BIOFIRE BCID2 Panel Achieves 98.9% Sensitivity for Pathogen Identification from Positive Blood Cultures
A multicenter FDA clinical study of the BIOFIRE Blood Culture Identification 2 Panel demonstrated 98.9% sensitivity and 99.6% specificity across 1,074 positive blood culture samples for bacteria and yeast targets. Antimicrobial resistance marker detection showed 97.9% positive percent agreement, with resistance markers in Enterobacterales closely correlating with phenotypic susceptibility results. The panel enables rapid identification of pathogens and key resistance determinants.
The original study
Multicenter Evaluation of the BIOFIRE Blood Culture Identification 2 Panel for Detection of Bacteria, Yeasts, and Antimicrobial Resistance Genes in Positive Blood Culture Samples.
- Authors
- Rhoads DD, Pournaras S, Leber A, Balada-Llasat JM, Harrington A, Sambri V, et al.
- Journal
- Journal of clinical microbiology
- Type
- Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't
- PMID
- 37227281
Original abstract
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 Enterobacterales correlated closely with phenotypic susceptibility and resistance. We conclude that the BIOFIRE BCID2 Panel produced accurate results in this clinical trial.