Sacks D B, Lim M M, Valdes R, Kessler G
Department of Pathology, Washington University Medical Center, St. Louis, MO 63110.
Am J Clin Pathol. 1990 Jan;93(1):84-90. doi: 10.1093/ajcp/93.1.84.
The authors evaluated the analytic and clinical performance of a sensitive radial partition fluorescent enzyme immunoassay for thyrotropin (TSH) performed on Stratus and compared it with a nonsensitive radioimmunoassay (RIA) method. Sensitivity of 0.15 mIU/L was obtained, and precision, specificity, and linearity were acceptable. A good correlation was observed between the two assays in samples from 311 hospitalized patients (r = 0.976). Stratus TSH results were outside the reference range for 20% of clinically euthyroid patients (n = 126), and 2.4% had undetectable levels. The clinically hyperthyroid group (n = 11) with the exception of one patient had TSH values below 0.2 mIU/L. Only 39% of hypothyroid patients on thyroid hormone replacement (n = 74) had TSH values in the reference range, with 38% and 23% exhibiting low and high values, respectively. All untreated primary hypothyroid patients (n = 8) had elevated TSH concentrations. The authors conclude that this sensitive TSH assay is useful for diagnosing hyperthyroidism when there is a clinical suspicion but cannot be recommended for thyroid screening in hospitalized patients.
作者评估了在Stratus上进行的促甲状腺激素（TSH）敏感放射分区荧光酶免疫测定法的分析性能和临床性能，并将其与不敏感的放射免疫测定法（RIA）进行比较。获得了0.15 mIU/L的灵敏度，精密度、特异性和线性均可接受。在311例住院患者的样本中，两种测定法之间观察到良好的相关性（r = 0.976）。Stratus TSH结果在20%临床甲状腺功能正常患者（n = 126）的参考范围之外，2.4%的患者检测不到TSH水平。临床甲亢组（n = 11）除1例患者外，TSH值均低于0.2 mIU/L。接受甲状腺激素替代治疗的甲减患者（n = 74）中，只有39%的患者TSH值在参考范围内，分别有38%和23%的患者TSH值偏低和偏高。所有未经治疗的原发性甲减患者（n = 8）TSH浓度均升高。作者得出结论，这种敏感的TSH测定法在临床怀疑有甲亢时有助于诊断，但不推荐用于住院患者的甲状腺筛查。
