DEVICE FOR RAPID DETECTION OF DENGUE--SPECIFIC ANTIBODY

登革热是由蚊媒RNA病毒引起的。一亿 世界各地每年都有登革热病例发生，使登革热病毒成为 在全球发病率方面最重要的虫媒病毒。登革热可以 临床上表现出类似于其他发烧疾病的症状 不是通过蚊子传播的，比如麻疹。能够迅速地 区分登革热和其他黄病毒感染(或无关 疾病)可以加快病媒控制措施，并将提供一个基础 进行适当的病人管理。在第一阶段的研究中，我们将生产 并在微量白板中评估一种新的重组登革热抗原 检测病毒特异性Ig G和Ig M的免疫测定法。敏感度和 基于重组抗原的检测的特异性将与 常规全病毒抗原制剂使用成对的急性和 四起登革热原发和继发感染的恢复期血清 血清型和乙型脑炎。重组人的能力 与抗登革热抗体形成复合物的抗原也将 在硝酸纤维素膜/乳胶颗粒夹心免疫分析中进行评估， 为了说明所选择的试剂和结合物是 函数形式类似于半定量试纸测试 在第二阶段开发和验证。 建议的商业应用： 登革热快速免疫诊断产品的潜在市场包括 全球每年有1亿人感染登革热病毒。这个 建议的快速检测可以渗透到这个开发不足的市场，并 取代历史上使用的繁琐、耗时的技术 登革热血清诊断。

Dengue fever is caused by a mosquito-borne RNA virus. One hundred million cases of dengue fever occur annually worldwide, making dengue virus the most significant arbovirus in terms of global morbidity. Dengue fever can present clinically with symptoms similar to other febrile illnesses that are not transmitted by mosquitoes, such as measles. The ability to rapidly differentiate between dengue and other flavivirus infections (or unrelated diseases) could expedite vector control measures, and would provide a basis for appropriate patient management. In Phase I research, we will produce and evaluate a novel recombinant dengue antigen in a micrtoiter plate immunoassay for detecting virus-specific IgG and IgM. The sensitivity and specificity of the recombinant antigen-based assay will be compared to conventional whole virus antigen preparations using paired acute and convalescent sera from primary and secondary infections of the four dengue serotypes and Japanese encephalitis. The ability of the recombinant antigen to form complexes with anti-dengue antibodies will also be evaluated in a nitrocellulose membrane/latex-particle sandwich immunoassay, in order to illustrate that the selected reagents and conjugates are functional in a format analogous to the semi-quantitative dipstick test to be developed and validate during Phase II. PROPOSED COMMERCIAL APPLICATION: The potential market for a dengue rapid-immunodiagnostic product includes the 100 million people infected worldwide with dengue virus each year. The proposed rapid test could penetrate this poorly exploited market and supplant the cumbersome, time-consuming techniques historically used for dengue serodiagnosis.