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: 8288714
• 负责人: CHARLOTTE Ann GAYDOS
• 金额: $ 41.41万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8288714
• 关键词: Accident and Emergency department; Archives; Basic Science; Bedside Testings; Biological Assay; Care Technology Points; Caring; 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; preclinical study; 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，可用的保健测试（POCT）来识别性传播 高危人群中的疾病（STD）很重要。在美国，前十名可报告中的5个 疾病是性病，每年有> 1800万新的性病，耗资20亿美元。污名，隐私和 机密性问题使STD在医疗机构和非处方（OTC）中最适合POCT（OTC） 在家进行的测定。我们将开发一个开发和测试护理点测试的中心 （POCT）针对STD的“与将对POC设备进行内部临床测试的核心”合作 探索技术开发项目的科学家和工程师，满足临床需求 性病医疗保健专业人员之间的评估，向技术开发人员提供有关临床的培训 与STD POCT有关的问题，并提供行政结构以确保我们的中心实现 它的目标。对于Core 1，我们将提供专家测试实验室设施，以测试新开发的POCT 测定。我们有验证新测定法的丰富经验。我们还将测试独特的方法 通过Internet向最终用户提供家用的OTC分析以及测量的新颖方法 OTC型测定在初级保健环境中的可接受性和准确性。对于核心2，我们将提供赠款 向科学家开发新测定法，并利用我们的分子和基本科学专业知识 中心的调查人员选择适当的申请。我们将确保核心3和4在 综合方式提供''''评估，其结果将吸引科学家 社区并指示他们开发有意义的测定法 和特殊性，并积极影响公共卫生。对于Core 5，我们将提供有效的管理 复杂中心的结构，所有核心活动的整合，对成员的响应能力 希望访问该中心并为POCT提供行政服务的研究社区 中心。我们将实施五个相互补充并与Nibib中其他中心合作的核心 POCT研究网络促进从原型开发到内部试验测试的过渡， 通过确保此类测定的规格和资格具有科学优点，足以 未来的临床试验和FDA提交。