Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

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.

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Key information

Conditions

Upper Resp Tract Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Loyola University Medical Center, Maywood, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

Primary outcomes

sensitivity and specificity of device

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

BioFire Diagnostics, LLC

Industry

Registry information

Official study title

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

Acronym: RP2

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jan 6, 2017
Registry last updated: Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed