六西格玛在肿瘤标志物检测性能评价和质量管理中的应用价值  

The Application Value of 6σin Performance Assessment andQuality Management of Detection of Tumor Markers

作　　者：吴婷婷[1] 邓胜明[1] 李清茹[1] 桑士标[1] WU Tingting;DENG Shengming;LI Qingru;SANG Shibiao(Department of Nuclear Medicine,the First Affiliated Hospital of Soochow University,Suzhou 215006,China)

机构地区：[1]苏州大学附属第一医院核医学科,江苏苏州215006

出　　处：《标记免疫分析与临床》2022年第8期1410-1415,共6页Labeled Immunoassays and Clinical Medicine

基　　金：江苏省青年医学重点人才项目(编号:QNRC2016749);姑苏卫生青年拔尖人才项目(编号:2020080);苏州市民生科技计划(编号:SYS2019038);放射医学与辐射防护国家重点实验室资助项目(编号:GZK1202127)。

摘　　要：目的应用六西格玛(6σ)理论评价肿瘤标志物检测项目的分析性能,设计个性化质控方案,指导实验室质量持续改进。方法选取苏州大学附属第一医院核医学科2020年6月至2020年12月甲胎蛋白(AFP)、癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原15-3(CA15-3)、糖类抗原19-9(CA19-9)、总前列腺特异性抗原(TPSA)、游离前列腺特异性抗原(FPSA)、细胞角蛋白19片段(CYFRA21-1)、铁蛋白(FER)、β-绒毛膜促性腺激素(β-HCG)、鳞状细胞癌抗原(SCCA)11个项目的室内质控累积在控变异系数(coefficient of variation,CV)作为各项目不精密度的估计值,采用2020年全国肿瘤标志物室间质量评价(EQA)数据作为偏倚计算的来源,使用国家卫生健康委临床检验中心(NCCL)室间质量评价(EQA)标准和基于生物学变异导出的适当标准作为质量规范,计算肿瘤标志物11个项目的σ值,结合Westgard西格玛规则,绘制标准化西格玛性能验证图,评价各项目分析性能,设计个性化质控策略,对σ<6的项目,计算质量目标指数(QGI),查找性能不佳原因,明确质量改进方向。结果当使用国家EQA标准时,σ<3的项目为CA19-91项,占9.09%;3≤σ<4的项目为CEA、CA125、CA15-3、TPSA、FER和β-HCG 6项,占54.55%;4≤σ<5的项目为FPSA、CYFRA21-1和SCCA 3项,占27.27%;5≤σ<6的项目为AFP 1项,占9.09%;无σ≥6的项目;平均σ值为3.86;当使用生物学变异导出的适当标准时,σ<3的项目为CEA、CA15-3和FER 3项,占33.33%;4≤σ<5的项目为AFP 1项,占11.11%;5≤σ<6的项目为CA19-9、TPSA和CYFRA21-13项,占33.33%;σ≥6的项目为CA125、SCCA 2项,占22.22%;平均σ值为4.81;根据质量目标指数提示81.82%的项目需要优先改进精密度,9.09%的项目需要优先改进正确度,9.09%的项目需要同时改进正确度和精密度。结论6σ质量管理方法能够客观评价肿瘤标志物检测项目的性能水平,指导实验室为项目设计个性化质控规则并采取多种质量改进措�Objective To evaluate the analytical performance of tumor markers,design personalized quality control scheme,and to guide the improvement of laboratory quality by using 6σtheory.Methods The coefficient of variation(CV)of AFP,CEA,CA125,CA15-3,CA19-9,TPSA,FPSA,CYFRA21-1,ferritin,β-HCG and SCCA were used as the estimated imprecision of each item,and the national EQA data in 2020 was used as the source of bias calculation.EQA standard of National Center for Clinical Laboratories(NCCL)and the appropriate standard derived from biological variation were used as quality specifications to calculate the quality ofσvalues of tumor markers.According to Westgardσrules,standardizedσperformance verification chart was draw to evaluate the analysis performance of each item and design personalized quality control strategy.Through calculating the quality goal index(QGI),we identified the potential reasons for the poor performance,and clarified the direction of quality improvement.Results Based on national EQA standards,σ<3 item was CA19-9,accounting for 9.09%;3≤σ<4 items were CEA,CA125,CA15-3,TPSA,ferritin andβ-HCG,accounting for 54.55%;4≤σ<5 items were FPSA,CYFRA21-1 and SCCA,accounting for 27.27%;5≤σ<6 item was AFP,accounting for 9.09%.The average value ofσwas 3.86.According the appropriate criteria derived from biological variation,σ<3 items were CEA,CA15-3 and ferritin,accounting for 33.33%;4≤σ<5 item as AFP,accounting for 11.11%;5≤σ<6 items,including CA19-9,TPSA and CYFRA21-1,accounted for 33.33%;σ≥6 items were CA125 and SCCA,accounting for 22.22%.The average value ofσwas 4.81.According to the QGI,81.82%of the items needed to improve the precision,9.09%of the items needed to improve the accuracy,and 9.09%of the items needed to improve the accuracy and precision.Conclusion The 6σtheory can objectively evaluate the performance of tumor markers,guide the laboratory to design personalized quality control rules for the items and lead to a variety of quality improvement measures,which is helpful to monit

关 键 词：六西格玛 肿瘤标志物 质量管理 

分 类 号：R-331[医药卫生]