4种抗磷脂酶A2受体抗体检测方法在诊断原发性膜性肾病中的比较

doi:10.3969/j.issn.1673-8640.2026.09.009

摘要/Abstract

摘要：

目的探讨4种方法[酶联免疫吸附试验（ELISA）、间接免疫荧光法（IFA）、流式荧光发光法（FLIA）和化学发光免疫分析法（CLIA）]检测抗磷脂酶A2受体（PLA2R）抗体在原发性膜性肾病（PMN）诊断中的性能。方法选取2023年9月—2024年6月上海市第一人民医院PMN患者103例（PMN组）、非PMN患者177例（非PMN组）、正常对照者40名（正常对照组）。收集所有研究对象的临床资料，并采用4种方法同时检测血清抗PLA2R抗体。采用受试者工作特征（ROC）曲线得出4种方法检测抗PLA2R抗体诊断PMN的最佳临界值，采用正常对照组血清样本验证临界值。结果 IFA、CLIA、FLIA、ELISA检测血清抗PLA2R抗体的敏感性分别为84.47 %、82.52 %、78.64 %、63.11 %，特异性均为100 %。ELISA、FLIA、CLIA检测血清抗PLA2R抗体诊断PMN的曲线下面积（AUC）分别为0.988 2、0.988 7、0.970 7，临界值分别设定为2.730 RU·mL^-1、7.015 U·mL^-1、3.705 U·mL^-1时，可提升敏感性而不显著降低特异性。IFA的临界值取1∶10时，诊断PMN的效能最高。结论 4种方法中IFA的敏感性最高，CLIA和FLIA次之，ELISA最低。ELISA、FLIA、CLIA的临界值分别取2.730 RU·mL^-1、7.015 U·mL^-1、3.705 U·mL^-1时，可提高PMN的诊断敏感性而不显著降低特异性。

关键词: 抗磷脂酶A2受体抗体, 间接免疫荧光法, 流式荧光发光法, 化学发光免疫分析法, 原发性膜性肾病

Abstract:

Objective To investigate the performance of 4 methods [enzyme-linked immunosorbent assay （ELISA），indirect immunofluorescence assay（IFA），flow luminescence immunoassay（FLIA）and chemiluminescence immunoassay（CLIA）] in determining anti-phospholipase A2 receptor（PLA2R）antibodies in the diagnosis of primary membranous nephropathy（PMN）. Methods A total of 103 patients with PMN（PMN group），177 patients without PMN（non-PMN group）and 40 healthy subjects（healthy control group）were enrolled from Shanghai General Hospital from September 2023 to June 2024. The clinical data were collected，and serum anti-PLA2R antibodies were determined using the 4 methods. The optimal cut-off value for determining anti-PLA2R antibodies in diagnosing PMN was obtained using receiver operating characteristic（ROC）curve，and the cut-off value was verified using the serum samples of healthy control group. Results The sensitivities of IFA，CLIA，FLIA and ELISA for determining serum anti-PLA2R antibodies were 84.47%，82.52%，78.64% and 63.11%，respectively. The specificities were 100%. The areas under curves（AUC）for determining serum anti-PLA2R antibodies in diagnosing PMN by ELISA，FLIA and CLIA were 0.988 2，0.988 7 and 0.970 7，respectively. The cut-off values were set at 2.730 RU·mL^-1， 7.015 U·mL^-1 and 3.705 U·mL^-1，respectively，which could improve the sensitivity without significantly reducing the specificity. The cut-off value of IFA was 1∶10，and its diagnostic efficacy for PMN was the highest. Conclusions Among the 4 methods，IFA has the highest sensitivity，followed by CLIA and FLIA，and ELISA has the lowest. When the cut-off values of ELISA，FLIA and CLIA are set at 2.730 RU·mL^-1，7.015 U·mL^-1 and 3.705 U·mL^-1，respectively，the diagnostic sensitivity of PMN could be improved without significantly reducing specificity.

Key words: Anti-phospholipase A2 receptor antibody, Indirect immunofluorescence assay, Flow luminescence immunoassay, Chemiluminescence immunoassay, Primary membranous nephropathy

中图分类号:

R446.62

王均芬, 俞琦, 娄加陶, 范秋灵, 张如霖, 张荣, 孙懿. 4种抗磷脂酶A2受体抗体检测方法在诊断原发性膜性肾病中的比较[J]. 检验医学, 2026, 41(9): 879-883.

WANG Junfen, YU Qi, LOU Jiatao, FAN Qiuling, ZHANG Rulin, ZHANG Rong, SUN Yi. Comparison of 4 anti-phospholipase A2 receptor antibody determination methods in the diagnosis of primary membranous nephropathy[J]. Laboratory Medicine, 2026, 41(9): 879-883.

图/表 3

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