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

描述(由申请人提供)： 有必要开发可接受的、可用的护理点检测(POCT)，以确定高危人群中的性传播疾病(STD)。在美国，前十大可报告疾病中有五种是性传播疾病，每年有1800万新的性传播疾病造成20亿美元的损失。耻辱、隐私和保密问题使性传播疾病成为医疗机构POCT和在家中进行非处方药(OTC)分析的最佳选择。我们将建立一个“性病护理点检测(POCT)开发和测试中心”，其核心将进行POC设备的内部临床测试，在探索性技术开发项目上与科学家和工程师合作，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与STD POCT相关的临床问题培训，并提供管理结构以确保我们中心实现其目标。对于核心1，我们将提供专家测试实验室设施，用于测试新开发的POCT分析。我们在验证新的化验方面有丰富的经验。我们还将测试通过互联网向最终用户提供家庭非处方药检测的独特方法，以及在初级保健环境中衡量非处方药类型检测的可接受性和准确性的新方法。对于Core 2，我们将为科学家提供资金，以开发新的分析方法，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4以一种综合的方式进行工作，以提供需求评估，其结果将到达技术界的科学家手中，并指导他们开发在敏感性和特异性方面有意义的分析方法，并对公众健康产生积极影响。对于核心5，我们将为一个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。我们将实施五个相辅相成的核心，并与NIBIB POCT研究网络中的其他中心合作，通过确保此类分析的规格和资格具有足以用于未来临床试验和FDA提交的科学价值，促进从原型开发到内部中试测试的过渡。

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.