Rapid antigen detection test for Dengue infection

描述(申请人提供)：登革热是一种通过蚊子传播的人类急性病毒性疾病，由黄病毒科成员登革病毒引起。它在世界许多地区流行，特别是热带和亚热带地区，最近在德克萨斯州和夏威夷爆发了疫情。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出血热。NIAID将登革热归类为新出现的病原体和A类生物防御剂。目前还没有疫苗，良好的管理是成功解决该疾病的关键。快速、准确的诊断是临床决策的关键。目前，感染的诊断是通过免疫球蛋白或免疫球蛋白M酶联免疫吸附试验或聚合酶链式反应来确定的。这些测试有一些缺点，包括成本、进行测试所需的时间、对昂贵设备的要求以及它们的敏感性和特异性，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建议通过开发一种快速、廉价、高度敏感的护理点检测方法来解决这一问题，用于检测感染者血清中的病毒抗原。为了实现这一目标，我们将首先通过使用由一组大型、独特的抗登革热单抗构建的新型抗体微阵列，在不同疾病阶段的患者的血清中识别特定类型的登革热抗原。一旦确定了目标抗原，我们将对已识别的单抗进行侧向流动试纸分析，或所谓的“快速”检测，并评估它们在几个登革热流行地区(台湾、波多黎各)的表现。抗原分析的灵敏度将通过使用特殊构造的高灵敏度手持式荧光读取器来提高。我们打算以非常低的成本生产荧光阅读器。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)，并组建了一支世界级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拥有无与伦比的专业知识。 这项应用的目的是开发一种特异性抗原测试，用于登革病毒感染的早期诊断。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。它还被列为生物恐怖主义毒剂。早期诊断可能会改善治疗结果。

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.