Abstract
Objectives
The Unyvero molecular assay was tested for the clinical resolution of discordant results, evaluating its role in prosthetic joint infection diagnosis.
Methods
Multiplex PCR was performed on 45 samples from prosthesis treatment (either sonication or dithiothreitol). Analytical performance was compared to that of biofilm culture using Musculoskeletal Infection Society criteria as gold standard.
Results
Unyvero and biofilm culture showed similar agreement rates compared to the gold standard (34/43 and 32/43, respectively). Both methods showed six additional identifications compatible with true infection; five positive results from biofilm culture were deemed contaminations.
Conclusions
The Unyvero system showed good performances and a significantly shorter turnaround time compared to cultural methods, presenting an added value to PJI diagnosis even when performed following a composite approach.
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Acknowledgements
The authors wish to thank Curetis® for providing free of charge the devices and consumables necessary for the study as a trial run. The company played no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript.
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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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All authors declare no conflicts of interest and no competing financial interests.
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Ethical approval or informed consent was not required, since the study has been performed using exclusively anonymized leftover samples derived from a previous study. The anonymization was achieved by using the current procedure (AVR-PPC P09, rev.2) checked by the local Ethical Board.
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Zannoli, S., Sambri, A., Morotti, M. et al. Unyvero ITI® system for the clinical resolution of discrepancies in periprosthetic joint infection diagnosis. Musculoskelet Surg 105, 39–42 (2021). https://doi.org/10.1007/s12306-019-00626-x
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DOI: https://doi.org/10.1007/s12306-019-00626-x