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).

Grant Number: 5R33AI154643-05
NIH Institute/Center: NIH
Principal Investigator: Waseem Asghar