Meningitis/Encephalitis (ME) Panel

The following organisms are identified using the BioFire ME Panel:
 

Bacteria	Viruses	Yeast
• Escherichia coli K1 • Haemophilus influenzae • Listeria monocytogenes • Neisseria meningitidis (encapsulated) • Streptococcus agalactiae • Streptococcus pneumoniae	• Cytomegalovirus (CMV) • Enterovirus (EV) • Herpes simplex virus 1 (HSV1) • Herpes simplex virus 2 (HSV2) • Human herpesvirus 6 (HHV6) • Human parechovirus (HPeV) • Varicella zoster virus (VZV)	• Cryptococcus neoformans/gattii

BFME

Cerebrospinal Fluid (CSF) 
 

0.2 mL

None

Specimen should not be centrifuged after collection.

Sterile Transport container

Room Temperature

Room Teperature: 24 hours (15 - 25 C)
Refrigerated: 7 days (2-8 C)
Frozen: Not acceptable

• CSF collected from CSF shunts
• Specimens in transport medium
• Specimens past stability requirement
• Centrifuged specimes
• Specimens other than CSF
• Leaking specimen

Daily

Daily

• False negative results may occur when the concentration of organism(s) in the specimen is below the device limit of detection.
• Due to the small number of positive prospective and retrospective specimens for certain organisms, performance characteristics for Escherichia coli, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Cytomegalovirus, and Human parechovirus were established primarily using contrived clinical specimens.
• Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for HSV-1, HSV-2, Human parechovirus, Varicella, HHV-6, and C. neoformans/gattii were established with retrospective clinical specimens.
• This test is a qualitative test and does not provide a quantitative value for the organism(s) in the specimen.
• Results from this test must be correlated with clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
• The performance of this test has not been established for CSF specimens from patients without signs and/or symptoms of meningitis and/or encephalitis.
• The performance of this test has not been specifically evaluated for CSF specimens from immunocompromised individuals.
• The effect of antibiotic treatment on test performance has not been evaluated.
• The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.
• This test in not intended for use with CSF collected from indwelling medical devices (e.g., CSF shunts).
• CSF specimens should not be centrifuged prior to testing.
• The effect of interfering substances has only been evaluated for those listed in the labeling. Interference by substances other than those described in the Interference section of the Instruction Booklet could lead to erroneous results.
• A negative FilmArray ME Panel result does not exclude the possibility of CNS infection and should not be used as the sole basis for diagnosis, treatment, or other management decisions. There is a risk of false negative values due to the presence of sequence variants or rearrangements in the gene targets of the assay, procedural errors, inhibitors in specimens, technical error, sample mix-up, or infections caused by an organisms not detected by the FilmArray ME Panel. Test results may also be affected by concurrent antimicrobial therapy or levels of organism in the sample that are below the limit of detection.
• The detection of organism nucleic acid is dependent upon proper sample collection, transportation, storage, and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. There is a risk of false positive and false negative results caused by improperly collected, transported, or handled specimens. The RNA process control and the PCR2 control will not indicate whether or not nucleic acid has been lost due to inadequate collection, transport, or storage of specimens.
• Positive and negative predictive values are highly dependent on prevalence. False positive results are more likely for low prevalence analytes.
• Viral, bacteria, and yeast nucleic acid may persist in vivo independently of organism viability. Detection of organism targets does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms.
• HHV-6 or CMV can exist in latent form that is reactivated during infection due to other pathogens, including agents not detected by the FilmArray ME Panel that may cause meningitis/encephalitis (e.g., Mycobacterium tuberculosis or HIV). When detected by the FilmArray ME, HHV-6 or CMV should be considered as the likely cause of meningitis/encephalitis only in appropriate clinical settings and following expert consultation.
• Viral shedding into the CSF often occurs in cases of zoster (shingles; caused by reactivation of VZV). VZV may not be the cause of CNS disease in these cases.
• Organism and amplicon contamination may produce erroneous results for this test. Particular attention should be given to the laboratory precautions noted under the preventing organism and amplicon contamination sections.
• Some organisms detected by the FilmArray ME Panel, such as S. pneumoniae and H. influenzae can be shed from the respiratory tract of healthy individual. HSV-1 may also be shed from individuals with active or recurrent cold sores. Particular attention should be given to the laboratory precautions noted under the preventing organism and amplicon contamination sections. Caution should also be exercised during specimen collection and testing to prevent contamination leading to false positives.
• If two or more organisms are detected in a specimen, retesting is recommended to confirm the polymicrobial result.
• Cross-reactivity with organisms in addition to those listed in the Analytical Specificity section of the Instruction Booklet may lead to erroneous results. Cross-reactivity with human rhinoviruses may occur, but rhinoviruses are rarely present in CSF and are not a recognized cause of meningitis. Caution should be exercised during specimen collection and testing to prevent contamination with rhinovirus associated with respiratory infections.
• Only E. coli strains possessing the K1 capsular antigen will be detected. All other E. coli strains/serotypes will not be detected.
• Only encapsulated strains of N. meningitidis will be detected. Unencapsulated N. meningitidis will not be detected.

Not Detected

Central nervous system (CNS) infections are responsible for causing inflammatory conditions of the brain and/or meningeal tissues surrounding the brain (i.e., meningitis, encephalitis, meningoencephalitis; here collectively termed ME). Approximately 15% of cases are fatal and many other cases result in life-long disabilities such as loss of limbs, visual and hearing deficits, seizures, and altered learning and memory. The FilmArray ME panel conducts tests for the identification of 14 potential CNS pathogens from CSF. The specimen can be tested using the FilmArray ME Panel with results available within about one hour.