Trials / Completed
CompletedNCT02968355
Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,084 (actual)
- Sponsor
- BioFire Defense LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational study | Observational study |
Timeline
- Start date
- 2018-03-26
- Primary completion
- 2021-03-30
- Completion
- 2021-03-30
- First posted
- 2016-11-18
- Last updated
- 2024-07-05
Locations
11 sites across 10 countries: United States, Cambodia, Georgia, Ghana, Honduras, Kenya, Peru, Tanzania, Thailand, Uganda
Source: ClinicalTrials.gov record NCT02968355. Inclusion in this directory is not an endorsement.