ZAMBART Project, University of Zambia, Nationalist Road, Ridgeway, Lusaka, Zambia.
BMC Infect Dis. 2012 Aug 8;12:183. doi: 10.1186/1471-2334-12-183.
Zambia's national HIV testing algorithm specifies use of two rapid blood based antibody assays, DetermineHIV-1/2 (Inverness Medical) and if positive then Uni-Gold Recombigen HIV-1/2 (Trinity Biotech). Little is known about the performance of oral fluid based HIV testing in Zambia. The aims of this study are two-fold: 1) to compare the diagnostic accuracy (sensitivity and specificity) under field conditions of the OraQuick ADVANCE Rapid HIV-1/2 (OraSure Technologies, Inc.) to two blood-based rapid antibody tests currently in use in the Zambia National Algorithm, and 2) to perform a cost analysis of large-scale field testing employing the OraQuick.
This was a operational retrospective research of HIV testing and questionnaire data collected in 2010 as part of the ZAMSTAR (Zambia South Africa TB and AIDS reduction) study. Randomly sampled individuals in twelve communities were tested consecutively with OraQuick test using oral fluid versus two blood-based rapid HIV tests, Determine and Uni-Gold. A cost analysis of four algorithms from health systems perspective were performed: 1) Determine and if positive, then Uni-Gold (Determine/Uni-Gold); based on current algorithm, 2) Determine and if positive, then OraQuick (Determine/OraQuick), 3) OraQuick and if positive, then Determine (OraQuick/Determine), 4) OraQuick and if positive, then Uni-Gold (OraQuick/Uni-Gold). This information was then used to construct a model using a hypothetical population of 5,000 persons with varying prevalence of HIV infection from 1-30%.
4,458 participants received both a Determine and OraQuick test. The sensitivity and specificity of the OraQuick test were 98.7 (95%CI, 97.5-99.4) and 99.8 (95%CI, 99.6-99.9), respectively when compared to HIV positive serostatus. The average unit costs per algorithm were US$3.76, US$4.03, US$7.35, and US$7.67 for Determine/Uni-Gold, Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold, respectively, for an HIV prevalence of 15%.
An alternative HIV testing algorithm could include OraQuick test which had a high sensitivity and specificity. The current Determine/Uni-Gold testing algorithm is the least expensive when compared to Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold in the Zambian setting. From our field experience, oral fluid based testing offers many advantages over blood-based testing, especially with self testing on the horizon.
赞比亚国家艾滋病毒检测算法指定使用两种快速血液抗体检测，即 DetermineHIV-1/2（Inverness Medical），如果呈阳性，则使用 Uni-Gold Recombigen HIV-1/2（Trinity Biotech）。关于赞比亚口腔液艾滋病毒检测的性能知之甚少。本研究的目的有两个：1）在野外条件下，比较 OraQuick ADVANCE 快速艾滋病毒 1/2（OraSure Technologies，Inc.）与目前在赞比亚国家算法中使用的两种血液快速抗体检测的诊断准确性（灵敏度和特异性），2）对使用 OraQuick 进行大规模现场测试进行成本分析。
这是一项关于 HIV 检测的回顾性研究，数据来自 2010 年作为 ZAMSTAR（赞比亚南非结核病和艾滋病减少）研究的一部分收集的问卷调查。从 12 个社区中随机抽取的个体连续使用口腔液 OraQuick 测试与两种血液快速 HIV 测试（Determine 和 Uni-Gold）进行测试。从卫生系统的角度对四种算法进行成本分析：1）使用当前算法的 Determine 和阳性，则使用 Uni-Gold（Determine/Uni-Gold），2）使用当前算法的 Determine 和阳性，则使用 OraQuick（Determine/OraQuick），3）OraQuick 和阳性，则使用 Determine（OraQuick/Determine），4）OraQuick 和阳性，则使用 Uni-Gold（OraQuick/Uni-Gold）。然后，根据不同的 HIV 感染率（1-30%），利用 5000 名假设人群的信息构建了一个模型。
共有 4458 名参与者同时接受了 Determine 和 OraQuick 检测。当与 HIV 阳性血清状态相比时，OraQuick 检测的灵敏度和特异性分别为 98.7（95%CI，97.5-99.4）和 99.8（95%CI，99.6-99.9）。对于 HIV 流行率为 15%的情况下，四种算法的平均单位成本分别为 3.76 美元、4.03 美元、7.35 美元和 7.67 美元，分别为 Determine/Uni-Gold、Determine/OraQuick、OraQuick/Determine 和 OraQuick/Uni-Gold。
一种替代的艾滋病毒检测算法可以包括 OraQuick 检测，该检测具有很高的灵敏度和特异性。在赞比亚，与 Determine/OraQuick、OraQuick/Determine 和 OraQuick/Uni-Gold 相比，当前的 Determine/Uni-Gold 检测算法是最便宜的。根据我们的现场经验，与血液检测相比，口腔液检测具有许多优势，尤其是在自我检测即将出现的情况下。
