Performance of Premarket Rapid Hepatitis C Virus Antibody Assays in 4 National Human Immunodeficiency Virus Behavioral Surveillance System Sites
Performance of Premarket Rapid Hepatitis C Virus Antibody Assays in 4 National Human Immunodeficiency Virus Behavioral Surveillance System Sites
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DOI：
10.1093/cid/cir499
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发表时间：
2011-10-15
影响因子：
11.8
通讯作者：
DiNenno, Elizabeth A.
中科院分区：
文献类型：
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作者：
Smith, Bryce D.;Teshale, Eyasu;DiNenno, Elizabeth A.
背景疾病控制和预防中心（CDC）估计，410万美国人感染了丙型肝炎病毒（HCV），其中75%-80%患有慢性HCV感染，许多人不知道自己的感染。在美国，注射毒品者（PWID）占所有HCV抗体（抗-HCV）携带者的57.5%。目前，在美国还没有批准用于HCV感染的即时检测。2009年，作为国家艾滋病毒行为监测系统的一部分，对报告在过去12个月内使用过注射毒品的人进行了人体免疫缺陷病毒（艾滋病毒）和抗丙型肝炎病毒的调查和检测。在美国4个城市的现场环境中评价了来自3家制造商（Chembio、MedMira和OraSure）的即时检测（手指针刺和2种口腔液快速检测）的灵敏度和特异性。不同检测试剂盒和研究中心的灵敏度（78.9%-97.4%）和特异性（80.0%-100.0%）存在差异。Chembio、MedMira和OraSure检测的最高检测特异性灵敏度分别为94.0%、78.9%和97.4%;最高特异性分别为97.7%、83.3%和100%。在多变量分析中，在纽约市的1个研究中心，假阴性的抗-HCV结果与Chembio口服检测的HIV阳性相关（校正比值比，8.4-9.1; P <0.01）。敏感的快速抗-HCV检测对于高流行率、高风险人群（如PWID）是适当和可行的，可以通过社会服务环境（如注射器交换计划和美沙酮维持治疗计划）接触这些人群。
Background. The Centers for Disease Control and Prevention (CDC) estimates that 4.1 million Americans have been infected with hepatitis C virus (HCV) and 75%-80% of them are living with chronic HCV infection, many unaware of their infection. Persons who inject drugs (PWID) account for 57.5% of all persons with HCV antibody (anti-HCV) in the United States. Currently no point-of-care tests for HCV infection are approved for use in the United States.Methods. Surveys and testing for human immunodeficiency virus (HIV) and anti-HCV were conducted among persons who reported injection drug use in the past 12 months as part of the National HIV Behavioral Surveillance System in 2009. The sensitivity and specificity of point-of-care tests (finger-stick and 2 oral fluid rapid assays) from 3 manufacturers (Chembio, MedMira, and OraSure) were evaluated in field settings in 4 US cities.Results. Sensitivity (78.9%-97.4%) and specificity (80.0%-100.0%) were variable across assays and sites. The highest assay-specific sensitivities achieved for the Chembio, MedMira, and OraSure tests were 94.0%, 78.9% and 97.4%, respectively; the highest specificities were 97.7%, 83.3%, and 100%, respectively. In multivariate analysis, false-negative anti-HCV results were associated with HIV positivity for the Chembio oral assay (adjusted odds ratio, 8.4-9.1; P < .01) in 1 site (New York City).Conclusions. Sensitive rapid anti-HCV assays are appropriate and feasible for high-prevalence, high-risk populations such as PWID, who can be reached through social service settings such as syringe exchange programs and methadone maintenance treatment programs.