六西格玛质量管理方法在电化学发光肿瘤标志物检测质量控制中的应用  

Application of 6σ quality management method in quality control of detecting tumor marker by electrochemical luminescence

作　　者：黄潇苇[1] 朱义芳 王娴[1] 曾着黎[1] 何春容[1] HUANG Xiao-wei;ZHU Yi-fang;WANG Xian(Clinical Laboratory,The Third People's Hospital of Chengdu,Chengdu 610031,China)

机构地区：[1]成都市第三人民医院临床医学检验部,四川成都610031 [2]四川省骨科医院检验科,四川成都610031

出　　处：《中国医学装备》2019年第10期35-38,共4页China Medical Equipment

基　　金：四川省卫计委科学技术基金(18PJ126)“ZG16第三外显子甲基化转录抑制ZG16及下游APC/β-catenin通路调控结肠癌细胞侵袭转移”;成都市卫计委课题(2018069)“CNTN3蛋白在胃癌中的表达与疾病预后的相关性分析”

摘　　要：目的:应用六西格玛(6σ)质量管理方法分析电化学发光检测的肿瘤标志物项目质量控制数据,评价其分析性能,设计质量控制方法,指导质量改进。方法:收集2018年度实验室电化学发光检测的甲胎蛋白(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)、铁蛋白(FERR)、总前列腺特异抗原(TPSA)和游离前列腺特异抗原(FPSA)8个参加卫生部室间质量评价的肿瘤标志物室内质量控制及室间质量评价的数据,按照卫生部室间质评允许总误差(TEa)标准,采用6σ计算公式计算检验项目σ值,评价检测项目分析性能,设计质量控制方法,计算检测项目的质量目标指数(QGI),查找导致性能不佳的主要原因,提出优先改进方案。结果:在8个肿瘤标志物项目中,σ≥6的项目3个,5≤σ<6的项目3个,4≤σ<5的项目2个;当σ≥6时,采用1-3S(n=2,R=1)质量控制方法即可满足质量控制要求,根据QGI值,AFP、CA153、CA199及TPSA需优先改进精密度,CA125需要同时改进准确度和精密度。结论:6σ质量管理是临床实验室开展质量控制的一项有效的管理工具,有助于提高临床实验室质量水平。Objective:To analyze the data of quality control that electrochemical luminescence detected tumor marker by applying 6σquality management,and evaluate the analysis performance of 6σquality management,and design quality control method,and guide the improvement of quality.Methods:The data of internal quality control and external quality assessment of 8 tumor markers(AFP,CEA,CA125,CA15-3,CA19-9,FERR,TPSA and FPSA)which took part in external quality assessment of Ministry of Health(MOH)and were detected by electrochemical luminescence in 2018 year were collected.As the standards of allowable total error(TEa)of external quality assessment of MOH,the computational formula of 6σvalue was adopted to calculateσvalue of detection items,and to evaluate analysis performance of detection items,and to design quality control method,and to calculate quality goal index(QGI)of detection items,and to seek the main reasons that leaded to poor performance,and to provide prior improvement scheme.Results:In 8 tumor markers items,theσvalues of 3 test items were more than or equal to 6,and theσvalues of 3 test items were between 5 and 6 or equal to 5,and theσvalues of 2 test items were between 4 and 5 or equal to 4.The results met the requirement of quality control according to the 1-3S(n=2,R=1)quality control method,when theσmetric values had been over 6 or equal to 6.The precisions of AFP,CA153,CA199 and TPSA needed to be improved at priority,and both precision and accuracy of CA125 needed to be improved.Conclusion:6σquality management method is a effective management tool in implementing quality control of clinical laboratory,and it contributes to constantly improve quality level of clinical laboratory.

关 键 词：6西格玛 质量控制 肿瘤标志物 

分 类 号：R446.1[医药卫生—诊断学]