Abstract
BackgroundInfectious 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.MethodsOver 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).Results56/171 (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%).ConclusionThe 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.
Highlights
Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics
Clinical data on the performance of the FilmArray ME was reported by various users worldwide [7,8,9,10,11,12,13] with diagnostic specificity and sensitivity in good concordance to the multicenter study Admittedly, both false positive and false negative detections have been reported throughout the studies, with one example of an erroneously diagnosed Human herpesvirus (HSV)-1 meningitis in a patient with an underlying tuberculous meningitis [14] and one study indicating a potential of missing viral infections in a pediatric cohort [10]
Aside from the inarguably higher costs of multiplex molecular detection methods compared to standard laboratory procedures like bacterial culture, the remaining uncertainty in interpretation of results is a key point in the controversial discussion concerning the clinical utility of such syndromic testing approaches in infectious meningitis/ encephalitis [15]
Summary
Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. Clinical data on the performance of the FilmArray ME was reported by various users worldwide [7,8,9,10,11,12,13] with diagnostic specificity and sensitivity in good concordance to the multicenter study Admittedly, both false positive and false negative detections have been reported throughout the studies, with one example of an erroneously diagnosed HSV-1 meningitis in a patient with an underlying tuberculous meningitis [14] and one study indicating a potential of missing viral infections in a pediatric cohort [10]. Aside from the inarguably higher costs of multiplex molecular detection methods compared to standard laboratory procedures like bacterial culture, the remaining uncertainty in interpretation of results is a key point in the controversial discussion concerning the clinical utility of such syndromic testing approaches in infectious meningitis/ encephalitis [15]. Risk for infection was prospectively assessed by Gram-stain, and only samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians were subsequently analyzed with the Film Array ME assay
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