四种型号便携式血糖仪的准确度验证  

Accuracy Verification for Four Models of Portable Blood Glucose Meters

作　　者：解宏杰[1] 邱玲[1] 国秀芝[1] 侯立安[1] 李鹏昌[1] 王凯[1] 程歆琦[1] 刘荔[1] 李春厚[1] 

机构地区：[1]北京协和医院检验科,北京100730

出　　处：《现代检验医学杂志》2013年第2期113-117,共5页Journal of Modern Laboratory Medicine

摘　　要：目的验证北京协和医院（PUMCH）在用及备用四种型号249台便携式血糖仪的精密度及与全自动生化分析仪测定结果的可比性。方法分别在罗氏卓越型、罗氏活力型、拜耳拜安康／1816、强生稳豪倍优四种型号血糖仪中随机抽取2台，连续测定高、中、低3个血糖水平的肝素锂抗凝全血各20次，计算批内不精密度；每种型号选择1台血糖仪分别使用两个批号试纸，交替检测同一份肝素锂抗凝全血共20次，计算批号间总不精密度。将249台血糖仪分14组，并选取32份不同浓度肝素锂抗凝全血分别在每组血糖仪上检测。同步分离血浆在Beckman AU5400上检测葡萄糖浓度，绘制散点图并拟合回归方程，判断医学决定水平处偏差或平均百分偏差是否符合该院判定标准。现场采集30名志愿者末梢血及静脉血对采用葡萄糖氧化酶方法检测的强生公司2台血糖仪追加新鲜血比对试验。结果四种型号8台血糖仪高、中水平批内变异分别在1．29％～6．18％和1．18％～3．10％之间，低水平（血糖浓度小于5．5mmol／L）批内标准差在0．05～0．15mmol／L之间；批号间变异在0．24％～3．28％之间，批号间平均偏差分别在0．03～0．39mmol／L之间。血糖仪与Beckman AU5400比对结果的回归方程分别为Y=1．0526X＋0．0946，Y=1．0528X＋0．077，Y=0．9459X＋0．0564，Y=0．973X-0．0718，r分别为0．9940，0．9938，0．9908和0．9791，在医学决定水平处结果偏差均小于0．63mmol／L或15％；平均百分偏差分别为-4．1％～2．3％，-1．4％～6．0％，-3．5％～-2．3％，-5．6％～-0．8％。强生公司2台血糖仪追加新鲜末梢全血比对试验结果的回归方程分别为Y=0．766X＋1．1669，Y=0．8383X＋0．79G4，r分别为0．8750，0．8850。在医学决定水平处结果偏差均小于0．63mmol／L或15％；平均百分偏差分别为-2．49％，-1．22％。结论罗氏卓越型有1�Objective To verify the precision of four models POCT blood glucose meters and compare the results of 249 meters using in PUMCH with automatic chemistry analyzer. Methods Got two meters from Accu-Chek Performa,Accu-Chek Active, Bayer ContourTM TS,OneTouch UltaVue randomly,and measured three levels of lithium heparin anticoagulant blood twenty times and calculated with-in run imprecision. Got one meter with two lots test strips, alternately measured one level blood twenty times and calculated total imprecision between different lots. Divided 249 meters into 14 groups and measured thirty-two lithium heparin anticoagulant blood respectively. At the same time, to separate plasma and measure on Beckman AU5400. Drawn scatter point diagrams and fitted regression equations. To compare the results of finger stick blood on OneTouch UltaVue meters and venous serum on Beckman AU5400 for complementary assessment. Results The with-in CV% of eight meters at high level and middle level were 1.291 % - 6.18 %, 1.18 % - 3.10 %, and at low level （blood glucose concentration was less than 5.5 mmol/L） s were 0.05-0.15 mmol/L CV% between different lots were 0.24%-3.28% ,and average deviations between different lots were 0.03 - 0.39 mmol/L. The regression equations compared with Beckman AU5400 were as follows：Y= 1. 052 6X＋0. 094 6,Y= 1. 052 8X＋0. 077,Y=0. 945 9X＋0. 056 4,Y=0. 973X-0. 071 8, the r were respectively equal to 0. 994 0,0. 993 8,0. 990 8,0. 979 1, at medical decision level the differences were all less than 0. 63 mmol/L or 15 %. The average percent difference were respectively equal to -4. 1 % - 2.3 %, -1.4 % -6.0 %, -3.5 % -2.3%,-5.6%-0.8%. The regression equations of additional finger stick blood experiment for two OneTouch UltaVue meters were Y=0. 766Xq-1. 166 9,Y=0. 838 3Xq-0. 796 4,r were 0. 875,0. 885,at medical decision level the differences were all less than 0. 63 mmol/L or 15 %. Average percent differences were respectively equal to -2.49 %,- 1.22 %. Conclusion All blood glucose meters had passed except

关 键 词：床旁检验 便携式血糖仪 精密度 准确度 比对实验 

分 类 号：R446[医药卫生—诊断学]