Abstract
Ruling out an infection in one-stage knee and hip revisions for presumed aseptic failure by conventional tissue cultures takes up to 14 days. Multiplex polymerase chain reaction (mPCR) is a quick test (4–5 h) for detecting pathogens. The purpose of this study was to evaluate the diagnostic accuracy of an automated mPCR of synovial fluid obtained intraoperatively in unsuspected knee and hip revisions. A prospective study was conducted with 200 patients undergoing a one-stage knee or hip revision. Synovial fluid was analyzed with the mPCR Unyvero implant and tissue infection G2 cartridge (U-ITI G2) system and compared to intraoperative tissue cultures. The primary outcome measure was the diagnostic accuracy, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), of the mPCR U-ITI G2 system compared to conventional cultures. In the knee revision group, there were no patients with a positive mPCR in combination with positive cultures. This resulted in a non-calculable sensitivity and PPV. The specificity and NPV in the knee revision group of the mPCR compared to tissue cultures was 96.8% and 96.8%, respectively. In the hip revision group, the sensitivity, specificity, PPV, and NPV of the mPCR compared to tissue cultures was 36.4%, 96.6%, 57.1%, and 92.5%, respectively. Sixteen mismatches occurred between the mPCR and tissue cultures. The mPCR U-ITI G2 system is a quick and reliable synovium fluid test for ruling out infection in presumed aseptic knee and hip revisions with a high NPV compared with tissue cultures, although some mismatches were observed. Periprosthetic tissue cultures are still advised as back-up for false negative and positive mPCR test results.
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The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.
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Acknowledgments
We would like to thank Charlotte van der Velden for drafting the initial protocol of this study. In addition, we thank the PJI unit of the Sint Maartenskliniek (Denise Telgt, Karin Veerman, Fidel Vos, Marrigje Nabuurs) for their critical and valuable discussions. We thank Malou te Molder and Nathalie Pruijn for assisting with a number of analyses. Furthermore, we thank Curetis (Holzgerlingen, Germany) for installing a Unyvero implant and tissue infection multiplex PCR System for this study in the hospital. The company had no influence in the design of the study nor the interpretation of the results.
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The study was performed in line with the principles of the Declaration of Helsinki and the ICH Guidelines for Good Clinical Practice. A waiver was granted by medical ethical Committee on Research Involving Human Subjects Radboudumc (registration number 2017-3549; 7-9-2017).
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Jacobs, A.M.E., Heesterbeek, P.J.C., Bovendeert, F.A.T. et al. Ruling out underlying infection in 200 presumed aseptic knee and hip revision arthroplasties using a multiplex PCR system. Eur J Clin Microbiol Infect Dis 40, 1283–1290 (2021). https://doi.org/10.1007/s10096-021-04155-z
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DOI: https://doi.org/10.1007/s10096-021-04155-z