摘要
目的评价便携式血糖仪系统准确性及血细胞比容对其检测结果准确性的影响。方法参照GB/T19634-2005的要求选择50例临床标本,选择当前应用广泛的5种型号血糖仪各2台,分别进行双份测定,与己糖激酶法结果比较,评价血糖仪的系统准确性。制备高、中、低血糖浓度各5个血细胞比容水平的标本,分别用5款血糖仪测定血糖浓度,与己糖激酶法结果比较,评价不同血糖浓度水平下血细胞比容对血糖仪检测结果准确性的影响。结果按照ISO 15197:2003的准确性判断标准,StatStrip Xpress、Accu-Check、Optium Xceed、Contour TS、Rightest GM300在准确限内的结果分别为100%、99%、97%、100%、75%;按照新版ISO 15197:2013的标准,StatStrip Xpress、Accu-Check、Optium Xceed、Contour TS、Rightest GM300在准确限内的结果分别为100%、99%、92%、98%、72%。在高、中、低3种血糖浓度、5个血细胞比容水平下,StatStrip Xpress的结果符合ISO15197:2003和ISO15197:2013的准确性要求;Accu-Check的结果满足ISO 15197:2003的准确性要求;Optium Xceed、Contour TS、Rightest GM300的检测结果超出了ISO15197:2003的最低允许限或无检测结果。结论血糖仪检测体系之间的准确性差异较大,部分血糖仪符合新版ISO15197:2013标准,大部分符合ISO15197:2003的要求,个别血糖仪达不到ISO15197:2003的准确性最低标准。在使用前需要对其进行评价或验证,同一医院不同血糖仪之间需要进行比对以确保血糖结果的准确可比。
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 19634-2005.2meters were respectively selected from the 5types 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.5hematocrit levels samples with high,middle and low blood glucose concentrations were respectively prepared and detected the blood glucose concentration by using 5types of blood glucose meter and the detection results were compared with those detected 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 15197-2003,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 15197-2013,which were 100%,99%,92%,98% and 72% respectively.Under high,middle and low blood glucose concentrations and 5hematocrit levels samples,the results of StatStrip Xpress conformed to the accuracy requirements of ISO15197：2003and ISO15197：2013;the results of Accu-Check met the accuracy requirements of ISO15197：2003;while the detection results of Optium Xceed,Contour TS and Rightest GM300 exceeded the minimal allowable limit or had no detection results.Conclusion The accuracy has great differences among different blood detection systems.Partial blood glucose meters conform to the standard of new version ISO15197：2013,the majority conform to the requirements of ISO15197：2003,individual meter can not reach the lowest accuracy requirement of ISO15197：2003.Therefore before using the blood glucose meters,their evaluation and verification should be conducted.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.
出处
《检验医学与临床》
CAS
2015年第14期2003-2005,2008,共4页
Laboratory Medicine and Clinic
基金
四川省科技厅项目(2013FZ0010)
