Clinical trial NCT03012217: Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2
Official title: Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 (RP2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Resp Tract Infection
Lead sponsor: BioFire Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2017-01-06
Enrollment: 1612
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only residual NPS specimens from patients with clinician-ordered respiratory pathogen testing will be enrolled.

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.

Eligibility criteria: 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

Primary outcomes:
measure: sensitivity and specificity of device
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
References: