Immulite 1000化学发光仪检测IL-6的性能验证  

The performance verification of Immulite 1000 on measuring IL-6

作　　者：阮向军[1] 董峰[1] 王红霞[1] 杨丽[1] 余伟 王成彬[1] 

机构地区：[1]解放军总医院临床检验科,北京100853 [2]西门子医学诊断产品有限公司,北京10010

出　　处：《临床检验杂志（电子版）》2012年第4期233-237,共5页Clinical Laboratory Journal(Electronic Edition)

摘　　要：目的研究Immulite 1000检测IL-6的性能与特点,验证其是否能够用于IL-6的临床检测,为检验同行提供相关信息。方法对Immulite1000测定IL-6的精密度、可比性、线性、稳定性等指标进行测试。结果 Immulite 1000测定IL-6精密度批内CV<2.31%,批间CV<6.1%,总体CV<6.6%,均能满足日常工作要求。Immulite 1000与Cobas e 411测定IL-6显示出较好的一致性。二者测定结果之间相关系数为0.926(P<0.05),差值与均值的95%置信区间为(-154.94,128.21)。线性范围为6.23 pg/ml^971.3pg/ml,线性回归方程为y=1.0746x-11.191,R^2=0.9944。携带污染率为1.13%。结论对IL-6的检测建议在采血后24h内完成,Immulite1000检测IL-6显示了良好的精密度、线性、与Cobas e 411测定IL-6的结果有较好的一致性,能够用于临床IL-6的检测。Objective To study the characteristic and performance of SIEMENS Immulite 1000 on measuring IL-6,verify if it can be applied in clinical test,and we envision that these paper will benefical for the further understanding on engaging in clincal laboratory.Methods The analytic characteristics including precision,comparison,linearity,carry-over,stability of IL-6 were examined.Results The coefficient of variation(CV) was less than 2.31%,6.1%and 6.6%for within,between and total,respectively,all precision CV we test can satisfy the requirement for daily work.It shows good consistency between Immulite 1000 and Cobas e 411 on measuring IL-6,the correlation coefficient was 0.926(P<0.05),the confidence interval between difference and average was(-154.94,128.21).Linear range was 6.23pg/m^971.3pg/ml,y=1.0746x-11.191,R^2=0.9944.The carry-over was 1.13%.Conclusion we suggested that the measurement of IL-6 should be finished in 24h,and the test of IL-6 by Immulite 1000 indicated good precision,linearity,comparied with Cobas e 411,it showed good consistency,we concluded that Immulite 1000 can be used in clinical measurement for IL-6.

关 键 词：性能验证 IL-6 定量检测 比对 

分 类 号：R446.6[医药卫生—诊断学]