Gaines-Das R E, Brettschneider H, Bristow A F
Who International Laboratory for Biological Standards, National Institute for Biological Standards and Control, Herts, U.K.
Ann Biol Clin (Paris). 1991;49(10):522-7.
This report describes the results of a collaborative study organized by a joint working group of IFCC and WHO and involving nine manufacturers of TSH immunometric assay kits. The study was designed to determine whether a calibrator with a common matrix gives better between-laboratory agreement for calibration of serum samples than the various kit calibrators, and to assess various materials for their suitability for use as common matrices. Kit calibrators or calibrators consisting of the IRP for TSH made up in two common matrices, 1) serum from patients with untreated thyrotoxicosis or 2) serum taken from subjects treated with suppressive doses of triiodothyronine, gave similar results for the between-laboratory variation of estimates of TSH concentration for a range of serum samples. Dose-response curves for the two calibrators in 'common' matrices were similar to one another and to those fort the kit calibrator. However, the occurrence of non-specific serum effects is shown by the comparison of results for these calibrators with results for calibrators made up in a third common matrix, serum treated with wheat germ lectin. Dose response curves for this calibrator were dissimilar to those for the other calibrators and between-laboratory variation for estimates in terms of this latter calibrator showed a substantial increase. Moreover, although the between-laboratory variances for estimates of the TSH concentration in terms of each of these calibrators (except those made up in serum treated with in the wheat germ lectin) were similar for any one sample from five hyperthyroid patients, the variances were not consistent between samples, even for samples with similar mean TSH concentrations.(ABSTRACT TRUNCATED AT 250 WORDS)
本报告描述了由国际临床化学和检验医学联合会（IFCC）与世界卫生组织（WHO）联合工作组组织、九家促甲状腺激素免疫分析试剂盒制造商参与的一项合作研究的结果。该研究旨在确定具有共同基质的校准品在血清样本校准方面是否比各种试剂盒校准品能产生更好的实验室间一致性，并评估各种材料作为共同基质的适用性。试剂盒校准品或由促甲状腺激素国际参考制品（IRP）在两种常见基质中配制而成的校准品，即1）未经治疗的甲状腺毒症患者的血清或2）接受抑制剂量三碘甲状腺原氨酸治疗的受试者的血清，对于一系列血清样本促甲状腺激素浓度估计值的实验室间变异给出了相似的结果。两种“常见”基质校准品的剂量-反应曲线彼此相似，且与试剂盒校准品的曲线相似。然而，将这些校准品的结果与在第三种常见基质（经麦胚凝集素处理的血清）中配制的校准品的结果进行比较，显示出非特异性血清效应的存在。这种校准品的剂量-反应曲线与其他校准品不同，且基于后者校准品的估计值的实验室间变异显著增加。此外，尽管对于来自五名甲状腺功能亢进患者的任何一个样本，基于这些校准品（除了在经麦胚凝集素处理的血清中配制的校准品）中每一种的促甲状腺激素浓度估计值的实验室间方差相似，但即使对于平均促甲状腺激素浓度相似的样本，样本之间的方差也不一致。（摘要截短于250字）
