Rekhviashvili Natela, Stevens Wendy, Marinda Edmore, Gonin René, Stevens Gwynneth, McIntyre James, Wood Robin
Department of Molecular Medicine and Hematology, National Health Laboratory Service (NHLS), University of the Witwatersrand (WITS), Faculty of Health Science, Medical School, 7 York Road, Parktown, Johannesburg 2193, South Africa.
J Virol Methods. 2007 Dec;146(1-2):14-21. doi: 10.1016/j.jviromet.2007.05.024. Epub 2007 Jul 12.
The South African National Antiretroviral Treatment Guideline recommends the use of HIV viral load assays for routine monitoring of HIV-1 positive patients on Highly Active Antiretroviral Therapy (HAART). Approved commercial HIV-1 viral load assays are expensive for developing countries where a large number of patients are treated in the public sector. The evaluation of an in-house HIV-1 viral load assay (LUX assay) is described using 458 plasma specimens. Good specificity of the LUX assay was demonstrated using 50 seronegative plasma specimens. A group of 142 HIV-1 positive patients was used to assess the agreement between the LUX assay and the COBAS Amplicor assay. An intra class correlation (ICC) coefficient of 0.85 (CI 95%) indicated good agreement between the assays. The Bland-Altman model showed good agreement between the assays for approximately 87% of the results (mean 0.03 [-1.26; 1.32], CI 95%). In a cohort of 55 patients followed-up longitudinally the LUX assay showed similar declines in viral load to the COBAS Amplicor assay in response to therapy. Viral rebound was detected in 5 patients out of 55 by both assays. Thus, the LUX assay compares well to the gold standard and represents an affordable alternative for high volume testing in resource limited settings.
《南非国家抗逆转录病毒治疗指南》建议，对于接受高效抗逆转录病毒疗法（HAART）的HIV-1阳性患者，使用HIV病毒载量检测进行常规监测。对于在公共部门治疗大量患者的发展中国家而言，获批的商用HIV-1病毒载量检测成本高昂。本文描述了使用458份血浆标本对一种内部HIV-1病毒载量检测方法（LUX检测法）进行的评估。使用50份血清阴性血浆标本证明了LUX检测法具有良好的特异性。一组142名HIV-1阳性患者被用于评估LUX检测法与COBAS Amplicor检测法之间的一致性。组内相关系数（ICC）为0.85（95%置信区间），表明两种检测方法之间具有良好的一致性。Bland-Altman模型显示，约87%的结果在两种检测方法之间具有良好的一致性（均值0.03 [-1.26；1.32]，95%置信区间）。在对55名患者进行纵向随访的队列中，LUX检测法显示，在治疗反应方面，病毒载量下降情况与COBAS Amplicor检测法相似。两种检测方法均在55名患者中的5名患者身上检测到病毒反弹。因此，LUX检测法与金标准相比效果良好，是资源有限环境下进行大量检测的一种经济实惠的替代方法。
