Lower Respiratory Tract Infection Clinical Trial
Official title:
Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel BioFire Study #DX-SDY-024947
The purpose of the Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel BioFire Study #DX-SDY-024947 is to collect data in support of the proposal to the FDA to support the classification of the LRTI panel as an in vitro diagnostic device for the diagnosis of lower respiratory tract infections. The study will enroll up to 1500 specimens across at least 3 study sites of sputum and bronchoalveolar lavage (BAL) specimens that are left over as excess from routine clinical care. Additionally, the study will collect residual whole blood or blood fractionation to evaluate the utility of procalcitonin (PCT) as an additional test to diagnose lower respiratory infection when it is available. Enrolled sputum and BAL specimens will be run on the FilmArray LRTI panel. If residual whole blood or blood fractionation is available it will be sent to BioFire Diagnostics, LLC where they will perform PCT testing. All specimens will be excess from routine standard of care testing.
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