Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

Completed

• Conditions: Upper Resp Tract Infection
• Interventions: Other: Observational Study

• Registration Number: NCT03012217
• Lead Sponsor: BioFire Diagnostics, LLC

Brief Summary

This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Respiratory Panel (RP) 2. 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.

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 Timeline

• Study Start: 2016-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1612

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Specimens that meet inclusion criteria	Observational Study	-

Primary Outcome Measures

Name	Time	Method
sensitivity and specificity of device	3 months

Trial Locations

Locations (3)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States