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

有必要开发可接受的、可用的关注点检测(POCT)来识别性传播 高危人群中的性病(STD)发病率很高。在美国，可报告的前10名中有5名 疾病是性传播疾病，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 保密问题使性病成为医疗机构POCT和非处方药(OTC)的最佳选择 化验在家里进行。我们将建立一个“关注点测试开发和测试中心” (POCT)针对性传播疾病，其核心将对POC设备进行内部临床测试，与 科学家和工程师在探索性技术开发项目上，完成临床需求 对性病医疗保健专业人员进行评估，为技术开发人员提供临床培训 与STD POCT有关的问题，并提供管理结构以确保我们的中心实现 它的目标。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 化验。我们在验证新的化验方面有丰富的经验。我们还将测试独特的方法 通过互联网向最终用户提供家庭非处方药检测，以及测量的新方法 初级保健环境中非处方药类型检测的可接受性和准确性。对于核心2，我们将提供赠款 为科学家开发新的分析方法，以及利用我们的分子和基础科学专业知识 中心的研究人员正在选择合适的应用程序。我们将确保核心3和4在 提供需求评估的综合方式，其结果将到达技术领域的科学家手中 社区，并指导他们开发在灵敏度方面有意义的分析方法 和特异性，并对公共卫生产生积极影响。对于Core 5，我们将提供有效的管理 复杂中心的结构，所有核心活动的集成，对成员的响应 希望访问该中心并为POCT提供行政服务的研究社区 中心。我们将实施五个相辅相成的核心，并与NIBIB中的其他中心合作 POCT研究网络，以促进从原型开发到内部试点测试的过渡， 通过确保这种分析的规格和资格具有足够的科学价值 未来的临床试验和FDA提交的。

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.