The need to develop acceptable, available Point-of-Care-Tests (POCT) for identifying Sexually TransmittedDiseases (STDs) in at-risk populations is significant. In the United States, 5 of the top 10 reportablediseases are STDs and, per year, there are >18 million new STDs that cost >$2 billion. Stigma, privacy, andconfidentiality issues make STDs optimal for POCT at healthcare facilities and for over-the-counter (OTC)assays performed at home. We will develop a 'Center for Developing and Testing of Point of Care Tests(POCT) for STDs' with Cores that will conduct in-house clinical testing of POC devices, collaborate withscientists and engineers on exploratory technology development projects, complete a clinical needsassessment among STD healthcare professionals, provide training to technology developers on clinicalissues pertaining to STD POCT, and provide an administrative structure to ensure that our Center achievesits goals. For Core 1, we will provide expert testing laboratory facilities for testing newly developed POCTassays. We have extensive experience validating new assays. We will also test unique methods ofhome-delivering OTC assays to end users, via the Internet, as well as novel approaches for measuringacceptability and accuracy of OTC-type assays in primary care settings. For Core 2, we will provide grantsto scientists to develop new assays, as well as utilize the molecular and basic scientific expertise of ourCenter's investigators in selecting appropriate applications. We will insure that Cores 3 and 4 work in anintegrated fashion to provide the'needs assessment, results of which will reach scientists in the technologycommunity and instruct them toward developing assays that will be meaningful, with regard to sensitivityand specificity, and positively influence public health. For Core 5, we will provide an effective managementstructure for a complex Center, the integration of all Core activities, responsiveness to members of theresearch community wishing to access the Center, and provide administrative services to the POCTCenter. We will implement five Cores that complement each other and work with other Centers in the NIBIBPOCT Research Network to facilitate transitions from prototype development through in-house pilot testing,by ensuring that such assays' specifications and qualifications have scientific merit that is sufficient forfuture clinical trials and FDA submission.
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