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

性传播疾病护理点技术研究中心

• 批准号: 8105397
• 负责人: CHARLOTTE Ann GAYDOS
• 金额: $ 60.94万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8105397
• 关键词: Accident and Emergency department; Archives; Basic Science; Bedside Testings; Biological Assay; Care Technology Points; Chlamydia trachomatis; Clinic; Clinical; Clinical Microbiology; Clinical Trials; Collection; Communities; Complement; Complex; Confidentiality; Cost of Illness; Development; Devices; Diagnostic; Diagnostic tests; Disease; Engineering; Ensure; Fluorescent Antibody Technique; Freezing; Future; Goals; Gold; Grant; Health Personnel; Health Professional; Health care facility; Home environment; Housing; Human immunodeficiency virus test; Internet; Laboratories; Laboratory Diagnosis; Licensing; Mails; Measures; Methods; Molecular; Mycoplasma genitalium; National Institute of Biomedical Imaging and Bioengineering; Needs Assessment; Neisseria gonorrhoeae; Nucleic Acid Amplification Tests; Patients; Performance; Persons; Populations at Risk; Preparation; Primary Health Care; Privacy; Public Health; Qualifying; Reporting; Research; Research Personnel; Sampling; Scientist; Sensitivity and Specificity; Serologic tests; Services; Sexually Transmitted Diseases; Specificity; Specimen; Stigmata; Structure; Swab; Technology; Telephone; Test Result; Testing; Text; Training; Trichomonas; Trichomonas vaginalis; United States; United States Food and Drug Administration; Urine; Vagina; Work; experience; follow-up; interest; laboratory facility; member; novel strategies; pre-clinical; primary care setting; prototype; research clinical testing; social stigma; technology development

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.

需要开发可接受的、可用的现场护理测试（POCT），以识别性传播疾病。 高危人群中的性传播疾病（性病）是重要的。在美国，前10名报告中有5名 每年有超过1800万新的性病，花费超过20亿美元。耻辱，隐私，和 保密性问题使性病成为医疗机构POCT和非处方药（OTC）的最佳选择 在家中进行的分析。我们将建立一个“床旁检测开发和测试中心 （POCT）的性病”与核心，将进行内部临床测试的POC设备，合作与 科学家和工程师对探索性技术开发项目，完成临床需求 在性病医疗保健专业人员中进行评估，为技术开发人员提供临床 有关STD POCT的问题，并提供一个行政结构，以确保我们的中心实现 它的目标。至于核心一，我们会提供专家测试实验室设施，以测试新开发的POCT 分析。我们在验证新检测方法方面拥有丰富的经验。我们还将测试独特的方法， 通过互联网向最终用户提供家庭OTC检测，以及新的测量方法 初级保健环境中OTC型测定的可接受性和准确性。对于核心2，我们将提供赠款 科学家开发新的检测方法，并利用我们的分子和基础科学专业知识， 中心的研究人员在选择适当的应用程序。我们将确保核心3和4的工作在一个 以综合方式提供“需求评估”，评估结果将传达给技术领域的科学家 并指导他们开发有意义的检测方法， 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 一个复杂的中心的结构，所有核心活动的整合，对成员的响应， 希望访问中心的研究社区，并为POCT提供行政服务 中心我们将实施五个相辅相成的核心，并与NIBIB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， 通过确保此类测定的规格和资格具有足以 未来的临床试验和FDA申报。