Real-World Evaluation of the BioFire FilmArray ME Panel: Diagnostic Accuracy and Clinical Utility

Area of Science:

• Clinical microbiology
• Infectious diseases
• Neurology

Background:

• Central nervous system (CNS) infections pose significant risks.
• Traditional diagnostics can delay pathogen identification.
• Rapid multiplex panels offer potential for faster diagnosis.

Purpose of the Study:

• To evaluate the real-world clinical utility and diagnostic performance of the FilmArray ME multiplex panel for CNS infections.
• To compare multiplex panel results with conventional diagnostic methods.

Main Methods:

• A retrospective analysis of 955 patients with suspected CNS infections.
• Comparison of FilmArray ME panel results against clinical, laboratory, and imaging data.
• Classification of results as true-positive, true-negative, false-positive, or false-negative.

Main Results:

• The FilmArray ME panel detected pathogens in 8.4% of patients.
• Streptococcus pneumoniae, Enterovirus, and HSV-1 were common detections.
• Overall sensitivity was 94.8% and specificity was 99.4%.
• Pathogens outside the panel's scope were identified in 3.9% of cases.

Conclusions:

• The FilmArray ME panel offers rapid and accurate detection of common meningitis and encephalitis pathogens.
• The panel should complement, not replace, conventional diagnostics due to potential false negatives and coverage limitations.
• Clinical assessment remains crucial for managing CNS infections.