Multiplexed POC Diagnostic System for Bio-Threat Agents

生物威胁因子多重 POC 诊断系统

• 批准号: 7009717
• 负责人: George B Sigal
• 金额: $ 430.96万
• 依托单位: MESO SCALE DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7009717
• 关键词: Bacillus anthracis; Brucella; Coxiella burnetii; Francisella tularensis; Venezuelan equine encephalitis virus; Yersinia pestis; animal tissue; biohazard detection; biomedical equipment development; bioterrorism /chemical warfare; botulinum toxins; clinical biomedical equipment; clinical research; communicable disease diagnosis; cooperative study; diagnosis design /evaluation; human tissue; influenzavirus A; influenzavirus B; portable biomedical equipment; rapid diagnosis; respiratory syncytial virus; ricin; serology /serodiagnosis; staphylococcal enterotoxin; vaccinia virus

DESCRIPTION (provided by applicant): The development of a Multiplexed Point-of-Care Diagnostic System (MPDS) for rapid diagnosis of patients exposed to biological threat agents is proposed. The system will perform multiplexed measurements to allow for simultaneous detection and identification of multiple agents in both liquid (e.g., blood) and swab samples. Additional capabilities will include multiplexed serological testing of blood for antibody responses to threat agents. The proposed MPDS will consist of two elements: low cost, disposable cartridges and a small portable instrument for reading of cartridges. The disposable, single-use cartridges will contain all reagents necessary to conduct the assays and will use electrochemiluminescent detection. Two cartridge designs are proposed: one to measure analytes in liquid samples, including whole blood and plasma, and another to extract and measure analytes collected on swabs. The cartridges will be automatically processed and analyzed on a compact, portable instrument, providing results in less than 15 minutes. Specific goals of the program include: (1) refinement of MSD's cartridge and cartridge reader designs and demonstration of pilot scale production of both cartridges and reader; (2) development of multiplexed serology and direct detection assays for 10 biothreat agents; (3) transfer of the assay panels to the pilot cartridges and reader; (4) optimization of the assays on the cartridge platform in real matrices; and (5) extensive evaluation of assay performance. On successful completion of the proposed program, the system and assays will be developed to a level where they can subsequently be entered into pre-clinical and clinical validation studies. The proposed test panel for both antigen and serological tests include the following ten threat agents: Bacillus anthracis (BA), Yersinia pestis (YP), Francisella tularensis (FT), Coxiella burnetii (Q Fever), Brucellosis ssp, vaccinia virus, Venezuelan Equine Encephalitis (VEE), botulinum toxin A, ricin, and Staphylococcal enterotoxin B (SEB). In addition to these targets, the panel developed for swab samples will include assays for influenza A, influenza B, and RSV to identify patients whose symptoms are due to common respiratory ailments. Relevance: There is an urgent need for diagnostic systems capable of identifying biological threat agents and the diseases they cause. The proposed diagnostic system will fill that gap by providing rapid point-of-care diagnostics with the reliability and performance of the centralized laboratory. The system will be able to quickly identify individuals exposed to biological threat agents or their toxins, differentiate those individuals infected with common non-threat upper respiratory disease, and allow retrospective serological diagnosis to assist in epidemiological studies. The system is designed to be used by personnel without specialized training and will require no pre-processing of samples.

描述（由申请人提供）：提出了用于快速诊断暴露于生物威胁剂的患者的多路复用点诊断系统（MPD）的开发。该系统将执行多路复用测量，以允许同时检测和鉴定液体（例如血液）和拭子样品中的多种药物。其他功能将包括对威胁剂的抗体反应的血血血清学测试。拟议的MPD将由两个要素组成：低成本，一次性墨盒和一种用于阅读墨盒的小型便携式仪器。一次性的一次性墨盒将包含进行测定所需的所有试剂，并将使用电化学发光检测。 提出了两种墨盒设计：一种用于测量液体样品中的分析物，包括全血和血浆，另一种用于提取和测量在拭子上收集的分析物。将在紧凑的便携式仪器上自动处理和分析墨盒，在不到15分钟的时间内提供结果。该计划的具体目标包括：（1）MSD的墨盒和墨盒读取器设计的完善以及墨盒和读取器的试验量表生产的演示； （2）开发10种生物治疗剂的多重血清学和直接检测试验； （3）将测定面板转移到飞行员墨盒和读取器； （4）用实际矩阵在墨盒平台上优化测定； （5）对测定性能的广泛评估。在成功完成拟议的计划后，该系统和测定将被开发到一个可以将其输入临床前和临床验证研究的水平。 The proposed test panel for both antigen and serological tests include the following ten threat agents: Bacillus anthracis (BA), Yersinia pestis (YP), Francisella tularensis (FT), Coxiella burnetii (Q Fever), Brucellosis ssp, vaccinia virus, Venezuelan Equine Encephalitis (VEE), botulinum toxin A, ricin和葡萄球菌肠毒素B（SEB）。除这些目标外，针对拭子样品开发的面板还将包括对流感，流感B和RSV的测定，以鉴定其症状是由于常见的呼吸疾病所致。相关性：迫切需要诊断系统能够识别生物威胁药及其引起的疾病。拟议的诊断系统将通过为集中实验室的可靠性和性能提供快速的护理诊断来填补这一空白。该系统将能够迅速识别暴露于生物威胁剂或其毒素的个体，使那些感染了常见的非威胁性上呼吸道疾病的人，并允许回顾性血清学诊断以协助流行病学研究。该系统旨在不受专门培训的人员使用，不需要预先处理样本。