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.
Keywords: Diagnosis; PCR; Prosthetic joint infection.