摘要目的 分析我国糖化血红蛋白(HbA1c)正确度验证计划中不同检测系统的质量水平.方法 横断面调查.通过室间质评软件收集参加2014年第1次全国糖化血红蛋白正确度验证室间质评(EQA)实验室的HbA1c数据.对所有实验室检测结果按仪器进行分组统计,剔除小于5家实验室的检测系统数据后计算各组观察到的偏倚(Bias％)、变异系数(CV％)和西格玛值(σ),并将各组的Bias％和CV％绘制在室间质量评价西格玛图上;同时计算201411和201412两个样品的平均Bias％、平均CV％和加权σ.结果 123家实验室分为9个仪器小组;以6％为HbA1c的允许总误差,201411样品(靶值为5.4％)的平均Bias％为3.70％,平均CV为4.55％,加权西格码水平为0.51σ-;201412样品(靶值为7.8％)的平均Bias％为2.42％,平均CV为3.56％,加权西格码水平为1.24--.从西格玛图中可看出201411样品所有检测系统都未达到2,201412只有1个检测系统达到2σ-.结论 我国HbA1c许多检测系统的结果和参考测量程序赋予的靶值之间存在明显的偏倚,不精密度也存在较大的问题,采用室间质评西格玛图可提示需要改进检测方法的质量水平保证检测结果的可靠性,促使HbA1c更好地应用于临床.

abstractsObjective To investigate the results of different measuring procedures of hemoglobin A1c (HbA1c) trueness verification scheme in China.Methods Cross sectional survey.The data were collected via the External Quality Assessment (EQA) software from laboratories participated in the First HbA1c trueness verification EQA.Then the collected data were divided into several groups based on laboratory instruments and the data from less than 5 group were excluded.The observed imprecision, bias and sigma (σ) were calculated and the bias％ and CV％ were drew in the sigma chart.The average bias％, CV％ and weighted average σ of each level were also calculated.Results Total 123 laboratories were divided into 9 groups and setting 6％ as the Allowable Total Error, the average bias％, CV％ and weighted average σ of 201411 (target value was 5.4％) were 3.70％, 4.55％ and 0.51 respectively σ, of 201412 (target value was 7.8％)were 2.42％ , 3.56％ and 1.24σ respectively.None of the group achieved the 2σ quality of 201411, and 1 group achieved the 2σ quality of 201412.Conclusions There are obvious biases among the results of many measuring systems and the target value assigned by reference measuring procedures of HbA1c, as well as the imprecision.The Sigma External Quality Assessment Chart is a visual tool, indicating that the quality of measuring systems necessitate improvement therefore to ensure the reliability of results and make better use of HbA1c in clinical application.