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血清学检测在检测美国人群中感染 2009 年甲型 H1N1 流感病毒中的敏感性和特异性。

Sensitivity and specificity of serologic assays for detection of human infection with 2009 pandemic H1N1 virus in U.S. populations.

机构信息

Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Centers for Disease Control andPrevention,2 Atlanta, Georgia 30333, USA.

出版信息

J Clin Microbiol. 2011 Jun;49(6):2210-5. doi: 10.1128/JCM.00229-11. Epub 2011 Apr 6.

DOI:10.1128/JCM.00229-11
PMID:21471339
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3122722/
Abstract

Swine origin 2009 H1N1 influenza virus has spread globally to cause the first influenza pandemic of the 21st century. Serological studies can improve our understanding of the extent of human infection and risk factors associated with the transmission of this pandemic virus. The "gold standard" for serodiagnosis of human influenza virus infection is the detection of seroconversion between acute- and convalescent-stage samples. However, the timing of seroepidemiological investigations often precludes the collection of truly acute-phase sera, requiring development of serological criteria for evaluating convalescent-phase sera that optimize detection of true positives and true negatives. To guide seroepidemiological investigations into the spread of the novel 2009 pandemic H1N1 virus, we characterized serum antibody responses to 2009 H1N1 virus in 87 individuals with confirmed viral infection and 227 nonexposed U.S. individuals using microneutralization (MN) and hemagglutination inhibition (HI) assays. Sensitivity and specificity were determined for each assay alone and in combination for detection of 2009 H1N1 virus-specific antibodies in convalescent-phase sera. Although the HI assay was more specific for detecting antibody to 2009 H1N1, the MN assay was more sensitive, particularly for detecting low-titer seroconversions. A combination of titers (MN ≥ 40 and HI ≥ 20) provided the highest sensitivity (90%) and specificity (96%) for individuals aged <60 years and 92% specificity for adults aged ≥ 60 years for detection of serologically confirmed 2009 H1N1 infections in U.S. populations during the first pandemic waves. These studies provide an approach to optimize timely serological investigations for future pandemics or outbreaks of novel influenza viruses among humans.

摘要

猪源 2009 年 H1N1 流感病毒已在全球范围内传播,引发了 21 世纪的首次流感大流行。血清学研究可以帮助我们更好地了解人类感染的程度以及与这种大流行病毒传播相关的危险因素。血清学诊断人类流感病毒感染的“金标准”是检测急性和恢复期样本之间的血清转化。然而,血清流行病学研究的时间往往不允许采集真正的急性期血清,因此需要开发血清学标准来评估恢复期血清,以优化对真阳性和真阴性的检测。为了指导对新型 2009 年大流行 H1N1 病毒传播的血清流行病学研究,我们使用微量中和(MN)和血凝抑制(HI)试验,对 87 名经证实的病毒感染个体和 227 名未接触过的美国个体的血清抗体反应进行了 2009 年 H1N1 病毒的特征描述。单独和联合使用每种检测方法,对恢复期血清中 2009 年 H1N1 病毒特异性抗体的检测进行了敏感性和特异性分析。虽然 HI 检测对检测针对 2009 年 H1N1 的抗体更具特异性,但 MN 检测更敏感,尤其是对低滴度的血清转化检测。联合滴度(MN≥40 和 HI≥20)可提高对年龄<60 岁人群中血清学确诊的 2009 年 H1N1 感染的检测敏感性(90%)和特异性(96%),对年龄≥60 岁的成年人的特异性为 92%,可用于美国人群在首次大流行浪潮中针对新型流感病毒的未来大流行或暴发进行及时的血清学调查。这些研究为未来人类新型流感病毒大流行或暴发的及时血清学调查提供了一种方法。