NCT03361670
Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel
COMPLETED
NCT03361670
OBSERVATIONAL
Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel
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.
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.
Lower Resp Tract Infection
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- Type: OTHER
- Name: Observational Study
- Description:
- Arm Group Labels: Specimens that meet inclusion criteria
- BioFire Diagnostics, LLC