Wang Christina, Catlin Don H, Demers Laurence M, Starcevic Borislav, Swerdloff Ronald S
Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Research and Education Institute, Torrance, California 90502, USA.
J Clin Endocrinol Metab. 2004 Feb;89(2):534-43. doi: 10.1210/jc.2003-031287.
The diagnosis of male hypogonadism requires the demonstration of a low serum testosterone (T) level. We examined serum T levels in pedigreed samples taken from 62 eugonadal and 60 hypogonadal males by four commonly used automated immunoassay instruments (Roche Elecsys, Bayer Centaur, Ortho Vitros ECi and DPC Immulite 2000) and two manual immunoassay methods (DPC-RIA, a coated tube commercial kit, and HUMC-RIA, a research laboratory assay) and compared results with measurements performed by liquid chromatography-tandem mass spectrometry (LC-MSMS). Deming's regression analyses comparing each of the test results with LC-MSMS showed slopes that were between 0.881 and 1.217. The interclass correlation coefficients were between 0.92 and 0.97 for all methods. Compared with the serum T concentrations measured by LC-MSMS, the DPC Immulite results were biased toward lower values (mean difference, -90 +/- 9 ng/dl) whereas the Bayer Centaur data were biased toward higher values (mean difference, +99 +/- 11 ng/dl) over a wide range of serum T levels. At low serum T concentrations (<100 ng/dl or 3.47 nmol/liter), HUMC-RIA overestimated serum T, Ortho Vitros ECi underestimated the serum T concentration, whereas the other two methods (DPC-RIA and Roche Elecsys) showed differences in both directions compared with LC-MSMS. Over 60% of the samples (with T levels within the adult male range) measured by most automated and manual methods were within +/- 20% of those reported by LC-MSMS. These immunoassays are capable of distinguishing eugonadal from hypogonadal males if adult male reference ranges have been established in each individual laboratory. The lack of precision and accuracy, together with bias of the immunoassay methods at low serum T concentrations, suggests that the current methods cannot be used to accurately measure T in females or serum from prepubertal subjects.
男性性腺功能减退的诊断需要证明血清睾酮（T）水平较低。我们使用四种常用的自动免疫分析仪器（罗氏 Elecsys、拜耳 Centaur、奥森 Vitros ECi 和 DPC Immulite 2000）以及两种手动免疫分析方法（DPC-RIA，一种包被管商业试剂盒，和 HUMC-RIA，一种研究实验室检测方法）检测了 62 名性腺功能正常和 60 名性腺功能减退男性的系谱样本中的血清 T 水平，并将结果与液相色谱 - 串联质谱法（LC-MSMS）的测量结果进行了比较。将每个检测结果与 LC-MSMS 进行比较的 Deming 回归分析显示，斜率在 0.881 至 1.217 之间。所有方法的组内相关系数在 0.92 至 0.97 之间。与通过 LC-MSMS 测量的血清 T 浓度相比，在广泛的血清 T 水平范围内，DPC Immulite 的结果偏向较低值（平均差异，-90±9 ng/dl），而拜耳 Centaur 的数据偏向较高值（平均差异，+99±11 ng/dl）。在低血清 T 浓度（<100 ng/dl 或 3.47 nmol/升）时，HUMC-RIA 高估了血清 T，奥森 Vitros ECi 低估了血清 T 浓度，而其他两种方法（DPC-RIA 和罗氏 Elecsys）与 LC-MSMS 相比在两个方向上都显示出差异。大多数自动和手动方法测量的超过 60% 的样本（T 水平在成年男性范围内）在 LC-MSMS 报告值的±20% 以内。如果在每个单独的实验室中建立了成年男性参考范围，这些免疫分析能够区分性腺功能正常和性腺功能减退的男性。免疫分析方法在低血清 T 浓度时缺乏精密度和准确性以及偏差，表明目前的方法不能用于准确测量女性或青春期前受试者血清中的 T。
