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首页> 外文期刊>Transfusion medicine and hemotherapy: offizielles Organ der Deutschen Gesellschaft fur? Transfusionsmedizin und Immunham?atologie >Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country
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Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country

机译：个体捐赠核酸测试的安全测试算法：低流行国家的10年经验

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Introduction: A highly sensitive and specific nucleic acid test (NAT) for the blood-borne viruses human immunodeficiency virus (HIV), hepatitis C (HCV), and hepatitis B (HBV) is essential for the safety of blood components. Since more than 2 decades, NAT screening of blood donations has become standard in developed countries that have implemented the individual-donation (ID-NAT) and mini-pool NAT (MP-NAT) approaches. With this powerful technique, confirmation of initial reactive (IR) NAT samples becomes a challenge. Different algorithms are currently in use to eliminate false reactive results. To show that the algorithm implemented in 2007, that uses repeat testing of IR samples in duplicate runs, is a safe strategy, especially in low endemic countries, data from a 10-year experience of ID-NAT were extensively analyzed when follow-up data were available. Methods: From July 2007 to December 2014, the Procleix Ultrio assay on a Procleix Tigris system, and from January 2015 to December 2017, the cobas MPX on a cobas 8800 platform, were used for ID-NAT screening. All IR samples were subjected to repeat testing in duplicate independent runs. Only when both tests remained negative were the products released. Donor data from the last 10 years were investigated retrospectively, looking for the reoccurrence of a reactive result in a follow-up sample. Only those donors with at least an x + 1 donation result were included for the confirmation of a false reactive result. Results: From the 1,830,657 donations tested, 2,450 samples were IR (0.13%); only 228 were repeat reactive ([RR], 18 HIV, 61 HCV, and 149 HBV samples), and 2,222 were non-RR (0.12%). Follow-up data were available from 1,267 donors (57%) for further analysis. All except one of these donors were ID-NAT-negative in all follow-up samples. The one exception was from a donor who acquired a fresh HBV infection 10 years after the IR donation (in the x + 28 donation) and subsequently seroconverted. Subsequent serological tests from all succeeding donations (x + 1, x + 2, etc.) were negative in all the other cases, proving that no seroconversion took place after the IR ID-NAT result. Conclusions: The algorithm to deal with IR ID-NAT donations using duplicate repeat testing is very safe and cost-effective in low-prevalence countries. There is no unnecessary destruction of blood products, no counseling of false reactive donors, and also no need to add further complexity to the screening algorithm. (c) 2019 S. Karger AG, Basel
机译：介绍：用于血型病毒人免疫缺陷病毒（HIV），丙型肝炎（HCV）和乙型肝炎（HBV）的高敏感和特异性核酸试验（NAT）对于血液成分的安全至关重要。自超过2年以来，NAT筛选献血已成为已发达国家的标准，已实施单独捐赠（ID-NAT）和迷你池NAT（MP-NAT）方法。通过这种强大的技术，确认初始反应性（IR）NAT样本成为挑战。目前正在使用不同的算法来消除错误的反应结果。为了表明，在2007年实现的算法，它使用重复运行的IR样品的重复测试，是一种安全的战略，特别是在低流行国家，来自后续数据的10年ID-NAT经验的数据被广泛分析可用。方法：从2007年7月到2014年12月，Procleix超卓在Procleix Tigris系统上，从2015年1月到2017年12月，COBAS 8800平台上的COBAS MPX用于ID-NAT筛选。所有IR样品都经过重复的独立运行重复测试。只有当两个测试保持负面时才释放的产品。回顾性地研究了过去10年的捐赠者数据，寻找随访样本中的反应性结果的再发产。仅包括至少具有X + 1捐赠结果的供体用于确认错误的反应性结果。结果：从测试的1,830,657份测试中，2,450个样品为IR（0.13％）;仅228重复反应（[RR]，18 HIV，61 HCV和149 HBV样品），2,222个是非RR（0.12％）。可从1,267个捐助者（57％）获得后续数据，以进一步分析。除了这些捐赠者之一除外，所有后续样本中的否则都是否则的。一个例外来自一位捐赠者，他在红外捐赠10年后获得了新鲜的HBV感染（在X + 28捐赠）并随后血管转化。在所有其他情况下，所有成功捐赠（x + 1，x + 2等）的后续血清学检测都是阴性，证明在IR ID-NAT结果之后没有发生血清转换。结论：使用重复重复测试处理IR ID-NAT捐款的算法在低流行国家非常安全和成本效益。没有不必要的血液制品破坏，没有假反应供体的咨询，也无需增加进一步复杂于筛选算法。 （c）2019年S. Karger AG，巴塞尔

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