质量管理规则联合质量目标指数在肿瘤标志物检测质量控制中的应用

Application of quality management rules combined with quality goal index in quality control of tumor marker detection

目的探讨质量管理规则联合质量目标指数(QGI)在肿瘤标志物检测质量控制中的应用效果。方法采用化学发光免疫分析仪及配套试剂、校准物和质控品检验血清甲胎蛋白(AFP)、鳞状细胞癌抗原(SCCA)、癌胚抗原(CEA)、总前列腺特异抗原(TPSA)、神经元特异性烯醇化酶(NSE)、糖类抗原125(CA125)、糖类抗原15-3(CA15-3)、糖类抗原19-9(CA19-9)、糖类抗原72-4(CA15-3),并获取变异系数(CV)、不准确度(Bias)及允许总误差(TEa),分析9项肿瘤标志物σ值、检测性能、σ水平对应Westgard质量控制规则关系选择、QGI值、质控改进方向和改进结果。结果9项肿瘤标志物检查显示,CEA、TPSA的σ水平≥6,世界一流,选择1_(3S)(N=2,R=1);NSE、CA125的σ水平在5≤σ值<6,性能优秀,选择1_(3S)2_(2S)R_(4S)(N=2,R=1);AFP、CA19-9、CA72-4的σ水平在4≤σ值<5,性能良好,选择1_(3S)2_(2S)R_(4S)4_(1S)(N=4,R=1或N=2,R=2);SCCA、CA15-3的σ水平在3≤σ值<4,性能一般,选择1_(3s)2_(2s)R_(4s)4_(1s)8_(x)(N=4,R=2或N=2,R=4)。除CEA的QGI指数为0.9以外,其他8项均在0.8以内,除TPSA和CEA不选择改进方向以外,其余7项均选择优先改进精密度,经改进后7项σ值和检测性能均提高。结论质量管理规则联合QGI用于肿瘤标志物检测质量控制中能提高检验性能和明确质量改进方向。

Objective To explore the application effects of quality management rules combined with quality goal index(QGI)in quality control of tumor marker detection.Methods Chemiluminescence im⁃munoassay analyzer and matching reagents,calibrator and quality control were used to detect the levels of se⁃rum alpha⁃fetoprotein(AFP),squamous cell carcinoma antigen(SCCA),carcinoembryonic antigen(CEA),total prostate specific antigen(TPSA),neuron specific enolase(NSE),carbohydrate antigen 125(CA125),carbohydrate antigen 15⁃3(CA15⁃3),carbohydrate antigen 19⁃9(CA19⁃9)and carbohydrate antigen 72⁃4(CA72⁃4),and the coefficient of variation(CV),inaccuracy(Bias).Total error allowance(TEa)were cal⁃culated.Theσvalue,detection performance,selection of Westgard quality control relationship corresponding toσlevel,QGI value,quality control improvement direction and improvement results of the 9 tumor markers were analyzed.Results Nine tumor marker results showed that theσlevels of CEA and TPSA were≥6,with world⁃class performance and relationship of 13S(N=2,R=1).Theσlevels of NSE and CA125 were 5≤σ<6,with excellent performance and relationship of 1_(3S)2_(2S)R_(4S)(N=2,R=1).Theσlevels of AFP,CA19⁃9 and CA72⁃4 were 4≤σ<5,with good performance and 1_(3S)2_(2S)R_(4S)4_(1S)(N=4,R=1 or N=2,R=2).Theσlevels of SCCA and CA15⁃3 were 3≤σvalue<4,showing general performance and 1_(3s)2_(2s)R_(4s)4_(1s)8_(x)(N=4,R=2 or N=2,R=4).Except the QGI index of CEA which is 0.9,the other 8 items were all within 0.8.Except for TP⁃SA and CEA which do not choose the direction of improvement,the remaining 7 items were selected to prefer⁃entially improve the precision.After improvement,theσvalues and detection performances of the 7 items were enhanced.Conclusion The combination of quality management rules and QGI in the quality control of tumor marker detection can improve the performance of the test and clarify the direction of quality improvement.