Systemic Infection
Conditions
Brief summary
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 CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.
Interventions
OTHERObservational Study
Exclusion from the study
Sponsors
BioFire Diagnostics, LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture * Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity) * Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED) * Specimen is at least 500 µL (1.5 mL collection desired)
Exclusion criteria
* Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity) * Physician determines that participation in the study is an unacceptable health risk * Minimum volume requirement is not met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays) | 12 months |
Countries
United States
Outcome results
None listed