胶乳增强免疫比浊法检测糖化血红蛋白的性能评价

The Performance Evaluation of Latex Enhanced Immunoturbidimetry for Glycosylated Hemoglobin A1c Analysis

目的对应用胶乳增强免疫比浊法在日立7600-020全自动生化分析仪上检测糖化血红蛋白（Hb A1c）的性能进行评价。方法应用胶乳增强免疫比浊法在日立7600-020全自动生化分析仪上检测Hb A1c,对其精密度、空白检测限、线性、携带污染率进行评价,并与BIO-RAD（D-10N）高效液相色谱法（HPLC）检测Hb A1c进行相关性分析,同时对参考区间进行验证。结果日立7600-020全自动生化分析仪上检测Hb A1c的低高水平的CV%批内分别为1.6%、0.5%;CV%批间分别为2.6%、1.3%;CV%总分别为3.5%、2.6%。检测限为0.1%。在2.0%~17.6%范围内线性良好（Y=1.0046X-0.0619,R2=0.9996）。携带污染率为1.03%,样本间交叉污染小。日立7600-020分析仪与BIO-RAD（D-10N）分析仪检测Hb A1c的结果呈明显相关（Y=1.0064X-0.0769,R2=0.9942）,95%置信区间为（-0.41~0.52）且百分偏倚的绝对值均小于6%。20名健康人群的Hb A1c测定结果为4.0%~5.5%,在厂家提供的参考区间内。结论应用胶乳增强免疫比浊法在日立7600-020全自动生化分析仪上检测Hb A1c的性能良好,可供临床使用。

Objective To evaluate the performance of latex enhanced immunoturbidimetry method on fully automated analyzer 7600-020 for glycosylated hemoglobin A1 c detection. Methods The Hb A1 c was detected on7600-020 analyzer by latex enhanced immunoturbidimetry method,and the precision,detection limit,linearity and interference of detection were evaluated. The correlation and consistency of Hb A1 c result detected by Latex enhanced immune turbidimetric method and high performance liquid chromatographies（ HPLC） were also analyzed. The reference interval was verified as well. Results The coefficients variation（ CV） of within-batch with low and high value samples were 1. 6% and 0. 5%,the CV of inter-batch were 2. 6% and 1. 3%,and the CV of total were 3. 5% and 2. 6%. The detection limit was 0. 1%. Linearity was demonstrated well in the range of 2. 0% to 17. 6%（ Y = 1. 0046X- 0. 0619,R2= 0. 9996）,and the interference was low to1. 03%. The correlation of Hb A1 c detection results between 7600-020 analyzer and BIO-RAD（ D-10n） analyzer was obviously well（ Y = 1. 0064X- 0. 0769,R2= 0. 9942）. The 95% confidence interval was（- 0. 41,0. 52）,and the absolute value of percentage bias were all less than 6%. The detection results of Hb A1 c in 20 healthy subject samples were 4. 0%-5. 5%,which were included in the reference interval recommended by the manufacture. Conclusion The performance of latex enhanced immunoturbidimetry method on fully automated analyzer 7600-020 for glycosylated hemoglobin A1 c detection was good and it may be suitable for clinical application.