酶标法检测CA242不确定度的评估分析  

The evaluation of measurement uncertainty of CA242 with ELISA

作　　者：周艳秋 高红军 田颖 王洪武 

机构地区：[1]煤炭总医院中心实验室,北京100028

出　　处：《中国医药导报》2011年第15期93-94,96,共3页China Medical Herald

摘　　要：目的:探讨临床检验过程中定量酶标法(ELISA)检测CA242的不同影响因素,评估CA242的测量不确定度。方法:参考CNAS-GL06:2006《化学分析中不确定度的评估指南》等测量不确定度指南文件,重复检测低、中、高值3例标本,对本实验室开展的CA242检测评估其测量不确定度。结果:低、中、高值标本测定结果分别为4.482、41.892、102.355 U/ml,其相应的扩展不确定度为0.829、8.066、19.732 U/ml。随着标本浓度的上升,移液器加样引入的不确定度逐渐增加,而标准曲线拟合引入的不确定度则恰好相反。精密度和酶标仪测定OD值引入的不确定度所占比例最小。结论:在临床工作中应严格控制ELISA实验条件,特别是控制反应温度和环境温度,保证加样的准确性和稳定性,以获得准确可靠的结果。Objective：To investigate the effects of different factors on the results of quantitative ELISA,and evaluate the uncertainty in measurement（UM） of ELISA taking CA242 as an example.Methods：Referred to CNAS-GL06：2006 ＂Guidance on Evaluating the Uncertainty in Chemical Analysis＂ and other guidelines,three samples of low value,middle value and high value were repeatedly measured,and the UM of ELISA was estimated.Results：The results of the three samples were 4.482、41.892、102.355 U/ml,and the expanded uncertainty were 0.829、8.066、19.732 U/ml.With the sample value increasing the uncertainty of adding sample of transferpettor increased gradually,but the uncertainty of the calibrator curve decreased.The uncertainty ratios of the precision and the value of absorbance were smallest.Conclusion：To gain accurate and reliable results,the conditions of ELISA tests,in particular,the room temperature and adding sample process should be controlled strictly and make sure of the stability and accuracy of operation and the standard curve.

关 键 词：测量不确定度 定量酶标法 CA242 

分 类 号：R446.112[医药卫生—诊断学]