6σ管理在肿瘤标志物检测过程评价中的应用  

Application of 6σManagement in the Evaluation of Tumor Marker Detection Process

作　　者：雷长喜 张青[2] LEI Chang-xi;ZHANG Qing(Department of Nuclear Medicine,Yingtan People's Hospital,Yingtan,Jiangxi Province,335000 China;Department of Nuclear Medicine,the First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi Province,330000 China)

机构地区：[1]鹰潭市人民医院核医学科,江西鹰潭335000 [2]南昌大学第一附属医院核医学科,江西南昌330000

出　　处：《中国卫生产业》2020年第27期10-12,15,共4页China Health Industry

摘　　要：目的评价7种肿瘤标志物检测性能,查明检测性能不佳的原因,找出改进措施及选择更适宜的质控规则。方法选取7种肿瘤标志物检测评估允许总误差(TEA%),不精密度(CV%),偏倚度(Bias%),六西格玛(6σ)值,评价7种肿瘤标记物检测的质量差异,根据质量目标指数提出改进措施,根据σ值选择合适的质量控制规则。结果7个肿瘤标志物中,根据σ值计算结果,CEA,AFP,CA19-9,CA15-3,TPSA的σ值>5,占71.4%;CA125和HCG项目的σ值<5,占28.6%,HCG的σ值<4,属于临界水平,同时结合QGI<0.8的提示,需改进精密度。若达到6σ的更高目标要求,AFP,CEA,CA125,TPSA可优先改进精密度,CA15-3,CA19-9达到6σ要求,无需改进。结论应用6σ对于评价肿瘤标志物的检测结果具有重要的应用价值。Objective To evaluate the detection performance of 7 tumor markers,to find out the reasons for the poor detection performance,to find out improvement measures and to select more appropriate quality control rules.Methods Select 7 kinds of tumor markers to detect and evaluate the total allowable error(TEA%),imprecision(CV%),bias(Bias%),6σvalue,and evaluate the quality difference of the 7 tumor markers according to the quality target index,propose improvement measures and select appropriate quality control rules based on the sigma value.Results Among the 7 tumor markers,according to the calculation results of sigma value,theσvalues of CEA,AFP,CA19-9,CA15-3,and TPSA were>5,accounting for 71.4%;theσvalue of CA125 and HCG items was<5,accounting for 28.6%,theσvalue of HCG was less than 4,which was a critical level.At the same time,combined with the hint of QGI less than 0.8,the precision should be improved.If the higher target requirement of 6σwas reached,AFP,CEA,CA125,TPSA can give priority to improving the precision,and CA15-3,CA19-9 meet the 6σrequirement,no improvement is needed.Conclusion The application 6σSigma has important application value for evaluating the detection results of tumor markers.

关 键 词：六西格玛 肿瘤标志物 质量控制 评价 

分 类 号：R730.4[医药卫生—肿瘤]