化学发光免疫分析法检测血浆肾素、醛固酮在原发性醛固酮增多症诊断中的价值  

Diagnostic value of measuring the plasma renin and aldosterone by chemiluminescence immunoassay in the primary aldosteronism

作　　者：程艾邦 李明轩 陈波[1] 曹晟 蒋塨豪 许建忠[1] 李燕[1] 王继光[1] CHENG Yibang;LI Mingxuan;CHEN Bo

机构地区：[1]上海交通大学医学院附属瑞金医院高血压科上海市高血压研究所,上海200025

出　　处：《诊断学理论与实践》2020年第5期474-480,共7页Journal of Diagnostics Concepts & Practice

摘　　要：目的:验证化学发光免疫分析法检测肾素、醛固酮的准确性,并探讨其在原发性醛固酮增多症(以下简称原醛)诊断中的应用价值和可靠性。方法:采用化学发光免疫分析法、酶联免疫吸附试验法、放射免疫分析法检测高血压科门诊及住院患者的肾素浓度或活性、醛固酮浓度,以静脉生理盐水滴注试验为确诊试验。使用Pearson相关分析及Bland-Altman法比较3种方法测得结果间的一致性,并绘制受试者操作特征曲线(receiver operator characteristic curve,ROC曲线),计算化学发光免疫分析法测得的血浆醛固酮(浓度)/肾素(活性或浓度)比值(aldosterone to renin ratio,ARR)诊断原醛的曲线下面积及最佳临界值。结果:化学发光免疫分析法测得的肾素、醛固酮浓度与酶联免疫吸附试验法、放射免疫分析法测得的结果间显著相关(r≥0.67,P<0.01,r≥0.79,P<0.01);化学发光免疫分析法检测肾素浓度时若使用不含酶抑制剂,较使用含酶抑制剂,其测得的结果与放射免疫分析法测得肾素活性间的相关性更高(0.80比0.67,P<0.01)。在45例高血压患者中,化学发光免疫分析法检测获得的ARR,其诊断原醛的ROC曲线下面积为0.91,最佳临界值为18.26(pg/mL)/(pg/mL),诊断灵敏度和特异度均为86.7%。结论:化学发光免疫分析法检测肾素、醛固酮的准确率高,可作为临床筛查原醛的检测技术。Objectives To verify the accuracy of measuring the plasma renin and aldosterone by chemiluminescence immunoassay(CLIA)and assess its diagnostic efficacy in primary aldosteronism(PA).Methods:The plasma renin and aldosterone level were detected in out-and in-patients using CLIA,enzyme-linked immunosorbent assay(ELISA)and radioimmunoassay,and the intravenous saline infusion test was conducted as confirmatory test.The consistence among three tests was assessed with Pearson correlation analysis and Bland-Altman analysis.The aldosterone and renin level detected by CLIA were used to calculate aldosterone to renin ratio(ARR).The receiver operator characteristic curve(ROC curve)was performed to determine the optimized ARR cut-off value and the area under ROC curve(AUC)for diagnosing PA.Results:The aldosterone and renin concentration detected by CLIA were significantly correlated with the results tested by ELISA(rennin and aldosterone concentration)and radioimmunoassay(renin activity and aldosterone concentration)respec-tively(r≥0.67,P<0.01;r≥0.79,P<0.01).Compared with that by CLIA using blood collection tube with the enzyme inhibitor,rennin concentration by CLIA using blood collection tube without enzyme inhibitor had a better correlation with renin activity by radioimmunoassay(correlation coefficient:0.80 vs.0.67,P<0.01).In 45 hypertension patients,the AUC of ARR acquired by CLIA for diagnosing PA was 0.91 and the optimized ARR cut-off value was 18.26[(pg/mL)/(pg/mL)],and both sensitivity and specificity were 86.7%.Conclusions:CLIA could be used for clinical PA screening as a reliable detective method since it has high accuracy of measuring plasma renin and aldosterone.

关 键 词：原发性醛固酮增多症 肾素 醛固酮 化学发光免疫分析 放射免疫分析 

分 类 号：R544.1[医药卫生—心血管疾病]