RADXHIV VIRAL LOAD

ABSTRACT The Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases (JH-CIDID) aims to accelerate the development of point-of-care HIV viral load in vitro devices using the Rapid Acceleration of Diagnostics Technology (RADx Tech) model. We are requesting some supplemental funds to cover time for staff and faculty salaries needed for the extended time period and tailored work scope for each HIV point-of-care viral load platform to be evaluated. This cost extension will support three HIV point-of-care viral load assays where individualized assessments were collaboratively developed with the companies that are appropriate for their stage of development and tailored to their platforms to accelerate the attainment of critical milestones to derisk these promising assays. Differences in the technical approach and platform maturity required more individualized work plans and IRB amendments than was originally anticipated. In vitro devices are independently evaluated by JH-CIDID through benchtop evaluations to test diagnostic performance with blinded panels for performance, userability, hands-on time, and turnaround time. Key technical challenges are communicated to developers through written feedback. Those with acceptable benchtop performance will undergo prospective pre-clinical testing with fresh blood and iteratively improve to accelerate development and derisk expensive clinical trials for regulatory approval. 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. Our group is ideally placed to leverage existing infrastructure and expertise in clinical point-of-care diagnostic evaluation, deep HIV clinical and laboratory expertise, and a variety of accredited labs for gold-standard testing.