Wians F H, Jacobson J M, Dev J, Heald J I, Ortiz G
Department of Pathology/SGHQLCC, Wilford Hall USAF Medical Center, Lackland AFB, San Antonio, TX 78236-5300.
Clin Chem. 1988 Mar;34(3):568-75.
We evaluated the analytical and clinical performance of three "sensitive" immunoradiometric assay (IRMA) kits (Tandem-R TSH HS, Hybritech, Inc.; EchoClonal TSH, Bio-Rad; Coat-A-Count TSH IRMA, Diagnostic Products Corp.) for measurement of thyrotropin (TSH) and compared their performance against a "regular" IRMA (ARIA-HT, Becton-Dickinson) to determine whether these assays might eliminate the need to perform the thyroliberin (TRF) stimulation test. We concluded that the Tandem and EchoClonal kits may obviate the need to perform TRF stimulation tests in some patients. Using only the basal TSH concentration to predict the TSH response to TRF, we found all three sensitive TSH assays to be useful for detecting abnormal thyrotroph function. Dose-response, linearity, analytical recovery, and specificity were acceptable for all kits, but intra-assay precision at very low TSH concentrations and analytical sensitivity differed considerably among the kits. Using the EchoClonal assay, we established a normal reference interval for TSH of 0.4-4.6 milli-int. units/L.
我们评估了三种“敏感”免疫放射分析（IRMA）试剂盒（Tandem-R TSH HS，Hybritech公司；EchoClonal TSH，伯乐公司；Coat-A-Count TSH IRMA，诊断产品公司）检测促甲状腺激素（TSH）的分析性能和临床性能，并将它们的性能与一种“常规”IRMA（ARIA-HT，贝克顿-迪金森公司）进行比较，以确定这些检测方法是否可以取代促甲状腺素释放激素（TRF）刺激试验。我们得出结论，Tandem和EchoClonal试剂盒可能使某些患者无需进行TRF刺激试验。仅使用基础TSH浓度来预测TSH对TRF的反应，我们发现所有三种敏感的TSH检测方法对于检测促甲状腺细胞功能异常均有用。所有试剂盒的剂量反应、线性、分析回收率和特异性均可接受，但在非常低的TSH浓度下的批内精密度和分析灵敏度在各试剂盒之间差异很大。使用EchoClonal检测方法，我们建立了TSH的正常参考区间为0.4 - 4.6毫国际单位/升。
