# Clinical Core > **NIH NIH U54** · JOHNS HOPKINS UNIVERSITY · 2024 · $500,514 ## Abstract Clinical Core Project Summary The long-term goal of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases (JH-C[ID]2) is to accelerate infectious disease diagnostic point-of-care (POC) technology innovation and access to impact global public health. Diagnostic advances in vitro devices (IVD) during the COVID-19 pandemic have propelled development of point-of-care (POC) platforms for sexually transmitted infections (STI) and other emerging and re-emerging infectious diseases. The public has embraced self-testing and used it to assess their ‘status’ for SARS-CoV-2 infection. However, thoughtful evaluation of the performance and implementation of STI POC tests (POCT) is necessary to avoid losing the gains in patient care and public health provided by well-established, centralized testing within a healthcare setting. In order to responsibly accelerate the development of POC and at-home self-tests, companies need access to clinical expertise to refine use case and intended use so that POC tests are complementary and increase access to diagnostic certainty. Over the last 3 cycles of our POCTRN Center, developers have valued the JH-C[ID]2 resources including the availability of specific types of samples and sample formats to validate their technology at all stages of development. We have previously established clinical sites in diverse, ‘real-world’ settings where POCTs are the most impactful: emergency department (Johns Hopkins), ambulatory settings for adults (John G. Bartlett Specialty Practice, Baltimore City Health Department [BCHD]) and adolescents (Cincinnati Children’s Adolescent Clinic), pharmacies, and resource-limited settings (Infectious Diseases Institute (IDI), Kampala, Uganda). In this U54 cycle, we will be poised to perform pre-clinical pilots and iterative prospective evaluations of performance to identify IVD that can be successfully commercialized and adopted by the public, or that need further refinement or removal from the pipeline (go/no- go decisions). The Core’s experienced Investigators will verify diagnostic performance by evaluating the technology at Johns Hopkins, serve on the Clinical Review Committee to provide developers’ access to clinical expertise, enlarge the number of samples available for iterative development, and provide our clinical sites for pre-clinical pilots. The Clinical Core will: 1) evaluate the diagnostic performance of prototype POC devices for STIs and emerging and re-emerging infectious diseases in intended populations; 2) provide clinical and regulatory expertise through the Clinical Review Committee; and 3) evaluate acceptability and usability and end- users test experience and preference for POC tests as well as their feasibility within clinical workflows. As the oldest and well-established POCTRN Center, our model of POC test development support has led to the FDA clearance or emergency use authorization of numerous STI and COVID-19 in vitro devices. The JH-C[ID]2 is well-posit... ## Key facts - **NIH application ID:** 10928769 - **Project number:** 5U54EB007958-17 - **Recipient organization:** JOHNS HOPKINS UNIVERSITY - **Principal Investigator:** Matthew Hamill - **Activity code:** U54 (R01, R21, SBIR, etc.) - **Funding institute:** NIH - **Fiscal year:** 2024 - **Award amount:** $500,514 - **Award type:** 5 - **Project period:** 2007-09-11 → 2028-07-31 ## Primary source NIH RePORTER: https://reporter.nih.gov/project-details/10928769 ## Citation > US National Institutes of Health, RePORTER application 10928769, Clinical Core (5U54EB007958-17). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10928769. Licensed CC0. --- *[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*