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Comparison and commutability study between standardized liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) and chemiluminescent enzyme immunoassay for aldosterone measurement in blood
Endocrine Journal ( IF 1.3 ) Pub Date : 2022-01-28 , DOI: 10.1507/endocrj.ej21-0278
Tetsuo Nishikawa 1 , Fumitoshi Satoh 2 , Yuichi Takashi 3 , Toshihiko Yanase 4 , Hiroshi Itoh 5 , Isao Kurihara 5, 6 , Hirotaka Shibata 7 , Yutaka Oki 8 , Mitsuhide Naruse 9 , Hidehiko Sasamoto 10 , Katsuhiko Kuwa 11
Affiliation  

A commutability confirmation test for the blood aldosterone measurement was performed on liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) as a designated comparison method (DCM) and four chemiluminescent enzyme immunoassay (CLEIA) measurement procedures based on metrological traceability. A conventional radioimmunoassay (RIA) and two measurement procedures of CLEIA which obtains RIA equivalent values were also compared. The relationship between the DCM value and the CLEIA value with respect to 120 pg/mL of the RIA value, which is the screening criterion of primary aldosteronism (PA) was clarified. For the correlation test, 75 samples of patient serum and plasma were used. Regression analysis revealed that the standardized LC-MS/MS and four CLEIA measurement procedures were in good agreement. This is the effect of measurement specificity and calibration using by certified reference material (CRM). The median of the LC-MS/MS corresponding to 120 pg/mL of RIA was 48.5 pg/mL. In the mean of standardized four CLEIA values corresponding to the 48.5 pg/mL of LC-MS/MS value was 47.51 pg/mL and the standard deviation (SD) was 2.93 pg/mL. However, the correlation between the RIA value and the RIA equivalent of the two measurement procedures by CLEIA differed depending on the measurement procedure. This is due to the influence of RIA measurement performance. Standardized CLEIA measurements are suitable for routine measurement procedure. When converting the LC-MS/MS equivalent value by the standardized CLEIA to the conventional RIA value, it is necessary to use the conversion formula.



中文翻译:

标准化液相色谱-质谱/质谱(LC-MS/MS)与化学发光酶免疫法测定血液中醛固酮的比较和互换性研究

采用液相色谱-质谱/质谱 (LC-MS/MS) 作为指定的比较方法 (DCM) 和基于计量溯源的四种化学发光酶免疫测定 (CLEIA) 测量程序,对血液醛固酮测量进行了互换性确认试验。还比较了常规放射免疫测定法 (RIA) 和获得 RIA 等效值的 CLEIA 的两种测量程序。明确了作为原发性醛固酮增多症(PA)筛查标准的 RIA 值 120 pg/mL 的 DCM 值和 CLEIA 值之间的关系。对于相关性检验,使用了 75 个患者血清和血浆样本。回归分析表明,标准化的 LC-MS/MS 和四个 CLEIA 测量程序非常一致。这是使用有证参考材料 (CRM) 的测量特异性和校准的效果。对应于 120 pg/mL RIA 的 LC-MS/MS 的中位数为 48.5 pg/mL。对应于 48.5 pg/mL 的 LC-MS/MS 值的标准化四个 CLEIA 值的平均值为 47.51 pg/mL,标准偏差 (SD) 为 2.93 pg/mL。但是,CLEIA 的两种测量程序的 RIA 值和 RIA 等效值之间的相关性因测量程序而异。这是由于 RIA 测量性能的影响。标准化 CLEIA 测量适用于常规测量程序。将标准化 CLEIA 的 LC-MS/MS 等效值转换为常规 RIA 值时,需要使用转换公式。

更新日期:2022-01-27
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