Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.

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.

Inclusion Criteria:

• 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.