Paterson N, Biggart E M, Chapman R S, Beastall G H
Ann Clin Biochem. 1985 Nov;22 ( Pt 6):606-11. doi: 10.1177/000456328502200609.
The LKB 'Delfia, immunofluorometric assay for serum TSH has been evaluated. The assay is simple and rapid to perform and is capable of processing in excess of 100 specimens within a working day. The sensitivity of the assay is 0.05 microU/L, with a working range extending beyond 324 microU/L. The change in signal at each point over the standard curve approaches 1000-fold, significantly greater than that of a typical immunoradiometric assay. Mean figures for intra-assay and inter-assay precision were 4.7% and 8.6% CV, respectively. Mean recovery of added TSH was 98.3%, and samples containing high levels of endogenous TSH diluted parallel to the standard curve. The method showed good correlation with an immunoradiometric assay for TSH. The reference ranges for clinically defined groups of subjects were euthyroid 0.47-3.84 microU/L (n = 83); primary hypothyroidism 15--greater than 324 microU/L (n = 28); thyrotoxicosis less than 0.05 microU/L (n = 46). It is concluded that the 'Delfia' assay offers the clinical biochemistry laboratory an attractive and reliable alternative to a sensitive immunoradiometric assay for serum TSH.
已对LKB公司的“德尔菲法”血清促甲状腺激素免疫荧光分析法进行了评估。该分析方法操作简单、快速，一个工作日内能够处理超过100份标本。该分析方法的灵敏度为0.05微国际单位/升，工作范围超过324微国际单位/升。标准曲线上各点的信号变化接近1000倍，显著高于典型的免疫放射分析法。批内精密度和批间精密度的平均值分别为4.7%和8.6%变异系数。添加促甲状腺激素的平均回收率为98.3%，含有高水平内源性促甲状腺激素的样本与标准曲线呈平行稀释。该方法与促甲状腺激素免疫放射分析法显示出良好的相关性。临床定义的各受试者组的参考范围为：甲状腺功能正常者0.47 - 3.84微国际单位/升（n = 83）；原发性甲状腺功能减退症患者15 - 大于324微国际单位/升（n = 28）；甲状腺毒症患者小于0.05微国际单位/升（n = 46）。结论是，“德尔菲法”分析为临床生物化学实验室提供了一种有吸引力且可靠的替代方法，可用于血清促甲状腺激素的灵敏免疫放射分析。
