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, economical, field-grade, screening assay for the detection of severe diarrhea-causing pathogens including Salmonella spp., E. coli O157, Shigella spp., Cryptosporidium spp., Campylobacter spp., Noroviruses and Rotaviruses. The test will utilize lateral flow (dipstick) chromatography incorporated into a unique, multiplex cassette that will enable 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 II study we will continue the preliminary development work started in the Phase I feasibility investigation. Specifically we will: (1) continue to identify produce, evaluate and optimize the target antigens from the above panel of pathogens in lateral flow systems; (2) as necessary, identify complementary target antigens for each disease category for added sensitivity and specificity; (3) design and development sample preparatory and lateral flow platforms for each assay and combine into a multiplex device; and (5) evaluate the clinical sensitivity and specificity of the test using fecal specimens from confirmed infected, or control individuals.