Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting
Completed · Not applicable
Conditions studied: Respiratory Tract Infections
In brief
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.
Key facts
- Study ID
- NCT03029299
- Run by
- BioFire Diagnostics, LLC
- People needed
- 83
- Starts
- 2017-04-04
- Expected to finish
- 2017-09-15
- Last updated by the study team
- 2017-09-25
Who can join
Age: any, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, or fatigue.
- Subject provides written informed consent/assent/parental permission
- Willing and able to provide NPS specimen
You may not qualify if…
- Subject is unable to provide consent/assent/parental permission
- Children whose legal guardian is not available to give permission
- Unable/unwilling to provide NPS specimen
- Non-English speaking
Where it is running
- University of California, Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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