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. 2024 Dec;96(12):e70103.
doi: 10.1002/jmv.70103.

Performance Evaluation of Molecular Detection of Enteroviruses: Results of 18 Years of Quality Control for Molecular Diagnostics (QCMD) External Quality Assessment Program, 2005-2022

Kimberley S M Benschop  1 , Harry Staines  2   3 , Emily Mckloud  3 , Elaine McCulloch  3 , Dorothy Montgomery  3 , Greg Sutton  3 , Oliver Donoso Mantke  3 , Anton van Loon  3
Affiliations

Performance Evaluation of Molecular Detection of Enteroviruses: Results of 18 Years of Quality Control for Molecular Diagnostics (QCMD) External Quality Assessment Program, 2005-2022

Kimberley S M Benschop et al. J Med Virol. 2024 Dec.

Abstract

The gold standard for enterovirus (EV) detection is the polymerase chain reaction based on the detection of the 5' untranslated region of the virus. Correct detection of EV is crucial for patient and public health purposes. The performance of diagnostic and public health laboratories on molecular EV-detection was analyzed using data from the external quality assessment program distributed by Quality Control for Molecular Diagnostics (QCMD) between 2005 and 2022. Overall performance on core samples of both laboratory types has improved over the years for in-house or commercial assays (overall performance rate > 94.8%) since 2013. A similar improvement was observed for negative/specificity samples. Performance on EV-positive samples varied, with the lowest performance observed on samples containing enterovirus D68 (B3 strain) and echovirus 11. Significant differences in performance were observed between laboratory and assay types. Performance of diagnostic laboratories (91.8) was significantly higher than of public health laboratories (89.9%; p < 0.0001). Additionally, a significant higher performance of diagnostic laboratories using commercial assays was observed (92.5% vs. 91.2% for in-house assays; p < 0.0001). In contrast, the performance of public health laboratories using in-house assays (90.1%) was higher than commercial assays (89.2%; p = 0.3608). The data document the improved performance of diagnostic and public health laboratories using either commercial or in-house assays.

Keywords: QCMD; commercial assay; enterovirus; external quality assessment; in‐house assay; laboratory.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Overall performance on core samples tested by laboratory type (A and B by year and C pooled over time) and assay type (B by year and C pooled over time) within the QCMD Enterovirus EQA program for molecular detection from 2005 to 2022.
Figure 2
Figure 2
Commercial assay‐related performance with odds ratios of the top five most commercial assays used: Argene, Biomerieux, Cepheid, ELITech, and Fast‐track diagnostics within the QCMD Enterovirus EQA program for molecular detection from 2005 to 2022.
Figure 3
Figure 3
Performance on EV‐positive core samples overall (A) and by laboratory type (B) and assay type (C) within the QCMD Enterovirus EQA program for molecular detection from 2005 to 2022.
See this image and copyright information in PMC

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References

    1. Picornavirus Study Group , accessed June 2024, 2024, http://www.picornastudygroup.com/.
    1. Harvala H., Benschop K. S. M., Berginc N., et al., “European Non‐Polio Enterovirus Network: Introduction of Hospital‐Based Surveillance Network to Understand the True Disease Burden of Non‐Polio Enterovirus and Parechovirus Infections in Europe,” Microorganisms 9, no. 9 (2021): 1827. - PMC - PubMed
    1. Harvala H., Broberg E., Benschop K., et al., “Recommendations for Enterovirus Diagnostics and Characterisation Within and Beyond Europe,” Journal of Clinical Virology 101 (2018): 11–17. - PubMed
    1. Harvala H., Jasir A., Penttinen P., Pastore Celentano L., Greco D., and Broberg E., “Surveillance and Laboratory Detection for Non‐Polio Enteroviruses in the European Union/European Economic Area, 2016,” Eurosurveillance 22, no. 45 (2017): 16–00807, 10.2807/1560-7917.ES.2017.22.45.16-00807. - DOI - PMC - PubMed
    1. Bubba L., Broberg E. K., Jasir A., et al., “Circulation of Non‐Polio Enteroviruses in 24 EU and EEA Countries Between 2015 and 2017: A Retrospective Surveillance Study,” Lancet Infectious Diseases 20, no. 3 (2020): 350–361. - PubMed

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