Performance Evaluation of Multiplex Molecular Syndromic Panel vs. Singleplex PCR for Diagnosis of Acute Central Nervous System Infections
2025
Liliana Gabrielli | Miriam Tomaiuolo | Isabella Banchini | Alice Balboni | Andrea Liberatore | Federica Lanna | Alessia Cantiani | Alessia Bertoldi | Matteo Pavoni | Lamberto Manzoli | Tiziana Lazzarotto
Acute central nervous system (CNS) infections, such as meningitis and encephalitis, represent medical emergencies that require rapid identification of the causative pathogen to guide appropriate therapeutic interventions. The QIAstat-Dx®: Meningitis/Encephalitis (QIA/ME) is a molecular syndromic panel that enables the simultaneous detection of multiple pathogens and provides the visualization of cycle threshold (Ct) values, offering rapid results for prompt clinical management. This study retrospectively tested, with the QIA/ME panel, 170 cerebrospinal fluid (CSF) samples from patients with CNS infections, confirmed through routine diagnostic workflows. The results were compared with those obtained from bacterial culture and singleplex PCR for viral detection. The QIA/ME demonstrated 100% concordance with reference methods for bacterial and yeast infections. For viral infections, the overall detection rate was 85.9%. Specifically, when singleplex PCR results exceeded 250 copies/mL for DNA viruses and 500 copies/mL for the RNA virus, the concordance rate with the QIA/ME was 96.8%. In contrast, when PCR values were below these thresholds, the concordance rate dropped to 43.8%. A strong overall correlation was observed between the viral load measured by singleplex PCR and Ct values from the QIA/ME (&rho: = &minus:0.83, p <: 0.001). Only for enterovirus a weak correlation was found (&rho: = &minus:0.40, p = 0.056). The QIA/ME panel is an effective diagnostic tool for viral CNS infections, allowing for the visualization of Ct values that reflect pathogen load in samples and which could be useful in guiding clinical decision-making and patient management.
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