Sunday, May 18, 2025
5/18/2025
Development of a robust HIV-1 diagnostic system (HIV-eCaDI) for at-home testing - Human immunodeficiency virus (HIV) is a highly contagious global pathogen that infects millions of individuals annually. Almost 38 million individuals worldwide are living with HIV, and approximately 62% with HIV are receiving antiretroviral therapy. Rapid, sensitive, and accurate detection of HIV infection is critical for controlling transmission and accurately prescribe antiviral treatment to patients. Laboratory-based detection of HIV genomes, antigens and specific antibodies in patient samples is commonly used detect acute HIV infection, but tends to be slow and require in-clinic sample collection. Rapid point-of-care diagnostic HIV assays are commercially available for Pre-Exposure Prophylaxis (PrEP) patients but are relatively insensitive and cannot detect early phase infections or directly detect viral particles to indicate an acute infection, increasing the chance of unknowingly transmitting HIV to their partners. Therefore, development of new types of low-cost at-home HIV diagnostics are urgently needed to improve HIV detection and help clinicians, public health departments, and individuals limit the spread of HIV. The goal of this application is to continue development of a novel electrochemical diagnostic system we call the HIV electrochemical Capillary-Driven Immunoassay (HIV-eCaDI) to selectively detect HIV-1 p24 antigen present in patient blood samples at limits of detection of 10 pg/ml in a simple, rapid, and inexpensive format that can be easily perform at home by individuals undergoing PrEP. HIV-eCaDI is a fundamentally different point-of-care system that integrates inexpensive automated unpowered microfluidic sample preparation with a highly sensitive and accurate electrochemical detection modality to provide robust diagnostics results that can rapidly provide critical data to physicians and public health departments. The heart of this system is our eCaDI system, a disposable hybrid paper/plastic-based electrochemical sensor unit we have developed that is designed to automate sample preparation and analyte detection in patient blood samples. The disposable eCaDI cartridge is integrated with an inexpensive custom onboard near field communication potentiostat that is powered and controlled by the user’s mobile phone, providing simple, robust, and user-friendly HIV monitoring and patient data management. The proposed HIV-eCaDI system leverages a number of different Colorado State University strengths (infectious diseases, electrochemistry, microfluidics platform development) with deidentified clinical samples from Columbia University Medical Center towards development and validation of a single fully integrated and highly adaptable system to rapidly detect HIV infection early that will save lives and help HIV positive individuals maintain quality of life.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).