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

NCT03029299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2017-09-25

No results posted yet for this study

Summary

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.

Conditions

  • Respiratory Tract Infections

Interventions

DEVICE

FilmArray RP EZ

Patients in the intervention arm will be tested with the FilmArray RP EZ and the results of the test will be provided to the treating clinician

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2017-09-15
Completion
2017-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03029299 on ClinicalTrials.gov