testing under clinician order for respiratory pathogen analysis
• Specimen has been held at appropriate temperature
• Sufficient volume remaining after standard of care testing and available for use in the study

You may not qualify if…

• Specimen other than NPS in VTM (e.g. nasopharyngeal aspirate, anterior or midturbinate swab, oropharyngeal swab, NPS collected in medium other than VTM)
• Specimen cannot be tested within the defined storage parameters
• Insufficient specimen volume for testing

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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