A Multiplex Point-of-Care Test for Vaginal Infections

阴道感染的多重护理点测试

• 批准号: 7136533
• 负责人: Matthew Steele
• 金额: $ 76.33万
• 依托单位: PATH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7136533
• 关键词: AIDS; Chlamydia trachomatis; Neisseria gonorrhoeae; archives; bacteria; cell sorting; clinical research; diagnostic tests; gold; health; infection; motivation; nucleic acids; performance; syndrome; university

DESCRIPTION (provided by applicant): The goal of the proposed research is to adapt and apply an existing nucleic acid (NA) amplification lab-on-a card platform to the specific identification of organisms responsible for common vaginal infections in patients presenting to primary health care settings in resource-limited settings. Component functions to be integrated into this platform include sample processing to support the direct use of self-collected clinical specimens and integrated parallel NA amplification and detection. This new, robust diagnostic test will provide clinicians with a rapid, highly sensitive, specific, easy-to-use, and cost-effective tool to detect vaginal infections at the point of care. In the five-year term of the proposed project, the following activities and milestones will be achieved: Aim 1: Selection, adaptation, and optimization of simple, robust, patient-obtained vaginal specimen collection methods and materials for diagnostic use in vaginal syndromes at the point of care. We will select three candidate sampling devices and comparatively evaluate their performance characteristics including NA collection and exfoliated cell counts among women presenting to a Seattle STD clinic. Aim 2: Development and optimization of an integrated parallel (NA) amplification lab-on-a-card diagnostic for the rapid identification of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacteria specific for bacterial vaginosis individually or simultaneously from a single clinical specimen. We will develop and validate all assay components including the specimen/card interface, on-card NA extraction and capture, NA amplification, and detection for each of the organisms of interest. Aim 3: Integration of sample processing, NA amplification, and detection onto a single, STI diagnostics lab-on-a-card. Individual assays developed in Aim 2 will be integrated to produce a single lab-on-a-card system. This system will provide rapid (the goal is 30 minutes) and accurate (the goal is 95% sensitivity and specificity compared to current gold standards) results while minimizing operator skill and equipment requirements to enable at or near point-of-care deployment. Aim 4: Use of archived and prospectively collected vaginal specimens to support diagnostic card development. At each stage of development we will use clinically collected specimens to evaluate the performance of the card and its components. After a functional, integrated card is developed, we will also carry out a prospective, preclinical evaluation of the unit to better assess its performance in the field. The proposed project will be conducted through a consortium agreement among four independent parties: Program for Appropriate Technology in Health (PATH); Micronics, Inc.; the University of Washington Center for AIDS and STD; and the Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA.

描述（由申请人提供）：拟议研究的目标是适应和应用现有的核酸（NA）扩增卡上实验室平台，以特定识别导致资源有限的初级卫生保健机构患者常见阴道感染的生物体。该平台将集成的组件功能包括支持直接使用自采临床标本的样品处理和集成的平行NA扩增和检测。这种新的、强大的诊断测试将为临床医生提供一种快速、高度敏感、特异性强、易于使用和具有成本效益的工具，以便在护理点检测阴道感染。在拟议项目的五年期限内，将实现以下活动和里程碑：目标1：选择、调整和优化简单、可靠、患者获得的阴道标本采集方法和材料，用于在护理点诊断阴道综合征。我们将选择三种候选取样装置，并比较评估其性能特征，包括在西雅图性病诊所就诊的女性中NA收集和去角质细胞计数。目标2：开发和优化一种集成平行（NA）扩增卡片实验室诊断方法，用于快速识别沙眼衣原体、淋病奈瑟菌、阴道毛滴虫和细菌性阴道病特异性细菌，这些细菌可以单独或同时从单个临床标本中进行检测。我们将开发和验证所有检测组件，包括样品/卡片接口，卡片上NA提取和捕获，NA扩增和检测每个感兴趣的生物体。目标3：将样品处理，NA扩增和检测集成到单个STI诊断实验室卡上。在目标2中开发的单个分析将被整合到一个单一的卡上实验室系统中。该系统将提供快速（目标为30分钟）和准确（与目前的金标准相比，目标是95%的灵敏度和特异性）的结果，同时最大限度地降低操作员技能和设备要求，使其能够在护理点或附近部署。目标4：使用存档和预期收集的阴道标本来支持诊断卡的开发。在开发的每个阶段，我们将使用临床收集的标本来评估卡片及其组件的性能。在开发出功能齐全的集成卡片后，我们还将对该单元进行前瞻性临床前评估，以更好地评估其在该领域的表现。拟议的项目将通过四个独立方之间的联合协议进行：适当卫生技术规划；细微的公司;华盛顿大学艾滋病和性病研究中心；以及华盛顿州西雅图的弗雷德·哈钦森癌症研究中心（FHCRC）。