Sgoutas D S, Barton E G, Hammarstrom M, Pete P M, Sgouta S A
Department of Pathology, Emory University, Atlanta, GA 30322.
Clin Chem. 1989 Aug;35(8):1785-9.
We compared four sensitive procedures for thyrotropin (TSH)--Corning's Magic-Lite, ElectroNucleonics' Delfia, Baxter's Stratus, Nichols' Allegro--for their ability to completely discriminate TSH concentrations in sera in euthyroidism, hyperthyroidism, and hypothyroidism. We evaluated the analytical and clinical performance of these procedures according to previously published criteria. All procedures we examined fulfilled the criterion stipulating less than 1% overlap between the assay variation at the lower normal range limit and the assay sensitivity. Both measurements were made with an interassay CV not exceeding 10% to 15%. All procedures produced results that correlated well for specimens with TSH concentrations of greater than 0.4 milli-int. unit/L, and all four procedures clearly distinguished hypothyroid from euthyroid subjects. In a hyperthyroid-euthyroid comparison, three of the procedures, the Magic-Lite, Delfia, and Allegro, differentiated the two with 97% accuracy, the Stratus procedure with only 90% accuracy. The procedures appeared to differ even more in the measurement of TSH in serum of patients undergoing suppressive treatment with thyroid hormones and in hospitalized nonthyroidally ill patients. The observed differences among procedures were thought to be related in part to a matrix serum effect, which is accentuated in samples from hospitalized patients.
我们比较了四种检测促甲状腺激素（TSH）的灵敏方法——康宁公司的Magic-Lite、电子核子公司的Delfia、百特公司的Stratus、尼科尔斯公司的Allegro——它们在鉴别甲状腺功能正常、甲状腺功能亢进和甲状腺功能减退患者血清中TSH浓度方面的能力。我们根据先前公布的标准评估了这些方法的分析性能和临床性能。我们检测的所有方法均符合以下标准：在正常范围下限的检测变异与检测灵敏度之间的重叠率低于1%。两种测量的批间变异系数均不超过10%至15%。对于TSH浓度大于0.4毫国际单位/升的标本，所有方法得出的结果相关性良好，并且所有四种方法都能清楚地区分甲状腺功能减退患者与甲状腺功能正常的患者。在甲状腺功能亢进与甲状腺功能正常的比较中，Magic-Lite、Delfia和Allegro这三种方法区分两者的准确率为97%，Stratus方法的准确率仅为90%。在接受甲状腺激素抑制治疗的患者以及住院的非甲状腺疾病患者的血清TSH测量中，这些方法之间的差异似乎更大。据认为，各方法之间观察到的差异部分与基质血清效应有关，这种效应在住院患者的样本中更为明显。
