PURPOSE: This prospective study was undertaken to evaluate the diagnostic accuracy of the Synovasure™ α-defensin lateral flow assay to detect or exclude infection and to compare it to the sensitivity and specificity of other diagnostic criteria according to the International Consensus Group on Periprosthetic Joint Infection (PJI). METHODS: All patients who have undergone revision total knee arthroplasty (TKA) from September 2015 to July 2016 were included: 16 chronic (more than 3 months after performing arthroplasty) infections and 35 aseptic joints were identified. The diagnostic performance of single test was assessed by receiver operating characteristic (ROC) curve analyses. The sensitivity and specificity were calculated for each of the cut-off values and the area under the curve (AUC) was also calculated. RESULTS: The median synovial fluid (SF) leukocyte count, as well as the neutrophil percentage, was significantly higher in patients with PJI than in those with aseptic failure (p < 0.001). The sensitivity of α-defensin was 87.5% (95%; CI 74.6-94.7), the specificity was 97.1% (95% CI 86.9-99.7), the positive predictive value 93.3% (95% CI 81.8-98.1), and negative predictive value was 94.4% (95% CI 83.2-98.6). The results in terms of sensitivity and negative predictive value were greater than those of the other tests (cultures, synovial cell count, erythrocyte sedimentation rate, and C-reactive protein). The diagnostic accuracy of α-defensin, with an area under the curve of 0.92, was found to be higher than all the minor criteria for PJI. CONCLUSIONS: In this study, the α-defensin lateral flow test was found to have the highest performance of all tests studied to identify PJI. Synovasure™ holds the potential to be included in the daily clinical practice. LEVEL OF EVIDENCE: Level I diagnostic study.
- Periprosthetic joint infection
- Revision knee arthroplasty
- Synovial fluid