Development and Evaluation of a Novel Diagnostic Test for Active Tuberculosis

活动性结核病新型诊断测试的开发和评估

• 批准号: 7900071
• 负责人: Nira Pollock
• 金额: $ 12.66万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7900071
• 关键词: Adult; Antibodies; Antibody Formation; Antigens; Area; Basic Science; Bedside Testings; Biological Assay; Child; Clinical; Clinical Microbiology; Clinical Research; Clinical Trials; Communicable Diseases; Data; Detection; Development; Development Plans; Devices; Diagnosis; Diagnostic; Diagnostic tests; Diagnostics Research; Disease; Doctor of Philosophy; Drug resistance in tuberculosis; Educational Curriculum; Effectiveness; Enzyme-Linked Immunosorbent Assay; Epidemic; Evaluation; Extreme drug resistant tuberculosis; Goals; HIV; Health; Infection; Instruction; Israel; Laboratories; Lung diseases; Mass Spectrum Analysis; Medical center; Medicine; Methods; Microbiology; Monitor; Morbidity - disease rate; Multi-Drug Resistance; Mus; Mycobacterium tuberculosis; Organism; Patient Care; Patients; Performance; Peru; Pharmacotherapy; Population; Principal Investigator; Proteins; Public Health; Public Health Schools; Pulmonary Tuberculosis; Reagent; Recombinant Proteins; Recombinants; Research; Research Methodology; Research Personnel; Resources; Running; Sensitivity and Specificity; Specificity; Sputum; Structure; Technology; Test Result; Testing; Time; Training; Treatment Efficacy; Treatment outcome; Tuberculosis; Urine; Work; active method; career; career development; experience; improved; instructor; interest; mortality; novel; novel diagnostics; novel therapeutics; patient oriented research; performance tests; point of care; pre-clinical; prevent; programs; prospective; protein expression; prototype; socioeconomics; theories; tool; tuberculosis treatment

DESCRIPTION (provided by applicant): Nira Pollock, MD, PhD, is currently an instructor of medicine and infectious diseases (ID) at Beth Israel Deaconess Medical Center (BIDMC). The candidate's long-term goal is to develop an independent patient-oriented research career focused on the development and evaluation of new diagnostic tests for infectious diseases. Dr. Pollock's interest in diagnostics emerged from her strong combined basic science and clinical training and was focused by her ID specialization. Recognizing the rise of global tuberculosis (TB) case rates in the era of HIV and the limitations placed on TB control efforts by the weaknesses of currently available TB diagnostics, the candidate has chosen to focus her research and clinical efforts on TB. Under the guidance of two senior Harvard-affiliated TB researchers, Dr. Antonio Campos-Neto and Dr. Edward Nardell, she has initiated a promising TB diagnostic development project and has prepared a multi-disciplinary career development plan which will allow her to develop into an independent translational researcher with an exceptionally strong grounding in both ID and clinical microbiology. For her project, Dr. Pollock will work to develop a new urine antigen detection test for diagnosis of active TB disease. Her goal is to create a fully non-invasive, point-of-care, rapid test which would be useful in resource-limited settings, thereby making a substantial contribution to patient care and TB control. After completing pre-clinical development, she will evaluate the new test by integrating testing into an established clinical study of TB in Peru, run by Partners in Health. This will allow her to assess test performance for routine diagnosis of active pulmonary TB in adults, as well as to gain preliminary data about test utility for diagnosis of TB in children and for monitoring treatment efficacy. Dr. Pollock will combine her research program with a structured, comprehensive didactic curriculum in clinical research methodology at the Harvard School of Public Health. Finally, she will continue to develop her expertise in clinical microbiology through further practical experience in the BIDMC microbiology laboratory, recognizing that the clinical microbiology laboratory provides an ideal setting for applied infectious diseases diagnostics research. RELEVANCE (See instructions): The goal of this project is to develop a new, rapid, simple, and highly accurate urine test for diagnosis of active tuberculosis (TB). This test could dramatically change how TB is diagnosed world-wide, and thus could help prevent the spread of this highly contagious and often deadly disease.

简介（由申请人提供）：Nira Pollock，医学博士，博士，目前是贝斯以色列女执事医疗中心（BIDMC）医学和传染病（ID）讲师。候选人的长期目标是发展一个独立的以患者为导向的研究事业，专注于开发和评估新的传染病诊断测试。Pollock博士对诊断的兴趣源于她强大的基础科学和临床培训的结合，并专注于她的ID专业。认识到艾滋病毒时代全球结核病病例率的上升以及现有结核病诊断方法的弱点对结核病控制工作造成的限制，该候选人选择将其研究和临床工作的重点放在结核病上。在两位哈佛大学附属结核病高级研究人员Antonio Campos-Neto博士和Edward Nardell博士的指导下，她启动了一个有前景的结核病诊断开发项目，并准备了一个多学科的职业发展计划，这将使她成为一名独立的转化研究人员，在ID和临床微生物学方面都有非常坚实的基础。在她的项目中，波洛克博士将致力于开发一种新的尿液抗原检测方法，用于诊断活动性结核病。她的目标是创建一种完全无创的即时快速检测方法，在资源有限的环境中发挥作用，从而为患者护理和结核病控制作出重大贡献。在完成临床前开发后，她将通过将测试纳入秘鲁由卫生合作伙伴开展的结核病临床研究来评估新的测试。这将使她能够评估成人活动性肺结核常规诊断的测试性能，并获得关于儿童结核病诊断和监测治疗效果的测试效用的初步数据。波洛克博士将把她的研究项目与哈佛大学公共卫生学院临床研究方法论的结构化、全面的教学课程结合起来。最后，她将通过在BIDMC微生物实验室的进一步实践经验，继续发展她在临床微生物学方面的专业知识，认识到临床微生物实验室为应用传染病诊断研究提供了理想的环境。相关性（见说明书）：该项目的目标是开发一种新的、快速、简单和高度准确的尿液检测方法来诊断活动性结核病（TB）。这种检测可能会极大地改变结核病在世界范围内的诊断方式，从而有助于防止这种高度传染性且往往致命的疾病的传播。