Measurement of total serum testosterone levels using commercially available kits: High degree of between-kit variability
Measurement of total serum testosterone levels using commercially available kits: High degree of between-kit variability
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DOI：
10.1016/s0015-0282(97)00464-0
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发表时间：
1998-02-01
影响因子：
6.7
通讯作者：
Azziz, R
中科院分区：
文献类型：
--
作者：
Boots, LR;Potter, S;Azziz, R
目的：血清总睾酮的测量在男性性腺功能减退症和女性雄激素过多症的管理中具有确定的临床作用。我们研究了六种不同的市售睾酮检测试剂盒之间的变异性和精密度，并将其与已建立的内部方法进行比较。设计：实验室观察性前瞻性研究。设置：第三大学医学中心临床实验室。患者：三组样本，分别为男性（n = 36）和女性（n = 15），分别具有高、正常或低水平的性激素结合球蛋白（SHBG），干预措施：个体和合并使用六种不同的市售测定法和一种内部方法分析（男性和女性）血清样本的总睾酮浓度。主要结果指标：测定试剂盒间变异性和平均（+/- SD）SHBG水平的影响，将使用试剂盒和内部方法获得的结果进行比较，并且测定内变异性（即，结果：男性样本在用不同试剂盒获得的结果中表现出26.3%-40.8%的差异，这对于具有最低SHBG水平的样本最大。对于女性样本，试剂盒间变异性范围为57%-115%（平均值为77%）。使用商业方法获得的结果与使用我们的内部测定获得的结果的百分比偏差，男性（平均方差，194%）大于女性（平均方差，67%）。使用内部方法时，雌性样本池的批内变异系数为3.8%，使用市售试剂盒时，范围为8.9%-21.2%。男性池内的变异系数为3.1%，使用的内部方法和范围从3.3%-5.5%与使用的商业kitchs. Conclusions（S）：大多数市售试剂盒用于测量血清总睾酮水平表现出显着的试剂盒之间的变异性，这是最大的女性样本。此外，具有最低SHBG水平的样品具有最高的试剂盒间方差。这些数据有力地表明，使用商业试剂盒测量血清总睾酮可能具有有限的实用性，特别是对于高雄激素血症的检测。(C)1998年，美国生殖医学会。
Objective: The measurement of total serum testosterone has an established clinical role in the management of male hypogonadism and female androgen excess disorders. We studied the between-kit variability and precision of six different commercially available testosterone assays and compared them with an established in-house method.Design: Laboratory observational prospective study.Setting: Tertiary university medical center clinical laboratory.Patient(s): Three groups of samples each of men (n = 36) and women (n = 15) who had high, normal, or low levels of sex hormone-binding globulin (SHBG), respectively, were studied.Intervention(s): Individual and pooled (male and female) serum samples were analyzed for total testosterone concentration using six different commercially available assays and one in-house method.Main Outcome Measure(s): The between-kit variability and the effect of the mean (+/- SD) SHBG level were determined, the results obtained with the use of the kits and the in-house method were compared, and the intraassay variability (i.e., precision) was evaluated.Result(s): Male samples demonstrated a 26.3%-40.8% variance in the results obtained with different kits, which was greatest for samples with the lowest SHBG levels. For female samples, between-kit variability ranged from 57%-115% (average, 77%). The percent deviation of the results obtained with the use of commercial methods from those obtained with the use of our in-house assay was greater for men (mean variance, 194%) than for women (mean variance, 67%). The female pool intraassay coefficient of variation was 3.8% with the use of the in-house method and ranged from 8.9%-21.2% with the use of the commercial kits. The male pool intraassay coefficient of variation was 3.1% with the use of the in-house method and ranged from 3.3%-5.5% with the use of the commercial kits.Conclusion(s): Most commercially available kits for measuring the total serum testosterone level demonstrated significant between-kit variability, which was greatest for female samples. Further, samples with the lowest SHBG levels had the highest between-kit variances. These data strongly suggest that the measurement of total serum testosterone using commercial kits may have limited utility, particularly for the detection of hyperandrogenemia. (C) 1998 by American Society for Reproductive Medicine.