Point of care immunoassay for rapid diagnosis of tinea capitis
Point of care immunoassay for rapid diagnosis of tinea capitis
批准号:
9348517
负责人:
Amanda Burnham-Marusich
金额:
$3.15万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2016
资助国家:
美国
项目状态:
已结题
起止时间:
2016-09-16 至 2017-07-31
关键词:
Adverse effectsAfricanAfrican AmericanAntibioticsAntifungal AgentsAntigensArthrodermataceaeBindingBiological MarkersCaringCell WallChildChildhoodClinicalCommunicable DiseasesCommunitiesCommunity HealthDetectionDiagnosisDiagnostic testsDisadvantagedDiseaseElementsFamilyFederally Qualified Health CenterGeneral PopulationGoalsHairHair follicle structureHealth AllianceHealth Care CostsHealth PersonnelHealthcare SystemsHigh PrevalenceHome environmentHumanImmunoassayIndividualInfectionLateralLow incomeMedicalMicroscopyModificationMonoclonal AntibodiesMycosesNevadaOralPatientsPerformancePhasePolysaccharidesPopulationPregnancy TestsProceduresProcessProviderRelative RisksResearchSamplingScalp structureSchoolsSiteSkinSolidTarget PopulationsTestingTimeTineaTinea Capitisaccurate diagnosisbasecommercializationcompliance behaviorcostfungusgalactomannanhealth care disparityhealth disparitypoint of careproduct developmentprototyperapid diagnosissocioeconomic disadvantagesuccessuser centered design
中文摘要
头癣(头癣)是头皮毛囊的一种真菌皮肤真菌感染,3%-8%的人受到影响。
美国儿科人口。头癣是一个主要的医疗保健差距,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血统的个人。诊断
头癣目前依赖于培养和显微镜检查。两者都很昂贵,需要时间和需求
相当多的专业知识。这个项目的目标是一种免疫分析,它将快速识别是否存在
皮肤刮痕和头发中的皮肤真菌。目标人群将主要是个人
处境不利的儿童,临床表现为头癣。该方法将是一种免疫检测方法,用于
半乳甘露聚糖作为皮肤真菌生物标志物的研究。该产品将是一种快速而廉价的产品
侧向流动免疫分析(LFIA)。LFIA平台对医护人员和患者都很熟悉
因为其格式与家庭验孕法完全相同。因此,就会有现成的
所有利益相关者对测试的接受度。
在初步研究中,生产了一种与半乳甘露聚糖反应的多步研究级LFIA。
所有主要皮肤真菌以及皮肤真菌感染患者的临床样本提取液。这个
这项第一阶段提案的目标是将目前的研究级LFIA转换为适合于
关怀(PoC)使用。这一目标将通过追求三个具体目标来实现。目标1将优化
皮肤真菌半乳甘露聚糖的样品处理和提取程序。目标2将优化
单步POC格式检测半乳甘露聚糖的原型侧向流动免疫分析。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、负担得起的文化诊断测试
可接受的,并可交付给服务于健康差距人群的站点。结果将是快速诊断
以及治疗使儿童蒙受耻辱的感染,使他们在开始治疗之前无法上学,以及
增加了医疗保健系统的相当大的成本。
英文摘要
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.
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