The introduction of blood donor screening by virus nucleic acid amplification technology (NAT) in the mid to late 1990s was driven by the so-called AIDS and hepatitis C virus (HCV) epidemic, with thousands of recipients of infected blood products and components. Plasma fractionators were the first to introduce NAT testing besides pathogen reduction procedures, to reduce the virus transmission risk through their products. To achieve a similar safety standard, NAT was then also introduced for labile blood components. German transfusion centres were the first to start in-house NAT testing of their donations in pools of up to 96 samples for HCV, hepatitis B virus (HBV), and human immunodeficiency virus-1 (HIV-1). Years later the diagnostics industry provided commercial HCV and HIV-1 and later HBV NAT tests on automated platforms. NAT tests for HIV-2, hepatitis A virus, and Parvovirus B19 followed, again driven by transfusion centres with their in-house tests. When severe acute respiratory syndrome corona virus (SARS-CoV) and West Nile Virus emerged it was the NAT that enabled the manufacturers and transfusion centres to instantly introduce sensitive and specific screening tests. Subsequent automation including sample preparation has significantly reduced the costs and complexity of the procedure and made it affordable to middle income countries as well. Currently more than 60 million donations per year are NAT tested worldwide and the remaining residual risk of virus transmission by blood components and products could be reduced to almost zero. Automation rendered possible the reduction of pool size in conjunction with increased throughput and sensitivity. Thus, antibody and antigen testing may be dispensable in the long run, particularly in the combination of NAT testing with pathogen reduction. There are new technologies on the horizon like digital droplet PCR, next-generation sequencing, lab-on-a-chip, and digital antigen assays, which are comparably sensitive. However, each of these has limitations, either in throughput, costs, automation, time to result, specificity, or the need for NAT as an integral part of the technology. Thus, NAT is still the shortest and most efficient means to the result. Donor screening NAT also contributed significantly to our knowledge on how fast viruses replicate, and on the respective diagnostic window. In conjunction with animal and patient studies, we have learned more about the minimal infectious dose and the epidemics in the donor population.

中文翻译：

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核酸扩增技术献血者检测的历史和未来


20 世纪 90 年代中后期，由于所谓的艾滋病和丙型肝炎病毒 (HCV) 流行，引入了病毒核酸扩增技术 (NAT) 的献血者筛查，成千上万的接受者接受了受感染的血液制品和成分。血浆分离器首先在病原体减少程序之外引入 NAT 测试，以降低通过其产品传播病毒的风险。为了达到类似的安全标准，随后还针对不稳定的血液成分引入了 NAT。德国输血中心率先开始对其捐献的血液进行内部 NAT 检测，检测样本包含多达 96 个 HCV、乙型肝炎病毒 (HBV) 和 1 型人类免疫缺陷病毒 (HIV-1)。多年后，诊断行业在自动化平台上提供了商业 HCV 和 HIV-1 以及后来的 HBV NAT 测试。接下来是针对 HIV-2、甲型肝炎病毒和细小病毒 B19 的 NAT 测试，同样由输血中心的内部测试推动。当严重急性呼吸综合征冠状病毒 (SARS-CoV) 和西尼罗河病毒出现时，NAT 使制造商和输血中心能够立即引入敏感和特定的筛查测试。随后的自动化，包括样品制备，大大降低了程序的成本和复杂性，并使中等收入国家也能负担得起。目前，全球每年有超过 6000 万份献血经过 NAT 测试，血液成分和产品传播病毒的剩余风险可降至几乎为零。自动化使得池大小的减小以及吞吐量和灵敏度的提高成为可能。 因此，从长远来看，抗体和抗原检测可能是可有可无的，特别是在 NAT 检测与病原体减少相结合的情况下。数字液滴 PCR、新一代测序、芯片实验室和数字抗原测定等新技术即将出现，这些技术都相当敏感。然而，这些技术中的每一个都存在局限性，无论是在吞吐量、成本、自动化、获得结果的时间、特异性方面，还是在 NAT 作为技术的组成部分的需求方面。因此，NAT仍然是最短、最有效的手段。供体筛查 NAT 还极大地增进了我们对病毒复制速度和相应诊断窗口的了解。结合动物和患者研究，我们更多地了解了最小感染剂量和供体人群中的流行病。