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Multicenter Study
. 2023 Oct 24;61(10):e0042623.
doi: 10.1128/jcm.00426-23. Epub 2023 Sep 13.

Evaluation of the QIAstat-Dx Meningitis/Encephalitis Panel, a multiplex PCR platform for the detection of community-acquired meningoencephalitis

Thomas Sundelin #  1 , Johanna Bialas #  2 , Juana de Diego  2 , Markus Hermanowski  2 , Hendrik Leibhan  2 , Léa Ponderand  3   4 , Marti Juanola-Falgarona  5 , Tara Jones  6 , Melisa Rey  5 , Sarah Johnson  6 , Josep Pareja  5 , Yvan Caspar #  3   4
Affiliations
Multicenter Study

Evaluation of the QIAstat-Dx Meningitis/Encephalitis Panel, a multiplex PCR platform for the detection of community-acquired meningoencephalitis

Thomas Sundelin et al. J Clin Microbiol. .

Abstract

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.

Keywords: QIAstat-Dx; encephalitis; meningitis; molecular diagnostics; multiplex; real-time PCR.

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Conflict of interest statement

QIAGEN provided support in the form of salaries for M.J.F., M.R., S.J., and J.P. T.J. was contracted by QIAGEN for clinical consulting. S.J. declares QIAGEN stock or stock option ownership. Y.C., L.P., J.B., M.H., J.D.D., H.L., and T.S. declare that their institution received financial support and study materials from QIAGEN to perform the study and that QIAGEN provided clinical writing support. T.S. declares to have received paid travel expenses by QIAGEN for a user meeting.

Figures

Fig 1
Fig 1
Flow chart diagram depicting the number of samples enrolled and analyzed. Asterisk (*) means that out of the 585 clinical specimens tested, the internal control failed to amplify for 6 specimens, but each of these 6 specimens was found to be positive for a pathogen. The positive results for these six specimens were valid, but the negative results were invalid and were not used in total analysis.
See this image and copyright information in PMC

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