Calibration and evaluation of routine methods by serum certified reference material for aldosterone measurement in blood

Endocrine journal

Sadayoshi Ito¹  Katsuhiko Kuwa²  Mitsuhide Naruse³  Hirotaka Shibata⁴  Yutaka Oki⁵  Keiko Sakurai⁶  Toshihiko Yanase⁷  Hiroshi Itoh⁷  Fumitoshi Satoh⁸  Isao Kurihara⁹  Tetsuo Nishikawa^1,10  Masao Omura^1,10  Akiko Takatsu^1,11  Migaku Kawaguchi^1,11  Hidehiko Sasamoto^1,12 

[1] Metabolism, Tohoku University Graduate School of Medicine, Sendai, Japan;Aska Pharma Medical Co., Ltd., Kawasaki, Japan;Department of Community and Family Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan;Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, Fukuoka, Japan;Department of Endocrinology and Metabolism, Rheumatology and Nephrology, Faculty of Medicine, Oita University, Yufu, Japan;Department of Endocrinology, Metabolism and Hypertension, National Hospital Organization Kyoto Medical Center, Kyoto, Japan;Department of Endocrinology, Metabolism and Nephrology, School of Medicine Keio University, Tokyo, Japan;Division of Clinical Hypertension, Endocrinology &Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan;Endocrinology and Diabetes Center, Yokohama Rosai Hospital, Yokohama, Japan;National Metrology Institute of Japan, National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan;Reference Material Institute for Clinical Chemistry Standards, Kawasaki, Japan

关键词: Standardization;    Serum certified reference material;    Traceability;    Calibration;   

DOI  :  10.1507/endocrj.EJ16-0304

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

We attempted to study the standardization of aldosterone measurement in blood.The serum certified reference material (serum CRM) was established by spiking healthy human serum with pure aldosterone.ID-LC/MS/MS as a reference measurement procedure was performed by using the serum CRM.LC-MS/MS as a comparison method (CM) was routinely used for clinical samples, and the values with and without calibration by the serum CRM were compared.The serum CRM demonstrated similar reactivity with peripheral blood plasma as clinical samples in routine methods (RM) of RIA, ELISA, and CLEIA.In comparison between RM and CM, the results in regression analysis indicated that the range of the correlation coefficient (r) was 0.913 - 0.991, the range of y intercept was 0.9 - 67.3 pg/mL and the range of slope was 0.869 - 1.174.The values by RM in 100 - 150 pg/mL for the diagnostic level, had a significant calibration effect, and the relative difference between calibrated value in RM and result by CM was within ±20%.Furthermore, the calibrated value using the serum CRM was 10,187 pg/mL, which corresponds to measured value of 14,000 pg/mL using RIA for the adrenal venous sampling.Measured values between plasma and serum as a sample for the aldosterone measurement from clinical samples showed no significant differences.In conclusion, we succeeded to prepare the certified reference material of aldosterone for RM.Then, we can accurately calculate corrected values by using our equation for four RMs of determination of aldosterone.

【 授权许可】

Unknown