开放生化检测系统校准限值的设置与应用  

The configuration of calibration limits for non-matched chemistry system

作　　者：王志伟 梅艳芳 毛东英 蔡永梅 WANG Zhiwei;MEI Yanfang;MAO Dongying;CAI Yongmei(The Medical Laboratory Center,General Hospital of Ningxia Medical University,Yinchuan,Ningxia 750004,China)

机构地区：[1]宁夏医科大学总医院医学实验中心,宁夏银川750004

出　　处：《国际检验医学杂志》2021年第14期1715-1719,共5页International Journal of Laboratory Medicine

基　　金：宁夏回族自治区重点研发计划项目(2019BEG03014);宁夏回族自治区重点研发计划项目(2020BEG03006)。

摘　　要：目的研究开放生化检测系统项目校准限值的设置,实现对开放生化检测系统检测过程的监控。方法分别测定水空白和校准品,获取各项目试剂空白及校准品校准限值初始值;回顾性分析过去12个月的校准结果,对所设校准限值进行修正和优化,同时分析相同项目校准限值在不同仪器间的差异。结果限值可用于对校准测得的吸光度批内、批间精密度,试剂空白和校准因子最大、最小值进行监控。30个项目中,校准因子最大允许相对偏差范围为2.12%~30.60%,29项小于18.00%、27项小于15.00%、10项小于5.00%。两台仪器共同测定的26个项目中,试剂空白吸光度、校准品吸光度和校准因子P值小于0.05的分别为19项(73.00%)、21项(81.00%)和22项(85.00%),证实两台仪器校准结果差异有统计学意义(P<0.05)。结论通过在开放生化检测系统设置校准限值,实现对校准过程监控,减少由校准引入系统误差,进而监测整个分析检测系统。不同项目校准限值存在差异,应当根据试剂和分析仪器特点进行个性化设置、优化;同一项目校准限值在不同仪器亦存在差异,在进行设定应用时应当兼顾。Objective To study the configuration of calibration limits for non-matched chemistry system in order to monitor the system.Methods The water blank and calibrator were determined respectively,and the initial values of the calibration limits of reagent blank and calibrator were obtained.The calibration results of the past 12 months were analyzed retrospectively,and the calibration limits were modified and optimized.Meanwhile,the differences of the calibration limits of the same item among different instruments were analyzed.Results The limits could be used to monitor the intra-and inter batch precision of absorbance,reagent blank and the maximum and minimum values of calibration factor.Among the 30 items,the maximum allowable relative deviation of calibration factor was 2.12%-30.60%,29 items were less than 18.00%,27 items were less than 15.00%,and 10 items were less than 5.00%.Among the 26 items determined by the two instruments,19 items(73.00%)were reagent blank absorbance,21 items(81.00%)were calibrator absorbance and 22 items(85.00%)were calibration factor P value less than 0.05,which confirmed that there were significant differences between the two instruments.Calibration limits could be used to monitor the repeat precision,calibration tracking,maximum and minimum values of reagent blank and calibration factor.The allowable relative deviations of the 30 tests were different and between 2.12%and 30.60%.There is significant difference in calibration results between two instruments(P<0.05).Conclusion By setting calibration limits in the non-matched chemistry system,the calibration process can be monitored,and the system error introduced by calibration can be reduced,so as to monitoring the whole analysis and detection system.The calibration limits of different items are different,which should be set and optimized according to the characteristics of reagents and analytical instruments;the calibration limits of the same item are also different in different instruments,which should be taken into account when setting

关 键 词：开放生化检测系统 校准 限值 全自动生化分析仪 

分 类 号：R446.1[医药卫生—诊断学]