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.

中文翻译：

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个人捐赠核酸检测的安全检测算法：在低流行国家的 10 年经验

简介：对血液传播病毒人类免疫缺陷病毒 (HIV)、丙型肝炎 (HCV) 和乙型肝炎 (HBV) 进行高度敏感和特异的核酸检测 (NAT) 对于血液成分的安全至关重要。二十多年来，献血的 NAT 筛查已成为发达国家实施个人献血 (ID-NAT) 和小池 NAT (MP-NAT) 方法的标准。使用这种强大的技术，初始反应 (IR) NAT 样本的确认成为一项挑战。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 2007 年实施的算法，在重复运行中重复测试 IR 样本，是一种安全的策略，尤其是在低流行国家，当有后续数据可用时，对来自 10 年 ID-NAT 经验的数据进行了广泛分析。方法：2007 年 7 月至 2014 年 12 月，Procleix Tigris 系统上的 Procleix Ultrio 检测和 2015 年 1 月至 2017 年 12 月 cobas 8800 平台上的 cobas MPX 用于 ID-NAT 筛选。所有 IR 样品都在重复的独立运行中进行了重复测试。只有当两次测试都为阴性时，产品才被释放。对过去 10 年的供体数据进行了回顾性调查，以寻找后续样本中反应性结果的再次发生。只有那些至少有 x + 1 次捐赠结果的捐赠者才被包括在内，以确认错误的反应结果。结果：在测试的 1,830,657 份捐献中，2,450 份样本为 IR（0.13%）；只有 228 例重复反应（[RR]，18 例 HIV，61 例 HCV，和 149 个 HBV 样本），2,222 个是非 RR（0.12%）。1,267 名捐赠者 (57%) 的随访数据可用于进一步分析。在所有后续样本中，除了其中一名供体外，所有供体均为 ID-NAT 阴性。一个例外是捐献者在 IR 捐献 10 年后（在 x + 28 次捐献中）获得了新的 HBV 感染，随后发生了血清转化。在所有其他情况下，所有后续捐赠（x + 1、x + 2 等）的后续血清学检测均为阴性，证明在 IR ID-NAT 结果后未发生血清转化。结论：使用重复重复测试处理 IR ID-NAT 捐赠的算法在低流行率国家非常安全且具有成本效益。没有对血液制品进行不必要的破坏，没有对假反应献血者的咨询，