Kallner A, Kallner G, Lundell G, Sjöberg H E
Scand J Clin Lab Invest. 1987 Apr;47(2):157-64.
The performance of three different highly sensitive immuno-assays for thyrotropin in serum (S-TSH) was compared. Specimens from 803 patients with suspected hyperthroidism or other thyroid disease were used. Hyperthyroid patients were identified and characterized by determining serum thyroid hormones and by clinical observation. The performance of the methods in discriminating between hyperthyroidism and euthyroidism was described in terms of diagnostic sensitivity and specificity. The performance was also assessed by systematically varying the reference values. If patients with treated hyperthroidism were eliminated, the three S-TSH assays performed equally well at a suggested lower reference value of 0.4 mU/l. A diagnostic efficiency of more than 0.95 was achieved at the observed prevalence of disease (0.12). A graphical model which allows an adjustment of reference values to favour sensitivity or specificity is presented. Reference values were also calculated from the euthyroid subjects using parametric and non-parametric approaches. The specificity, when using the recommended discrimination level, suggests that patients with low S-TSH values should be subjected to further investigation by biochemical or other methods.
比较了三种不同的血清促甲状腺激素（S-TSH）高敏免疫测定方法。使用了来自803例疑似甲状腺功能亢进或其他甲状腺疾病患者的样本。通过测定血清甲状腺激素和临床观察来识别和表征甲状腺功能亢进患者。根据诊断敏感性和特异性描述了这些方法在区分甲状腺功能亢进和甲状腺功能正常方面的性能。还通过系统地改变参考值来评估性能。如果排除接受过治疗的甲状腺功能亢进患者，在建议的较低参考值0.4 mU/l时，三种S-TSH测定方法表现相当。在观察到的疾病患病率（0.12）下，诊断效率超过0.95。提出了一种图形模型，可对参考值进行调整以提高敏感性或特异性。还使用参数化和非参数化方法从甲状腺功能正常的受试者中计算参考值。使用推荐的鉴别水平时，特异性表明S-TSH值低的患者应通过生化或其他方法进行进一步检查。
