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J Clin Microbiol. 2016 Sep;54(9):2251-61. doi: 10.1128/JCM.00730-16. Epub 2016 Jun 22.

Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens.

Author information

1
Nationwide Children's Hospital, Columbus, Ohio, USA amy.leber@nationwidechildrens.org.
2
Nationwide Children's Hospital, Columbus, Ohio, USA.
3
The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
4
Primary Children's Medical Center, Salt Lake City, Utah, USA.
5
Detroit Medical Center, Detroit, Michigan, USA.
6
Loyola University Medical Center, Maywood, Illinois, USA.
7
University of California San Diego School of Medicine, San Diego, California, USA.
8
Rhode Island Hospital, Providence, Rhode Island, USA.
9
University of Maryland School of Medicine, Baltimore, Maryland, USA.
10
The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
11
The Johns Hopkins Hospital, Baltimore, Maryland, USA.
12
Children's Hospital Los Angeles, Los Angeles, California, USA.
13
Diagnostic Laboratory Services (The Queen's Medical Center), Aiea, Hawaii, USA John A. Burns School of Medicine, Honolulu, Hawaii, USA.
14
Diagnostic Laboratory Services (The Queen's Medical Center), Aiea, Hawaii, USA.
15
BioFire Diagnostics, LLC, Salt Lake City, Utah, USA.

Abstract

Rapid diagnosis and treatment of infectious meningitis and encephalitis are critical to minimize morbidity and mortality. Comprehensive testing of cerebrospinal fluid (CSF) often includes Gram stain, culture, antigen detection, and molecular methods, paired with chemical and cellular analyses. These methods may lack sensitivity or specificity, can take several days, and require significant volume for complete analysis. The FilmArray Meningitis/Encephalitis (ME) Panel is a multiplexed in vitro diagnostic test for the simultaneous, rapid (∼1-h) detection of 14 pathogens directly from CSF specimens: Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus pneumoniae, Streptococcus agalactiae, cytomegalovirus, enterovirus, herpes simplex virus 1 and 2, human herpesvirus 6, human parechovirus, varicella-zoster virus, and Cryptococcus neoformans/Cryptococcus gattii We describe a multicenter evaluation of 1,560 prospectively collected CSF specimens with performance compared to culture (bacterial analytes) and PCR (all other analytes). The FilmArray ME Panel demonstrated a sensitivity or positive percentage of agreement of 100% for 9 of 14 analytes. Enterovirus and human herpesvirus type 6 had agreements of 95.7% and 85.7%, and L. monocytogenes and N. meningitidis were not observed in the study. For S. agalactiae, there was a single false-positive and false-negative result each, for a sensitivity and specificity of 0 and 99.9%, respectively. The specificity or negative percentage of agreement was 99.2% or greater for all other analytes. The FilmArray ME Panel is a sensitive and specific test to aid in diagnosis of ME. With use of this comprehensive and rapid test, improved patient outcomes and antimicrobial stewardship are anticipated.

PMID:
27335149
PMCID:
PMC5005480
[Available on 2017-03-01]
DOI:
10.1128/JCM.00730-16
[Indexed for MEDLINE]
Free PMC Article

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