不同允许总误差在特定蛋白检测性能评价与质量控制规则选择中的应用

目的评估不同国际标准提供的允许总误差(TEa)下特定蛋白检测的分析性能差异,运用6西格玛(σ)参数选择和优化质量控制规则。方法收集2009和2010年的室内质量控制数据以及参加卫生部临床检验中心的能力比对实验的数据,计算各检测项目的不精密度和偏倚(Bias)。TEa分别引用美国临床试验室修正法案(CLIA’88)、德国Rilibak质控指南以及生物学变异的要求。根据变异系数(CV)、Bias和TEa计算σ值,同时绘制标准化σ性能评价图。计算未达6σ的质量目标指数(QGI),查找导致性能不佳的主要原因,以判断优先改进精密度或准确度。结果 2009年IgA、IgG、IgM、C3、C4、C反应蛋白(CRP)6个检测项目根据3种不同的TEa要求计算的σ水平从0.53～6.95不等,除生物学变异要求下的CRPσ值为6.95,其余均未达到6σ。2010年6个项目的σ水平从1.33～29.39不等,除IgG项目和生物学变异要求下的IgA和C3未达到6σ要求外,其余均达到了6σ要求。结论根据σ水平可以评价实验室的分析性能并选择室内质量控制规则,经济合理的开展室内质量控制。

Application of different allowable total error in the performance evaluation of specific protein determination and selecting quality control rule

Objective To evaluate the performance of specific protein under different allowable total error（TEa） of different international standards,apply 6 sigma（σ） metrics into selecting and improving quality control rule.Methods The data from internal quality control and the proficiency test of the National Center for Clinical Laboratory in 2009 and 2010 were collected respectively,and the imprecision and bias were calculated.TEa was quoted from Clinical Laboratory Improvement Amendments 88（CLIA′ 88）,German Guidelines for Quality and biological variation requirements.According to the coefficient of variation（CV）,bias and TEa,σ was calculated,and quality control strategy was designed.In addition,the quality goal index（QGI） below 6σ was calculated to find problem and decide the priority improvement of precision and accuracy.Results According to IgA,IgG,IgM,C3,C4 and C reactive protein（CRP） with 3 different TEa in 2009,the σ were 0.53-6.95 respectively.The items were below 6σ except CRP,and under biological variation requirements the CRP σ was 6.95.In 2010,the σ of the 6 items was 1.33-29.39 respectively,and all items were above 6σ except IgG and C3 under biological variation requirements.Conclusions Using the σ metric,the performance and appropriate internal quality control can be chosen and developed economically and reasonably.