采用标准溯源实验室方法评估四款医院专用血糖监测系统精准性

Accuracy evaluation of four hospital blood glucose monitoring systems with a standard traceability laboratory method

目的采用经可溯源的同位素稀释质谱法标化的实验室葡萄糖参考检测方法,对四款医院专用血糖监测系统(blood glucose monitoring systems,BGMS)的精准性及临床安全性进行评估。方法对Accu Chek InformⅡ、GLUPAD、金准Plus及Stat Strip四款医院专用BGMS精准性和安全性进行评估,并分别按照国际标准规范ISO 15197:2003和ISO 15197:2013评估BGMS的达标率。结果 Accu Chek InformⅡ、GLUPAD、金准Plus及Stat Strip符合ISO 15197:2003标准比例分别为99.6%、98.3%、97.9%及99.6%,符合ISO 15197:2013标准比例分别为97.9%、95.4%、95.0%及98.8%。Parks误差栅格图显示,四款BGMS检测结果落在A区比例均超过95%,A区+B区均超过99%。结论 Accu Chek InformⅡ、GLUPAD、金准Plus及Stat Strip四款医院专用血糖监测系统均具有较高的精准性和临床安全性。

ObjectiveTo evaluate the accuracy and clinical safety of four hospital-specific blood glucose monitoring systems （BGMS） with reference measurement of laboratory glucose test, which is standardized by traceable isotope dilution mass spectrometry. MethodFour hospital-specific BGMS, namely AccuChek Inform Ⅱ , GLUPAD, Gold-Accu Plus and StatStrip, were evaluated for accuracy and safety. Both International Standard Speci？cation ISO 151972003 and ISO 15197：2013 were used for assess the compliance rate. ResultThe compliance rates of AccuChek Inform Ⅱ , GLUPAD, Gold-Accu Plus and StatStrip with ISO 15197：2003 were 99.6%, 98.3%, 97.9%, and 99.6%, respectively. The compliance rates of those four BGMSs with ISO 15197：2013 were 97.9%, 95.4%, 95.0%, and 98.8%, respectively. Moreover, the Parks Error Grid analysis showed that more than 95% glucose values were in Zone A of four BGMSs, and more than 99% results were in Zone A ＋ B. ConclusionThese four hospital-speci？c BGMSs above have high accuracy and clinical safety.