摘要
目的探讨自助式智能尿液检测设备分析尿液化学指标的性能评价,比较其与不同全自动尿液化学检测系统的一致性。方法按照实验方案及要求,收集样本并采用北京中医药大学东方医院的6种尿液分析系统对12项尿样指标进行检测,验证自助式智能尿液检测设备的重复性、室内比对及参考区间,评价设备性能及一致性。结果分析2819例患者结果中,自助式智能尿液检测设备的生物参考区间按性别分两组验证,总符合率≥90%,重复性符合率≥90%,室内比对结果除尿比重与尿微量白蛋白符合率<80%外,其余项目符合率均≥80%。自助式智能尿液检测设备与新健康成XC-2000生化仪检测尿M-Alb的相关性结果r=0.712,具有显著的相关性。自助式智能尿液检测设备与Sysmex UC-3500、ARKRAY AX-4030及Mindray UA-5800全自动尿液干化学分析系统检测尿糖的一致性结果分别为Kappa=0.854、Kappa=0.811、Kappa=0.883,与尿酮体的一致性结果分别为Kappa=0.819、Kappa=0.920、Kappa=0.815,均具有显著的一致性。结论自助式智能尿液检测设备性能良好,与全自动生化分析仪检测尿微量白蛋白指标方面具有显著的正相关,与全自动尿液干化学分析仪检测尿糖与尿酮体指标方面有高度的一致性。有助于对健康群体的筛查,该设备应用便捷卫生,检测快速,价格低廉,结果准确,符合尿液筛检要求。
Objective To evaluate the performance of urine chemical indexes analyzed by the self-service intelligent urinalysis combined device,and to determine and compare the consistency between the self-service intelligent urinalysis combined device and different fully automated urine chemistry analyzer.Methods According to the experimental scheme and requirements,study samples were collected and 12 indexes of urine samples were test by 6 types of automated urine analyzer of Dongfang Hospital.The results were verified repeatability.The internal comparison was conducted and reference interval of the self-service intelligent urinalysis combined device was determined.We then evaluated equipment performance and consistency.Results During the analysis of 2819 patients’results,according to gender,we verified the biological reference interval of the self-service intelligent urinalysis combined device and divided them into two groups.The results showed a total coincidence rate≥90%,and the compliance rate of repeatability≥90%,excepted SG and M-Alb less than 80%.The coincidence rate of internal comparison results were equal or greater than 80%.The correlation between self-service intelligent urinalysis combined device and XC-2000 biochemical analyzer for test urine M-Alb was r=0.712,suggesting that there were significantly correlations.The consistency results of the self-service intelligent urinalysis combined device and Sysmex UC-3500,ARKRAY AX-4030,Mindray UA-5800 for testing urine glucose were Kappa=0.854,Kappa=0.811,Kappa=0.883,while for testing urine ketone body were Kappa=0.819,Kappa=0.920,Kappa=0.815,respectively,indicating a significantly consistency between groups.Conclusion The performance of self-service intelligent urinalysis combined device is good,with a significant positive correlation with XC-2000 biochemical analyzer for test urine M-Alb,and has a high consistency with automatic urine dry chemical analyzer to test urine glucose and ketone body indexes.The self-service intelligent urinalysis combined device can help to screen healthy people,which is convenient and hygienic to use,quickly to test and with low price.The results is accurate,with compliance with urine screening requirements.
作者
张静冉
马子坤
韩冉
崔悦欣
陈维鑫
徐杰
ZHANG Jingran;MA Zikun;HAN Ran;CUI Yuexin;CHEN Weixin;XU Jie(Department of Clinical Laboratory,Profile of Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《标记免疫分析与临床》
2025年第5期1040-1047,共8页
Labeled Immunoassays and Clinical Medicine
基金
北京中医药大学东方医院临床研究横向课题(编号:HX202402)。
