MAGLUMI 4000型化学发光分析仪检测肿瘤标志物的性能评价

The Evaluation of Analytical Performance of MAGLUMI 4000 Chemiluminescence Analyzer for Detecting Tumor Markers

目的对深圳市新产业MAGLUMI 4000型化学发光分析仪检测甲胎蛋白(AFP)、糖类抗原125(CA125)、癌胚抗原(CEA)、鳞状细胞癌相关抗原(SCCA)、铁蛋白(Ferritin)、前列腺特异性抗原(PSA)、糖类抗原15-3(CA15-3)、糖类抗原19-9(CA19-9)、游离前列腺特异性抗原(F-PSA)、糖类抗原72-4(CA72-4)十个肿瘤标志物进行性能评价。方法用MAGLUMI 4000化学发光仪检测AFP、CA125、CEA、SCCA、Ferritin、PSA、CA15-3、CA19-9、F-PSA、CA72-4,对以上检测的精密度、正确度、线性、参考区间进行评价,并与雅培、罗氏相关检测结果进行方法比对研究。结果 MAGLUMI 4000化学发光免疫分析仪测定AFP、CA125、CEA、SCCA、Ferritin、PSA、CA15-3、CA19-9、F-PSA、CA72-4对应高低两个水平质控品的重复精密度变异系数(CV)均<6.25%,期间精密度变异系数(CV)均<8.33%;各项目正确度偏倚值<1/2Tea;各检测结果在线性范围内,线性良好(AFP:R^2=0.9984;CA125:R^2=0.9989;CEA:R^2=0.998;SCCA:R^2=0.9998;Ferritin:R^2=0.9997;PSA:R^2=0.9997;CA15-3:R^2=0.9977;CA19-9:R^2=0.9998;F-PSA:R^2=0.999;CA72-4:R^2=0.9982),主要分析性能满足验证要求,厂家提供的参考区间可以接收;方法间相关性分析表明AFP、CA125、CEA、SCCA、Ferritin、PSA、CA15-3、F-PSA、CA72-4相关性良好(r值分别为0.996,P<0.01;0.9966,P<0.01;0.9965,P<0.01;0.988,P<0.01;0.9935,P<0.01;0.9914,P<0.01;0.9902,P<0.01;0.996,P<0.01;0.9997,P<0.01),CA19-9相关性较差(r值为0.8932,P<0.01);线性回归分析Cusum检验显示各检测方法间偏移无统计学意义(P>0.05);Kappa一致性分析表明,CA125、CEA、PSA、F-PSA、CA72-4检测Kappa值大于0.75,结果一致性较好,SCCA、Ferritin、CA15-3检测结果一致性一般,AFP、CA19-9检测结果一致性较差。结论本实验室肿瘤标志物使用深圳市新产业试剂在MAGLUMI 4000全自动化学发光分析仪上进行检测,分析性能符合要求,厂家声称结果可靠,可满足临床检测要求。因为不同厂商检测原理和试剂存在差异,导致有检测结果一致性较差的标志物,建议不要在同一实验室使用两种方法检测。

Objective To evaluate the detection of alpha-fetoprotein(AFP),carbohydrate antigen 125(CA125),carcinoembryonic antigen(CEA),squamous cell carcinoma associated antigen(SCCA),ferritin(Ferritin),prostate specific antigen(PSA),carbohydrate antigen 15-3(CA15-3),carbohydrate antigen 19-9(CA19-9),free prostate specific antigen(F-PSA) and carbohydrate antigen 72-4(CA72-4) with MAGLUMI 4000 chemiluminescence analyzer from Shenzhen New Industries.Methods AFP,CA125,CEA,SCCA,Ferritin,PSA,CA15-3,CA19-9,F-PSA and CA72-4 were detected by MAGLUMI 4000 chemiluminescence instrument. The precision,accuracy,linearity and reference interval of the above items were evaluated,and their correlations with the results of Abbott and Roche were investigated.Results The repetitive precision coefficients of variation(CV) of AFP,CA125,CEA,SCCA,Ferritin,PSA,CA15-3,CA19-9,F-PSA and CA72-4 were all less than 6.25% and the period precision coefficient of variation(CV) was less than 8.33%,and the accuracy bias of each item was less than 1/2 Tea. In the linear range,the linearity was good(AFP:R^2=0.9984;CA125:R^2=0.9989;CEA:R^2=0.998;SCCA:R2 =0.9998;Ferritin:R^2=0.9997;PSA:R^2=0.9997;CA15-3:R^2=0.9977;CA19-9:R^2=0.9998;F-PSA:R^2=0.999;CA72-4:R^2=0.9982),the main analysis performance met the verification requirements,and the reference interval provided by the manufacturer was acceptable. Inter-correlation analysis showed that AFP,CA125,CEA,SCCA,Ferritin,PSA,CA15-3、F-PSA and CA72-4 were well correlated(r values were 0.996,P<0.01;0.9966,P<0.01;0.9965,P<0.01;0.988,P<0.01;0.9935,P<0.01;0.9914,P<0.01;0.9902,P<0.01;0.996,P<0.01;0.9997,P<0.01),respectively). The correlation of CA19-9 was poor(r value was 0.8932,P<0.01). Cusum test based on linear regression model showed that there was no statistically significant deviation between the methods(P>0.05). Kappa consistency analysis showed that the Kappa values of CA125,CEA,PSA,F-PSA and CA72-4 were all greater than 0.75,and the results were consistent. SCCA,Ferritin,CA15-3 results were generally consistent,while AFP,CA19-9 results were less consistent.Conclusion The laboratory tumor samples in this laboratory is tested on the MAGLUMI 4000 automatic chemiluminescence analyzer using the new industrial reagents from Shenzhen manufacturer. The analytical performance meets the requirements. The manufacturer claims that the results value is reliable and can meet the clinical testing requirements. Because different manufacturers have different detection principles and reagents,which resulting in inconsistent test results. It is recommended not to use two different methods in the same laboratory.