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.

头癣（头皮癣）是一种头皮毛囊的真菌性皮肤癣菌感染，影响 3-8% 的头皮毛囊。 美国儿科人口。头癣是一个重大的医疗保健差异，因为它主要发生在 具有弱势社会经济背景和撒哈拉以南非洲裔的个人。诊断 头癣目前依赖于培养和显微镜检查。两者都很昂贵，需要时间并且需要 相当多的专业知识。该项目的目标是通过免疫分析快速识别是否存在 皮肤刮屑和头发中的皮肤癣菌。目标人群主要是个人 具有头癣临床表现的弱势儿童。该方法将是一种免疫测定 细胞壁半乳甘露聚糖作为皮肤真菌的生物标志物。该产品将是一种快速且廉价的 侧流免疫分析（LFIA）。 LFIA 平台为医护人员和患者所熟悉 因为其格式与家庭妊娠测试的格式相同。这样一来，就会有准备好的 所有利益相关者接受测试。 在初步研究中，生产了一种多步骤研究级 LFIA，它与半乳甘露聚糖发生反应 所有主要皮肤癣菌以及皮肤癣菌感染患者的临床样本提取物。这 第一阶段提案的目标是将当前的研究级 LFIA 转变为适合点的格式 护理（POC）使用。这一目标将通过追求三个具体目标来完成。目标1将优化 样品处理和从皮肤癣菌中提取半乳甘露聚糖的程序。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法。目标3将 使用临床样本评估原型头癣 LFIA。 如果成功，这项研究将产生一种高效、有效、负担得起、符合文化的诊断测试 可以接受，并且可以交付给为健康差异人群服务的场所。结果将是快速诊断 以及治疗使儿童蒙受耻辱的感染，使他们无法上学直到开始治疗，以及 给医疗保健系统增加了相当大的成本。