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

doi:10.16150/j.1671-2870.2020.05.006

摘要/Abstract

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。

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

Abstract:

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) respectively（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.

Key words: Primary aldosteronism, Renin, Aldosterone, Chemiluminescence immunoassay, Radioimmunoassay

中图分类号:

R544.1

程艾邦, 李明轩, 陈波, 曹晟, 蒋塨豪, 许建忠, 李燕, 王继光. 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[J]. 诊断学理论与实践, 2020, 19(05): 474-480.

CHENG Yibang, LI Mingxuan, CHEN Bo, CAO Sheng, JIANG Gonghao, XU Jianzhong, LI Yan, WANG Jiguang. Diagnostic value of measuring the plasma renin and aldosterone by chemiluminescence immunoassay in the primary aldosteronism[J]. Journal of Diagnostics Concepts & Practice, 2020, 19(05): 474-480.

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参考文献 11

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[8]	Morimoto R, Ono Y, Tezuka Y, et al. Rapid screening of primary aldosteronism by a novel chemiluminescent immunoassay[J]. Hypertension, 2017, 70(2):334-341. doi: 10.1161/HYPERTENSIONAHA.117.09078 pmid: 28652474
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参数	原发性高血压（n=30）	原发性醛固酮增多症（n=15）	P值
年龄（岁）	46.9±18.7	51.2±10.3	0.33
女性（名）	14	7	1.00
体质量指数（kg/m²）	24.9±3.3	25.5±3.0	0.58
诊室收缩压（mmHg）	136.0±15.3	139.0±13.6	0.52
诊室舒张压（mmHg）	81.0±14.1	84.4±10.0	0.41
诊室心率（次/min）	79.0±14.6	76.6±7.0	0.46
24 h动态收缩压（mmHg）	128.2±12.0	139.7±10.2	0.01
24 h动态舒张压（mmHg）	77.8±10.2	90.0±8.7	0.002
24 h动态心率（次/min）	72.8±10.1	75.1±6.9	0.54
血肌酐（μmol/L）	77.3±22.3	79.6±23.1	0.75
eGFR[mL/（min·1.73 m²）]	88.9±20.3	83.0±18.6	0.35
血钾（mmol/L）	3.97±0.28	3.50±0.30	<0.001
降压药物数量（种）	1.1±0.61	1.5±0.5	0.21

	原醛确诊试验		合计
	-	+	合计
化学发光免疫分析法（-）	26	2	28
化学发光免疫分析法（+）	4	13	17
合计	30	15	45

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