便携式尿酸分析仪校准方法研究  

Research on the Calibration Method for Portable Uric Acid Analyzers

作　　者：崔宏恩 殷格漫 武利庆 杨铮 于海容 周倩 张凯 CUI Hongen;YIN Geman;WU Liqing;YANG Zheng;YU Hairong;ZHOU Qian;ZHANG Kai(Jiangsu Institute of Metrology,Nanjing 210023,China;National Institute of Metrology,Beijing 100029,China;Jiangsu Institute of Medical Device Testing,Nanjing 210009,China;Shandong Institute of Metrology,Jinan 250014,China;Sinocare Inc.,Changsha 410215,China;Jiangsu Yuyue Kailite Biotechnology Co.,Ltd.,Zhenjiang 212300,China)

机构地区：[1]江苏省计量科学研究院,南京210023 [2]中国计量科学研究院,北京100029 [3]江苏省医疗器械检验所,南京210009 [4]山东省计量科学研究院,济南250014 [5]三诺生物传感股份有限公司,长沙410215 [6]江苏鱼跃凯立特生物科技有限公司,镇江212300

出　　处：《计量科学与技术》2024年第4期45-49,30,共6页Metrology Science and Technology

基　　金：江苏省市场监督管理局科技项目(KJ2024010)。

摘　　要：便携式尿酸分析仪的准确与否对痛风和高尿酸血症患者日常监测尿酸有着直接影响,针对其校准规范的缺失,需制定其校准规范。基于搭建的便携式尿酸分析仪校准装置,通过提出便携式尿酸分析仪校准方法,确定其技术指标,结合校准案例进行验证以及对相关影响因素进行分析。依据校准方法,便携式尿酸分析仪的示值误差和重复性的验证结果符合技术要求,成功建立的便携式尿酸分析仪校准方法,可为《便携式尿酸分析仪校准规范》的编写提供有益参考,促进便携式尿酸分析仪的量值溯源和标准化。The accuracy of portable uric acid analyzers directly affects the daily monitoring of uric acid in patients with gout and hyperuricemia.Due to the lack of calibration standards for these analyzers,it is necessary to establish a calibration protocol.Based on the developed calibration device for portable uric acid analyzers,a calibration method is proposed,and technical indicators are determined.The method is verified through calibration cases,and relevant influencing factors are analyzed.According to the calibration method,the verification results of the indication error and repeatability of the portable uric acid analyzer meet the technical requirements.The successfully established calibration method for portable uric acid analyzers can provide a useful reference for the development of the"Calibration Specification for Portable Uric Acid Analyzers"and promote the traceability and standardization of portable uric acid analyzers.

关 键 词：计量学 尿酸 计量特性 校准 溯源 便携式尿酸分析仪 

分 类 号：TB99[一般工业技术—计量学]