NCT03012217

Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT03012217

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

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

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.

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

Disease(s) and\or Condition(s)

Upper Resp Tract Infection

Primary Purpose

Intervention/Treatment

- Type: OTHER
- Name: Observational Study
- Description:
- Arm Group Labels: Specimens that meet inclusion criteria

Sponsor

BioFire Diagnostics, LLC