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

摘要

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.%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/T 19634-2005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。