Blood screening by nucleic acid amplification technology: Current issues, future challenges
Blood screening by nucleic acid amplification technology: Current issues, future challenges
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DOI：
10.1016/s1084-8592(00)00006-0
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发表时间：
2000-03-01
期刊：
影响因子：
--
通讯作者：
Dragon, E
中科院分区：
文献类型：
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作者：
Gallarda, JL;Dragon, E
工作背景：核酸扩增技术（NAT）目前正在美国临床试验中进行评估，以确定献血人群中人类免疫缺陷病毒（HIV）和丙型肝炎病毒（HCV）RNA的小型混合检测的安全性和有效性。虽然输血传播的HIV和HCV感染的风险是非常低的，仍然有一个小的机会，血液捐赠的受感染的个人血清转换前可以逃脱检测目前的抗体为基础的assessment.Methods：本报告介绍了扩增技术正在使用和审查周围的NAT为基础的血液筛查的几个问题。比较了NAT与当前酶免疫分析技术的性能特点，并讨论了NAT在减少输血传播感染方面的优势。结论：目前美国进行的HIV和HCV RNA迷你池NAT检测临床试验已成功识别转阳前感染性血液单位。虽然目前基于NAT的筛查系统是半自动化的，但迷你池测试代表了政府和非政府机构在高度监管的输血行业中前所未有的创新。尽管存在成本效益问题，但基于公众对通过输血获得的传染病的看法，基于NAT的血液供应筛查有望成为输血医学的标准。
Background: Nucleic acid amplification technology (NAT) is presently being evaluated in US clinical trials to determine the safety and efficacy of mini-pool testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) RNA in the blood-donor population. Although the risk for transfusion-transmitted HIV and HCV infection is extremely low, there is still a small chance that blood donated by infected individuals before seroconversion can escape detection by current antibody-based assays.Methods: This report describes the amplification technologies being used and reviews several issues surrounding NAT-based blood screening. The performance features of NAT and current enzyme immunoassay technologies are compared, and the benefits of NAT in reducing transfusion-transmitted infections are discussed.Conclusions: The current US clinical trials of mini-pool NAT testing for HIV and HCV RNA have successfully identified preseroconversion infectious blood units. Although the current NAT-based screening systems are semiautomated, mini-pool testing represents an unprecedented innovation among government and nongovernment agencies in the highly regulated blood transfusion industry. Despite cost-effectiveness issues, based on the public perception of infectious diseases acquired through blood transfusion, NAT-based screening of the blood supply is expected to become a standard in transfusion medicine.