Specimen Requirements

Minimum Specimen Requirements

Stability

Days Performed

7 days a week

Turnaround Time

8 hours

Methodology

Reference Range

Clinical Info

The Biofire FilmArray Meningitis/Encephalitis (ME) Panel is an FDA-approved qualitative multiplexed nucleic acid-based in vitro diagnostic test capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from CSF specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. The following organisms are included on the panel: E. coli (K1 strains only), Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis (encapsulated strains only), Streptococcus agalactiae (group B Streptococcus), Streptococcus pneumoniae, cytomegalovirus (CMV), human herpesvirus 6 (HHV-6), human parechoviruses (HPeV), varicella zoster virus (VZV), enteroviruses (EV), herpes simplex viruses 1 and 2 (HSV-1, HSV-2), and Cryptococcus neoformans/gattii. The assay is designed to target the most common causes of community-onset meningitis/encephalitis, and has the highest yield when use is restricted to patients with CSF pleocytosis. Severely immunocompromised patients and neonates may also benefit from testing in the absence of pleocytosis. This panel does not cover the most common pathogens in post-surgical or shunt infection, and should not be used in these settings. This assay should always be accompanied by cultures when bacterial meningitis is suspected. If there is suspicion of cryptococcal meningitis, antigen (CrAg) testing should be ordered separately due to its superior sensitivity. See clinical limitations section for additional assay limitations.

Clinical Limitation

For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. This test is not intended for use with CSF collected from indwelling medical devices (e.g., CSF shunts). Only E. coli strains possessing the K1 capsular antigen will be detected by the BIOFIRE ME Panel. All other E. coli strains/serotypes will not be detected. Only encapsulated strains of N. meningitidis will be detected by the BIOFIRE ME Panel. Unencapsulated N. meningitidis will not be detected. Patients with a suspicion of cryptococcal meningitis and a negative cryptococcal PCR result, such as by the BIOFIRE ME Panel, should be tested for cryptococcal antigen (CrAg). Viral shedding into the CSF often occurs in cases of zoster (shingles; caused by reactivation of VZV). Detection of VZV in CSF may not indicate the cause of CNS disease in these cases. Herpesviruses (CMV, HHV-6, HSV-1, HSV-2, and VZV) can exist in latent forms that may be reactivated during infection by other pathogens, including agents not detected by the BIOFIRE ME Panel that may cause meningitis/encephalitis (e.g., Mycobacterium tuberculosis or HIV). HHV-6 can be chromosomally integrated into somatic cells (ciHHV-6) and into the germ cell line (iciHHV-6) allowing for persistent and sporadic reactivation in confirmed carriers or someone related to a confirmed carrier. When detected by the BIOFIRE ME Panel, herpesvirus results should be considered as the likely cause of meningitis/encephalitis only in appropriate clinical context and following expert consultation. In meta-analyses, this panel has been shown to be less analytically sensitive than targeted HSV-1/2 PCR testing. Standalone HSV-1/2 PCR testing should be considered for patients with a high pre-test probability of HSV encephalitis even if this panel is negative. As with any nucleic acid amplification test, positive results do not rule out coinfection with other organisms, detected organisms may not be the definite cause of disease, and negative results do not rule out infection. Some patients may experience financial toxicity with this expanded multiplex panel, as it is variably reimbursed by insurance.

Clinical Reference

1. Leber AL, Everhart K, Balada-Llasat JM, Cullison J, Daly J, Holt S, Lephart P, Salimnia H, Schreckenberger PC, DesJarlais S, Reed SL, Chapin KC, LeBlanc L, Johnson JK, Soliven NL, Carroll KC, Miller JA, Dien Bard J, Mestas J, Bankowski M, Enomoto T, Hemmert AC, Bourzac KM. Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens. J Clin Microbiol. 2016 Sep;54(9):2251-61. doi: 10.1128/JCM.00730-16. Epub 2016 Jun 22. PMID: 27335149. 2. Trujillo-Gómez J, Tsokani S, Arango-Ferreira C, Atehortúa-Muñoz S, Jimenez-Villegas MJ, Serrano-Tabares C, Veroniki AA, Florez ID. Biofire FilmArray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections: A systematic review and diagnostic test accuracy meta-analysis. EClinicalMedicine. 2022 Feb 14;44:101275. doi: 10.1016/j.eclinm.2022.101275. PMID: 35198914. 3. Broadhurst MJ, Dujari S, Budvytiene I, Pinsky BA, Gold CA, Banaei N. Utilization, Yield, and Accuracy of the FilmArray Meningitis/Encephalitis Panel with Diagnostic Stewardship and Testing Algorithm. J Clin Microbiol. 2020 Aug 24;58(9):e00311-20. doi: 10.1128/JCM.00311-20. PMID: 32493787. 4. U.S. Food and Drug Administration (FDA). Evaluation of Automatic Class III Designation for FilmArray Meningitis/Encephalitis (ME) Panel DEN150013. Accessed Aug 8, 2025. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150013.pdf.