拜安进~在血糖低值区域检测精准性的评估  

Accuracy of the CONTOUR^(TM) plus BGMS at low concentration of blood glucose

作　　者：王煜非[1] 唐峻玲 董璐[1] 顾程晨[1] 贾伟平[1] 

机构地区：[1]上海交通大学附属第六人民医院内分泌代谢科,上海市糖尿病临床医学中心,上海市糖尿病研究所,上海市糖尿病重点实验室,200233

出　　处：《中国糖尿病杂志》2016年第7期634-637,共4页Chinese Journal of Diabetes

摘　　要：目的评估拜安进血糖监测系统(BGMS)在血糖浓度<5.6 mmol/L的精准性。方法纳入200例正常体检者或糖尿病患者的血样,直接检测或经孵育酵解葡萄糖制备低浓度和极低浓度血糖的样本,采用拜安进和YSI 2300 STAT PLUS葡萄糖检测分析仪检测葡萄糖浓度。参考ISO最新发布的ISO 15197:2013标准评价拜安进检测结果的精准性。结果拜安进准确性为99.67%,Parkes误差栅格分析图显示血糖值99.83%落在A区,100%落在A、B区。3个批次批内标准差(s)为0.049~0.074,CV为1.37%~2.88%,批间5为0.049~0.071,CV为1.39%~2.78%。结论拜安进BGMS在血糖低值区域监测表现出高的精确性和准确性,符合最新的国际血糖监测系统标准的准确性要求。Objective To assess the accuracy of the CONTOURTM plus BGMS at low concentration of blood glucose 〈5.6 mmol/L. Methods Blood samples from 200 healthy adults and diabetic patients were collected. Blood samples with low level and very low level glucose were prepared by incubation and glycolysis. The glucose concentration were detected by CONTOUR TM plus BGMS and YSI 2300 STAT PLUS glucose analyzer respectively. Accuracy of CONTOURTM plus BGMS was evaluated by ISO 15197∶2013 released by ISO. Results The accuracy of CONTOURTM plus BGMS was 99.67% ,Parkes error‐grid analysis showed that 99.83% glucose readings fell in A zone ,and 100% glucose readings fell in A and B zone. The intra‐s （standard deviations） were 0.049～0.074 ,intra‐CV were 1.37% ～2.88% ;the inter‐s were 0.049～0.071 ,inter‐CV were 1.39% ～2.78%. Conclusion The CONTOURTM plus BGMS meets the accuracy standards as set out in ISO 15197∶2013 in measuring blood glucose within the hypoglycemic range.

关 键 词：拜安进血糖监测系统 血糖低值区域 精准性 自我监控 

分 类 号：R587.1[医药卫生—内分泌]