Highly Sensitive HIV Viral Load Assay for Point-of-Care Settings

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PROJECT SUMMARY: More than 36.7 million people are living with AIDS as reported by World Health Organization (WHO) recently. HIV caused over 35 million deaths so far. The epidemic continues to grow with nearly 2.1 million new cases of HIV in 2015 including over 47,000 new cases of HIV infection in US. Currently, only 34% of HIV infected people are getting antiretroviral therapy (ART) treatment in developing world despite ART being affordable or even freely available. The fundamental challenges to reduce HIV burden and its prevalence include the lack of point-of-care assays for viral load in rural areas having limited access to basic laboratory infrastructure and trained technicians. In developed countries, HIV-1 viral load is regularly used to closely monitor and assess the patient response to ART, to ensure drug adherence and to stage disease progression. In contrast, developing countries are using CD4+ T lymphocyte count and clinical symptoms to guide ART following the WHO guidelines with the exception of infants, where viral load assays are required. However, studies have shown that CD4+ T cell counting strategy cannot detect early virological failure which leads to accumulation of drug-resistant strains in infected individuals and reduces ART efficacy. Thus, a rapid, inexpensive, disposable, and simple viral load test is urgently needed. Current viral load technologies are based on the quantification of HIV-1 RNA, p24 antigen, and reverse transcriptase activity. These HIV-1 viral load assays are expensive ($50-200 per test), and technically complex, thus requiring trained technicians to run the assays. Here, we will use our expertise in microchip fabrication, microfluidics, surface functionalization, lensless imaging, and biosensing to create a disposable HIV-1 viral load chip that can (i) selectively capture HIV from whole blood/plasma, (ii) be highly sensitive (can detect <1000 viral copies/mL), inexpensive (~$1), and rapid (within 45 minutes), (iii) can handle small volume of plasma/whole blood (1mL) and (iv) be highly stable (refrigeration free) to aid in HIV quantification and treatment at POC settings. We envision that the proposed technology will aid in rapid viral load quantification benefiting millions of patients around the world. !