Department of Orthopaedic Surgery and Traumatology, Inselspital, University Hospital of Bern, Bern, Switzerland.
Department of Orthopaedic Surgery and Traumatology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
Knee Surg Sports Traumatol Arthrosc. 2018 Oct;26(10):3039-3047. doi: 10.1007/s00167-018-4904-8. Epub 2018 Mar 20.
(1) To determine the overall accuracy of synovial alpha-defensin, synovial C-reactive protein (sCRP), interleukin-6 (sIL-6), and leukocyte esterase (sLE) as diagnostic markers for periprosthetic joint infection (PJI) and (2) to independantly evaluate the accuracy of both the laboratory-based ELISA alpha-defensin test and the Synovasure™ alpha-defensin test kit.
An EMBASE and MEDLINE (PubMed) database search was performed using a set of professionally set search terms. Two independent reviewers rated eligible articles. Sensitivity and specificity were meta-analysed using a bivariate random-effects model.
Accuracy values were extracted from 42 articles. Pooled sensitivity and specificity of the represented biomarkers were: alpha-defensin ELISA 0.97 (95% CI 0.91-0.99) and 0.97 (95% CI 0.94-0.98), respectively; Synovasure™ test kit assay 0.80 (95% CI 0.65-0.89) and 0.89 (95% CI 0.76-0.96), respectively; sLE 0.79 (95% CI 0.67-0.87) and 0.92 (95% CI 0.87-0.92), respectively; sIL-6 0.76 (95% CI 0.65-0.84) and 0.91 (95% CI 0.88-0.94), respectively; sCRP 0.86 (95% CI 0.81-0.91) and 0.90 (95% CI 0.86-0.93), respectively.
The labararory-based alpha-defensin ELISA test showed the highest ever reported accuracy for PJI diagnosis. However, this did not apply for the Synovasure™ alpha-defensin test, which was comparable in its overall diagnostic accuracy to sCRP, sIL-6 and sLE. The later biomarkers also did not yield an overall diagnostic accuracy higher than that previously reported for synovial white cell count (sWBC) or culture bacteriology. Based on current evidence, no synovial biomarker should be applied as a standalone diagnostic tool. Furthermore, the use of the laboratory-based alpha-defensin ELISA test should be encouraged, still, the Synovasure™ alpha-defensin test kit should be critically appreciated.
III.
（1）确定滑液 α-防御素、滑液 C 反应蛋白（sCRP）、白细胞介素 6（sIL-6）和白细胞酯酶（sLE）作为人工关节周围感染（PJI）的诊断标志物的整体准确性，（2）独立评估基于实验室的 ELISA α-防御素试验和 Synovasure™α-防御素试验试剂盒的准确性。
使用一套专业设定的搜索词在 EMBASE 和 MEDLINE（PubMed）数据库中进行搜索。两位独立的审查员对合格的文章进行了评分。使用双变量随机效应模型对敏感性和特异性进行了荟萃分析。
从 42 篇文章中提取了准确性值。代表生物标志物的汇总敏感性和特异性分别为：ELISA α-防御素 0.97（95%CI 0.91-0.99）和 0.97（95%CI 0.94-0.98）；Synovasure™试剂盒测定 0.80（95%CI 0.65-0.89）和 0.89（95%CI 0.76-0.96）；sLE 0.79（95%CI 0.67-0.87）和 0.92（95%CI 0.87-0.92）；sIL-6 0.76（95%CI 0.65-0.84）和 0.91（95%CI 0.88-0.94）；sCRP 0.86（95%CI 0.81-0.91）和 0.90（95%CI 0.86-0.93）。
基于实验室的 ELISA α-防御素试验在 PJI 诊断方面表现出了迄今为止报道的最高准确性。然而，这并不适用于 Synovasure™α-防御素试验，其整体诊断准确性与 sCRP、sIL-6 和 sLE 相当。后三种生物标志物的总体诊断准确性也没有高于之前报道的滑液白细胞计数（sWBC）或培养细菌学。基于当前的证据，没有一种滑膜生物标志物可以作为单独的诊断工具。此外，应鼓励使用基于实验室的 α-防御素 ELISA 试验，但应谨慎评估 Synovasure™α-防御素试验试剂盒。
III。
