Comparative field evaluation of HIV rapid diagnostic assays using serum, urine, and oral mucosal transudate specimens

Clinical and diagnostic virology Pub Date : 1997-02-01 DOI:10.1016/S0928-0197(96)00261-9

David R. Tribble , Guénaël R. Rodier , Magdy D. Saad , Gérard Binson , Fabrice Marrot , Said Salah , Chakib Omar , Ray R. Arthur

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引用次数: 10

Abstract

Background: Comparative field utility of selected HIV-1 assays using homologous collections of serum, urine and oral mucosal transudate (OMT) was determined in adult populations from a tuberculosis hospital and STD clinic in Djibouti, East Africa.

Study design: Enzyme immunoassay with confirmatory Western blot was performed on all serum specimens for comparison with rapid, instrument-free assays (SUDS HIV-1, Murex; TestPack Abbott; and COMBAIDS HIV 1 + 2, SPAN Diagnostics) using various specimen sources. Delayed (48 h post-collection) testing was also performed on urine. Sensitivity and specificity for the rapid assays, in descending order, were as follows: serum SUDS HIV-1 assay (100%, 98.3%), serum COMBAIDS assay (98.4%, 99.6%), and OMT SUDS HIV-1 assay (98.4%, 94.5%).

Results: The OMT EIA optical density cutoff value was modified resulting in an improved specificity from 89.1 to 99.6%; however, sensitivity decreased from 100 to 98.5%. Urine EIA and rapid assays demonstrated unacceptable test performance for use as a screening test.

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使用血清、尿液和口腔粘膜渗出标本进行HIV快速诊断试验的现场比较评价

背景:在东非吉布提的一家结核病医院和性病诊所的成年人群中，使用同源收集的血清、尿液和口腔粘膜漏出物(OMT)对选定的HIV-1检测方法进行了比较。研究设计:对所有血清标本进行酶免疫分析和验证性Western blot，与快速、无仪器检测(SUDS HIV-1, Murex;TestPack艾伯特;COMBAIDS HIV 1 + 2, SPAN Diagnostics)使用各种标本来源。尿液延迟(采集后48小时)检测。快速检测的灵敏度和特异性由高到低依次为:血清SUDS HIV-1检测(100%，98.3%)、血清COMBAIDS检测(98.4%，99.6%)和OMT SUDS HIV-1检测(98.4%，94.5%)。结果:修改了OMT EIA光密度截止值，特异性从89.1提高到99.6%;然而，灵敏度从100下降到98.5%。尿液环境影响评估和快速分析表明，作为筛选试验的测试性能是不可接受的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Clinical and diagnostic virology

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