An observational study in Upper Respiratory Infections, sponsored by BioFire Diagnostics, LLC. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2015-07-24.
Sponsored by BioFire Diagnostics, LLC · Observational
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 1,082 is above the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →BioFire Diagnostics, LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals with signs and/or symptoms of respiratory infections
Exclusion Criteria:
Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness
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.
Time frame: 1.5 hour
Epidemiology of respiratory infections in a CLIA-waived setting
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.
Time frame: Up to 9 months
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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BioFire Diagnostics, LLC