Comparison of ID-LC-MS/MS and two CLIAs in measuring plasma aldosterone
10.3760/cma.j.issn.1009-9158.2019.07.010
- VernacularTitle: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
- Author:
Wenbo LUO
1
;
Weiyan ZHOU
;
Xilian YI
;
Qianqian LI
;
Miao LI
;
Haijian ZHAO
;
Jiangtao ZHANG
;
Tianjiao ZHANG
;
Jie ZENG
;
Ying YAN
;
Chuanbao ZHANG
Author Information
1. 中国医学科学院北京协和医学院北京医院国家老年医学中心国家卫生健康委临床检验中心北京市临床检验工程技术研究中心
- Keywords:
Aldosterone;
Luminescence;
Immunoassay;
Chromatography;
liquid;
Tandem mass spectrometry
- From:
Chinese Journal of Laboratory Medicine
2019;42(7):545-551
- CountryChina
- Language:Chinese
-
Abstract:
Objective Accurate 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. Methods A 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). Results All 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 (R2=0.985, CCC=0.967), while System B showed relevantly bad correlations and comparability with both System A (R2=0.538, CCC=0.605) and ID-LC/MS/MS (R2=0.547, CCC=0.528).. However, the average relevant bias of two CLIAs exceeded the bias requirement derived from biological variation (18.60％). Conclusion Significant 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.
