Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

Upper Resp Tract Infection Clinical Trial

— RP2  

Official title:

Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 (RP2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012217
• Other study ID #: DX-SDY-026541
• Status: Completed
• Phase: N/A
• First received: January 3, 2017
• Last updated: January 10, 2017
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: BioFire Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1612
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Resp Tract Infection

Intervention

Other:
• Observational Study

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Loyola University Medical Center	Maywood	Illinois
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and specificity of device		3 months	No