新型即时检测 calprotectin 在全膝关节置换术后假体周围关节感染中的诊断效用：一项前瞻性队列研究。
Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Periprosthetic Joint Infection After Total Knee Arthroplasty: A Prospective Cohort Study.
机构信息
Department of Orthopedic Surgery, Cleveland Clinic, Cleveland, Ohio.
Department of Orthopedic Surgery, Cleveland Clinic Florida, Weston, Florida.
出版信息
J Bone Joint Surg Am. 2021 Jun 2;103(11):1009-1015. doi: 10.2106/JBJS.20.01089.
BACKGROUND
Despite several synovial fluid biomarkers for the diagnosis of periprosthetic joint infection (PJI) having been investigated, point-of-care (POC) tests using these biomarkers are not widely available. Synovial calprotectin has recently been reported to effectively exclude the diagnosis of PJI. Thus, the objective of this study was to test the value of a calprotectin POC test for PJI diagnosis in patients undergoing total knee arthroplasty (TKA) using the 2013 Musculoskeletal Infection Society (MSIS) PJI diagnosis criteria as the gold standard.
METHODS
Synovial fluid samples were prospectively collected from 123 patients who underwent revision TKA at 2 institutions within the same health-care system from October 2018 to January 2020. The study was conducted under institutional review board approval. Data collection comprised demographic, clinical, and laboratory data in compliance with the MSIS criteria. Synovial fluid samples were analyzed by calprotectin POC tests in accordance with the manufacturer's instructions. Revisions were categorized as septic or aseptic using MSIS criteria by 2 independent reviewers blinded to the calprotectin results. Calprotectin test performance characteristics with sensitivities, specificities, positive predictive values, negative predictive values, and areas under the receiver operating characteristic curve (AUC) were calculated for 2 different PJI diagnosis scenarios: (1) a threshold of ≥50 mg/L, and (2) a threshold of ≥14 mg/L.
RESULTS
According to the MSIS criteria, 53 revision TKAs were septic and 70 revision TKAs were aseptic. In the ≥50-mg/mL threshold scenario, the calprotectin POC performance showed a sensitivity of 98.1%, a specificity of 95.7%, a positive predictive value of 94.5%, a negative predictive value of 98.5%, and an AUC of 0.969. In the ≥14-mg/mL threshold scenario, the sensitivity was 98.1%, the specificity was 87.1%, the positive predictive value was 85.2%, the negative predictive value was 98.4%, and the AUC was 0.926.
CONCLUSIONS
The calprotectin POC test has excellent PJI diagnostic characteristics, including high sensitivity and specificity in patients undergoing revision TKA. This test could be effectively implemented as a rule-out test. However, further investigations with larger cohorts are necessary to validate these results.
LEVEL OF EVIDENCE
Diagnostic Level I. See Instructions for Authors for a complete description of levels of evidence.
背景
尽管已经研究了几种用于诊断假体周围关节感染（PJI）的关节滑液生物标志物，但使用这些生物标志物的即时检测（POC）测试并未广泛应用。最近有报道称，关节滑液钙卫蛋白可有效排除 PJI 的诊断。因此，本研究旨在使用 2013 年肌肉骨骼感染学会（MSIS）PJI 诊断标准作为金标准，检验 POC 钙卫蛋白检测在接受全膝关节置换术（TKA）的患者中诊断 PJI 的价值。
方法
本前瞻性研究于 2018 年 10 月至 2020 年 1 月在同一医疗系统的 2 家机构，对接受翻修 TKA 的 123 例患者采集关节滑液样本。本研究获得了机构审查委员会的批准。数据采集符合 MSIS 标准，包括人口统计学、临床和实验室数据。根据制造商的说明，通过 POC 钙卫蛋白检测分析关节滑液样本。通过 2 位独立的盲法审核钙卫蛋白检测结果的审查员，使用 MSIS 标准将翻修手术分为感染性和非感染性。计算了两种不同 PJI 诊断场景下（1）≥50mg/L 阈值和（2）≥14mg/L 阈值时，钙卫蛋白检测的性能特征，包括敏感性、特异性、阳性预测值、阴性预测值和受试者工作特征曲线（ROC）下面积（AUC）。
结果
根据 MSIS 标准，53 例翻修 TKA 为感染性，70 例为非感染性。在≥50mg/ml 阈值情况下，POC 钙卫蛋白检测的敏感性为 98.1%，特异性为 95.7%，阳性预测值为 94.5%，阴性预测值为 98.5%，AUC 为 0.969。在≥14mg/ml 阈值情况下，敏感性为 98.1%，特异性为 87.1%，阳性预测值为 85.2%，阴性预测值为 98.4%，AUC 为 0.926。
结论
在接受翻修 TKA 的患者中，钙卫蛋白 POC 检测具有出色的 PJI 诊断特征，包括高敏感性和特异性。该检测可作为一种排除性检测有效实施。但是，还需要更大样本量的研究来验证这些结果。
证据等级
诊断 1 级。请参阅作者须知，以获取完整的证据等级描述。
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