Burke D S, Brundage J F, Redfield R R, Damato J J, Schable C A, Putman P, Visintine R, Kim H I
Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, D.C. 20307-5100.
N Engl J Med. 1988 Oct 13;319(15):961-4. doi: 10.1056/NEJM198810133191501.
In a program screening civilian applicants for U.S. military service for human immunodeficiency virus (HIV) infection, we studied the frequency of false positive diagnoses retrospectively among applicants seropositive for HIV in a subpopulation with a very low prevalence of infection. That subpopulation was defined as consisting of all applicants tested between October 16, 1985, and June 30, 1987, who were young (17 or 18 years of age) and resided in a rural county in a state with a low incidence of reported acquired immunodeficiency syndrome (n = 135,187). Serum specimens from 15 applicants positive for HIV in this low-prevalence subpopulation were retrieved from a serum bank and retested by two Western blot methods, radioimmunoprecipitation, and an immunoassay constructed from a molecularly cloned and expressed viral envelope polypeptide. Fourteen of the 15 samples were unequivocally positive on all retest assays, and 1 was negative. Thus, the measured rate of false positive diagnoses in this program was 1 in 135,187 persons tested. Factors important in achieving a low false positive rate were redundant, multistep testing algorithm, conservative criteria for interpreting Western blots, the requirement that a second, newly drawn serum specimen be tested for verification before a diagnosis of HIV was considered established, and tight quality control of laboratory testing procedures. We conclude that a screening program for HIV infection in a low-prevalence population can have an acceptably low false positive rate.
在一项针对美国军队文职申请人进行人类免疫缺陷病毒（HIV）感染筛查的项目中，我们对感染率极低的亚人群中HIV血清反应阳性申请人的假阳性诊断频率进行了回顾性研究。该亚人群定义为1985年10月16日至1987年6月30日期间接受检测的所有申请人，他们年龄较小（17或18岁），居住在一个获得性免疫缺陷综合征报告发病率较低的州的农村县（n = 135,187）。从血清库中检索出该低感染率亚人群中15名HIV阳性申请人的血清样本，并通过两种蛋白质印迹法、放射免疫沉淀法以及一种由分子克隆和表达的病毒包膜多肽构建的免疫测定法进行重新检测。15个样本中的14个在所有重新检测中均明确为阳性，1个为阴性。因此，该项目中测得的假阳性诊断率为每135,187名受检者中有1例。实现低假阳性率的重要因素包括冗余的多步骤检测算法、解释蛋白质印迹的保守标准、在考虑确立HIV诊断之前要求对新采集的第二份血清样本进行检测以进行验证，以及对实验室检测程序的严格质量控制。我们得出结论，在低感染率人群中进行HIV感染筛查项目可以有一个可接受的低假阳性率。
