PMID- 37227281
OWN - NLM
STAT- MEDLINE
DCOM- 20230622
LR  - 20230701
IS  - 1098-660X (Electronic)
IS  - 0095-1137 (Print)
IS  - 0095-1137 (Linking)
VI  - 61
IP  - 6
DP  - 2023 Jun 20
TI  - Multicenter Evaluation of the BIOFIRE Blood Culture Identification 2 Panel for 
      Detection of Bacteria, Yeasts, and Antimicrobial Resistance Genes in Positive 
      Blood Culture Samples.
PG  - e0189122
LID - 10.1128/jcm.01891-22 [doi]
LID - e01891-22
AB  - 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 bioMerieux 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.
FAU - Rhoads, Daniel D
AU  - Rhoads DD
AUID- ORCID: 0000-0002-7636-5191
AD  - Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, 
      Cleveland, Ohio, USA.
AD  - Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
AD  - Infection Biology Program, Lerner Research Institute, Cleveland Clinic, 
      Cleveland, Ohio, USA.
FAU - Pournaras, Spyros
AU  - Pournaras S
AD  - Laboratory of Clinical Microbiology, Attikon University Hospital, School of 
      Medicine, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Leber, Amy
AU  - Leber A
AUID- ORCID: 0000-0002-3075-3586
AD  - Nationwide Children's Hospital, Columbus, Ohio, USA.
FAU - Balada-Llasat, Joan-Miquel
AU  - Balada-Llasat JM
AD  - The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
FAU - Harrington, Amanda
AU  - Harrington A
AD  - Loyola University Medical Center, Maywood, Illinois, USA.
FAU - Sambri, Vittorio
AU  - Sambri V
AD  - The Greater Romagna Area Hub Laboratory, Cesena, Italy.
AD  - DIMES, University of Bologna, Bologna, Italy.
FAU - She, Rosemary
AU  - She R
AD  - Keck School of Medicine of University of Southern California, Los Angeles, 
      California, USA.
FAU - Berry, Gregory J
AU  - Berry GJ
AUID- ORCID: 0000-0002-0767-6826
AD  - Northwell Health Laboratories, Lake Success, New York, USA.
FAU - Daly, Judy
AU  - Daly J
AD  - Primary Children's Hospital, Salt Lake City, Utah, USA.
FAU - Good, Caryn
AU  - Good C
AD  - University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
FAU - Tarpatzi, Aikaterini
AU  - Tarpatzi A
AD  - Laboratory of Clinical Microbiology, Attikon University Hospital, School of 
      Medicine, National and Kapodistrian University of Athens, Athens, Greece.
FAU - Everhart, Kathy
AU  - Everhart K
AD  - Nationwide Children's Hospital, Columbus, Ohio, USA.
FAU - Henry, Tai
AU  - Henry T
AD  - The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
FAU - McKinley, Kathleen
AU  - McKinley K
AD  - Loyola University Medical Center, Maywood, Illinois, USA.
FAU - Zannoli, Silvia
AU  - Zannoli S
AD  - The Greater Romagna Area Hub Laboratory, Cesena, Italy.
FAU - Pak, Pil
AU  - Pak P
AD  - Keck School of Medicine of University of Southern California, Los Angeles, 
      California, USA.
FAU - Zhang, Fan
AU  - Zhang F
AD  - Northwell Health Laboratories, Lake Success, New York, USA.
FAU - Barr, Rebecca
AU  - Barr R
AD  - Primary Children's Hospital, Salt Lake City, Utah, USA.
FAU - Holmberg, Kristen
AU  - Holmberg K
AD  - bioMerieux, Inc., Salt Lake City, Utah, USA.
FAU - Kensinger, Bart
AU  - Kensinger B
AD  - bioMerieux, Inc., Salt Lake City, Utah, USA.
FAU - Lu, Daisy Y
AU  - Lu DY
AD  - bioMerieux, Inc., Salt Lake City, Utah, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230525
PL  - United States
TA  - J Clin Microbiol
JT  - Journal of clinical microbiology
JID - 7505564
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Anti-Infective Agents)
SB  - IM
MH  - Humans
MH  - Blood Culture
MH  - *Bacteremia/microbiology
MH  - Anti-Bacterial Agents
MH  - Retrospective Studies
MH  - Drug Resistance, Bacterial
MH  - Bacteria/genetics
MH  - Yeasts/genetics
MH  - *Anti-Infective Agents
PMC - PMC10281132
OTO - NOTNLM
OT  - BCID2
OT  - PCR
OT  - antimicrobial resistance
OT  - bacteremia
OT  - blood culture
OT  - rapid diagnostics
OT  - sepsis
COIS- 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 bioMerieux, 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, bioMerieux, 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 bioMerieux and also participated in other BIOFIRE 
      clinical studies. A.H. has received industry sponsored grant funding from 
      bioMerieux (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 bioMerieux for 
      speaking engagements.
EDAT- 2023/05/25 13:06
MHDA- 2023/06/22 06:42
PMCR- 2023/05/25
CRDT- 2023/05/25 10:04
PHST- 2023/06/22 06:42 [medline]
PHST- 2023/05/25 13:06 [pubmed]
PHST- 2023/05/25 10:04 [entrez]
PHST- 2023/05/25 00:00 [pmc-release]
AID - 01891-22 [pii]
AID - jcm.01891-22 [pii]
AID - 10.1128/jcm.01891-22 [doi]
PST - ppublish
SO  - J Clin Microbiol. 2023 Jun 20;61(6):e0189122. doi: 10.1128/jcm.01891-22. Epub 
      2023 May 25.