化学发光免疫分析仪在慢性乙肝血清学检测中的价值分析  

Analysis on the value of chemiluminescence immunoassay analyzer in serological detection of chronic hepatitis B

作　　者：吕松琴 杨永锐 李光敏 徐丽萍 聂磊 黄山 李晓非 LV Songqin;YANG Yongrui;LI Guangmin;XU Liping;NIE Lei;HUANG Shan;LI Xiaofei(Clinical Lab,Third People's Hospital of Kunming/Yunnan Provincial Clinical Medical Centre for Infectious Diseases,Kunming Yunnan 650041,China)

机构地区：[1]昆明市第三人民医院/云南省传染性疾病临床医学中心检验科,云南昆明650041

出　　处：《云南医药》2025年第1期23-26,共4页Medicine and Pharmacy of Yunnan

基　　金：昆明市卫健委卫生科研课题项目(2022-03-08-010)。

摘　　要：目的分析比较进口罗氏Cobas e601与国产万泰生物Caris 200全自动化学发光免疫分析仪检测慢性乙肝患者乙肝六项的结果。方法收集2023年1月1日-2023年6月30日本院肝病科就诊的慢性乙肝患者血清样本1292份,采用2种方法检测HBsAg-QN(定量)、HBsAb、HBeAg、HBeAb、HBcAb和HBcAb-IgM六项,分析比较2种方法的符合率、一致性等指标。结果HBsAg-QN结果阳性符合率为99.15%(1281/1292),趋势基本一致,同时呈高度正相关(r=0.990,P<0.001)。罗氏HBsAg-QN 866.90(170.15,3600.00)IU/mL低于万泰HBsAg-QN 1617.62(296.70,7213.66)IU/mL,差异有统计学意义(P<0.001)。除HBsAb阳性符合率仅12.94(11/85)外,其余四项阳性符合率均>85%;HBcAb阴性符合率50%(1/2),其余四项阴性符合率均>95%;各项总符合率均大于>90%。HBeAg和HBeAb一致性较好(Kappa>0.9),HBcAb一致性一般(Kappa=0.499),HBsAb和HBcAb-IgM一致性较差(Kappa<0.4)。结论2种方法HBsAg-QN,HBeAg、HBeAb和HBcAb可以平行替代,HBsAb和HBcAb-IgM结果一致性较差。Objective Comparative analysis of the results of six items of HBV of chronic hepatitis B patients detected by the imported Roche Cobas e601 fully automated electrochemiluminescence immunoassay analyzer and the domestic Wantai Biopharm Caris 200 fully automated chemiluminescence immunoassay analyzer.Methods A total of 1292 serum samples of chronic hepatitis B patients treated in the hospital from January 1,2023 to June 31,2023 were collected.Two methods were used to detect HBsAg-QN(quantitative),HBsAb,HBeAg,HBeAb,HBcAb and HBcAb-IgM.The coincidence rate,consistency and other indicators of the two methods were analyzed and compared.Results The positive coincident rate of HBsAg-QN was 99.15%(1,281/1,292),the trend was basically consistent,and there was a high positive correlation(r=0.990,P<0.001).The Roche HBsAg-QN 866.90(170.15,3600.00)IU/mL was lower than Wantai HBsAg-QN 1617.62(296.70,7213.66)IU/mL,the difference was statistically significant(P<0.001).The positive coincident rate of HBsAb was only 12.94%(11/85),and the positive coincidence rate of the other four items was more than 85%.The negative coincident rate of HBcAb was only 50%(1/2),the remaining four items were all>95%.The total coincidence rate was greater than 90%.The consistency of HBeAg and HBeAb was good(Kappa>0.9),while the consistency of HBcAb was general(Kappa=0.499),and the consistency of HBsAb and HBcAb-IgM was poor(Kappa<0.4).Conclusions The Roche Cobas e601 fully automatic electrochemiluminescence immunoassay analyzer and Wantai Biopharm Caris 200 fully automated chemiluminescence immunoassay analyzer can be used alternatively for HBsAg-QN,HBeAg,HBeAb,and HBcAb detection.The consistency of HBsAb and HBcAb-IgM is poor.

关 键 词：全自动化学发光免疫分析仪 慢性乙肝患者 血清学检测 

分 类 号：R512.62[医药卫生—内科学]