Home Cellular science FAU wins $1.3m grant to develop rapid, automated HIV self-test

FAU wins $1.3m grant to develop rapid, automated HIV self-test


In 2020, 37.7 million people worldwide were living with HIV and 680,000 people died of AIDS-related illnesses last year. Since the start of the epidemic, more than 36.3 million people have died of AIDS-related illnesses.

Although antiretroviral therapy is effective in saving the lives of AIDS patients, the implementation of therapy worldwide has been significantly hampered by the lack of diagnostics for monitoring treatment and disease management. According to recent statistics from USAIDs, coverage of antiretroviral therapy is still only 59%, despite being affordable or available free of charge in most countries. In addition, around the world, about 1 in 4 people who have contracted the virus do not know their HIV status.

Florida Atlantic University’s College of Engineering and Computer Science, in collaboration with FAU’s Schmidt College of Medicine, received a three-year, $1.3 million grant from the National Institutes of Health (NIH) to an automated HIV self-test. An additional $1.3 million will potentially be awarded after a programmatic review of progress in Phase I.

With this grant, researchers are developing an affordable, disposable HIV-1 self-test chip that can selectively detect HIV from whole blood samples, be highly sensitive in detecting HIV during acute infection, treatment, and viral rebound; be quick within 40 minutes; very stable without the need for refrigeration; and fully automated providing true sample capability in response.

“The biggest challenge to reducing HIV in developing countries with limited resources is the absence of self-testing tests for viral load and the lack of trained technicians as well as modern laboratory infrastructure”, said Waseem Asghar, senior researcher and associate professor at FAU. “Currently, there is no reliable technology that can detect HIV in the early stages of infection or measure viral rebound in antiretroviral therapy in treated patients as a self-test.”

One of the fundamental challenges to reducing the burden of HIV and its prevalence is the lack of self-testing tests sensitive enough to detect new HIV infections within the first two weeks, i.e. the acute phase, post-infection and viral rebound in patients with suppressed viral load receiving antiretroviral therapy. Current self-testing technologies only detect the host antibody response to HIV infection, which typically occurs three to four weeks after initial infection and is not an indicator of treatment failure and viral rebound.

Asghar is developing this technology with co-investigator Massimo Caputi, a professor of biomedical sciences at FAU, who has expertise in the molecular biology of HIV-1 and the regulatory mechanisms of cell and viral splicing. Caputi has made important contributions to understanding how cellular proteins modulate HIV-1 genome replication.

The new technology uses an innovative microfluidic design integrated with molecular amplification that enables HIV testing without the need for skilled technicians to operate, making it suitable for self-testing format in developing countries as well as in developed nations. The researchers plan to validate the operation of the microchip with blood/plasma samples from more than 200 HIV-infected subjects.

“No molecular HIV self-testing technology has yet been commercialized that is capable of detecting HIV during the early stages of acute infection or viral rebound in patients on antiretroviral therapy and there is an urgent need to develop reliable and affordable HIV self-testing technologies.” said Stella Batalama, Dean of the College of Engineering and Computer Science. “The technology developed by Professors Asghar and Caputi and our colleagues will be a game-changer to help increase access to HIV testing and improve treatment outcomes.”

Republished with kind permission from FAU. Photo: Sandhya Sharma, Ph.D. student in the Department of Electrical and Computer Engineering at FAU and research assistant in Asghar’s lab works with Waseem Asghar, Ph.D. Credit: Alex Dolce, Florida Atlantic University