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首页> 美国卫生研究院文献>Clinical and Diagnostic Laboratory Immunology >Performance of a Redesigned HIV Selectest Enzyme-Linked Immunosorbent Assay Optimized To Minimize Vaccine-Induced Seropositivity in HIV Vaccine Trial Participants
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Performance of a Redesigned HIV Selectest Enzyme-Linked Immunosorbent Assay Optimized To Minimize Vaccine-Induced Seropositivity in HIV Vaccine Trial Participants

机译：经过重新设计的HIV选择性酶联免疫吸附试验的性能优化可最大程度地减少HIV疫苗试验参与者的疫苗诱导的血清阳性。

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Vaccine-induced seropositivity (VISP) or seroreactivity (VISR), defined as the reaction of antibodies elicited by HIV vaccines with antigens used in HIV diagnostic immunoassays, can result in reactive assay results for vaccinated but uninfected individuals, with subsequent misclassification of their infection status. The eventual licensure of a vaccine will magnify this issue and calls for the development of mitigating solutions in advance. An immunoassay that discriminates between antibodies elicited by vaccine antigens and those elicited by infection has been developed to address this laboratory testing need. The HIV Selectest is based on consensus and clade-specific HIV peptides that are omitted in many HIV vaccine constructs. The assay was redesigned to enhance performance across worldwide clades and to simplify routine use via a standard kit format. The redesigned assay was evaluated with sera from vaccine trial participants, HIV-infected and uninfected individuals, and healthy controls. The HIV Selectest exhibited specificities of 99.5% with sera from uninfected recipients of 6 different HIV vaccines and 100% with sera from normal donors, while detecting HIV-1 infections, including intercurrent infections, with 95 to 100% sensitivity depending on the clade, with the highest sensitivities for clades A and C. HIV Selectest sensitivity decreased in very early seroconversion specimens, which possibly explains the slightly lower sensitivity observed for asymptomatic blood donors than for clinical HIV cases. Thus, the HIV Selectest provides a new laboratory tool for use in vaccine settings to distinguish the immune response to HIV vaccine antigens from that due to true infection.
机译：疫苗诱导的血清阳性（VISP）或血清反应性（VISR），定义为HIV疫苗引发的抗体与HIV诊断免疫测定中使用的抗原的反应，可导致接种但未感染的个体产生反应性测定结果，并随后对其感染状况进行错误分类。最终获得疫苗许可会扩大这个问题，并要求提前开发缓解措施。已经开发出区分疫苗抗原引发的抗体和感染抗原引发的抗体的免疫测定法，以解决这种实验室测试的需要。 HIV Selectest基于共识和进化枝特有的HIV肽，在许多HIV疫苗构建物中已被省略。重新设计了该测定法，以增强全球进化枝的性能，并通过标准试剂盒形式简化常规使用。重新设计的检测方法是用来自疫苗试验参与者，HIV感染者和未感染者以及健康对照者的血清评估的。 HIV Selectest对6种不同HIV疫苗未感染者的血清特异性为99.5％，对正常供者血清的特异性为100％，同时检测HIV-1感染（包括并发感染），根据进化枝的敏感性为95％至100％。进化枝A和C的敏感性最高。HIV在很早的血清转换样本中，选择性敏感性下降，这可能解释了无症状献血者的敏感性略低于临床HIV病例。因此，HIV Selectest提供了一种新的实验室工具，可用于疫苗设置，以区分对HIV疫苗抗原的免疫反应与真正感染引起的免疫反应。

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