In the developing world, many people with health problems never receive an accurate diagnosis or appropriate treatment because clinicians lack tools to detect and diagnose diseases and conditions quickly, accurately, and inexpensively. Sophisticated medical tests that could help improve care are not only often unaffordable, they require extensive laboratory facilities and deliver results days later – a hardship for people who may live many miles from the nearest health clinic. Advances in a number of scientific disciplines, coupled with new miniaturization technologies, are creating possibilities for the development of diagnostic tests that could be used at point-of-care to accurately detect and diagnose many health problems. 

Dr. Kelso's team is developing rapid, affordable, point-of-care systems for both immuno and molecular tests. The project's objective is to design low-cost delivery platforms that can perform assays in resource-poor settings.

In the exploratory phase, investigators are using HIV as the model for both immuno and molecular test platforms. The molecular diagnostic test device will be based on real-time polymerase chain reaction (PCR), with reagents dispensed into disposable cartridges that will not require refrigeration. Investigators envision that the cartridges would be inserted into a small, table-top instrument, and whole blood samples would be added. The system would extract and purify RNA targets before they are amplified and detected. This device may be especially useful for screening infants and monitoring patients receiving antiretroviral drugs. The immunodiagnostic system will be based on lateral flow technology. Researchers are investigating new labels as well as a hand-held reader that together could result in sensitivities approaching those of clinical analyzers. This system potentially could be used to aid in early detection for people recently infected who are antibody negative but antigen positive, and also might be used for screening and monitoring.

Investigators are working to develop molecular and immuno platforms simultaneously, while also conducting market research in southern and eastern Africa to help guide their designs. During the project's early months, the team managed the transfer of Abbott Molecular's real-time HIV assay and investigators began work to adapt it to resource-poor settings. Work on the immunodiagnostic platform has focused on labeling and detection methods.