Goncharov N, Katsya G, Dobracheva A, Nizhnik A, Kolesnikova G, Todua T, Lunenfeld B
National Center of Endocrinology, Moscow, Russia.
Aging Male. 2005 Sep-Dec;8(3-4):194-202. doi: 10.1080/13685530500355566.
Accurate measurement of serum testosterone (T) is essential for proper diagnosis of androgen deficiency. There are now several modern assay technologies, including automated ones, for measurement of T. In this study, we compared analytical performance of five modern immunoassay technologies commonly used for measurement of total T: Vitros ECi (Ortho-Clinical Diagnostics; normal range (n.r.) 4.6-34 nmol/L); Architect (Abbott Laboratories; n.r. 9.7-34 nmol/L); Access (Beckman Coulter; n.r. 5.3-23 nmol/L); Delfia (Perkin-Elmer; n.r. 9.3-34 nmol/L); and manual EIA DRG kits (n.r. 8.3-42 nmol/L), with the classical RIA (3H-T), after extraction (n.r. 11-33 nmol/L), as a reference method. Total T was measured using all above-mentioned methods in serum samples from 100 male patients, aged 16-65 years. Mean T concentrations in these 100 serum samples assayed by all non-isotopic methods were statistically significantly higher than those obtained by RIA. Delfia showed the highest T levels (19.3 nmol/L versus 12.1 nmol/L by RIA) with a positive bias 60-100%. Almost similar results were obtained using Architect, with a positive bias 40-70%. The closest correlation in results was found between Vitros ECi and RIA (12.7 nmol/L versus 12.1 nmol/L). In the studied samples, the median of differences ranged from minimal (-0.4 nmol/L for Vitros ECi) to maximal (-7.25 nmol/L for Delfia). For all non-isotopic methods, with the exception of Vitros ECi, differences in subjects with low T level (< 10 nmol/L) were statistically significantly larger than in the subjects with high T (T > 10 nmol/L). All other methods showed different degrees of dissimilarities with the RIA, especially in the range of low testosterone concentrations, which is of importance in the clinical assessment of women and pubertal boys.
准确测量血清睾酮（T）对于正确诊断雄激素缺乏至关重要。目前有几种现代检测技术，包括自动化技术，可用于测量T。在本研究中，我们比较了常用于测量总T的五种现代免疫分析技术的分析性能：Vitros ECi（奥瑟临床诊断公司；正常范围（n.r.）4.6 - 34 nmol/L）；Architect（雅培实验室；n.r. 9.7 - 34 nmol/L）；Access（贝克曼库尔特公司；n.r. 5.3 - 23 nmol/L）；Delfia（珀金埃尔默公司；n.r. 9.3 - 34 nmol/L）；以及手动酶免疫分析DRG试剂盒（n.r. 8.3 - 42 nmol/L），以经典的放射免疫分析（3H - T）作为参考方法，放射免疫分析在提取后（n.r. 11 - 33 nmol/L）进行。使用上述所有方法对100名年龄在16 - 65岁的男性患者的血清样本进行总T测量。通过所有非同位素方法检测的这100份血清样本中的平均T浓度在统计学上显著高于通过放射免疫分析获得的浓度。Delfia显示的T水平最高（19.3 nmol/L，而放射免疫分析为12.1 nmol/L），正偏差为60 - 100%。使用Architect获得了几乎相似的结果，正偏差为40 - 70%。在Vitros ECi和放射免疫分析之间发现结果的相关性最紧密（12.7 nmol/L对12.1 nmol/L）。在所研究的样本中，差异的中位数范围从最小（Vitros ECi为 - 0.4 nmol/L）到最大（Delfia为 - 7.25 nmol/L）。对于所有非同位素方法，除了Vitros ECi外，T水平低（< 10 nmol/L）的受试者的差异在统计学上显著大于T水平高（T > 10 nmol/L）的受试者。所有其他方法与放射免疫分析均表现出不同程度的差异，尤其是在低睾酮浓度范围内，这在女性和青春期男孩的临床评估中具有重要意义。
