A Multiplex Point-of-Care Test for Vaginal Infections

阴道感染的多重护理点测试

• 批准号: 7469414
• 负责人: Matthew Steele
• 金额: $ 64.34万
• 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/7469414
• 关键词: Acquired Immunodeficiency Syndrome; Agreement; Archives; Bacteria; Bacterial Vaginosis; Bedside Testings; Biological Assay; Cell Count; Characteristics; Chlamydia trachomatis; Class; Clinic; Clinical; Collaborations; Collection; Detection; Development; Devices; Diagnostic; Diagnostic tests; Equipment; Evaluation; Fred Hutchinson Cancer Research Center; Goals; Gold; Health; Individual; Infection; Laboratories; Methods; Microfluidics; Movement; Neisseria; Neisseria gonorrhoeae; Nucleic Acids; Organism; Patients; Performance; Polymerase Chain Reaction; Primary Health Care; Process; Public Health; Reagent; Research; Research Personnel; Resources; Sampling; Sensitivity and Specificity; Specimen; Staging; Standards of Weights and Measures; Syndrome; System; Technology; Time; Trichomonas vaginalis; Universities; Vagina; Vaginal Discharge; Validation; Washington; Woman; Women' s Health; base; cost; instrument; interest; multidisciplinary; pathogen; point of care; pre-clinical; programs; prospective; research and development; sample collection; skills; tool; vaginal fluid

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(申请人提供)：拟议研究的目标是调整和应用现有的核酸(NA)扩增实验室-卡上平台，以具体识别在资源有限的情况下向初级卫生保健机构提出的患者中导致常见阴道感染的微生物。集成到该平台中的组件功能包括支持直接使用自收集的临床标本的样本处理和集成的并行NA扩增和检测。这一新的、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、易于使用和成本效益高的工具，在护理点检测阴道感染。在拟议项目的五年期间，将实现以下活动和里程碑：目标1：选择、适应和优化简单、可靠、患者获得的阴道标本采集方法和材料，用于在护理地点诊断阴道综合征。我们将选择三种候选采样设备，并比较评估它们的性能特征，包括在西雅图一家性病诊所就诊的妇女的NA采集和脱落细胞计数。目的：建立和优化集成平行扩增(NA)一卡式诊断方法，用于从单个临床标本中单独或同时快速鉴定沙眼衣原体、淋球菌、阴道毛滴虫和细菌性阴道病的细菌。我们将开发和验证所有的检测组件，包括样本/卡片接口、卡上NA提取和捕获、NA扩增以及对每个感兴趣的生物的检测。目标3：将样品处理、NA扩增和检测集成到一个单一的STI诊断实验室。在AIM 2中开发的单个分析将被整合，以产生一个单一的一卡通实验室系统。该系统将提供快速(目标是30分钟)和准确(与当前黄金标准相比，目标是95%的敏感度和特异度)结果，同时将操作员技能和设备要求降至最低，以实现在或接近护理点部署。目的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样本来评估该卡及其组件的性能。在开发出具有功能的集成卡后，我们还将对该设备进行前瞻性的临床前评估，以更好地评估其在现场的表现。拟议的项目将通过四个独立各方之间的财团协议进行：健康适当技术计划(Path)；Microronics，Inc.；华盛顿大学艾滋病和性病中心；以及华盛顿州西雅图的弗雷德·哈钦森癌症研究中心(FHCRC)。