摘要

Background: Periprosthetic joint infection (PJI) is a complication of total joint arthroplasty (TJA). The leukocyte esterase (LE) strip test and histology are diagnostic methods for PJI. The aims of this study were to determine the sensitivity and specificity of the LE strip test and to compare it with histology in the diagnosis of PJI. Material/Methods: Between January and December 2015, 93 patients who underwent TJA with PJI were enrolled in the study. Synovial fluid samples were tested with an LE strip, and three synovial tissue samples from each patient underwent frozen section and formalin-fixed histology. Recent criteria from the Musculoskeletal Infection Society (MSIS) were used for the diagnosis of PJI. Results: Ninety-three patients studied included 38 cases of PJI and 55 non-infected cases. Sensitivity and specificity of the LE strip test were 92.1% (95% CI, 77.5-97.9%) and 96.4% (95% CI, 86.4-99.4%), respectively. There was no significant difference in sensitivity (p=0.249) or specificity (p=0.480) between frozen and paraffin sections for histology; the two methods were strongly correlated (phi=0.892). Comparison of the LE test results with histology showed a strong correlation (phi=0.758, and phi=0.840). Conclusions: The findings of this preliminary study have shown that the LE strip test on synovial fluid showed similar sensitivity and specificity as histology for the diagnosis of PJI, indicating that that further controlled clinical studies should be performed to investigate the role of the LE strip test for the early diagnosis of PJI.