Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting

Completed

• Conditions: Upper Respiratory Infections

• Registration Number: NCT02232711
• Lead Sponsor: BioFire Diagnostics, LLC

Brief Summary

The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with signs and/or symptoms of a respiratory infection. The study data will be used to support an application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or high complexity CLIA certification.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-05
• Study Start: 2014-11
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1082

Inclusion Criteria

• Displays signs and/or symptoms of respiratory infections
• Adult patients must provide informed consent
• Parental consent for children (<18)

Exclusion Criteria

• Adult patients unable to provide informed consent
• Children that are currently in foster care, or are wards of the state

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness	1.5 hour	In general, performance of the FilmArray RP EZ test in the CLIA-waived setting is expected to meet at least 95% positive and negative percent agreement with the results obtained from FilmArray RP in the moderate/high- complexity setting for each pathogen on the panel.

Secondary Outcome Measures

Name	Time	Method
Epidemiology of respiratory infections in a CLIA-waived setting	Up to 9 months	Seasonality and rate of respiratory infection at each of the CLIA-waived sites using the FilmArray RP EZ to collect prospectively enrolled specimens will be evaluated at the end of the study.

Trial Locations

Locations (4)

Naval Health Research Center; 🇺🇸 San Diego, California, United States

UTMB Primary Care Pavilion; 🇺🇸 Galveston, Texas, United States

South Main Clinic; 🇺🇸 Salt Lake City, Utah, United States

Barnes-Jewish/Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States