JHU-Clin Trans Valid

总结 性传播感染（STI）的护理点（POC）诊断可以对公共卫生产生积极影响， 医疗保健系统和患者相关的结果。具有长周转时间的基于检验的STI诊断测试 时间仍然是高资源环境中的护理标准;诊断通常在患者 离开诊所，损害了提供者确保治疗和中断传播的能力。病征 管理仍然是低资源环境和紧急情况下STI治疗的护理标准 部门和紧急护理环境，导致高比例的过度和治疗不足， 症状尽管有一些新的POC STI测试与功能原型，开发人员面临着重大的 商业化的障碍，包括有限的患者样本检测和适当的 临床护理环境进行性能测试。从最终用户那里获得原型和早期设计的反馈 对于评估实际测试以加速采用也至关重要。了解POC STI测试如何 整合到临床工作流程中，在不中断护理的情况下提供及时的诊断， 通过允许同一次就诊的诊断确定性和有针对性的治疗来预防性传播感染。执行方面的具体障碍 包括缺乏关于新测试在不同环境中的性能特征的数据，以及缺乏提供者 了解POC STI测试。我们已经开发了方法和工具来评估POCT对性病的效果， POC测试在不同环境中的终端用户中的可接受性和可用性。临床的工作 翻译和验证核心将由三个核心目标指导：1）评估诊断准确性， 原型POC设备用于STI诊断的可用性和可接受性，2）描述和评价 对性传播疾病实施POCT，包括最终用户对偏好、可接受性、可用性和 测试经验我们还将评估对患者和伴侣健康、行为和福祉的影响， 以及对医疗服务和/或公共卫生结果的影响，以及3）制定可持续的， 可供开发人员和最终用户搜索的STI诊断观察数据库。我们的中心允许开发人员在所有 开发管道的各个阶段，以实现一站式购物;从早期的迭代测试， 我们精心策划的生物储存库，在不同的环境中进行临床试验，包括城市急诊室， 一个青少年流动诊所，在乌干达的一个低资源环境，并通过互联网访问与自我采样。 我们将根据每个站点的最终用户需求来实现特定站点的目标。临床翻译 和验证核心将加速新的POC STI测试的开发，这将是准确和快速的 领养的

Summary Point of care (POC) diagnosis of sexually transmitted infections (STIs) can positively impact public health, the healthcare system and patient-related outcomes. Laboratory-based STI diagnostic tests with long turn-around times remain the standard of care in high-resource settings; the diagnosis often returns after the patient has left the clinic compromising the provider's ability to ensure treatment and interrupt transmission. Syndromic management continues to be the standard of care for STI treatment in low-resource settings and in emergency departments and urgent care settings which leads to high rates of over and under treatment for those with symptoms. Despite a number of new POC STI tests with functional prototypes, developers face significant barriers to commercialization, which include limited access to patient samples for testing and appropriate clinical care settings for performance testing. Getting feedback from end-users on prototypes and early designs is also critical for evaluating tests in practice to accelerate adoption. Understanding how POC STI tests can be integrated into clinical work flow to provide timely diagnosis without disrupting care could transform care for STIs by allowing same-visit diagnostic certainty and targeted treatment. Specific barriers to implementation include lack of data regarding performance characteristics of new tests in diverse settings and lack of provider awareness of POC STI tests. We have developed methods and tools to evaluate POCT for STDs performance, acceptability and usability of POC tests among end-users in diverse settings. The work of the Clinical Translation and Validation Core will be guided by three Core aims: 1) To evaluate diagnostic accuracy, usability and acceptability of prototype POC devices for STI diagnosis, 2) To describe and evaluate implementation of POCT for STDs including end-users' assessment of preference, acceptability, usability, and test experience. We will also assess the impact on patient and partners' health, behaviors and well-being as well as the impact on healthcare delivery and/or public health outcomes, and 3) Develop a sustainable, searchable STI Diagnostic Watch database for developers and end-users. Our Center allows developers at all stages of the development pipeline to have one-stop shopping; from early iterative testing with samples from our well-curated biorepository, to clinical testing in diverse settings including an urban emergency department, an adolescent ambulatory clinic, a low-resource setting in Uganda, and by internet access with self-sampling. We will address site-specific aims based on end-user needs particular to each site. This Clinical Translation and Validation Core will accelerate development of new POC STI tests that will be accurate and rapidly adopted.