强生稳豪倍优型和雅培辅理善越佳型便携式血糖仪检测结果比较

Comparison of Detection Results of Two Portable Blood Glucose Meters(Johnson OneTouch Ultra and Abbott FreeStyle Optium Xceed)

目的评价强生稳豪倍优型(OneTouch Ultra)和雅培辅理善越佳型(FreeStyle Optium)两种便携式血糖仪的性能及与全自动生化分析仪检测血糖结果比对分析,探讨临床血糖快速检测准确可靠的方法。方法在两种便携式血糖仪上用3个浓度的质控品进行检测,连续检测5d,计算批内和总的变异系数。检测53例患者末梢血和静脉血浆血糖,SPSS统计学软件分析数据,评价两种便携式血糖仪的准确性及与全自动生化仪测定结果的相关性。结果强生稳豪倍优型血糖仪(OneTouch Ultra)和雅培辅理善越佳型(FreeStyle Optium)两种便携式血糖仪对3个浓度的质控品所测结果的变异系数(CV%)介于1.9%~3.1%和5.7%~11.1%,强生稳豪倍优型血糖仪3个质控水平均达到便携式血糖仪精密度的要求,雅培辅理善越佳型质控中值未达要求,与全自动生化仪所测结果的相关系数分别为r=0.99、r=0.98,相关性较好。强生稳豪倍优型血糖仪所测数据100%符合国家对便携式血糖仪准确性要求,雅培辅理善越佳型所测结果70%(血糖浓度小于4.2mmol·L-1)和79%(血糖浓度大于4.2mmol·L^(-1))符合要求,低于国家标准(95%)的要求。结论强生稳豪倍优型血糖仪的精密度和准确度均达到了临床要求。须定期对便携式血糖仪与实验室全自动生化分析仪结果进行比对,保证检测结果准确。

Objective To verify the performance of two kinds of portable blood glucose meters （Johnson OneTouch Ultra glucose meter and Abbott FreeStyleOptium Xceed）, compare the two meters with automatic biochemistry analyzer on the blood glucose detection, and provide an accurate and reliable method for the rapid detection of clinical blood glucose. Methods Control materials and patients samples with 3 gradual levels were detected continually for 5 days and then the coefficient of variation （CV） was calculated. Capillary blood glucose of 53 diabetes patients were measured by two portable glucose meters, and venous plasma glucose of the same patients were measured by hexokinase method as control. The results were measured by SPSS to determine the accuracy of two meters and the correlation between results of the two meters and automatic biochemical analyzer. Results The results of materials and patients samples with 3 gradual levels detected by the two meters （OneTouch Ultra and Optium Xceed） were 1.9%-3.1% and 5.7%-11.1%. OneTouch Ultra＇s performance in the precision was good, but Abbott Optium Xceed was not up to the requirements of quality control of the median level. The correlation coefficients between the two portable blood glucose meters and the total automatic biochemical analyzer were （R） =0. 99 and （R） =0.98, respectively, with better correlation. The data of Johnson OneTouch Ultra had 100% accuracy and was in line with the state portable glucose meter accuracy requirements while the acuracy of Abbott Optium Xceed measured results was only 70% （blood glucose concentration was less than 4.2mmol/ L） and 79% （blood glucose concentration was more than 4.2mmol/L） to meet the requirements respectively, which were lower than the requirements of the national standard （95%）. Conclusion The preci sion and accuracy of Johnson OneTouch Ultra glucose meter have reached the clinical requirements. The portable glucose meter needs to be compared regularly with laboratory automatic biochemical analyzer to ensure accurate results.