TIME-COURSE OF DETECTION OF VIRAL AND SEROLOGIC MARKERS PRECEDING HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 SEROCONVERSION - IMPLICATIONS FOR SCREENING OF BLOOD AND TISSUE DONORS
TIME-COURSE OF DETECTION OF VIRAL AND SEROLOGIC MARKERS PRECEDING HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 SEROCONVERSION - IMPLICATIONS FOR SCREENING OF BLOOD AND TISSUE DONORS
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DOI：
10.1046/j.1537-2995.1995.35295125745.x
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发表时间：
1995-02-01
期刊：
影响因子：
2.9
通讯作者：
PETERSEN, LR
中科院分区：
文献类型：
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作者：
BUSCH, MP;LEE, LLL;PETERSEN, LR
背景：自1985年实施抗HIV筛查以来，几乎所有通过血液或组织传播的人类免疫缺陷病毒(HIV)都可以追溯到感染后但抗体血清转换之前的血液，这段时间被称为窗口期。在这项研究中，评估了感染后立即检测病毒和血清标志物的新方法的性能，并估计了这些方法所实现的窗口期的缩短。研究设计和方法：确定了三项针对感染艾滋病毒高危人群的队列研究。这些研究包括控制良好的HIV-1(HIV-1)聚合酶链式反应(PCR)分析，这些样本来自HIV-1血清转换男同性恋者或静脉吸毒者的一系列感染前样本。在1989年建立的病毒裂解物抗HIV-1酶免疫吸附试验(EIA)证实的81名抗HIV-1血清转换者中，有13人(16%)的血清转换前标本为PCR阳性。在本研究中，对这13份PCR阳性样本的血清进行了10项同期EIA和6项补充试验，以及FAR、血浆p24抗原和HIV-1RNA的检测。38名HIV-1DNA聚合酶链式反应阴性的队列参与者的预转换血清也进行了选定的抗HIV EIA检测，并检测了p24抗原和HIV-1RNA。根据这些实验室数据和所有81名男性抽血的间隔时间，通过建立数学模型来分析血清转换数据，估计这些新检测方法所实现的前转换窗口期的缩短。结果：在13例转阴前PCR阳性样本中，有9例(69%)的抗HIV可被一种或多种当代抗HIV-1或抗HIV-2 EIA检测到。补充抗体检测在所有4个EIA无反应的孕前转换样本中均为阴性，在9个EIA反应的PCR阳性样本中有很高比例为阴性或不确定。13份标本中p24抗原阳性8份(69%)，HIV-1RNA阳性11份(85%)。与基于病毒裂解物的抗HIV EIA指数相比，窗口期的估计减少如下：当代抗HIV-1/2 EIA，20.3天(95%CI，8.0-32.5)；p24抗原和DNA PCR，26.4天(95%CI，12.6-38.7)；和RNA PCR，31.0天(95%CI，16.7-45.3)。结论：最近抗HIV检测灵敏度的提高导致转换前窗口期显著缩短。因此，通过实施直接病毒检测分析可以实现的窗口期的逐步减少已大大减少。
Background: Almost all human immunodeficiency virus (HIV) transmission via blood or tissues that has occurred since anti-HIV screening was implemented in 1985 is traceable to blood given after infection but before antibody seroconversion, a time that is referred to as the window period. In this study, the performance of newer assays designed to detect viral and serologic markers soon after infection is assessed, and the reduction in the window period achieved by these assays is estimated.Study Design and Methods:Three cohort studies of persons at high risk for acquiring HIV infection were identified. These studies included well-controlled HIV type 1 (HIV-1) polymerase chain reaction (PCR) analyses of serial preseroconversion specimens from HIV-1-seroconverting homosexual men or intravenous drug users. Of 81 enrollees with anti-HIV-1 seroconversion documented by a viral lysate anti-HIV-1 enzyme immunosorbent assay (EIA) available in 1989, 13 (16%) had PCR-positive preseroconversion specimens. In the present study, sera from these 13 PCR-positive samples were further tested for anti-HIV by 10 contemporary EIAs and 6 supplemental assays, as well as being tested far,plasma p24 antigen and HIV-1 RNA. Preseroconversion sera from 38 HIV-1 DNA PCR-negative cohort participants were also tested by selected anti-HIV EIAs and tested for p24 antigen and HIV-1 RNA. On the basis of these laboratory data and the intervals between blood drawing in all 81 men, the reduction in the preseroconversion window period achieved by these new assays was estimated with a mathematical model developed to analyze seroconversion data.Results: Nine (69%) of the 13 preseroconversion PCR-positive samples had anti-HIV that was detectable by one or more contemporary anti-HIV-1 or anti-HIV type 2 EIA. Supplemental antibody assays were negative on all four EIA-nonreactive preseroconversion samples and negative or indeterminate on a high proportion of the nine EIA-reactive PCR-positive samples. Eight (69%) of the 13 samples were p24 antigen-positive, and 11 (85%) were HIV-1, RNA-positive. The estimated reductions in the window period (relative to the index viral lysate-based anti-HIV EIA) were as follows: contemporary anti-HIV-1/2 EIAs, 20.3 days (95% Cl, 8.0-32.5); p24 antigen and DNA PCR, 26.4 days (95% Cl, 12.6-38.7); and RNA PCR, 31.0 days (95% Cl, 16.7-45.3).Conclusion: Recent improvement in the sensitivity of anti-HIV assays has resulted in significant shortening of the preseroconversion window period. Consequently, the incremental reduction in the window period that could be achieved by implementing direct virus-detection assays has diminished significantly.