AMHERST — A University of Massachusetts Amherst engineering professor has developed an at-home HIV test sensitive enough to rival — or exceed — results from standard laboratory testing, and has won a two-year, $1.3 million grant from the National Institutes of Health to move the technology toward commercial use.
Chang Liu, an associate professor in the Riccio College of Engineering, is working to close a persistent gap in HIV diagnosis that the World Health Organization still considers a major global health issue. While AIDS-related deaths have fallen sharply over four decades of medical advances, to about 630,000 a year globally, 1.3 million new infections still occur annually, according to WHO figures from 2024. In the U.S., more than 30,000 new transmissions are recorded each year despite the federal “Ending the HIV Epidemic” initiative.
A major obstacle, Liu said, is what public health officials call the “first 95” benchmark — a global goal of ensuring 95% of people living with HIV, or human immunodeficiency virus, know their status. Worldwide, only about 87% do, meaning an estimated 5.3 million people are unaware they’re infected. HIV attacks the cells that help the body fight off infections and is spread through passed along bodily fluids.
UMASS / Contributed
“This population serves as a silent reservoir of transmission,” Liu said. “This lack of awareness of HIV status is even more serious in resource-limited settings, such as rural areas within the U.S.”
Existing at-home HIV tests have helped expand access in areas with limited clinical resources, but they lag behind lab testing in sensitivity. Standard self-tests, which detect HIV antibodies, typically don’t return a positive result until about 25 days after infection. Lab-based PCR tests, which detect viral RNA, can identify infection in about 10 days but require specialized equipment and clinical settings, making them costly and inaccessible for at-home use.
A third method tests for proteins shed by the virus itself — namely, a protein called p24 — but has historically been considered too insensitive for early detection, typically taking about 20 days post-infection to yield results, and has been limited to clinical settings.
“I started [building the HIV test] in collaboration with Dr. Helmut Albrecht,” Liu said. “I learned from him that there is a need for accurate testing technologies for HIV at the point-of-care, such as self-testing or testing at front-line clinics.”
In his research, Liu explains that his HIV testing technology can detect the antigen that most tests tend to miss. The system — called the “Click Chemistry Amplified Nanopore,” or CAN — is a proprietary detection method that can sense, design and identify extremely low concentrations of the p24 protein, an early indicator of HIV infection.
In an initial validation study using real patient samples, the device detected p24 in 87.3% of patients with low viral loads, compared with 18.2% for ELISA, the antibody/antigen test commonly used in labs. Among patients with high viral loads, Liu’s device detected the protein in 100% of cases, compared with 42.1% for ELISA. Those results were achieved with a prototype about the size of a shoebox.
With the help of the NIH award, Liu’s technology will undergo tests on 300 patients at Prisma Health in South Carolina. Tests will also be conducted to decide the technology’s ability to track virus fluctuations in patients that are undergoing antiretroviral therapy, a combination of medications that aim to help treat HIV.
Liu will use the testing information to build a prototype, move on to commercializing the product and work toward meeting the “first 95” benchmark.
“With NIH’s support, we are going to validate the device together with Prisma Health to evaluate its performance in real-world scenarios,” Liu said.