Field evaluation of alternative testing strategies for the detection of HIV infection in Beijing.

Biomedical and environmental sciences : BES Pub Date : 2007-08-01

Fa-Xin Hei, Yan Jiang, Wei-Dong Sun, Qi-Yun Zhang, Qin Zhang, Jing-Rong Ye, Hai-Lin Liu, Hong-Yan Lu, Xiong He

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Abstract

Objective: To identify a cost-efficient alternative antibody testing strategy for screening and confirmation of HIV infection by rapid simple tests (RSTs) and enzyme-linked immunosorbent assays (ELISAs).

Methods: Four RSTs (RST1, RST2, RST3, and RST4) and five ELISAs (ELISA1, ELISA2, ELISA3, ELISA4, and ELISA5) were evaluated in two phases by using banked and serum specimens prospectively collected at regional hospitals and voluntary counseling and testing (VCT) centers in Beijing. A total of 200 banked serum specimens were included in the first phase, including 62 HIV-positive, 127 HIV-negative and 11 indeterminate specimens. All specimens were tested by four RSTs and five ELISAs respectively. The second phase involved prospective testing of 389 routine specimens, including 92 HIV-positive, 287 HIV-negative, and 10 indeterminate specimens. All the specimens were tested by two RSTs (RST2 and RST4) and three ELISAs (ELISA1, ELISA3, and ELISA4), which were selected for their respective excellent sensitivity and/or specificity. Western blot (WB) was used as a gold standard for confirming the reactivity of all the specimens.

Results: Sensitivity, specificity, and efficacy were calculated for each assay in two phases. In the first phase, four assays (ELISA4, RST2, RST3, and RST4) had a specificity of 100%. For the determination of efficacy, ELISA4, RST2, and RST4 were selected in the second phase. ELISA1 and ELISA3 which have a sensitivity of 95.9% and 93.2% respectively also entered this phase. In the second phase, all the five assays (ELISA1, ELISA3, ELISA4, RST2, and RST4) had a sensitivity and specifity of over 90%. ELISA1 had a sensitivity of 99% and ELISA4 a specificity of 99%.

Conclusion: The sensitivity ELISA1 and the specificit of ELISA4 are comparable to ELISA/WB standard strategy. Application of this alternative testing strategy provides a cost-effective method for determining HIV prevalence in Beijing.

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北京地区HIV感染检测替代检测策略的现场评价。

目的:通过快速简单试验(RSTs)和酶联免疫吸附试验(elisa)，确定一种经济有效的替代抗体检测策略，用于筛查和确认HIV感染。方法:采用北京地区医院和自愿咨询检测中心前瞻性采集的血清标本，分两阶段对4种rst (RST1、RST2、RST3、RST4)和5种elisa (ELISA1、ELISA2、ELISA3、elis4、elis5)进行评价。第一阶段共纳入200份血清标本，其中62份hiv阳性，127份hiv阴性，11份不确定。所有标本分别采用4种RSTs和5种elisa检测。第二阶段涉及对389例常规标本进行前瞻性检测，包括92例hiv阳性，287例hiv阴性和10例不确定标本。所有标本均采用两种rst (RST2和RST4)和三种elisa (ELISA1、ELISA3和elis4a)进行检测，选择这三种elisa因其各自具有优异的灵敏度和/或特异性。Western blot (WB)作为确认所有标本反应性的金标准。结果:计算了两期检测的灵敏度、特异性和有效性。在第一阶段，四项检测(ELISA4、RST2、RST3和RST4)的特异性为100%。为了确定疗效，第二期选择了ELISA4、RST2和RST4。灵敏度分别为95.9%和93.2%的ELISA1和elis3也进入该阶段。在第二阶段，5种检测方法(ELISA1、ELISA3、ELISA4、RST2和RST4)的敏感性和特异性均超过90%。ELISA1的敏感性为99%，ELISA1的特异性为99%。结论:ELISA1的敏感性和特异性与ELISA/WB标准策略相当。这种替代检测策略的应用为确定北京地区的艾滋病毒流行情况提供了一种经济有效的方法。

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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