摘要
目的:对测量不确定度在ELISA检测中的评定和应用作出探讨,提供一种表示ELISA检测结果质量的方法,并寻找改进ELISA检测质量的途径。方法:分别使用GUM法和自上而下评定法对ELISA检测中的测量不确定度进行评定。结果:应用GUM法举例评定测量不确定度得出:人血浆(清)HIV抗原抗体反应吸光度与cutoff比值(B)=4.335;U=1.3;k=2。应用自上而下评定法举例评定测量不确定度得出:人血浆(清)HCV抗体反应吸光度与cutoff比值=3.747;U=32.8;k=2。结论:ELISA检测引入测量不确定度后,会更科学地判定检测结果,解决了"灰区"设定"难"的问题。通过分析各分量的相对贡献,可有效改进检测工作质量,提升实验室检测水平。通过设立目标不确定度,可严格控制检测结果质量,以达到预期的质量要求。
Objective： To evaluate the role of measurement uncertainty in ELISA assay that provides a way of representation for the quality of results and improves the quality of the detection. Methods：Evaluate measurement uncertainty in ELISA test by using GUM and Top-down approach,respectively. Results：By GUM method, the absorbance value and cutoff value of the ratio in HIV antigen-antibody reaction of human plasma was 4.335,U=1.3 （k=2）. Relatively,Using Top-down approach absorbance value and cutoff value of the ratio in HCV antibody reaction of human plasma was 3.747, U=32.8 （k=2）. Conclusion： Measurement uncertainty is introduced to ELISA what makes results more scientifically and Solves the problems of ＂gray zone＂. Analyzing relative contribution of various components of uncertainty on measurement results can improve work quality and enhance the level of laboratory testing. Setting the target uncertainty is help to quality control to achieve the ideal requirements.
出处
《甘肃医药》
2014年第3期163-167,共5页
Gansu Medical Journal
关键词
不确定度
ELISA
评定
measurement uncertainty
ELISA
evaluation
