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.

头皮癣（头皮癣）是一种真菌性皮肤真菌感染的头皮毛囊，折磨3-8%的人， 美国儿科人群。头皮炎是一个主要的医疗保健差距，因为它主要发生在 具有不利社会经济背景和撒哈拉以南非洲血统的个人。诊断 目前，脑膜炎主要依赖于培养和显微镜检查。两者都很昂贵，需要时间和要求 相当的专业知识。该项目的目标是一种免疫测定法，将快速识别存在的 皮肤刮屑和毛发中的皮肤真菌。目标人群将是个人，主要是 弱势儿童，临床表现为头癣。该方法将是一种免疫测定法， 细胞壁半乳甘露聚糖作为皮肤真菌的生物标志物。该产品将是一个快速和廉价的 侧流免疫测定（LFIA）。LFIA平台为医护人员和患者所熟悉 因为它的格式和家用验孕棒的格式相同。因此， 所有利益相关者接受测试。 在初步研究中，制备了多步研究级LFIA，其与以下半乳甘露聚糖反应： 所有主要的皮肤真菌以及来自皮肤真菌感染患者的临床样品的提取物。的 第一阶段提案的目标是将目前的研究级LFIA转变为适合于点的格式， 护理（POC）使用。这一目标将通过实现三个具体目标来实现。目标1将优化 样品处理和从皮肤真菌中提取半乳甘露聚糖的方法。目标2将优化 用于以单步POC形式检测半乳甘露聚糖的原型侧流免疫测定。目标3将 使用临床样本评估原型头状回盲LFIA。 如果成功，这项研究将产生一个诊断测试，是高效，有效，负担得起的，文化 可接受的，并可交付给服务于健康差异人群的网站。结果将是快速诊断 和治疗感染，使儿童蒙受耻辱，使他们无法上学，直到开始治疗， 给医疗保健系统增加了相当大的成本。