This trial is completed!
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You can access this
clinical trial
if you have
Respiratory Tract Infections
and you are
under 100
years old
-
The phase for this study is not defined.
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The purpose

BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed molecular-based in vitro diagnostic platform for infectious disease testing known as the FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS) specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived classification by the FDA in October 2016 and is the first highly-multiplexed molecular test to receive this designation. The purpose of this study is to measure patient outcomes following implementation of the RP EZ test and to also gather data about physician office workflow and user interactions with the device. These data will be used to understand how the adoption of such tests may influence patient care in the CLIA-waived setting.

Provided treatments

  • Device: FilmArray RP EZ
Tris trial is registered with FDA with number: NCT03029299. The sponsor of the trial is BioFire Diagnostics, LLC and it is looking for 83 volunteers for the current phase.
Official trial title:
Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting