两种血细胞分析仪方法学比较和偏倚评估  

Evaluation of Method Comparison and Bias of Outcome between Two Different Blood Cell Analyzers

作　　者：张海涛[1] 李华[1] 李洁[1] 林斌[1] 马筱玲[1] 

机构地区：[1]安徽省立医院检验科培训基地,安徽省立医院检验科,合肥230001

出　　处：《临床输血与检验》2013年第1期50-53,共4页Journal of Clinical Transfusion and Laboratory Medicine

摘　　要：目的验证日本SYSMEX公司生产的XT-1800血细胞分析仪的准确度性能。方法根据美国临床实验室标准化委员会(NCCLS)标准化文件EP9-A2的要求,将该仪器与日本SYSMEX公司生产的XS-800i血细胞分析仪进行对比,进行偏倚评估分析。结果 XT-1800与XS-800i的WBC、RBC、HGB、HCT、MCV和PLT的相关系数r>0.975,医学决定水平处的系统误差Bc均小于规定的允许总误差Ea,在临床的可接受范围。结论日本SYSMEX公司生产的XT-1800和XS-800i血细胞分析仪WBC、RBC、HGB、HCT、MCV和PLT测定结果基本一致,可以为临床提供准确一致的报告。Objective To evaluate the performances of the XT-1800 hematology analyzer produced by SYSMEX company in Japan. Methods We compared with the XS-800i blood analyzer produced by the same company according to regulations EP9-A2 formulated by U.S. Committee for Clinical Laboratory Standards （NCCLS）. Results The correlation coefficient of the values （WBC,RBC,HGB,HCT,MCV and PLT） were 〉0. 975 measured by two instruments. Systematic error Bc in the medical decision level was less than the allowable total error Ea, in the acceptable range. Conclusion The precison of WBC, RBC, HGB, HCT, MCV, and PLT examined by XT-1800 can meet the reqirements of clinical trials.

关 键 词：血细胞分析仪 EP9-A2 偏倚评估 

分 类 号：R457.12[医药卫生—治疗学]