UMass Amherst engineer Chang Liu is advancing a home HIV diagnostic that aims to match or surpass laboratory sensitivity during the earliest phase of infection. With support from a two-year, $1.3 million National Institutes of Health award, his team is moving a promising prototype toward real-world usability and eventual commercialization.
Early diagnosis is central to meeting the “first 95” goal—ensuring that 95% of people living with HIV know their status. Although global AIDS-related deaths have fallen over the past decades, new infections persist. A key challenge remains the large population unaware of their infection, particularly in areas where access to advanced testing is limited.
Current at-home self-tests primarily detect HIV antibodies, but they typically become positive weeks after exposure—about 25 days in early studies. By contrast, nucleic-acid approaches such as PCR can identify HIV roughly 10 days after infection by measuring viral RNA, yet they require clinic-based workflows, sophisticated instrumentation, and higher cost.
Liu’s strategy targets a different biological signal: the p24 antigen, a protein shed by HIV. Antigen-based tests have historically been considered insufficiently sensitive, often needing closer to 20 days post-infection and typically being run in clinical settings. The project tackles that perceived bottleneck with a new detection mechanism designed for extreme sensitivity without complex preprocessing.
The core innovation combines click chemistry with nanopore sensing, referred to as Click Chemistry Amplified Nanopore (CAN) sensing. The method leverages the ability of target proteins to be detected under conditions that do not demand the intensive sample preparation characteristic of PCR workflows.
In Liu’s earlier validation using real patients, CAN sensing detected p24 in 87.3% of individuals with low viral load, compared with 18.2% detection by ELISA, and reached 100% detection in high viral load cases where ELISA detected 42.1%. The prototype used in that study was about the size of a shoebox.
This NIH-funded phase focuses on transforming proof-of-concept hardware into a self-testing platform. The team will refine the device design and conduct clinical validation with 300 patients in South Carolina through Prisma Health, under the guidance of Helmut Albrecht, medical director of an infectious diseases research center.
Beyond initial screening, the study will also evaluate how the test performs for tracking antigen level changes in patients undergoing antiretroviral therapy. Ultimately, the program targets creation of a spinoff startup to move the technology from lab development to public health impact.
Subject of Research: At-home HIV diagnostics; p24 antigen detection; nanopore sensing; click chemistry
Article Title: At-Home, Lab-Quality HIV Tests Awarded $1.3 Million for Development at UMass Amherst
Web References: https://www.nature.com/articles/s41467-022-34273-x
References: “first test” validation article in Nature Communications (as linked above)
Image Credits: UMass Amherst
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