10款便携式血糖仪与中心实验室检测静脉血糖的比对研究  

A Comparative Study Between 10 Portable Glucometers and Central Laboratory for Determining Blood Glucose in Venous Blood

作　　者：王艳[1] 王清涛[2] 张顺利[2] 王宁[2] 周睿[2] WANG Yan;WANG Qingtao;ZHANG Shunli;WANG Ning;ZHOU Rui(Clinical Laboratory Center,Beijing Jishuitan Hospital,Beijing100035,China;Department of Clinical Laboratory,Beijing Chaoyan Hospital,Capital Medical University,Beijing 100020,China)

机构地区：[1]北京积水潭医院医学检验中心,北京100035 [2]首都医科大学附属北京朝阳医院检验科,北京100020

出　　处：《标记免疫分析与临床》2022年第11期1931-1936,1980,共7页Labeled Immunoassays and Clinical Medicine

基　　金：国家临床重点专科建设项目(编号:QTW);北京积水潭医院“学科骨干”专项经费(编号:XKGG 202125)。

摘　　要：目的评价10款便携式血糖仪与中心实验室检测静脉血糖的准确性和一致性,为医疗机构便携式血糖仪的选择和质量管理提供依据。方法采用仪器配套质控品评价便携式血糖仪精密度。收集22份不同浓度的静脉全血标本,分别在便携式血糖仪和中心实验室生化分析仪上检测,每份标本重复测定3次取均值,评价血糖仪与中心实验室检测结果的相关性和一致性。参照《便携式血糖仪临床操作和质量规范中国专家共识》进行血糖仪性能评价。结果当血糖浓度<5.5mmol/L时,10款血糖仪标准差(s)分布在±0.05~±0.20mmol/L;当血糖浓度≥5.5mmol/L时,10款血糖仪变异系数(CV)分布在1.2%~4.5%。10款血糖仪与中心实验室分析仪相关系数分布在0.979~0.997。根据评价标准,10款便携式血糖仪与中心实验室检测结果偏差范围的总符合率分布在63.6%~100.0%,其中有5款总符合率>95.5%。结论10款便携式血糖仪精密度均较好,与中心实验室检测结果有较好相关性。医疗机构应合理选择并管理便携式血糖仪,保证其检测结果准确性和可靠性。Objective The objective of this study was to evaluate the accuracy and consistency of 10 portable glucometers compared with central laboratory for determining blood glucose in venous blood,and to provide a reference for the selection and quality management of portable glucometers in medical institutions.Methods The precision of each portable glucometer was evaluated using glucose commercial control materials depending on the type of instrument.22 venous whole blood samples of different concentrations were pooled in this study,which were determined by 10 glucometers and the central laboratory system separately.Each sample was measured with triplicate.The mean measurement results of each system were compared with results of the central laboratory,and correlation and consistency evaluation were performed in accordance to the Chinese Expert Consensus on portable glucometers.Results When the glucose concentration was<5.5mmol/L,the standard deviation(s)of the 10 devices ranged from±0.05 to±0.20mmol/L.When the glucose concentration was≥5.5mmol/L,the coefficient of variation(CV)of the 10 devices ranged from 1.2 to 4.5%.The correlation coefficient ranged from 0.979 to 0.997.According to the evaluation criteria,the total coincidence rates of the difference between the portable devices and the central laboratory ranged from 63.6 to 100.0%,and 5 of the 10 devices had more than 95.5%of the total coincidence rate.Conclusion 10 portable glucometers perform well in terms of precision and correlation evaluations.It is important to choose a suitable portable glucometer to ensure the accuracy and reliability of its measurement results in medical institutions.

关 键 词：即时检验 血糖仪 中心实验室 比对 

分 类 号：R392-33[医药卫生—免疫学]