2084. Prospective, Multi-Center Analysis of a BioFire(®) FilmArray(®) Childhood Systemic Infection (CSI) Panel for Detection of Viral Bloodstream Infections in a Pediatric Emergency Department Setting

BACKGROUND: Early determination of viral etiology among febrile children with suspicion of systemic infection by use of rapid molecular assay could impact patient care. BioFire(®) FilmArray(®) Childhood Systemic Infection (CSI) Panel is a non-FDA cleared research use only sample-to-answer PCR-based assay that includes identification of seven viruses from 200 µl of whole blood collected from children suspected of systemic infection. The aim of this prospective multicenter study was to determine the viral diagnostic yield and potential impact of CSI panel on management of pediatric sepsis. METHODS: Children <18 years with suspected systemic infections were prospectively enrolled in emergency rooms at seven healthcare facilities. Febrile children with a clinician order of blood culture for sepsis evaluation were enrolled and additional blood was collected with the standard of care (SOC) blood culture. Blood samples were tested by the CSI Panel on the FilmArray platform. Demographic and laboratory test results from SOC blood, urine and cerebrospinal fluid (CSF) cultures were recorded. RESULTS: Among 1,022 children enrolled, data for 1,002 was complete. The CSI Panel testing of whole blood detected 203 (20%) viral infections including 14 (7%) with dual/multiple viruses. The median age of children with viral detections (20 months) was significantly lower than children without viral detections (54 months) (P < 0.01).The viruses detected were enterovirus (54%), adenovirus (22%), cytomegalovirus (15%), parvovirus B19 (15%) and parechovirus (3%). Herpes simplex virus 1 and 2 were not detected. Among 203 positive and 799 negative viral detections with the CSI Panel, blood culture was positive in 2 (1%) and 24 (3%) children respectively (P = 0.14). All CSF bacterial cultures ordered were negative. Urine culture was positive in 7/83 (8.4%) and 31/266 (11.7%) viral positive and negative children respectively (P = 0.55). CONCLUSION: The CSI Panel detected virus in blood from 20% of febrile children suspected of systemic infection. Concurrent bacterial infection of blood and urine was lower in children that were viral positive vs. negative. Prompt determination of viral etiology using the CSI Panel has the potential to optimize care of children with suspected systemic infection. DISCLOSURES: N. Kanwar, Biofire Diagnostics: Collaborator, Research grant. J. Dien Bard, BioFire Diagnostics: Research Contractor, Research support. A. Leber, Nationwide Children’s Hospital: Research Contractor, Research support. J. Dunn, BioFire: Investigator, Research support. K. C. Chapin, Biofire: Research Contractor, Research support. C. A. Rostad, Biofire Diagnostics: Collaborator, Research support. A. J. Blaschke, BIoFire Diagnostics, LLC: I have intellectual property licensed to BioFire through the University of Utah, Independent Contractor and Investigator, Consulting fee, Licensing agreement or royalty and Research support. M. Jones, BioFire Dx: Employee, Salary. E. Ott, BioFire Diagnostics: Employee, Salary. J. Bastar, BioFire Diagnostics, LLC.: Employee, Salary. R. Selvarangan, BioFire Diagnostics: Investigator and Scientific Advisor, Consulting fee, Research support and Speaker honorarium.