Low Cost Multi-pathogen Laser Diagnostic for HIV and AIDS Co-Infections

HIV 和 AIDS 合并感染的低成本多病原体激光诊断

基本信息

批准号：
7920271
负责人：
Christopher John Myatt
金额：
$ 108.21万
依托单位：
MBIO DIAGNOSTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-01-15 至 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7920271
关键词：
AIDS clinical trial group Acquired Immunodeficiency Syndrome Address Antigens Architecture Archives Area Award Biological Assay Brazil Businesses California Caring Cellular Phone Chairperson Chemistry Clinic Clinical Clinical Microbiology Clinical Trials Collaborations Collection Communicable Diseases Country Cryptococcus Custom Data Set Detection Development Devices Diagnosis Diagnostic Diagnostic tests Disease Doctor of Philosophy Electronics Epidemic Epidemiology Fluorescence Funding Goals Government Agencies Guidelines HIV HIV Infections HIV diagnosis Head Hepatitis B Surface Antigens Hospitals Immunoassay Individual Infection Institutes Intellectual Property International Ions Laboratories Lasers Legal patent Licensing Life Lighting Marketing Measurement Medical Medicine Methods Mycobacterium tuberculosis National Institute of Allergy and Infectious Disease Nobel Prize Optics Outcome Patients Persons Phase Physical condensation Population Positioning Attribute Prevention and Treatment of Opportunistic Infection Price Procedures Protocols documentation Public Health Quality Control Reader Reagent Recording of previous events Research Research Personnel Resources Risk Running Sampling Secure Series Serologic tests Services Site Small Business Innovation Research Grant Staging Surface System Technology Testing Therapeutic Time Tuberculosis United States United States National Institutes of Health Universities Virus Diseases Work antiretroviral therapy base burden of illness cohort commercialization cost cost efficient design detector experience global health high risk improved instrument instrumentation meetings member novel diagnostics operation pathogen photonics point of care point-of-care diagnostics product development programs prototype public health relevance quality assurance research and development skills software systems stem

项目摘要

DESCRIPTION (provided by applicant): Diagnosis and medical management of HIV-infected individuals is significantly enhanced if one can simultaneously define the subset of the most common co-infections for which patients are at risk. Unfortunately, running such a series of parallel diagnostic tests is cost prohibitive, particularly in low-resource settings. Precision Photonics Corporation proposes to continue development of a low-cost, point-of-care, multiplexed fluorescence immunoassay system for the diagnosis of HIV and common co-infections from a single sample. The technology uses a proprietary laser illumination method combined with low- cost consumer electronics (e.g., DVD player lasers) and optics (consumer and cell phone cameras). The specific aims of the proposed project are to: (1) Transfer the reference design fluorescence reader and cartridge system completed during Phase II into an investigational device, positioned for an investigational device exemption (IDE) application to the FDA, including a fluorescent reader, cartridge, and system software. (2) Expand the multiplexed co-infection assay panel to include M. tuberculosis serology based on a panel of new diagnostic antigens and direct detection of hepatitis B surface antigen and Cryptococcus antigen. Aim 2 will also establish stabilization protocols, reagent packaging, and shelf life dataset, as well as quality assurance/quality control procedures. (3) Place instruments at collaborator sites and develop datasets based on three collections of clinical samples, including a cohort of archived samples collected through UCSD clinics; samples collected from international sites through collaboration with the NIAID AIDS Clinical Trials Group (ACTG); and clinical samples collected and tested in Brazil. The outcome of this program will be a low cost, IDE-stage instrument with working diagnostic panel assays and a validated dataset to be bundled as part of an FDA submission. PUBLIC HEALTH RELEVANCE: The research and development performed in this project, if successful, will enable very low cost, easy to use tests at the point-of-care to help in the assessment of disease status of AIDS patients, particularly in resource limited settings. The simplicity and low cost of the technology will facilitate the use of antiretroviral therapy, greatly prolonging the lives of those infected with HIV and reducing the burden of disease in populations where HIV is endemic.

描述（由申请人提供）：如果可以同时定义患者处于危险中的最常见的共同感染的子集，则对艾滋病毒感染者的诊断和医疗管理将显着增强。不幸的是，运行这样一系列并行诊断测试的成本高昂，尤其是在低资源环境中。 Precision Photonics Corporation建议继续开发低成本，护理点，多重荧光免疫测定系统，以诊断HIV和单个样本中常见的共同感染。该技术使用专有的激光照明方法与低成本的消费电子产品（例如DVD播放器激光器）和光学（消费者和手机摄像头）相结合。拟议项目的具体目的是：（1）将在II期期间完成的参考设计荧光读取器和墨盒系统转移到研究设备中，该设备定位为研究设备豁免（IDE）施加到FDA，包括荧光读取器，墨盒，墨盒和系统软件。（2）将多重共感染测定面板扩展到基于新诊断抗原和直接检测丙型肝炎表面抗原和加密抗原抗原的结核分枝杆菌血清学。 AIM 2还将建立稳定协议，试剂包装和保质期数据集，以及质量保证/质量控制程序。（3）将仪器放置在合作者站点上，并根据三个临床样本集合开发数据集，包括通过UCSD诊所收集的一系列存档样品；通过与NIAID AIDS临床试验小组（ACTG）合作从国际站点收集的样本；以及在巴西收集和测试的临床样本。该计划的结果将是具有工作诊断面板测定法的低成本，IDE阶段的仪器，并且作为FDA提交的一部分捆绑的经过验证的数据集。公共卫生相关性：如果成功的话，在该项目中执行的研发将使非常低的成本，易于使用的测试，以帮助评估艾滋病患者的疾病状况，尤其是在资源有限的环境中。该技术的简单性和低成本将有助于使用抗逆转录病毒疗法，从而大大延长感染了艾滋病毒的人的生活，并减轻了艾滋病毒特有的人群中疾病负担。