090-70-1461

Meningitis/Encephalitis (ME) Panel by FilmArray, PCR, CSF

CSF/Sterile Container

CSF 0.5-1 mL (Minimum volume = 0.5 mL)

Sterile Container

1. Specimen is added any preservative solution or transport media
2. Specimen that has been centrifuged Shunt fluid 

Specimen Type	Temperature	Time
CSF	Room temperature	1 day
	Refrigerated, 2oC to 8oC	7 days

090-70-1461

Meningitis/Encephalitis (ME) Panel by FilmArray, PCR, CSF

Test daily

3 hours  
(Specimen received to reported)

Molecular biology & Genetics, Laboratory Department
Tel.14168

7 days

090-70-1461

Meningitis/Encephalitis (ME) Panel by FilmArray, PCR, CSF

Central nervous system (CNS) infections are responsible for causing inflammatory conditions of the brain and/or meningeal tissues surrounding the brain. 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. 

Pathogens	Reference value
Escherichia coli K1	Not detected
Haemophilus influenzae	Not detected
Listeria monocytogenes	Not detected
Neisseria meningitidis	Not detected
Streptococcus agalactiae	Not detected
Streptococcus pneumoniae	Not detected
Cytomegalovirus (CMV)	Not detected
Enterovirus (EV)	Not detected
Herpes simplex virus 1 (HSV-1)	Not detected
Herpes simplex virus 2 (HSV-2)	Not detected
Human herpesvirus 6 (HHV-6)	Not detected
Human parechovirus (HPeV)	Not detected
Varicella zoster virus (VZV)	Not detected
Cryptococcus neoformans/gattii	Not detected

1. Results from the FilmArray ME Panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient 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 infection caused by an organism not detected by the FilmArray ME Panel
2. Results from this test must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
3. The FilmArray ME Panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.  
4. Positive results do not rule out co-infection with organisms not included in the FilmArray ME Panel. 
5. The FilmArray ME Panel is not intended for testing of specimens collected from indwelling CNS medical devices. 
6. False negative results may occur when the concentration of organism(s) in the specimen is below the device limit of detection. In the prospective clinical study, two specimens were positive by standard of care culture and negative with the FilmArray ME Panel.
7. The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.
8. Only E. coli strains possessing the K1 capsular antigen will be detected. All other E. coli strains/serotypes will not be detected.
9. Only encapsulated strains of N. meningitidis will be detected. Unencapsulated N. meningitidis will not be detected.

Manufacturer’s package inserts. FilmArray Meningitis/Encephalitis (ME) Panel, June 2021, BioFire Diagnostics, Salt Lake City, UT 84108, USA.