A novel diagnostic tool to aid vaccine evaluation and surveillance of enterotoxigenic E. coli and Shigella

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Project Summary Enterotoxigenic Escherichia coli (ETEC) and Shigella (ES) are the leading causes of moderate-to-severe diarrhea among children < 5 years of age in impoverished areas of the world. Recurrence of infection results in death, stunting, impaired cognitive development and long-term disability. Due to the huge impact of ES in children, vaccine development has been prioritized and accelerated in recent years. As promising vaccine candidates for ES move toward field trials in endemic areas, an improved understanding of the epidemiology of ES and identify the hotspots of these diseases are critical to plan Phase 3 trials and to assess the potential benefits of vaccine use. A critical constraint is the complex diagnostic methods currently required for detecting ES infections. These methods are neither sufficiently sensitive nor standardized and are not feasible in resource poor settings (RPS) where these infections are endemic. Therefore, the country-specific burden of ES is not readily available. Consequently regional public health officials and policy makers lack a clear appreciation of the impact that ES have on child health in their countries. Therefore, a diagnostic method which is sensitive, rapid and feasible for RPS is critically important and urgently required. Our recent work suggests that a direct detection from stool method LAMPES, is simple, easy to use and rapid. With limited training, we anticipate it can be carried out in basic laboratories and fields. Here we propose to evaluate the performance of our novel assay LAMPES and compare with the existing detection methods for ES using stool samples from children with and without diarrhea in an endemic setting, Kolkata, India. Given, this assay is rapid, sensitive, specific, easy to use, mostly equipment and electricity free, easy to scale up we believe LAMPES is an ideal tool to fill the gap in vaccine evaluation and ES disease surveillance in the endemic countries.