Squire C R, Fraser W D
University Department of Clinical Chemistry, Royal Liverpool University Hospital, UK.
Ann Clin Biochem. 1995 May;32 ( Pt 3):307-13. doi: 10.1177/000456329503200308.
After an initial evaluation of the standard procedure for performance of a third generation TSH (thyroid stimulating hormone) assay (Amerlite TSH-30) modifications were made to standardize the timing of measurement of light emission following signal reagent addition. By adopting this optimized procedure, a significant improvement in assay sensitivity was achieved when compared to a second generation TSH assay (DAKO). Using the optimized assay the sensitivity was 0.003 mU/L (20 replicates of zero) or 0.009 mU/L [22% CV (coefficient of variation) from the precision profile]. Recovery of added TSH and parallelism of the assay were good. A significant negative bias was detected for the Amerlite TSH-30 assay when compared to the DAKO assay (log y = 0.92 log x-0.33, n = 210). Excellent discrimination was achieved between euthyroid, hypothyroid and thyrotoxic subjects. A high percentage of thyrotoxic patients had undetectable TSH and the spread of values between thyrotoxic and euthyroid was greater with the third generation assay. In patients receiving thyroxine therapy a higher percentage had detectable TSH values. The optimized Amerlite TSH 30 assay offers improved assay performance when compared to a second generation assay.
在对第三代促甲状腺激素（TSH）检测（Amerlite TSH - 30）的标准操作程序进行初步评估后，对添加信号试剂后发光测量的时间进行了标准化修改。采用此优化程序后，与第二代TSH检测（DAKO）相比，检测灵敏度有显著提高。使用优化后的检测方法，灵敏度为0.003 mU/L（20次零值重复）或0.009 mU/L[根据精密度曲线得出的变异系数（CV）为22%]。添加TSH的回收率和检测的平行性良好。与DAKO检测相比，Amerlite TSH - 30检测存在显著的负偏差（log y = 0.92 log x - 0.33，n = 210）。在甲状腺功能正常、甲状腺功能减退和甲状腺毒症患者之间实现了出色的区分。高比例的甲状腺毒症患者TSH检测不到，第三代检测中甲状腺毒症患者和甲状腺功能正常患者之间的值分布更宽。在接受甲状腺素治疗的患者中，更高比例的患者TSH值可检测到。与第二代检测相比，优化后的Amerlite TSH 30检测提供了更好的检测性能。
