300 - Pediatric Center Evaluation of the BioFire^® Blood Culture Identification 2 Panel Versus the Original BioFire^®FilmArray^® Blood Culture Identification Panel for the Detection of Microorganisms and Resistance Markers in Positive Blood Cultures

Background: Studies show a rising annual incidence of severe sepsis, with bloodstream infections continuing to impact children. Rapid identification of causative agents and timely administration of targeted therapy can positively impact patient outcomes and improve antibiotic stewardship. 
 
The BioFire^® Blood Culture Identification 2 (BCID2) Panel (BioFire Diagnostics, LLC), an updated version of the FDA-cleared BioFire^® FilmArray^® Blood Culture Identification (BCID) Panel, designed for use on positive blood cultures (PBCs), assesses 43 analytes, including 17 novel analytes (8 bacterial, 2 fungal, and 7 antimicrobial resistance genes), with a similar turnaround time.
 

Methods: De-identified residual PBCs for which clinician-ordered testing per standard of care (SoC) had been performed were enrolled and tested with an Investigation-Use-Only version of the BCID2 Panel. Only one positive bottle per patient was enrolled.  Results of  BCID2 and BCID were compared.

Results: 116 PBCs (48 aerobic and 68 anaerobic) were evaluated using the BioFire BCID2 Panel and results were compared to the BioFire BCID Panel.  Of the 116 cases, 103 were positive on both the BioFire BCID2 Panel and the BioFire BCID Panel.  Ten cases were negative on both tests.  While the two panels showed 97% agreement, three cases were discrepant. Using culture (SoC) as the tiebreaker, two cases were false positive and one case was false negative on the BioFire BCID Panel. In all three cases, results from culture and the BioFire BCID2 Panel were in agreement.  As expected, no organisms were detected on the BioFire BCID2 Panel in PBCs from 10% (12/116) of PBC bottles where culture identified only organisms that are not part of the panel menu.  With the BioFire BCID2 Panel’s expanded platform, two cases identified as Enterobacteriaceae on the BioFire BCID Panel were identified to the genus level on the BioFire BCID2 Panel; 31 cases detected to the genus level on the BioFire BCID Panel were identified to the species level on the BioFire BCID2 Panel.
 

Conclusion: Overall, the BioFire BCID2 Panel performed well against the BioFire BCID Panel for identification of bloodstream pathogens and provided additional discrimination of some pathogens to the genus or species level.
 
Data presented are from assays that have not been cleared or approved for diagnostic use.