Qualitative Alpha-defensin Versus The Main Available Tests For The Diagnosis Of Periprosthetic Joint Infection: Best Predictor Test?

Abstract. Introduction: Biomarkers such as α-defensin demonstrated to be a potentially useful option in periprosthetic joint infection (PJI) diagnosis. Recently, a new point-of-care test for α-defensin level detection in synovial fluid has been commercialized in Europe. The aim of this study is to compare the α-defensin test (Synovasure^TM) diagnostic ability with the main available clinical tests for periprosthetic joint infection diagnosis in a practical clinical setting of a Bone Infection Unit.

Methods: Between 2015 and 2017, 146 patients with suspected chronic PJI were screened with Synovasure^TM. Seventy-three of these met the Musculoskeletal Infection Society (MSIS) criteria and were included in the analysis. According to MSIS criteria, 40 patients (54.7%) were classified as infected and 33 (45.3%) as not infected. The results obtained with Synovasure^TM were recorded and compared with standard diagnostic methods for PJI diagnosis.

Results: Synovasure^TM showed a sensitivity of 85.0 % (95% CI 70.2 to 94.3) and a specificity of 96.9 % (95% CI 83.8 to 99.9) for PJI detection. The positive likelihood ratio of Synovasure^TM was 27.2 (95% CI 3.9 to 188.1) and the negative likelihood ratio was 0.2 (95% CI 0.1 to 0.3). The diagnostic odds ratio was 181.3 (95% CI 20.7 to 1590.4). Synovasure^TM demonstrated a statistical significant difference when compared to Erythrocyte Sedimentation Rate (ESR) and C-reactive Protein (CRP) specificity (at least one positive test) and preoperative culture sensitivity (1 positive culture).

Conclusion: Our findings show that Synovasure^TM sensitivity is lower than quantitative α-D test, but when compared to the main available tests shows a good specificity and the highest DOR. On the SF it is the easier test to do, due to the fact that it needs a minimal amount of SF and it is not limited by blood contamination or antibiotic use. Whereas there is no single standalone test, Synovasure^TM should be considered a reliable additional test for periprosthetic joint infection diagnosis in everyday clinical practice.