论文部分内容阅读
目的评估拜安进血糖监测系统(BGMS)在血糖浓度<5.6 mmol/L的精准性。方法纳入200例正常体检者或糖尿病患者的血样,直接检测或经孵育酵解葡萄糖制备低浓度和极低浓度血糖的样本,采用拜安进和YSI 2300 STAT PLUS葡萄糖检测分析仪检测葡萄糖浓度。参考ISO最新发布的ISO 15197:2013标准评价拜安进检测结果的精准性。结果拜安进准确性为99.67%,Parkes误差栅格分析图显示血糖值99.83%落在A区,100%落在A、B区。3个批次批内标准差(s)为0.049~0.074,CV为1.37%~2.88%,批间5为0.049~0.071,CV为1.39%~2.78%。结论拜安进BGMS在血糖低值区域监测表现出高的精确性和准确性,符合最新的国际血糖监测系统标准的准确性要求。
Objectives To assess the accuracy of the BAYAN BGMS (blood glucose monitoring system <5.6 mmol / L). Methods Blood samples of 200 normal subjects or diabetic patients were included in the study. Glucose was directly detected or incubated to prepare low- and low-concentration blood glucose samples. The concentration of glucose was measured by using Ataxia and YSI 2300 STAT PLUS glucose analyzer. According to the latest release of ISO ISO 15197: 2013 standard Baian into the test results of the accuracy. Results The accuracy of Baian into 99.67%, Parkes error grid analysis showed 99.83% of blood glucose fall in A, 100% fall in A, B area. The standard deviations (s) of three batches were 0.049-0.074, CV was 1.37% -2.88%, batch 5 was 0.049-0.071, CV was 1.39% -2.78%. Conclusions Baianjin BGMS showed high accuracy and accuracy in the monitoring of low blood glucose levels, meeting the accuracy requirements of the latest international blood glucose monitoring system standards.