Project Summary The Johns Hopkins Center for Point-of-Care Technologies Research for STDs aims to accelerate the development of over-the-counter HIV self-tests as well as HIV viral load point-of-care in vitro devices using the Rapid Acceleration of Diagnostics Technology (RADx Tech) model. This RADx Tech program was developed to address the COVID-19 pandemic and the emerging and urgent need to increase the number of tests available to Americans to know their status and diagnose infection either as OTC self-tests or POC in vitro devices. This hybrid approach with increased central laboratory testing moved the infectious diseases testing paradigm toward point-of-need. The HIV epidemic is now in its 4th decade. The critical role of diagnostics in identifying people living with HIV and linking them to treatment or prevention has been highlighted by the United Nations Programme on HIV/AIDS. We propose to select, fund, and support HIV POC IVD as well as self-tests to accelerate the attainment of critical milestones to derisk promising IVD. We will create a laboratory verification core to test general diagnostic performance of devices against a spiked plasma panel and to perform desktop evaluations with blinded panels for performance, userability, hands-on time, and turnaround time. We will provide companies with clinical use case consultation through the Clinical Review Committee, as well as prospective pre-clinical pilot testing when appropriate. Our group is ideally placed to leverage existing infrastructure and expertise in clinical POC diagnostic evaluation, deep HIV clinical and laboratory expertise, and a variety of CAP accredited labs for gold-standard testing.