TY - JOUR
T1 - Calibration and evaluation of routine methods by serum certified reference material for aldosterone measurement in blood
AU - Nishikawa, Tetsuo
AU - Omura, Masao
AU - Kawaguchi, Migaku
AU - Takatsu, Akiko
AU - Satoh, Fumitoshi
AU - Ito, Sadayoshi
AU - Kurihara, Isao
AU - Itoh, Hiroshi
AU - Yanase, Toshihiko
AU - Shibata, Hirotaka
AU - Oki, Yutaka
AU - Naruse, Mitsuhide
AU - Sakurai, Keiko
AU - Sasamoto, Hidehiko
AU - Kuwa, Katsuhiko
N1 - Publisher Copyright:
© 2016 The Japan Endocrine Society.
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - Calibration
KW - Serum certified reference material
KW - Standardization
KW - Traceability
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U2 - 10.1507/endocrj.EJ16-0304
DO - 10.1507/endocrj.EJ16-0304
M3 - Article
C2 - 27593175
AN - SCOPUS:85007614121
VL - 63
SP - 1065
EP - 1080
JO - Endocrine Journal
JF - Endocrine Journal
SN - 0918-8959
IS - 12
ER -
