Antigen Immunoassay for Diagnosis of Coccidioidomycosis

抗原免疫分析诊断球孢子菌病

• 批准号: 8392843
• 负责人: SEAN BAUMAN
• 金额: $ 29.54万
• 依托单位: IMMUNO-MYCOLOGICS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8392843
• 关键词: Antibodies; Antigens; Bacterial Infections; Bacteriophages; Binding; Biological Assay; Biological Markers; Coccidioides; Coccidioidomycosis; Detection; Development; Diagnosis; Diagnostic; Disease; Early Diagnosis; Ensure; Enzyme Immunoassay; Fever; Goals; Health Care Costs; Human; Immunoassay; Infection; Lateral; Libraries; Life; Morbidity - disease rate; Mus; Mycoses; Patients; Phage Display; Phase; Proteins; Proteus; Research Project Grants; Sampling; Serological; Serum; Small Business Innovation Research Grant; Specimen; Technology; Testing; Translational Research; United States; Urine; Validation; Virus Diseases; base; human disease; improved; pathogen; phase 1 study; research study; success; tool; validation studies

DESCRIPTION (provided by applicant): Coccidioidomycosis, also known as "Valley Fever," is a fungal disease caused by Coccidioides spp. that infects an estimated 150,000 people each year in the United States. Current diagnosis of coccidioidomycosis relies on detection of anti-coccidioidal antibodies in patient sera. However, the sensitivity of this serological assay is particularly low in the first few weeks of illness. A promising strategy to improve early diagnosis of Coccidioides infections is to detect specific protein antigens from Coccidioides which are shed into urine or serum. However, antigenuria/antigenemia-based diagnostic assays for coccidioidomycosis are not yet available, resulting in a critical need for the development of this type of diagnostic. The goal of this project is an immunoassay that will use serum or urine as a sample to diagnose coccidioidomycosis. Our overall hypothesis is that protein biomarker targets are shed into the urine or serum of Coccidioides-infected mice. The approach will be the use of scFv phage display technology to facilitate the identification of Coccidioides biomarkers in urine and serum from Coccidioides-infected mice. The product will be an immunoassay in the lateral flow assay (LFA) or enzyme immunoassay (EIA) format in order to facilitate earlier diagnosis of coccidioidomycosis. Criteria for success of this Phase I SBIR would be the identification and validation of at least one protein biomarker from the urine or serum of Coccidioides-infected mice. If the goals of this Phase I project are achieved, a Phase II application will use the protei biomarker(s) and/or antibody(s) generated from this Phase I project to construct and evaluate an immunoassay in LFA or EIA format. If successful, this translational research project could dramatically decrease the morbidity and health care costs associated with coccidioidomycosis through earlier diagnosis. PUBLIC HEALTH RELEVANCE: Coccidioidomycosis is a common and sometimes life-threatening, fungal infection which is difficult to diagnose early due to its symptomatic similarit to viral and bacterial infections. This is a translational research study whose initial goal is to identify biomarkers that are shed into the urine or serum of Coccidioides-infected mice with the ultimate goal of developing an immunoassay that will facilitate earlier diagnosis of coccidioidomycosis. If successful, this project could dramatically decrease the morbidity and health care costs associated with coccidioidomycosis through earlier diagnosis.

描述（由申请方提供）：球孢子菌病，也称为“山谷热”，是一种由球孢子菌属引起的真菌疾病。在美国每年大约有15万人感染这种病毒。目前球孢子菌病的诊断依赖于患者血清中抗球孢子菌抗体的检测。然而，这种血清学检测的灵敏度在疾病的最初几周特别低。改善早期诊断的一种有前途的策略 检测球孢子菌感染的方法是检测球孢子菌分泌到尿液或血清中的特异性蛋白抗原。然而，球孢子菌病的抗原尿/抗原血症为基础的诊断检测还没有，导致迫切需要开发这种类型的诊断。这个项目的目标是一种免疫测定法，将使用血清或尿液作为样本来诊断球孢子菌病。我们的总体假设是，蛋白质生物标志物靶标脱落到类球孢子虫感染小鼠的尿液或血清中。该方法将使用scFv噬菌体展示技术，以促进从球孢子虫感染的小鼠的尿液和血清中鉴定球孢子虫生物标志物。该产品将是侧流测定（LFA）或酶免疫测定（EIA）形式的免疫测定，以促进球孢子菌病的早期诊断。该I期SBIR成功的标准是从类球孢子菌感染小鼠的尿液或血清中鉴定和验证至少一种蛋白质生物标志物。如果实现了该I期项目的目标，则II期应用将使用从该I期项目产生的蛋白质生物标志物和/或抗体来构建和评估LFA或EIA格式的免疫测定。如果成功的话，这个转化研究项目可以通过早期诊断大大降低球孢子菌病的发病率和医疗费用。 公共卫生相关性：球孢子菌病是一种常见的，有时危及生命的真菌感染，由于其症状与病毒和细菌感染相似，很难早期诊断。这是一项转化研究，其最初目标是鉴定脱落到球孢子菌感染小鼠尿液或血清中的生物标志物，最终目标是开发一种免疫测定法，以促进球孢子菌病的早期诊断。如果成功，该项目可以通过早期诊断大大降低球孢子菌病的发病率和医疗费用。