- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03012217
Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 (RP2)
Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 (RP2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The FilmArray Respiratory Panel 2 (RP2) is an automated sample-to-answer PCR-based diagnostic for the identification of common upper respiratory viral and bacterial pathogens in nasopharyngeal swab (NPS) specimens collected in viral transport media (VTM). The purpose of this study is to prospectively collect and test residual NPS specimens and generate performance data to support regulatory classification of the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.
Clinical performance evaluations will be initiated at sites in the US and/or EU during the 2016/2017 respiratory illness season, approximately September through December.Prior to performing the prospective clinical evaluation, each participating site will have the necessary Institutional Review Board (IRB) reviews (or equivalent for non-U.S. sites).
Specimens for inclusion in this study will be residual, de-identified NPS collected in VTM leftover from clinician-ordered respiratory pathogen testing.
Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory.
This study is funded by BioFire Diagnostics, LLC. The FilmArray device conforms to the requirements of the European Union In Vitro Diagnostic Directive (IVDD). This study was designed such that every precaution has been taken to protect the health and safety of patients, users, and other persons.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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-
Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Utah
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Salt Lake City, Utah, United States, 84108
- Primary Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Specimen is residual NPS in VTM left over from standard of care testing under clinician order for respiratory pathogen analysis
- Specimen has been held at appropriate temperature
- Sufficient volume remaining after standard of care testing and available for use in the study
Exclusion criteria:
- Specimen other than NPS in VTM (e.g. nasopharyngeal aspirate, anterior or midturbinate swab, oropharyngeal swab, NPS collected in medium other than VTM)
- Specimen cannot be tested within the defined storage parameters
- Insufficient specimen volume for testing
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Specimens that meet inclusion criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sensitivity and specificity of device
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DX-SDY-026541
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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