SBIR-STTR Award

Preventing HIV infection is a global and national priority, and a number of behavioral, vaccine-based, and drug-based strategies are the focus of intensive research. In order to accurately assess and compare different prevention strategies, HIV incidence, i.e., the rate at which new HIV infection is acquired in a population, needs to be measured accurately. The objective of this project is the development of a portable and cost-effective fully automated diagnostic test for classification of HIV infection into recent (last 4-12 months) or long-standing. The test will be based on MSD's MULTI-ARRAY Point-Of-Care platform. In Phase I, we will compare several assay formats, including that semi-quantitatively measure levels and avidity of antibodies against multiple HIV proteins. We will multiplex up to 12 antigens. The test will require less than 20 ul of plasma, and time to result will be less than one hour. Our plan for Phase II is to expand and fine-tune the panel by including additional antigens, to perform an analytical verification of the final assay format, and to develop and validate an algorithm to discriminate recent from long-standing HIV infection.