Multicenter Evaluation of the BIOFIRE Blood Culture Identification 2 Panel for Detection of Bacteria, Yeasts, and Antimicrobial Resistance Genes in Positive Blood Culture Samples.

Diagnostic tools that can rapidly identify and characterize microbes growing in blood cultures are important components of clinical microbiology practice because they help to provide timely information that can be used to optimize patient management. This publication describes the bioMérieux BIOFIRE Blood Culture Identification 2 (BCID2) Panel clinical study that was submitted to the U.S. Food & Drug Administration. Results obtained with the BIOFIRE BCID2 Panel were compared to standard-of-care (SoC) results, sequencing results, PCR results, and reference laboratory antimicrobial susceptibility testing results to evaluate the accuracy of its performance. Results for 1,093 retrospectively and prospectively collected positive blood culture samples were initially enrolled, and 1,074 samples met the study criteria and were included in the final analyses. The BIOFIRE BCID2 Panel demonstrated an overall sensitivity of 98.9% (1,712/1,731) and an overall specificity of 99.6% (33,592/33,711) for Gram-positive bacteria, Gram-negative bacteria and yeast targets which the panel is designed to detect. One hundred eighteen off-panel organisms, which the BIOFIRE BCID2 Panel is not designed to detect, were identified by SoC in 10.6% (114/1,074) of samples. The BIOFIRE BCID2 Panel also demonstrated an overall positive percent agreement (PPA) of 97.9% (325/332) and an overall negative percent agreement (NPA) of 99.9% (2,465/2,767) for antimicrobial resistance determinants which the panel is designed to detect. The presence or absence of resistance markers in

Déclaration de conflit d'intérêts

The authors declare a conflict of interest. This info is included in the body of the manuscript: Authors received research funds paid to their institutions from BIOFIRE Diagnostics, LLC, which is now known as bioMérieux, Inc. K.H., B.K., and D.Y.L. are employed by the study sponsor. D.D.R. was employed by University Hospitals Cleveland Medical Center during this study. D.D.R. has received research support from Altona, BD, bioMérieux, Bio-Rad, Cepheid, Cleveland Diagnostics, Luminex, HelixBind, Hologic, Qiagen, Q-Linea, Specific Diagnostics, Thermo Fisher, and Vela; and D.D.R. has or has had advisory relationships with Luminex, Next Gen Diagnostics, Renascent Diagnostics, Roche, and Seegene. A.L. has received research funding from BIOFIRE, Cepheid, and Luminex. J.-M.B.-L. has served as a consultant for bioMérieux and also participated in other BIOFIRE clinical studies. A.H. has received industry sponsored grant funding from bioMérieux (BIOFIRE), and Beckman Coulter, and she has consulted for Bio-Rad. G.J.B. has given educational seminars sponsored by BIOFIRE and has also served on a BIOFIRE advisory panel. R.S. has received honoraria from bioMérieux for speaking engagements.