Sigma值在建立室内质控允许误差中的应用探讨

Application Discussion of the Sigma Value in Establishment of Allowance Error of Internal Quanlity Control

目的通过Sigma值的计算,建立适合现有质量体系的室内允许误差。方法依据EP5文件得出各检测项目的不精密度,同时根据参与美国病理家协会校准验证活动得出的各项目的斜率、截距,计算出各项目不同医学决定水平处的偏倚,得出各检测项目的Sigma值,若超出范围,则根据最适Sigma值对该项目的室内允许误差进行相应调整,最终得到适合各检测项目的允许误差。结果血清磷(P)、C-反应蛋白(CRP)、C4继续使用CLIA’88中规定的最大允许误差,IgA,IgG,IgM,C3,血清铁(Iron)的室内允许误差在CLIA’88规定的基础上有所缩减。结论该方法可与方法验证一起对检测系统的性能作出完整评价,并对标准中没有给出最大允许误差或室内变异较大的项目得出暂定的允许误差,同时通过室内质控、试剂批号验证的检验,达到质量持续性提升的最终目标。

Objective To establish suitable current quality system of detection for the internal allowable limits of error. Methods Obtained every test＇s imprecision according to EP5 doucument, and with participation of College of American Pathologists calibration verification that obtained the test of slope and intercept ,calculated the bias by the various medical decision level,accessed the Sigma value for the test. If the Sigma value out-of-scope,in accordance with the optimal value of the item,Sigma made some adjuste with internal allowable limits of error. Accordingly, finally obtaining suitable internal allowable limits of error. Results Serum phosphorus,C-reactive protein and complement 4 continued to use CLIA＇88 stipulated in the maximum allowable error, immunoglobulin A, immunoglobulin G, immunoglobulin M, complement 3 and serum iron internal allowable limits of error on the basis of CLIA＇ 88 had to reduce. Conclusion The method can be together with the method validation make a complete evaluation of analysis system performance,while obtain the test tentative tolerances error which the standard can not given the maximum allowable error or variance larger ,through confirming internal quality control and the lots of reagents validation ,continuing to upgrade the quality of the ultimate goal.