Le Goff Caroline M, Gonzalez-Antuña Ana, Peeters Stéphanie D, Fabregat-Cabello Neus, Van Der Gugten Jessica G, Vroonen Laurent, Pottel Hans, Holmes Daniel T, Cavalier Etienne
Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Liège, Belgium.
Department of Pathology and Laboratory Medicine, St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.
Clin Mass Spectrom. 2018 Jun 15;9:7-17. doi: 10.1016/j.clinms.2018.06.002. eCollection 2018 Aug.
Aldosterone measurement is critical for diagnosis of primary aldosteronism and disorders of the renin-angiotensin system. We developed an LC-MS/MS method for plasma and urinary aldosterone and compared it to our RIA method. We present a reference interval study for a Belgian population.
68 plasma and 23 urine samples were assayed for as part of a method comparison. For the reference interval study, we enrolled 282 healthy Caucasian volunteers (114 Male: mean age 35 ± 11 y and 168 Female: mean age 42 ± 13 y). A subset of 139 healthy volunteers agreed to a 24-h urine collection. For the method validation, 5 plasma and 8 urine pools were run in triplicate and quadruplicate, respectively, on 3 different days.
Between-run imprecision (CV) was 2.8-5.1% for plasma and 4.5-8.6% for urine, except at the low urine concentration of 2.99 nmol/L where a CV of 15.4% was observed. The limit of quantitation was 0.04 nmol/L for plasma and 6.65 nmol/L for urine. Recoveries, based on spiking experiments into natural matrix, did not differ significantly from 100%. Regression comparisons showed that, on average, RIA generated results were 59% and 11% higher than LC-MS/MS for plasma and urine, respectively. The MS reference interval we propose for plasma aldosterone is 0.07 nmol/L-0.73 nmol/L for women and 0.04 nmol/L-0.41 nmol/L for men. No gender difference was observed for urine aldosterone. The reference interval was determined to be <60.94 nmol/day.
The LC-MS/MS method was validated and reference intervals for plasma and urine were established. A significant bias between RIA and LC-MS/MS was noted.
醛固酮测定对于原发性醛固酮增多症和肾素-血管紧张素系统疾病的诊断至关重要。我们开发了一种用于血浆和尿液醛固酮的液相色谱-串联质谱（LC-MS/MS）方法，并将其与我们的放射免疫分析（RIA）方法进行比较。我们展示了一项针对比利时人群的参考区间研究。
作为方法比较的一部分，对68份血浆和23份尿液样本进行了检测。在参考区间研究中，我们招募了282名健康的白种人志愿者（114名男性：平均年龄35±11岁，168名女性：平均年龄42±13岁）。139名健康志愿者的一个子集同意进行24小时尿液收集。为进行方法验证，分别在3个不同日期对5份血浆混合样本和8份尿液混合样本进行了一式三份和一式四份检测。
批间不精密度（CV）对于血浆为2.8 - 5.1%，对于尿液为4.5 - 8.6%，但在尿液浓度低至2.99 nmol/L时观察到CV为15.4%。血浆的定量限为0.04 nmol/L，尿液的定量限为6.65 nmol/L。基于向天然基质中加标的实验，回收率与100%无显著差异。回归比较表明，平均而言，RIA法所得血浆和尿液结果分别比LC-MS/MS法高59%和11%。我们提出的血浆醛固酮的质谱参考区间，女性为0.07 nmol/L - 0.73 nmol/L，男性为0.04 nmol/L - 0.41 nmol/L。尿液醛固酮未观察到性别差异。参考区间确定为<60.94 nmol/天。
LC-MS/MS方法得到验证，并建立了血浆和尿液的参考区间。注意到RIA法和LC-MS/MS法之间存在显著偏差。
