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同位素稀释质谱法与两种化学发光免疫分析法醛固酮测定结果一致性评价
罗文波
周伟燕
易喜连
李倩倩
李淼
赵海建
张江涛
张天娇
曾洁
闫颖
张传宝
作者及单位信息
·
DOI： 10.3760/cma.j.issn.1009-9158.2019.07.010
Comparison of ID-LC-MS/MS and two CLIAs in measuring plasma aldosterone
Luo Wenbo
Zhou Weiyan
Yi Xilian
Li Qianqian
Li Miao
Zhao Haijian
Zhang Jiangtao
Zhang Tianjiao
Zeng Jie
Yan Ying
Zhang Chuanbao
Authors Info & Affiliations
Luo Wenbo
Peking Union Medical College, Chinese Academy of Medical Science, Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Zhou Weiyan
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Yi Xilian
Peking Union Medical College, Chinese Academy of Medical Science, Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Li Qianqian
Waters Corporation, Shanghai 201206, China
Li Miao
Beijing Hospital, National Center of Gerontology, Endocrine Laboratory, Beijing 100730, China
Zhao Haijian
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Zhang Jiangtao
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Zhang Tianjiao
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Zeng Jie
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Yan Ying
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Zhang Chuanbao
Peking Union Medical College, Chinese Academy of Medical Science, Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
·
DOI： 10.3760/cma.j.issn.1009-9158.2019.07.010
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摘要

目的比较同位素稀释质谱法与两种化学发光免疫法间醛固酮测定结果的相关性与一致性，结合国家卫生健康委临床检验中心2018年醛固酮室间质评数据，评价我国醛固酮检测现状。

方法方法学评价。2018年7至11月收集北京医院内分泌科剩余血浆标本，用同位素稀释质谱法、进口系统A与国产系统B检测45份临床血浆样本、4份质控品、5份冻干牛血清样本与3份新鲜冰冻混合人血清样本。根据EP15-A3指南评价方法不精密度，以Deming回归分析方法间相关性，Bland-Altman图分析方法间绝对与相对偏差，以一致性相关系数（CCC）评价方法间一致性。

结果3种方法的不精密度均满足生物学变异导出的适当性能要求。进口A系统与LC-MS/MS间具有较好相关性与一致性（ R 2=0.985，CCC=0.967），国产系统B与进口系统A或LC-MS/MS间相关性与一致性较差（ R 2 分别为0.538和0.547，CCC分别为0.605和0.528）。以LC-MS/MS为参比方法，方法间平均相对偏差均不满足生物学变异最低偏倚要求（18.60%）。

结论LC-MS/MS法与两种化学发光免疫法测定血浆醛固酮结果存在差异，建立醛固酮参考方法研制有证参考物质，完善醛固酮检测溯源体系，改进免疫试剂特异性，是推动醛固酮临床检测标准化的努力方向。

醛固酮;发光;免疫测定;色谱法，液相;串联质谱法
ABSTRACT

ObjectiveAccurate measurement of aldosterone is critical in the diagnosis of primary aldosteronism. We compared the harmonization of three assays including isotope dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) and two chemiluminescence immunoassays (CLIAs: system A and system B) for the aldosterone measurement.

MethodsA total of 45 plasma samples, 4 quality control materials, 5 lyophilized bovine serums, and 3 fresh frozen human serum pools were measured by three assays respectively. Based on CLSI EP15-A3 rule, the precision was assessed by coefficient of variance. Deming regression and Bland & Altman plots was performed for method comparison, and correlation coefficient was calculated for concordance (CCC).

ResultsAll three methods met the performance criteria based on desirable biological variation for precision (<7.35%). System A showed a relevantly good correlation and comparability with ID-LC/MS/MS ( R 2=0.985, CCC=0.967), while System B showed relevantly bad correlations and comparability with both System A ( R 2=0.538, CCC=0.605) and ID-LC/MS/MS ( R 2=0.547, CCC=0.528).. However, the average relevant bias of two CLIAs exceeded the bias requirement derived from biological variation (18.60%).

ConclusionSignificant differences were found in the measurement of plasma aldosterone using ID-LC-MS/MS and two CLIAs, which urges the establishment of traceability hierarchy and improvement of reagents' specificity for standardization of aldosterone measurement in clinical settings.

Aldosterone;Luminescence;Immunoassay;Chromatography, liquid;Tandem mass spectrometry
Zhang Chuanbao, Email: nc.defgrabo.lccngnahzbc
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引用本文

罗文波,周伟燕,易喜连,等. 同位素稀释质谱法与两种化学发光免疫分析法醛固酮测定结果一致性评价[J]. 中华检验医学杂志,2019,42(7)：545-551.

DOI:10.3760/cma.j.issn.1009-9158.2019.07.010

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醛固酮（aldosterone，Ald）是由肾上腺皮质球状带细胞分泌的一种盐皮质激素，是原发性醛固酮增多症（primary aldosteronism，PA）筛查、确诊与治疗的重要指标之一 [ 1 , 2 ]。PA是继发性高血压的主要原因之一，在高血压人群中发病率为5.5%~29%，由于PA筛查试验在高血压人群中覆盖率低，这一数据显然被低估 [ 3 , 4 ]。与原发性高血压相比，PA患者的心脑肾等靶器官损伤更为严重，及时手术治疗或应用醛固酮受体阻滞剂，能有效延缓或阻断病程进展改善预后 [ 5 , 6 , 7 ]。作为目前PA筛查与确诊的重要指标，醛固酮的临床准确测定及其检测结果一致化具有重要意义。
目前在临床醛固酮检测领域，自动便捷的化学发光免疫分析法（chemiluminescence immunoassay，CLIA）已逐步代替步骤繁琐且具有放射性污染的放射免疫分析法（radioimmunoassay，RIA）。免疫分析法均以抗原-抗体特异性结合为基本原理，鉴于抗原抗体结合位点的特异性不足，且不同公司间的抗原抗体存在差异，不可避免地存在交叉反应、不同公司间可比性不足、不同实验室间复现性差的问题 [ 2 , 8 , 9 , 10 ]。与免疫分析法相比，同位素稀释液相色谱串联质谱（isotope dilution liquid chromatography tandem mass spectrometry，ID-LC-MS/MS）技术具有准确性好、特异性高的优势。随着技术的发展，醛固酮等激素及大分子临床质谱技术逐渐进入常规实验室检测领域 [ 11 ]。Ray等 [ 12 ]发现，与RIA或CLIA相比，ID-LC-MS/MS方法具有更佳的准确性与复现性，但测定的醛固酮结果偏低。目前国内外醛固酮测定缺乏标准化，本研究拟对LC-MS/MS与国内常用的两种醛固酮CLIA检测方法性能进行比较，结合对2018年全国醛固酮室间质量评价（external quality assessment，EQA）计划结果的分析，对目前国内临床醛固酮检测一致化现状进行评估。
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备注信息
A
张传宝，Email： nc.defgrabo.lccngnahzbc
B
所有作者均声明不存在利益冲突，感谢沃特世科技上海有限公司为本实验提供仪器使用支持
C
国家自然科学基金 (81201337)
北京生物医药产业跨越发展工程项目 (G20工程，Z161100001816043)
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