Development and Commercialization of an Innovative Rapid HIV-1 Incidence Assay

DESCRIPTION (provided by applicant): The objective of this project is to develop a commercially viable point of care Rapid HIV-1 Incidence Assay and establish its suitability for determination of recency of HIV-1 infection in whole blood, plasma, serum specimens for epidemiological, research and surveillance purposes. It is further intended to determine the feasibility of the application of the assay to dried blood spot and oral fluid specimens. Potential development of the assay into a combined incidence/diagnostic assay including applicable regulatory submissions is not intended until Phase II of the project. Recent advances in development of accurate assays for distinguishing recent from long-term HIV infections have been limited to complex laboratory based assays. However, many resource constrained countries and laboratories need to be able to estimate HIV incidence rates in populations, but do not have ready access to full laboratory facilities. The proposed Rapid HIV-1 Incidence Assay, once establ