全自动发光免疫定量分析项目室内质量控制靶值确定方法的比较  

Comparison of the methods for determining the target value of internal quality control on quantitative automatic luminescence immunoassay

作　　者：程实[1] 王涛[1] 张亮[1] 陆军[1] 张雅莹[1] 安成[1] 

机构地区：[1]中国中医科学院广安门医院检验科,北京100053

出　　处：《检验医学与临床》2017年第2期211-214,共4页Laboratory Medicine and Clinic

摘　　要：目的比较全自动发光免疫定量分析项目确立室内质量控制靶值的不同方法,评估该实验室内简易方法的可行性。方法收集2016年1月1日至2016年3月31日,中国中医科学院广安门医院检验科免疫室全自动免疫发光分析仪上22个检测项目的质控数据,模拟2种方法(传统方法、简易方法)确定室内质量控制的暂定靶值。比较2种方法确立暂定靶值的差异。同时按照即刻法累积靶值与传统方法进行比较。结果除E2(40862)、FPSA、2GTesto(40881/2)、TT3(40861/2,40881)以及FT4(40881)外,其他项目经2种方法所得均值差异无统计学意义(P>0.05)。Levey-Jennings质控图对失控的检出能力差异无统计学意义(P>0.05)。即刻法相对于传统方法,易造成结果假在控或假失控。结论在该实验室内,应用简易方法确定室内质量控制暂定靶值能够代替传统方法确定的暂定靶值,满足临床需求,保证室内质控的正常进行,缩短靶值累积时间,降低成本,并且可以避免即刻法造成的假失控或假在控现象。Objective To compare the different methods of determining the target value of the internal quality control（IQC）and evaluate the feasibility of the simple method in our laboratory.Methods The quality control data of the 22 items on siemens IMMULITE 2000,Abbott ARCHITECT I2000,Roche Cobas E601 in our laboratory,during January 1,2016 to March 31,2016.We simulated two methods（traditional method and simple method）to establish the provisional target value of IQC with these data.The differences between the two methods were compared.At the same time,the data was processed with instant technique quality control,and then compared with the traditional methods.Results The mean values of the simple method and the traditional method had no statistical difference（P〉0.05）,in addition to E2（40862）,FPSA,2GTesto（40881/2）,TT3（40861/2,40881）and FT4（40881）outside.And there was no significant difference in monitoring the warming points and the out of control points in the Levey-Jennings quality control chart between the two methods（P〈0.05）.Compared with the traditional method,the instant technique quality control was easy to cause false results in control or false out of control.Conclusion In our laboratory,the simple method could replace traditional method with a stable detection system.It can meet the clinical needs,ensure the normal operation of IQC,shorten the time of establishing a target value.And the simple method can avoid the false in control and out of control,compared with the instant technique quality control.

关 键 词：免疫定量分析 室内质量控制 暂定靶值 

分 类 号：R446[医药卫生—诊断学]