A pilot study to assess the performance of a rapid ultrasound particle agglutination method for the detection of HIV antibodies.
A pilot study to assess the performance of a rapid ultrasound particle agglutination method for the detection of HIV antibodies.
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DOI：
10.1080/15321819.2021.1981376
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发表时间：
2022-03-04
影响因子：
--
通讯作者：
Ossina N
中科院分区：
文献类型：
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作者：
Bystryak S;Bandwar RP;Ossina N
抗 HIV 抗体筛查和确证试验包括灵敏度有限的快速诊断试验 (RDT)，以及费力且需要熟练技术的高灵敏度 ELISA 和蛋白质印迹试验。因此，对新型快速、简单且高度灵敏的测试的需求尚未得到满足。进行了一项初步研究，以评估最近开发的超声颗粒凝集 (UPA) 方法的性能，该方法用于高灵敏度 HIV 抗体检测，使用 51 个确诊阳性和 310 个推测阴性血浆样本以及 6 个市售抗 HIV-1 血清转化小组（总共 56 名成员）。 UPA 方法的最佳截止值是通过受试者操作特征 (ROC) 分析确定的，临床敏感性和特异性分别为 100% 和 98.1%。与一些使用 HIV 血清转化组的已建立的 RDT 和 ELISA 测试相比，UPA 的性能特征显示，HIV 抗体检测比其他 RDT 和第二代 ELISA 早 2 天，并且与第三代 ELISA 大约在同一时间。 UPA 方法性能特征的初步分析表明，它满足 WHO 指南关于 RDT 作为一线检测的最低要求。这项试点研究为临床实践中用于 HIV 抗体检测的 UPA 方法进行更详细的验证研究铺平了道路。
Anti-HIV antibody screening and confirmatory tests include rapid diagnostics tests (RDT), which have limited sensitivity, and high sensitivity ELISA and western blot tests which are laborious and require technical proficiency. Thus, there is an unmet need for novel rapid, simple, and highly sensitive tests. A pilot study was conducted to assess the performance of a recently developed ultrasound particle agglutination (UPA) method for high sensitivity HIV antibody detection using 51 confirmed positive and 310 presumably negative plasma samples, and 6 commercially available anti-HIV-1 seroconversion panels (total 56 members). Optimal cut-off value of the UPA method was determined by receiver operating characteristics (ROC) analysis providing clinical sensitivity and specificity of 100% and 98.1%, respectively. The performance characteristics of UPA, compared with those of some established RDT’s and ELISA tests using HIV seroconversion panels, showed 2 days earlier HIV antibody detection than other RDT’s and 2nd generation ELISA, and at approximately the same time as 3rd generation ELISA. The preliminary analysis of the UPA method performance characteristics showed that it meets minimum requirements of the WHO guidelines for RDTs as first-line assays. This pilot study paves the way for more detailed validation studies of the UPA method for HIV antibody detection in clinical practice.