Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
Public ClinicalTrials.gov record NCT02232711. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02232711
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,082 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2014
- Primary completion
- Jun 30, 2015
- Completion
- Jun 30, 2015
- Last update posted
- Jul 23, 2015
2014 – 2015
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Naval Health Research Center | San Diego | California | 92152 | — |
| Barnes-Jewish/Washington University School of Medicine | St Louis | Missouri | 63103 | — |
| UTMB Primary Care Pavilion | Galveston | Texas | 77550 | — |
| South Main Clinic | Salt Lake City | Utah | 84115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02232711, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2015 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02232711 live on ClinicalTrials.gov.