2种HBsAg定量检测系统对HBV不同感染阶段及不同基因型样本检测的一致性评价  

Consistency of 2 HBsAg quantitation determination systems in different HBV infection phases and different genotypes

作　　者：刘杨[1] 彭道荣[1] 马越云[1] 程晓东[1] 张涛[1] 王菁[1] 郝晓柯[1] 

机构地区：[1]第四军医大学西京医院检验科,陕西西安710032

出　　处：《检验医学》2016年第4期288-292,共5页Laboratory Medicine

基　　金：国家高技术研究发展计划资助项目(2011AA02A101)

摘　　要：目的分析罗氏MODULAR E170电化学发光免疫分析系统（简称罗氏E170）和雅培i2000化学发光微粒子免疫分析系统（简称雅培i2000）定量检测慢性乙型肝炎不同感染阶段、不同基因型患者的乙型肝炎表面抗原（HBs Ag）结果的一致性。方法收集临床未经抗病毒治疗的慢性乙型肝炎患者血清样本共125例,根据《慢性乙型肝炎防治指南（2010年版）》中的标准,将样本分为免疫耐受期、免疫清除期、低复制期和再活动期4组,同时根据基因型（B/C）及HBs Ag水平（HBs Ag≤1 000 IU/m L/HBs Ag〉1 000 IU/m L）分组。用罗氏E170和雅培i2000 2种系统平行检测HBs Ag,分析各组间2种系统检测结果的一致性。结果 2种系统检测结果总体相关性、一致性好（r=0.989,P均〈0.001）;在4个不同感染阶段,2种系统检测结果的相关性好（r值为0.977~0.993,P均〈0.001）;在一致性分析中,免疫清除期、低复制期和再活动期样本检测结果的一致性较好,但在免疫耐受期罗氏E170检测结果较雅培i2000高,偏差为0.114 log IU/m L;B、C基因型组2种系统检测结果的相关性、一致性均好（r值均〉0.95,P均〈0.001）;在HBs Ag高水平组中,2种系统检测结果的r值为0.959（P〈0.001）,相关性较HBs Ag低水平组略差,但在专业可接受范围内;且在HBs Ag高水平组中,2种系统的偏差较大,罗氏E170检测结果比雅培i2000平均高0.076 log IU/m L。结论 2种系统检测不同感染阶段及不同基因型样本的相关性和一致性较好,但在检测免疫耐受期及高值样本时罗氏E170结果较雅培i2000偏高。临床上用HBs Ag预测抗病毒治疗的效果时,治疗前后应尽量选择同一系统的结果,以避免由于不同系统间的差异造成对治疗效果的错误评估。Objective To analyze the consistency of Roche MODULAR E170 electrochemiluminescence immunoassay system（Roche E170）and Abbott i2000 chemiluminescence microparticle immunoassay system（Abbott i2000）for hepatitis B surface antigen（HBs Ag） quantitation determination in different hepatitis B virus（HBV）infection phases and different genotypes. Methods A total of 125 serum samples were collected from chronic hepatitis B patients without antiviral treatment,and they were classified into 4 different phases according to the Guideline of Prevention and Treatment for Chronic Hepatitis B,including immune tolerant phase,immune clearance phase,low replicative phase and hepatitis B e antigen（HBe Ag）-negative hepatitis phase. Simultaneously,they were classified according to genotypes（B/C）and different HBs Ag levels（HBs Ag ≤ 1 000 IU/m L / HBs Ag1 000 IU/m L）as well. All the samples were determined by the 2 systems,and the consistency was analyzed. Results The correlation and consistency of the 2 systems were good（r=0.989,P〈0.001）. The correlations of the 4 different HBV infection phases were good（r=0.977-0.993,P〈0.001）. The consistencies of the 2 systems during immune clearance phase,low replicative phase and HBe Ag-negative hepatitis phase were good. However,during immune tolerant phase,the results of Roche E170 were higher than those of Abbott i2000,and the bias was 0.114 log IU/m L. For B and C genotypes,the correlation and consistency were good（r 0.95,P〈0.001）. The 2 systems′ r was 0.959 in high HBs Ag level group,and the bias between Roche E170 and Abbott i2000 was 0.076 log IU/m L. Even though the correlation was poor,it was falling in professional acceptable range. Conclusions The consistencies of the 2 systems for different HBV infection phases and different genotypes are good,but during immune tolerant phase and in high HBs Ag level samples,the same system should be used to evaluate the efficacy of antiviral therapy,in order to avoid differences.

关 键 词：乙肝表面抗原 定量检测 相关性 一致性 

分 类 号：R446.62[医药卫生—诊断学]