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

BioFire Defense

Status: Completed

Conditions: Fever

Treatments: Other: Observational study

Study type: Observational

Funder types: Industry; Other U.S. Federal agency; NIH

Identifiers

NCT02968355

SDY-017266

HHSN272201600002C (Other Grant/Funding Number)

W911QY-13-D-0080 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,084 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

2,084 participants in 1 patient group

Subjects/Specimens

Description:

Subjects/Specimens that meet the eligibility criteria

Treatment:

Other: Observational study