At-Home, Lab-Quality HIV Tests Awarded $1.3 Million for Development at UMass Amherst
In early studies, the prototype detected cases of HIV not caught by lab tests
AMHERST, Mass. — Chang Liu , associate professor in the Riccio College of Engineering at the University of Massachusetts Amherst, wants people to have access to at-home HIV tests sensitive enough for early diagnosis comparable to—or exceeding—lab standards. A new two-year, $1.3 million award from the National Institutes of Health will help him advance his proof-of-concept work toward commercialization.
With 40 years of intervention, AIDS-related mortality has significantly declined to approximately 630,000 deaths per year globally. Despite this progress, 1.3 million new infections occur annually. In the U.S., the “Ending the HIV Epidemic” initiative has made strides, but there are still more than 30,000 new transmissions yearly.
A major bottleneck in progressing further is meeting the “first 95” benchmark: aiming for 95% of people living with HIV to know their status. Globally, 87% of people know their status, meaning that roughly 5.3 million individuals are unaware of their infection.
“This population serves as a silent reservoir of transmission,” says Liu, primary investigator of this research. “This lack of awareness of the HIV status is even more serious in resource-limited settings, such as rural areas within the U.S.”
One of the primary barriers to meeting the “first 95” is access to diagnostic technology. Existing home self-tests have made some headway in these diagnostic deserts, but they are less sensitive than in-lab tests, showing a positive result about 25 days after infection. These tests measure for HIV antibodies. PCR tests that measure viral RNA can detect HIV about 10 days after infection—but can only be conducted in a clinic or hospital setting, require advanced equipment to prepare and run, and are much more expensive.
There is a third type of HIV test that measures for proteins shed by the HIV virus (namely p24 antigen). Historically, these tests have been deemed too insensitive for early detection—taking closer to 20 days post-infection to yield a positive response—and are administered in a clinic or hospital setting. But where others saw a technological barrier, Liu saw an opportunity: Proteins do not require the same kind of pre-processing to be detected as PCR tests do.
Designing a proprietary mechanism called Click Chemistry Amplified Nanopore (CAN) sensing, Liu and colleagues invented a device capable of detecting extremely low concentrations of the p24 antigen. In Liu’s first test validating this device with real patients, it detected p24 in 87.3% of patients with low viral load, where ELISA only detects 18.2%, and 100% in patients with high viral load, where ELISA only detects 42.1%. These results were met with a prototype about the size of a shoebox.
Phase one of this NIH-supported work demonstrated the technology’s feasibility. This new grant for phase two supports the development of their prototype to make it ready for commercialization. This includes refining the prototype design and clinically validating it for self-testing use with 300 patients at Prisma Health in South Carolina, with Helmut Albrecht, medical director of the Center of Infectious Diseases Research and Policy at Prisma Health and the University of South Carolina.
“The device should be very easy for them to operate, even if they have limited education or no technical background,” says Liu. In addition to the initial screening, this new phase will also evaluate the device’s ability to track antigen fluctuations in patients undergoing antiretroviral therapy.
Ultimately, the grant’s target outcome is to create a spinoff startup to bring this technology from the lab to the public.