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

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.

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Key information

Conditions

Upper Respiratory Infections Communicable Diseases Disease Attributes Disease Progression Infections Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Health Research Center, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness

Time frame: 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 outcomes

Epidemiology of respiratory infections in a CLIA-waived setting

Time frame: 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.

Sponsors and collaborators

Lead sponsor

BioFire Diagnostics, LLC

Industry

Collaborators

United States Department of Defense

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 5, 2014
Registry last updated: Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed