Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: BioFire Diagnostics, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

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

Treatment Details

Interventions

• FilmArray RP EZ (Molecular-based Diagnostic Test)

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Subjects are tested using the FilmArray RP EZ and the results are provided to the clinician for use in determination of patient care (along with any other clinician-ordered testing)

Group II: Control Active Control 1 Intervention

Subjects receive standard of care testing as determined by the clinician.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, Los Angeles Los Angeles, CA

Who Is Running the Clinical Trial?

BioFire Diagnostics, LLC

Lead Sponsor

Trials

15

Patients Recruited

17,900+

University of California, Los Angeles

Collaborator

Trials

1594

Patients Recruited

10,430,000+