7 种已发表的 LC-MS/MS 方法测定血清中睾酮、雄烯二酮和脱氢表雄酮的比较。
Comparison of 7 Published LC-MS/MS Methods for the Simultaneous Measurement of Testosterone, Androstenedione, and Dehydroepiandrosterone in Serum.
机构信息
Endocrine Laboratory, Department of Clinical Chemistry, VU University Medical Center, Amsterdam, Netherlands;
Endocrinology Unit and Center for Applied Biomedical Research, Department of Medical and Surgical Sciences, S. Orsola Malpighi Hospital, University of Bologna, Bologna, Italy;
出版信息
Clin Chem. 2015 Dec;61(12):1475-83. doi: 10.1373/clinchem.2015.242859. Epub 2015 Oct 26.
BACKGROUND
Recently, LC-MS/MS was stated to be the method of choice to measure sex steroids. Because information on the mutual agreement of LC-MS/MS methods is scarce, we compared 7 published LC-MS/MS methods for the simultaneous measurement of testosterone, androstenedione, and dehydroepiandrosterone (DHEA).
METHODS
We used 7 published LC-MS/MS methods to analyze in duplicate 55 random samples from both men and women. We performed Passing-Bablok regression analysis and calculated Pearson correlation coefficients to assess the agreement of the methods investigated with the median concentration measured by all methods, and we calculated the intraassay CV of each method derived from duplicate results and the CVs between the methods.
RESULTS
Median concentrations of testosterone were 0.22-1.36 nmol/L for women and 8.27-27.98 nmol/L for men. Androstenedione and DHEA concentrations were 0.05-5.53 and 0.58-18.04 nmol/L, respectively. Intraassay CVs were 2.9%-10%, 1.2%-8.8%, 2.7%-13%, and 4.3%-16% for testosterone in women, testosterone in men, androstenedione, and DHEA. Slopes of the regression lines calculated by Passing-Bablok regression analysis were 0.92-1.08, 0.92-1.08, 0.90-1.13, and 0.91-1.41 for all testosterone values, testosterone in women, androstenedione, and DHEA. Intermethod CVs were 14%, 8%, 30%, and 22% for testosterone in women, testosterone in men, androstenedione, and DHEA.
CONCLUSIONS
In general, the LC-MS/MS methods investigated show reasonable agreement. However, some of the assays show differences in standardization, and others show high variation.
背景
最近，LC-MS/MS 被认为是测量性激素的首选方法。由于关于 LC-MS/MS 方法之间相互一致性的信息很少，我们比较了 7 种已发表的用于同时测量睾酮、雄烯二酮和脱氢表雄酮 (DHEA) 的 LC-MS/MS 方法。
方法
我们使用 7 种已发表的 LC-MS/MS 方法，对来自男性和女性的 55 个随机样本进行重复分析。我们进行了 Passing-Bablok 回归分析，并计算了 Pearson 相关系数，以评估所研究方法与所有方法测量的中位数浓度的一致性，我们还计算了每种方法的重复结果的内标 CV 和方法之间的 CV。
结果
女性的睾酮中位数浓度为 0.22-1.36 nmol/L，男性为 8.27-27.98 nmol/L。雄烯二酮和 DHEA 的浓度分别为 0.05-5.53 和 0.58-18.04 nmol/L。女性睾酮、男性睾酮、雄烯二酮和 DHEA 的内标 CV 分别为 2.9%-10%、1.2%-8.8%、2.7%-13%和 4.3%-16%。Passing-Bablok 回归分析计算的回归线斜率分别为所有睾酮值、女性睾酮、雄烯二酮和 DHEA 的 0.92-1.08、0.92-1.08、0.90-1.13 和 0.91-1.41。女性睾酮、男性睾酮、雄烯二酮和 DHEA 的方法间 CV 分别为 14%、8%、30%和 22%。
结论
总体而言，所研究的 LC-MS/MS 方法显示出合理的一致性。然而，一些测定方法在标准化方面存在差异，而其他方法则显示出较大的变异性。
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