核酸检测技术在江苏省盐城地区献血者筛查中的应用  

Application of Nucleic Acid Amplification Technology in Screening Blood Donors in Yancheng of Jiangsu Province

作　　者：黄宏亮 徐志华 贾红志 王晖 

机构地区：[1]盐城市中心血站,江苏盐城224005

出　　处：《国际输血及血液学杂志》2014年第1期20-22,共3页International Journal of Blood Transfusion and Hematology

摘　　要：目的探讨核酸检测技术在江苏省盐城地区无偿献血者血液筛查中的可行性及必要性。方法随机抽取2011年7月4日至2012年7月3日，盐城地区无偿献血者血液标本中酶联免疫吸附试验（ELISA）为阴性且谷丙转氨酶（ALT）检测合格的标本34925份作为研究对象。采用罗氏诊断COBAS$201系统以6混样检测模式对本组标本进行乙型肝炎病毒（HBV）／N型肝炎病毒／人类免疫缺陷病毒核酸三项联合检测，核酸筛查阳性标本送卫生和计划生育委员会临床检验中心确认。结果本组34925份ELISA／ALT检测合格标本中，共筛出57例核酸阳性，阳性率为0．16％；20例送临床检验中心标本中，13例确认为阳性（65％），均为病毒载量低于20IU／mL的HBV感染；其中，9例为隐匿性乙型肝炎，2例为ELISA漏检。结论ELISA检测在本地区献血者血液筛查工作中存在漏检情况，主要为隐匿性乙型肝炎造成的HBV漏检；核酸检测技术能有效检出ELISA检测漏检的病毒感染者，可作为ELISA检测的有效补充，提高临床用血的安全性。Objective To explore the feasibility and necessity of the application of nucleic acid amplification technology （NAT） in screening blood donors in Yancheng. Methods From July 4th, 2011 to July 3rd, 2012, a total of 34 925 blood samples which were negative in enzyme-linked immunosorbent assay （ELISA） and qualified in alanine aminotransferase （ALT） detection, were selected in this study stochastically. All the samples were detected hepatitis B virus （HBV）/ hepatitis C virus / human immunodeficiency virus by Roche Cobas $201 System in 6 samples pooling. NAT positive samples were reconfirmed by National Center for Clinical Laboratories （NCCL）. Results The results showed that 57 samples in 34 925 serological negative specimens were NAT positive, and the rate of positive detection was 0.16 %. Twenty of them were reconfirmed by NCCL and 13 were conformed HBV positive presented a viral load below 20 IU/mL. Of the 13 reconfirmed HBV positive samples, 9 samples were occult hepatitis B （OBI）, 2 samples were ELISA omission. Conclusions ELISA could miss some virus, and occult infection of HBV are exist in local blood donors. NAT could be the supplement to the ELISA to improve the safety of local clinical blood use.

关 键 词：乙型 肝炎病毒 丙型 人类免疫缺陷病毒 核酸检测 

分 类 号：R446.6[医药卫生—诊断学]