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Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

NCT03012217 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1612

Last updated 2017-01-12

No results posted yet for this study

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.

Conditions

  • Upper Resp Tract Infection

Interventions

OTHER

Observational Study

Sponsors & Collaborators

  • BioFire Diagnostics, LLC

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012217 on ClinicalTrials.gov