医用便携式血糖仪与生化分析仪检测结果的对比研究  

Comparative study of the test results of medical portable blood glucose meter and biochemical analyzer

作　　者：凌伟丽 潘一会 Ling Weii;Pan Yihui(Department of Logistics Support,The First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China;Department of Medical Engineering,First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China)

机构地区：[1]温州医科大学附属第一医院后勤保障部,温州325000 [2]温州医科大学附属第一医院医学工程部,温州325000

出　　处：《现代仪器与医疗》2024年第5期5-10,共6页Modern Instruments & Medical Treatment

摘　　要：目的评价医用便携式血糖仪在临床血糖检测方面的性能,为医疗机构采购便携式血糖仪提供参考。方法本研究采集2024年3月10日温州医科大学附属第一医院的5份人体静脉全血样本,血糖浓度为1.7~3.5mmol/L、3.5~6.1mmol/L、6.2~8.3mmol/L、8.4~13.9mmol/L、14.0~25.0mmol/L。分别采用6个品牌各10台血糖仪和生化分析仪重复检测2次,参照《便携式血糖仪临床操作和质量管理指南WS/T781-2021》评价各品牌血糖仪的准确度、精密度及与生化分析仪的相关性和可比性。结果当血糖浓度<5.5 mmol/L时,6个品牌血糖仪绝对偏差分布在-0.52~+0.54 mmol/L,标准差(s)分布在0.04~0.13mmol/L;当血糖浓度≥5.5mmol/L时,相对偏差分布在-19.88%~12.78%,变异系数(CV)分布在1.3%~3.65%。6个品牌血糖仪与生化分析仪相关系数分布在0.997~0.999,检测结果偏差范围的符合率分布在91%~100%,其中有5个品牌符合率>95%,1个品牌相对偏差超出±15%。结论6个品牌便携式血糖仪精密度均较好,与生化分析仪检测结果有较好相关性。5个品牌便携式血糖仪准确度较好,1个品牌准确度未达到指南要求。医疗机构采用新型号的血糖仪前,有必要进行精密度、准确度和相关性等验证。Objective To evaluate the performance of medical portable blood glucose meters in clinical blood glucose detection,and to provide a reference for medical institutions to purchase portable blood glucose meters.Methods In this study,five human venous whole blood samples were collected from the First Affiliated Hospital of Wenzhou Medical University on March 10,2024,and the blood glucose concentrations were 1.7 to 3.5 mmol/L,3.5 to 6.1 mmol/L,6.2 to 8.3 mmol/L,8.4 to 13.9 mmol/L,and 14.0 to 25.0 mmol/L.10 blood glucose meters and biochemical analyzers from each of 6 brands were used to repeat the test twice,and the accuracy,precision,relevance and comparability with biochemical analyzers of each brand were evaluated according to the“Guidelines for Clinical Operation and Quality Management of Portable Blood Glucose Meters WS/T781-2021”.Results When the blood glucose concentration<5.5 mmol/L,the absolute deviation of the six brands of blood glucose meters was-0.52~+0.54 mmol/L,and the standard deviation(s)was 0.04~0.13mmol/L.When the blood glucose concentration≥5.5 mmol/L,the relative deviation was-19.88%~12.78%,and the coefficient of variation(CV)was 1.3%~3.65%.The correlation coefficient between 6 brands of blood glucose meters and biochemical analyzers was 0.997~0.999,and the coincidence rate of the deviation range of the test results was 91%~100%,of which 5 brands had>coincidence rate95%,and the relative deviation of 1 brand exceeded±15%.Conclusion The precision of the six brands of portable blood glucose meters is good,and there is a good correlation with the detection results of biochemical analyzers.The accuracy of 5 brands of portable blood glucose meters was good,and the accuracy of 1 brand did not meet the requirements of the guidelines.Before adopting a new model of blood glucose meter,it is necessary to verify the precision,accuracy,and relevance of the new blood glucose meter.

关 键 词：便携式血糖仪 生化分析仪 性能对比 精密度 准确度 可比性 

分 类 号：TH77[机械工程—仪器科学与技术] R197.32[机械工程—精密仪器及机械]