Antigen Detection assay for the Diagnosis of Melioidosis

诊断类鼻疽的抗原检测分析

• 批准号: 8883363
• 负责人: David P AuCoin
• 金额: $ 67.35万
• 依托单位: INBIOS INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-15 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8883363
• 关键词: Abscess; Acute; Advanced Development; Aerosols; Affinity; Algorithms; Antibiotic Therapy; Antibiotics; Antigens; Archives; Area; Australia; Award; Bacteria; Biological Assay; Biological Markers; Blood typing procedure; Buffers; Burkholderia pseudomallei; Case Study; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinical; Country; Detection; Development; Diagnosis; Diagnostic; Diagnostic Reagent; Diagnostic tests; Disease; Enzyme-Linked Immunosorbent Assay; Feasibility Studies; Genetic Variation; Goals; Gold; Gram-Negative Bacteria; Health; Housing; Human; Immunoassay; In Vitro; Infection; International; Laboratories; Lateral; Lead; Left; Libraries; Melioidosis; Membrane; Modeling; Monoclonal Antibodies; Morbidity - disease rate; Mus; National Institute of Allergy and Infectious Disease; Organ; Patients; Performance; Phase; Polysaccharides; Preparation; Prevalence Study; Production; Public Health; Pus; Reproducibility; Resistance; Sampling; Sepsis; Serum; Site; Skin Tissue; Small Business Technology Transfer Research; Soil; Specificity; Specimen; Sputum; Symptoms; Testing; Thailand; Tropical Disease; Urine; Validation; Variant; Work; cost effective; cross reactivity; design; diagnosis standard; effective therapy; experience; field study; in vivo; mortality; point of care; pre-clinical; preclinical evaluation; prototype; rapid diagnosis; scale up; soft tissue

DESCRIPTION (provided by applicant): Burkholderia pseudomallei is a Gram-negative bacterium that is the causative agent of melioidosis. The bacterium causes significant morbidity and mortality in tropical regions and endemic areas are expanding. Melioidosis is difficult to trea and diagnose due to the fact that B. pseudomallei is resistant to common antibiotics and symptoms are non-specific. Mortality rates reach 45% and 20% in Thailand and Australia respectively, even with antibiotic treatment. Currently, there is no validated diagnostic product for the diagnosis of melioidosis. Culturing of patient samples is the "gold standard" for diagnosis; however this can take 3-7 days. Our goal is to develop a rapid point-of-care lateral flow immunoassay (LFI) for the detection of the B. pseudomallei capsular antigen (CPS) directly from patient samples. Phase I STTR Specific Aims focused on producing a library of anti-CPS monoclonal antibodies (mAbs), optimizing the LFI components and sample preparation, and performing a feasibility study on archived melioidosis patient samples. The objectives of this Phase II application is advanced development and validation of the prototype AMD LFI that incorporates a higher affinity CPS mAb. By completing these goals we hope to produce an optimized LFI that possesses sensitivity equal to or greater than culturing of patient samples. To achieve these goals we have established an experienced team. A strong partnership exists between Dr. AuCoin's laboratory and InBios International that has led to the development of an encouraging prototype LFI. In addition, both groups will work closely with experts in endemic areas (Thailand and Australia) who will be conducting a large preclinical evaluation of the LFI with different patient sample types.

描述（由申请人提供）：Burkholderia pseudomallei是一种革兰氏阴性细菌，是Melioidosis的病因。细菌在热带地区和流行地区引起明显的发病率和死亡率正在扩大。由于假单胞菌对常见抗生素具有抗性，并且症状是非特异性的，因此很难进行梅尔塞多利份病。即使接受抗生素治疗，泰国和澳大利亚的死亡率分别达到45％和20％。当前，尚无诊断诊断梅利前病的诊断产品。培养患者样品是诊断的“黄金标准”。但是，这可能需要3-7天。我们的目标是直接从患者样品中开发出快速的护理侧向流免疫测定（LFI），以检测直接从患者样品中检测出芽孢杆菌囊囊抗原（CPS）。 I期STTR特定的目的是致力于生产抗CPS单克隆抗体（MAB）的库，优化LFI成分和样品制备，并对存档的Melioidosis患者样品进行可行性研究。该II阶段应用的目标是融合了较高亲和力CPS mAb的原型AMD LFI的高级开发和验证。通过完成这些目标，我们希望产生优化的LFI，其具有等于或更大的患者样品的灵敏度。为了实现这些目标，我们建立了一个经验丰富的团队。 Aucoin博士的实验室和Inbios International之间存在着强有的合作伙伴关系，这导致了令人鼓舞的LFI的发展。此外，这两个小组将与流行地区（泰国和澳大利亚）的专家紧密合作，他们将对具有不同患者样本类型的LFI进行大量的临床前评估。