斑点酶联免疫分析仪校准用模拟斑点标准物质  

Development of reference materials of simulated spots for the calibration of the enzyme-linked immunospot analyzer

作　　者：李兰英[1] 王乐乐[1] 唐冬梅[1] 闻艳丽[1] 孟娇然[1] 丁敏[1] 武利庆 米薇[2] 鲁絮 Markus Rueger 刘刚[1] Li Lanying;Wang Lele;Tang Dongmei;Wen Yanli;Meng Jiaoran;Ding Min;Wu Liqing;Mi Wei;Lu Xu;Markus Rueger;Liu Gang(Shanghai Institute of Measurement and Testing Technology;National Institute of Metrology;AID Diagnostic Technology(Beijing)Co.,Ltd;Autoimmun Diagnostika GmbH)

机构地区：[1]上海市计量测试技术研究院 [2]中国计量科学研究院 [3]艾迪创格(北京)科技有限公司 [4]德国艾迪(AID)公司

出　　处：《上海计量测试》2020年第4期2-6,共5页Shanghai Measurement and Testing

基　　金：国家质量基础的共性技术研究与应用重点专项(2017YFF0204603)。

摘　　要：根据斑点酶联免疫分析仪的技术参数,结合酶联斑点的培养生长特性,采用AutoCAD设计模拟斑点图形,研制了模拟斑点标准物质,经过均匀性和稳定性检验,由八家实验室采用人工识别计数的方法进行协同定值,并进行不确定度评估。结果表明,该标准物质均匀性良好,在实验室室温避光条件下保存,稳定性在1 a以内,并成功应用到斑点酶联免疫分析仪的计量校准工作中,对仪器示值误差和重复性的计量特性进行实验研究,为仪器日常的校准工作以及国家计量校准规范的制定提供了实验基础。Reference materials(RMs)of simulated spots were developed using AutoCAD design to simulate the pattern of spots according to the technical parameters of enzyme-linked immunospot analyzer and the culture and growth characteristics of enzyme-linked spots.The homogeneity and the stability of the RMs were strictly inspected.The assessment of the RMs was certified using artifical counting method by 8 different laboratories,and the uncertainty evaluation was performed finally.The analysis results showed that the RMs were homogeneous and stable for at least one year in dark at room temperature.The RMs of simulated spots were used to research on the metrological properties which including indication error and repeatability of measurement.Results of this work provide novel experimental support for the estabilishment of the national metrology calibration specification and routine calibration of enzyme-linked immunospot analyzer.

关 键 词：模拟斑点 标准物质 斑点酶联免疫分析仪 计量校准 

分 类 号：R446.6[医药卫生—诊断学]