Related Experiment Video
Updated: Jan 3, 2026
Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
Diagnostic test accuracy of the BioFire® FilmArray® meningitis/encephalitis panel: a systematic review and
1Department of Pathology, Rhode Island Hospital, Providence, RI, USA; The Warren Alpert Medical School of Brown University, Providence, RI, USA.
Background:
The FilmArray® meningitis/encephalitis (ME) panel is a multiplex PCR assay which can detect the most commonly identified pathogens in central nervous system infections. It significantly decreases the time to diagnosis of ME and data has yielded several positive outcomes. However, in part, reports of both false positive and false negative detections have resulted in concerns about adoption.
Objectives:
The aim was to evaluate the ME panel in a diagnostic test accuracy review.
Data Sources:
The PubMed and EMBASE databases were systematically searched through May 2019.
Study Eligibility Criteria:
Eligible studies were those providing sensitivity and specificity data for the ME panel compared with a reference standard. Studies providing details on false positive and false negative results of the panel as well as further investigation (adjudication) of the discordant results between the panel and comparator assays were included and assessed separately.
Participants:
Patients with suspected ME for whom a panel was ordered were included.
Methods:
The ME panel was compared to reference standard methods for diagnosing community-acquired ME. We performed a meta-analysis and calculated the summary sensitivity and specificity of the ME panel. Moreover, we evaluated the false positive and false negative results of the panel.
Results:
Thirteen studies (3764 patients) were included in the review and 8 of them (3059 patients) were pooled in a meta-analysis. The summary estimates of sensitivity and specificity with 95% confidence intervals (CI) was 90% (95% CI 86-93%) and 97% (95% CI 94-99%), respectively. When we looked specifically at studies that assessed further the false positive and false negative results, false positive detections were 11.4% and 4% before and after adjudication, respectively. The highest proportion of false positive was observed for Streptococcus pneumoniae followed by Streptococcus agalactiae. False negative isolates were 2.2% and 1.5% before and after adjudication, respectively. Herpes simplex virus 1 and 2, enterovirus and Cryptococcus neoformans/gattii had the highest proportions of false negative determinations. False negative C. neoformans/gattii were mostly patients with positive antigen titres, on treatment or cleared disease.
Conclusions:
The currently available literature suggests that the ME panel has high diagnostic accuracy. However, the decision for implementation should be individualized based on the needs of the patient population, the capabilities of the laboratory, and the knowledge of the healthcare providers that will utilize the test.
Insights
The FilmArray® meningitis/encephalitis (ME) panel shows high diagnostic accuracy for central nervous system infections. While generally reliable, careful consideration of specific patient populations and laboratory capabilities is advised for optimal implementation.
Area of Science:
- Clinical diagnostics
- Infectious disease microbiology
- Molecular diagnostics
Background:
- The FilmArray® meningitis/encephalitis (ME) panel is a multiplex PCR assay for detecting central nervous system pathogens.
- It offers rapid diagnosis of ME, leading to positive clinical outcomes.
- Concerns regarding false positive and false negative results impact its widespread adoption.
Purpose of the Study:
- To evaluate the diagnostic test accuracy of the ME panel.
- To assess the sensitivity and specificity of the ME panel for diagnosing meningitis/encephalitis.
- To analyze false positive and false negative results associated with the ME panel.
Main Methods:
- Systematic literature search of PubMed and EMBASE databases up to May 2019.
- Inclusion of studies reporting sensitivity and specificity data for the ME panel against a reference standard.
- Meta-analysis to calculate summary sensitivity and specificity, with separate assessment of discordant results.
Main Results:
- Thirteen studies (3764 patients) were reviewed; 8 studies (3059 patients) were meta-analyzed.
- Summary sensitivity was 90% (95% CI 86-93%) and specificity was 97% (95% CI 94-99%).
- Post-adjudication, false positive rates were 4% (highest for S. pneumoniae, S. agalactiae) and false negative rates were 1.5% (highest for HSV 1/2, enterovirus, C. neoformans/gattii).
Conclusions:
- The ME panel demonstrates high diagnostic accuracy based on current literature.
- Implementation decisions should be individualized, considering patient population needs, laboratory capacity, and healthcare provider expertise.
- Further investigation of discordant results is crucial for refining test interpretation.
