BIOFIRE^® FILMARRAY^® ME Panel

Simple, comprehensive meningitis/encephalitis testing

The BIOFIRE^® 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 [2]*. It is designed for use with the integrated BIOFIRE^® FILMARRAY^® system [3], 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 BIOFIRE^® 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 BIOFIRE^® FILMARRAY^® ME Panel can contribute to better antimicrobial resistance management [4] by avoiding unnecessary antibiotic use; reducing lengths of hospital stays and decrease costs⁵.

• 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

The other availabl e panels are:

• BIOFIRE^® FILMARRAY^® BCID panels [5]
• BIOFIRE^® FILMARRAY^® Respiratory panel [6]
• BIOFIRE^® FILMARRAY^® GI panel [7]
• BIOFIRE® FILMARRAY^® Pneumonia plus Panel [8]

14 target pathogens at once

BIOFIRE^® FILMARRAY^® ME Panel targets:

* FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid [2]. FDA press release, October 8, 2015; CE-mark pending soon

References:

1) http://www.comomeningitis.org/news-and-events/world-meningitis-day [9]. Accessed April 3, 2015

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

3) NINDS. Meningitis and Encephalitis Fact Sheet [10]. 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 [2]- FDA press release, October 8, 2015

5) K.M. McNabb et al. Implementation of a Rapid Molecular Meningitis Panel. Poster 2017.  New Hanover Regional Medical Center. Wilmington, North Carolina