体外凝血检测传感器性能分析与不确定度评定

doi:10.3901/JME.2022.12.018

机械工程学报 ›› 2022, Vol. 58 ›› Issue (12): 18-28.doi: 10.3901/JME.2022.12.018

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体外凝血检测传感器性能分析与不确定度评定

王哲¹, 李晓¹, 陈启梦², 赵梓朝³, 孟祥凯¹, 于源华¹

1. 长春理工大学生命科学技术学院长春 130022;
2. 长春理工大学光电工程学院长春 130022;
3. 吉林省计量科学研究院长春 130103

收稿日期:2021-08-12 修回日期:2022-01-13 出版日期:2022-06-20 发布日期:2022-09-14
通讯作者: 陈启梦(通信作者),女,1989年出生,博士,讲师,硕士研究生导师。主要研究方向为精密仪器结构设计。E-mail:qmchen1989@163.com
作者简介:王哲,男,1988年出生,博士,讲师,硕士研究生导师。主要研究方向为光机电一体化产品仿真与优化设计、生物医学传感技术。E-mail:wz@cust.edu.cn;于源华,女,1963年出生,博士,教授,博士研究生导师。主要研究方向为光机电一体化医疗仪器研究与开发。E-mail:yuyuanhua8888@126.com
基金资助:
吉林省科技发展计划资助项目（20200404180YY、20200602050ZP、20210201084GX）

Performance Analysis and Uncertainty Evaluation of in Vitro Coagulation Test Sensors

WANG Zhe¹, LI Xiao¹, CHEN Qimeng², ZHAO Zizhao³, MENG Xiangkai¹, YU Yuanhua¹

1. School of Life Science and Technology, Changchun University of Science and Technology, Changchun 130022;
2. School of Optoelectronic Engineering, Changchun University of Science and Technology, Changchun 130022;
3. Jilin Institute of Metrology, Changchun 130103

Received:2021-08-12 Revised:2022-01-13 Online:2022-06-20 Published:2022-09-14

摘要/Abstract

摘要： 针对常规传感器标定方法无法满足体外凝血检测传感器性能分析等实际问题，建立一种体外凝血检测传感器性能分析与测量不确定度评定方法。根据体外凝血检测传感器工作原理及结构特点，采用光谱共焦位移传感器对凝血检测传感器进行静态特性分析，并且借助于五轴精密机械加工机床进行位移标定，搭建运动轴、测量轴、传感轴三轴共线的测量装置，通过建立高阶曲线拟合方程对传感器性能参数进行在线标定；采用误差精度理论，对传感器自身误差引入的不确定度、传感器安装误差引入的不确定度、上级溯源引入的不确定度等因素进行不确定度分析与评定。利用本方法对体外凝血检测传感器进行性能分析与不确定度评定，标定结果表明传感器灵敏度为0.659 V/μm，迟滞为4.88%，线性度由0.007 6%提高到0.002 5%，重复性为0.003 3%，通过计算合成测量不确定度为0.84 μm，小于体外凝血检测传感器频响特性指标允许误差为±1 μm。所以搭建的测量系统的精度可以保证体外凝血检测的精度，验证了建立的体外凝血检测传感器性能分析与测量不确定度评定方法可以满足传感器精度分析的要求，为提升此类传感器的研制工艺提供核心技术。

关键词: 凝血检测, 传感器, 曲线拟合, 性能分析, 不确定度

Abstract: As conventional sensor calibration is not a satisfying solution for practical issues such as performance analysis of in vitro coagulation test sensors, an approach to performance analysis and uncertainty evaluation of in vitro coagulation test sensors is established. According to operation principle and structural characteristics of in vitro coagulation test sensors, static characteristic analysis of coagulation test sensors with a chromatic confocal displacement sensor is carried out. In addition, it conducted displacement calibration by the aid of a five-axis precision machine tool, construction of measuring equipment, in which axes of motion, measurement and sensing were collinear, and online calibration of sensor performance parameters through high-order curve fitting equations. In accordance with error accuracy theory, it analyzed and evaluated uncertainties of sensor errors, sensor installation errors and upper source tracing etc. By this approach, performance analysis and uncertainty evaluation of in vitro coagulation test sensors were carried out. Its calibration results indicated that sensitivity, delay, linearity and repeatability of the sensors were, respectively, 0.659 V/μm, 4.88%, 0.002 5% rising from 0.007 6%, and 0.003 3%. According to calculation, the uncertainty of synthetic measurement is 0.84 μm, which is less than ±1μm, the permissible error of frequency response characteristic indexes of in vitro coagulation test sensors. Therefore, the accuracy of this measuring system built can ensure that of in vitro coagulation tests. It is verified that the established approach to performance analysis and uncertainty evaluation of in vitro coagulation test sensors can meet demands of sensor accuracy analysis and provides core technology to improve development process of this type of sensor.

Key words: coagulation test, sensors, curve fitting, performance analysis, uncertainties

中图分类号:

TH165

王哲, 李晓, 陈启梦, 赵梓朝, 孟祥凯, 于源华. 体外凝血检测传感器性能分析与不确定度评定[J]. 机械工程学报, 2022, 58(12): 18-28.

WANG Zhe, LI Xiao, CHEN Qimeng, ZHAO Zizhao, MENG Xiangkai, YU Yuanhua. Performance Analysis and Uncertainty Evaluation of in Vitro Coagulation Test Sensors[J]. Journal of Mechanical Engineering, 2022, 58(12): 18-28.

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体外凝血检测传感器性能分析与不确定度评定

Performance Analysis and Uncertainty Evaluation of in Vitro Coagulation Test Sensors

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