经皮黄疸分析仪的校准方法及不确定度评定研究  

Calibration method and uncertainty evaluation of transcutaneous jaundice analyzers

作　　者：张佳文 杨广达 林建阳[1] ZHANG Jia-wen;YANG Guang-da;LIN Jian-yang(Department of Asset Management,the First Hospital of China Medical University,Shenyang 110001,China;Department of Medical Laboratory,Shenyang Metrology Testing Institution,Shenyang 110001,China)

机构地区：[1]中国医科大学附属第一医院资产管理部,沈阳110001 [2]沈阳计量测试院医化所,沈阳110001

出　　处：《医疗卫生装备》2022年第1期54-57,共4页Chinese Medical Equipment Journal

基　　金：国家自然科学基金青年科学基金资助项目(81302841);辽宁省高等学校优秀人才支持计划资助项目(LJQ2014086)。

摘　　要：目的:研究经皮黄疸分析仪的校准及不确定度评定方法,保障其计量性能准确可靠。方法:确立基于标准色板的经皮黄疸分析仪量值溯源方法,在标准环境条件下对3台不同厂家的经皮黄疸分析仪进行校准,对经皮黄疸分析仪的零值稳定性、模拟黄疸示值误差和模拟黄疸测量重复性3项计量性能参数进行综合评价。通过建立测量模型,完成经皮黄疸分析仪测量结果的不确定度分析与评定。结果:3台经皮黄疸分析仪的零值稳定性、模拟黄疸示值误差和模拟黄疸测量重复性测量结果均在计量性能要求范围内;不确定度评定结果与被测经皮黄疸分析仪生产厂家说明书中的最大允许误差绝对值之比小于1/3,可以满足测量要求。结论:使用标准色板对经皮黄疸分析仪进行校准与不确定度评定具有可行性,可满足医院临床使用需求。Objective To investigate the evaluation method for the calibration and uncertainty of transcutaneous jaundice analyzers to ensure the accuracy and reliability of their metrology.Methods A standard color palettes-based method was developed for the traceability of transcutaneous jaundice analyzers.Three transcutaneous jaundice analyzers from different manufacturers were calibrated under standard environmental conditions,and three metrological performance indexes,namely zero stability,error of simulated jaundice indication and repeatability of simulated jaundice measurement,were comprehensively evaluated.The uncertainty analysis and evaluation of the measurement results of the transcutaneous jaundice analyzers were completed by establishing measurement models.Results All the three indexes of zero stability,error of simulated jaundice indication and repeatability of simulated jaundice measurement satisfied the requirements of metrology performances;the ratios of the uncertainty evaluation results to the absolute values of the maximum permissible error in the manufacturer's instructions for the measured transdermal jaundice analyzers were all lower than 1/3 and could meet the measurement requirements.Conclusion It is feasible to use the standard color palette to calibrate the transcutaneous jaundice analyzer,so that the needs of clinical use in hospitals can be met.

关 键 词：经皮黄疸分析仪 校准 不确定度评定 经皮胆红素 血清总胆红素 

分 类 号：R318.6[医药卫生—生物医学工程] TH776[医药卫生—基础医学]