At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
In Brief
An observational study for Upper Respiratory Infections. Completed, enrolled 1,082 participants across 4 sites.
Detailed 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.