title: Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for 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 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.
authors.affiliation: Nationwide Children's Hospital, Columbus, Ohio, USA amy.leber@nationwidechildrens.org.
authors.forename: Amy L
authors.initials: AL
authors.lastname: Leber
authors.affiliation: Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Kathy
authors.initials: K
authors.lastname: Everhart
authors.affiliation: The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
authors.forename: Joan-Miquel
authors.initials: JM
authors.lastname: Balada-Llasat
authors.affiliation: The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
authors.forename: Jillian
authors.initials: J
authors.lastname: Cullison
authors.affiliation: Primary Children's Medical Center, Salt Lake City, Utah, USA.
authors.forename: Judy
authors.initials: J
authors.lastname: Daly
authors.affiliation: Primary Children's Medical Center, Salt Lake City, Utah, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Holt
authors.affiliation: Detroit Medical Center, Detroit, Michigan, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Lephart
authors.affiliation: Detroit Medical Center, Detroit, Michigan, USA.
authors.forename: Hossein
authors.initials: H
authors.lastname: Salimnia
authors.affiliation: Loyola University Medical Center, Maywood, Illinois, USA.
authors.forename: Paul C
authors.initials: PC
authors.lastname: Schreckenberger
authors.affiliation: Loyola University Medical Center, Maywood, Illinois, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: DesJarlais
authors.affiliation: University of California San Diego School of Medicine, San Diego, California, USA.
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Reed
authors.affiliation: Rhode Island Hospital, Providence, Rhode Island, USA.
authors.forename: Kimberle C
authors.initials: KC
authors.lastname: Chapin
authors.affiliation: Rhode Island Hospital, Providence, Rhode Island, USA.
authors.forename: Lindsay
authors.initials: L
authors.lastname: LeBlanc
authors.affiliation: University of Maryland School of Medicine, Baltimore, Maryland, USA.
authors.forename: J Kristie
authors.initials: JK
authors.lastname: Johnson
authors.affiliation: University of Maryland School of Medicine, Baltimore, Maryland, USA.
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Soliven
authors.affiliation: The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Karen C
authors.initials: KC
authors.lastname: Carroll
authors.affiliation: The Johns Hopkins Hospital, Baltimore, Maryland, USA.
authors.forename: Jo-Anne
authors.initials: JA
authors.lastname: Miller
authors.affiliation: Children's Hospital Los Angeles, Los Angeles, California, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Dien Bard
authors.affiliation: Children's Hospital Los Angeles, Los Angeles, California, USA.
authors.forename: Javier
authors.initials: J
authors.lastname: Mestas
authors.affiliation: Diagnostic Laboratory Services (The Queen's Medical Center), Aiea, Hawaii, USA John A. Burns School of Medicine, Honolulu, Hawaii, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Bankowski
authors.affiliation: Diagnostic Laboratory Services (The Queen's Medical Center), Aiea, Hawaii, USA.
authors.forename: Tori
authors.initials: T
authors.lastname: Enomoto
authors.affiliation: BioFire Diagnostics, LLC, Salt Lake City, Utah, USA.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Hemmert
authors.affiliation: BioFire Diagnostics, LLC, Salt Lake City, Utah, USA.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Bourzac
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001419:Bacteria / Q000145:classification / Q000302:isolation & purification; D001424:Bacterial Infections / Q000175:diagnosis / Q000382:microbiology; D020314:Central Nervous System Fungal Infections / Q000175:diagnosis / Q000382:microbiology; D002555:Cerebrospinal Fluid / Q000382:microbiology* / Q000821:virology*; D002648:Child; D002675:Child, Preschool; D004660:Encephalitis / Q000175:diagnosis* / Q000209:etiology; D005260:Female; D005658:Fungi / Q000145:classification / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008581:Meningitis / Q000175:diagnosis* / Q000209:etiology; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013997:Time Factors; D014777:Virus Diseases / Q000175:diagnosis / Q000821:virology; D014780:Viruses / Q000145:classification / Q000302:isolation & purification; D055815:Young Adult