Multicenter Evaluation of the BioFire FilmArray Meningitis Encephalitis Panel for the Detection of Bacteria, Viruses and Yeast in Cerebrospinal Fluid Specimens Journal Article

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Authors: Leber, A. L.; Everhart, K; Balada-Llasat, J. M.; Cullison, J.; Daly, J.; Holt, S.; Lephart, P.; Salimnia, H.; Schreckenberger, P. C.; DesJarlais, S.; Reed, S. L.; Chapin, K. C.; LeBlanc, L.; Johnson, J. K.; Soliven, N. L.; Carroll, K.; Miller, J. A.; Dien Bard, J; Mestas, J.; Bankowski, M.; Enomoto, T.; Hemmert, A. C.; Bourzac, K.
Article Title: Multicenter Evaluation of the BioFire FilmArray Meningitis Encephalitis Panel for the Detection of Bacteria, Viruses and Yeast in Cerebrospinal Fluid Specimens
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 analysis. 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 ( approximately 1 hour) detection of 14 pathogens directly from CSF specimens: Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus pneumoniae, S. agalactiae, cytomegalovirus, enterovirus, herpes simplex virus types 1 and 2, human herpesvirus type 6, human parechovirus, varicella zoster virus, and Cryptococcus neoformans/gattii We describe a multicenter evaluation of 1560 prospectively collected CSF specimens with performance compared to culture (bacterial analytes) and PCR (all other analytes). The FilmArray ME Panel demonstrated a sensitivity/Positive Percent Agreement of 100% for 9 of 14 analytes. Enterovirus and human herpesvirus type 6 had agreement 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 for a sensitivity and specificity of 0 and 99.9% respectively. The specificity/negative percent 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.
Journal Title: Journal of clinical microbiology
ISSN: 1098-660X; 0095-1137
Publisher: American Society for Microbiology. All Rights Reserved  
Date Published: 2016
Language: ENG
DOI/URL:

JCM.00730-16
Notes: LR: 20160623; CI: Copyright (c) 2016; JID: 7505564; aheadofprint