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Performance evaluation of a newly developed molecular assay for the accurate diagnosis of gastroenteritis associated with norovirus of genogroup II

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Abstract

The performance of a newly proposed fully automated cassette-based sample-to-results solution for norovirus (NoV) detection, InGenius Norovirus ELITe MGB®, was evaluated. A total of 120 selected archival stool samples from children hospitalized for acute gastroenteritis were used to compare the results to a reference real-time RT-PCR. The InGenius NoV assay showed optimal diagnostic accuracy (sensitivity, 100%; specificity, 95.7%) and was able to correctly detect the entire wide panel of epidemiologically relevant genotypes tested. These preliminary results suggest that the InGenius NoV assay can be recommended as a valuable method for accurate diagnosis of NoV GII infection in epidemic and sporadic gastroenteritis.

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Acknowledgements

We wish to thank ELITechGroup Molecular Diagnostics for providing InGenius kits and consumables used in this study and additional financial support. The funders had no role in the decision to submit the work for publication.

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Authors and Affiliations

  1. Department of Health Promotion Sciences and Mother and Child Care “G. D’Alessandro”, University of Palermo, Via del Vespro, 133, 90127, Palermo, Italy

    Simona De Grazia, Floriana Bonura, Vincenzo Cappa, Sara Li Muli, Arcangelo Pepe, Noemi Urone & Giovanni M. Giammanco

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  1. Simona De Grazia
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  2. Floriana Bonura
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  3. Vincenzo Cappa
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  4. Sara Li Muli
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  6. Noemi Urone
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  7. Giovanni M. Giammanco
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Corresponding author

Correspondence to Simona De Grazia.

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The authors declare that they have no conflict of interest.

Ethical approval

Ethical approval was granted by University Hospital Ethical Committee Palermo 1 (No. 02/2017).

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Handling Editor: Tim Skern.

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De Grazia, S., Bonura, F., Cappa, V. et al. Performance evaluation of a newly developed molecular assay for the accurate diagnosis of gastroenteritis associated with norovirus of genogroup II. Arch Virol 163, 3377–3381 (2018). https://doi.org/10.1007/s00705-018-4010-8

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  • DOI: https://doi.org/10.1007/s00705-018-4010-8

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