An Assessment of a New Rapid Multiplex PCR Assay for the Diagnosis of Meningoencephalitis

Diagnostics (Basel). 2024 Apr 11;14(8):802. doi: 10.3390/diagnostics14080802.

Abstract

The rapid and broad microbiological diagnosis of meningoencephalitis (ME) has been possible thanks to the development of multiplex PCR tests applied to cerebrospinal fluid (CSF). We aimed to assess a new multiplex PCR panel (the QIAstat-Dx ME panel), which we compared to conventional diagnostic tools and the Biofire FilmArray ME Panel. The pathogens analyzed using both methods were Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae, Enterovirus, herpes simplex virus 1-2, human herpesvirus 6, human parechovirus, varicella zoster virus, and Cryptococcus neoformans/gattii. We used sensitivity, specificity, PPV, NPV, and kappa correlation index parameters to achieve our objective. Fifty CSF samples from patients with suspected ME were included. When conventional methods were used, 28 CSF samples (56%) were positive. The sensitivity and specificity for QIAstat-Dx/ME were 96.43% (CI95%, 79.8-99.8) and 95.24% (75.2-99.7), respectively, whereas the PPV and NPV were 96.43% (79.8-99.8) and 95.24% (75.1-99.7), respectively. The kappa value was 91.67%. Conclusions: A high correlation of the QIAstat-Dx ME panel with reference methods was shown. QIAstat-Dx ME is a rapid-PCR technique to be applied in patients with suspected ME with a high accuracy.

Keywords: FilmArray ME; QIAstat-Dx ME; encephalitis; meningitis; multiplex PCR.

Grants and funding

ISGlobal (CEX2018-000806-S) is recipient of a Severo Ochoa Award of Excellence from MINECO (Government of Spain). ISGlobal acknowledges support from the Generalitat de Catalunya through the CERCA Program. This work was also supported by the Instituto de Salud Carlos III [Carlos III Institute of Health] (PI20/00766) and award 2021SGR01569 from the Agència de Gestió d’Ajuts Universitaris i de Recerca of the Generalitat de Catalunya [Agency for Management of University and Research Grants of the Catalan Government].