A Multiplexed Point-of-Care Assay for the Detection of Enteric Pathogens that Cause Severe Diarrhea in Deployed Soldiers

The objective of this study is to develop a robust, field-grade, screening assay for the detection of severe diarrheal disease-causing pathogens including E. coli O157, Salmonella spp., Shigella spp., Cryptosporidium spp., Campylobacter spp., Noroviruses, and Rotaviruses. The test will utilize lateral flow (dipstick) chromatography incorporated into a unique, multiplex cassette that enables the simultaneous screening of multiple analytes. The proposed immunochromatographic assay would be a very useful rapid screening test to assess individuals presenting with diarrhea of likely infectious etiology. In this Phase 1 study we shall evaluate the ability of a panel of antibodies, with specificity for the families of enteric pathogens listed above, to function as the basis of an antigen-capture detection system. We will then construct prototype assays that will be evaluated against samples from individuals with confirmed infections. Further development of the assay would take place in a Phase 2 proposal.