Point of care immunoassay for rapid diagnosis of tinea capitis

快速诊断头癣的护理点免疫分析

• 批准号: 9348517
• 负责人: Amanda Burnham-Marusich
• 金额: $ 3.15万
• 依托单位: DXDISCOVERY, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-16 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9348517
• 关键词: Adverse effects; African; African American; Antibiotics; Antifungal Agents; Antigens; Arthrodermataceae; Binding; Biological Markers; Caring; Cell Wall; Child; Childhood; Clinical; Communicable Diseases; Communities; Community Health; Detection; Diagnosis; Diagnostic tests; Disadvantaged; Disease; Elements; Family; Federally Qualified Health Center; General Population; Goals; Hair; Hair follicle structure; Health Alliance; Health Care Costs; Health Personnel; Healthcare Systems; High Prevalence; Home environment; Human; Immunoassay; Individual; Infection; Lateral; Low income; Medical; Microscopy; Modification; Monoclonal Antibodies; Mycoses; Nevada; Oral; Patients; Performance; Phase; Polysaccharides; Population; Pregnancy Tests; Procedures; Process; Provider; Relative Risks; Research; Sampling; Scalp structure; Schools; Site; Skin; Solid; Target Populations; Testing; Time; Tinea; Tinea Capitis; accurate diagnosis; base; commercialization; compliance behavior; cost; fungus; galactomannan; health care disparity; health disparity; point of care; product development; prototype; rapid diagnosis; socioeconomic disadvantage; success; user centered design

Tinea capitis (scalp ringworm) is a fungal dermatophyte infection of scalp hair follicles that afflicts 3-8% of the U.S. pediatric population. Tinea capitis is a major health care disparity because it occurs predominantly among individuals with a disadvantaged socioeconomic background and sub-Saharan African descent. Diagnosis of tinea capitis is currently dependent on culture and microscopy. Both are expensive, take time and require considerable expertise. The goal of this project is an immunoassay that will rapidly identify the presence of dermatophyte fungi in skin scrapings and hair. The target population will be individuals, primarily disadvantaged children, with a clinical presentation of tinea capitis. The approach will be an immunoassay for cell wall galactomannans as biomarkers for dermatophyte fungi. The product will be a rapid and inexpensive lateral flow immunoassay (LFIA). The LFIA platform is familiar to health care workers and patients alike because the format is identical to that of the home pregnancy test. As a consequence, there would be ready acceptance of the test by all stakeholders. In preliminary studies, a multi-step research-grade LFIA was produced that is reactive with galactomannans of all major dermatophytes as well as extracts of clinical samples from patients with dermatophyte infection. The objective of this Phase I proposal is to move the current research-grade LFIA to a format suitable for point-of- care (POC) use. This objective will be completed by pursuit of three specific aims. Aim 1 will optimize procedures for sample treatment and extraction of galactomannan from dermatophytes. Aim 2 will optimize a prototype lateral flow immunoassay for detection of galactomannan in a single-step POC format. Aim 3 will evaluate a prototype tinea capitis LFIA using clinical samples. If successful, this study will produce a diagnostic test that is efficient, effective, affordable, culturally acceptable, and deliverable to sites that serve health disparity populations. The result will be rapid diagnosis and treatment of an infection that stigmatizes children, keeps them from school until treatment is initiated, and adds a considerable cost to the health care system.

Tinea Capitis（头皮癣）是头皮毛囊的真菌皮肤植物感染，折磨3-8％ 美国小儿人口。 Tinea Capitis是主要的医疗保健差异，因为它主要发生 具有处境不利的社会经济背景和撒哈拉以南非洲血统的人。诊断 Tinea Capitis目前取决于培养和显微镜。两者都是昂贵的，需要时间，需要 大量专业知识。该项目的目的是免疫测定法，它将迅速识别 皮肤刮擦和头发中的皮肤菌真菌。目标人群将是个人，主要是 不利的儿童，伴有tinea帽炎的临床表现。该方法将是一种免疫测定 细胞壁的半乳糖量作为皮肤真菌的生物标志物。该产品将是快速且便宜的 侧流免疫测定（LFIA）。 LFIA平台对医护人员和患者都很熟悉 因为该格式与家庭妊娠试验的格式相同。结果，会准备好 所有利益相关者都接受测试。 在初步研究中，产生了多步研究级的LFIA，该LFIA与半乳糖室具有反应性 所有主要的皮肤植物以及来自皮肤植物感染患者的临床样品的提取物。这 该阶段I建议的目的是将当前的研究级LFIA转移到适合于 - 护理（POC）使用。该目标将通过追求三个特定目标来完成。 AIM 1将优化 样品处理和从皮肤植物中提取半乳糖的程序。 AIM 2将优化 原型侧流免疫测定法，用于以单步POC格式检测半乳糖量。目标3意志 使用临床样品评估原型Tinea Capisis lfia。 如果成功，这项研究将产生高效，有效，负担得起，文化的诊断测试 可接受的，可交付到服务健康差异人群的网站。结果将是快速诊断 以及对儿童污名化的感染的治疗 为医疗保健系统增加了相当大的成本。