应用NCCLS EP10-A2文件初步评价HA8160糖化血红蛋白仪的性能

Preliminary evaluation of HA8160 analyzer for hemoglobin a1c detection by EP10-A2

目的初步评价HA8160糖化血红蛋白分析仪测定糖化血红蛋白(HbA1c)的临床应用性能。方法按照美国临床实验室标准化委员会(NCCLS)颁布的EP10-A2文件,连续5 d按特定顺序测定高、中、低浓度样本的HbA1c,采用Excel软件计算测定结果的偏差、总不精密度,以及截距、斜率、非线性、携带污染、漂移。结果当样本高中低靶值分别为:10.30%、7.75%和5.20%时,其偏差分别为0.22%,0.22%,0.23%,总不精密度分别为0.776%,1.169%,1.427%,测定值与靶值的线性良好(y=0.9987x+0.2312,r2=0.9985);截距为0.235,与靶值有恒定误差(P<0.01),斜率、非线性、携带污染、漂移分别为0.998,0.468,0.001和0.003,差异均无统计学意义(P>0.01)。结论该分析仪测定HbA1c的准确度和精密度良好,均在允许范围内,线性良好,携带污染低,稳定性好,性能指标符合临床应用要求。

Objective To preliminarily evaluate the performance of HA8160 analyzer for hemoglobin A1c detection.Methods According to the NCCLS Document EP10-A2,HbA1c of 3 specimens at high,middle and low concentrations were measured by HA8160 analyzer by a special order in 5 days.Microsoft Office Excel was used for analyzing the bias,the total imprecision,intercept,slope rate,nonlinearity,carryover contamination and drift.Results When the concentration of HbA1c at high-,middle-,and low-value was 10.3%,7.75% and 5.2%,the bias was 0.22%,0.22% and 0.23%.The total imprecision was 0.776%,1.169% and 1.427% respectively.The regression equation was y = 0.9987x ＋ 0.2312,r2 = 0.9985.The intercept showed constant error was 0.235.The slope rate,nonlinearity,carryover contamination and drift was 0.998,0.468,0.001,0.003 respectively,which did not show significant difference（P 0.01）.Conclusion Both the bias and precision of HA8160 analyzer were within the acceptable range,good linearity,nonlinearity,low carryover contamination and good stability.All these indexes were within allowed limit.The performance of this analyzer can satisfy clinical application requirements.