Department of Orthopaedics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Bone Joint J. 2019 Aug;101-B(8):970-977. doi: 10.1302/0301-620X.101B8.BJJ-2018-1390.R2.
The aim of this study was to evaluate the diagnostic accuracy of the synovial alpha-defensin enzyme-linked immunosorbent assay (ELISA) for the diagnosis of prosthetic joint infection (PJI) in the work-up prior to revision of total hip (THA) and knee arthroplasty (TKA).
Inclusion criteria for this prospective cohort study were acute or chronic symptoms of the index joint without specific exclusion criteria. Synovial fluid aspirates of 202 patients were analyzed and semiquantitative laboratory alpha-defensin ELISA was performed. Final diagnosis of PJI was established by examination of samples obtained during revision surgery.
Sensitivity and specificity of the alpha-defensin ELISA for PJI were 78.2% (95% confidence interval (CI) 66.7 to 88.5) and 96.6% (95% CI 93.0 to 99.3). Positive and negative predictive values were 89.6% (95% CI 80.6 to 97.8) and 92.2% (95% CI 87.5 to 96.1). The test remained false-negative in 22% of septic revisions, most of which were due to coagulase-negative staphylococci all occurring in either late-chronic or early-postoperative PJI.
The routine use of synovial fluid alpha-defensin laboratory ELISA in the preoperative evaluation of symptomatic THAs and TKAs is insufficient to accurately diagnose PJI. Particularly in cases involving low-virulence organisms, such as coagulase-negative staphylococci, there remains a need for tests with a higher sensitivity. Cite this article: 2019;101-B:970-977.
本研究旨在评估关节液α-防御素酶联免疫吸附试验(ELISA)在全髋关节(THA)和膝关节置换术(TKA)翻修术前评估中对诊断假体关节感染(PJI)的诊断准确性。
本前瞻性队列研究的纳入标准为索引关节有急性或慢性症状,但无特定排除标准。分析了 202 例患者的关节滑液抽吸物,并进行了半定量实验室α-防御素 ELISA 检测。通过翻修术中获得的样本检查确定 PJI 的最终诊断。
α-防御素 ELISA 对 PJI 的敏感性和特异性分别为 78.2%(95%置信区间 66.7 至 88.5)和 96.6%(95%置信区间 93.0 至 99.3)。阳性和阴性预测值分别为 89.6%(95%置信区间 80.6 至 97.8)和 92.2%(95%置信区间 87.5 至 96.1)。在 22%的感染性翻修中,该检测仍为假阴性,其中大多数为凝固酶阴性葡萄球菌引起,均发生于迟发性慢性或早期术后 PJI。
在有症状的 THA 和 TKA 的术前评估中,常规使用关节液α-防御素实验室 ELISA 不足以准确诊断 PJI。在涉及低毒力病原体(如凝固酶阴性葡萄球菌)的情况下,仍需要具有更高敏感性的检测方法。