The objective of this project is to develop a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and establish its suitability fo determination of recency of HIV-1 infection. An accurate tool for distinguishing recent from long-term HIV infections is important in the determination of HIV incidence rates in populations, and may also be useful for providing tailored therapeutic, counseling and contact follow-up of individuals. The assay will be developed based on technology developed and licensed by the U.S. Centers for Disease Control (CDC). Upon completion of technology transfer from the CDC, Sedia will incorporate proprietary technology to develop a robust, stable, user-friendly assay. The project is of significant relevance to the CDC, as the CDC currently manages a national HIV/AIDS surveillance system that is the nation's source for timely information used to track the epidemic in the U.S. The CDC uses HIV recency data from that system to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay may be used as well by researchers, epidemiologists, other governmental and private public health organizations and vaccine trial program managers to understand and target the epidemic, as well as assess effectiveness of intervention programs. Sedia intends to collaborate with the CDC on this project by developing the assay according to CDC needs and specifications, and evaluate the resulting assay in cooperation with the CDC using archived cross-sectional serum specimens of known recency to determine the accuracy of the test, before expanding testing to multiple outside investors in Phase II of the project. PUBLIC HEALTH RELEVANCE: This project is for the development of a commercially viable single well HIV-1 Limiting Antigen Avidity EIA and to establish its suitability for determination o recency of HIV-1 infection. The CDC uses HIV recency data to make estimates of HIV incidence and track the epidemic, and is seeking to obtain more accurate data through the use of better assays, such as the HIV-1 Limiting Antigen Avidity EIA. The assay will be used to generate improved estimates of HIV incidence not only in the U.S., but in populations around the world.