Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

Completed

• Conditions: Evaluation of Test Panel
• Interventions: Other: Observational study

• Registration Number: NCT02547636
• Lead Sponsor: BioFire Diagnostics, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Study Start: 2015-12
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1822

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects/specimens that meet the inclusion criteria	Observational study	Subjects/specimens that meet the inclusion criteria

Primary Outcome Measures

Name	Time	Method
Clinical specificity of the FilmArray NGDS Warrior Panel	8 months

Trial Locations

Locations (6)

Tripler Army Medical Center; 🇺🇸 Honolulu, Hawaii, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

Navy Medical Center San Diego/Naval Health Research Center; 🇺🇸 San Diego, California, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Washington University/Barnes Jewish Hospital; 🇺🇸 St. Louis, Missouri, United States