DEVICE FOR RAPID DETECTION OF DENGUE--SPECIFIC ANTIBODY

登革热特异性抗体快速检测装置

• 批准号: 2005001
• 负责人: Gary Steven Bignami
• 金额: $ 10万
• 依托单位: HAWAII BIOTECH, INC.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-01 至 1997-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2005001
• 关键词: antiviral antibody; bioengineering /biomedical engineering; communicable disease diagnosis; dengue; dengue virus; diagnosis design /evaluation; diagnostic tests; enzyme linked immunosorbent assay; genetic strain; human tissue; immunoglobulin G; immunoglobulin M; microorganism culture; permease; rapid diagnosis; recombinant proteins; virus antigen

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.

登革热是由蚊子传播的RNA病毒引起的。 一亿 世界范围内每年发生登革热病例，使登革热病毒成为 就全球发病率而言，最重要的虫媒病毒。 登革热可以 临床上表现出与其他发热性疾病相似的症状， 不是由蚊子传播的，比如麻疹。 能够迅速 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， 进行适当的患者管理。 在第一阶段的研究中，我们将生产 并在显微平板中评价新的重组登革抗原 用于检测病毒特异性IgG和IgM的免疫测定。的敏感性和 将比较基于重组抗原的测定的特异性， 常规的全病毒抗原制备， 四种登革病毒原发和继发感染的恢复期血清 血清型和日本脑炎。 重组体的能力 抗原与抗登革抗体形成复合物也将 在硝酸纤维素膜/乳胶颗粒夹心免疫测定中评价， 为了说明所选择的试剂和缀合物 以类似于半定量试纸测试的形式起作用， 在第二阶段进行开发和验证。 拟定商业应用： 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。 的 拟议的快速检测可以渗透到这个开发不足的市场， 取代了繁琐，耗时的技术， 登革热血清学诊断