4种POCT血糖仪的性能评价及与全自动生化分析仪血糖检测结果的比对分析  

Performance Evaluation of 4 POCT Blood Glucose Meters and Comparative Analysis of Blood Glucose Test Results with Automatic Biochemical Analyzer

作　　者：井沆[1] 孙杰[1] 李丹[1] 井冰 马云霞 王树辉[1] JING Hang;SUN Jie;LI Dan;JING Bing;MA Yun-xia;WANG Shu-hui(Guizhou Province People's Hospital,Guiyang,Guizhou 550002;Dengzhou Central Hospital,Dengzhou,Henan 474150)

机构地区：[1]贵州省人民医院,贵州贵阳550002 [2]邓州市中心医院,河南邓州474150

出　　处：《智慧健康》2021年第14期8-11,15,共5页Smart Healthcare

基　　金：贵州省人民医院青年基金项目(项目编号:GZSYQN[2017]08)。

摘　　要：目的本试验旨在研究临床经常使用的4种不同分析原理POCT血糖仪的性能验证评价,同时与本院生化分析仪血糖检测结果进行比对分析,评价其结果的一致性,为医院临床使用POCT血糖仪提供数据参考。方法使用4种POCT血糖仪厂家自带的2个水平的质控品进行检测并分别计算批内变异系数、批间变异系数和总变异系数,完成精密度性能评价。对4种POCT血糖仪进行卫健委临检中心POCT室间质评结果测试,完成正确度性能评价分析。对4种POCT血糖仪的血糖检测结果分别和全自动生化分析仪检测血糖的结果进行比对试验及结果分析。结果 4种POCT血糖仪的精密度及正确度结果均符合《共识》中对血糖仪精密度及正确度的要求。对4种POCT血糖仪与生化分析仪的血糖结果进行统计学差异分析,结果显示,差异均无统计学意义(P>0.05),其相关系数分别为:0.9956、0.9956、0.9946和0.9964,均大于0.98,说明相关性良好。结论 4种POCT血糖仪的性能验证符合要求,血糖仪与生化分析仪血糖测定结果基本一致。医院应合理选择并正确使用POCT血糖仪,完善的POCT质量管理体系是保证血糖检测结果准确性和可靠性的重要前提。Objective The purpose of this experiment is to explore the performance verification and evaluation of 4 POCT blood glucose meters with different analytical principles used in clinical practice,and to compare and analyze the blood glucose measurement results with the biochemical analyzer in our hospital to evaluate the consistency of the results,so as to provide reference for hospitals to use POCT blood glucose meters and better guide clinical work.Methods The 4 POCT blood glucose meters use 2 levels of quality control products provided by the manufacturer respectively to detect and calculate the coefficient of variation within batches,coefficient of variation between batches and total coefficient of variation,so as to complete precision evaluation.4 POCT blood glucose meters were tested by POCT laboratory quality assessment in the temporary inspection center of the National Health Commission,and accuracy performance evaluation analysis was completed.The difference and correlation analysis were conducted on the blood glucose test results of each POCT blood glucose meter and automatic biochemical analyzer.Results All the 4 POCT blood glucose meters meet the requirements of the national blood glucose testing system for precision and accuracy of blood glucose meters,and all the above results meet the requirements of repeatability (accuracy) of blood glucose meters in the《Consensus》.Paired T-test showed that there was no statistically significant difference between the detection results of 4 POCT blood glucose meters and biochemical analyzers (P>0.05);The correlation coefficients were 0.9956,0.9956,0.9946 and 0.9964 respectively,all greater than 0.98,indicating a good correlation.Conclusion The performance verification of 4 POCT blood glucose meters meets the requirements,and the results of blood glucose meters and biochemical analyzer are basically consistent,with good correlation.Hospitals should reasonably choose and correctly use POCT blood glucose meters,and a perfect POCT quality management system guarantees

关 键 词：POCT血糖仪 生化分析仪 血糖检测 比对分析 

分 类 号：R446.1[医药卫生—诊断学]