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As of the end of 2023, approximately 40 million people globally were living with HIV, and around 630,000 individuals died from AIDS-related illnesses that same year. Despite a substantial decline in deaths from previous years, AIDS-related deaths continue to represent a critical global health concern. While antiretroviral therapy (ART) has significantly increased life expectancy for people living with HIV, the lack of effective diagnostic tools and disease management strategies has hindered widespread implementation. Only 59% of those in need have access to ART, and approximately one in four individuals with HIV remain unaware of their status. Moreover, people on ART who maintain uninterrupted treatment might experience viral rebound between viral load tests, staying unaware of treatment failure and remaining potentially infectious for weeks or even months.

One of the key challenges in managing HIV is the absence of self-testing technologies capable of detecting new infections during the early acute phase (the first two weeks after infection) or identifying viral rebound in patients on ART. To date, no self-test has been developed to detect HIV during the acute phase or viral rebound in patients with suppressed viral loads on ART. In response to the pressing need for a rapid, affordable, and reliable self-test for early HIV detection, researchers at Florida Atlantic University (Boca Raton, FL, USA), in collaboration with other experts, are developing an innovative disposable microchip technology for HIV-1 self-testing. This technology would detect HIV within the first two weeks post-infection and monitor viral rebound in ART-suppressed patients. Additionally, the technology could be adapted for use in detecting other infectious diseases such as flaviviruses, hepatitis, tuberculosis, malaria, and SARS-CoV-2.

Unlike current HIV tests, which can be expensive, the new technology is expected to cost less than USD 5 per test. Present HIV testing methods, such as PCR-based assays, are costly, requiring expensive lab equipment, skilled technicians, and reagents, making them unsuitable for self-testing. Although miniaturized versions exist, they tend to be labor-intensive, and other tests are costly, require refrigeration, and have long turnaround times. Moreover, rapid tests that detect HIV antibodies are ineffective for early detection since antibodies typically appear three to four weeks after infection. Drawing on expertise in microchip fabrication, microfluidics, isothermal amplification, imaging, and microelectronics, the research team is working on an HIV-1 self-testing chip that can selectively detect HIV in whole blood samples.

The assay being developed will enable early detection of HIV during the acute infection phase or viral rebound, provide rapid results, and remain stable without the need for refrigeration. This handheld device will be battery-powered and fully automated, providing true "sample-in-answer-out" functionality with minimal user involvement. After loading the blood sample into the magnetic actuation platform, results will be available within 40 minutes, a substantial improvement over conventional assays that take several hours and require clinical lab infrastructure.

“Development of this novel self-testing technology is a game changer because it addresses a fundamental gap in HIV detection and management, particularly in impoverished areas where access to health care is limited,” said Stella Batalama, Ph.D., dean of the College of Engineering and Computer Science. “By developing an affordable, easy-to-use self-testing platform, we can empower individuals to detect HIV early, reduce transmission and improve treatment outcomes. This innovation has the potential to save countless lives, offering hope to those who otherwise might not have access to timely care, ultimately helping to curb the global HIV epidemic.” 

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