不经衍生化的高灵敏串联质谱法测定血清雌二醇及其在儿童和青少年中的参考区间。
Highly sensitive tandem mass spectrometric measurement of serum estradiol without derivatization and pediatric reference intervals in children and adolescents.
机构信息
Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada.
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
出版信息
Clin Chem Lab Med. 2023 Apr 11;61(10):1820-1828. doi: 10.1515/cclm-2022-1231. Print 2023 Sep 26.
OBJECTIVES
Monitoring estradiol (E2) is important for determining the onset of pubertal development as well as in the evaluation of girls with precocious puberty. However, E2 measurement remains an analytical challenge in children, who have lower circulating levels. We developed and evaluated a simple and sensitive LC-MS/MS procedure for serum E2 quantification in pediatric populations and established age- and sex-specific pediatric reference intervals.
METHODS
Residual patient serum samples were used to evaluate the analytical performance of our in-house LC-MS/MS E2 assay. The evaluation included accuracy, precision, linearity, functional sensitivity (LLoQ), and method comparison. Age- and sex-specific pediatric E2 reference intervals were also established from a cohort of 405 healthy children (birth to 18 years) recruited with informed consent. Age- and sex-specific differences were assessed, and outliers were removed. Reference intervals were established using the robust method.
RESULTS
The assay imprecision was <5.3 %. Assay linearity ranged from 13.7 to 1923.3 pmol/L. The LLoQ corresponding to a CV of 20 % was determined to be 8.9 pmol/L. Bland-Altman analysis revealed a mean bias of 29.3 pmol/L or 9.1 % between our LC-MS/MS E2 assay and an external reference laboratory measuring E2 by LC-MS/MS.
CONCLUSIONS
Our LC-MS/MS E2 assay shows acceptable accuracy, precision, functional sensitivity (LLoQ), and linearity for E2 quantification. Our LC-MS/MS E2 assay also showed good agreement with an external reference laboratory measuring E2 by LC-MS/MS. In addition, using CALIPER samples, we established robust age- and sex-specific pediatric E2 reference intervals to improve accuracy of test result interpretation and clinical decision making.
目的
监测雌二醇（E2）对于确定青春期开始以及评估性早熟女孩非常重要。然而，由于儿童的循环 E2 水平较低，因此 E2 的测量仍然是一个分析挑战。我们开发并评估了一种简单而灵敏的 LC-MS/MS 方法，用于儿童人群血清 E2 的定量，并建立了年龄和性别特异性的儿科参考区间。
方法
使用剩余的患者血清样本评估我们内部的 LC-MS/MS E2 测定的分析性能。评估包括准确性、精密度、线性、功能灵敏度（LLOQ）和方法比较。还从知情同意招募的 405 名健康儿童（出生至 18 岁）队列中建立了年龄和性别特异性的儿科 E2 参考区间。评估了年龄和性别差异，并去除了离群值。使用稳健的方法建立参考区间。
结果
该测定的不精密度<5.3%。测定的线性范围为 13.7 至 1923.3 pmol/L。CV 为 20%时确定的 LLOQ 为 8.9 pmol/L。Bland-Altman 分析显示，我们的 LC-MS/MS E2 测定与通过 LC-MS/MS 测量 E2 的外部参考实验室之间的平均偏差为 29.3 pmol/L 或 9.1%。
结论
我们的 LC-MS/MS E2 测定在 E2 定量方面具有可接受的准确性、精密度、功能灵敏度（LLOQ）和线性。我们的 LC-MS/MS E2 测定与通过 LC-MS/MS 测量 E2 的外部参考实验室也具有良好的一致性。此外，使用 CALIPER 样本，我们建立了稳健的年龄和性别特异性儿科 E2 参考区间，以提高测试结果解释和临床决策的准确性。
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