A Simple, Sensitive and Accurate HIV-1 Viral Load Test

简单、灵敏且准确的 HIV-1 病毒载量测试

• 批准号: 6746632
• 负责人: XING-XIANG LI
• 金额: $ 29.97万
• 依托单位: CELLEX, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-01 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6746632
• 关键词: AIDS; AIDS /HIV diagnosis; HIV infections; bioassay; biomarker; biomedical equipment development; clinical biomedical equipment; clinical research; diagnosis design /evaluation; diagnosis quality /standard; drug screening /evaluation; human immunodeficiency virus 1; human tissue; pathologic process; patient monitoring device; portable biomedical equipment; virus RNA; virus load

DESCRIPTION (provided by applicant): Monitoring HIV viral load, or the concentration of viral RNA in the plasma, is part of the standard care of HIV-infected individuals. Since HIV viral load is indicative of current virologic status, it is used as a marker for disease progression and anti-retroviral drug therapy efficacy. Two critical decisions in HIV/AIDS patient care are primarily based on HIV viral load measurements: when to initiate drug therapy and when to switch or adjust drug therapy regimen, as recommended in the "Guidelines for the use of Antiretroviral Agents in HIV-infected Adults and Adolescents". Although three HIV-1 viral load tests are commercially available in US, they are all complicated to operate and expensive to use. More importantly, these tests are inaccurate with coefficient of variation (CV) up to 100%. The poor performance characteristics for these tests reflect the limitation of the technologies, which involve multiple cycles of amplification steps to amplify the target (HIV-1 RNA) or signal in order to improve the sensitivity. The complex and expensive nature of these tests also limits their use mostly to the developed countries; few HIV infected patients in developing countries have access to viral load testing even if they have access to charitable sources of anti-retroviral drugs. We propose here to use our microparticle based amplification (MBA) technology to develop a simple, sensitive and accurate HIV-1 viral load test. Specifically, we will validate the MBA-based assay in terms of its (a) simplicity--three steps with total assay time of < 2.0 hours and labor time < 30 minutes; (b) sensitivity--better than 100 HIV-1 RNA copies, (c) accuracy--a coefficient of variation of < 50%, and (d) comparability with a FDA approved test--correlation of coefficient (R 2) >_0.9. A successful outcome of this Phase I study will lead to a Phase II study, during which we will demonstrate the assay performance in ctinical settings by testing large numbers of clinical samples. The successful outcome of Phase II study will lead to the commercialization of the test, which will give users a less expensive and more accurate alternative for HIV-1 viral load test.

描述(由申请人提供)：监测艾滋病毒病毒载量，或血浆中病毒RNA的浓度，是艾滋病毒感染者标准护理的一部分。由于HIV病毒载量是当前病毒学状态的指示器，因此它被用作疾病进展和抗逆转录病毒药物治疗效果的标志。艾滋病毒/艾滋病患者护理中的两个关键决定主要基于艾滋病毒病毒载量的测量：何时开始药物治疗以及何时切换或调整药物治疗方案，如《艾滋病毒感染成人和青少年抗逆转录病毒药物使用指南》所建议的那样。 虽然美国有三种HIV-1病毒载量检测方法可以在市场上买到，但操作起来都很复杂，使用起来也很昂贵。更重要的是，这些测试是不准确的，变异系数(CV)高达100%。这些测试的糟糕性能特征反映了这些技术的局限性，这些技术涉及多个周期的扩增步骤来放大目标(HIV-1RNA)或信号，以提高灵敏度。这些检测的复杂和昂贵的性质也限制了它们的使用，主要是在发达国家；发展中国家的艾滋病毒感染患者很少有机会接受病毒载量测试，即使他们可以获得抗逆转录病毒药物的慈善来源。 我们建议使用我们的基于微粒的扩增(MBA)技术来开发一种简单、敏感和准确的HIV-1病毒载量检测方法。具体地说，我们将从以下方面验证基于MBA的检测：(A)简单--总检测时间为2.0小时和分娩时间&lt；30分钟的三步法；(B)灵敏度--优于100个HIV-1RNA拷贝；(C)准确性--变异系数为50%；以及(D)与FDA批准的检测的可比性--相关系数(R2)和_0.9。 这项第一阶段研究的成功结果将导致第二阶段研究，在此期间，我们将通过测试大量临床样本来展示其在临床环境中的分析性能。第二阶段研究的成功结果将导致该测试的商业化，这将为用户提供一种成本更低、更准确的HIV-1病毒负载测试替代方案。