Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Mar 15;13(6):1110.
doi: 10.3390/diagnostics13061110.

Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections

Hervé Le Bars  1 , Neil Madany  2 , Claudie Lamoureux  1   3 , Clémence Beauruelle  1   3 , Sophie Vallet  2   3 , Christopher Payan  2   3 , Léa Pilorgé  2
Affiliations

Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections

Hervé Le Bars et al. Diagnostics (Basel). .

Abstract

Point-of-care syndromic PCR (POC SPCR) assays are useful tools for the rapid detection of the most common causative agents of community-acquired infections responsible for meningitis and encephalitis infections. We evaluated the performance characteristics of the new QIAstat-Dx® Meningitis/Encephalitis panel (QS) compared to the laboratory reference methods and the POC SPCR Biofire® FilmArray® Meningitis Encephalitis Panel (FA). Viral (Enterovirus, Parechovirus, HSV-1, HSV-2, HHV-6, VZV) and bacterial (E. coli K1, H. influenzae, L. monocytogenes, encapsulated N. meningitidis, M. pneumoniae, S. agalactiae, S. pneumoniae, S. pyogenes) pathogens were suspended at low concentrations and tested with the POC SPCR systems. The reproducibility, analytical specificity, carryover contamination, interferences and clinical samples were evaluated. All samples tested positive with both QS and FA except for those containing the lowest concentrations of Enterovirus-D68-B3, Echovirus-30 and S. agalactiae which were only detected by FA. In terms of analytical specificity, we observed 3 false positive results out of 48 QS tests versus 1 out of 37 FA tests. For the other studied criteria, both QS and FA performed as expected. Our results suggest that the performance characteristics of QS are close to those of FA. A prospective multicenter study would be useful to complete the performances evaluation of QS.

Keywords: PCR; bacteria; cerebrospinal fluid; encephalitis; meningitis; point of care; syndromic; virus.

PubMed Disclaimer

Conflict of interest statement

The corresponding author states on behalf of all the authors that all potential conflicts of interest have been disclosed.

Figures

Figure 1
Figure 1
Strategy for assessing the detection of low viral and Mp loads, from step 1 to 3, using CSF diluted pool with positive results with R-GENE® in 5 replicates and tested by two point-of-care syndromic PCR QIAstat Dx® (QS) and FilmArray® (FA).
See this image and copyright information in PMC

References

    1. Choi J.J., Westblade L.F., Gottesdiener L.S., Liang K., Li H.A., Wehmeyer G.T., Glesby M.J., Simon M.S. Impact of a multiplex polymerase chain reaction panel on duration of empiric antibiotic therapy in suspected bacterial meningitis. Open Forum Infect. Dis. 2021;8:ofab467. doi: 10.1093/ofid/ofab467. - DOI - PMC - PubMed
    1. Clague M., Kim C., Zucker J., Green D.A., Sun Y., Whittier S., Thakur K.T. Impact of implementing the cerebrospinal fluid FilmArray Meningitis/Encephalitis panel on duration of intravenous acyclovir treatment. Open Forum Infect. Dis. 2022;9:ofac356. doi: 10.1093/ofid/ofac356. - DOI - PMC - PubMed
    1. Hoen B., Varon E., de Debroucker T., Fantin B., Grimprel E., Wolff M., Duval X., Expert and Reviewing Group Management of acute community-acquired bacterial meningitis (excluding newborns). Long version with arguments. Med. Mal. Infect. 2019;49:405–441. doi: 10.1016/j.medmal.2019.03.009. - DOI - PubMed
    1. Menasalvas-Ruiz A.I., Salvador-Garcia C., Moreno-Docon A., Alfayate-Miguelez S., Perez Canovas C., Sanchez-Solis M. Enterovirus reverse transcriptase polymerase chain reaction assay in cerebrospinal fluid: An essential tool in meningitis management in childhood. Enferm. Infecc. Microbiol. Clin. 2013;31:71–75. doi: 10.1016/j.eimc.2012.07.007. - DOI - PubMed
    1. Trujillo-Gomez J., Tsokani S., Arango-Ferreira C., Atehortua-Munz S., Jimenez-Villegas M.J., Serrano-Tabares C., Veroniki A.A., Florez I.D. Biofire Filmarray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections: A systematic review and diagnostic test accuracy meta-analysis. EClinicalMedicine. 2022;44:101275. doi: 10.1016/j.eclinm.2022.101275. - DOI - PMC - PubMed

LinkOut - more resources