Diagnostic Performance of the QIAstat-Dx Meningitis/Encephalitis Panel: Insights From Seven Clinical Evaluations

Abstract

Central nervous system (CNS) infections require prompt and accurate diagnosis to enable timely and targeted antimicrobial therapy. Syndromic PCR-based assays, such as the QIAstat-Dx Meningitis/Encephalitis Panel (QIA-ME), allow rapid detection of key pathogens directly from cerebrospinal fluid (CSF). We conducted a narrative review of seven studies (2023-2025) evaluating the diagnostic performance of QIA-ME. A total of 1007 clinical CSF samples, ranging from 5 to 585, were retrospectively analyzed, with 8 to 14 targets assessed per study. Positive percent agreement (PPA) ranged from 90.6% to 100%, while negative percent agreement (NPA)-available in only three studies-ranged from 75.0% to 97.7%. In three studies, head-to-head comparisons with the BioFire FilmArray Meningitis/Encephalitis Panel (FA-ME) revealed minimal variation in performance, reinforcing the robustness of QIA-ME. However, target-specific limitations were noted, particularly for herpesviruses such as HSV-1. Methodological heterogeneity across studies-in terms of design, comparator methods, and sample size-limits generalizability. The exclusion of cytomegalovirus and inclusion of Mycoplasma pneumoniae and Streptococcus pyogenes in the QIA-ME panel raise concerns about the clinical utility of low-prevalence targets, especially as M. pneumoniae was not detected in any clinical sample. Despite these limitations, the integration of amplification curve analysis and the strong concordance with FA-ME support QIA-ME as a valuable tool for CNS infection diagnostics. Prospective real-world studies are warranted to clarify the clinical value of individual targets and guide appropriate use across varied patient settings.

Keywords: PCR assay; encephalitis; meningitis; syndromic panel.