Luraschi Paola, Brambilla Simona, Infusino Ilenia, Franzini Carlo
Laboratorio di Chimica Clinica, Ospedale L. Sacco, Milan, Italy.
Clin Chim Acta. 2003 Jul 1;333(1):41-5. doi: 10.1016/s0009-8981(03)00163-3.
Analytical evaluations of an available system for capillary zone electrophoresis (CZE) of serum protein have been reported. However, data concerning long-term precision and stability of the system, operated under routine conditions, are lacking. We report data from an internal quality control (QC) scheme, obtained over a 1-year period.
Measurements were done with a pair of instruments (Beckman Paragon CZE 2000 system), each equipped with seven capillaries. After preliminary (1 month) assessment of possible inter-capillary and inter-instrument variations, the QC material (a home prepared serum pool stored in the frozen state) was assayed daily over a 1-year period.
Maximum inter-capillary and inter-instrument differences were 3.1% and 2.4%. No significant trend was observed for daily values (205 measurements over 1 year); in the same period overall imprecision values (CV) were in the interval 1.2% (albumin) to 3.2-6.1% (globulin zones). Mean monthly imprecision (CV) values were in the interval 1.1% (albumin) to 5.2% (globulin zones). There was no significant trend of monthly means with time. The observed imprecision values were within the biological variation-derived goals for imprecision.
It is concluded that the assessed analytical instruments, operated in routine conditions, show long-term stability and imprecision consistent with the clinical use of the results produced.
已有关于血清蛋白毛细管区带电泳（CZE）现有系统的分析评估报告。然而，缺乏该系统在常规条件下运行的长期精密度和稳定性数据。我们报告了在1年期间通过内部质量控制（QC）方案获得的数据。
使用一对仪器（贝克曼Paragon CZE 2000系统）进行测量，每台仪器配备7根毛细管。在对可能的毛细管间和仪器间差异进行初步（1个月）评估后，在1年期间每天对QC材料（一种冷冻保存的自制血清混合液）进行检测。
毛细管间和仪器间的最大差异分别为3.1%和2.4%。未观察到每日测量值（1年中进行205次测量）有显著趋势；同一时期，总体不精密度值（CV）在1.2%（白蛋白）至3.2 - 6.1%（球蛋白区）之间。每月平均不精密度（CV）值在1.1%（白蛋白）至5.2%（球蛋白区）之间。每月平均值随时间无显著趋势。观察到的不精密度值在生物变异推导的不精密度目标范围内。
得出的结论是，在常规条件下运行的评估分析仪器显示出长期稳定性和不精密度，与所产生结果的临床应用一致。
