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FilmArray Meningitis Encephalitis Panel Approved by FDA

On October 8, The US Food and Drug Administration (FDA) approved the FilmArray Meningitis/Encephalitis Panel, which is manufactured by BioFire Diagnostics LLC (Salt Lake City, Utah). This is the first nucleic acid based test that can simultaneously detect 14 pathogens in cerebrospinal fluid (CSF). FilmArray Meningitis/Encephalitis Panel detects the following pathogens:

Bacteria and yeast

  • Escherichia coli K1
  • Haemophilus influenzae
  • Listeria monocytogenes
  • Neisseria meningitidis
  • Streptococcus agalactiae
  • Streptococcus pneumoniae
  • Cryptococcus neoformans/gattii

Viruses

  • Cytomegalovirus
  • Enterovirus
  • Herpes simplex virus 1
  • Herpes simplex virus 2
  • Human herpesvirus 6
  • Human parechovirus
  • Varicella zoster virus

Results are available approximately 60 minutes after the start of testing. Quick turnaround should allow physicians to prescribe definitive treatment much sooner than with conventional testing. The cost of performing FilmArray is less than the cumulative sum of testing for each pathogen individually.

Physicians should still order CSF bacterial and fungal cultures because FilmArray does not detect all pathogens causing CNS infection and does not test for antimicrobial susceptibility.

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