Related Experiment Video
Updated: Dec 28, 2025
Enhanced Rabies Surveillance Using a Direct Rapid Immunohistochemical Test
Published on: April 30, 2019
Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis
Susanne Pfefferle1, Martin Christner2, Martin Aepfelbacher2
1Institut für Medizinische Mikrobiologie, Virologie und Hygiene, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. s.pfefferle@uke.de.
Background:
Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversial, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its relatively high costs. The aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using a pragmatic and simple sample selection strategy to reduce the overall cost burden.
Methods:
Over a period of 18 months we received 4623 CSF samples (2338 hospitalizations, 1601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. positive Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N = 171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Those samples were also analyzed by reference methods: culture only (n = 45), PCR only (n = 20) or both methods (n = 106).
Results:
56/171 (32.75%) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57%), viral pathogens were detected in 27/56 (48.21%) and yeast DNA was detected in 1/56 (1.79%) of positive samples. Double detection occurred in 2/56 samples. In 52/56 (92.86%) FilmArray ME positive samples, results could be confirmed by the reference assays (sensitivity = 96.30%, specificity =96.58%).
Conclusion:
The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.
Insights
The FilmArray ME assay offers fast and reliable infectious meningitis diagnosis in real-world settings. While effective, experienced interpretation is crucial, and it should not replace traditional methods entirely.
Area of Science:
- Clinical microbiology
- Infectious diseases
- Molecular diagnostics
Background:
- Infectious meningitis requires rapid diagnostics for optimal patient outcomes.
- Syndromic panel testing, like FilmArray ME, can expedite diagnosis and targeted therapy.
- Clinical utility of FilmArray ME is debated due to interpretation challenges, limited real-world data, and cost.
Purpose of the Study:
- To evaluate the clinical performance of the FilmArray ME assay in a real-world tertiary university hospital setting.
- To assess the assay's utility using a cost-effective sample selection strategy.
- To analyze the diagnostic accuracy and reliability of FilmArray ME for infectious meningitis.
Main Methods:
- A pragmatic sample selection strategy was employed, focusing on CSF samples with high pretest probability of meningitis.
- Over 18 months, 171 CSF samples underwent FilmArray ME analysis.
- Results were compared against reference methods including culture and PCR.
Main Results:
- 32.75% (56/171) of samples tested positive via FilmArray ME.
- Bacterial, viral, and yeast pathogens were identified, with double detections in 2 samples.
- High concordance with reference methods was observed (sensitivity 96.30%, specificity 96.58%).
Conclusions:
- The FilmArray ME assay demonstrates speed and reliability for infectious meningitis management in routine workflows.
- Accurate interpretation requires experienced personnel aware of potential false results.
- Molecular testing should complement, not replace, traditional diagnostics, especially for antimicrobial susceptibility testing.
