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人类免疫缺陷病毒(HIV)当前临床试验的现状:应用与局限性

Status of current clinical tests for human immunodeficiency virus (HIV): applications and limitations.

作者信息

Houn H Y, Pappas A A, Walker E M

机构信息

Department of Pathology, University of Arkansas for Medical Sciences, Little Rock.

出版信息

Ann Clin Lab Sci. 1987 Sep-Oct;17(5):279-85.

PMID:3314657
Abstract

Two laboratory tests are currently used to detect the human immunodeficiency virus (HIV) specific antibodies that are produced when an individual has been infected by the virus at some time. These include the enzyme-linked immunosorbent assay (ELISA) as the screening test and the Western blot (WB) as the confirmatory test. They are not yet optimally effective and have brought with them some problems, especially when used to screen low risk populations such as asymptomatic blood donors. Currently licensed ELISA tests used to detect HIV have sensitivities that range between 93 percent and 99 percent, and all have specificities greater than 99 percent. An important concern is that the positive predictive value for the ELISA screening test is low in spite of the fairly high sensitivity and high specificity values. This poor predictive value is due to the low prevalence of individuals in the general population who have been infected with HIV. Multiple causes of false positive ELISA and Western blot tests have been identified. They can be eliminated by utilizing reagent antigens which are produced by recombinant deoxyribonucleic acid (DNA). The false negative ELISA and Western blot tests can be reduced by tests designed to detect IgM antibodies to HIV.

摘要

目前有两种实验室检测方法用于检测人体免疫缺陷病毒(HIV)特异性抗体,这些抗体是个体在过去某个时间感染该病毒后产生的。其中包括作为筛查试验的酶联免疫吸附测定(ELISA)和作为确认试验的蛋白质印迹法(WB)。它们目前并非最佳有效方法,并且带来了一些问题,特别是在用于筛查低风险人群(如无症状献血者)时。目前用于检测HIV的经许可的ELISA检测方法的灵敏度在93%至99%之间,并且所有方法的特异性均大于99%。一个重要问题是,尽管ELISA筛查试验具有相当高的灵敏度和特异性值,但其阳性预测值却很低。这种较差的预测值是由于普通人群中感染HIV的个体患病率较低。已经确定了ELISA和蛋白质印迹试验出现假阳性的多种原因。通过使用由重组脱氧核糖核酸(DNA)产生的试剂抗原,可以消除这些原因。通过设计用于检测针对HIV的IgM抗体的试验,可以减少ELISA和蛋白质印迹试验的假阴性。

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引用本文的文献

1
Anti-HIV seroprevalence in California blood and plasma donors.加利福尼亚州血液及血浆捐献者中的抗艾滋病毒血清阳性率。
West J Med. 1988 Nov;149(5):620-2.
2
Sensitivity and specificity of pooled versus individual sera in a human immunodeficiency virus antibody prevalence study.一项人类免疫缺陷病毒抗体流行率研究中混合血清与个体血清的敏感性和特异性
J Clin Microbiol. 1989 Aug;27(8):1893-5. doi: 10.1128/jcm.27.8.1893-1895.1989.