Performances analytiques et impact thérapeutique de la PCR multiplex Unyvero® ITI dans les infections ostéo-articulaires sur matériel

Abstract : The current diagnosis methods of periprosthetic joint infections (PJI) based on conventional culture, yield 10 to 30% of false negative results, and the time to results is long. Molecular methods represent a faster diagnostic alternative. The aim of this study was to evaluate the diagnostic performances of Unyvero ITI G2 multiplex PCR (Curetis) and the clinical impact of this PCR on therapeutic decisions. A prospective non-interventional monocenter study was performed including 21 patients with a suspicion of PJI. A multiplex PCR was performed on joint fluids in addition to standard culture. A group of experts (infectious disease specialists, orthopeadic surgeons, microbiologists) analyzed a posteriori the impact of the multiplex PCR in the patient management. Among the 22 analyzed samples, 9 were negative and 13 positive in culture. Of the 18 interpretable results, the rate of concordance was 67% (12/18). The sensitivity was 62% and the specificity 80%. The median time to results was shorter for the PCR (23h) than for the conventional culture (20 days). Of the 18 results presented to the expert group, the clinicians would have started an appropriate treatment sooner for 6 patients (from 2 to 22 days earlier), 6 results would have led to an erroneous therapeutic decision (erroneously stop or modification of an antibiotic treatment or surgical care) and 6 results would have had no clinical impact. This pilot study highlights the faster reporting of PCR results, that enable clinicians to start a targeted therapy earlier. The clinical impact of this antibiotherapy change is currently being further evaluated from a health-economic point of view.
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Master Thesis
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Claire Richarme. Performances analytiques et impact thérapeutique de la PCR multiplex Unyvero® ITI dans les infections ostéo-articulaires sur matériel. Sciences pharmaceutiques. 2018. ⟨dumas-02169365⟩

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