Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

Completed

Conditions studied: Evaluation of Test Panel

In brief

This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.

Key facts

Study ID

NCT02547636

Run by

BioFire Diagnostics, LLC

People needed

1822

Starts

2015-12-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Whole blood (prospectively collected via informed consent):
• Adult subject has a recorded or self-reported fever within the previous 24 hours
• Subject provides informed consent prior to enrollment and specimen collection
• Subject has not previously provided a whole blood specimen for this study
• Whole blood (residual)
• Whole blood (in EDTA) submitted to laboratory for standard of care testing
• Specimen is not from an individual with a specimen previously enrolled in the study
• Positive Blood Culture:
• Culture was detected as positive by an automated blood culture system
• Culture is not from a patient previously enrolled in the study
• Negative Blood Culture:
• Culture not detected as positive by an automated blood culture system
• Culture is not from a patient previously enrolled in the study
• Sputum:
• Specimen was accepted for testing by the respective site's microbiology laboratory
• Specimen is not from an individual that has a sputum already enrolled in the study

Where it is running

• Navy Medical Center San Diego/Naval Health Research Center — San Diego, California, United States
• Tripler Army Medical Center — Honolulu, Hawaii, United States
• Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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