Development of a simple, rapid and affordable HIV RNA test for early diagnosisof HIV-infection in infants and for antiviral therapy monitoring in resource-limited settings. (360G-Wellcome-077645_Z_05_Z)

Recent initiatives such as that of the World Health Organisation to provide 3 million HIV-infected individuals with antiretroviral therapy (ART) by 20051 will increase the availability of HIV treatment in developing countries. Such large-scale treatment projects will also require diagnostics and a means to monitor treatment to be fully effective. In the developed world, measurement of HIV load is standard for diagnosis and monitoring of HIV-infected individuals. Currently available HIV load assays are unsuitable for resource-limited settings because they are complex, time-consuming and require expensive instruments and test kits as well as cold-chain shipment and storage of reagents. The availability of a simple and robust test for the determination of HIV load will be crucial for the successful implementation of HIV treatment in the developing world.The objective of this project is to develop a simple and rapid HIV RNA assay designed specifically to assist health care workers in developing countries both with the early diagnosis of HIV infection, particularly in neonates, and for HIV therapy monitoring when appropriate quantitation standards are included. The proposed assays will be based on visual detection of isothermally amplified HIV RNA by dipstick. Rather than reporting absolute quantification of viral RNA, the assay will give readout of clinically relevant thresholds.