One hour detection of clinically significant pathogens from cerebrospinal fluid using the BioFire FilmArray® Meningitis/Encephalitis Panel (#305)
Objective
Meningitis and encephalitis are life threatening conditions which can have serious consequences if not managed early. This study evaluated the effectiveness of the BioFire FilmArray® Meningitis/Encephalitis (ME) Panel (BioMérieux) to provide simultaneous rapid nucleic acid detection of 14 pathogens in cerebrospinal fluid (CSF), including herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), human herpes virus 6 (HHV-6), varicella-zoster virus (VZV), enterovirus (EV), cytomegalovirus (CMV), human parechovirus (HPeV), Neisseria meningitidis, Streptococcus pneumoniae, Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Streptococcus agalactiae (GBS), and Cryptococcus neoformans/gattii.
Methods
A total of 126 CSF samples were included in this study and tested on the FilmArray® ME Panel according to the manufacturer’s instructions. Specimens also underwent routine bacterial culture, and multiplex polymerase chain reaction (PCR) testing using the AusDiagnostics CSF assay and results compared.
Results
The FilmArray® ME Panel detected at least one positive target in 52% (66/126) of specimens tested. Of the targets comparable to the AusDiagnostics CSF assay (HSV-1, HSV-2, VZV, EV, HPeV, N. meningitidis, S. pneumoniae, H. influenzae, L. monocytogenes, and C. neoformans/gattii), the ME Panel had 98% (124/126) correlation with the reference tests. All targets demonstrated 100% sensitivity and 100% specificity, with the exception of HSV-2 (2 false positive) and C. neoformans/gattii (1 false negative). HHV-6 was detected in 4 specimens and confirmed positive by a reference laboratory.
Conclusion
The BioFire FilmArray® ME Panel is highly sensitive and specific assay that provides results in approximately 1 hour. These results were available approximately 24 hours earlier compared to the routine AusDiagnostics CSF assay. Further evaluation is required for CMV, HHV-6, GBS, and E. coli K1 to assess clinical sensitivity and specificity. The ability to obtain a rapid result may have the potential to allow for early administration of targeted therapy, reducing hospital stay, associated costs and most importantly has the potential to save lives.