便携式血糖仪测量结果正确度和精密度评价方法的研究

Evaluation on the accuracy and precision of the results obtained from portable blood glucose meters

目的探讨不同评价标准对便携式血糖仪血糖测量结果正确度和精密度评价结果的影响。方法以5个水平冰冻人血清葡萄糖标准物质为评价样本评价A～E 5种常用便携式血糖仪的正确度和精密度,分别按计量学溯源标准、国标标准判断各血糖仪测量结果的正确度,分别按国标标准、自定义标准判断各血糖仪测量结果的精密度。结果按计量学溯源标准判断,各血糖仪血糖测量结果的正确度均不可接受;按国标标准判断,B血糖仪血糖测量结果的正确度可接受,其他均不可接受。按国标标准,血糖测量结果的精密度均符合要求;按自定义标准,D、E 2种血糖测量结果的精密度不符合要求。结论用不同的正确度、精密度评价标准可得出不同的结论,血糖仪测量结果正确度、精密度的评价方法亟待完善。

Objective：To investigate the effect of different evaluation standards on the accuracy and precision of the results obtained from different portable blood glucose meters. Methods：The accuracy and precision of 5 kinds of commonly used portable blood glucose meters, A^E, were evaluated using 5 concentration levels of glucose standard materials. The accuracy of the result obtained from each blood glucose meter was evaluated with the metrological traceability standard and national standard, while the precision of the result with the national standard and customized standard. Results：Judged with the metrological traceability standard, the accuracy of the results obtained from all blood glucose meters was unacceptable, while, judged with the national standard, the accuracy of results was also unacceptable except B branded blood glucose meter. Judged with the national standard, the precision of the results obtained from all blood glucose meters was acceptable, while, judged with the customized standard, the precision of the results was also acceptable except D and E branded blood glucose meters. Conclusion：When evaluated wirh different standards, the acceptability of the accuracy and precision of portable blood glucose meters was different. The evaluation methods for the accuracy and precision of the portable blood glucose meters should be improved.