Trials / Completed
CompletedNCT02232711
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,082 (actual)
- Sponsor
- BioFire Diagnostics, LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2014-09-05
- Last updated
- 2015-07-24
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02232711. Inclusion in this directory is not an endorsement.