Rasmussen A K, Hilsted L, Perrild H, Christiansen E, Siersbaek-Nielsen K, Feldt-Rasmussen U
Medical Department P2131, Rigshospitalet, Copenhagen, Denmark.
Clin Chim Acta. 1997 Mar 18;259(1-2):117-28. doi: 10.1016/s0009-8981(96)06478-9.
A comparison of four different commercial immunometric thyrotropin (TSH) assays (Amerlite R TSH-30 Ultrasensitive assay from Kodak, BeriLux R hTSH from Behring Werke, Delfia R hTSH Ultra from Wallac and IMX R Ultrasensitive hTSH from Abbott) was made by measuring serum TSH in 81 consecutive patients referred to hospital for various reasons with a serum TSH less than 0.8 mlU/l in the IMX assay. The analytical and functional assay sensitivities of each of the assays were analysed. Even though three of the methods had a sensitivity corresponding to third generation assays, we could only demonstrate an overall agreement of serum TSH when comparing two of the kits. The measurements in Delfia Ultra and Berilux showed good agreement (P = 0.7, paired t-test and bias = 0.003 mIU/l), while the comparisons between the other assays showed different measurements (P < 0.00001, paired t-test and bias more than 0.07 mIU/l). Differences in the calibrators used in the assays might explain some of the discrepancy, although all methods were calibrated according to the same international standard. Also, differences in the specificity of the TSH monoclonal antibodies used in the assays might be an evident explanation and further studies of the specificity of the monoclonal antibodies are needed. An international collaborative study to clarify reasons for the differences between the TSH assays and to standardize the measurements is recommended.
通过对81例因各种原因入院且IMX检测法测得血清促甲状腺激素（TSH）低于0.8 mIU/l的患者进行血清TSH检测，比较了四种不同的商业化免疫比浊法促甲状腺激素（TSH）检测试剂盒（柯达公司的Amerlite R TSH - 30超敏检测试剂盒、贝林公司的BeriLux R hTSH试剂盒、瓦里安公司的Delfia R hTSH Ultra试剂盒和雅培公司的IMX R超敏hTSH试剂盒）。分析了每种检测方法的分析灵敏度和功能灵敏度。尽管其中三种方法的灵敏度与第三代检测方法相当，但在比较两种试剂盒时，我们仅发现血清TSH总体上具有一致性。Delfia Ultra和BeriLux的测量结果显示出良好的一致性（P = 0.7，配对t检验，偏差 = 0.003 mIU/l），而其他检测方法之间的比较显示测量结果不同（P < 0.00001，配对t检验，偏差超过0.07 mIU/l）。检测中使用的校准品差异可能是造成部分差异的原因，尽管所有方法均按照相同的国际标准进行校准。此外，检测中使用的TSH单克隆抗体特异性差异可能也是一个明显的原因，因此需要对单克隆抗体的特异性进行进一步研究。建议开展一项国际合作研究，以阐明TSH检测方法之间存在差异的原因并实现测量标准化。
