CDC scientists have developed a device for simultaneous rapid diagnosis of HIV infection and for identification of recent HIV-1 infection. The device utilizes immunochromatographic or flow-through principles to detect HIV antibodies within clinical samples. This device may be used for diagnosis of HIV infection, as well as to distinguish between recent infection (6 months) and long-term infection (>1 year). This latter application has added significance for surveillance, counseling, partner notification and other related prevention concerns, including the estimation of HIV incidence in cross-sectional populations. The device, if formatted as a self-contained kit, would utilize a single platform containing all required reagents, making it simple and easy for use by minimally trained technicians. The entire testing process, including the determination of incident infections, has been designed to minimize assay processing time. This device has potential as an important tool for regional incidence measurements, which can aid targeting of prevention activities and allocation of resources by HIV/AIDS prevention programs, as well as serve as an indicator of the effectiveness of intervention strategies.