Multicenter evaluation of the multiplex polymerase chain reaction QIAstat-Dx Meningitis/Encephalitis Panel for the detection of central nervous system pathogens directly in the cerebrospinal fluid

ABSTRACT Rapid and accurate detection of pathogens causing meningitis/encephalitis (MEN/EN) is critical to improving clinical outcomes. Multiplex polymerase chain reaction (PCR) enables simultaneous detection of multiple pathogens from the cerebrospinal fluid (CSF), offering advantages over traditional methods. This multicenter study evaluated the performance of the QIAstat-Dx Meningitis/Encephalitis (ME) Panel versus conventional methods, including the BioFire FilmArray ME (BFME) Panel. The CSF samples from patients with suspected MEN/EN along with contrived samples were tested across 13 sites in Europe/USA. Positive percent agreement (PPA) and negative percent agreement (NPA) between the QIAstat-Dx ME Panel and comparator methods were determined. A total of 1,667 clinical samples (1,527 prospective, 140 archived) were tested. Pathogens were detected by the QIAstat-Dx ME Panel in 115 (7.5%) prospective samples, including Streptococcus pneumoniae (1.1%), Haemophilus influenzae (0.5%), Listeria monocytogenes (0.3%), S. agalactiae (0.2%), Escherichia coli K1 (0.1%), Neisseria meningitidis (0.1%), S. pyogenes (0.1%), enterovirus (1.5%), human herpesvirus-6 (1.0%), herpes simplex virus-2 (0.9%) and −1 (0.3%), varicella zoster virus (0.7%), cytomegalovirus (0.3%), human parechovirus (0.3%), and Cryptococcus gattii/neoformans (0.4%). Overall PPA versus BFME ( n = 1,664) was 85.4%, increasing to 95.3% after discordance resolution. PPA was 100% for N. meningitidis , S. pneumoniae , and S. agalactiae . Overall NPA was 99.9%. Among 1,154 contrived positive samples, only 27 (2.3%) incorrect results were observed. The QIAstat-Dx ME Panel demonstrated high concordance with BFME, supporting its use as a reliable, fully automated multiplex PCR platform for rapid diagnosis of community-acquired MEN/EN. IMPORTANCE This multicenter study demonstrated that the QIAstat-Dx ME Panel delivers clinical performance comparable to that of the BioFire FilmArray ME (BFME) Panel, supporting its validity as a reliable syndromic molecular diagnostic tool for MEN/EN. With its broad pathogen coverage, rapid turnaround time (TAT), and the ability to provide amplification curves and Ct values, the QIAstat-Dx ME Panel offers a valuable option for broad and timely detection of bacterial, viral, and fungal CNS pathogens. When used alongside the SoC diagnostic methods, this panel has the potential to improve early diagnosis, guide targeted therapy, and support effective clinical management of patients with suspected MEN/EN.