Marschner I, Wood W G, van Thiel D, Habermann J, König A, Scriba P C
J Clin Chem Clin Biochem. 1983 May;21(5):301-11.
The results of a thyrotropin external quality assessment survey (EQAS) carried out in 1980 using the "Munich Model" and including a "matched reagent" experiment are presented and are compared with the results from similar surveys carried out in 1974 and 1977. Despite the fact that in 1974 only 4 different kits were used, compared with 12 in 1977 and 17 in 1980, the inter-laboratory precision has continually improved. This was reflected by the inter-laboratory coefficient of variation (CV) for all laboratories, which, for a sample with ca. 15 microU/l thyrotropin were: 65% (1974), 22% (1977) and 12% (1980), and for a sample containing ca. 5 microU/l thyrotropin: 75% (1974), 45% (1977) and 20% (1980). During the same period, the fraction of participants using commercial kits increased from 0.65 to 0.95. There was a definite trend towards shorter assays, even though with such assays there is a danger that the measured values for low thyrotropin concentrations will be too high. In spite of the fact that the "high-blank" effects have to a large extent disappeared, many kits showed an unacceptably high cross-reactivity with human chorionic gonadotropin. A fraction of 0.30 of all participants in 1974 used computer-assisted data-processing, compared with 0.78 in 1980. In 1980, the most commonly used algorithm was a spline function (0.46 of participants using a computer for data-processing). Although the number of kits has increased, the precision has improved, showing that more robust methods are now employed. This has partly come about because of the introduction of human thyrotropin-free serum as matrix for the standards (1974 - 0.16, 1980 - 0.83 of all participants). Further external quality assessment programmes are discussed for the continual monitoring of hormone assay performance.
本文展示了1980年采用“慕尼黑模型”开展的促甲状腺激素外部质量评估调查（EQAS）结果，该调查包含一项“匹配试剂”实验，并将其与1974年和1977年开展的类似调查结果进行了比较。尽管1974年仅使用了4种不同试剂盒，而1977年为12种，1980年为17种，但实验室间精密度仍在持续提高。这体现在所有实验室的实验室间变异系数（CV）上，对于促甲状腺激素约为15微国际单位/升的样本，该系数分别为：1974年65%、1977年22%、1980年12%；对于促甲状腺激素约为5微国际单位/升的样本：1974年75%、1977年45%、1980年20%。同一时期，使用商业试剂盒的参与者比例从0.65增至0.95。检测时间有明确的缩短趋势，尽管此类检测存在低促甲状腺激素浓度测量值过高的风险。尽管“高空白”效应在很大程度上已消失，但许多试剂盒与人绒毛膜促性腺激素的交叉反应性仍高得令人无法接受。1974年所有参与者中有0.30使用计算机辅助数据处理，1980年这一比例为0.78。1980年，最常用的算法是样条函数（使用计算机进行数据处理的参与者中有0.46使用该函数）。尽管试剂盒数量增加，但精密度提高，表明现在采用了更稳健的方法。部分原因是引入了不含人促甲状腺激素的血清作为标准品的基质（所有参与者中，1974年为0.16，1980年为0.83）。文中还讨论了进一步的外部质量评估计划，以持续监测激素检测性能。
