血清抗 PLA2R 抗体作为特发性膜性肾病的诊断生物标志物：中国患者的最佳截断值。
Serum anti-PLA2R antibody as a diagnostic biomarker of idiopathic membranous nephropathy: The optimal cut-off value for Chinese patients.
机构信息
Department of Nephrology, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan 250014, China.
Department of Nephrology, Shandong Provincial Qianfoshan Hospital, Shandong University, Jinan 250014, China.
出版信息
Clin Chim Acta. 2018 Jan;476:9-14. doi: 10.1016/j.cca.2017.11.006. Epub 2017 Nov 7.
BACKGROUND
The M-type phospholipase A2 receptor (PLA2R) is a specific target autoantigen identified in idiopathic membranous nephropathy (IMN). The autoantibody against PLA2R (anti-PLA2R) may be used to diagnose IMN. However, the appropriate diagnosis cut-off value for Chinese patients with IMN has not been established.
METHODS
In total, 119 patients who underwent renal biopsy (57 patients with IMN and 62 patients with non-IMN glomerulonephritis) and 22 healthy individuals were recruited for our observation study from Qianfoshan Hospital between September 2011 and March 2016. The serum concentration of anti-PLA2R was measured using a quantitative enzyme-linked immunosorbent assay (ELISA). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and receiver operating characteristic (ROC) curve of anti-PLA2R in diagnosing IMN were analysed based on the ELISA detection.
RESULTS
The sensitivity, specificity, PPV, and NPV of anti-PLA2R in the diagnosis of IMN in the Chinese patients were 82.5, 75, 69.1, and 86.3% for the 2RU/ml cut-off value; 78.9, 91.7, 86.5, and 86.5% for the 2.6RU/ml cut-off value; 59.6, 95.2, 89.5, and 77.7% for the 14RU/ml cut-off value; 50.9, 96.4, 90.6, and 74.3% for the 20RU/ml cut-off value; and 47.4, 97.6, 93.1, and 73.2% for the 40RU/ml cut-off value, respectively. The area under the ROC curve was 0.879.
CONCLUSIONS
The cut-off value of 2.6RU/ml is recommended for the use of anti-PLA2R for the diagnosis of IMN in Chinese patients based on the ELISA.
背景
M 型磷脂酶 A2 受体（PLA2R）是特异地在特发性膜性肾病（IMN）中发现的自身抗原靶标。针对 PLA2R 的自身抗体（抗-PLA2R）可用于诊断 IMN。然而，尚未建立针对中国 IMN 患者的适当诊断截断值。
方法
我们的观察性研究共纳入 2011 年 9 月至 2016 年 3 月期间在千佛山医院接受肾活检的 119 名患者（57 名 IMN 患者和 62 名非 IMN 肾小球肾炎患者）和 22 名健康个体。使用定量酶联免疫吸附试验（ELISA）测量血清抗-PLA2R 浓度。基于 ELISA 检测，分析了抗-PLA2R 在诊断 IMN 中的灵敏度、特异性、阳性预测值（PPV）、阴性预测值（NPV）和受试者工作特征（ROC）曲线。
结果
对于 2RU/ml 截断值，抗-PLA2R 诊断中国患者 IMN 的灵敏度、特异性、PPV 和 NPV 分别为 82.5%、75%、69.1%和 86.3%；对于 2.6RU/ml 截断值，分别为 78.9%、91.7%、86.5%和 86.5%；对于 14RU/ml 截断值，分别为 59.6%、95.2%、89.5%和 77.7%；对于 20RU/ml 截断值，分别为 50.9%、96.4%、90.6%和 74.3%；对于 40RU/ml 截断值，分别为 47.4%、97.6%、93.1%和 73.2%。ROC 曲线下面积为 0.879。
结论
根据 ELISA，建议将 2.6RU/ml 截断值用于中国患者的抗-PLA2R 诊断 IMN。
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