不同方法检测抗 PLA2R 抗体的性能和临床实用性比较。
Comparison of performance and clinical utility of different methods for detecting anti-PLA2R antibody.
机构信息
Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; Zhengzhou University, Zhengzhou, China.
Department of Nephrology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; Nephrology Laboratory, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; Laboratory Animal Platform of Academy of Medical Sciences, Zhengzhou University, Zhengzhou, China; Zhengzhou University, Zhengzhou, China.
出版信息
Clin Chim Acta. 2023 Aug 1;548:117514. doi: 10.1016/j.cca.2023.117514. Epub 2023 Aug 9.
OBJECTIVES
This study aimed to compare the performance of enzyme-linked immunosorbent assay (ELISA) and magnetic particle chemiluminescence immunoassay (MP-CLIA) for detecting anti-phospholipase A2 receptor (PLA2R) antibody and their clinical significance in idiopathic membranous nephropathy (IMN) patients.
METHODS
Serum samples from 448 patients with different types of nephropathy, including 222 with IMN, were tested using both methods. Sensitivity, specificity, and prognostic significance of PLA2R antibody levels were evaluated.
RESULTS
Similar sensitivity and specificity of ELISA and MP-CLIA in identifying IMN patients was found. However, MP-CLIA performed better than ELISA in predicting the prognosis of IMN patients. Adjusting the cutoff value reduced the false-negative rate in both methods. Logistic regression analysis identified six variables, including MP-CLIA-PLA2R levels, eGFR, lymphocyte count, B lymphocyte count, NK cell count, and complement 4, as predictors of renal function outcomes in IMN patients.
CONCLUSIONS
Both ELISA and MP-CLIA are reliable methods for detecting anti-PLA2R antibodies in IMN patients. However, MP-CLIA is more accurate in predicting the prognosis of IMN. Combining MP-CLIA-PLA2R with other variables can help predict renal function outcomes in IMN patients. Our study emphasizes the importance of considering both analytical performance and clinical utility when selecting a PLA2R antibody assay kit.
目的
本研究旨在比较酶联免疫吸附测定（ELISA）和磁微粒化学发光免疫分析（MP-CLIA）检测抗磷脂酶 A2 受体（PLA2R）抗体的性能及其在特发性膜性肾病（IMN）患者中的临床意义。
方法
采用两种方法检测了来自 448 例不同类型肾病患者（包括 222 例 IMN 患者）的血清样本。评估了 PLA2R 抗体水平的敏感性、特异性和预后意义。
结果
发现 ELISA 和 MP-CLIA 在识别 IMN 患者方面具有相似的敏感性和特异性。然而，MP-CLIA 在预测 IMN 患者的预后方面优于 ELISA。调整截断值可降低两种方法的假阴性率。Logistic 回归分析确定了 6 个变量，包括 MP-CLIA-PLA2R 水平、eGFR、淋巴细胞计数、B 淋巴细胞计数、NK 细胞计数和补体 4，作为预测 IMN 患者肾功能结局的指标。
结论
ELISA 和 MP-CLIA 均是检测 IMN 患者抗 PLA2R 抗体的可靠方法。然而，MP-CLIA 在预测 IMN 的预后方面更为准确。结合 MP-CLIA-PLA2R 与其他变量可有助于预测 IMN 患者的肾功能结局。本研究强调在选择 PLA2R 抗体检测试剂盒时，既要考虑分析性能，又要考虑临床实用性。
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