Comparison of ID-LC-MS/MS and two CLIAs in measuring plasma aldosterone
Wenbo Luo, Weiyan Zhou, Xilian Yi, Qianqian Li, Miao Li, Haijian Zhao, Jiangtao Zhang, Tianjiao Zhang, Jie Zeng, Ying Yan, Chuanbao Zhang
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 (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%).
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.
Key words:
Aldosterone; Luminescence; Immunoassay; Chromatography, liquid; Tandem mass spectrometry
Contributor Information
Wenbo Luo
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
Weiyan Zhou
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Xilian Yi
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
Qianqian Li
Waters Corporation, Shanghai 201206, China
Miao Li
Beijing Hospital, National Center of Gerontology, Endocrine Laboratory, Beijing 100730, China
Haijian Zhao
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Jiangtao Zhang
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Tianjiao Zhang
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Jie Zeng
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Ying Yan
Beijing Hospital, National Center of Gerontology, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing 100730, China
Chuanbao Zhang
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
