Background: Infectious meningitis and encephalitis are potentially life-threatening diseases, in which rapid identification of the responsible microorganism is imperative. Therefore, recent guidelines recommend the use of molecular tests for rapid detection of pathogens directly from cerebrospinal fluid (CSF). BIOFIRE® Meningitis/Encephalitis (ME) Panel (BioMérieux) is a syndromic panel largely used in clinical laboratory practice for the direct detection of 14 pathogens (6 bacteria, 7 viruses and 1 yeast) in CSF samples. The aim of this study was to systematically review and summarize the literature evidence about the diagnostic accuracy of the BIOFIRE® ME Panel.
Materials/methods: We searched PubMed up to November 1, 2019 to identify studies reporting on the diagnostic accuracy of the BIOFIRE® ME Panel in comparison with conventional methods (i.e. based on microscopy, culture and/or PCR). Two reviewers independently selected articles, extracted data and performed a quality assessment. We generated a bivariate random-effects model to obtain pooled sensitivity and specificity estimates. The R software 3.6.0 (mada package) and Microsoft Excel software 1.30 were used for statistical analysis.
Results: We selected 23 articles from 567 search records, including 6931 CSF samples tested by the BIOFIRE® ME Panel and conventional methods for 63,967 results in total. Overall pooled sensitivity and specificity were 84.9% (95% confidence interval [CI], 74.4–91.5) and 99.5% (95% CI, 98.9–99.8), respectively. Pooled sensitivity was higher for bacteria (91.6%; 95% CI, 86.4–94.9) than for virus (90.2%; 95% CI, 86.0–93.3) and Cryptococcus (52.4%; 95% CI, 28.1–75.7). By single targets, pooled sensitivities ranged from 72.5% (95% CI, 59.5–82.5) for herpes simplex virus 1 to 92.0% (95% CI, 87.3–95.1) for enterovirus. Pooled specificities were higher than 98.0% for all the targets. Additionally, cumulative positive predictive values ranged from 58.3% (95% CI, 51.5–64.7) for human herpesvirus 6 to 100% for both Listeria monocytogenes and paraechovirus.
Conclusions: Based on these findings, the BIOFIRE® ME Panel is an accurate tool for the laboratory diagnosis of the most common aetiological agents of meningitis/encephalitis worldwide.