国产板式化学发光免疫分析系统与罗氏cobas E602免疫分析系统对肿瘤标志物检测结果的比对分析

刘纲毅+欧红娟+容亓

【摘要】 目的 通過比对分析国产科美板式化学发光免疫分析系统与罗氏电化学发光免疫分析系统测定糖类抗原199（Ca199）、糖类抗原125（Ca125）、糖类抗原153（Ca153）、总前列腺特异性抗原（tPSA）的检测结果，进而对国产科美板式化学发光免疫分析系统进行方法学评价。

方法 用科美板式化学发光免疫分析系统和罗氏cobas E602免疫分析系统按项目分组分别检测80份临床血清样本，以罗氏cobas E602分析系统为参考系统，对科美板式化学发光分析系统进行比对分析，计算两系统检测结果之间的灵敏度、特异度、两者检测符合率等指标，对两系统的检测结果做相关回归分析，并采用Kappa统计对两系统检测结果的一致性进行分析。

结果 科美板式化学发光分析系统（Y）与罗氏cobas免疫分析系统（X）的相关回归方程和相关系数为：tPSA（y=1.067x-0.798，r=0.973），Ca199（y=0.450x+4506，r=0.913），Ca125（y=0.151x+48.29，r=0.779），Ca153（y=0.794x+11.12，r=0.740）；两系统结果的灵敏度、特异度、符合率及一致性强度为： Ca199（灵敏度97.44%，特异度95.12%，符合率96.25%，Kappa=0.902，最强一致性），tPSA（灵敏度95.56%，特异度85.71%，符合率91.25%，Kappa=0.800，高度一致性），Ca153（灵敏度81.63%，特异度9355%，符合率86.25%，Kappa=0.706，高度一致性），Ca125（灵敏度67.80%，特异度100%，符合率91.25%，Kappa=0.518，中度一致性）。

结论 科美板式化学发光免疫分析系统与罗氏cobas E602电化学发光免疫分析系统的检测结果相关性一般，检测Ca199、tPSA、Ca153的结果一致性较好，而Ca125需要修正参考区间以取得与罗氏cobas E602分析系统更好的结果一致性。

【关键词】 板式化学发光免疫分析；肿瘤标志物；免疫检测系统；比对研究

中图分类号：R730.43 文献标识码：A DOI：10.3969/j.issn.1003-1383.2017.03.007

【Abstract】 Objective To evaluate the methodology of domestic Kemei chemiluminescence immunoassay system through comparing and analyzing test results of carbohydrate antigen 199（CA199），carbohydrate antigen 125（CA125），carbohydrate antigen 153（CA153） and total prostate specific antigen（tPSA） detected by Kemei chemiluminescence immunoassay system and Roche electrochemiluminescence immunoassay system.

Methods 80 clinical serum samples grouped according to projects were detected by Roche Cobas E602 chemiluminescence system and Kemei plate chemical immunoassay system，respectively.Roche Cobas E602 analysis system was treated as reference system，and then testing results were compared with those of Kemei plate chemical detection system.And then，sensitivity，specificity，detection compliance rate and other indicators between the testing results of the two systems were calculated，regression analysis was carried out on the results of the two systems，and Kappa statistics was used for analyzing the consistency and relationship of testing results of the two systems.

Results The regression equation and correlation coefficient of each indicator of Kemei plate chemiluminescence analysis system（Y） and Roche Cobas E602 immunoassay system（X） were：tPSA （y=1.067x-0.798，r=0.973），Ca199 （y=0.450x+45.06，r=0.913），Ca125 （y=0.151x+48.29，r=0.779），Ca153 （y=0.794x+11.12，r=0.740）.The sensitivity，specificity，detection compliance rate and consistency strength of two the system were：Ca199（sensitivity 97.44%，specificity 95.12%，detection compliance rate 96.25% and Kappa=0.902，with the strongest consistency），tPSA（sensitivity 95.56%，specificity 85.71%，detection compliance rate 91.25%，Kappa=0.800，with high consistency），Ca153（sensitivity 81.63%，specificity 93.55%，detection compliance rate 86.25%，Kappa=0.706，with high consistency），Ca125（sensitivity 67.80%，specificity 100%，detection compliance rate 91.25%，Kappa=0.518，with moderate consistency）.

Conclusion The detection results of Kemei plate chemiluminescence immunoassay system and Roche Cobas E602 electrochemiluminescence immunoassay system have no significantly correlation，Ca199，tPSA and Ca153 levels of these two systems have good consistency，however，the reference interval of Ca125 is still needed to modify to achieve better consistency with Roche Cobas E602.

【Key words】 plate chemiluminescence immunoassay；tumor markers；immunoassay analysis system；comparative study

肿瘤是严重威胁人类健康的高发病率和高死亡率性疾病，随着环境恶化、社……