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

描述（由申请人提供）：监测HIV病毒载量，或血浆中病毒RNA的浓度，是HIV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，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载量测量：何时开始药物治疗以及何时切换或调整药物治疗方案，这是《感染艾滋病毒的成人和青少年使用抗逆转录病毒药物指南》所建议的。

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.