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

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.