Meningitis and encephalitis, inflammatory conditions of the central nervous system, are serious public health concerns. These conditions may be caused by a large number of pathogens, including bacteria, viruses, yeast, and parasites. Depending upon the pathogen involved, meningitis and encephalitis can quickly lead to death or result in life-long physical or cognitive challenges. The signs and symptoms caused by these pathogens are often very similar to one another, thus making it difficult to quickly determine the responsible agent and appropriate treatment. Current microbiological methods used to identify pathogens from cerebrospinal fluid (CSF) are often slow and laborious, thus leaving patients undiagnosed, possibly untreated or inadequately treated, and potentially spreading infection for up to several days. BioFire Diagnostics, Inc. has developed the FilmArray Meningitis/Encephalitis (ME) Panel, an innovative molecular diagnostic device for simultaneous rapid identification of 16 common pathogens (bacteria, viruses, and yeast) from CSF of patients suspected of having meningitis and/or encephalitis. The FilmArray ME Panel consists of a uniquely-designed "lab-in-a-pouch" that works together with the FilmArray Instrument to perform all steps necessary for detection and identification of the pathogens (from nucleic acid extraction to multiplex nested PCR and data analysis). The test can be set up in a matter of minutes, requiring only minimally trained operators, and returns clear unambiguous results in approximately one hour. The goal of this project is to perform an early assessment of the FilmArray ME Panel in the hospital laboratory setting to evaluate its performance and its utility as a diagnostic test for meningitis/encephalitis. The early assessment of the FilmArray ME Panel will involve testing fresh, prospectively-collected, de-identified residual CSF specimens from children and adults submitted to the hospital laboratory for pathogen testing. The first task will be to evaluate the sensitivity and specificity of the FilmArray ME results by comparison to standard laboratory reference methods, such as culture for bacteria and yeast, and PCR for viruses. The second task will be to analyze the data with regards to different factors, such as age group of the patients, immune status, final diagnosis, and hospitalization status, to determine the utility of the device overall and for specific groups of patients. Together these data will help to determine if the FilmArray ME Panel is appropriately designed to fill the unmet diagnostic needs for meningitis/encephalitis and if any changes can be made to improve the device before larger studies are performed for regulatory clearance as an in vitro diagnostic (IVD) test.

Public Health Relevance

Meningitis and encephalitis are serious inflammatory conditions of the central nervous system that can be caused by several pathogens, primarily bacteria, viruses, and yeast. In this application, pilot testing will be conducted to evaluate the performance and clinical utility of the FilmArray Meningitis/Encephalitis (ME) Panel, a rapid (~1 hour), automated, sensitive, user friendly and inexpensive test able to detect 16 meningitis/encephalitis pathogens. Outcomes from this evaluation will allow optimization of the test prior to full clinical testing for eventual regulatory-clearance and diagnostic use, which has the potential to improve patient care and public health.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Research Grants (R03)
Project #
1R03AI112865-01
Application #
8750823
Study Section
Special Emphasis Panel (ZRG1-IDM-V (12))
Program Officer
Dugan, Vivien Grace
Project Start
2014-08-01
Project End
2016-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
1
Fiscal Year
2014
Total Cost
$93,000
Indirect Cost
$31,000
Name
Biofire Diagnostics, Inc.
Department
Type
DUNS #
556915205
City
Salt Lake City
State
UT
Country
United States
Zip Code
84108