Holownia P, Conway G S, Shrivastava U, Round J, Honour J W
Cobbold Laboratories, University College and Middlesex School of Medicine, London, UK.
Clin Chim Acta. 1993 Jan 31;214(1):31-43. doi: 10.1016/0009-8981(93)90300-s.
We report the evaluation of a commercial coated tube kit (Medgenix) to the measurement of testosterone in plasma/serum samples. The accuracy, precision, specificity and recovery of the assay and the affinity of antibody for ligand were established. The range of concentrations of testosterone providing satisfactory analyses was 0.48-48 nmol/l, which is appropriate for general clinical use. Results of analysis of male and female samples obtained from the routine hospital laboratory in endocrinologically-defined groups were also reviewed. In all groups of male subjects and in normal females, the kit provided results in close agreement to those of an extraction method. With samples from women with various reproductive disorders, as well as with some samples obtained from external quality controls, the kit showed a small but significant negative bias relative to the results of the extraction method. There was, however, no evidence of bias with samples from a separate group of volunteer women with the polycystic ovary syndrome. No interference due to SHBG was detected. Clinical sensitivities using the kit were equivalent to those obtained using the extraction RIA. There was no evidence of spuriously high results in samples from females which has been a common problem with direct radioimmunoassay of testosterone.
我们报告了对一种商用包被管试剂盒（Medgenix）用于血浆/血清样本中睾酮测量的评估。确定了该测定方法的准确性、精密度、特异性和回收率以及抗体对配体的亲和力。提供满意分析结果的睾酮浓度范围为0.48 - 48 nmol/l，适用于一般临床应用。还回顾了从内分泌学定义组的常规医院实验室获得的男性和女性样本的分析结果。在所有男性受试者组和正常女性中，该试剂盒提供的结果与提取法的结果非常一致。对于患有各种生殖疾病的女性样本以及从外部质量控制获得的一些样本，该试剂盒相对于提取法的结果显示出较小但显著的负偏差。然而，来自另一组患有多囊卵巢综合征的志愿女性样本没有偏差迹象。未检测到由于性激素结合球蛋白（SHBG）引起的干扰。使用该试剂盒的临床敏感性与使用提取放射免疫分析法（RIA）获得的敏感性相当。在女性样本中没有出现结果假性升高的证据，而这一直是睾酮直接放射免疫测定法的一个常见问题。
