现代检验医学杂志2013，Vol.28Issue(2)：113-117,5.DOI:10.3969/j.issn.1671-7414.2013.02.035
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
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
作者信息
摘要
Abstract
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 One-Touch 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 rwere respectively equal to 0.994 0,0.993 8,0.990 8,0.979 l,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=0.766X+1.166 9,Y=0.838 3X+0.796 4, rwere 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 one meter of Accu-Chek Performa.Stopped using the unqualified blood glucose meter, and classified management according to different test methods.关键词
床旁检验/便携式血糖仪/精密度/准确度/比对实验Key words
POCT/blood glucose meter/imprecision/accuracy/comparison test分类
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解宏杰,邱玲,国秀芝,侯立安,李鹏昌,王凯,程歆琦,刘荔,李春厚..四种型号便携式血糖仪的准确度验证[J].现代检验医学杂志,2013,28(2):113-117,5.
