Microtech 648 ISO型电泳分析仪测定血清蛋白的性能验证研究及应用  

Performance Qualification and Application to Measure Serum Protein with Microtech 648 ISO Electrophoresis Analyzer

作　　者：苗玉发[1] 马犇[1] 潘东升[1] 刘芳[1] 汪巨峰[1] 李波[1] 

机构地区：[1]中国食品药品检定研究院,北京100176

出　　处：《医学研究杂志》2012年第9期37-39,共3页Journal of Medical Research

基　　金：国家"重大新药创制"科技重大专项基金资助项目(2008ZX09305-002)

摘　　要：目的验证Microtech 648 ISO型电泳分析仪的性能,并建立实验动物的血清蛋白电泳参考值。方法用商业质控血清作为测试物,分别测定日内精密度、日间精密度、灵敏度和准确性。结果 Alb、α1、α2、β、γ区带的日间CV分别为2.5%、7.4%、7.6%、7.1%、9.9%;在同一膜片上的日内CV值分别为1.6%、8.9%、4.9%、4.6%、5.4%;在不同膜片上的日内CV值分别为3.5%、8.7%、9.3%、9.3%、5.8%;准确度在可接受的范围内;白蛋白和球蛋白的检测灵敏度分别为1.1g/L和1.2g/L。用验证后的仪器建立了常用实验动物的血清蛋白电泳参考值。结论 Microtech 648 ISO型电泳分析仪的性能良好,可以用于实验研究。Objective To qualify the performance to measure serum protein with Microtech 648 ISO electrophoresis analyzer, and establish reference ranges for serum protein eleetrophoresis of laboratory animals. Methods Precision, sensitivity and accuracy were ana-lyzed using commercial quality control serum. Results The day to day CV of Alb, α1 , α2 , β, γ was 2.5% ,7.4% ,7.6% ,7. 1% and 9.9% , respectively. The within - day CV of Alb, α1 , α2 , β, γ, on the same film was 1.6% ,8.9% ,4.9% ,4.6% ,5.4% , respectively. The within - day CV of Alb, α1, α2 , β, γ on different films was 3.5 % , 8.7 % , 9.3 % , 9.3 % , 5.8 % , respectively. Accuracy was acceptable, and sensitivity of album and globulin was 1. lg/L and 1.2g/L. Reference ranges of laboratory animals were established using the qualified electrophoresis analyzer. Conclusion Performance of Microtech 648 ISO electrophoresis analyzer is good, and can be used in scientific studies.

关 键 词：电泳 精密度 灵敏度 准确性 参考值 

分 类 号：R446.11[医药卫生—诊断学]