Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases

描述（由申请人提供）： 开发可接受的、可用的用于在高危人群中识别性传播疾病（STD）的护理点测试（POCT）的必要性非常重要。在美国，前10大可报告疾病中有5种是性病，每年有超过1800万例新的性病，花费超过20亿美元。耻辱感、隐私和保密问题使得性病最适合在医疗机构进行POCT和在家中进行非处方（OTC）检测。我们将与Cores一起建立一个“用于开发和测试用于STD的床旁检测（POCT）的中心”，该中心将对POC设备进行内部临床测试，与科学家和工程师合作进行探索性技术开发项目，完成STD医疗保健专业人员的临床需求评估，为技术开发人员提供有关STD POCT临床问题的培训，并提供一个行政结构，以确保我们的中心实现其目标。对于核心1，我们将提供专业的测试实验室设施，用于测试新开发的POCT检测。我们在验证新检测方法方面拥有丰富的经验。我们还将测试通过互联网向最终用户提供家庭OTC检测的独特方法，以及在初级保健环境中测量OTC类型检测的可接受性和准确性的新方法。对于核心2，我们将为科学家提供赠款，以开发新的检测方法，并利用我们中心研究人员的分子和基础科学专业知识来选择适当的应用。我们将确保核心3和核心4以综合方式工作，以提供需求评估，其结果将传达给技术界的科学家，并指导他们开发在灵敏度和特异性方面有意义的检测方法，并对公共卫生产生积极影响。对于核心5，我们将为复杂的中心提供有效的管理结构，整合所有核心活动，响应希望访问中心的研究社区成员，并为POCT中心提供行政服务。我们将实施五个相互补充的核心，并与NIBIB POCT研究网络中的其他中心合作，通过确保此类检测试剂盒的质量标准和资格具有足够的科学价值以用于未来的临床试验和FDA申报，促进从原型开发到内部试点测试的过渡。

DESCRIPTION (provided by applicant): The need to develop acceptable, available Point-of-Care-Tests (POCT) for identifying Sexually Transmitted diseases (STDs) in at-risk populations is significant. In the United States, 5 of the top 10 reportable diseases are STDs and, per year, there are >18 million new STDs that cost >$2 billion. Stigma, privacy, and confidentiality 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 with scientists and engineers on exploratory technology development projects, complete a clinical needs assessment among STD healthcare professionals, provide training to technology developers on clinical issues pertaining to STD POCT, and provide an administrative structure to ensure that our Center achieves its goals. For Core 1, we will provide expert testing laboratory facilities for testing newly developed POCT assays. We have extensive experience validating new assays. We will also test unique methods of home-delivering OTC assays to end users, via the Internet, as well as novel approaches for measuring acceptability and accuracy of OTC-type assays in primary care settings. For Core 2, we will provide grants to scientists to develop new assays, as well as utilize the molecular and basic scientific expertise of our Center's investigators in selecting appropriate applications. We will insure that Cores 3 and 4 work in an integrated fashion to provide the needs assessment, results of which will reach scientists in the technology community and instruct them toward developing assays that will be meaningful, with regard to sensitivity and specificity, and positively influence public health. For Core 5, we will provide an effective management structure for a complex Center, the integration of all Core activities, responsiveness to members of the research community wishing to access the Center, and provide administrative services to the POCT Center. We will implement five Cores that complement each other and work with other Centers in the NIBIB POCT 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 for future clinical trials and FDA submission.