2种全自动免疫检测系统鳞状细胞癌抗原结果的一致性评价

Consistency evaluation results of squamous cell carcinoma antigen measured by two automated immunoassay systems

目的比较罗氏cobas e602和雅培Architect i2000 SR全自动免疫分析系统鳞状细胞癌抗原(squamous cell carcinoma antigen,SCCA)结果的一致性。方法收集检验科方法学变更平行检测期间临床血清样本4231例,分别用上述检测系统检测SCCA水平;参考CLSI EP15-A2文件进行精密度评价;采用随机抽样的方法抽取138例SCCA结果数据,通过相关性分析、回归分析和一致性检验分析两系统SCCA检测结果的相关性、一致性和偏差;采用Kappa分析对4231例患者SCCA结果进行分析,并通过线性回归方程对罗氏系统结果进行校正,计算校正前后两系统的诊断符合率、阳性符合率、阴性符合率,评价二者SCCA结果的诊断一致性。结果两检测系统的精密度分别为2.35%~3.56%、0.99%~1.70%;二者具有较好的相关性(rs=0.939),Passing Bablok回归方程为:y=0.156+1.034x(截距=0.156,斜率=1.034),百分偏倚平均值在可接受范围内(-9.30%),但有多于5%的数据点落在95%一致性界限外;山形图折叠处靠近0(-0.28 mg/L);组内相关系数为0.912(95%CI:0.880~0.937);经校正后,罗氏与雅培SCCA结果的总符合率、阳性符合率、Kappa值由92.86%、54.91%、0.660提高至93.83%、90.98%、0.778。结论2种SCCA检测系统相关性、一致性较好,但存在系统性偏差,可通过回归方程将结果进行转换后再进行临床判断。

Objective To evaluate the consistency of squamous cell carcinoma antigen(SCCA)results between Roche cobase 602 and Abbott Architect i2000 SR automated immunoassay system.Methods A total of 4231 clinical serum samples were collected during the parallel detection of methodological changes in the Department of Clinical Laboratory,and the SCCA levels were detected by the above immunoassay systems.The precision was evaluated by referring to CLSIEP15-A2 protocols.The data of 138cases of SCCA results were selected by random sampling,and the correlation,consistency and deviation of SCCA results of the two systems were analyzed by correlation analysis,regression analysis and consistency test.The SCCA results of 4231 patients were analyzed by Kappa analysis,and the results of Roche system were corrected by linear regression equation.The diagnostic coincidence rate,positive coincidence rate and negative coincidence rate of the two systems before and after correction were calculated,to evaluate the diagnostic consistency of the two systems.Results The precision of the two detection systems was 2.35%-3.56%and 0.99%-1.70%respectively,and there was a strong correlation between them(r s=0.939).The Passing Bablok regression equation was as follows:y=0.156±1.034x(intercept=0.156,slope=1.034),the average percentage bias was within the acceptable range(-9.30%),but more than 5%of data points fell outside the 95%control limit.The folding of the mountain map was close to 0(-0.28 mg/L).The intra-group correlation coefficient was 0.912(95%CI:0.880-0.937).After correction,the total coincidence rate,positive coincidence rate and Kappa value of Roche and Abbott SCCA results increased from 92.86%,54.91%,and 0.660 to 93.83%,90.98%and 0.778,respectively.Conclusion The two SCCA detection systems have good correlation and consistency,but there is a systematic deviation.Therefore,the results can be transformed by regression equation before clinical judgment.