多台生化分析仪多项目同时进行比对的实验研究设计及应用  

Design of method comparison and bias estimation of multi tests on multi instruments

作　　者：邱玲[1] 程歆琦[1] 刘荔[1] 刘福成[1] 刘茜[1] 葛增梅[1] 

机构地区：[1]中国医学科学院 北京协和医院检验科,100730

出　　处：《中华检验医学杂志》2007年第9期1001-1004,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的设计同时在多台生化分析仪上对多个检测项目进行方法比较和偏倚评估的实验。方法参照美国临床和实验室标准化协会 EP9-A文件,并改进其中样本收集要求,每天取患者新鲜混合血清8份,连续5 d在11台自动生化分析仪上测定所有参加比对的项目,每批重复2次。计算线性方程、相关系数及平均百分偏差,同时评价医学决定水平处的系统偏差。结果以 ALT 测定为例,各仪器相关系数在0.994～1.000之间,平均百分偏差在-0.460%～4.927%之间,40 U/L 和300 U/L 处的系统偏差分别在-1.510～1.834和～3.101～9.188之间。结论 28个项目在不同仪器之间的相对偏倚在线形范围内可接受,2个项目在调整系数后结果可接受,淀粉酶和脂肪酶在不同仪器方法间的比对结果不接受。Objective To design an experiment for method-comparison and bias estimation of multi tests on multi instruments. Methods According to the procedure described by the NCCLS approved guideline EP9-A and improving the method of sample collection, we took 8 patient mixing samples each day to analyze all comparison tests on 11 auto-chemistry analyzer within following 5 days. The duplicates were assessed within the same run. The coefficient of correlation and average bias% were calculated, and the system errors at medical decided levels were assessed. Resallts Taking ALT as an example, the coefficients of correlation were between 0. 994 - 1. 000, and the average bias% were between - 0. 460% - 4. 927%, SE at 40U/L was - 1.510 - 1. 834 and SE at 300 U/L was - 3. 101 - 9. 188. Conclusion In all tests that joined the comparison among the different instruments, 28 tests were acceptable, 2 tests were acceptable after modifying the coefficients, and AMY and LIP were not acceptable.

关 键 词：评价研究 可重复性 结果 偏差 

分 类 号：R446.1[医药卫生—诊断学]