特种蛋白检验项目室内质控方法的研究

Application of internal quality control procedures in special protein assays

目的评价特种蛋白检测项目的分析性能,优化质量控制方法。方法根据西格玛(σ)=[允许总误差(TEa)-偏倚(bias)]/变异系数(CV)公式,计算并评价每一检验项目的σ水平。另根据操作过程规范图(OPS图)选择最佳的质控方案,通过计算质量目标指数(QGI值)以判断优先改进精密度或准确度。结果按6σ标准IgG、IgA性能为优秀,IgM、C3为良好,C4为临界;依据OPS图法,当N=2时,IgG和IgA分别采用13s和13.5s/R4s/9X质控规则,其他三项均采用13s/22S/R4S/10X质控规则;误差检出概率(Ped)达到90%(C4为50%),假失控概率(Prf)要小于5%。根据QGI结果 ,5项特种蛋白检测方法均需要优先改进精密度。结论联合应用6σ方法和OPS图法对临床实验室进行质量控制是必要和可行的。

Aim To assess the performance of the special protein assays,then to optimize their internal quality control procedures. Method 1. Calculating and evaluating the sigma value with the equation σ=（TEa-bias）/ CV; 2. Selecting the best QC measurement and number with Operational Process Specifications （OPS）; 3. Deciding the priority of improvement of imprecision or inaccuracy with Quality Goal Index （QGI）. Results According to the standard of 6 sigma decision chart, the performance of IGG and IGA is excellent,IGM and C3 is good and C4 is borderline; Ped reaches to 90% （ C4：Ped reaches to 50%）and Pfr is less than 5%,which meet the request of clinic quality. The IGG and IGA assays apply 13s and 13.5s/R4s/9X （N=2）rule respectively according to OPS,when the others use 13s/22S/R4S/10X rule; The precision of each Special Protein assay should be improved first according to QGI. Conclusion The combination of Six Sigma methodology and OPS is an efficient and effective tool for quality management in clinical chemistry laboratory.