Rapid antigen detection test for Dengue infection

描述（由申请人提供）：登革热是一种由登革热病毒（黄病毒科成员）引起的蚊子传播的人类急性病毒性疾病。它在世界许多地方，特别是热带和亚热带地区流行，最近在德克萨斯州和夏威夷爆发。据估计，每年有1亿新的登革热感染病例，其中多达50万人发展为危及生命的登革热出血热。登革热被NIAID归类为重新出现的病原体和A类生物防御剂。目前没有疫苗，良好的管理对于成功解决这一疾病至关重要。快速、准确的诊断是临床决策的关键。目前，通过IgG或IgM ELISA或PCR确定感染的诊断。这些测试具有许多缺点，包括成本、进行它们所需的时间、对昂贵设备的要求以及它们的灵敏度和特异性，特别是在急性/早期疾病中。因此，改进登革热检测的必要性至关重要。InBios International提出通过开发一种快速、廉价、高灵敏度的即时检测方法来检测感染个体血清中的病毒抗原，从而解决这一问题。在追求这一目标，我们将首先确定类型特异性登革热抗原的患者血清中的疾病的不同阶段，通过使用新的抗体微阵列构建了一个大的，独特的，面板的抗登革热单克隆抗体。一旦确定了靶抗原，我们将使用已确定的单克隆抗体进行侧向流试纸条测定或所谓的“快速”测试，并评估其在几个登革热流行地区（台湾，波多黎各）的性能。通过使用特殊构造的高灵敏度手持式荧光读数器，将提高抗原测定的灵敏度。我们打算以非常低的成本生产荧光读取器。在追求这些目标的过程中，InBios将利用其在黄病毒研究方面的丰富经验（我们拥有FDA批准的西尼罗河病毒诊断方法），并组建了一支世界一流的生物医学科学家团队，他们在登革热病理生物学，诊断开发和原型仪器设计方面具有无与伦比的专业知识。 本申请的目的是开发用于登革热病毒感染的早期诊断的特异性抗原测试。这种病毒在世界上许多热带和亚热带地区流行，可能是致命的。它也被列为生物恐怖主义制剂。早期诊断可以改善治疗效果。

DESCRIPTION (provided by applicant): Dengue is a mosquito-transmitted acute viral disease of man caused by the Dengue virus, a member of the flaviviridae family. It is endemic in many parts of the world, particularly tropical and sub-tropical regions and quite recently there have been outbreaks in Texas and Hawaii. It has been estimated that there are 100 million new case of Dengue infection per year, up to half a million of which progress to life-threatening Dengue Hemorrhagic Fever. Dengue is classified by NIAID as a re-emerging pathogen and a Category A biodefense agent. Currently there is no vaccine and good management is critical for a successful resolution of the disease. A rapid, accurate diagnosis is the key to clinical decision making. Currently, diagnosis of infection is determined by either IgG or IgM ELISA or PCR. These tests have a number of drawbacks including cost, the time needed to carry them out, the requirement for expensive equipment and their sensitivity and specificity particularly in acute/early stage disease. Hence the need for improved Dengue testing is paramount. InBios International proposes to address this issue by developing a rapid, inexpensive, highly sensitive, point-of-care assay for the detection of viral antigens in the serum of infected individuals. In the pursuit of this objective, we will first identify type-specific Dengue antigens in the sera of patients at different stages of disease by using novel antibody microarrays constructed with a large, unique, panel of anti-dengue Mabs. Once target antigens have been identified we will make lateral flow dipstick assays, or so-called "rapid" tests with the identified monoclonal antibodies and evaluate their performance in several Dengue-endemic regions (Taiwan, Puerto Rico). The sensitivity of the antigen assay will be increased by the use of a specially constructed, high sensitivity hand held fluorescence reader. We intend that the fluorescence reader will be produced at very low cost. In the pursuit of these goals, InBios will draw on its considerable experience in flavivirus research (we have an FDA approved diagnostic for West Nile Virus) and furthermore has put together a world class team of biomedical scientists with peerless expertise in Dengue pathobiology, diagnostic development and prototype instrument design. The aims of this application are to develop a specific antigen test for the early diagnosis of Dengue virus infections. This virus is endemic in many tropical and sub-tropical regions of the world and can be fatal. It is also listed as a bioterrorism agent. Early diagnosis could lead to improved treatment outcomes.