Evaluation of the QIAstat-Dx Meningitis/Encephalitis Panel, a multiplex PCR platform for the detection of community-acquired meningoencephalitis
Open accessAbstract
Rapid identification of the causative pathogens of central nervous system infections is essential for providing appropriate management and improving patient outcomes. The performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel—a multiplex PCR testing platform—in detecting pathogens implicated in meningitis and/or encephalitis was evaluated using BioFire FilmArray ME Panel as a comparator method. This multicenter study analyzed 585 retrospective residual cerebrospinal fluid specimens and 367 contrived specimens. The QIAstat-Dx ME Panel showed positive percent agreement (PPA) values of 100% for Neisseria meningitidis , Streptococcus agalactiae , Escherichia coli K1, Listeria monocytogenes , and Cryptococcus gattii / neoformans on clinical samples compared to the BioFire FilmArray ME Panel. The PPA values observed for Haemophilus influenzae and Streptococcus pneumoniae were 80% and 88.24%, respectively. Negative percent agreement (NPA) values were >99.0% for each of the six bacterial targets and one fungal target tested with clinical samples. One viral target, herpes simplex virus 1, exhibited a PPA value of 100.0%, while the remaining viral targets—human parechovirus, herpes simplex virus 2, human herpes virus 6, and varicella zoster virus—were >90.0%, with the exception of enterovirus, which had a PPA value of 77.8%. The QIAstat-Dx ME Panel detected five true-positive and four true-negative cases compared to BioFire FilmArray ME Panel. The NPA values for all viral pathogens were >99.0%. Overall, the QIAstat-Dx ME Panel showed comparable performance to the BioFire FilmArray ME Panel as a rapid diagnostic tool for community-acquired meningitis and encephalitis.
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HSV-1 and C. neoformans/gattii were detected equally by both QIA/ME and FA/ME platforms, suggesting the same sensitivity issues regarding these targets.
“In particular, HSV-1 and C. neoformans/gattii were detected equally by both platforms, suggesting the same sensitivity issues regarding these targets.”
From Performance Evaluation of Multiplex Molecular Syndromic Panel vs. Singleplex PCR for Diagnosis of Acute Central Nervous System Infections (2025) · cites this paper as [14]
The QIA/ME panel exhibits similar performance to the FA/ME panel.
“A recent clinical trial [14], involving three European testing sites, demonstrated that the QIA/ME exhibits similar performance to the FA/ME.”
From Performance Evaluation of Multiplex Molecular Syndromic Panel vs. Singleplex PCR for Diagnosis of Acute Central Nervous System Infections (2025) · cites this paper as [14]
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“A recent clinical trial [14], involving three European testing sites, demonstrated that the QIA/ME exhibits similar performance to the FA/ME.”
- Authors
- Sundelin, T., Bialas, J., de Diego, J., Hermanowski, M., Leibhan, H., Ponderand, L., Juanola-Falgarona, M., Jones, T., Rey, M., Johnson, S., Pareja, J., & Caspar, Y.
- Affiliations
- Herlev Hospital (DK)
- Charité – Universitätsmedizin Berlin (DE)
- Labor Berlin-Charite Vivantes Services GmbH , Berlin, Germany
- Laboratoire de bactériologie, CHU Grenoble Alpes , La Tronche, France
- STAT-Dx Life S.L. (a QIAGEN Company), Carrer de Baldiri Reixac , Barcelona, Spain
- Qiagen (United Kingdom) (GB)
- Qiagen (Spain) (ES)
- Centre National de la Recherche Scientifique (FR)
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2023-10-24
- Volume
- 61
- Issue
- 10
- Pages
- e0042623-e0042623
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC10595057
- OpenAlex
- W4386705223
- Cited by
- 33
- References
- 21
- Citations by year
- 2026: 7 · 2025: 19 · 2024: 7
- FWCI
- 6.42
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Clinical Microbiology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Bacterial Identification and Susceptibility Testing
- Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
- Health Sciences › Medicine › Infectious Diseases › Infectious Encephalopathies and Encephalitis
- Keywords
- multiplex PCR, community-acquired meningitis, encephalitis, central nervous system infection, cerebrospinal fluid, diagnostic accuracy, Neisseria meningitidis, Streptococcus agalactiae, Escherichia coli K1, Listeria monocytogenes, Cryptococcus gattii, Cryptococcus neoformans, Haemophilus influenzae, Streptococcus pneumoniae, herpes simplex virus, viral encephalitis, rapid pathogen detection
- MeSH terms
- Encephalitis, Humans, Meningitis, Meningoencephalitis, Retrospective Studies, Multiplex Polymerase Chain Reaction
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