检验医学与临床Issue(14)：2003-2005,2008,4.DOI:10.3969/j.issn.1672-9455.2015.14.011
便携式血糖仪系统准确性评价及血细胞比容对其检测结果的影响
System accuracy evaluation of portable blood glucose meters and influence of hematocrit on their detection results
摘要
Abstract
Objective To evaluation the system accuracy of the portable blood glucose meters and the influence of hematocrit on the accuracy of their detection results.Methods 50 clinical samples were selected according to the requirements of GB/T 1 9634-2005.2 meters were respectively selected from the 5 types of widely used portable blood glucose meters at present and performed the double-sample detection.The detection results were compared with those detected by the hexokinase method for evaluating the systematic accuracy of blood glucose meter.5 hematocrit levels samples with high,middle and low blood glucose concentrations were respectively prepared and detected the blood glucose concentration by using 5 types of blood glucose meter and the detection results were compared with those de-tected by the hexokinase method for evaluating influence of hematocrit on the accuracy of their detection results under different blood glucose concentrations.Results According to the accuracy judgment standard of ISO 1 5 1 97 -2003, the results of StatStrip Xpress,Accu-Check,Optium Xceed,Contour TS and Rightest GM300 within the accuracy limit were 100%,99%,92%,98% and 72% respectively;according to the accuracy judgment standard of new version IOS 1 5 1 97-2013,which were 100%,99%,92%,98% and 72% respectively.Under high,middle and low blood glu-cose concentrations and 5 hematocrit levels samples,the results of StatStrip Xpress conformed to the accuracy re-quirements of ISO1 5 1 97:2003 and ISO1 5 1 97:2013;the results of Accu-Check met the accuracy requirements of ISO 1 5 1 97:2003;while the detection results of Optium Xceed,Contour TS and Rightest GM300 exceeded the minimal al-lowable limit or had no detection results.Conclusion The accuracy has great differences among different blood detec-tion systems.Partial blood glucose meters conform to the standard of new version ISO1 5 1 97:2013,the majority con-form to the requirements of ISO1 5 1 97:2003,individual meter can not reach the lowest accuracy requirement of ISO1 5 1 97:2003.Therefore before using the blood glucose meters,their evaluation and verification should be conduc-ted.The different blood glucose meters in the same hospital need to conduct the comparison for ensuring the accuracy and comparability of blood glucose detection results.关键词
便携式血糖仪/准确性/血细胞比容Key words
glocose meter/system accuracy/hematocrit引用本文复制引用
艾承锦,廖明星,潘瑞琪,陈玲娟,陈晓玲,张爽..便携式血糖仪系统准确性评价及血细胞比容对其检测结果的影响[J].检验医学与临床,2015,(14):2003-2005,2008,4.基金项目
四川省科技厅项目(2013FZ0010)。 （2013FZ0010）
