Performance Characteristics:
Analytical Sensitivity (Manufacturer's claim):
Escherichia coli K1: 1,000 CFU/mL
Haemophilus influenzae: 1,000 CFU/mL
Listeria monocytogenes: 1,000 CFU/mL
Neisseria meningitidis: ~1,800 copies/mL
Streptococcus agalactiae: 1,000 CFU/mL
Streptococcus pneumoniae: ~1,500 copies/mL
Cytomegalovirus : 4,300 copies/mL
Enterovirus: 50 TCID50/mL
Herpes simplex virus 1: 1,510 copies/mL
Herpes simplex virus 2: 1,290 copies/mL
Human herpes virus 6: 10,000 copies/mL
Human parechovirus: 500 TCID50/mL
Varicella zoster virus: 1,660 copies/mL
Cryptococcus neoformans/gattii: 100 CFU/mL
Analytical Specificity (Manufacturer's claim):
Tested 107 organisms comprising of commonly encountered gram-positive and gram-negative bacteria, viruses, fungi and pathogenic protists, and demonstrated no cross-reaction for all except for Haemophilus haemolyticus and Human Rhinoviruses that are found in the upper respiratory tract but rarely isolated from CSF.
Assay Limitations:
1. Herpes simplex virus (HSV) PCR may be falsely negative in early (<3 days) or late (>7 days) disease. Repeat testing or alternative testing may need to be considered.
2. False-negative results have been reported in patients with disseminated cryptococcal infections or meningitis. Fungal culture, CSF microscopy and cryptococcal antigen testing should always be performed in patients with clinical suspicion of cryptococcal infection.
3. Only encapsulated strains of Neisseria meningitidis will be detected.
4. Some organisms detected by the FilmArray ME Panel, such as Streptococcus pneumoniae and Haemophilus influenzae can be shed from the respiratory tract of healthy individuals. HSV-1 may also be shed from individuals with active or recurrent cold sores. Caution should therefore be exercised during specimen collection (e.g. facemask should be worn by all present during collection) to prevent contamination leading to false positive results.
5. Please note that other than for pathogens listed above, this assay does not detect other important central nervous system pathogens, e.g. Toxoplasma gondii, Mycobacteria tuberculosis, Treponema pallidum, human immunodeficiency virus, members of the Flavivirus genus, etc.
6. Haemophilus haemolyticus is a commensal bacterium of the upper respiratory tract and rarely isolated from CSF, was observed to cross react with Haemophilus influenzae at concentrations > 1x10E5 CFU/mL.
7. Human Rhinoviruses are respiratory pathogens and rarely isolated from CSF, were observed to cross react with Enterovirus.
8. A negative FilmArray ME Panel result does not exclude the possibility of central nervous system infection and should not be used as the sole basis for diagnosis, treatment, or other management decisions.
