Special Precautions/Comments:

N.B. Must be received in lab as soon as possible after collection. WBCs & RBCs may lyse after 2 hrs.

QEH: Do not send through tube system, must be hand delivered to pathology.

SRH & STDH: Please contact the laboratory to arrange transport if necessary.

The FilmArray Meningitis/Encephalitis (ME) Panel is used to detect the following:

• Escherichia coli K1
• Haemophilus influenzae
• Listeria monocytogenes
• Neisseria meningitidis (encapsulated)
• Streptococcus agalactiae
• Streptococcus pneumoniae
• Cytomegalovirus (CMV)
• Enterovirus
• Herpes Simplex Virus 1 (HSV-1)
• Herpes Simplex Virus 2 (HSV-2)
• Human herpesvirus 6 (HHV-6)
• Human parechovirus
• Varicella Zoster Virus (VZV)
• Cryptococcus neoformans/gattii

Interferences:  Due to the potential for interference from protein and the potential for specimen damage from bleach, care should be taken in the interpretation of negative FilmArray ME Panel test results from CSF specimens that may contain unusually high levels of proteins (>15 mg/mL) or specimens that may have been exposed to bleach prior to testing.

Method:  Nested multiplex PCR (nmPCR) and high-resolution melting analysis to detect and identify multiple nucleic acid targets from clinical specimens.  Calibration: BioFire Torch Module self-tests.  EQA scheme: The laboratory has enrolled in EQA schemes for CSF PCR. Performance will be continuously reviewed.  IQC: Internal kit controls (FilmArray)

Interpretation: CSF Meningitis/Encephalitis (ME) Panel PCR test will be performed if the specimen meets the following requirements:

• Non-bloody CSF with a white cell count (WCC) ≥20
• Requested by the Consultant Microbiologist

Heavily blood stained samples (high RBC) with a high WCC may be tested only at the request of the Consultant Microbiologist.

Additional Information:

Background information:  The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.

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.