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Migration from RIA to LC-MS/MS for aldosterone determination: Implications for clinical practice and determination of plasma and urine reference range intervals in a cohort of healthy Belgian subjects
Journal of Mass Spectrometry and Advances in the Clinical Lab ( IF 2.1 ) Pub Date : 2018-06-15 , DOI: 10.1016/j.clinms.2018.06.002
Caroline M. Le Goff , Ana Gonzalez-Antuña , Stéphanie D. Peeters , Neus Fabregat-Cabello , Jessica G. Van Der Gugten , Laurent Vroonen , Hans Pottel , Daniel T. Holmes , Etienne Cavalier

Background

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.

Methods

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.

Results

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.

Conclusions

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.



中文翻译:

从RIA迁移到LC-MS / MS进行醛固酮测定:对比利时健康人群的临床实践以及血浆和尿液参考范围区间测定的意义

背景

醛固酮的测量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。我们开发了用于血浆和尿醛固酮的LC-MS / MS方法,并将其与RIA方法进行了比较。我们为比利时人群提供参考间隔研究。

方法

作为方法比较的一部分,分析了68个血浆和23个尿液样品。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名健康志愿者的一部分同意接受24小时尿液收集。为了进行方法验证,在3个不同的日期分别一式三份和一式四份运行5个血浆和8个尿液池。

结果

血浆间运行不精确度(CV)为2.8%至5.1%,尿液间不精确度(CV)为2.89 nmol / L的低尿液浓度,其中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。根据掺入天然基质的实验,回收率与100%的差异不大。回归比较显示,RIA产生的血浆和尿液的平均结果分别比LC-MS / MS高59%和11%。我们建议血浆醛固酮的MS参考区间为女性0.07 nmol / L–0.73 nmol / L,男性0.04 nmol / L–0.41 nmol / L。尿醛固酮未观察到性别差异。确定参考间隔为<60.94 nmol /天。

结论

验证了LC-MS / MS方法并确定了血浆和尿液的参考间隔。注意到RIA和LC-MS / MS之间存在明显偏差。

更新日期:2018-06-15
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