NCT03361670

Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT03361670

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel

Summary

This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively collect and test residual Bronchoalveolar lavage (BAL) and sputum specimens and generate performance data to support regulatory classification of the FilmArray LRTI as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.

Eligibility

Inclusion Criteria:

* Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted under clinician order for standard care LRT testing
* Specimen has not been centrifuged
* Specimen has not been pre-treated
* Specimen has at least 1.5 mL of residual volume
* Specimen was collected from a subject not already enrolled in the study
* Specimen is fresh (stored at \~4°C, not frozen) and was enrolled with 24 hours of collection

Exclusion Criteria:

* Specimen was centrifuged, pre-treated, or is less than 1.5mL
* Specimen was collected from a subject known to have cystic fibrosis
* Specimen was collected from a subject known to have tuberculosis
* Specimen was collected from a subject that was previously enrolled in the study
* Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours.

Disease(s) and\or Condition(s)

Lower 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