The Discharge Syndromes: Concordance and Interactions Study (DiSCIS) application from UAB is responsible for supporting each of the three projects in the application. The overall goal of the Laboratory Core is to facilitate the work being performed within each of the individual projects and importantly to also move the field of STI diagnostics forward in a manner that is directly translatable to improved epidemiologic and clinical capacity in a variety of settings. The Laboratory Core has many years of experience serving as a clinical trial site for studies of new diagnostics and treatment trials and as such has state of the art platforms on hand that facilitate all testing described by each of the projects. Further, the Core Director, Dr. Barbara Van Der Pol has extensive experience developing new assays and adapting existing ones in order to expand the capacity of the laboratory to support novel research strategies. The existing expertise of the UAB Infectious Diseases Laboratory has positioned us perfectly to achieve our goal. The three aims of the Laboratory Core are: 1) to provide data using bio-samples from cohort participants in support of all 3 projects by performing molecular diagnostic assays for known STI's and generating data describing the microbial communities in urogenital and extra-genital samples; 2) to create and maintain a bio- repository of longitudinal samples in optimal storage conditions for potential culture, molecular, immunological and serological assays; and, 3) to develop new diagnostic assays for organisms identified in Projects 1 and 2 as associated with negative outcomes. The DiSCIS Laboratory Core will provide: all clinical sample collection materials, including collection and handling protocols; kits for home collection which will also include detailed instructions for participants; personnel to receive, log and aliquot all samples in order to maximize performance of all laboratory procedures; molecular diagnostics using commercially available platforms as well as laboratory developed assays; sample prep for microbiome analyses; and bio-repository services to create a resource for future research efforts. Performing all assays which are shared by 2 or more of the projects in a single laboratory will ensure efficiency, standardization and cost-savings by ensuring training and adherence to protocols and allowing volume-based reagent price reductions. Use of a single laboratory for management of a bio-repository is essential to creating a shared resource that can be effectively maintained and regulated. The archived samples will be available to researchers in this project, new investigators and scientists from other institutions.
