Development of an automated HIV self-testing assay

Project Summary Although antiretroviral therapy (ART) is effective in saving AIDS patients' lives, the implementation of ART worldwide has been drastically hampered by the lack of treatment monitoring diagnostics and disease management. According to the recent statistics by USAIDS, the coverage of ART is still only 59%, despite ART being affordable or freely available in most countries. In addition, worldwide, about 1 in 4 of the people that contracted the virus are unaware of their HIV status. One of the fundamental challenges to reduce HIV burden and its prevalence is the absence of HIV self-testing assays which are sensitive enough to detect new HIV infections during the first two-weeks (acute phase) post-infection and viral rebound in virally supressed patients receiving ART. Current self-testing technologies only detect the host antibody response to HIV infection, which usually arises 3-4 weeks after the initial infection and it is not an indicator of therapy failure and viral rebound. No self-testing technologies have yet been commercialized that are able to detect HIV during the early stages of acute infection or viral rebound in suppressed patients on ART. To increase access to HIV testing and to improve treatment outcomes, there is an urgent need to develop reliable and affordable HIV self-testing technologies. To address these challenges, we propose to develop a disposable self-testing HIV-1 chip that can (i) selectively detect HIV from whole blood samples, (ii) be highly sensitive to detect HIV during the acute infection, treatment and viral rebound (<1000 copies/ml), (iii) be rapid (within 40 minutes), (iv) be highly stable (refrigeration-free), and (v) be fully automated (true sample-in-answer- out).