HarmoSter 研究报告：不同的 LC-MS/MS 雄烯二酮、DHEAS 和睾酮方法比较吻合；然而，统一校准是一把双刃剑。
Report from the HarmoSter study: different LC-MS/MS androstenedione, DHEAS and testosterone methods compare well; however, unifying calibration is a double-edged sword.
机构信息
Department of Medical and Surgical Sciences, Endocrinology Research Group, Center for Applied Biomedical Research, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
出版信息
Clin Chem Lab Med. 2024 Jan 12;62(6):1080-1091. doi: 10.1515/cclm-2023-1138. Print 2024 May 27.
OBJECTIVES
Current liquid chromatography-tandem mass spectrometry (LC-MS/MS) applications for circulating androgen measurements are technically diverse. Previously, variable results have been reported for testosterone. Data are scarce for androstenedione and absent for dehydroepiandrosterone sulfate (DHEAS). We assessed the agreement of androstenedione, DHEAS and testosterone LC-MS/MS measurements among nine European centers and explored benefits of calibration system unification.
METHODS
Androgens were measured twice by laboratory-specific procedures in 78 patient samples and in EQA materials. Results were obtained by and external calibration. Intra- and inter-laboratory performances were valued.
RESULTS
Intra-laboratory CVs ranged between 4.2-13.2 % for androstenedione, 1.6-10.8 % for DHEAS, and 4.3-8.7 % and 2.6-7.1 % for female and male testosterone, respectively. Bias and trueness in EQA materials were within ±20 %. Median inter-laboratory CV with vs. external calibration were 12.0 vs. 9.6 % for androstenedione (p<0.001), 7.2 vs. 4.9 % for DHEAS (p<0.001), 6.4 vs. 7.6 % for female testosterone (p<0.001) and 6.8 and 7.4 % for male testosterone (p=0.111). Median bias vs. all laboratory median with and external calibration were -13.3 to 20.5 % and -4.9 to 18.7 % for androstenedione, -10.9 to 4.8 % and -3.4 to 3.5 % for DHEAS, -2.7 to 6.5 % and -11.3 to 6.6 % for testosterone in females, and -7.0 to 8.5 % and -7.5 to 11.8 % for testosterone in males, respectively.
CONCLUSIONS
Methods showed high intra-laboratory precision but variable bias and trueness. Inter-laboratory agreement was remarkably good. Calibration system unification improved agreement in androstenedione and DHEAS, but not in testosterone measurements. Multiple components, such as commutability of calibrators and EQA materials and internal standard choices, likely contribute to inter-laboratory variability.
目的
目前用于循环雄激素测量的液相色谱-串联质谱（LC-MS/MS）应用技术多种多样。此前，睾酮的检测结果存在差异。关于雄烯二酮和脱氢表雄酮硫酸酯（DHEAS）的检测数据较少。本研究评估了欧洲 9 个中心之间的雄烯二酮、DHEAS 和睾酮 LC-MS/MS 检测结果的一致性，并探讨了校准系统统一的益处。
方法
在 78 例患者样本和外部质量评估（EQA）材料中，实验室特异性程序两次测量雄激素。结果由 和外部校准获得。评估了实验室内部和实验室之间的性能。
结果
雄烯二酮的实验室内部 CV 范围为 4.2-13.2%，DHEAS 的 CV 范围为 1.6-10.8%，女性和男性睾酮的 CV 范围分别为 4.3-8.7%和 2.6-7.1%。EQA 材料中的偏倚和准确度在±20%范围内。与外部校准相比， 与外部校准的实验室间中位数 CV 分别为 12.0%和 9.6%（p<0.001），7.2%和 4.9%（p<0.001），6.4%和 7.6%（p<0.001），6.8%和 7.4%（p=0.111）。与 和外部校准的所有实验室中位数相比，雄烯二酮的中位偏倚分别为-13.3%至 20.5%和-4.9%至 18.7%，DHEAS 的中位偏倚分别为-10.9%至 4.8%和-3.4%至 3.5%，女性睾酮的中位偏倚分别为-2.7%至 6.5%和-11.3%至 6.6%，男性睾酮的中位偏倚分别为-7.0%至 8.5%和-7.5%至 11.8%。
结论
该方法显示出较高的实验室内部精密度，但存在可变的偏倚和准确度。实验室间的一致性非常好。校准系统的统一提高了雄烯二酮和 DHEAS 的一致性，但对睾酮的检测没有影响。多个因素，如校准品和 EQA 材料的可互换性以及内标选择，可能导致实验室间的差异。
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