【摘要】 目的评价HLC-723 G7糖化血红蛋白分析仪的临床应用性能,并建立深圳地区健康人群糖化血红蛋白(HbA1c)的参考区间及用于糖尿病筛查的"cut-off"值。方法对HLC-723 G7测定HbA1c的精密度、准确度、线性、携带污染进行评价;并检测482例健康体检者和150例糖尿病患者HbA1c。结果HLC-723 G7测定HbA1c高、低两水平批内精密度的CV分别为0.69%、0.94%,总精密度的CV分别为1.25%、1.79%;HLC-723 G7与VARIANTⅡ测定HbA1c结果呈明显相关(r=0.996,Sy.x=0.28,P<0.001),在6.0%、7.0%、9.0%的相对偏倚分别为-0.40%-、0.14%、0.20%;HLC-723 G7测定HbA1c在3.1%-15.9%范围内线性良好(r=0.999,P<0.001),高值标本对低值标本的测定结果无明显携带污染;深圳地区健康人群HbA1c总体参考区间为4.5%-6.1%;HbA1c用于糖尿病筛查受试者工作(ROC)曲线下面积为0.934,"cut-off"值5.9%处灵敏度为82.0%,特异性为91.3%。结论HLC-723 G7糖化血红蛋白分析仪测定HbA1c性能良好,可用于糖尿病的早期筛查。更多还原

【Abstract】 Objective To analyze the performance characteristics of the glycohemoglobin analyzer HLC-723 G7 and to establish the reference values of HbA1c in shenzhen healthy people and the"cut-off"point of screening diabetes.Methods Identified the precision,accuracy,linear range and the carryover rates of the glycohemoglobin analyzer HLC-723 G7;482 healthy people and 150 patients with diabetes were collected and analyzed by HLC-723 G7.Results The coefficient variance(CV) of within-batch precision was 0.69%,0.94% and the CV of total precision was 1.25%,1.79% in high/low level respectively;The results of HbA1c between HLC-723 G7 and VARIANT II were correlated(r=0.996,Sy.x=0.28,P<0.001),and the relative biases was-0.40%,-0.14%,0.20% at different level of 6.0%,7.0%,9.0%;Linearity was demonstrated well for HLC-723 G7(r=0.999,P<0.001) when HbA1c was 3.1%-15.9%;The carryover rate of HLC-723 G7 was 0%;The reference range of HbA1c was 4.5%-6.1% in shenzhen healthy people;The area under curve(AUC) of receiver operating characteristic(ROC) was 0.934 for HbA1c to Screen diabetes.When the optimum cut off point was 5.9%,the value of sensitivity was 82.0% and specificity was 91.3%.Conclusion The glycohemoglobin analyzer HLC-723 G7 had good performance and it could early be used to screen diabetes.更多还原