以转录介导扩增技术大规模筛查无偿献血者的应用研究  

Application of transcription mediated amplification( TMA) technique in large scale voluntary blood donor screening

作　　者：张立波[1,2] 夏欣一[3] 马贵明[2] 姚根宏[1,3] 

机构地区：[1]南京大学医学院,江苏南京210093 [2]南京红十字血液中心实验室,江苏南京210003 [3]南京大学医学院附属金陵医院,江苏南京210002

出　　处：《东南国防医药》2014年第1期6-9,共4页Military Medical Journal of Southeast China

基　　金：国家自然科学基金(30901652)

摘　　要：目的研究和探讨以转录介导扩增(transcription mediated amplification,TMA)技术对无偿献血者进行大规模病毒核酸检测,以增强临床使用血液的安全性。方法以TMA技术对无偿献血者血液进行HBV DNA、HCV RNA、HIV1 RNA 3项联合病毒核酸检测,同时对上述样本以ELISA技术检测HIV、HBV和HCV抗原或抗体。结果 54 744份献血者血液中以TMA技术共检出病毒核酸阳性样本208例,阳性检出率为0.38%。ELISA检出阴性而TMA检出阳性的样本共75份,阳性率为0.14%,其中病毒核酸阳性共46份,即HBV DNA阳性45份与HIV1 RNA阳性1份,HCV RNA阳性未检出视为不确定结果 29份。ELISA阴性而病毒核酸阳性共46份,ELISA检测漏检率为0.08%。结论以TMA技术对无偿献血者血液进行大规模病毒核酸检测能有效缩短无偿献血人群中HIV、HBV和HCV检测的"窗口期",显著降低输血可能存在的风险。Objective To research and investigate the effect of applying the viral nucleic acid test （NAT） on the safety of blood transfusion in large scale. Methods Voluntary donors＇ blood samples were tested with TMA technique by detecting HBV DNA, HCV RNA, HIVl RNA nucleic acid. The samples were test with ELISA at the same, by detecting HIV/HBV/HCV antigen or antibody. Results 208 viral nucleic acid positive samples were detected out of 54 744 donors＇ blood samples and the positive rate was 0.38%. EL1SA negative, NAT positive samples were further tested with discrimination assays. 45 samples were confitaned as HBV DNA positive, none as HCV RNA positive and 1 as HIV1 RNA positive. Conclusion TMA can efficiently shorten the window period of HIV, HBV and HCV infection in blood screening in large scale,therefore significantly decrease the potential risks of blood transfusion.

关 键 词：核酸检测 转录介导扩增技术 窗口期 血液安全 

分 类 号：R446.5[医药卫生—诊断学]