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

TLDR

Rapid diagnosis and treatment of infectious meningitis and encephalitis are critical to minimize morbidity and mortality, yet conventional CSF testing—Gram stain, culture, antigen detection, and molecular methods—often lacks sensitivity or specificity, takes days, and requires large volumes. The study evaluates the FilmArray Meningitis/Encephalitis Panel, a multiplexed in‑vitro diagnostic that detects 14 pathogens directly from CSF within ~1 h, across 1,560 prospectively collected specimens. The panel simultaneously detects 14 bacterial, viral, and fungal pathogens from CSF, and its performance was compared to culture for bacterial analytes and PCR for the remaining analytes. The FilmArray ME Panel achieved 100 % sensitivity for 9 of 14 analytes, 95.7 % for enterovirus and 85.7 % for HHV‑6, with overall specificity ≥99.2 % and no false positives for most pathogens, demonstrating high sensitivity and specificity that could improve patient outcomes and antimicrobial stewardship.

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.