奥普分析仪上检测糖化血红蛋白性能评价及临床应用价值  

Performance evaluation and clinical application value of glycosylated hemoglobin analysis on Opper

作　　者：屈金辉 黄津[1] 杨雅琼[1] 白雪[1] 王毅[1] 

机构地区：[1]天津市天津医院检验科,天津300211

出　　处：《医学检验与临床》2017年第9期15-17,共3页Medical Laboratory Science and Clinics

摘　　要：目的：评价奥普分析仪检测糖化血红蛋白（HbAlc）的性能,探讨其临床应用价值.方法：对奥普公司的全自动特定蛋白即时检测分析仪上使用胶乳增强免疫比浊法检测HbA1c的批内精密度、 日间稳定性及携带污染率进行评价,并与BIO-RAD-D10高效液相色谱法（HPLC）检测HbAlc进行正确度比对分析.同时对其进行临床应用评价.结果：高中低三个水平的批内精密度CV分别为1.64%、1.58%和2.23%;高低两个质控水平的日间变异CV分别为1.73%和1.24%;正确度实验的线性回归方程为y=1.0387x-0.2587,相关系数指数r2=0.9611;交叉污染率为1.83%.45例糖尿病患者的HbA1c与健康体检者比较差异有统计学意义.结论：奥普分析仪上检测HbA1c的性能良好,HbA1c是诊断糖尿病的较好的参考指标.Objective： To evaluate the performance of Opper for glycosylated hemoglobin （HbAlc） detection, and to explore its clinical value. Methods： The HbAlc was detected on Opper, by lgatex enhanced immuneoturbidimetry, and the precision, diurnal variation andcarryover were evaluated. BIO-RAD-D10 was used to verify the accuracy.At the same time, the value of clinical application was evaluated. Results： The CV ofwithin batch with the three levels of precision were 1.64%, 1.58% and 2.23%; The CV of diurnal variation were 1.73% and 1.24%; the correlation regression equation of accuracy verification is y = 1.0387x -0.2587, with correlation coefficient index/2 =0.9611; The carryover was 1.83%. Conclusion： The performance of Opper for glycosylated hemoglobin （HbAlc） was good andHbAlc is a preferable indicator for the diagnosis of diabetes.

关 键 词：糖化血红蛋白 性能评价 胶乳增强免疫比浊 临床应用 

分 类 号：R587.1[医药卫生—内分泌]