Rapid and Simple Paper Diagnostic Test to Detect Enteric Pathogens in the Developing World

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Project Summary According to the World Health Organization, there are 1.7 billion cases of gastroenteritis every year and approximately 1.5 million children deaths. Diarrheal disease is the second leading cause of death in children under five years of age, mostly in the developing world. A wide-range of bacterial, viral, and parasitic pathogens can cause disease, with co-infections being common in low income countries with high disease burden. Clinical determination of therapy in resource- limited healthcare settings is frequently performed without etiological knowledge. As a result, antibiotics are overprescribed and poorly targeted, and infections caused by pathogens with high mortality rates may not be given adequate quality of care. Diagnostic testing for these pathogens is inconsistent because detection of these common pathogens traditionally requires transporting patients or patient samples, possibly over long distances, to a limited number of diagnostic laboratories, and then performing multiple tests across microbiology, virology, and molecular laboratories. Results may not be available for several days during which patients’ conditions may deteriorate without appropriate treatment. The rapid identification of pathogens that cause infectious diarrheal disease at the point-of-care may save lives and improve health outcomes by enabling prompt and appropriate treatment. Potential users in the developing world could include tertiary clinics in rural areas or urban low-income populations with low health care utilization and national public health field officers who investigate outbreaks. The goal of our project is to determine the feasibility of developing an innovative paper strip test that can integrate the steps of low cost, simple stool sample preparation and concentration method using hollow silica microspheres for total nucleic acid capture with multiplexed nucleic acid amplification and detection on a paper strip device. We will test 600 stool samples from patients enrolled in an ongoing study of GI disease in low-income neighborhoods of Bangladesh where the prevalence of infection by pathogens like Cholera, Salmonella, Shigella, Campylobacter is high. Success in this project can have broad impact in the development of other simple, point- of-care differential detection tests for pathogens causing other diseases in other sample types.