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确认抗HIV反应性的另一种方法:一项多国合作研究。

An alternative approach to confirming anti-HIV reactivity: a multi-country collaborative study.

作者信息

Mortimer J

机构信息

PHLS Communicable Disease Surveillance Centre, London, England.

出版信息

Bull World Health Organ. 1992;70(6):751-6.

PMID:1486672
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2393407/
Abstract

The confirmation of positive screening assay reactions for antibodies to human immunodeficiency virus type 1 (anti-HIV-1) by Western blot is expensive and often gives indeterminate results. We therefore carried out a collaborative study to investigate the confirmation of screening assay reactions using a second screening assay. For this purpose, seven laboratories prospectively tested sequential specimens, using at least one additional screening assay, until about 50 confirmed anti-HIV-1-positive specimens had been identified in each test centre. The reactions of 16 assays were analysed in pairs (assay A and assay B), using assay B on specimens reactive in assay A: A+/B+ reactions were considered positive and A-, negative anti-HIV results. These outcomes were compared with those obtained using confirmatory Western blot. In all, 7950 specimens were tested, and 359 were reported as positive by the laboratories. Within the test centres, eight screening assay pairings gave rise to no false-positive or false-negative results, and these combinations were at least as accurate as a single screening assay followed by Western blot. From 6.3% to 8.3% of the Western blot results were indeterminate. The number of specimens examined was too small to justify recommending for general use named pairs of screening assays; the choice of these would, in any case, depend on local conditions. However, individual laboratory managers may wish to investigate the large potential savings to be made by confirming HIV infection using a second screening assay on initially reactive specimens. If the more sensitive screening assay is used first, the sensitivity of this approach may be improved by further investigation of specimens that react as A+B-.

摘要

通过蛋白质印迹法确认针对1型人类免疫缺陷病毒抗体(抗HIV-1)的筛查试验阳性反应成本高昂,且常常得出不确定的结果。因此,我们开展了一项合作研究,以调查使用第二种筛查试验来确认筛查试验反应的情况。为此,七个实验室对连续的标本进行前瞻性检测,使用至少一种额外的筛查试验,直到每个检测中心识别出约50例经确认的抗HIV-1阳性标本。对16种检测方法的反应进行成对分析(检测方法A和检测方法B),对在检测方法A中呈反应性的标本使用检测方法B:A+/B+反应被视为阳性,A-反应则为抗HIV结果阴性。将这些结果与使用确证性蛋白质印迹法获得的结果进行比较。总共检测了7950份标本,各实验室报告了359份为阳性。在各检测中心内,八种筛查检测方法配对未产生假阳性或假阴性结果,并且这些组合至少与单一筛查试验后再进行蛋白质印迹法一样准确。蛋白质印迹法结果中有6.3%至8.3%为不确定结果。所检查的标本数量太少,不足以推荐特定的筛查检测方法组合供普遍使用;无论如何,这些组合的选择将取决于当地情况。然而,个别实验室管理人员可能希望研究通过对最初呈反应性的标本使用第二种筛查试验来确认HIV感染能实现的巨大潜在节省。如果首先使用更敏感的筛查试验,通过进一步调查呈A+B-反应的标本,这种方法的敏感性可能会提高。

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本文引用的文献

1
Evaluation of enzyme-linked immunosorbent assays: a method of data analysis.酶联免疫吸附测定的评估:一种数据分析方法。
J Virol Methods. 1988 Oct;22(1):51-9. doi: 10.1016/0166-0934(88)90087-0.
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Field testing and comparative evaluation of rapid, visually read screening assays for antibody to human immunodeficiency virus.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
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Evaluation of a human immunodeficiency virus test algorithm utilizing a recombinant protein enzyme immunoassay.利用重组蛋白酶免疫测定法对人类免疫缺陷病毒检测算法的评估
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Performance and cost-effectiveness of a dual rapid assay system for screening and confirmation of human immunodeficiency virus type 1 seropositivity.一种用于筛查和确认人类免疫缺陷病毒1型血清阳性的双重快速检测系统的性能和成本效益。
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5
Simplified and less expensive confirmatory HIV testing.简化且成本更低的HIV确证检测。
Bull World Health Organ. 1991;69(6):747-52.