The goal of this contract is to develop a Rapid HIV point-of-care Diagnostic Device for resource-limited settings. The diagnostic technology must demonstrate feasibility for use in resource-limited settings and in POC clinics without the use of supporting laboratory equipment such as centrifuges, vortexes or pipettes. In addition, if proposed testing requires processing of patient samples for downstream applications, the processing must be self-contained and require limited sample manipulation and safe containment of potentially infectious material. The output should be in a visual format, without ambiguity, and include a full process negative and internal positive control.