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

Completed

Conditions studied: Upper Respiratory Infections

In brief

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.

Key facts

Study ID

NCT02232711

Run by

BioFire Diagnostics, LLC

People needed

1082

Starts

2014-11-01

Expected to finish

2015-07-01

Last updated by the study team

2015-07-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Naval Health Research Center — San Diego, California, United States
• Barnes-Jewish/Washington University School of Medicine — St Louis, Missouri, United States
• UTMB Primary Care Pavilion — Galveston, Texas, United States
• South Main Clinic — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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