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.
Study Type
OBSERVATIONAL
Enrollment
1,082
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
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
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