Rapid saliva antigen test for SARS-CoV-2 detection

用于检测 SARS-CoV-2 的快速唾液抗原检测

• 批准号: 10691588
• 负责人: MARK A ARONICA
• 金额: $ 43.4万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-05 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10691588
• 关键词: 2019-nCoV; Affect; Biological Assay; Bioluminescence; COVID-19 assay; COVID-19 detection; COVID-19 pandemic; Cessation of life; Clinical; Clinical Research; Complement; Complex; Coronavirus; Development; Engineering; Equipment; Escherichia coli; Event; Feasibility Studies; Financial cost; Freeze Drying; Goals; Health; Home; Hospitals; Laboratories; Loudness; Luciferases; Patients; Production; Proteins; Public Health; Saliva; Sampling; Schools; Sensitivity and Specificity; Sports; Structure; Technology; Testing; Virus Diseases; Woman; antigen test; base; burden of illness; clinical diagnostics; cost; cross reactivity; design; design verification; detection sensitivity; experience; microbial; novel coronavirus; pandemic disease; point of care testing; prototype; salivary assay; test strip; viral detection

Summary Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents a major health threat to hu- mankind. The SARS-CoV-2 pandemic is not only an enormous burden to public health but has already significantly affected the global economy. As of today, the novel coronavirus has caused over 596 million confirmed cases and 6.5 million deaths globally and the number continues to grow (https//coronavirus.jhu.edu). Here, we propose to develop a simple, rapid, and sensitive assay, which is based on the split luciferase complementation on the trimeric structure of spike proteins. The proposed technology takes advantage of the trimeric structure of the spikes to form the complex of two complementary luciferase fragments to simply generate a bright blue bioluminescence. In Aim 1 we will validate our test with clinical samples and perform cross reactivity, microbial interference and endogenous interfering substances studies. In Aim 2, we will focus on the strip and dark box optimization and design verification. Aim 2 will be accomplished with the help of Jeff Hall (BioActive labs LLC) who has all the necessary equipment and materials to complete a 2,000-3,500 strip and several dark box prototype productions.

总结 严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是人类健康的主要威胁， 人类SARS-CoV-2大流行不仅是公共卫生的巨大负担， 严重影响了全球经济。截至今天，新型冠状病毒已造成超过5.96亿人死亡， 全球确诊病例和650万例死亡，而且这一数字还在继续增长（https//coronavirus. jhu.edu）。 在这里，我们建议开发一种简单，快速，灵敏的检测，这是基于分裂荧光素酶 刺突蛋白的三聚体结构上的互补。所提出的技术利用 刺突的三聚体结构以形成两个互补荧光素酶片段的复合物， 产生明亮的蓝色生物荧光。 在目标1中，我们将使用临床样本验证我们的检测，并进行交叉反应性、微生物干扰和 内源性干扰物质研究。在目标2中，我们将专注于条带和黑盒优化， 设计验证目标2将在Jeff Hall（BioActive labs LLC）的帮助下完成，他拥有所有的 必要的设备和材料，以完成2000 - 3500条和几个暗箱原型 制作。