Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

ClinicalTrials.gov ID: NCT03012217

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03012217
Recruitment status: Completed
Study type: Observational
Phase: Not listed
Lead sponsor: BioFire Diagnostics, LLC; Industry
Enrollment: 1,612 participants

Conditions and interventions

Conditions

Upper Resp Tract Infection

Interventions

Observational Study Other

Other

Eligibility (public fields only)

Age range: Not listed
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2016 (Type not available)
Primary completion: Dec 2016 (Actual)
Completion: Dec 2016 (Actual)
Last update posted: Jan 12, 2017

2016

United States locations

U.S. sites: 3
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
Loyola University Medical Center	Maywood	Illinois	60153	—
Nationwide Children's Hospital	Columbus	Ohio	43205	—
Primary Children's Hospital	Salt Lake City	Utah	84108	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03012217, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 12, 2017 · Synced Nov 14, 2026