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

TL;DR

This study evaluates a rapid diagnostic test for CNS infections, showing it is accurate but should be used alongside traditional methods.

Contribution

The study provides a real-world evaluation of the FilmArray ME panel's diagnostic accuracy and clinical utility for CNS infections.

Findings

The FilmArray ME panel detected pathogens in 8.4% of patients with high sensitivity and specificity.

3.9% of cases involved bacteria not covered by the panel, such as Acinetobacter baumannii and Stenotrophomonas maltophilia.

The panel should complement, not replace, conventional diagnostics due to limitations in coverage and clinical relevance.

Abstract

Central nervous system (CNS) infections carry high morbidity and mortality, yet traditional diagnostics often fail to identify the causative agent promptly. Rapid multiplex panels offer broader and faster pathogen detection, making it important to understand their real‐world clinical value. In order to evaluate the diagnostic performance of the multiplex panel, panel results were compared with clinical, laboratory, and imaging data. Concordance between the panel and reference methods defined true‐positive and true‐negative results, and discrepancies were classified as false positives or false negatives. A total of 955 patients were included. The FilmArray ME panel detected at least one pathogen in 8.4% of patients. Streptococcus pneumoniae was the most common bacterial agent, and Enterovirus and HSV‐1 were the most frequent viral detections. Overall sensitivity and specificity were 94.8% and 99.4%. Sensitivity was 91.6% in children and 97.6% in adults, and specificity was 99.6% in children and 99.1% in adults. We also identified in 3.9% of cases bacterial pathogens outside the ME panel’s coverage, most commonly Acinetobacter baumannii and Stenotrophomonas maltophilia, organisms usually associated with healthcare‐related or neurosurgical infections. Our large real‐world cohort shows that the FilmArray ME panel provides rapid, accurate detection of key meningitis and encephalitis pathogens. Nonetheless, false‐negative bacterial findings, detection of viruses with limited clinical relevance, and the presence of infections due to organisms outside the panel indicate that it should complement, not replace, conventional diagnostics and careful clinical assessment.