应用NCCLS EP10-A2文件对免疫球蛋白检测系统进行初步性能评价

Evaluation on Preliminary Performance of Immuno-protein Detection System by the NCCLS EP10-A2 Paper

目的对AU5800检测免疫球蛋白(Ig)A,G,M进行初步性能评价。方法依照美国临床实验室标准委员会(NCCLS)EP10-A2文件提供的方法,于2016年5月5—9日选取低中高浓度质控血清共50个样本对AU5800检测IgA,G,M进行初步评价,计算其偏倚,总不精密度及其截距,斜率,非线性,携带污染,漂移,并与各项目对应设定值做比较。结果检测IgA、G、M的偏倚,总不精密度都在允许范围内,线性、漂移、携带污染均差异无统计学意义。但截距和斜率差异有统计学意义,分别为IgA:-0.904,1.656,IgM:-0.116,1.131。结论 AU5800检测IgA,G,M的精密度、偏倚、线性、漂移、携带污染均符合EP10-A2文件标准,已能满足临床需要。

Objective To evaluate the preliminary performance of immuno-protein detection system by the NCCLS EP10-A2 paper. Methods The IgA, G, M of 50 samples of low, moderate and high concentrations in quality control serum was initially evaluated from May 5, 2016 to May 9, 2016 according to the（NCCLS）EP10-A2 method, and the bias, total imprecision, intercept, slope, nonlinear and drift were tested and compared with the corresponding setting value of various items. Results The bias of IgA, G, M was tested and the total impression was in the allowed range, and there were no obvious differences in the linear, drift and residual contamination, but there were obvious differences in the intercept and slope, respectively IgA：-0.904,1.656,IgM：-0.116,1.131. Conclusion The precision, bias, linear,drift, residual contamination of IgA, G, M tested by AU5800 can meet the paper standards of EP10-A2, which can meet the clinical demands.