Development Lateral Flow Assay

开发侧流分析

• 批准号: 7928388
• 负责人: Paul K. Olson
• 金额: $ 20万
• 依托单位: KYPHA, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7928388
• 关键词: Address; Age related macular degeneration; American; Area; Arthritis; Award; Bedside Testings; Biological Assay; Blood; Businesses; Clinic; Clinical; Clinical Trials; Complement; Complement 3; Complement Activation; Detection; Development; Diagnosis; Disease; Enzyme-Linked Immunosorbent Assay; Equipment; Goals; Hour; Human; Immune system; Immunoassay; Injury; Lateral; Marketing; Mediating; Membrane Proteins; Organ failure; Patients; Pharmacologic Substance; Play; Process; Reader; Reagent; Recovery; Research; Role; Running; Sampling; Serologic tests; Serological; Serum; Shipping; Ships; Shock; Site; Stroke; Technology; Testing; Time; Tissues; Trauma; Validation; arm; base; catalyst; complement system; cost; cost effective; cytokine; drug development; innovation; point of care; public health relevance; warm temperature

DESCRIPTION (provided by applicant): The goal of this project is to develop a lateral flow assay for detecting complement levels and complement activation status in a patient. This assay will give results in seconds versus either hours or days that normal complement lab assays have. It also will give more accurate results than conventional assays. The complement system is a group of more than 30 serum and membrane proteins that comprise an important effector arm of the innate immune system. However, complement can also damage host tissue, leading to its being termed a "double-edged sword." Complement plays a role in many, and diverse, diseases such as age- related macular degeneration (AMD), arthritis, stroke, trauma, and more. Altogether more than 30 million Americans suffer from complement-involved disorders. One problem facing detecting and treating these diseases are fast and reliable assays. For some indications such as trauma massive complement activation can occur within minutes of injury. This often proceeds a cytokine storm that can cause shock or organ failure. Knowing the cytokine storm is imminent allows preemptive treatment. In other cases the samples must be shipped for complement is very labile and does not store well at temperatures warmer than -80C. A lateral flow assay will allow immediate accurate results that are not available to most labs at present. PUBLIC HEALTH RELEVANCE: We intend to develop a point of care, lateral flow assay for the detection and quantification of complement component 3 and its metabolites. This is to address the variability of other assay formats caused by the duration of the assay, and the test article handling and storage.

描述（由申请方提供）：本项目的目标是开发一种用于检测患者补体水平和补体激活状态的侧流试验。该检测试剂盒将在几秒钟内给出结果，而正常补体实验室检测试剂盒的结果是几小时或几天。它也将提供比常规测定更准确的结果。补体系统是一组超过30种血清和膜蛋白，其构成先天免疫系统的重要效应臂。然而，补体也可以损害宿主组织，导致其被称为“双刃剑”。“补体在许多不同的疾病中发挥作用，如年龄相关性黄斑变性（AMD）、关节炎、中风、创伤等。总共有3000多万美国人患有补体相关疾病。检测和治疗这些疾病所面临的一个问题是快速和可靠的测定。对于某些适应症，如创伤，大量补体激活可在受伤后几分钟内发生。这通常会导致细胞因子风暴，导致休克或器官衰竭。知道细胞因子风暴即将来临，就可以进行先发制人的治疗。在其他情况下，样本必须运输，因为补体非常不稳定，在温度高于-80 ℃时不能很好地储存。侧流检测将允许目前大多数实验室无法获得的即时准确结果。 公共卫生关系：我们打算开发一种用于检测和定量补体成分3及其代谢物的即时检测、侧流测定。这是为了解决由试验持续时间以及供试品处理和储存引起的其他试验形式的变异性。