体液免疫9项指标总误差与不确定度比较分析

目的 利用总误差(TE)和不确定度的统计方法评价体液免疫项目的检测质量。方法 利用伯乐质量控制软件计算2013年1月～10月金陵医院中心实验科体液免疫项目室内质量控制累积均值((-overx)),累积标准差(s),累积变异系数(CV),利用中国卫生部临床检验中心室间质评回报数据[共2次(201311～201315,201321～201325)]计算体液免疫项目检测结果与靶值的相对偏倚(bias%)和相对平均偏倚(bias%^-),结合室内质量控制累积CV计算TE。使用室间质评回报数据和室内质量控制累积CV,采用Nordtest法计算每个项目的不确定度。结果 2个质量控制水平的免疫球蛋白G(IgG)、免疫球蛋白A(IgA)、免疫球蛋白M(IgM)、补体3(C₃)、补体4(C₄)、抗链球菌溶血素“O”(ASO)、类风湿因子(RF)、C反应蛋白(CRP)和免疫球蛋白E(IgE)的最大TE分别为:13.07%,14.05%,13.99%,15.68%,14.84%,14.5%,16.55%,14.19%和10.05%; 这些项目的最大扩展不确定度分别为:15.44%,15.82%,16.23%,17.67%,16.73%,19.96%,19.01%,16.25%和10.86%。IgG,IgA,IgM,C3的不确定度构成比中偏倚和不精密度所占比例大致相同,而C4,CRP,IgE的不确定度主要受不精密度影响。ASO,RF的不确定度主要受偏倚影响。结论 TE和不确定度之间有一致性,可作为实验室检测质量分析和改进的重要依据,不确定度可提供更多参考价值。

Comparison Research Between Total Error and Uncertainty in Nine Humoral Immune Items

Objective To evaluate the performance of humoral immune items by the statistical method of total error(TE)and uncertainty.Methods The data of internal quality control were collected by Bio-Rad quality controllsoftware from January to October 2013,and the accumulation means((-overx)),accumulation standard deviations(s)and accumulation coefficients of variation(CV)were computed.According to the external quality assessment plans from Chinese National Center for Clinical Laboratories
[2 reports(201311～201315,201321～201325)].The relative bias(bias%)and relative average bias(bias%^-)of humoral immune item results and target values were calculated.TE was calculated with the accumulation coefficients of variation and the relative bias.By Nordtest method,the uncertainties of humoral immune items werecalculated according to the external quality assessment data and internal quality control accumulation CV.Results The maximum TEs with every 2 internal quality control levels of immunoglobulin G(IgG),immunoglobulin A(IgA),immunoglobulin M(IgM),complement 3(C₃),complement 4(C₄),antistreptolysin “O”(ASO),rheumatoid factor(RF),C-reactive protein(CRP),immunoglobulin E(IgE)were 13.07,14.05,13.99,15.68,14.84,14.,16.55,14.19,10.05.The uncertainties of those items were 15.44,15.82,16.23,17.67,16.73,19.96,19.01,16.25,10.86.In the constituent ratioof the uncertainties,imprecision play major roles in items of C4,CRP,IgE while bias play major roles in items of ASO,RF.The two elements approach parity initems of IgG,IgA,IgM,C3.Conclusion Both TE and uncertainty have good consistency,and they can be the important reference for the analysis and improvement of laboratory quality.But uncertainty can provide more informations for reference.