Our group has robust infrastructure and a clinical research pipeline for evaluating the performance of serologic tests and nucleic acid amplification POC HIV tests from proof-of-concept through prototype pre-clinical testing to FDA-approvable clinical studies of performance against laboratory-based gold- standard comparators. We will expand existing biorepositories of well-characterized and curated participants that we will enroll prospectively for our evaluation studies. We will store remnant samples for future use in evaluating HIV assay prototypes to inform development. Located in a CDC designated hotspot, Baltimore, we have large clinical populations of people living with HIV (PLWH) and well-characterized longitudinal cohorts of high-risk patients. We also have extensive experience with needs assessments and use case-based implementation of novel POC diagnostic tests with consideration of provider workflows in diverse settings such as the Emergency Department. This holistic, value-based approach is needed to maximize future access and adoption of new tests and test methods which will be needed to decrease HIV incidence and improve public health.