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  • FILMARRAY® Meningitis/Encephalitis (ME) Panel

FILMARRAY® Meningitis/Encephalitis (ME) Panel

Meningitis/Encephalitis panel for FilmArray® multiplex PCR system

The FILMARRAY® Meningitis-Encephalitis (ME) Panel enables rapid and accurate automated testing for common pathogens that cause central nervous system infections, including viruses, bacteria and yeast.

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 14 targets
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Simple, comprehensive meningitis/encephalitis testing

The FILMARRAY®® Meningitis/Encephalitis (ME) Panel tests cerebrospinal fluid (CSF) for the 14 most common pathogens responsible for community acquired meningitis or encephalitis including viruses, bacteria and yeast. The Panel received FDA De Novo clearance in October 2015*. It is designed for use with the integrated FILMARRAY® system, an FDA, CE-IVD, and TGA certified multiplex PCR system.  With sample preparation, amplification, detection and analysis in one automated system, total run time is about an hour, with only 2 minutes of hands-on time.

Meningitis affects more than 1.2 million people and bacterial meningitis causes 120,000 deaths globally each year 1. It often affects healthy people, but environmental factors and immunocompromised conditions (due, for example, to HIV or chemotherapy) are significant risks. Meningitis can cause brain damage, hearing loss, blindness and death. Symptoms can appear suddenly and escalate quickly, so rapid diagnosis is critical to patient outcomes.  Yet, due to overlapping symptoms, rapid identification of the causative agents is not possible based on clinical indications alone.2,3

 

Now, the unique FILMARRAY® ME Panel is the first system to be able to simultaneously test for 14 targets on a single CSF sample. This provides accurate identification with a rapid one-hour turnaround, helping clinicians to quickly ensure appropriate care. Testing CSF for multiple organisms has previously been problematic because it may be difficult to obtain enough fluid from the patient to run multiple tests4. The FILMARRAY® ME Panel can contribute to better antimicrobial resistance management by avoiding unnecessary antibiotic use; reducing lengths of hospital stays and decrease costs; and reducing patient mortality and morbidity due to meningitis

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 14 targets

 

FILMARRAY® ME is the newest of four FDA-cleared and CE-marked panels for use on the FILMARRAY®  multiplex PCR system. Taken together, the four FILMARRAY® panels comprise the largest infectious disease pathogen menu commercially available. The other available panels are:

 

14 target pathogens at once

FILMARRAY®™ ME Panel targets:

Bacteria Viruses
  • Escherichia coli K1
  • Haemophilus influenzae
  • Listeria monocytogenes
  • Neisseria meningitidis
  • Streptococcus agalactiae
  • Streptococcus pneumoniae
  • Cytomegalovirus (CMV)
  • Enterovirus
  • Herpes simplex virus 1 (HSV-1)
  • Herpes simplex virus 2 (HSV-2)
  • Herpes simplex virus 3 (HSV-3)
  • Human parechovirus
  • Varicella zoster virus (VZV)
 
Yeast
  • Cryptococcus neoformans/gattii

FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid. FDA press release, October 8, 2015; CE-mark pending soon

 

References:

1) http://www.comomeningitis.org/news-and-events/world-meningitis-day. Accessed April 3, 2015

2) Bamberger DM. Am Fam Physician. 2010;82:1491-1498.

3) NINDS. Meningitis and Encephalitis Fact Sheet. Updated November 24, 2014. Accessed January 6, 2015.

4) FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid- FDA press release, October 8, 2015

 

Panel Specification

Sample Handling Performance Parameters
Sample Type: Cerebrospinal Fluid Hands-on time: Approx. 2 minutes
Sample Volume: 200 μL Run turnaround time: About an hour
 

 

Pioneering diagnostics