Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
- Conditions
- Fever
- Registration Number
- NCT02968355
- Lead Sponsor
- BioFire Defense LLC
- Brief Summary
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.
- Detailed Description
The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P. ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the sensitivity and specificity of the GF Panel when used to test blood collected from subjects with fever or who have recently had fever. This multi-center study is being conducted at locations around the world.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2084
- Whole blood in EDTA (prospectively collected via informed consent)
- Subject has a recorded or self-reported fever within the past two days.
- Subject has not participated in the study within the last 30 days.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel 18 months Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
George Washington University
🇺🇸Washington, District of Columbia, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Naval Medical Research Unit Two
🇰🇭Phnom Penh, Cambodia
United States Army Medical Research Directorate Georgia
🇬🇪Tbilisi, Georgia
Naval Medical Research Unit Three
🇬🇭Navrongo, Ghana
Universidad Nacional Autonoma de Honduras
🇭🇳Tegucigalpa, Central District, Honduras
United States Army Medical Research Directorate Kenya
🇰🇪Kisumu, Kenya
Naval Medical Research Unit Six
🇵🇪Iquitos, Peru
Kilimanjaro Christian Medical Centre
🇹🇿Moshi, Tanzania
Armed Forces Research Institute of Medical Sciences
🇹🇭Bangkok, Thailand
Scroll for more (1 remaining)George Washington University🇺🇸Washington, District of Columbia, United States