Research Project
6746632
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.
