便携式血糖仪与全自动生化分析仪的比对分析

目的 将便携式血糖仪与全自动生化分析仅进行比对,了解血糖仅的质量,规范血糖仪的管理,保障临床末梢血糖的监测结果可靠,为临床提供可信的依据.方法 以日立7170A全自动生化分析仪作为参考仪器,便携式血糖仪作为比对仪器,选取新鲜血清,在同一时间进行重复测定,并记录结果.用Excel 2003软件对检测结果采用回归和相关分析,求其相关系数(r)及回归方程(Y=bX+a),以卫生部室间评估的允许误差或根据生物学变异确定的偏倚为判断依据,由方法学比较评估的系统误差(SE)或相对偏差(≤1/2)卫生部室间评价允许误差或根据生物学变异确定的偏倚,为便携式血糖仪与日立7170A全自动生化分析仪检测结果的临床可接受性.结果 便携式血糖仪与日立7170A全自动生化分析仪检测结果相关性很好(r＞0.975,P＞0.05).结论 便携式血糖仪与日立7170A全自动生化分析仪检测结果具有较好的可比性.

Comparative analysis between portable blood glucose meter and fully automatic biochemical analyzer

Purpose To compare the portable blood glucose meter and the fully automatic biochemical analyzer to understand the quality of the blood glucose meters,regulate their management,ensure the reliable results of clinical peripheral blood sugar monitoring and provide the credible basis for clinic.Methods With the Hitachi 7170A fully automatic biochemical analyzer as the reference instrument and the portable glucose meter as the comparative apparatus,fresh serum was collected and conducted the repeat determination at the same time,and the results were recorded.The Excel 2003 software was adopted to perform the regression and correlation analysis on the detection results and calculate the correlation coefficient（r） and the regression equation（Y=bX＋a）.With the allowable error regulated by the External Quality Assurance of Ministry of Health or bias determined according to the biological variability as the judging basis,the systematic error（SE） or relative deviation（≤1/2）,the allowable error regulated by the External Quality Assurance of Ministry of Health or bias determined according to the biological variability was the clinical acceptability of the detection results in the portable blood glucose meter and the Hitachi 7170A automatic biochemical analyzer.Results The detection results of the portable blood glucose meter and the Hitachi 7170 fully automatic biochemical analyzer correlation showed very good correlation（r0.975,P〈0.05）.Conclusion The detection results of the portable blood glucose meter and the Hitachi 7170A fully automatic biochemical analyzer has good comparability.