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Test Code:
090-70-1461

Order Name:
Meningitis/Encephalitis (ME) panel by Film Array, CSF

 
Useful For:
The FilmArray ME Panel is indicated as an aid in the diagnosis of 14 potential CNS pathogens  of meningitis and/or encephalitis.
 
Methodology:
1. Multiplex and Nested Polymerase Chain Reaction (PCR)
2. High Resolution Melting Analysis
 
Test List In Profile:
Escherichia coli K1  
Haemophilus influenzae 
Listeria monocytogenes 
Neisseria meningitidis 
Streptococcus agalactiae 
Streptococcus pneumoniae 

Cytomegalovirus (CMV) 
Enterovirus (EV)
Herpes simplex virus 1 (HSV-1) 
Herpes simplex virus 2 (HSV-2) 
Human herpesvirus 6 (HHV-6) 
Human parechovirus (HPeV) 
Varicella zoster virus (VZV) 
Cryptococcus neoformans/gattii 
 
AliasesName:
ME panel by film array
FilmArray Meningitis/Encephalitis Panel
Meningitis/Encephalitis Multiplex PCR
Meningitis/Encephalitis Syndromic panel
 
 
 
Test Code:
090-70-1461

Order Name:
Meningitis/Encephalitis (ME) panel by Film Array, CSF

 
Collection Specimen Or Container:
CSF/Sterile Container
 
Specimen Testing Type:
CSF 0.5-1 mL (Minimum volume = 0.5 mL)
 
Sub Mission Container:
Sterile Container
 
Rejection Criteria:
1. Specimen is added any preservative solution or transport media
2. Specimen that has been centrifuged Shunt fluid 
 
Specimen Stabillity:
Specimen Type Temperature Time
CSF Room temperature  1 day
  Refrigerated, 2oC to 8oC 7 days
 
 
 
Test Code:
090-70-1461

Order Name:
Meningitis/Encephalitis (ME) panel by Film Array, CSF

 
Schedule:
Test daily
 
Turnaround Time:
Specimen is received during 8.00 am to 8.00 pm, the result will be reported within 3 hours.
If specimen is received after 8.00 pm, the result will be reported at 10.00 am in the next day.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department
Tel.14168
 
Specimen Retention Time:
7 days
 
 
 
Test Code:
090-70-1461

Order Name:
Meningitis/Encephalitis (ME) panel by Film Array, CSF

 
 
Clinical Information:
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. 
 
Reference Value:
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
 
Interpretation:
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.
 
Clinical Reference:
Manufacturer’s package inserts. FilmArray Meningitis/Encephalitis (ME) Panel, November 2019, BioFire Diagnostics, Salt Lake City, UT 84108, USA.