Antigen Detection Assay for the Diagnosis of Melioidosis

性状（由申请方提供）：类鼻疽伯克霍尔德菌是一种革兰氏阴性菌，是类鼻疽病的病原体。这种细菌在热带地区引起显著的发病率和死亡率，流行地区正在扩大。由于B。类鼻疽对普通抗生素有抗药性，症状没有特异性。在泰国和澳大利亚，即使使用抗生素治疗，死亡率也分别达到45%和20%。目前，没有经过验证的诊断产品用于诊断类鼻疽。患者样本的培养是诊断的“金标准”，但这可能需要3-5天。我们的目标是开发一种快速的床旁侧流免疫检测的B。从患者样品中直接提取类鼻疽荚膜抗原（CPS）。我们以前的研究已经确定CPS是一种脱落抗原，原型LFI已经产生了令人鼓舞的结果。该项目的目标是（i）产生高亲和力CPS特异性mAb库（ii）优化LFI构建，（iii）确定相容的样品类型和样品制备，以及（iv）定量患者样品中的CPS。通过完成这些目标，我们希望产生一种优化的LFI，其灵敏度等于或大于患者样本的培养。为了实现这些目标，我们组建了一支经验丰富的团队。AuCoin博士的实验室已经在与InBios合作开发LFI原型。此外，这两个小组将与地方病流行地区（泰国和澳大利亚）的专家密切合作，他们将用不同的样本类型对LFI进行评价。

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 3-5 days. Our goal is to develop a rapid point-of-care lateral flow immunoassay for the detection of the B. pseudomallei capsular antigen (CPS) directly from patient samples. Our previous studies have determined that the CPS is a shed antigen and a prototype LFI has yielded encouraging results. The goals of the project are to (i) produce a library of high affinity CPS specific mAbs (ii) optimize LFI construction, (iii) determine compatibe sample types and sample preparation and (iv) quantify CPS in patient samples. 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. Dr. AuCoin's laboratory is already collaborating with InBios on development of a prototype LFI. In addition, both groups will work closely with experts in endemic areas (Thailand and Australia) who will be conducting evaluation of the LFI with different sample types.