献血者HBsAg阴性HBV DNA阳性血液样本电化学发光检测分析  

Electrochemiluminescence immunoassay on blood samples sourcing from HBs Ag negative and HBV DNA positive donors

作　　者：陈少彬[1] 何子毅[1] 陈庆恺[1] 王庆[1] 余霖[1] 袁秋婷 刘泽民 黄素媛 

机构地区：[1]东莞市中心血站,广东东莞523930

出　　处：《中国输血杂志》2017年第10期1156-1158,共3页Chinese Journal of Blood Transfusion

基　　金：东莞市医疗卫生类科技计划一般项目(2015105101245)

摘　　要：目的对献血者血液筛查HBs Ag阴性HBV DNA阳性的样本,用电化学发光免疫分析法(ECLIA)和定量核酸(NAT)测定的结果并进行分析。方法对本血站2016年3-11月56 448例无偿献血者血液标本筛查出97例HBs Ag阴性HBV DNA定性检测阳性的样本(实验组)进行HBV DNA定量检测,再与随机抽取的100例HBs Ag和HBV DNA均阴性的样本(对照组)分别进行ECLIA检测HBs Ag和HBc Ab。结果实验组NAT定量检测HBV阳性有55例,其中病毒载量<20 IU/m L有36(65.45%)例,病毒载量>20 IU/m L有19(34.55%)例,病毒载量范围在(37.4~394)IU/m L(中位数41.3 IU/m L),与NAT定性阳性符合率为56.70%;实验组用ECLIA检出HBs Ag阳性15例,而对照组未检出HBs Ag阳性样本(χ2校正=14.612,P<0.05);实验组的HBc Ab阳性率96.91%(94/97)明显高于对照组的38.00%(38/100)(χ2=77.284,P<0.05),差异有统计学意义。结论核酸检测技术应用于献血者血液筛查可有效降低隐匿性乙型肝炎的输血传染;电化学发光免疫分析法能降低ELISA漏检HBs Ag风险;HBc Ab在HBV DNA阳性样本中的阳性率较高,可作为血液筛查的补充方法。Objective To analyze the HBs Ag-negative and HBV-DNA-positive donor blood samples with electrochemiluminescence immunoassay（ ECLIA） and quantitative analysis of nucleic acids technology（ NAT）. Methods A total of 97 samples with HBs Ag negativity and HBV-DNA positivity were obtained from 56 488 blood donor samples dating from March2016 to November 2016（ the experimental group）. HBV DNA quantitative assay were performed first to screen out the positive samples and they were then processed by ECLIA for HBs Ag and HBc Ab detection,which was also done on 100 HBs Ag and HBV DNA all-negative random samples as the control group. Results There were 55 HBV positive cases in the experimental group,of which,36 cases（ 65. 45%） possessed a viral load〈20 IU/m L and 19（ 34. 55%） cases were confirmed a viral load〉20 IU/m L. The range of viral load was（ 37. 4 ~ 394） IU/m L and the median was 41. 3 IU/m L. The positive coincidence rate with NAT qualitative assay was 56. 70%. There were 15 HBs Ag positive cases detected by ECLIA in the experimental group whereas none was detected in the control group（ χ^2= 14. 612,P〈0. 05）. The positive rate of HBc Ab in the experimental group was 96. 91%（ 94/97）,which is significantly higher than that of the control group 38. 00 %（ 38/100）（ χ^2= 77. 284,P〈0. 05）. Thus,the difference was statistically significant. Conclusion NAT screening can effectively reduce the risk of occult hepatitis b transmitted by blood while ECLIA is capable of reducing the risk of HBs Ag omission in enzymelinked immunosorbent assay（ ELISA）. The positive rate of HBc Ab was relatively high in the HBV-DNA-positive samples,thus it may be considered as a supplementary method for blood screening.

关 键 词：献血者 电化学发光法 HBV DNA HBCAB OBI 

分 类 号：R446.11[医药卫生—诊断学] R512.62[医药卫生—临床医学]