人类免疫缺陷病毒抗体快速视觉读取筛查检测方法的现场测试与比较评估

Field testing and comparative evaluation of rapid, visually read screening assays for antibody to human immunodeficiency virus.

作者信息

Spielberg F, Kabeya C M, Ryder R W, Kifuani N K, Harris J, Bender T R, Heyward W L, Quinn T C

机构信息

Program for Appropriate Technology in Health, Seattle.

出版信息

Lancet. 1989 Mar 18;1(8638):580-4. doi: 10.1016/s0140-6736(89)91610-3.

DOI:10.1016/s0140-6736(89)91610-3

PMID:2564112

Abstract

Five rapid, visually read assays for detection of antibody against human immunodeficiency virus (HIV) were evaluated on fresh serum samples from 4000 prospective blood donors at Mama Yemo Hospital, Kinshasa, Zaïre. The sensitivity of the assays, based on 214 specimens positive by western blot, ranged from 84.6% to 99.1%. The specificity, based on 3664 samples negative by enzyme-linked immunosorbent assay (ELISA) or western blot, ranged from 92.7% to 98.8%. Three readers scored each test result independently; disagreement about test interpretation occurred in 1.2-8.3% of the specimens. There was no correlation between assay performance and assay principle (agglutination or dot immunobinding) or antigen source (viral lysate or recombinant). Assays such as these can be readily implemented in a developing country transfusion centre, where blood screening by ELISA is not practicable.

摘要

在扎伊尔金沙萨的耶莫妈妈医院，对4000名潜在献血者的新鲜血清样本进行了五项用于检测人类免疫缺陷病毒（HIV）抗体的快速、肉眼可读检测方法的评估。基于214份经蛋白质印迹法检测呈阳性的标本，这些检测方法的灵敏度范围为84.6%至99.1%。基于3664份经酶联免疫吸附测定（ELISA）或蛋白质印迹法检测呈阴性的样本，其特异性范围为92.7%至98.8%。三名阅片者分别独立对每个检测结果进行评分；1.2%至8.3%的标本在检测结果解读上存在分歧。检测性能与检测原理（凝集或斑点免疫结合）或抗原来源（病毒裂解物或重组体）之间没有相关性。此类检测方法可在发展中国家的输血中心轻松实施，在这些地方通过ELISA进行血液筛查并不可行。