Enhanced Identification of Group B Streptococcus and Escherichia Coli in Young Infants with Meningitis Using the Biofire Filmarray Meningitis/Encephalitis Panel

Arora, Harbir; Asmar, Basim I.; Salimnia, Hossein; Agarwal, Prashant; Chawla, Sanjay; Abdel‐Haq, Nahed

doi:10.1097/inf.0000000000001551

Cited by 64 publications

(44 citation statements)

References 11 publications

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“…Syndrome-based testing represents a paradigm shift in the diagnosis of infectious diseases, and our results, along with those of previously published studies, suggest that the use of multiplex molecular panels may assist in the diagnosis of CNS infections. Specifically, multiplex panels may play an important role when antimicrobials are administered empirically prior to collection of a CSF sample, thereby potentially impacting the sensitivity of culture-based methods (24,25). However, routine implementation of multiplex CNS panels, such as the FilmArray ME panel, will require careful consideration and thoughtful utilization management strategies.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of a Commercial Multiplex Molecular Panel for Diagnosis of Infectious Meningitis and Encephalitis

et al. 2018

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Rapid and accurate laboratory tests are important for the timely diagnosis and treatment of central nervous system infections. The FilmArray meningitis/encephalitis (ME) panel (BioFire Diagnostics, Salt Lake City, UT) is an FDA-cleared, multiplex molecular panel that allows the detection of 14 pathogens (bacterial [ = 6], viral [ = 7], and fungal [ = 1] pathogens) from cerebrospinal fluid (CSF). In this study, we evaluated the performance characteristics of the FilmArray ME panel using clinical, residual CSF samples ( = 291) that tested positive by a routine method(s) (e.g., bacterial culture, individual real-time PCR assay) for a pathogen represented on the ME panel. Of note, a subset ( = 76) of the CSF specimens was collected during the prevaccine era and had been characterized as positive for a bacterial pathogen. The FilmArray ME panel demonstrated an overall percent positive agreement (PPA) of 97.5% (78/80) for bacterial pathogens, 90.1% (145/161) for viruses, and 52% (26/50) for Despite the low overall agreement (52%) between the ME panel and antigen testing for detection of, the percent positive agreement of the FilmArray assay for was 92.3% (12/13) when the results were compared directly to the results of routine fungal smear or culture. The FilmArray ME panel offers a rapid (∼60-min), syndrome-based approach for the detection of select meningitis and encephalitis pathogens.

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Section: Discussionmentioning

confidence: 99%

Evaluation of a Commercial Multiplex Molecular Panel for Diagnosis of Infectious Meningitis and Encephalitis

et al. 2018

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“…Most notably, N. meningitides, a worldwide leading meningitis pathogen, and L. monocytogenes detected in none of the samples [6]. Meanwhile, 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].…”

Section: Introductionmentioning

confidence: 99%

Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis

et al. 2020

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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.

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“…This means that prior to the FilmArray ME panel, there were limited options available to clinicians desperate to identify a definitive etiology in the absence of a positive culture. Small numbers of studies and case reports have noted increased detection of bacterial targets by the FilmArray ME panel alone (8,(17)(18)(19)(20). A study of 62 CSF samples from young infants tested by the FilmArray ME panel reported 7 more positive results for bacterial targets than found with culture; 7 of the positive results were from infants that received antibiotics prior to lumbar puncture (18).…”

mentioning

confidence: 99%

“…Small numbers of studies and case reports have noted increased detection of bacterial targets by the FilmArray ME panel alone (8,(17)(18)(19)(20). A study of 62 CSF samples from young infants tested by the FilmArray ME panel reported 7 more positive results for bacterial targets than found with culture; 7 of the positive results were from infants that received antibiotics prior to lumbar puncture (18). Within the first 4 months of implementation, the FilmArray ME panel identified two cases of culture-negative bacterial meningitis (S. pneumoniae and L. monocytogenes) that were confirmed by positive blood cultures (14).…”

mentioning

confidence: 99%

Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory

Bard

Alby

2018

J Clin Microbiol

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INTRODUCTIONSyndromic panels were first FDA cleared for detection of respiratory pathogens in 2008. Since then, other panels have been approved by the FDA, and most recently, the FilmArray meningitis/encephalitis panel (BioFire, Salt Lake City, UT) has become available. This assay detects 14 targets within 1 h and includes pathogens that typically cause different manifestations of infection, although they infect the same organ system. Several studies have reported both false-positive and false-negative results with this test, and all agree that the cost is significant. As with other panels, health care systems have adopted different strategies for offering this assay. Some have implemented strategies to limit the use of the test to certain patient populations, others have elected not to offer the test, and others have elected not to offer the test and instead request that providers order specific PCRs for the pathogens that best fit the patient's symptoms. In this Point-Counterpoint, Jennifer Dien Bard of the Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, and of the Keck School of Medicine at the University of Southern California explains why laboratories should offer these assays without restriction. Kevin Alby of the University of Pennsylvania explains the concerns about the use of these assays as first-line tests and why some limitations on their use might be appropriate.

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Enhanced Identification of Group B Streptococcus and Escherichia Coli in Young Infants with Meningitis Using the Biofire Filmarray Meningitis/Encephalitis Panel

Cited by 64 publications

References 11 publications

Evaluation of a Commercial Multiplex Molecular Panel for Diagnosis of Infectious Meningitis and Encephalitis

Evaluation of a Commercial Multiplex Molecular Panel for Diagnosis of Infectious Meningitis and Encephalitis

Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis

Point-Counterpoint: Meningitis/Encephalitis Syndromic Testing in the Clinical Laboratory

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