Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel

BioFire Diagnostics

Status: Completed

Conditions: Acute Fever

Study type: Observational

Funder types: Industry

Identifiers

NCT02477683

BFDxFIPilot

Details and patient eligibility

About

The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.

Enrollment: 1,514 patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• under age of 3
• has fever with no obvious focal infection
• written informed parental permission

Exclusion criteria

• parent/legal guardian unable to provide permission
• participation determined by a physician to be detrimental to patient health