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Multicenter Study
. 2024 Mar;43(3):511-516.
doi: 10.1007/s10096-024-04751-9. Epub 2024 Jan 11.

A multicenter evaluation of the QIAstat-Dx meningitis-encephalitis syndromic test kit as compared to the conventional diagnostic microbiology workflow

Stefan A Boers  1 , Robin van Houdt  2 , Nina M van Sorge  3 , Jelle Groot  2 , Yvette van Aarle  4 , Mario J A W M van Bussel  4 , Louise F E Smit  4 , Els Wessels  4 , Eric C J Claas  4
Affiliations
Multicenter Study

A multicenter evaluation of the QIAstat-Dx meningitis-encephalitis syndromic test kit as compared to the conventional diagnostic microbiology workflow

Stefan A Boers et al. Eur J Clin Microbiol Infect Dis. 2024 Mar.

Abstract

Purpose: Rapid diagnosis and treatment of infectious meningitis and encephalitis (ME) is critical to minimize morbidity and mortality. Recently, Qiagen introduced the CE-IVD QIAstat-Dx ME panel (QS-ME) for syndromic diagnostic testing of meningitis and encephalitis. Some data on the performance of the QS-ME in comparison to the BioFire FilmArray ME panel are available. In this study, the performance of the QS-ME is compared to the current diagnostic workflow in two academic medical centers in the Netherlands.

Methods: A total of 110 cerebrospinal fluid samples were retrospectively tested with the QS-ME. The results obtained were compared to the results of laboratory-developed real-time PCR assays (LDTs), IS-pro, bacterial culture, and cryptococcal antigen (CrAg) testing. In addition, the accuracy of the QS-ME was also investigated using an external quality assessment (EQA) panel consisting of ten samples.

Results: Four of the 110 samples tested failed to produce a valid QS-ME result. In the remaining 106 samples, the QS-ME detected 53/53 viral targets, 38/40 bacterial targets, and 7/13 Cryptococcus neoformans targets. The discrepant bacterial results consisted of two samples that were previously tested positive for Listeria monocytogenes (CT 35.8) and Streptococcus pneumoniae (CT 40), respectively. The QS-ME detected one additional result, consisting of a varicella-zoster virus signal (CT 35.9), in a sample in which both techniques detected Streptococcus pyogenes. Finally, 100% concordance was achieved in testing a blinded bacterial ME EQA panel.

Conclusion: The QS-ME is a relevant addition to the syndromic testing landscape to assist in diagnosing infectious ME.

Keywords: Central nervous system (CNS) infections; Encephalitis; Meningitis; QIAstat-Dx; Syndromic testing.

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Conflict of interest statement

The authors declare no competing interests.

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