Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care
Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care
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DOI：
10.1016/j.jviromet.2017.03.001
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发表时间：
2017-06-01
影响因子：
3.1
通讯作者：
Lee, Helen
中科院分区：
文献类型：
--
作者：
Goel, Neha;Ritchie, Allyson V.;Lee, Helen
尽管在资源贫乏的国家，艾滋病毒感染的抗逆转录病毒治疗的机会正在增加，但用于监测治疗效果的病毒载量测试仍然有限、昂贵，而且局限于中央实验室。Samba HIV-1半Q检测是一种基于核酸的扩增分析，用于监测实验室使用的半自动Samba I系统或用于护理点使用的全自动Samba II系统上的病毒载量。我们已经根据欧共体98/79体外诊断医疗器械指令的通用技术规范评估了Samba HIV-1半Q测试在Samba I和Samba II系统上的性能特征。在Samba I和Samba II平台上，该测试的敏感性、特异性、重复性和病毒亚型覆盖率相似。Samba I系统的临床性能与罗氏CAP/CTM检测进行了比较，并在伦敦的130个患者样本以及肯尼亚和津巴布韦的390个样本的现场进行了评估。Samba法与CAP/CTM法的总符合率为98.1%。在Samba II平台上进行的临床性能测试与雅培HIV-1实时检测进行了内部评估，获得了98.0%的符合率。因此，结果表明，Samba HIV-1半定量检测在Samba I和Samba II上的表现相同，并表明该测试适合在资源匮乏地区的护理点实施，这些地区迫切需要病毒载量检测，但往往无法获得。(C)2017爱思唯尔B.V.保留所有权利。
Although access to antiretroviral therapy for HIV infection is increasing in resource-poor countries, viral load testing for monitoring of treatment efficacy remains limited, expensive, and confined to centralized laboratories. The SAMBA HIV-1 Semi-Q Test is a nucleic acid-based amplification assay developed for viral load monitoring performed on either the semi-automated SAMBA I system for laboratory use or the fully automated SAMBA II system for point-of care use. We have assessed the performance characteristics of the SAMBA HIV-1 Semi-Q Test on SAMBA I and SAMBA II systems according to the Common Technical Specifications of the European Community's 98/79 In Vitro Diagnostic Medical Devices Directive. The sensitivity, specificity, reproducibility, and viral subtype coverage of the test were similar on the SAMBA I and SAMBA II platforms. The clinical performance on the SAMBA I system was compared with the Roche CAP/CTM assay and evaluated in-house with 130 patient specimens from London as well as in the field with 390 specimens in Kenya and Zimbabwe. The overall concordance between the SAMBA and CAP/CTM assays was 98.1%. The clinical performance of the test on the SAMBA II platform in comparison with the Abbott HIV-1 RealTime Assay was evaluated in-house with 150 specimens from Ukraine, yielding a concordance of 98.0%. The results thus show that the SAMBA HIV-1 Semi-QTest performs equivalently on SAMBA I and SAMBA II, and they suggest that the test is suitable for implementation at the point-of-care in resource-poor regions where viral load testing is desperately needed but often unavailable. (C) 2017 Elsevier B.V. All rights reserved.